21 CFR 26.41 - Exchange and endorsement of quality system evaluation reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Exchange and endorsement of quality system... DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES... endorsement of quality system evaluation reports. (a) Listed European Community (EC) conformity assessment...

21 CFR 26.41 - Exchange and endorsement of quality system evaluation reports.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Exchange and endorsement of quality system... DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES... endorsement of quality system evaluation reports. (a) Listed European Community (EC) conformity assessment...

21 CFR 26.41 - Exchange and endorsement of quality system evaluation reports.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Exchange and endorsement of quality system... DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES... endorsement of quality system evaluation reports. (a) Listed European Community (EC) conformity assessment...

21 CFR 26.41 - Exchange and endorsement of quality system evaluation reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Exchange and endorsement of quality system... DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES... endorsement of quality system evaluation reports. (a) Listed European Community (EC) conformity assessment...

Accessibility of Mobile Devices for Visually Impaired Users: An Evaluation of the Screen-Reader VoiceOver.

PubMed

Smaradottir, Berglind; Håland, Jarle; Martinez, Santiago

2017-01-01

A mobile device's touchscreen allows users to use a choreography of hand gestures to interact with the user interface. A screen reader on a mobile device is designed to support the interaction of visually disabled users while using gestures. This paper presents an evaluation of VoiceOver, a screen reader in Apple Inc. products. The evaluation was a part of the research project "Visually impaired users touching the screen - a user evaluation of assistive technology".

21 CFR 26.35 - Length and purpose of transition period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN... bodies (CAB's) of the other party with respect to the ability to perform quality system and product...

Development and Evaluation of a Pyriproxyfen-treated Device to Control the Dengue Vector, Aedes aegypti (L.) (Diptera: Culicidae)

DTIC Science & Technology

2013-03-01

Jersey: John Wiley & Sons, 2011. Fradin MS, Day JF. Comparative efficacy of insect repellents against mosquito bites. N Engl J Med 2002; 347: 13-8...control of Aedes aegypti mosquitoes , the vectors of these diseases, critically important. We developed and evaluated an Ae. aegypti control device...that is visually-attractive to mosquitoes . This pyriproxyfen-treated device was evaluated for its impact on Ae. aegypti egg production and population

76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee. April 18, October 18...- 15. CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Analgesic Drugs Advisory February 9...-6. Ophthalmic Devices Panel November 8-9. Orthopedic and Rehabilitation Devices September 13-14...

21 CFR 26.33 - Product coverage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... this subpart each covering a discrete range of products: (1) Quality System Evaluations. U.S.-type... system evaluation reports will be exchanged with regard to all products regulated under both U.S. and EC...

21 CFR 26.45 - Monitoring continued equivalence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.74 - Preservation of regulatory authority.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.75 - Suspension of recognition obligations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.78 - Agreements with other countries.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.66 - Designation and listing procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

Applying health economics for policy decision making: do devices differ from drugs?

PubMed

Sorenson, Corinna; Tarricone, Rosanna; Siebert, Markus; Drummond, Michael

2011-05-01

Medical devices pose unique challenges for economic evaluation and associated decision-making processes that differ from pharmaceuticals. We highlight and discuss these challenges in the context of cardiac device therapy, based on a systematic review of relevant economic evaluations. Key challenges include practical difficulties in conducting randomized clinical trials, allowing for a 'learning curve' and user characteristics, accounting for the wider organizational impacts of introducing new devices, and allowing for variations in product characteristics and prices over time.

21 CFR Appendices C-F to Subpart B... - [Reserved

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.19 - Information relating to quality aspects.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.41 - Exchange and endorsement of quality system evaluation reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES...; (2) Abbreviated reports of quality systems surveillance audits. (c) If the abbreviated reports do not... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exchange and endorsement of quality system...

21 CFR 26.12 - Nature of recognition of inspection reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.67 - Suspension of listed conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

21 CFR 26.68 - Withdrawal of listed conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

21 CFR Appendix B to Subpart A of... - List of Authorities

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

21 CFR 26.47 - Role and composition of the Joint Sectoral Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

A manufacturer's perspective: Hewlett Packard Y2K action plan.

PubMed

Rapp, W N

1999-01-01

Medical device manufacturers must ensure that their devices are safe and effective including investigating issues involved with the century rollover. Manufacturers must begin early to evaluate their products in order to allow time to correct and distribute these product corrections and communicate to their customers so they can prepare for the Y2K event.

Lifetime evaluation of large format CMOS mixed signal infrared devices

NASA Astrophysics Data System (ADS)

Linder, A.; Glines, Eddie

2015-09-01

New large scale foundry processes continue to produce reliable products. These new large scale devices continue to use industry best practice to screen for failure mechanisms and validate their long lifetime. The Failure-in-Time analysis in conjunction with foundry qualification information can be used to evaluate large format device lifetimes. This analysis is a helpful tool when zero failure life tests are typical. The reliability of the device is estimated by applying the failure rate to the use conditions. JEDEC publications continue to be the industry accepted methods.

Residual Isocyanates in Medical Devices and Products: A Qualitative and Quantitative Assessment

PubMed Central

Franklin, Gillian; Harari, Homero; Ahsan, Samavi; Bello, Dhimiter; Sterling, David A.; Nedrelow, Jonathan; Raynaud, Scott; Biswas, Swati; Liu, Youcheng

2016-01-01

We conducted a pilot qualitative and quantitative assessment of residual isocyanates and their potential initial exposures in neonates, as little is known about their contact effect. After a neonatal intensive care unit (NICU) stockroom inventory, polyurethane (PU) and PU foam (PUF) devices and products were qualitatively evaluated for residual isocyanates using Surface SWYPE™. Those containing isocyanates were quantitatively tested for methylene diphenyl diisocyanate (MDI) species, using UPLC-UV-MS/MS method. Ten of 37 products and devices tested, indicated both free and bound residual surface isocyanates; PU/PUF pieces contained aromatic isocyanates; one product contained aliphatic isocyanates. Overall, quantified mean MDI concentrations were low (4,4′-MDI = 0.52 to 140.1 pg/mg) and (2,4′-MDI = 0.01 to 4.48 pg/mg). The 4,4′-MDI species had the highest measured concentration (280 pg/mg). Commonly used medical devices/products contain low, but measurable concentrations of residual isocyanates. Quantifying other isocyanate species and neonatal skin exposure to isocyanates from these devices and products requires further investigation. PMID:27773989

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

PubMed

1998-05-18

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

Mail-Order Microfluidics: Evaluation of Stereolithography for the Production of Microfluidic Devices

PubMed Central

Au, Anthony K.; Lee, Wonjae; Folch, Albert

2015-01-01

The vast majority of microfluidic devices are developed in PDMS by molding (“soft lithography”) because PDMS is an inexpensive material, has physicochemical properties that are well suited for biomedical and physical sciences applications, and design cycle lengths are generally adequate for prototype development. However, PDMS molding is tediously slow and thus cannot provide the high- or medium-volume production required for the commercialization of devices. While high-throughput plastic molding techniques (e.g. injection molding) exist, the exorbitant cost of the molds and/or the equipment can be a serious obstacle for device commercialization, especially for small startups. High-volume production is not required to reach niche markets such as clinical trials, biomedical research supplies, customized research equipment, and classroom projects. Crucially, both PDMS and plastic molding are layer-by-layer techniques where each layer is produced as a result of physicochemical processes not specified in the initial photomask(s) and where the final device requires assembly by bonding, all resulting in a cost that is very hard to predict at the start of the project. By contrast, stereolithography (SL) is an automated fabrication technique that allows for the production of quasi-arbitrary 3D shapes in a single polymeric material at medium-volume throughputs (ranging from a single part to hundreds of parts). Importantly, SL devices can be designed between several groups using CAD tools, conveniently ordered by mail, and their cost precisely predicted via a web interface. Here we evaluate the resolution of an SL mail-order service and the main causes of resolution loss; the optical clarity of the devices and how to address the lack of clarity for imaging in the channels; and the future role that SL could play in the commercialization of microfluidic devices. PMID:24510161

Mail-order microfluidics: evaluation of stereolithography for the production of microfluidic devices.

PubMed

Au, Anthony K; Lee, Wonjae; Folch, Albert

2014-04-07

The vast majority of microfluidic devices are developed in PDMS by molding ("soft lithography") because PDMS is an inexpensive material, has physicochemical properties that are well suited for biomedical and physical sciences applications, and design cycle lengths are generally adequate for prototype development. However, PDMS molding is tediously slow and thus cannot provide the high- or medium-volume production required for the commercialization of devices. While high-throughput plastic molding techniques (e.g. injection molding) exist, the exorbitant cost of the molds and/or the equipment can be a serious obstacle for device commercialization, especially for small startups. High-volume production is not required to reach niche markets such as clinical trials, biomedical research supplies, customized research equipment, and classroom projects. Crucially, both PDMS and plastic molding are layer-by-layer techniques where each layer is produced as a result of physicochemical processes not specified in the initial photomask(s) and where the final device requires assembly by bonding, all resulting in a cost that is very hard to predict at the start of the project. By contrast, stereolithography (SL) is an automated fabrication technique that allows for the production of quasi-arbitrary 3D shapes in a single polymeric material at medium-volume throughputs (ranging from a single part to hundreds of parts). Importantly, SL devices can be designed between several groups using CAD tools, conveniently ordered by mail, and their cost precisely predicted via a web interface. Here we evaluate the resolution of an SL mail-order service and the main causes of resolution loss; the optical clarity of the devices and how to address the lack of clarity for imaging in the channels; and the future role that SL could play in the commercialization of microfluidic devices.

21 CFR 26.39 - Equivalence assessment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... perform any type of quality system or product evaluation covered by this subpart and with regard to any... any type of quality system or product evaluation. (b) The parties shall allow CAB's not listed for...

Value-based purchasing of medical devices.

PubMed

Obremskey, William T; Dail, Teresa; Jahangir, A Alex

2012-04-01

Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.

Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration

DTIC Science & Technology

2014-10-01

Evaluation Research (CDER), the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health ( CDRH ) to clarify...submitting a new application to the CDRH for a new product. This new product is the material that is produced in the validated manufacturing facility

New decision-making processes for the pricing of health technologies in Japan: The FY 2016/2017 pilot phase for the introduction of economic evaluations.

PubMed

Shiroiwa, Takeru; Fukuda, Takashi; Ikeda, Shunya; Takura, Tomoyuki

2017-08-01

Economic evaluation is used for decision-making processes in healthcare technologies in many developed countries. In Japan, no health economic data have been requested for drugs, medical devices, and interventions till date. However, economic evaluation is gradually gaining importance, and a trial implementation of the cost-effectiveness evaluation of drugs and medical devices has begun. Discussions on economic evaluation began in May 2012 within a newly established sub-committee of the Chuikyo, referred to as the "Special Committee on Cost Effectiveness." After four years of discussions, this committee determined that during the trial implementation, the results of the cost-effectiveness evaluation would be used for the re-pricing of drugs and medical devices at the end of fiscal year (FY) 2017. Chuikyo selected 13 products (7 drugs and 6 medical devices) as targets for this evaluation. These products will be evaluated until the end of FY 2017 based on the following process: manufacturers will submit the data of economic evaluation; the National Institute of Public Health will coordinate the review process; academic groups will perform the actual review of the submitted data, and the expert committee will appraise these data. This represents the first step to introducing cost-effectiveness analysis in the Japanese healthcare system. We believe that these efforts will contribute to the efficiency and sustainability of the Japanese healthcare system. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

The Difficult Airway Society 'ADEPT' guidance on selecting airway devices: the basis of a strategy for equipment evaluation.

PubMed

Pandit, J J; Popat, M T; Cook, T M; Wilkes, A R; Groom, P; Cooke, H; Kapila, A; O'Sullivan, E

2011-08-01

Faced with the concern that an increasing number of airway management devices were being introduced into clinical practice with little or no prior evidence of their clinical efficacy or safety, the Difficult Airway Society formed a working party (Airway Device Evaluation Project Team) to establish a process by which the airway management community within the profession could itself lead a process of formal device/equipment evaluation. Although there are several national and international regulations governing which products can come on to the market and be legitimately sold, there has hitherto been no formal professional guidance relating to how products should be selected (i.e. purchased). The Airway Device Evaluation Project Team's first task was to formulate such advice, emphasising evidence-based principles. Team discussions led to a definition of the minimum level of evidence needed to make a pragmatic decision about the purchase or selection of an airway device. The Team concluded that this definition should form the basis of a professional standard, guiding those with responsibility for selecting airway devices. We describe how widespread adoption of this professional standard can act as a driver to create an infrastructure in which the required evidence can be obtained. Essential elements are that: (i) the Difficult Airway Society facilitates a coherent national network of research-active units; and (ii) individual anaesthetists in hospital trusts play a more active role in local purchasing decisions, applying the relevant evidence and communicating their purchasing decisions to the Difficult Airway Society. © 2011 The Authors. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland.

A Performance Evaluation of a Lean Reparable Pipeline in Various Demand Environments

DTIC Science & Technology

2004-03-23

of defects (Dennis, 2002:90). Shingo espoused the true goal should be zero defects and to this end, invented the poka - yoke , or a simple, inexpensive...92). Despite the inability to eliminate human errors, poka - yoke devices can still enable the elimination of production defects (Dennis, 2002:91... Poka - yoke devices are essentially foolproofing mechanisms which incorporate automatic inspection into the production process. Despite the fact

[Supervision, administration and standard research related to tissue engineered medical products].

PubMed

Xi, Ting-fei; Chen, Liang; Zhao, Peng

2003-11-01

Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical & Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).

Implementing AORN recommended practices for product selection.

PubMed

Conrardy, Julie A

2012-06-01

This article focuses on the revised AORN "Recommended practices for product selection in perioperative practice settings." Hospitals and ambulatory surgery facilities should have protocols in place for product evaluation that includes a multidisciplinary team approach. The process for product evaluation and selection includes gathering information; establishing consistent requirements for product evaluation; performing a financial impact analysis; investigating a plan to standardize products; conducting an environmental impact analysis; determining whether to purchase single-use, reposable, or reusable products or reprocess single-use devices; developing an evaluation process based on objective criteria; and developing and implementing a comprehensive plan to introduce and use new products. Use of an evaluation tool that is based on objective criteria is one way to obtain valuable input during product evaluations. Because of varied roles and experiences, the perioperative RN is an integral member of the product selection committee. Published by Elsevier Inc.

21 CFR 26.42 - Exchange and endorsement of product evaluation reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exchange and endorsement of product evaluation reports. 26.42 Section 26.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturer's choice, type examination, and verification reports prepared to EC medical device requirements...

21 CFR 26.69 - Monitoring of conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN... cause to maintain, ongoing surveillance over their CAB's by means of regular audit or assessment; (b...

Ultrasound detection of cavitation as a phenomenon common to intervention devices causing tissue ablation

NASA Astrophysics Data System (ADS)

Bach, David S.; Armstrong, William F.; Erbel, Raimund; Ellis, Stephen G.; Sousa, Joao; Rosenschein, Uri

1992-08-01

Cavitation previously has been observed in association with ultrasonic angioplasty and high- frequency rotational atherectomy. This study evaluates the production of cavitation accompanying the use of several catheter-based devices under development or in current use in the practice of interventional cardiology. Catheters were examined in an in vitro model, and cavitation was evaluated using standard ultrasound imaging equipment. Cavitation was detected with each of the devices that effects tissue ablation, but not tissue resection. Devices produced characteristic patterns of cavitation dependent on the mode of energy release of the device. The size, but not the intensity, of the cavitation effect was proportional to the energy output of the devices. The precise role of cavitation in the mechanism of tissue ablation remains uncertain.

Claims in vapour device (e-cigarette) regulation: A Narrative Policy Framework analysis.

PubMed

O'Leary, Renée; Borland, Ron; Stockwell, Tim; MacDonald, Marjorie

2017-06-01

The electronic cigarette or e-cigarette (vapour device) is a consumer product undergoing rapid growth, and governments have been adopting regulations on the sale of the devices and their nicotine liquids. Competing claims about vapour devices have ignited a contentious debate in the public health community. What claims have been taken up in the state arena, and how have they possibly influenced regulatory outcomes? This study utilized Narrative Policy Framework to analyze the claims made about vapour devices in legislation recommendation reports from Queensland Australia, Canada, and the European Union, and the 2016 deeming rule legislation from the United States, and examined the claims and the regulatory outcomes in these jurisdictions. The vast majority of claims in the policy documents represented vapour devices as a threat: an unsafe product harming the health of vapour device users, a gateway product promoting youth tobacco uptake, and a quasi-tobacco product impeding tobacco control. The opportunity for vapour devices to promote cessation or reduce exposure to toxins was very rarely presented, and these positive claims were not discussed at all in two of the four documents studied. The dominant claims of vapour devices as a public health threat have supported regulations that have limited their potential as a harm reduction strategy. Future policy debates should evaluate the opportunities for vapour devices to decrease the health and social burdens of the tobacco epidemic. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 26.13 - Transmission of postapproval inspection reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Transmission of postapproval inspection reports...

21 CFR 26.14 - Transmission of preapproval inspection reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Transmission of preapproval inspection reports. 26...

21 CFR 26.78 - Agreements with other countries.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Agreements with other countries. 26.78 Section 26... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN...

Cost minimization analysis of different growth hormone pen devices based on time-and-motion simulations

PubMed Central

2010-01-01

Background Numerous pen devices are available to administer recombinant Human Growth Hormone (rhGH), and both patients and health plans have varying issues to consider when selecting a particular product and device for daily use. Therefore, the present study utilized multi-dimensional product analysis to assess potential time involvement, required weekly administration steps, and utilization costs relative to daily rhGH administration. Methods Study objectives were to conduct 1) Time-and-Motion (TM) simulations in a randomized block design that allowed time and steps comparisons related to rhGH preparation, administration and storage, and 2) a Cost Minimization Analysis (CMA) relative to opportunity and supply costs. Nurses naïve to rhGH administration and devices were recruited to evaluate four rhGH pen devices (2 in liquid form, 2 requiring reconstitution) via TM simulations. Five videotaped and timed trials for each product were evaluated based on: 1) Learning (initial use instructions), 2) Preparation (arrange device for use), 3) Administration (actual simulation manikin injection), and 4) Storage (maintain product viability between doses), in addition to assessment of steps required for weekly use. The CMA applied micro-costing techniques related to opportunity costs for caregivers (categorized as wages), non-drug medical supplies, and drug product costs. Results Norditropin® NordiFlex and Norditropin® NordiPen (NNF and NNP, Novo Nordisk, Inc., Bagsværd, Denmark) took less weekly Total Time (p < 0.05) to use than either of the comparator products, Genotropin® Pen (GTP, Pfizer, Inc, New York, New York) or HumatroPen® (HTP, Eli Lilly and Company, Indianapolis, Indiana). Time savings were directly related to differences in new package Preparation times (NNF (1.35 minutes), NNP (2.48 minutes) GTP (4.11 minutes), HTP (8.64 minutes), p < 0.05)). Administration and Storage times were not statistically different. NNF (15.8 minutes) and NNP (16.2 minutes) also took less time to Learn than HTP (24.0 minutes) and GTP (26.0 minutes), p < 0.05). The number of weekly required administration steps was also least with NNF and NNP. Opportunity cost savings were greater in devices that were easier to prepare for use; GTP represented an 11.8% drug product savings over NNF, NNP and HTP at time of study. Overall supply costs represented <1% of drug costs for all devices. Conclusions Time-and-motion simulation data used to support a micro-cost analysis demonstrated that the pen device with the greater time demand has highest net costs. PMID:20377905

Cost minimization analysis of different growth hormone pen devices based on time-and-motion simulations.

PubMed

Nickman, Nancy A; Haak, Sandra W; Kim, Jaewhan

2010-04-08

Numerous pen devices are available to administer recombinant Human Growth Hormone (rhGH), and both patients and health plans have varying issues to consider when selecting a particular product and device for daily use. Therefore, the present study utilized multi-dimensional product analysis to assess potential time involvement, required weekly administration steps, and utilization costs relative to daily rhGH administration. Study objectives were to conduct 1) Time-and-Motion (TM) simulations in a randomized block design that allowed time and steps comparisons related to rhGH preparation, administration and storage, and 2) a Cost Minimization Analysis (CMA) relative to opportunity and supply costs. Nurses naïve to rhGH administration and devices were recruited to evaluate four rhGH pen devices (2 in liquid form, 2 requiring reconstitution) via TM simulations. Five videotaped and timed trials for each product were evaluated based on: 1) Learning (initial use instructions), 2) Preparation (arrange device for use), 3) Administration (actual simulation manikin injection), and 4) Storage (maintain product viability between doses), in addition to assessment of steps required for weekly use. The CMA applied micro-costing techniques related to opportunity costs for caregivers (categorized as wages), non-drug medical supplies, and drug product costs. Norditropin(R) NordiFlex and Norditropin(R) NordiPen (NNF and NNP, Novo Nordisk, Inc., Bagsvaerd, Denmark) took less weekly Total Time (p < 0.05) to use than either of the comparator products, Genotropin(R) Pen (GTP, Pfizer, Inc, New York, New York) or HumatroPen(R) (HTP, Eli Lilly and Company, Indianapolis, Indiana). Time savings were directly related to differences in new package Preparation times (NNF (1.35 minutes), NNP (2.48 minutes) GTP (4.11 minutes), HTP (8.64 minutes), p < 0.05)). Administration and Storage times were not statistically different. NNF (15.8 minutes) and NNP (16.2 minutes) also took less time to Learn than HTP (24.0 minutes) and GTP (26.0 minutes), p < 0.05). The number of weekly required administration steps was also least with NNF and NNP. Opportunity cost savings were greater in devices that were easier to prepare for use; GTP represented an 11.8% drug product savings over NNF, NNP and HTP at time of study. Overall supply costs represented <1% of drug costs for all devices. Time-and-motion simulation data used to support a micro-cost analysis demonstrated that the pen device with the greater time demand has highest net costs.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Evaluation of the econo-mist device

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The Emission Control Technology Division (ECTD) was contacted by the General Services Administration (GSA) concerning a vapor injection device for use with automobile engines. The device is called the Econo-Mist and is a product of the FAP Corporation of Albuquerque, New Mexico. GSA had received information that the Econo-Mist reduced hydrocarbon and carbon monoxide emissions and increased fuel economy. At the request of GSA, ECTD agreed to test the device. A sample of the device was brought to the EPA laboratory in Ann Arbor, Michigan by FAP Corporation personnel on January 13, 1975.

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Specific requirements for approval. 23.7...

30 CFR 23.7 - Specific requirements for approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.7 Specific requirements for... apply. (g) Line powered telephones and signaling devices or systems shall be equipped with standby power... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Specific requirements for approval. 23.7...

30 CFR 18.28 - Devices for pressure relief, ventilation, or drainage.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Devices for pressure relief, ventilation, or drainage. 18.28 Section 18.28 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES...

Improving the light-emitting properties of single-layered polyfluorene light-emitting devices by simple ionic liquid blending

NASA Astrophysics Data System (ADS)

Horike, Shohei; Nagaki, Hiroto; Misaki, Masahiro; Koshiba, Yasuko; Morimoto, Masahiro; Fukushima, Tatsuya; Ishida, Kenji

2018-03-01

This paper describes an evaluation of ionic liquids (ILs) as potential electrolytes for single-layered light-emitting devices with good emission performance. As optoelectronic devices continue to grow in abundance, high-performance light-emitting devices with a single emission layer are becoming increasingly important for low-cost production. We show that a simple technique of osmosing IL into the polymer layer can result in high luminous efficiency and good response times of single-layered light-emitting polymers, even without the additional stacking of charge carrier injection and transport layers. The IL contributions to the light-emission of the polymer are discussed from the perspectives of energy diagrams and of the electric double layers on the electrodes. Our findings enable a faster, cheaper, and lower-in-waste production of light-emitting devices.

Triplet-triplet annihilation photon-upconversion: towards solar energy applications.

PubMed

Gray, Victor; Dzebo, Damir; Abrahamsson, Maria; Albinsson, Bo; Moth-Poulsen, Kasper

2014-06-14

Solar power production and solar energy storage are important research areas for development of technologies that can facilitate a transition to a future society independent of fossil fuel based energy sources. Devices for direct conversion of solar photons suffer from poor efficiencies due to spectrum losses, which are caused by energy mismatch between the optical absorption of the devices and the broadband irradiation provided by the sun. In this context, photon-upconversion technologies are becoming increasingly interesting since they might offer an efficient way of converting low energy solar energy photons into higher energy photons, ideal for solar power production and solar energy storage. This perspective discusses recent progress in triplet-triplet annihilation (TTA) photon-upconversion systems and devices for solar energy applications. Furthermore, challenges with evaluation of the efficiency of TTA-photon-upconversion systems are discussed and a general approach for evaluation and comparison of existing systems is suggested.

Manufacture and evaluation of 3-dimensional printed sizing tools for use during intraoperative breast brachytherapy.

PubMed

Walker, Joshua M; Elliott, David A; Kubicky, Charlotte D; Thomas, Charles R; Naik, Arpana M

2016-01-01

Three-dimensional (3D) printing has emerged as a promising modality for the production of medical devices. Here we describe the design, production, and implementation of a series of sizing tools for use in an intraoperative breast brachytherapy program. These devices were produced using a commercially available low-cost 3D printer and software, and their implementation resulted in an immediate decrease in consumable costs without affecting the quality of care or the speed of delivery. This work illustrates the potential of 3D printing to revolutionize the field of medical devices, enabling physicians to rapidly develop and prototype novel tools.

Touch the Page and Mimic Me: Evaluation of a Talking-Pen Learning Tool

ERIC Educational Resources Information Center

Odakura, Abigail

2013-01-01

The purpose of this paper is to evaluate the talking-pen device called the Mimic Me, an educational technology product of a large English conversation school in Japan, as an educational learning tool. The product will be reviewed in terms of its developmental appropriateness for the target audience based on current research. Although the Mimic Me…

Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.

PubMed

Markovic, Ingrid

2007-09-01

Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.

Improved infra-red procedure for the evaluation of calibrating units.

DOT National Transportation Integrated Search

2011-01-04

Introduction. The NHTSA Model Specifications for Calibrating Units for Breath : Alcohol Testers (FR 72 34742-34748) requires that calibration units submitted for : inclusion on the NHTSA Conforming Products List for such devices be evaluated using : ...

Integrating health economics modeling in the product development cycle of medical devices: a Bayesian approach.

PubMed

Vallejo-Torres, Laura; Steuten, Lotte M G; Buxton, Martin J; Girling, Alan J; Lilford, Richard J; Young, Terry

2008-01-01

Medical device companies are under growing pressure to provide health-economic evaluations of their products. Cost-effectiveness analyses are commonly undertaken as a one-off exercise at the late stage of development of new technologies; however, the benefits of an iterative use of economic evaluation during the development process of new products have been acknowledged in the literature. Furthermore, the use of Bayesian methods within health technology assessment has been shown to be of particular value in the dynamic framework of technology appraisal when new information becomes available in the life cycle of technologies. In this study, we set out a methodology to adapt these methods for their application to directly support investment decisions in a commercial setting from early stages of the development of new medical devices. Starting with relatively simple analysis from the very early development phase and proceeding to greater depth of analysis at later stages, a Bayesian approach facilitates the incorporation of all available evidence and would help companies to make better informed choices at each decision point.

Demystifying the U.S. Food and Drug Administration: I. Understanding agency structure and function.

PubMed

Levi, Benjamin; Lisiecki, Jeffrey; Rubin, Peter; D'Amico, Richard A; Hume, Keith M; Seward, Bill; Cederna, Paul S

2014-06-01

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Early decision-analytic modeling - a case study on vascular closure devices.

PubMed

Brandes, Alina; Sinner, Moritz F; Kääb, Stefan; Rogowski, Wolf H

2015-10-27

As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing. The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied. Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization. It was partially feasible to calculate value-based prices for the novel closure device which can be used to inform product design. However, modifying the care pathway may generate much more value from the payers' perspective than modifying the device per se. Manufacturers should thus explore the feasibility of combining reimbursement of their product with arrangements that make same-day discharge attractive also for hospitals. Due to the early nature of the product, the results are afflicted with substantial uncertainty.

Standardization of skin cleansing in vivo: part I. Development of an Automated Cleansing Device (ACiD).

PubMed

Sonsmann, F K; Strunk, M; Gediga, K; John, C; Schliemann, S; Seyfarth, F; Elsner, P; Diepgen, T L; Kutz, G; John, S M

2014-05-01

To date, there are no legally binding requirements concerning product testing in cosmetics. This leads to various manufacturer-specific test methods and absent transparent information on skin cleansing products. A standardized in vivo test procedure for assessment of cleansing efficacy and corresponding barrier impairment by the cleaning process is needed, especially in the occupational context where repeated hand washing procedures may be performed at short intervals. For the standardization of the cleansing procedure, an Automated Cleansing Device (ACiD) was designed and evaluated. Different smooth washing surfaces of the equipment for ACiD (incl. goat hair, felt, felt covered with nitrile caps) were evaluated regarding their skin compatibility. ACiD allows an automated, fully standardized skin washing procedure. Felt covered with nitrile as washing surface of the rotating washing units leads to a homogenous cleansing result and does not cause detectable skin irritation, neither clinically nor as assessed by skin bioengineering methods (transepidermal water loss, chromametry). Automated Cleansing Device may be useful for standardized evaluation of the cleansing effectiveness and parallel assessment of the corresponding irritancy potential of industrial skin cleansers. This will allow objectifying efficacy and safety of industrial skin cleansers, thus enabling market transparency and facilitating rational choice of products. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

PubMed

Renisch, B; Lauer, W

2014-12-01

An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

21 CFR 26.50 - Alert system and exchange of postmarket vigilance reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.50 Alert system and exchange of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Alert system and exchange of postmarket vigilance...

The Effects of Mobile-Computer-Supported Collaborative Learning: Meta-Analysis and Critical Synthesis

ERIC Educational Resources Information Center

Sung, Yao-Ting; Yang, Je-Ming; Lee, Han-Yueh

2017-01-01

One of the trends in collaborative learning is using mobile devices for supporting the process and products of collaboration, which has been forming the field of mobile-computer-supported collaborative learning (mCSCL). Although mobile devices have become valuable collaborative learning tools, evaluative evidence for their substantial…

Waste Disposal in the 21st Century and Diabetes Technology: A Little Coffee (Cup) or Beer (Can) with That Insulin Infusion (Set)

PubMed Central

Krisiunas, Ed

2011-01-01

The advent of single-use disposable syringes along with myriad similar products for the health care industry has raised interest in the impact of these devices on the environment. Interest does not stop at impact of the device, but also includes associated pharmaceutical agents. Across the spectrum of health care, providers as well as end users of products are assessing the impact of product design and contents upon land, air, and water. In this issue of Journal of Diabetes Science and Technology, Pfützner and colleagues tackle the issue by focusing on a product for the diabetes patient. As environmental sustainability has become part of the evaluation process of many products, their assessment sheds some interesting light on the impact of a group of devices when compared and contrasted against the ever-popular disposable coffee cup or beer/soda aluminum can. Regional variations in waste disposal practices need to be understood when conducting these types of assessments. PMID:21880225

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Establishment registration and product listing for human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in...

Using off-the-shelf medical devices for biomedical signal monitoring in a telemedicine system for emergency medical services.

PubMed

Thelen, Sebastian; Czaplik, Michael; Meisen, Philipp; Schilberg, Daniel; Jeschke, Sabina

2015-01-01

In order to study new methods of telemedicine usage in the context of emergency medical services, researchers need to prototype integrated telemedicine systems. To conduct a one-year trial phase-intended to study a new application of telemedicine in German emergency medical services-we used off-the-shelf medical devices and software to realize real-time patient monitoring within an integrated telemedicine system prototype. We demonstrate its feasibility by presenting the integrated real-time patient monitoring solution, by studying signal delay and transmission robustness regarding changing communication channel characteristics, and by evaluating issues reported by the physicians during the trial phase. Where standards like HL7 and the IEEE 11073 family are intended to enable interoperability of product grade medical devices, we show that research prototypes benefit from the use of web technologies and simple device interfaces, as they simplify product development for a manufacturer and ease integration efforts for research teams. Embracing this approach for the development of new medical devices eases the constraint to use off-the-shelf products for research trials investigating innovative use of telemedicine.

Impacts of mobile tablet computing on provider productivity, communications, and the process of care.

PubMed

Schooley, Benjamin; Walczak, Steven; Hikmet, Neset; Patel, Nitin

2016-04-01

Health information technology investments continue to increase while the value derived from their implementation and use is mixed. Mobile device adoption into practice is a recent trend that has increased dramatically and formal studies are needed to investigate consequent benefits and challenges. The objective of this study is to evaluate practitioner perceptions of improvements in productivity, provider-patient communications, care provision, technology usability and other outcomes following the adoption and use of a tablet computer connected to electronic health information resources. A pilot program was initiated in June 2013 to evaluate the effect of mobile tablet computers at one health provider organization in the southeast United States. Providers were asked to volunteer for the evaluation and were each given a mobile tablet computer. A total of 42 inpatient and outpatient providers were interviewed in 2015 using a survey style questionnaire that utilized yes/no, Likert-style, and open ended questions. Each had previously used an electronic health record (EHR) system a minimum of one year outside of residency, and were regular users of personal mobile devices. Each used a mobile tablet computer in the context of their practice connected to the health system EHR. The survey results indicate that more than half of providers perceive the use of the tablet device as having a positive effect on patient communications, patient education, patient's perception of the provider, time spent interacting with patients, provider productivity, process of care, satisfaction with EHR when used together with the device, and care provision. Providers also reported feeling comfortable using the device (82.9%), would recommend the device to colleagues (69.2%), did not experience increased information security and privacy concerns (95%), and noted significant reductions in EHR login times (64.1%). Less than 25% of participants reported negative impacts on any of these areas as well as on time spent on order submission, note completion time, overall workload, patient satisfaction with care experience and patient outcomes. Gender, number of years in practice, practice type (general practitioner vs. specialist), and service type (inpatient/outpatient) were found to have a significant effect on perceptions of patient satisfaction, care process, and provider productivity. Providers found positive gains from utilizing mobile devices in overall productivity, improved communications with their patients, the process of care, and technology efficiencies when used in combination with EHR and other health information resources. Demographic and health care work environment play a role in how mobile technologies are integrated into practice by providers. Copyright © 2016. Published by Elsevier Ireland Ltd.

Early-stage valuation of medical devices: the role of developmental uncertainty.

PubMed

Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard

2010-08-01

At the concept stage, many uncertainties surround the commercial viability of a new medical device. These include the ultimate functionality of the device, the cost of producing it and whether, and at what price, it can be sold to a health-care provider (HCP). Simple assessments of value can be made by estimating such unknowns, but the levels of uncertainty may mean that their operational value for investment decisions is unclear. However, many decisions taken at the concept stage are reversible and will be reconsidered later before the product is brought to market. This flexibility can be exploited to enhance early-stage valuations. To develop a framework for valuing a new medical device at the concept stage that balances benefit to the HCP against commercial costs. This is done within a simplified stage-gated model of the development cycle for new products. The approach is intended to complement existing proposals for the evaluation of the commercial headroom available to new medical products. A model based on two decision gates can lead to lower bounds (underestimates) for product value that can serve to support a decision to develop the product. Quantifiable uncertainty that can be resolved before the device is brought to market will generally enhance early-stage valuations of the device, and this remains true even when some components of uncertainty cannot be fully described. Clinical trials and other evidence-gathering activities undertaken as part of the development process can contribute to early-stage estimates of value.

Fabrication and Performance of Large Format Transition Edge Sensor Microcalorimeter Arrays

NASA Technical Reports Server (NTRS)

Chervenak, James A.; Adams, James S.; Bandler, Simon R.; Busch, Sara E.; Eckart, M. E.; Ewin, A. E.; Finkbeiner, F. M.; Kilbourne, C. A.; Kelley, R. L.; Porst, Jan-Patrick;

Design and implementation of a portal for the medical equipment market: MEDICOM.

PubMed

Palamas, S; Kalivas, D; Panou-Diamandi, O; Zeelenberg, C; van Nimwegen, C

2001-01-01

The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers Web sites with itself. The network of the Portal and the connected manufacturers sites is called the MEDICOM system. To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system s databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM s functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support.

Design and Implementation of a Portal for the Medical Equipment Market: MEDICOM

PubMed Central

Kalivas, Dimitris; Panou-Diamandi, Ourania; Zeelenberg, Cees; van Nimwegen, Chris

2001-01-01

Background The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers' Web sites with itself. The network of the Portal and the connected manufacturers' sites is called the MEDICOM system. Objective To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). Methods The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers' servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system's databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers' servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM's functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. Results The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. Conclusions The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support. PMID:11772547

75 FR 7568 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... methods and testing devices. In order to better identify and evaluate the risks of product- related incidents, the Commission staff seeks to solicit consumer opinions and perceptions related to consumer... experiences, opinions and/or perceptions on the use or pattern of use of a specific product or type of product...

Testing and characterizations of infrared sensor over the temperature range of 2 Kelvin to 300 Kelvin

NASA Technical Reports Server (NTRS)

Hansen, R. G.

1983-01-01

Various cryogenic techniques were used to evaluate state of the art electro-optic devices. As research, development, and production demands require more sensitive testing techniques, faster test results, and higher production throughput, the emphasis on supporting cryogenic systems increases. The three traditional methods currently utilized in electro-optic device testing are discussed: (1) liquid contaiment dewars; (2) liquid transfer systems; and (3) closed cycle refrigeration systems. Advantages, disadvantages, and the current state of the art of each of these cryogenic techniques is discussed.

Manufacturer evaluations of endograft modifications.

PubMed

Waninger, Matthew S; Whirley, Robert G; Smith, Louis J; Wolf, Ben S

2013-03-01

The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1). Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Devices for home evaluation of women's health concerns.

PubMed

Scolaro, Kelly L; Lloyd, Kimberly Braxton; Helms, Kristen L

2008-02-15

Devices used for home evaluation of fertility, pregnancy, menopause, colon cancer, breast cancer, and urinary-tract and vaginal yeast infections are discussed. Ovulation-prediction devices monitor natural changes in a woman's body during the menstrual cycle, including changes in basal body temperature, urinary luteinizing hormone, and urinary estrone-3-glucuronide concentrations. Also available are devices that identify changes in the content of sodium chloride and other electrolytes in saliva and cervical-vaginal mucus. Home pregnancy tests are designed to detect human chorionic gonadotropin in the urine. Both urine and saliva tests are available for home evaluation of menopause; the most common devices use urine to measure follicle-stimulating hormone. The saliva tests measure estradiol, progesterone, and testosterone. Devices for home screening for colon cancer use either the guaiac test or the fecal immunochemical test. For aid in breast self-examination, patients may use a simulated-breast product designed to train them to detect lumps or a thin, silicone-containing pad intended to increase the sensitivity of the fingers to abnormalities. Urine-dipstick tests can be used to screen for urinary-tract infection, and a swab or panty liner can be used to detect vaginal pH changes indicative of vaginal yeast infection. Home-based tests may be convenient and economical but also have limitations; pharmacists can help educate patients and clinicians. Many devices are available to help evaluate women's health concerns at home.

Fleet Evaluation and Factory Installation of Aerodynamic Heavy Duty Truck Trailers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beck, Jason; Salari, Kambiz; Ortega, Jason

2013-09-30

The purpose of DE-EE0001552 was to develop and deploy a combination of trailer aerodynamic devices and low rolling resistance tires that reduce fuel consumption of a class 8 heavy duty tractor-trailer combination vehicle by 15%. There were 3 phases of the project: Phase 1 – Perform SAE Typed 2 track tests with multiple device combinations. Phase 2 – Conduct a fleet evaluation with selected device combination. Phase 3 – Develop the devices required to manufacture the aerodynamic trailer. All 3 phases have been completed. There is an abundance of available trailer devices on the market, and fleets and owner operatorsmore » have awareness of them and are purchasing them. The products developed in conjunction with this project are at least in their second round of refinement. The fleet test undertaken showed an improvement of 5.5 – 7.8% fuel economy with the devices (This does not include tire contribution).« less

A methodology for evaluating the usability of audiovisual consumer electronic products.

PubMed

Kwahk, Jiyoung; Han, Sung H

2002-09-01

Usability evaluation is now considered an essential procedure in consumer product development. Many studies have been conducted to develop various techniques and methods of usability evaluation hoping to help the evaluators choose appropriate methods. However, planning and conducting usability evaluation requires considerations of a number of factors surrounding the evaluation process including the product, user, activity, and environmental characteristics. In this perspective, this study suggested a new methodology of usability evaluation through a simple, structured framework. The framework was outlined by three major components: the interface features of a product as design variables, the evaluation context consisting of user, product, activity, and environment as context variables, and the usability measures as dependent variables. Based on this framework, this study established methods to specify the product interface features, to define evaluation context, and to measure usability. The effectiveness of this methodology was demonstrated through case studies in which the usability of audiovisual products was evaluated by using the methods developed in this study. This study is expected to help the usability practitioners in consumer electronics industry in various ways. Most directly, it supports the evaluators' plan and conduct usability evaluation sessions in a systematic and structured manner. In addition, it can be applied to other categories of consumer products (such as appliances, automobiles, communication devices, etc.) with minor modifications as necessary.

76 FR 18558 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

... Sponsors: Exception From Informed Consent for Emergency Research; Availability AGENCY: Food and Drug... oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

Informatics in radiology: Efficiency metrics for imaging device productivity.

PubMed

Hu, Mengqi; Pavlicek, William; Liu, Patrick T; Zhang, Muhong; Langer, Steve G; Wang, Shanshan; Place, Vicki; Miranda, Rafael; Wu, Teresa Tong

2011-01-01

Acute awareness of the costs associated with medical imaging equipment is an ever-present aspect of the current healthcare debate. However, the monitoring of productivity associated with expensive imaging devices is likely to be labor intensive, relies on summary statistics, and lacks accepted and standardized benchmarks of efficiency. In the context of the general Six Sigma DMAIC (design, measure, analyze, improve, and control) process, a World Wide Web-based productivity tool called the Imaging Exam Time Monitor was developed to accurately and remotely monitor imaging efficiency with use of Digital Imaging and Communications in Medicine (DICOM) combined with a picture archiving and communication system. Five device efficiency metrics-examination duration, table utilization, interpatient time, appointment interval time, and interseries time-were derived from DICOM values. These metrics allow the standardized measurement of productivity, to facilitate the comparative evaluation of imaging equipment use and ongoing efforts to improve efficiency. A relational database was constructed to store patient imaging data, along with device- and examination-related data. The database provides full access to ad hoc queries and can automatically generate detailed reports for administrative and business use, thereby allowing staff to monitor data for trends and to better identify possible changes that could lead to improved productivity and reduced costs in association with imaging services. © RSNA, 2011.

Waste disposal in the 21st century and diabetes technology: a little coffee (cup) or beer (can) with that insulin infusion (set).

PubMed

Krisiunas, Ed

2011-07-01

The advent of single-use disposable syringes along with myriad similar products for the health care industry has raised interest in the impact of these devices on the environment. Interest does not stop at impact of the device, but also includes associated pharmaceutical agents. Across the spectrum of health care, providers as well as end users of products are assessing the impact of product design and contents upon land, air, and water. In this issue of Journal of Diabetes Science and Technology, Pfützner and colleagues tackle the issue by focusing on a product for the diabetes patient. As environmental sustainability has become part of the evaluation process of many products, their assessment sheds some interesting light on the impact of a group of devices when compared and contrasted against the ever-popular disposable coffee cup or beer/soda aluminum can. Regional variations in waste disposal practices need to be understood when conducting these types of assessments. © 2011 Diabetes Technology Society.

21 CFR 814.100 - Purpose and scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... concerning: (1) Any pediatric subpopulations (neonates, infants, children, adolescents) that suffer from the... of Orphan Products Development, and (2) Submitting an HDE to the Office of Device Evaluation (ODE...

The voice of the customer--Part 2: Benchmarking battery chargers against the Consumer's Ideal Product.

PubMed

Bauer, S M; Lane, J P; Stone, V I; Unnikrishnan, N

1998-01-01

The Rehabilitation Engineering Research Center on Technology Evaluation and Transfer is exploring how the end users of assistive technology devices define the ideal device. This work is called the Consumer Ideal Product program. In this work, end users identify and establish the importance of a broad range of product design features, along with the related product support and service provided by manufacturers and vendors. This paper describes a method for systematically transforming end-user defined requirements into a form that is useful and accessible to product designers, manufacturers, and vendors. In particular, product requirements, importance weightings, and metrics are developed from the Consumer Ideal Product battery charger outcomes. Six battery charges are benchmarked against these product requirements using the metrics developed. The results suggest improvements for each product's design, service, and support. Overall, the six chargers meet roughly 45-75% of the ideal product's requirements. Many of the suggested improvements are low-cost changes that, if adopted, could provide companies a competitive advantage in the marketplace.

21 CFR 1.101 - Notification and recordkeeping.

Code of Federal Regulations, 2011 CFR

2011-04-01

... products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case... Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. (ii) For... Research—Division of New Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and...

21 CFR 1.101 - Notification and recordkeeping.

Code of Federal Regulations, 2010 CFR

2010-04-01

... products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case... Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. (ii) For... Research—Division of New Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and...

An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke.

PubMed

Pei, Yu-Cheng; Chen, Jean-Lon; Wong, Alice M K; Tseng, Kevin C

2017-01-01

Case series. IV (case series). Robot-assisted therapy for upper limb rehabilitation is an emerging research topic and its design process must integrate engineering, neurological pathophysiology, and clinical needs. This study developed/evaluated the usefulness of a novel rehabilitation device, the MirrorPath , designed for the upper limb rehabilitation of patients with hemiplegic stroke. The process follows Tseng's methodology for innovative product design and development, namely two stages, device development and usability assessment. During the development process, the design was guided by patients' rehabilitation needs as defined by patients and their therapists. The design applied synchronic movement of the bilateral upper limbs, an approach that is compatible with the bilateral movement therapy and proprioceptive neuromuscular facilitation theories. MirrorPath consists of a robotic device that guides upper limb movement linked to a control module containing software controlling the robotic movement. Five healthy subjects were recruited in the pretest, and 4 patients, 4 caregivers, and 4 therapists were recruited in the formal test for usability. All recruited subjects were allocated to the test group, completed the evaluation, and their data were all analyzed. The total system usability scale score obtained from the patients, caregivers, and therapists was 71.8 ± 11.9, indicating a high level of usability and product acceptance. Following a standard development process, we could yield a design that meets clinical needs. This low-cost device provides a feasible platform for carrying out robot-assisted bilateral movement therapy of patients with hemiplegic stroke. identifier NCT02698605.

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

PubMed Central

Faunce, Thomas Alured

2006-01-01

• Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations. PMID:16569240

Radical production efficiency and electrical characteristics of a coplanar barrier discharge built by multilayer ceramic technology

NASA Astrophysics Data System (ADS)

Jõgi, Indrek; Erme, Kalev; Levoll, Erik; Stamate, Eugen

2017-11-01

The present study investigated the electrical characteristics and radical production efficiency of a coplanar barrier discharge (CBD) device manufactured by Kyocera by multilayer ceramic technology. The device consisted of a number of linear electrodes with electrode and gap widths of 0.75 mm, immersed into a ceramic dielectric barrier. A closed flow-through system necessary for the measurements was prepared by placing a quartz plate at a height of 3 mm from the ceramic barrier. The production of nitrogen radicals was determined from the removal of a trace amount of NO in pure N2 gas, while the production of oxygen radicals was determined by ozone production in pure O2 or synthetic air. The production efficiency of N and O radicals and NO oxidation in synthetic air was comparable with the efficiency of a volume barrier discharge device. The power density per unit of surface area of the CBD device was more than two times larger than that of a similar volume barrier discharge setup, which makes the CBD device a compact alternative for gas treatment. The production of ozone and different nitrogen oxides was also evaluated for the open system of the CBD which is usable for surface treatment. The ozone concentration of this system was nearly independent from the input power, while the concentration of nitrogen oxides increased with input power. The open system of the CBD was additionally tested for the treatment of a silicon surface. An increase of applied power decreased the time required to reduce the water contact angle below 10 degrees but also started to have an impact on the surface roughness.

Laboratory and semi-field evaluations of two (Transfluthrin) spatial repellent devices against Aedes aegypti (L.) (Diptera: Culicidae)

USDA-ARS?s Scientific Manuscript database

Two transfluthrin-based spatial repellent products (Raid Dual Action Insect Repellent and Home Freshener and Raid Shield (currently not commercially available), SC Johnson, Racine WI) were evaluated for spatial repellent effects against female Aedes aegypti (L.) mosquitoes underlaboratory (wind tunn...

New product ideas: from the mind to the market.

PubMed

Toter, K M

1987-02-01

If you have an idea for a new product, consider the following steps. Carefully research your product idea before looking for a company or research office to market it. You will save yourself a considerable amount of time and effort if you find that the same or a similar device is already on the market. Check to see if you signed a patent policy when you were hired. Some employers claim rights to discoveries made on the job. Obtain legal advice. A lawyer can provide information about nondisclosure agreements, patents, and other forms of protection for the inventor. Most major cities have a lawyer referral service offered through the bar association. They will answer some questions and will provide names of lawyers who specialize in that area of law. Before submitting your product idea to a company for evaluation, evaluate the company. Make sure they are a reputable medical supply company. Find out such things as how they plan to research your idea, and what your share as the inventor will be. Take notes when surveying professionals from other hospitals about your idea. The information gathered can be used when writing your product proposal. Submitting a list of hospitals experiencing problems that your device could solve is a good selling point. Keep records of all phone conversations and copies of all written correspondence between the inventor and the company or research office. Always try to get commitments in writing, and keep the lines of communication open. Major cities offer different sources that the inventor can turn to for help. Check around. Do not be afraid to ask questions. If you have carefully researched your product idea and really believe it will improve patient care, go for it! It might be a long hard road, and despite all your efforts, the device may never make it to the market. But if it does, seeing your device used to enhance patient care makes it all worthwhile.

Regulatory concerns in the development of biologic-biomaterial combinations. United States Food and Drug Administration.

PubMed

Chapekar, M S

1996-01-01

Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of "Points to Consider" documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

Event Narratives in 11-14 Year Olds with Autistic Spectrum Disorder

ERIC Educational Resources Information Center

King, Diane; Dockrell, Julie E.; Stuart, Morag

2013-01-01

Background: Children with autistic spectrum disorder (ASD) are known to have difficulties in narrative language and especially with use of evaluative enrichment devices. However, little is known about their production of event narratives. Aims: To establish if children with ASD differ from typically developing peers in their production of general…

78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... (CDRH) and the Center for Biologics Evaluation and Research (CBER). DATES: Submit either electronic or...-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH at... CDRH's Classification Product Code structure and organization. These 16 Panels have largely been the...

A handheld optical device for skin profile measurement

NASA Astrophysics Data System (ADS)

Sun, Jiuai; Liu, Xiaojin

2018-04-01

This paper describes a portable optical scanning device designed for skin surface measurement on both colour and 3D geometry through a relative easy and cost effective multiple light source photometric stereo method. The validation of colour recovered had been verified through its application on skin lesion segmentation in our early work. This paper focuses on the reconstructed topographic data which are subject to further evaluation and advancement. The evaluation work takes the skin in vitro as an application scenario and compares the experimental result to that obtained by using a commercial product. The experiments show that this handheld device can measure the skin profile significantly closer to that of the ground truth and have the additional function of skin colour recovery.

Biomedical applications of tissue engineering technology: regulatory issues.

PubMed

Hellman, K B

1995-01-01

Novel emerging technologies such as tissue engineering, which utilize the approaches of molecular and cell biology, biotechnology, as well as materials science and engineering, are being used in the development of a wide range of biomedical products developed by industries regulated by the U.S. Food and Drug Administration (FDA). The FDA's mission is to promote and protect the public health by ensuring the safety and effectiveness of pharmaceuticals and medical devices, including those manufactured by novel technology, as assessed by scientific principles and methods. Regulatory review is conducted on a product-by-product basis. To accomplish its mission over the wide range of products in its regulatory purview, the FDA has six centers, each staffed with the scientific and regulatory expertise to evaluate the products in the center's jurisdiction. Recent legislative and regulatory changes are designed to simplify and facilitate the administrative process for evaluating novel combination products emanating from such interdisciplinary technology as tissue engineering and to resolve questions of product regulatory jurisdiction. Under the new procedures, the FDA may designate a lead FDA center for product review based on the primary mode of action of the combination product, with additional center(s) designated to assist in the evaluation in a collaborative or consultative capacity. In addition, FDA centers have increased their cooperation and information sharing with regard to evolving interdisciplinary technology. The FDA InterCenter Tissue Engineering Initiative was established to develop information on intercenter efforts in the evaluation of tissue engineering applications and to identify areas for further consideration. The FDA InterCenter Tissue Engineering Working Group, comprised of staff from the Center for Biologies Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.

Handling the procurement of prostheses for total hip replacement: description of an original value based approach and application to a real-life dataset reported in the UK

PubMed Central

Messori, Andrea; Trippoli, Sabrina; Marinai, Claudio

2017-01-01

Objectives In most European countries, innovative medical devices are not managed according to cost–utility methods, the reason being that national agencies do not generally evaluate these products. The objective of our study was to investigate the cost-utility profile of prostheses for hip replacement and to calculate a value-based score to be used in the process of procurement and tendering for these devices. Methods The first phase of our study was aimed at retrieving the studies reporting the values of QALYs, direct cost, and net monetary benefit (NMB) from patients undergoing total hip arthroplasty (THA) with different brands of hip prosthesis. The second phase was aimed at calculating, on the basis of the results of cost–utility analysis, a tender score for each device (defined according to standard tendering equations and adapted to a 0–100 scale). This allowed us to determine the ranking of each device in the simulated tender. Results We identified a single study as the source of information for our analysis. Nine device brands (cemented, cementless, or hybrid) were evaluated. The cemented prosthesis Exeter V40/Elite Plus Ogee, the cementless device Taperloc/Exceed, and the hybrid device Exeter V40/Trident had the highest NMB (£152 877, £156 356, and £156 210, respectively) and the best value-based tender score. Conclusions The incorporation of value-based criteria in the procurement process can contribute to optimising the value for money for THA devices. According to the approach described herein, the acquisition of these devices does not necessarily converge on the product with the lowest cost; in fact, more costly devices should be preferred when their increased cost is offset by the monetary value of the increased clinical benefit. PMID:29259062

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review

PubMed Central

Manchaiah, Vinaya; Taylor, Brian; Dockens, Ashley L; Tran, Nicole R; Lane, Kayla; Castle, Mariana; Grover, Vibhu

2017-01-01

Background This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids. Method A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review. Results Included studies fell into three domains: 1) electroacoustic characteristics, 2) consumer surveys, and 3) outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level). Low-end (or low-cost) devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis), especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%–19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive outcomes of OTC devices in the elderly population. Of note, OTC outcomes appear better when a hearing health care professional supports these users. Conclusion While some direct-to-consumer hearing devices have the capability to produce adverse effects due to production of dangerously high sound levels and internal noise, the existing literature suggests that there are potential benefits of these devices. Research of direct-to-consumer hearing devices is limited, and current published studies are of weak quality. Much effort is needed to understand the benefits and limitations of such devices on people with hearing loss. PMID:28553093

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review.

PubMed

Manchaiah, Vinaya; Taylor, Brian; Dockens, Ashley L; Tran, Nicole R; Lane, Kayla; Castle, Mariana; Grover, Vibhu

2017-01-01

This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids. A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review. Included studies fell into three domains: 1) electroacoustic characteristics, 2) consumer surveys, and 3) outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level). Low-end (or low-cost) devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis), especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%-19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive outcomes of OTC devices in the elderly population. Of note, OTC outcomes appear better when a hearing health care professional supports these users. While some direct-to-consumer hearing devices have the capability to produce adverse effects due to production of dangerously high sound levels and internal noise, the existing literature suggests that there are potential benefits of these devices. Research of direct-to-consumer hearing devices is limited, and current published studies are of weak quality. Much effort is needed to understand the benefits and limitations of such devices on people with hearing loss.

In vivo evaluation of glucose permeability of an immunoisolation device intended for islet transplantation: a novel application of the microdialysis technique.

PubMed

Rafael, E; Wernerson, A; Arner, P; Wu, G S; Tibell, A

1999-01-01

Immunoisolation devices consist of semipermeable membranes chosen to protect the islets from the immune system but still allow sufficient passage of nutrients, oxygen, and the therapeutic products, insulin. The exchange between the device and the microcirculation will influence the survival of the graft as well as the metabolic efficacy of the islet implant. Glucose is the important trigger factor for insulin secretion. In this study, we evaluate the in vivo glucose permeability of the Theracyte immunoisolation device at various times after implantation. Empty devices were implanted s.c. in rats. The glucose kinetics in the device was compared to that in the SC tissue during i.v. glucose tolerance tests (IVGTTs), using the microdialysis technique. In rats studied on day 1, or 1, 2, and 4 weeks after implantation, the peak glucose levels (Cmax) were significantly lower, the times-to-peak (TTP) were significantly longer, and the areas under the curve during the first 40 min (AUC(0-40)) were significantly smaller in the device than in the SC fat. However, at 3 months all parameters improved and Cmax, TTP, and AUC(0-40) in the device did not differ significantly from those measured in the SC fat. Thus, during the first 4 weeks the device constitutes a significant diffusion barrier, but at 3 months the exchange between the lumen of devices and the blood stream improves. Our data indicate that implantation of the device several months before transplantation of the cellular graft would improve the exchange across the membrane during the early posttransplant period. This should have positive effects on graft survival and function. We also suggest that microdialysis is a useful tool for evaluating the in vivo performance of macroencapsulation devices.

The effect of simulated field storage conditions on the accuracy of rapid user-friendly blood pathogen detection kits.

PubMed

Bienek, Diane R; Charlton, David G

2012-05-01

Being able to test for the presence of blood pathogens at forward locations could reduce morbidity and mortality in the field. Rapid, user-friendly blood typing kits for detecting Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and Hepatitis B Virus (HBV) were evaluated to determine their accuracy after storage at various temperatures/humidities. Rates of positive tests of control groups, experimental groups, and industry standards were compared (Fisher's exact chi2, p < or = 0.05). Compared to the control group, 2 of 10 HIV detection devices were adversely affected by exposure to high temperature/high humidity or high temperature/low humidity. With one exception, none of the environmentally exposed HCV or HBV detection devices exhibited significant differences compared to those stored under control conditions. For HIV, HCV, and HBV devices, there were differences compared to the industry standard. Collectively, this evaluation of pathogen detection kits revealed that diagnostic performance varies among products and storage conditions, and that the tested products cannot be considered to be approved for use to screen blood, plasma, cell, or tissue donors.

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

PubMed Central

Morrison, Tina M.; Dreher, Maureen L.; Nagaraja, Srinidhi; Angelone, Leonardo M.; Kainz, Wolfgang

2018-01-01

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making. PMID:29479395

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

PubMed

Morrison, Tina M; Dreher, Maureen L; Nagaraja, Srinidhi; Angelone, Leonardo M; Kainz, Wolfgang

2017-01-01

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

[Differences between clinical trials according to the German law on pharmaceuticals (Arzneimittelgesetz) and trials according to the German law on medical products (Medizinproduktegesetz)].

PubMed

Krummenauer, F

2003-02-01

Similar to the registration process for pharmaceutical agents, medical devices have to undergo standardized clinical evaluation before being marketed and used in routine therapy or diagnostics. However, conduction, submission, and reporting of such clinical evaluations to authorities has to follow the German law on medical products(Medizinproduktegesetz,MPG), which in some central aspects differs remarkably from the German law on pharmaceuticals (Arzneimittelgesetz,AMG). Relevant deviations of MPG requirements from those of the AMG are reviewed with particular emphasis on submission, conduction, and reporting of trials to the authorities in charge. Whereas AMG-based trials focus on the proof of efficacy of pharmaceutical agents, the MPG demands instead proof of functionality of the medical devices; the MPG therefore concentrates more on technically satisfactory results in the context of function and patient safety. The aim of MPG trials is thus CE marking instead of AMG-based registration. However, this focus on functionality implies that medical devices need not necessarily be tested in a clinical trial--in some settings evidence-based evaluation alone will be sufficient. The decision on the necessity of a clinical trial is based mainly on the risk profile and invasive character of the device at hand. The early consideration of differences between AMG and MPG concerning the role and conduction of clinical trials will remarkably increase the (CE) certification process's outcome quality and juridical validity.

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.

PubMed

Cookson, Richard; Hutton, John

2003-02-01

Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.

Applying State-of-the-Art Technologies to Reduce Escape Times from Fires Using Environmental Sensing, Improved Occupant Egress Guidance, and Multiple Communication Protocols

DTIC Science & Technology

2009-02-06

that could monitor sensors, evaluate environmental 4 conditions, and control visual and sound devices was conducted. The home automation products used...the prototype system. Use of off-the-shelf home automation products allowed the implementation of an egress control prototype suitable for test and

76 FR 68769 - Bridging the Idea Development Evaluation Assessment and Long-Term Initiative and Total Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... complementary methodological frameworks of the IDEAL and TPLC initiatives, more comprehensive and applicable... devices, surgical operations, and invasive medical procedures; Unique study designs and reporting methods...

30 CFR 27.37 - Tests to determine adequacy of safety devices for bulbs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements... filament incandescent at normal operating voltage shall be broken in flammable methane-air or natural gas...

30 CFR 27.37 - Tests to determine adequacy of safety devices for bulbs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements... filament incandescent at normal operating voltage shall be broken in flammable methane-air or natural gas...

Simulation training tools for nonlethal weapons using gaming environments

NASA Astrophysics Data System (ADS)

Donne, Alexsana; Eagan, Justin; Tse, Gabriel; Vanderslice, Tom; Woods, Jerry

2006-05-01

Modern simulation techniques have a growing role for evaluating new technologies and for developing cost-effective training programs. A mission simulator facilitates the productive exchange of ideas by demonstration of concepts through compellingly realistic computer simulation. Revolutionary advances in 3D simulation technology have made it possible for desktop computers to process strikingly realistic and complex interactions with results depicted in real-time. Computer games now allow for multiple real human players and "artificially intelligent" (AI) simulated robots to play together. Advances in computer processing power have compensated for the inherent intensive calculations required for complex simulation scenarios. The main components of the leading game-engines have been released for user modifications, enabling game enthusiasts and amateur programmers to advance the state-of-the-art in AI and computer simulation technologies. It is now possible to simulate sophisticated and realistic conflict situations in order to evaluate the impact of non-lethal devices as well as conflict resolution procedures using such devices. Simulations can reduce training costs as end users: learn what a device does and doesn't do prior to use, understand responses to the device prior to deployment, determine if the device is appropriate for their situational responses, and train with new devices and techniques before purchasing hardware. This paper will present the status of SARA's mission simulation development activities, based on the Half-Life gameengine, for the purpose of evaluating the latest non-lethal weapon devices, and for developing training tools for such devices.

Tool to assess causality of direct and indirect adverse events associated with therapeutic interventions.

PubMed

Zorzela, Liliane; Mior, Silvano; Boon, Heather; Gross, Anita; Yager, Jeromy; Carter, Rose; Vohra, Sunita

2018-03-01

To develop and test a tool to assess the causality of direct and indirect adverse events associated with therapeutic interventions. The intervention was one or more drugs and/or natural health products, a device, or practice (professional delivering the intervention). Through the assessment of causality of adverse events, we can learn about factors contributing to the harm and consider what modification may prevent its reoccurrence. Existing scales (WHO-UMC, Naranjo and Horn) were adapted to develop a tool (algorithm and table) to evaluate cases of serious harmful events reported through a national surveillance study. We also incorporated a novel approach that assesses indirect harm (caused by the delay in diagnosis/treatment) and the health provider delivering the intervention (practice). The tool was tested, revised and then implemented to assess all reported cases of serious events resulting from use of complementary therapies. The use of complementary therapies was the trigger to report the event. Each case was evaluated by two assessors, out of a panel of five, representing different health care professionals. The tool was used in assessment of eight serious adverse events. Each event was independently evaluated by two assessors. The algorithm facilitated assessment of a serious direct or indirect harm. Assessors agreed in the final score on seven of eight cases (weighted kappa coefficient of 0.75). A tool to support the assessment of causality of adverse events was developed and tested. We propose a novel method to assess direct and indirect harms related to product(s), device(s), practice or a combination of the previous. Further research will probably help evaluate this approach across different settings and interventions.

Eco-efficiency evaluation of a smart window prototype.

PubMed

Syrrakou, E; Papaefthimiou, S; Yianoulis, P

2006-04-15

An eco-efficiency analysis was conducted using indicators suitably defined to evaluate the performance of an electrochromic window acting as an energy saving component in buildings. Combining the indicators for various parameters (control scenario, expected lifetime, climatic type, purchase cost) significant conclusions are drawn for the development and the potential applications of the device compared to other commercial fenestration products. The reduction of the purchase cost (to 200 euros/m2) and the increase of the lifetime (above 15 years) are the two main targets for achieving both cost and environmental efficiency. An electrochromic device, implemented in cooling dominated areas and operated with an optimum control strategy for the maximum expected lifetime (25 years), can reduce the building energy requirements by 52%. Furthermore, the total energy savings provided will be 33 times more than the energy required for its production while the emission of 615 kg CO2 equivalent per electrochromic glazing unit can be avoided.

Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.

Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use canmore » be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).« less

Design, fabrication, testing, and delivery of improved beam steering devices

NASA Technical Reports Server (NTRS)

1973-01-01

The development, manufacture, and testing of an optical steerer intended for use in spaceborne optical radar systems are described. Included are design principles and design modifications made to harden the device against launch and space environments, the quality program and procedures developed to insure consistent product quality throughout the manufacturing phase, and engineering qualification model testing and evaluation. The delivered hardware design is considered conditionally qualified pending action on further recommended design modifications.

Hybrid electro-optics and chipscale integration of electronics and photonics

NASA Astrophysics Data System (ADS)

Dalton, L. R.; Robinson, B. H.; Elder, D. L.; Tillack, A. F.; Johnson, L. E.

2017-08-01

Taken together, theory-guided nano-engineering of organic electro-optic materials and hybrid device architectures have permitted dramatic improvement of the performance of electro-optic devices. For example, the voltage-length product has been improved by nearly a factor of 104 , bandwidths have been extended to nearly 200 GHz, device footprints reduced to less than 200 μm2 , and femtojoule energy efficiency achieved. This presentation discusses the utilization of new coarse-grained theoretical methods and advanced quantum mechanical methods to quantitatively simulate the physical properties of new classes of organic electro-optic materials and to evaluate their performance in nanoscopic device architectures, accounting for the effect on chromophore ordering at interfaces in nanoscopic waveguides.

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength.

PubMed

Gingras, Kristen; Zaruby, Jeffrey; Maul, Don

2012-05-01

The objective of this study was to compare the biomechanical strength of two barbed suture devices: V-Loc™ 180 Wound Closure Device and Quill™ PDO Knotless Tissue-Closure Device following primary cosmetic skin closures in a porcine dermal model. This prospective randomized, controlled in vivo trial compared size 3/0 V-Loc™ 180 device to size 2/0 Quill™ PDO device. Both products were tested for dermal closure in adult porcine models and evaluated at five timepoints. At postoperative days 0, 3, 7, 14, and 28 sutured tissue regions were excised post mortem and tested for intradermal wound holding strength. Wounds closed with V-Loc™ 180 device were stronger than Quill™ PDO device at days 0, 3, 7, and 14 with these differences being significant (p < 0.05) at days 3 and 7. At day 3, the average maximum load of V-Loc™ 180 was 13.53 kgf and Quill™ PDO was 10.38 kgf (p = 0.002). At day 7, the average maximum load of V-Loc™ 180 was 10.4 kgf and Quill™ PDO was 7.56 kgf (p = 0.001). Throughout the duration of the study, there was no suture extrusion or tissue distortion and all wounds healed with no major complications. In this study, V-Loc™ 180 device was significantly stronger than Quill™ PDO device during the critical phases of wound healing in skin. Copyright © 2012 Wiley Periodicals, Inc.

Techniques for control of long-term reliability of complex integrated circuits. I - Reliability assurance by test vehicle qualification.

NASA Technical Reports Server (NTRS)

Van Vonno, N. W.

1972-01-01

Development of an alternate approach to the conventional methods of reliability assurance for large-scale integrated circuits. The product treated is a large-scale T squared L array designed for space applications. The concept used is that of qualification of product by evaluation of the basic processing used in fabricating the product, providing an insight into its potential reliability. Test vehicles are described which enable evaluation of device characteristics, surface condition, and various parameters of the two-level metallization system used. Evaluation of these test vehicles is performed on a lot qualification basis, with the lot consisting of one wafer. Assembled test vehicles are evaluated by high temperature stress at 300 C for short time durations. Stressing at these temperatures provides a rapid method of evaluation and permits a go/no go decision to be made on the wafer lot in a timely fashion.

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

PubMed

Walczuk, Imko; Eertmans, Frank; Rossel, Bart; Cegielska, Agnieszka; Stockfleth, Eggert; Antunes, Andre; Adriaens, Els

2018-06-01

Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze ® in Europe, Compound W ® Nitro-Freeze in the USA). This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner ® ; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie ® ; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. Oystershell Laboratories. Clinicaltrials.gov identifier, NCT03129373.

INNOVATIVE TECHNOLOGY VERIFICATION REPORT " ...

EPA Pesticide Factsheets

The EnSys Petro Test System developed by Strategic Diagnostics Inc. (SDI), was demonstrated under the U.S. Environmental Protection Agency Superfund Innovative Technology Evaluation Program in June 2000 at the Navy Base Ventura County site in Port Hueneme, California. The purpose of the demonstration was to collect reliable performance and cost data for the EnSys Petro Test System and six other field measurement devices for total petroleum hydrocarbons (TPH) in soil. In addition to assessing ease of device operation, the key objectives of the demonstration included determining the (1) method detection limit, (2) accuracy and precision, (3) effects of interferents and soil moisture content on TPH measurement, (4) sample throughput, and (5) TPH measurement costs for each device. The demonstration involved analysis of both performance evaluation samples and environmental samples collected in four areas contaminated with gasoline, diesel, or other petroleum products. The performance and cost results for a given field measurement device were compared to those for an off-site laboratory reference method,

INNOVATIVE TECHNOLOGY VERIFICATION REPORT " ...

EPA Pesticide Factsheets

The Synchronous Scanning Luminoscope (Luminoscope) developed by the Oak Ridge National Laboratory in collaboration with Environmental Systems Corporation (ESC) was demonstrated under the U.S. Environmental Protection Agency Superfund Innovative Technology Evaluation Program in June 2000 at the Navy Base Ventura County site in Port Hueneme, California. The purpose of the demonstration was to collect reliable performance and cost data for the Luminoscope and six other field measurement devices for total petroleum hydrocarbons (TPH) in soil. In addition to assessing ease of device operation, the key objectives of the demonstration included determining the (1) method detection limit, (2) accuracy and precision, (3) effects of interferents and soil moisture content on TPH measurement, (4) sample throughput, and (5) TPH measurement costs for each device. The demonstration involved analysis of both performance evaluation samples and environmental samples collected in five areas contaminated with gasoline, diesel, lubricating oil, or other petroleum products. The performance and cost results for a given field measurement device were compared to those for an off-site laboratory reference method,

Incorporation of stochastic engineering models as prior information in Bayesian medical device trials.

PubMed

Haddad, Tarek; Himes, Adam; Thompson, Laura; Irony, Telba; Nair, Rajesh

2017-01-01

Evaluation of medical devices via clinical trial is often a necessary step in the process of bringing a new product to market. In recent years, device manufacturers are increasingly using stochastic engineering models during the product development process. These models have the capability to simulate virtual patient outcomes. This article presents a novel method based on the power prior for augmenting a clinical trial using virtual patient data. To properly inform clinical evaluation, the virtual patient model must simulate the clinical outcome of interest, incorporating patient variability, as well as the uncertainty in the engineering model and in its input parameters. The number of virtual patients is controlled by a discount function which uses the similarity between modeled and observed data. This method is illustrated by a case study of cardiac lead fracture. Different discount functions are used to cover a wide range of scenarios in which the type I error rates and power vary for the same number of enrolled patients. Incorporation of engineering models as prior knowledge in a Bayesian clinical trial design can provide benefits of decreased sample size and trial length while still controlling type I error rate and power.

Integrating the results of user research into medical device development: insights from a case study.

PubMed

Martin, Jennifer L; Barnett, Julie

2012-07-19

It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product.

Integrating the results of user research into medical device development: insights from a case study

PubMed Central

2012-01-01

Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and reflective approach to development, which should result in improved business decisions and a higher quality end product. PMID:22812565

Prototype mobile luminance measurement system and level of service for evaluating rural high-speed nighttime delineation.

DOT National Transportation Integrated Search

2013-02-01

Transportation agencies routinely travel their extensive roadway networks conducting subjective roadway : assessments of traffic control devices both day and night. Retroreflectivity is a good tool for product testing : but can provide false positive...

Federal regulation of vision enhancement devices for normal and abnormal vision

NASA Astrophysics Data System (ADS)

Drum, Bruce

2006-09-01

The Food and Drug Administration (FDA) evaluates the safety and effectiveness of medical devices and biological products as well as food and drugs. The FDA defines a device as a product that is intended, by physical means, to diagnose, treat, or prevent disease, or to affect the structure or function of the body. All vision enhancement devices fulfill this definition because they are intended to affect a function (vision) of the body. In practice, however, FDA historically has drawn a distinction between devices that are intended to enhance low vision as opposed to normal vision. Most low vision aids are therapeutic devices intended to compensate for visual impairment, and are actively regulated according to their level of risk to the patient. The risk level is usually low (e.g. Class I, exempt from 510(k) submission requirements for magnifiers that do not touch the eye), but can be as high as Class III (requiring a clinical trial and Premarket Approval (PMA) application) for certain implanted and prosthetic devices (e.g. intraocular telescopes and prosthetic retinal implants). In contrast, the FDA usually does not actively enforce its regulations for devices that are intended to enhance normal vision, are low risk, and do not have a medical intended use. However, if an implanted or prosthetic device were developed for enhancing normal vision, the FDA would likely decide to regulate it actively, because its intended use would entail a substantial medical risk to the user. Companies developing such devices should contact the FDA at an early stage to clarify their regulatory status.

Other Products and Devices to Improve Hearing

MedlinePlus

... and Consumer Devices Consumer Products Hearing Aids Other Products and Devices to Improve Hearing Share Tweet Linkedin ... no hearing in one ear. Personal Sound Amplification Products Personal Sound Amplification Products (PSAPs), or sound amplifiers, ...

Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol.

PubMed

Maidment, David W; Barker, Alex B; Xia, Jun; Ferguson, Melanie A

2016-10-27

Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based 'hearing aid' apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. PROSPERO CRD4201502958. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

21 CFR 26.32 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... bodies (CAB's) assessed to be equivalent: (1) Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports; (2) Under the U.S. system, premarket (510(k)) product evaluation reports; (3...

EVALUATION OF PERSONAL COOLING DEVICES FOR A DIOXIN CLEAN-UP OPERATION

EPA Science Inventory

The study investigated the use of personal coolers to increase worker productivity and safety while working at elevated, ambient temperatures cleaning up dioxin contaminated soil.^The study included laboratory tests to measure the thermal characteristics of the chemical protectiv...

21 CFR 864.7250 - Erythropoietin assay.

Code of Federal Regulations, 2011 CFR

2011-04-01

... assay. (a) Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and...

21 CFR 864.7250 - Erythropoietin assay.

Code of Federal Regulations, 2014 CFR

2014-04-01

... assay. (a) Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and...

21 CFR 864.7250 - Erythropoietin assay.

Code of Federal Regulations, 2010 CFR

2010-04-01

... assay. (a) Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and...

21 CFR 864.7250 - Erythropoietin assay.

Code of Federal Regulations, 2012 CFR

2012-04-01

... assay. (a) Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and...

21 CFR 864.7250 - Erythropoietin assay.

Code of Federal Regulations, 2013 CFR

2013-04-01

... assay. (a) Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and...

10 CFR 32.210 - Registration of product information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... sent to the Office of Federal and State Materials and Environmental Management Programs, by an... device must include sufficient information about the design, manufacture, prototype testing, quality... the evaluation, the Commission issues a certificate of registration to the person making the request...

Evaluation of the break-out square post breakaway system.

DOT National Transportation Integrated Search

2015-02-01

Determine the effectiveness of the Break-Out Square (BOS) Post coupler as a : possible alternative to other breakaway devices. This product is designed to (upon : impact) break flush with grade with no damage apparent to base or anchor and offer a : ...

Planar Homojunction Gallium Nitride (GaN) P-i-N Device Evaluated for Betavoltaic Energy Conversion: Measurement and Analysis

DTIC Science & Technology

2016-09-01

REPORT DATE (DD-MM-YYYY) September 2016 2. REPORT TYPE Technical Report 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE Planar Homojunction...development of mass- production semiconductor processing methods of 4H-SiC. The ease of fabrication of thicker epitaxial layers make SiC a prime...the 0.1- and 1-nA current settings are very stable and represent the low intensity expected from radioisotope beta decay. 2.2 Planar GaN Device

Preventing hypothermia: comparison of current devices used by the US Army in an in vitro warmed fluid model.

PubMed

Allen, Paul B; Salyer, Steven W; Dubick, Michael A; Holcomb, John B; Blackbourne, Lorne H

2010-07-01

The purpose of this study was to develop an in vitro torso model constructed with fluid bags and to determine whether this model could be used to differentiate between the heat prevention performance of devices with active chemical or radiant forced-air heating systems compared with passive heat loss prevention devices. We tested three active (Hypothermia Prevention Management Kit [HPMK], Ready-Heat, and Bair Hugger) and five passive (wool, space blankets, Blizzard blankets, human remains pouch, and Hot Pocket) hypothermia prevention products. Active warming devices included products with chemically or electrically heated systems. Both groups were tested on a fluid model warmed to 37 degrees C versus a control with no warming device. Core temperatures were recorded every 5 minutes for 120 minutes in total. Products that prevent heat loss with an actively heated element performed better than most passive prevention methods. The original HPMK achieved and maintained significantly higher temperatures than all other methods and the controls at 120 minutes (p < 0.05). None of the devices with an actively heated element achieved the sustained 44 degrees C that could damage human tissue if left in place for 6 hours. The best passive methods of heat loss prevention were the Hot Pocket and Blizzard blanket, which performed the same as two of the three active heating methods tested at 120 minutes. Our in vitro fluid bag "torso" model seemed sensitive to detect heat loss in the evaluation of several active or passive warming devices. All active and most passive devices were better than wool blankets. Under conditions near room temperature, passive warming methods (Blizzard blanket or the Hot Pocket) were as effective as active warming devices other than the original HPMK. Further studies are necessary to determine how these data can translate to field conditions in preventing heat loss in combat casualties.

Cervical external immobilization devices: evaluation of magnetic resonance imaging issues at 3.0 Tesla.

PubMed

Diaz, Francis L; Tweardy, Lisa; Shellock, Frank G

2010-02-15

Laboratory investigation, ex vivo. Currently, no studies have addressed the magnetic resonance imaging (MRI) issues for cervical external immobilization devices at 3-Tesla. Under certain conditions significant heating may occur, resulting in patient burns. Furthermore, artifacts can be substantial and prevent the diagnostic use of MRI. Therefore, the objective of this investigation was to evaluate MRI issues for 4 different cervical external immobilization devices at 3-Tesla. Excessive heating and substantial artifacts are 2 potential complications associated with performing MRI at 3-Tesla in patients with cervical external immobilization devices. Using ex vivo testing techniques, MRI-related heating and artifacts were evaluated for 4 different cervical devices during MRI at 3-Tesla. Four cervical external immobilization devices (Generation 80, Resolve Ring and Superstructure, Resolve Ring and Jerome Vest/Jerome Superstructure, and the V1 Halo System; Ossur Americas, Aliso Viejo, CA) underwent MRI testing at 3-Tesla. All devices were made from nonmetallic or nonmagnetic materials. Heating was determined using a gelled-saline-filled skull phantom with fluoroptic thermometry probes attached to the skull pins. MRI was performed at 3-Tesla, using a high level of RF energy. Artifacts were assessed at 3-Tesla, using standard cervical imaging techniques. The Generation 80 and V1 Halo devices exhibited substantial temperature rises (11.6 degrees C and 8.5 degrees C, respectively), with "sparking" evident for the Generation 80 during the MRI procedure. Artifacts were problematic for these devices, as well. By comparison, the 2 Resolve Ring-based cervical external immobilization devices showed little or no heating (< or = 0.6 degrees C) and the artifacts were acceptable for diagnostic MRI examinations. The low degree of heating and minor artifacts associated with the Resolve-based cervical external immobilization devices indicated that these products are safe for patients undergoing MRI at 3-Tesla.

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

PubMed

Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

2016-01-01

Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

Arc spray process for the aircraft and stationary gas turbine industry

NASA Astrophysics Data System (ADS)

Sampson, E. R.; Zwetsloot, M. P.

1997-06-01

Technological advances in arc spray have produced a system that competes favorably with other thermal spray processes. In the past, arc spray was thought of as a process for very large parts that need thick buildups. However, an attachment device known as the arc jet system has been developed that focuses the pattern and accelerates the particles. This attachment device, coupled with the in-troduction of metal-cored wires that provide the same chemistries as plasma-sprayed powders, pro-vides application engineers with a viable economic alternative to existing spray methods. A comparative evaluation of a standard production plasma spray system was conducted with the arc spray process using the attachment device. This evaluation was conducted by an airline company on four major parts coated with nickel-aluminum. Results show that, for these applications, the arc spray process offers several benefits.

An ex vivo porcine skin model to evaluate pressure-reducing devices of different mechanical properties used for pressure ulcer prevention.

PubMed

Yeung, Ching-Yan C; Holmes, David F; Thomason, Helen A; Stephenson, Christian; Derby, Brian; Hardman, Matthew J

2016-11-01

Pressure ulcers are complex wounds caused by pressure- and shear-induced trauma to skin and underlying tissues. Pressure-reducing devices, such as dressings, have been shown to successfully reduce pressure ulcer incidence, when used in adjunct to pressure ulcer preventative care. While pressure-reducing devices are available in a range of materials, with differing mechanical properties, understanding of how a material's mechanical properties will influence clinical efficacy remains limited. The aim of this study was to establish a standardized ex vivo model to allow comparison of the cell protection potential of two gel-like pressure-reducing devices with differing mechanical properties (elastic moduli of 77 vs. 35 kPa). The devices also displayed differing energy dissipation under compressive loading, and resisted strain differently under constant load in compressive creep tests. To evaluate biological efficacy we employed a new ex vivo porcine skin model, with a confirmed elastic moduli closely matching that of human skin (113 vs. 119 kPa, respectively). Static loads up to 20 kPa were applied to porcine skin ex vivo with subsequent evaluation of pressure-induced cell death and cytokine release. Pressure application alone increased the percentage of epidermal apoptotic cells from less than 2% to over 40%, and increased cellular secretion of the pro-inflammatory cytokine TNF-alpha. Co-application of a pressure-reducing device significantly reduced both cellular apoptosis and cytokine production, protecting against cellular damage. These data reveal new insight into the relationship between mechanical properties of pressure-reducing devices and their biological effects. After appropriate validation of these results in clinical pressure ulcer prevention with all tissue layers present between the bony prominence and external surface, this ex vivo porcine skin model could be widely employed to optimize design and evaluation of devices aimed at reducing pressure-induced skin damage. © 2016 The Authors Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of The Wound Healing Society.

Aircraft Survivability: Live Fire Test and Evaluation, Spring 2010

DTIC Science & Technology

2010-01-01

OCPD ). These devices were examined in this program for their potential to reduce fire vulnerability. Testing for this test series, designated Live...divided into three categories: 1) short circuit, 2) separating arc gap, and 3) 90% conductor diameter reduction. The performance of the OCPDs was also...incorporated a production- representative tank configuration. All test configurations were evaluated with OCPD protection. In ballistic damage tests

32 CFR 22.105 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... applying existing technology to new products and processes in a general way. Advanced research is most... Category 6.3A) programs within Research, Development, Test and Evaluation (RDT&E). Applied research... technology such as new materials, devices, methods and processes. It typically is funded in Applied Research...

Known-component 3D-2D registration for quality assurance of spine surgery pedicle screw placement

NASA Astrophysics Data System (ADS)

Uneri, A.; De Silva, T.; Stayman, J. W.; Kleinszig, G.; Vogt, S.; Khanna, A. J.; Gokaslan, Z. L.; Wolinsky, J.-P.; Siewerdsen, J. H.

2015-10-01

A 3D-2D image registration method is presented that exploits knowledge of interventional devices (e.g. K-wires or spine screws—referred to as ‘known components’) to extend the functionality of intraoperative radiography/fluoroscopy by providing quantitative measurement and quality assurance (QA) of the surgical product. The known-component registration (KC-Reg) algorithm uses robust 3D-2D registration combined with 3D component models of surgical devices known to be present in intraoperative 2D radiographs. Component models were investigated that vary in fidelity from simple parametric models (e.g. approximation of a screw as a simple cylinder, referred to as ‘parametrically-known’ component [pKC] registration) to precise models based on device-specific CAD drawings (referred to as ‘exactly-known’ component [eKC] registration). 3D-2D registration from three intraoperative radiographs was solved using the covariance matrix adaptation evolution strategy (CMA-ES) to maximize image-gradient similarity, relating device placement relative to 3D preoperative CT of the patient. Spine phantom and cadaver studies were conducted to evaluate registration accuracy and demonstrate QA of the surgical product by verification of the type of devices delivered and conformance within the ‘acceptance window’ of the spinal pedicle. Pedicle screws were successfully registered to radiographs acquired from a mobile C-arm, providing TRE 1-4 mm and  <5° using simple parametric (pKC) models, further improved to  <1 mm and  <1° using eKC registration. Using advanced pKC models, screws that did not match the device models specified in the surgical plan were detected with an accuracy of  >99%. Visualization of registered devices relative to surgical planning and the pedicle acceptance window provided potentially valuable QA of the surgical product and reliable detection of pedicle screw breach. 3D-2D registration combined with 3D models of known surgical devices offers a novel method for intraoperative QA. The method provides a near-real-time independent check against pedicle breach, facilitating revision within the same procedure if necessary and providing more rigorous verification of the surgical product.

A novel portable device to measure the temperature of both the inner and the outer tubes of a parabolic receiver in the field

NASA Astrophysics Data System (ADS)

Hermoso, J. L. Navarro; Espinosa-Rueda, Guillermo; Martinez, Noelia; Heras, Carlos; Osta, Marta

2016-05-01

The performance of parabolic trough (PT) receiver tubes (RT) has a direct impact on Solar Thermal Energy (STE) plant production. As a result, one major need of operation and maintenance (O&M) in STE plants is to monitor the state of the receiver tube as a key element in the solar field. However the lack of specific devices so far has limited the proper evaluation of operating receiver tubés thermal performance. As a consequence non-accurate approximations have been accepted until now using infrared thermal images of the glass outer tube. In order to fulfill this need, Abengoa has developed a unique portable device for evaluating the thermal performance and vacuum state of parabolic trough receiver tubes placed in the field. The novel device described in this paper, simultaneously provides the temperature of both the inner steel tube and the outer glass tube enabling a check on manufacturers specifications. The on-field evaluation of any receiver tube at any operating temperature has become possible thanks to this new measuring device. The features and usability of this new measurement system as a workable portable device in operating solar fields provide a very useful tool for all companies in the sector contributing to technology progress. The originality of the device, patent pending P201431969, is not limited to the CSP sector, also having scientific significance in the general measuring instruments field. This paper presents the work carried out to develop and validate the device, also detailing its functioning properties and including the excellent results obtained in the laboratory to determine its accuracy and standard deviation. This information was validated with data collected by O&M teams using this instrument in a commercial CSP plant. The relevance of the device has been evidenced by evaluating a wide sample of RT and the results are discussed in this paper. Finally, all the on field collected data is used to demonstrate the high impact that using this unique portable device will have on a parabolic trough solar power plant.

Life cycle assessment of a road safety product made with virgin and recycled HDPE.

PubMed

Simões, Carla L; Xará, Susana M; Bernardo, C A

2011-04-01

The present study aims at evaluating the potential environmental impact of using recycled high-density polyethylene (HDPE) in the production of an anti-glare lamella (AGL), a road safety device currently manufactured from virgin (not recycled) polymer. The impact was evaluated using the life cycle assessment (LCA) technique and comparing two alternative systems: current AGL, manufactured from virgin HDPE, and optional AGL, made with recycled HDPE obtained from post-consumer packages. The AGL manufacturing phase was found to be responsible for most of the impacts in both systems, with the production of the raw material being the largest contributor for that phase. The present study makes a contribution to the problem of developing value-added products made from post-consumer polymeric recyclates.

Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke.

PubMed

Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea

2018-03-01

In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

PubMed

Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

2014-10-01

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

Investigation of rough surfaces on Cu2ZnSn(SxSe1-x)4 monograin layers using light beam induced current measurements

NASA Astrophysics Data System (ADS)

Neubauer, Christian; Babatas, Ertug; Meissner, Dieter

2017-11-01

Monograin technology has proven to be a successful way of manufacturing low cost photovoltaic applications using the pentanary Cu2ZnSn(SxSe1-x)4 (CZTSSe) as an absorber material in an industrial roll-to-roll process. For high efficient CZTSSe monograin device fabrication a thorough understanding of the impacts of the device characteristics and surface structure is important. A new evaluation method of Light Beam Induced Current (LBIC) images had to be developed to distinguish between different effects resulting from different surface orientations, grain sizes, packing densities and contacting areas. In this work we will show that with LBIC measurements it is possible to evaluate the quality and differences in produced CZTSSe monograin cells in a post-production and non-destructive step. The high spatial resolution evaluation allows investigating the homogeneity of single crystalline grains as well as certain areas of a CZTSSe device. By introducing a statistical method the active area as a major factor for the current density of a device will be calculated and evaluated. The results show that with LBIC measurements the active area can be quantified, which differs for the investigated cells up to 9%. Additionally, the homogeneity of short circuit current densities of the monograins and also of certain areas of a cell can be detected and quantified.

30 CFR 18.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... facilitate inspection and maintenance. (b) MSHA will test only electrical equipment that in the opinion of... shall be accessible for field inspection, where practicable. (e) An audible warning device shall be...

30 CFR 18.20 - Quality of material, workmanship, and design.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES... facilitate inspection and maintenance. (b) MSHA will test only electrical equipment that in the opinion of... shall be accessible for field inspection, where practicable. (e) An audible warning device shall be...

Effectiveness of a personalized device in the evaluation of mandibular second molar periodontal healing after surgical extraction of adjacent third molar.

PubMed

Pippi, Roberto

2013-01-01

The primary aim of the present study was to validate the effectiveness of a personalized device able to guide periodontal probing in evaluation of second molar periodontal healing after adjacent third molar surgical extraction. Secondarily, the study analyzed if any patient and tooth related factors affected the second molar periodontal healing as well as if they were able to affect the periodontal probing depth performed with or without the personalized device. Thirty-five lower second molars were evaluated after extraction of the adjacent third molar. Pre-operative as well as 3 and 12 month post-operative probing depths of the distal surface of the second molar were evaluated. All measurements were taken by two different methods: standard two-point and four-point probing using a personalized onlay-type guide. Periapical radiographs were also evaluated. The Pearson product moment and the general linear model with backward stepwise procedure were used for inferential statistics. The mean 12-month post-operative probing depth/mean pre-operative probing depth ratio obtained with the guided probing method showed a highly significant effect on the 12-month radiographic post-operative/pre-operative radiographic measure ratio. None of the examined patient- or tooth-related factors showed a significant effect on pre-operative/12-month post-operative radiographic measure ratio. The use of the proposed personalized device seems to provide a more reliable estimate of second molar periodontal healing after adjacent third molar surgical extraction. No patient-or tooth-related factors seem to be able to affect either second molar periodontal healing or probing depth measures obtained with or without the personalized device in individuals younger than 25 years old. It can be therefore recommended that lower third molar surgical extraction be performed in young adults.

Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

PubMed

Beall, Reed F; Nickerson, Jason W; Kaplan, Warren A; Attaran, Amir

2016-01-01

Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents. Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years). Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.

Development of fluorescence based handheld imaging devices for food safety inspection

NASA Astrophysics Data System (ADS)

Lee, Hoyoung; Kim, Moon S.; Chao, Kuanglin; Lefcourt, Alan M.; Chan, Diane E.

2013-05-01

For sanitation inspection in food processing environment, fluorescence imaging can be a very useful method because many organic materials reveal unique fluorescence emissions when excited by UV or violet radiation. Although some fluorescence-based automated inspection instrumentation has been developed for food products, there remains a need for devices that can assist on-site inspectors performing visual sanitation inspection of the surfaces of food processing/handling equipment. This paper reports the development of an inexpensive handheld imaging device designed to visualize fluorescence emissions and intended to help detect the presence of fecal contaminants, organic residues, and bacterial biofilms at multispectral fluorescence emission bands. The device consists of a miniature camera, multispectral (interference) filters, and high power LED illumination. With WiFi communication, live inspection images from the device can be displayed on smartphone or tablet devices. This imaging device could be a useful tool for assessing the effectiveness of sanitation procedures and for helping processors to minimize food safety risks or determine potential problem areas. This paper presents the design and development including evaluation and optimization of the hardware components of the imaging devices.

[Requirements for CE-marking of apps and wearables].

PubMed

Berensmann, Michael; Gratzfeld, Markus

2018-03-01

Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve a Notified Body. For the conformity assessment procedure according to annex II, the manufacturer implements a full quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.

Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration

DTIC Science & Technology

2015-12-01

Radiological Health ( CDRH ) to clarify the designation of the hydrogel. As a result of this meeting, steps required for an IND for the keratin...the Center for Biologics Evaluation Research (CBER), and the Center for Devices and Radiological Health 8 ( CDRH ) to clarify the designation of the...application to the CDRH for a new product. This new product is the material that is produced in the validated manufacturing facility at KeraNetics. This

Production and evaluation of measuring equipment for share viscosity of polymer melts included nanofiller with injection molding machine

NASA Astrophysics Data System (ADS)

Kameda, Takao; Sugino, Naoto; Takei, Satoshi

2016-10-01

Shear viscosity measurement device was produced to evaluate the injection molding workability for high-performance resins. Observation was possible in shear rate from 10 to 10000 [1/sec] that were higher than rotary rheometer by measuring with a plasticization cylinder of the injection molding machine. The result of measurements extrapolated result of a measurement of the rotary rheometer.

Perceived Benefits of Mobile Learning Devices for Doctoral Students in a School of Allied Health Professions.

PubMed

Cotter, J James; Gendron, T; Kupstas, P; Tartaglia, A; Will, L

2015-01-01

Graduate students increasingly use personal electronic devices for learning but little is known about how they evaluate their benefits as mobile learning devices (MLDs). This study surveyed students in a hybrid distance education doctoral (PhD) program about their perceptions of the benefits of MLDs. Overall, the study found a range of opinions about the value of MLDs with about one-half of respondents finding benefits. Respondents emphasized that the MLDs improved motivation and productivity and that they were helpful in reviewing course-casts of on-campus sessions. Continued research is needed on doctoral education in general and the increasing use of innovations such as MLDs.

Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry.

PubMed

Geissler, Norman; Byrnes, Trevor; Lauer, Wolfgang; Radermacher, Klaus; Kotzsch, Susanne; Korb, Werner; Hölscher, Uvo M

2013-02-01

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.

Establishment of a public docket for medical device/radiological health policy statements and operating procedure guides--FDA. Notice.

PubMed

1993-07-27

The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.

Evaluation of Measurement Tools for Tobacco Product Displays: Is there an App for that?

PubMed Central

Combs, Todd B.; Moreland-Russell, Sarah; Roche, Jason

2015-01-01

Tobacco product displays are a pervasive presence in convenience stores, supermarkets, pharmacies, and other retailers nationwide. The influence that tobacco product displays have on purchases and tobacco product initiation, particularly on young people and other vulnerable populations, is well known. An objective measurement tool that is valid, reliable, and feasible to use is needed to assess product displays in the retail setting. This study reports on the relative accuracy of various tools that measure area and/or distance in photos and thus could be applied to product displays. We compare results of repeated trials using five tools. Three tools are smartphone apps that measure objects in photos taken on the device; these are narrowed down from a list of 284 candidate apps. Another tool uses photos taken with any device and calculates relative area via a built-in function in the Microsoft Office Suite. The fifth uses photos taken with the Narrative Clip, a “life-logging” wearable camera. To evaluate validity and reliability, we assess each instrument's measurements and calculate intra-class correlation coefficients. Mean differences between observed measurements (via tape measure) and those from the five tools range from just over one square foot to just over two square feet. Most instruments produce reliable estimates though some are sensitive to the size of the display. Results of this study indicate need for future research to test innovative measurement tools. This paper also solicits further discussion on how best to transform anecdotal knowledge of product displays as targeted and disproportionate marketing tactics into a scientific evidence base for public policy change. PMID:29188220

A two-dimensional (2D) analytical subthreshold swing and transconductance model of underlap dual-material double-gate (DMDG) MOSFET for analog/RF applications

NASA Astrophysics Data System (ADS)

Narendar, Vadthiya; Rai, Saurabh; Tiwari, Siddharth; Mishra, R. A.

2016-12-01

The double-gate (DG) metal-oxide-semiconductor field effect transistors (MOSFETs) are the choice of technology in sub -100 nm regime of leading microelectronics industry. To enhance the analog and RF performance of DG MOSFET, an underlap dual-material (DM) DG MOSFET device structure has been considered because, it has the advantages of both underlap as well as that of dual-material gate (DMG). A 2D analytical surface potential, subthreshold current, subthreshold swing as well as transconductance modelling of underlap DMDG MOSFET has been done by solving the Poisson's equation. It has also been found that, numerically simulated data approves the analytically modelled data with commendable accuracy. As underlap length (Lun) increases, a substantial reduction of subthreshold current due to enhanced gate control over channel regime is observed. DMG structure facilitates to improve the average velocity of carriers which leads to superior drive current of the device. The underlap DMDG MOSFET device structure demonstrates an ameliorated subthreshold characteristic. The analog figure of merits (FOMs) such as transconductance (gm), transconductance generation factor (TGF), output conductance (gd), early voltage (VEA), intrinsic gain (AV) and RF FOMs namely cut-off frequency (fT), gain frequency product (GFP), transconductance frequency product (TFP) and gain transconductance frequency product (GTFP) have been evaluated. The aforesaid analysis revels that, the device is best suited for communication related Analog/RF applications.

Laboratory Tests

MedlinePlus

... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures In Vitro Diagnostics Tests Used In Clinical Care Tests Used In Clinical Care ...

30 CFR 23.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Definitions. 23.2 Section 23.2 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TELEPHONES AND SIGNALING DEVICES § 23.2 Definitions. (a) Adequate means appropriate and sufficient, as determined by mutual agreement o...

Environmental Technology Verification, Baghouse Filtration Products TTG Inc., TG800 Filtration Media (Tested August 2012)

EPA Science Inventory

Baghouses are air pollution control devices used to control particulate emissions from stationary sources and are among the technologies evaluated by the APCT Center. Baghouses and their accompanying filter media have long been one of the leading particulate control techniques fo...

Donaldson Company, Inc., Dura-Life #0701607 Filtration Media(Tested October 2011) (ETV Baghouse Filtration Products) Verification Report

EPA Science Inventory

Baghouses are air pollution control devices used to control particulate emissions from stationary sources and are among the technologies evaluated by the APCT Center. Baghouses and their accompanying filter media have long been one of the leading particulate control techniques fo...

Environmental Technology Verification; Baghouse Filtration Products TTG Inc., TG100 Filtration Media (Tested August 2012)

EPA Science Inventory

Baghouses are air pollution control devices used to control particulate emissions from stationary sources and are among the technologies evaluated by the APCT Center. Baghouses and their accompanying filter media have long been one of the leading particulate control techniques fo...

Evaluation of a mobile steam applicator for soil disinfestation in California strawberry

USDA-ARS?s Scientific Manuscript database

Steam-disinfestation of soil as an alternative to chemical fumigation was investigated in both research and commercial strawberry production field trials at four sites over two years (2011-2013) using new prototype commercial application equipment: a tractor-drawn device that physically mixed the st...

Integration of a mechanical forebody vortex control system into the F-15

NASA Technical Reports Server (NTRS)

Boalbey, Richard E.; Citurs, Kevin D.; Ely, Wayne L.; Harbaugh, Stephen P.; Hollingsworth, William B.; Phillips, Ronald L.

1994-01-01

The goal of the F-15 Forebody Vortex Control (FVC) program is to develop a production FVC system for the F-15. The system may consist of either a mechanically actuated device such as the strakes developed for the HARV program, or a pneumatic device such as the port blowing system being tested on the X-29. Both types of systems are being evaluated under this program. Background information on the F-15 and a description and overview of forebody vortex controls (FVC) will be presented.

Application of Multipurpose Cadastre to Evaluate Energy Security of Land Parcel (Case Study: Gedung A and Gedung B, Institut Teknologi Sumatra)

NASA Astrophysics Data System (ADS)

Alif, S. M.; Nugroho, A. P.; Leksono, B. E.

2018-03-01

Energy security has one of its dimensions: Short-term energy security which focuses on the ability of the energy system to react promptly to sudden changes within the supply-demand balance. Non-energy components (such as land parcel) that comprise an energy system are analysed comprehensively with other component to measure energy security related to energy supply. Multipurpose cadastre which is an integrated land information system containing legal, physical, and cultural is used to evaluate energy (electrical energy) security of land parcel. The fundamental component of multipurpose cadastre used to evaluate energy security is attribute data which is the value of land parcel facilities. Other fundamental components (geographic control data, base map data, cadastral data) are used as position information and provide weight in room (part of land parcel) valuation. High value-room means the room is comfortable and/or used productively by its occupant. The method of valuation is by comparing one facility to other facilities. Facilities included in room valuation are relatively static items (such as chair, desk, and cabinet) except lamps and other electronic devices. The room value and number of electronic devices which consume electrical energy are correlated with each other. Consumption of electrical energy of electronic devices in the room with average value remains constant while consumption in other room needs to be evaluated to save the energy. The result of this research shows that room value correlate weakly with number of electronic device in corresponding room. It shows excess energy consumed in low-value room. Although numbers of electronic devices do not always mean the consumption of electrical energy and there are plenty electronic devices, it is recommended for occupant to be careful in utilizing electronic devices in low-value room to minimize energy consumption.

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

PubMed Central

Beall, Reed F.; Nickerson, Jason W.; Kaplan, Warren A.; Attaran, Amir

2016-01-01

Background Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. Materials and Methods We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents. Results Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years). Conclusion Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable. PMID:26910128

76 FR 29006 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... Effects Devices and Image Display Devices and Components and Products Containing Same; Notice of... United States after importation of certain motion-sensitive sound effects devices and image display... devices and image display devices and components and products containing same that infringe one or more of...

78 FR 68091 - Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-898] Certain Marine Sonar Imaging Devices... importation of certain marine sonar imaging devices, products containing the same, and components thereof by... marine sonar imaging devices, products containing the same, and components thereof by reason of...

[The principle of registration, evaluation and testing of disinfecting preparations].

PubMed

Röhm-Rodowald, Ewa; Jakimiak, Bozenna; Podgórska, Marta

2008-01-01

Disinfectants are used to produce a state in which the number of living micro-organisms has been reduced to a level which is appropriate to the practical situation. For any products which are included in the Biocidal Directive 98/8/EC, for which specific activity is claimed, test data has to be approved by the regulatory authority and a product license obtained before the product can be offered for sale. Disinfectants can be recorded as biocidal products or medical devices. Presently, it is possible to measure the activity of a product on defined micro-organisms in specified experimental conditions. Efficacy is the result of the use of a product according to a defined application. To allow different requirements in different areas of application, separate tests and pass criteria have been or will be prepared for each of following three areas of application: medical, veterinary and group comprising food, industrial, domestic and institutional areas. The laboratory methods to be used for testing the activity of chemical disinfectants meets the European standards. The tests are categorised on a modular basis as follows: phase 1 tests, phase 2 step 1 tests, phase 2 step 2 tests and phase 3 tests. In order to claim that a product has disinfectant properties, suitable for use in the medical area, the product shall be tested according to European standards: phase 2 step 1 tests, phase 2 step 2 tests. Phase 1 tests are not required to support claims for chemical disinfectants used in human medicine. Only phase 1 tests are required to support claims for active substances for which no particular area of application is specified. Medical devices are subjects to the European Directive 93/42/EEC which requires that a product must carry a CE mark. Disinfectants which are intended specifically by its manufacturer to be used on medical devices are themselves medical devices and so these products, as well as conforming to the instrument disinfection European standards as specified in EN 14885, are also required to carry a CE mark.

An in vitro method for detecting chemical sensitization using human reconstructed skin models and its applicability to cosmetic, pharmaceutical, and medical device safety testing.

PubMed

McKim, James M; Keller, Donald J; Gorski, Joel R

2012-12-01

Chemical sensitization is a serious condition caused by small reactive molecules and is characterized by a delayed type hypersensitivity known as allergic contact dermatitis (ACD). Contact with these molecules via dermal exposure represent a significant concern for chemical manufacturers. Recent legislation in the EU has created the need to develop non-animal alternative methods for many routine safety studies including sensitization. Although most of the alternative research has focused on pure chemicals that possess reasonable solubility properties, it is important for any successful in vitro method to have the ability to test compounds with low aqueous solubility. This is especially true for the medical device industry where device extracts must be prepared in both polar and non-polar vehicles in order to evaluate chemical sensitization. The aim of this research was to demonstrate the functionality and applicability of the human reconstituted skin models (MatTek Epiderm(®) and SkinEthic RHE) as a test system for the evaluation of chemical sensitization and its potential use for medical device testing. In addition, the development of the human 3D skin model should allow the in vitro sensitization assay to be used for finished product testing in the personal care, cosmetics, and pharmaceutical industries. This approach combines solubility, chemical reactivity, cytotoxicity, and activation of the Nrf2/ARE expression pathway to identify and categorize chemical sensitizers. Known chemical sensitizers representing extreme/strong-, moderate-, weak-, and non-sensitizing potency categories were first evaluated in the skin models at six exposure concentrations ranging from 0.1 to 2500 µM for 24 h. The expression of eight Nrf2/ARE, one AhR/XRE and two Nrf1/MRE controlled gene were measured by qRT-PCR. The fold-induction at each exposure concentration was combined with reactivity and cytotoxicity data to determine the sensitization potential. The results demonstrated that both the MatTek and SkinEthic models performed in a manner consistent with data previously reported with the human keratinocyte (HaCaT) cell line. The system was tested further by evaluating chemicals known to be associated with the manufacture of medical devices. In all cases, the human skin models performed as well or better than the HaCaT cell model previously evaluated. In addition, this study identifies a clear unifying trigger that controls both the Nrf2/ARE pathway and essential biochemical events required for the development of ACD. Finally, this study has demonstrated that by utilizing human reconstructed skin models, it is possible to evaluate non-polar extracts from medical devices and low solubility finished products.

Evaluation of Two Models of Non-Penetrating Captive Bolt Devices for On-Farm Euthanasia of Turkeys

PubMed Central

Woolcott, Caitlin R.; Torrey, Stephanie; Serpa, Lilia; Schwean-Lardner, Karen; Widowski, Tina M.

2018-01-01

Simple Summary Animal care guidelines for livestock and poultry require farms to have euthanasia plans in place for birds that are sick, injured, or unable to access feed and water. Killing methods considered to be humane are those that induce rapid insensibility (stun) and result in brain death leading to irreversible respiratory and cardiac arrest. Therefore, the evaluation of the effectiveness of a killing method generally focuses on measures of insensibility and brain death. Non-penetrating captive bolt devices are intended to deliver sufficient force and energy to the head to result in immediate insensibility and brain death without penetrating the skin. We evaluated the effectiveness of two models of non-penetrating captive bolt devices when applied by stock people to different sizes and ages of turkeys, using signs of insensibility corroborated by ante- and post- mortem evaluation of brain damage. Both non-penetrating captive bolt devices used in this study were found to be highly effective at inducing immediate insensibility and would be appropriate for on-farm euthanasia of turkeys of various ages and size. Abstract On-farm euthanasia is a critical welfare issue in the poultry industry and can be particularly difficult to perform on mature turkeys due to their size. We evaluated the efficacy of two commercially available non-penetrating captive bolt devices, the Zephyr-EXL and the Turkey Euthanasia Device (TED), on 253 turkeys at three stages of production: 4–5, 10, and 15–20 weeks of age. Effectiveness of each device was measured using both ante- and post-mortem measures. Application of the Zephyr-EXL resulted in a greater success rate (immediate abolishment of brainstem reflexes) compared to the TED (97.6% vs. 89.3%, p = 0.0145). Times to last movement (p = 0.102) and cardiac arrest (p = 0.164) did not differ between devices. Ante- and post-mortem measures of trauma and hemorrhage were highly correlated. Skull fractures and gross subdural hemorrhage (SDH) were present in 100% of birds euthanized with both the Zephyr-EXL and TED devices. Gross SDH scores were greater in birds killed with the Zephyr-EXL than the TED (p < 0.001). Microscopic SDH scores indicated moderate to severe hemorrhage in 92% of turkeys for the Zephyr-EXL and 96% of turkeys for the TED, with no difference between devices (p = 0.844). Overall, both devices were highly effective inducing immediate insensibility through traumatic brain injury and are reliable, single-step methods for on-farm euthanasia of turkeys. PMID:29558419

Home Use Tests

MedlinePlus

... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures In Vitro Diagnostics Home Use Tests Home Use Tests Share Tweet Linkedin Pin it ...

Feasibility and Limitations of Vaccine Two-Dimensional Barcoding Using Mobile Devices.

PubMed

Bell, Cameron; Guerinet, Julien; Atkinson, Katherine M; Wilson, Kumanan

2016-06-23

Two-dimensional (2D) barcoding has the potential to enhance documentation of vaccine encounters at the point of care. However, this is currently limited to environments equipped with dedicated barcode scanners and compatible record systems. Mobile devices may present a cost-effective alternative to leverage 2D vaccine vial barcodes and improve vaccine product-specific information residing in digital health records. Mobile devices have the potential to capture product-specific information from 2D vaccine vial barcodes. We sought to examine the feasibility, performance, and potential limitations of scanning 2D barcodes on vaccine vials using 4 different mobile phones. A unique barcode scanning app was developed for Android and iOS operating systems. The impact of 4 variables on the scan success rate, data accuracy, and time to scan were examined: barcode size, curvature, fading, and ambient lighting conditions. Two experimenters performed 4 trials 10 times each, amounting to a total of 2160 barcode scan attempts. Of the 1832 successful scans performed in this evaluation, zero produced incorrect data. Five-millimeter barcodes were the slowest to scan, although only by 0.5 seconds on average. Barcodes with up to 50% fading had a 100% success rate, but success rate deteriorated beyond 60% fading. Curved barcodes took longer to scan compared with flat, but success rate deterioration was only observed at a vial diameter of 10 mm. Light conditions did not affect success rate or scan time between 500 lux and 20 lux. Conditions below 20 lux impeded the device's ability to scan successfully. Variability in scan time was observed across devices in all trials performed. 2D vaccine barcoding is possible using mobile devices and is successful under the majority of conditions examined. Manufacturers utilizing 2D barcodes should take into consideration the impact of factors that limit scan success rates. Future studies should evaluate the effect of mobile barcoding on workflow and vaccine administrator acceptance.

Incorporating patient-preference evidence into regulatory decision making.

PubMed

Ho, Martin P; Gonzalez, Juan Marcos; Lerner, Herbert P; Neuland, Carolyn Y; Whang, Joyce M; McMurry-Heath, Michelle; Hauber, A Brett; Irony, Telba

2015-10-01

Patients have a unique role in deciding what treatments should be available for them and regulatory agencies should take their preferences into account when making treatment approval decisions. This is the first study designed to obtain quantitative patient-preference evidence to inform regulatory approval decisions by the Food and Drug Administration Center for Devices and Radiological Health. Five-hundred and forty United States adults with body mass index (BMI) ≥ 30 kg/m(2) evaluated tradeoffs among effectiveness, safety, and other attributes of weight-loss devices in a scientific survey. Discrete-choice experiments were used to quantify the importance of safety, effectiveness, and other attributes of weight-loss devices to obese respondents. A tool based on these measures is being used to inform benefit-risk assessments for premarket approval of medical devices. Respondent choices yielded preference scores indicating their relative value for attributes of weight-loss devices in this study. We developed a tool to estimate the minimum weight loss acceptable by a patient to receive a device with a given risk profile and the maximum mortality risk tolerable in exchange for a given weight loss. For example, to accept a device with 0.01 % mortality risk, a risk tolerant patient will require about 10 % total body weight loss lasting 5 years. Patient preference evidence was used make regulatory decision making more patient-centered. In addition, we captured the heterogeneity of patient preferences allowing market approval of effective devices for risk tolerant patients. CDRH is using the study tool to define minimum clinical effectiveness to evaluate new weight-loss devices. The methods presented can be applied to a wide variety of medical products. This study supports the ongoing development of a guidance document on incorporating patient preferences into medical-device premarket approval decisions.

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

Tropkin, S. N.; Tlyasheva, R. R.; Bayazitov, M. I.; Kuzeev, I. R.

2018-03-01

Equipment of many oil and gas processing plants in the Russian Federation is considerably worn-out. This causes the decrease of reliability and durability of equipment and rises the accident rate. An air explosion is the one of the most dangerous cases for plants in oil and gas industry, usually caused by uncontrolled emission and inflammation of oil products. Air explosion can lead to significant danger for life and health of plant staff, so it necessitates safety device usage. A new type of a safety device is designed. Numerical simulation is necessary to analyse design parameters and performance of the safety device, subjected to air blast loading. Coupled fluid-structure interaction analysis is performed to determine strength of the protective device and its performance. The coupled Euler-Lagrange method, allowable in Abaqus by SIMULIA, is selected as the most appropriate analysis tool to study blast wave interaction with the safety device. Absorption factors of blast wave are evaluated for the safety device. This factors allow one to assess efficiency of the safety device, and its main structural component – dampener. Usage of CEL allowed one to model fast and accurately the dampener behaviour, and to develop the parametric model to determine safety device sizes.

76 FR 5206 - In the Matter of Certain Game Devices, Components Thereof, and Products Containing the Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-757] In the Matter of Certain Game Devices... importation of certain game devices, components thereof, and products containing the same by reason of... certain game devices, components thereof, and products containing the same that infringe one or more of...

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

21 CFR 25.34 - Devices and electronic products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

21 CFR 25.34 - Devices and electronic products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

21 CFR 25.34 - Devices and electronic products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

21 CFR 25.34 - Devices and electronic products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

21 CFR 25.34 - Devices and electronic products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

Early effects of extracorporeal shock wave treatment on osteoblast-like cells: a comparative study between electromagnetic and electrohydraulic devices.

PubMed

Martini, Lucia; Giavaresi, Gianluca; Fini, Milena; Borsari, Veronica; Torricelli, Paola; Giardino, Roberto

2006-11-01

Extracorporeal shockwave therapy (ESWT) has been increasingly applied to treat orthopedic and musculoskeletal pathologies. ESWT involves mechanical perturbations that, as with other physical therapies, can result in mechanical stimuli to a large number of cells, including bone cells. The aim of this study was to evaluate the effects of shock waves on osteoblast-like cells (MG63) when using two different generators of shock waves (electrohydraulic and electromagnetic devices), in terms of cell damage, cell viability, osteogenic phenotype expression, and cytokine production. MG63 cells were suspended in 1.5 mL screw-cap cryotubes (1 x 10 cells/mL), containing phosphate buffer solution (PBS), which were maintained at 37 degrees C during all the experimental times. Two levels of energy flux density (EFD) were evaluated for each device: 0.15 to 0.18 mJ/mm2 and 0.40 mJ/mm2. Cells were then cultivated for 72 hours starting from a concentration of 1 x 10 cells/mL, and biological activity and viability were evaluated 24 and 72 hours after treatment. The results obtained demonstrate that the factors most affecting osteoblast activity involve both the device and the level of EFD selected, and they must be considered all together. The use of the electromagnetic device and a level of EFD lower than 0.40 mJ/mm2 would appear to induce fewer immediate cytodestructive effects and better stimulate subsequent proliferation and the synthetic activity of MG63.

Advanced membrane devices. Interim report for October 1996--September 1997

DOE Office of Scientific and Technical Information (OSTI.GOV)

Laciak, D.V.; Langsam, M.; Lewnard, J.J.

1997-12-31

Under this Cooperative Agreement, Air Products and Chemicals, Inc. has continued to investigate and develop improved membrane technology for removal of carbon dioxide from natural gas. The task schedule for this reporting period included a detailed assessment of the market opportunity (Chapter 2), continued development and evaluation of membranes and membrane polymers (Chapter 3) and a detailed economic analysis comparing the potential of Air Products membranes to that of established acid gas removal processes (Chapter 4).

Lustre Distributed Name Space (DNE) Evaluation at the Oak Ridge Leadership Computing Facility (OLCF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Simmons, James S.; Leverman, Dustin B.; Hanley, Jesse A.

This document describes the Lustre Distributed Name Space (DNE) evaluation carried at the Oak Ridge Leadership Computing Facility (OLCF) between 2014 and 2015. DNE is a development project funded by the OpenSFS, to improve Lustre metadata performance and scalability. The development effort has been split into two parts, the first part (DNE P1) providing support for remote directories over remote Lustre Metadata Server (MDS) nodes and Metadata Target (MDT) devices, while the second phase (DNE P2) addressed split directories over multiple remote MDS nodes and MDT devices. The OLCF have been actively evaluating the performance, reliability, and the functionality ofmore » both DNE phases. For these tests, internal OLCF testbed were used. Results are promising and OLCF is planning on a full DNE deployment by mid-2016 timeframe on production systems.« less

Ultrasound for the evaluation of stenosis after flow diversion.

PubMed

McDougall, Cameron M; Khan, Khurshid; Saqqur, Maher; Jack, Andrew; Rempel, Jeremy; Derksen, Carol; Xi, Yin; Chow, Michael

2018-03-01

Flow diversion is a relatively new strategy used to treat complex cerebral aneurysms. The optimal method for radiographic follow-up of patients treated with flow diverters has not been established. The rate and clinical implications of in-stent stenosis for these devices is unclear. We evaluate the use of transcranial Doppler ultrasound (TCD) for follow-up of in-stent stenosis. We analyzed 28 patients treated with the Pipeline embolization device (PED) over the course of 42 months from January 2009 to June 2012. Standard conventional cerebral angiograms were performed in all patients. TCD studies were available in 23 patients. Angiographic and TCD results were compared and found to correlate well. TCD is a potentially useful adjunct for evaluating in-stent stenosis after flow diversion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

21 CFR 814.19 - Product development protocol (PDP).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA under...

Device for preparing combinatorial libraries in powder metallurgy.

PubMed

Yang, Shoufeng; Evans, Julian R G

2004-01-01

This paper describes a powder-metering, -mixing, and -dispensing mechanism that can be used as a method for producing large numbers of samples for metallurgical evaluation or electrical or mechanical testing from multicomponent metal and cermet powder systems. It is designed to make use of the same commercial powders that are used in powder metallurgy and, therefore, to produce samples that are faithful to the microstructure of finished products. The particle assemblies produced by the device could be consolidated by die pressing, isostatic pressing, laser sintering, or direct melting. The powder metering valve provides both on/off and flow rate control of dry powders in open capillaries using acoustic vibration. The valve is simple and involves no relative movement, avoiding seizure with fine powders. An orchestra of such valves can be arranged on a building platform to prepare multicomponent combinatorial libraries. As with many combinatorial devices, identification and evaluation of sources of mixing error as a function of sample size is mandatory. Such an analysis is presented.

Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

PubMed

Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini

2009-01-01

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

Design and evaluation of a nondestructive fissile assay device for HTGR fuel samples

DOE Office of Scientific and Technical Information (OSTI.GOV)

McNeany, S. R.; Knoll, R. W.; Jenkins, J. D.

1979-02-01

Nondestructive assay of fissile material plays an important role in nuclear fuel processing facilities. Information for product quality control, plant criticality safety, and nuclear materials accountability can be obtained from assay devices. All of this is necessary for a safe, efficient, and orderly operation of a production plant. Presented here is a design description and an operational evaluation of a device developed to nondestructively assay small samples of High-Temperature Gas-Cooled Reactor (HTGR) fuel. The measurement technique employed consists in thermal-neutron irradiation of a sample followed by pneumatic transfer to a high-efficiency neutron detector where delayed neutrons are counted. In general,more » samples undergo several irradiation and count cycles during a measurement. The total number of delayed-neutron counts accumulated is translated into grams of fissile mass through comparison with the counts accumulated in an identical irradiation and count sequence of calibration standards. Successful operation of the device through many experiments over a one-year period indicates high operational reliability. Tests of assay precision show this to be better than 0.25% for measurements of 10 min. Assay biases may be encountered if calibration standards are not representative of unknown samples, but reasonable care in construction and control of standards should lead to no more than 0.2% bias in the measurements. Nondestructive fissile assay of HTGR fuel samples by thermal-neutron irradiation and delayed-neutron detection has been demonstrated to be a rapid and accurate analysis technique. However, careful attention and control must be given to calibration standards to see that they remain representative of unknown samples.« less

Evaluation of the spectra Optia® mononuclear cell collection procedure in multiple myeloma patients.

PubMed

Long, Gwynn; Waller, Edmund K; Gregurek, Steven; Tricot, Guido; Marschner, Susanne; Bill, Jerry

2015-02-01

Peripheral blood stem cell (PBSC) rescue following myeloablative therapy is a mainstay of cancer therapy. To evaluate the ability of the Spectra Optia Apheresis System (SO), a newly developed apheresis device, the device was studied in multiple myeloma patients undergoing a first autologous PBSC transplant. To demonstrate that neutrophil recovery was not inferior to historical controls when SO harvested PBSCs were reinfused following myeloablative therapy. Multiple myeloma patients were mobilized according to the standard practice at four clinical sites. Following mobilization, MNC collections were performed on the SO. The collected cells were cryopreserved and reinfused following myeloablative chemotherapy. Neutrophil recovery defined by an absolute neutrophil count exceeding 500/μL (ANC500) was compared to historical data for patients transplanted following apheresis using the COBE Spectra (CS) device. The median day to neutrophil recovery was 12 days (range 10-14 days), with no significant difference in engraftment comparing patients transplanted with stem cells collected using the SO versus historical cohort of patients collected with the CS. CD34+ cell and MNC collection efficiency (CE) were 69.3% and 65.0% for the SO and CS, respectively. Platelet CE, product hematocrit and product granulocytes (as % of WBCs) using the SO were 21%, 2.3% and 28%, respectively. There were no device-related severe adverse events. The study's results confirm that the Spectra Optia Apheresis System's MNC Collection Protocol is safe and effective for its intended use and that engraftment kinetics of cells collected by SO is not inferior to the CS System. © 2014 Wiley Periodicals, Inc.

Collaboration of chemistry instructional games and group investigation (Gi) model to improve learning outcome in high school students

NASA Astrophysics Data System (ADS)

Puspita, Ita; Sugiyarto, Kristian H.; Ikhsan, Jaslin

2017-05-01

The aims of this research are to: (1) develop chemistry instructional games on reaction rate matter; and (2) reveal the collaboration of chemistry instructional games and group investigation model to improvement learning outcome in high school student. This study is research and development (R&D). The procedure of developing product was adapted from Borg & Gall that modified into three principal steps: product planning, product developing, and product evaluating. The product planning step consist of field study, literature study, and manufacturing product. Product developing was developed product using Adobe Flash Professional CS 6 program. The last, product evaluating was performed by year XI of high school students, uses experimental methods nonequivalent control-group design by control class and experiment class. The results of this research show that: (1) a software of chemistry instructional games successfully developed using Adobe Flash Professional CS 6 and can be run on Android device; and (2) the test results of students showed that the collaboration of instructional games and group investigation model able to improvement learning outcome of hight school student.

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

DOE Office of Scientific and Technical Information (OSTI.GOV)

Connor, Michael J.; Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California; Marshall, Deborah C.

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact).more » Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer–user training may help mitigate these events.« less

On the Use of the Platelet Activity State Assay for the In Vitro Quantification of Platelet Activation in Blood Recirculating Devices for Extracorporeal Circulation.

PubMed

Consolo, Filippo; Valerio, Lorenzo; Brizzola, Stefano; Rota, Paolo; Marazzato, Giulia; Vincoli, Valentina; Reggiani, Stefano; Redaelli, Alberto; Fiore, Gianfranco

2016-10-01

We designed an experimental setup to characterize the thrombogenic potential associated with blood recirculating devices (BRDs) used in extracorporeal circulation (ECC). Our methodology relies on in vitro flow loop platelet recirculation experiments combined with the modified-prothrombinase platelet activity state (PAS) assay to quantify the bulk thrombin production rate of circulated platelets, which correlates to the platelet activation (PA) level. The method was applied to a commercial neonatal hollow fiber membrane oxygenator. In analogous hemodynamic environment, we compared the PA level resulting from multiple passes of platelets within devices provided with phosphorylcholine (PC)-coated and noncoated (NC) fibers to account for flow-related mechanical factors (i.e., fluid-induced shear stress) together with surface contact activation phenomena. We report for the first time that PAS assay is not significantly sensitive to the effect of material coating under clinically pertinent flow conditions (500 mL/min), while providing straightforward information on shear-mediated PA dynamics in ECC devices. Being that the latter is intimately dependent on local flow dynamics, according to our results, the rate of thrombin production as measured by the PAS assay is a valuable biochemical marker of the selective contribution of PA in BRDs induced by device design features. Thus, we recommend the use of PAS assay as a means of evaluating the effect of modification of specific device geometrical features and/or different design solutions for developing ECC devices providing flow conditions with reduced thrombogenic impact. Copyright © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Evaluation of Skylab (EREP) data for forest and rangeland surveys

Treesearch

Robert C. Aldrich

1976-01-01

Data products from the Skylab Earth Resources Experiment Package were examined monocularly or stereoscopically using a variety of magnifying interpretation devices. Land use, forest types, physiographic sites, and plant communities, as well as forest stress, were interpreted and mapped at sites in Georgia, South Dakota, and Colorado. Microdensitometric techniques and...

Reverse Engineering Course at Philadelphia University in Jordan

ERIC Educational Resources Information Center

Younis, M. Bani; Tutunji, T.

2012-01-01

Reverse engineering (RE) is the process of testing and analysing a system or a device in order to identify, understand and document its functionality. RE is an efficient tool in industrial benchmarking where competitors' products are dissected and evaluated for performance and costs. RE can play an important role in the re-configuration and…

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

30 CFR 7.88 - Test to determine the gaseous ventilation rate.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY Diesel Engines... engine to the dynamometer and attach the sampling and measurement devices specified in § 7.86. (2) A... zeroed and spanned at the analyzer range to be used prior to testing. (4) Run the engine. (i) The...

Adolescent use of electronic nicotine delivery systems.

PubMed

Vincent, Debra; Potts, Jeanne; Durbin, Jessica; Moore, Jill M; Eley, Susan

2018-03-12

Use of electronic nicotine delivery systems is flourishing among adolescents. The long-term effects have not been fully determined; however, literature suggests there is potential for significant harm. Providers must be aware of usage trends, device safety, and product knowledge. Adolescents should be evaluated through routine screening, and cessation counseling should be initiated.

30 CFR 35.21 - Temperature-pressure spray-ignition tests.

Code of Federal Regulations, 2010 CFR

2010-07-01

... device shall be provided. (c) Test procedures. (1) A 21/2-quart sample of the fluid shall be poured into... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Temperature-pressure spray-ignition tests. 35..., EVALUATION, AND APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS Test Requirements § 35.21...

LEAD LEACHING FROM IN-LINE BRASS DEVICES: A CRITICAL EVALUATION OF THE EXISTING STANDARD

EPA Science Inventory

The ANSI/NSF 61, Section 8 standard is intended to protect the public from in-line brass plumbing products that might leach excessive levels of lead to potable water. Experiments were conducted to examine the practical rigor of this test. Contrary to expectations, the test was no...

Validation and calibration of a TDLAS oxygen sensor for in-line measurement on flow-packed products

NASA Astrophysics Data System (ADS)

Cocola, L.; Fedel, M.; Allermann, H.; Landa, S.; Tondello, G.; Bardenstein, A.; Poletto, L.

2016-05-01

A device based on Tunable Diode Laser Absorption Spectroscopy has been developed for non-invasive evaluation of gaseous oxygen concentration inside packed food containers. This work has been done in the context of the SAFETYPACK European project in order to enable full, automated product testing on a production line. The chosen samples at the end of the manufacturing process are modified atmosphere bags of processed mozzarella, in which the target oxygen concentration is required to be below 5%. The spectrometer allows in-line measurement of moving samples which are passing on a conveyor belt, with an optical layout optimized for bags made of a flexible scattering material, and works by sensing the gas phase in the headspace at the top of the package. A field applicable method for the calibration of this device has been identified and validated against traditional, industry standard, invasive measurement techniques. This allows some degrees of freedom for the end-user regarding packaging dimensions and shape. After deployment and setup of the instrument at the end-user manufacturing site, performance has been evaluated on a different range of samples in order to validate the choice of electro optical and geometrical parameters regarding sample handling and measurement timing at the actual measurement conditions.

A comparative study: use of a Brain-computer Interface (BCI) device by people with cerebral palsy in interaction with computers.

PubMed

Heidrich, Regina O; Jensen, Emely; Rebelo, Francisco; Oliveira, Tiago

2015-01-01

This article presents a comparative study among people with cerebral palsy and healthy controls, of various ages, using a Brain-computer Interface (BCI) device. The research is qualitative in its approach. Researchers worked with Observational Case Studies. People with cerebral palsy and healthy controls were evaluated in Portugal and in Brazil. The study aimed to develop a study for product evaluation in order to perceive whether people with cerebral palsy could interact with the computer and compare whether their performance is similar to that of healthy controls when using the Brain-computer Interface. Ultimately, it was found that there are no significant differences between people with cerebral palsy in the two countries, as well as between populations without cerebral palsy (healthy controls).

Implementing AORN recommended practices for hand hygiene.

PubMed

Patrick, Marcia; Van Wicklin, Sharon A

2012-04-01

This article focuses on implementing the revised AORN "Recommended practices for hand hygiene in the perioperative setting." The content of the document has been expanded and reorganized from the previous iteration and now includes specific activity statements about water temperature, water and soap dispensing controls, the type of dispensers to use, paper towel dispenser requirements, placement of soap and rub dispensers, and regulatory requirements for products and recommendations for hand hygiene practices. A successful hand hygiene program allows end users to have input into the selection and evaluation of products and should include educating personnel about proper hand hygiene, product composition and safety, and how and when to use specific products. Measures for competency evaluation and compliance monitoring include observations, quizzes, skills labs, electronic monitoring systems, handheld device applications, and data collection forms. Copyright © 2012 AORN, Inc. Published by Elsevier Inc. All rights reserved.

A Roundtable Discussion: Combination Products: Twice the Challenge?

PubMed

Baird, Nolan; Binion, Steven B; Cammack, Jon; Paine, Stephanie Del; Gonzales, Rosemary; Passut, Jena; Weiner, John Barlow Barr

2015-01-01

Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective July 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.

New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.

PubMed

Nagai, Sumimasa; Ozawa, Keiya

2017-01-01

In Japan, the Pharmaceuticals and Medical Devices Law was passed in 2014. In this new law, regenerative medical products were defined, and a conditional and term-limited approval system only for regenerative medical products was instituted. Therefore, regenerative medical products can be approved based on phase I and/or II trials. Gene therapy and adoptive cellular therapy are categorized as regenerative medical products. This law is intended for registration trials for marketing authorization. The Act on the Safety of Regenerative Medicine was also implemented in 2014. This act is intended for clinical research and medical practice involving processed cells other than registration trials. Under this act, a review of plans on medical treatments or clinical studies by a certified committee and submission of the plans to the Ministry of Health, Labour and Welfare (MHLW) are mandatory. The MHLW instituted the SAKIGAKE (meaning a pioneer or forerunner in Japanese) designation system in 2015. This designation is similar to the breakthrough therapy designation in the US and PRIME in the EU. In addition, the MHLW started the "Project for Enhanced Practical Application of Innovative Drugs, Medical Devices and Regenerative Medical Products" to promote personnel exchange and cooperation in writing of guidelines on the evaluation of innovative medical products between the Pharmaceuticals and Medical Devices Agency and academia. Some new guidelines regarding gene and cellular therapy were published. In this review, we comprehensively described these complicated regulations and problems to be solved in order to facilitate global readers' understanding of Japanese regulatory frameworks. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Evaluation of Ultra-Violet Photocatalytic Oxidation (UVPCO) forIndoor Air Applications: Conversion of Volatile Organic Compounds at LowPart-per-Billion Concentrations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hodgson, Alfred T.; Sullivan, Douglas P.; Fisk, William J.

2005-09-30

Efficient removal of indoor generated airborne particles and volatile organic compounds (VOCs) in office buildings and other large buildings may allow for a reduction in outdoor air supply rates with concomitant energy savings while still maintaining acceptable indoor air quality in these buildings. Ultra-Violet Photocatalytic Oxidation (UVPCO) air cleaners have the potential to achieve the necessary reductions in indoor VOC concentrations at relatively low cost. In this study, laboratory experiments were conducted with a scaled, prototype UVPCO device designed for use in a duct system. The experimental UVPCO contained two 30 by 30-cm honeycomb monoliths coated with titanium dioxide andmore » 3% by weight tungsten oxide. The monoliths were irradiated with 12 UVC lamps arranged in four banks. The UVPCO was challenged with four mixtures of VOCs typical of mixtures encountered in indoor air. A synthetic office mixture contained 27 VOCs commonly measured in office buildings. A cleaning product mixture contained three cleaning products with high market shares. A building product mixture was created by combining sources including painted wallboard, composite wood products, carpet systems, and vinyl flooring. A fourth mixture contained formaldehyde and acetaldehyde. Steady-state concentrations were produced in a classroom laboratory or a 20-m{sup 3} environmental chamber. Air was drawn through the UVPCO, and single pass conversion efficiencies were measured from replicate air samples collected upstream and downstream of the reactor section. Concentrations of the mixtures were manipulated, with concentrations of individual VOCs mostly maintained below 10 ppb. Device flow rates were varied between 165 and 580 m{sup 3}/h. Production of formaldehyde, acetaldehyde, acetone, formic acid, and acetic acid as reaction products was investigated. Conversion efficiency data were generated for 48 individual VOCs or groups of closely related compounds. Alcohols and glycol ethers were the most reactive chemical classes with conversion efficiencies often near or above 70% at the low flow rate and near 40% at the high flow rate. Ketones and terpene hydrocarbons were somewhat less reactive. The relative VOC conversion rates are generally favorable for treatment of indoor air since many contemporary products used in buildings employ oxygenated solvents. A commercial UVPCO device likely would be installed in the supply air stream of a building and operated to treat both outdoor and recirculated air. Assuming a recirculation rate comparable to three times the normal outdoor air supply rate, simple mass-balance modeling suggests that a device with similar characteristics to the study unit has sufficient conversion efficiencies for most VOCs to compensate for a 50% reduction in outdoor air supply without substantially impacting indoor VOC concentrations. Formaldehyde, acetaldehyde, acetone, formic acid, and acetic acid were produced in these experiments as reaction byproducts. No other significant byproducts were observed. A coupled steady-state mass balance model is presented and applied to VOC data from a study of a single office building. For the operating assumptions described above, the model estimated a three-fold increase in indoor formaldehyde and acetaldehyde concentrations. The outcome of this limited assessment suggests that evaluation of the potential effects of the operation of a UVPCO device on indoor concentrations of these contaminants is warranted. Other suggested studies include determining VOC conversion efficiencies in actual buildings and evaluating changes in VOC conversion efficiency as monoliths age with long-term operation.« less

Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.

PubMed

Edwards, Eric S; Edwards, Evan T; Simons, F Estelle R; North, Robert

2015-05-01

The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: 'human factors engineering,' 'human factors,' 'medical products,' 'epinephrine/adrenaline auto-injector,' 'healthcare' and 'patient safety.' This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.

An evaluation of 2 new devices for nasal high-flow gas therapy.

PubMed

Waugh, Jonathan B; Granger, Wesley M

2004-08-01

The traditional nasal cannula with bubble humidifier is limited to a maximum flow of 6 L/min to minimize the risk of complications. We conducted a bench study of 2 new Food and Drug Administration-approved nasal cannula/humidifier products designed to deliver at flows> 6 L/min. Using a digital psychrometer we measured the relative humidity and temperature of delivered gas from each device, at 5 L/min increments over the specified functional high-flow range. The Salter Labs unit achieved 72.5-78.7% relative humidity (5-15 L/min range) at ambient temperature (21-23 degrees C). The Vapotherm device achieved 99.9% relative humidity at a temperature setting of 37 degrees C (5-40 L/min). Both devices meet minimum humidification standards and offer practical new treatment options. The patient-selection criteria are primarily the severity of the patient's condition and cost.

Attenuation length measurements of a liquid scintillator with LabVIEW and reliability evaluation of the device

NASA Astrophysics Data System (ADS)

Gao, Long; Yu, Bo-Xiang; Ding, Ya-Yun; Zhou, Li; Wen, Liang-Jian; Xie, Yu-Guang; Wang, Zhi-Gang; Cai, Xiao; Sun, Xi-Lei; Fang, Jian; Xue, Zhen; Zhang, Ai-Wu; Lü, Qi-Wen; Sun, Li-Jun; Ge, Yong-Shuai; Liu, Ying-Biao; Niu, Shun-Li; Hu, Tao; Cao, Jun; Lü, Jun-Guang

2013-07-01

An attenuation length measurement device was constructed using an oscilloscope and LabVIEW for signal acquisition and processing. The performance of the device has been tested in a variety of ways. The test results show that the set-up has a good stability and high precision (sigma/mean reached 0.4 percent). Besides, the accuracy of the measurement system will decrease by about 17 percent if a filter is used. The attenuation length of a gadolinium-loaded liquid scintillator (Gd-LS) was measured as 15.10±0.35 m where Gd-LS was heavily used in the Daya Bay Neutrino Experiment. In addition, one method based on the Beer-Lambert law was proposed to investigate the reliability of the measurement device, the R-square reached 0.9995. Moreover, three purification methods for Linear Alkyl Benzene (LAB) production were compared in the experiment.

75 FR 34482 - Certain Biometric Scanning Devices, Components Thereof, Associated Software, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

..., Components Thereof, Associated Software, and Products Containing the Same; Notice of Investigation AGENCY: U... scanning devices, components thereof, associated software, and products containing the same by reason of... after importation of certain biometric scanning devices, components thereof, associated software, or...

Conceptual achievement of 1GBq activity in a Plasma Focus driven system.

PubMed

Tabbakh, Farshid; Sadat Kiai, Seyed Mahmood; Pashaei, Mohammad

2017-11-01

This is an approach to evaluate the radioisotope production by means of typical dense plasma focus devices. The production rate of the appropriate positron emitters, F-18, N-13 and O-15 has been studied. The beam-target mechanism was simulated by GEANT4 Monte Carlo tool using QGSP_BIC and QGSP_INCLXX physic models as comparison. The results for positron emitters have been evaluated by reported experimental data and found conformity between simulations and experimental reports that leads to using this code as a reliable tool in optimizing the DPF driven systems for achieving to 1GBq activity of produced radioisotope. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluation of the incorporation ratio of ZnO, PbO and CdO into cement clinker.

PubMed

Barros, A M; Tenório, J A S; Espinosa, D C R

2004-08-09

Zinc, lead, and cadmium are minor elements that might be brought by wastes to the cement kilns. This work studies the incorporation ratio of ZnO, PbO, and CdO when they are added to the clinker raw material. The cement raw material used in this work was prepared by mixing pure compounds, this choice was made to avoid the effect of other elements and provide a better understanding of the behavior of these metals during the clinkering process. The samples contained additions of 0.05, 0.10, 0.30, 0.50, 0.80 and 1.00 wt.% of a specific oxide (ZnO, PbO, or CdO) to the clinker raw-meal. The chlorine influence in the ZnO incorporation ratio was also evaluated. A device to simulate the thermal cycle imposed on the charge during the clinker production was used to evaluate the incorporation ratio of these oxides as well as thermogravimetric tests. The products of the tests in the simulator device were submitted to X-ray fluorescence chemical analysis or energy disperse scanning (EDS) microprobe analysis. The results led to the conclusions that the evaporation of Zn in cements kilns is due to the chlorine content and the Pb and Cd incorporation ratio stands around 50 wt.%.

Cybersecurity for Connected Diabetes Devices

PubMed Central

Klonoff, David C.

2015-01-01

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. PMID:25883162

Cybersecurity for Connected Diabetes Devices.

PubMed

Klonoff, David C

2015-04-16

Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. © 2015 Diabetes Technology Society.

The Effects of Mobile-Computer-Supported Collaborative Learning: Meta-Analysis and Critical Synthesis.

PubMed

Sung, Yao-Ting; Yang, Je-Ming; Lee, Han-Yueh

2017-08-01

One of the trends in collaborative learning is using mobile devices for supporting the process and products of collaboration, which has been forming the field of mobile-computer-supported collaborative learning (mCSCL). Although mobile devices have become valuable collaborative learning tools, evaluative evidence for their substantial contributions to collaborative learning is still scarce. The present meta-analysis, which included 48 peer-reviewed journal articles and doctoral dissertations written over a 16-year period (2000-2015) involving 5,294 participants, revealed that mCSCL has produced meaningful improvements for collaborative learning, with an overall mean effect size of 0.516. Moderator variables, such as domain subject, group size, teaching method, intervention duration, and reward method were related to different effect sizes. The results provided implications for future research and practice, such as suggestions on how to appropriately use the functionalities of mobile devices, how to best leverage mCSCL through effective group learning mechanisms, and what outcome variables should be included in future studies to fully elucidate the process and products of mCSCL.

The Influence of Internal Structures in Fused Deposition Modeling Method on Dimensional Accuracy of Components

NASA Astrophysics Data System (ADS)

Milde, Ján; Morovič, Ladislav

2016-09-01

The paper investigates the influence of infill (internal structures of components) in the Fused Deposition Modeling (FDM) method on dimensional and geometrical accuracy of components. The components in this case were real models of human mandible, which were obtained by Computed Tomography (CT) mostly used in medical applications. In the production phase, the device used for manufacturing, was a 3D printer Zortrax M200 based on the FDM technology. In the second phase, the mandibles made by the printer, were digitized using optical scanning device of GOM ATOS Triple Scan II. They were subsequently evaluated in the final phase. The practical part of this article describes the procedure of jaw model modification, the production of components using a 3D printer, the procedure of digitization of printed parts by optical scanning device and the procedure of comparison. The outcome of this article is a comparative analysis of individual printed parts, containing tables with mean deviations for individual printed parts, as well as tables for groups of printed parts with the same infill parameter.

The Effects of Mobile-Computer-Supported Collaborative Learning: Meta-Analysis and Critical Synthesis

PubMed Central

Sung, Yao-Ting; Yang, Je-Ming; Lee, Han-Yueh

2017-01-01

One of the trends in collaborative learning is using mobile devices for supporting the process and products of collaboration, which has been forming the field of mobile-computer-supported collaborative learning (mCSCL). Although mobile devices have become valuable collaborative learning tools, evaluative evidence for their substantial contributions to collaborative learning is still scarce. The present meta-analysis, which included 48 peer-reviewed journal articles and doctoral dissertations written over a 16-year period (2000–2015) involving 5,294 participants, revealed that mCSCL has produced meaningful improvements for collaborative learning, with an overall mean effect size of 0.516. Moderator variables, such as domain subject, group size, teaching method, intervention duration, and reward method were related to different effect sizes. The results provided implications for future research and practice, such as suggestions on how to appropriately use the functionalities of mobile devices, how to best leverage mCSCL through effective group learning mechanisms, and what outcome variables should be included in future studies to fully elucidate the process and products of mCSCL. PMID:28989193

Way for LEEPL technology to succeed in memory device application

NASA Astrophysics Data System (ADS)

Kim, In-Sung; Woo, Sang-Gyun; Cho, Han-Ku; Han, Woo-Sung; Moon, Joo-Tae

2004-05-01

Lithography for 65nm-node device is drawing a lot of attentions these days especially because lithography solution for this node is not clear and even tool makers tend to wait for the consensus in lithography roadmap to avoid the risk of erroneous amount of investment. Recently proposed concept of low energy electron-beam proximity-projection lithography (LEEPL)1,2 technology has already released its first production machine in 2003, which is being expected to cover the design rule down to 65nm-node and even smaller3. Although production of semiconductor device has been pursuing optical lithography, without any optical technology that is proved as a convincing solution for 65nm node and below, we need to take account of all the candidates. So we made an investigation on LEEPL technology and evaluated beta and first production tool to see the feasibility of printing sub-70nm resolution and of optic-first mix-and-match overlay from a chip maker"s point of view. Two different kinds of stencil masks were fabricated for the evaluation, which are fabricated in SiC and Si membrane. The former mask is for sparse contact holes(C/H) and the latter for dense C/Hs. Beta-tool showed a good resolving power of sub-70nm sparse C/Hs of SRAM with negligibly small proximity effect. It implies that LEEPL does not require much effort for proximity correction comparing to that required in optical lithography, which is one of the biggest issues in low-k1. LEEPL also showed a good capability of optic-first mix-and-match overlay correction and this is the most stringent and important functionality for optic-first mix-and-match application. However random intra-membrane image placement(IP) error that is a little bit larger than the requirement for sub-70nm node was observed, which is interpreted to come from the larger stress of 100MPa in 3X3mm2 dry-etched SiC unit membrane. For dense C/Hs, we failed, to the contrary, to obtain any good quality of stencil masks for DRAM cell patterns because of e-beam proximity effect which is unavoidable in the reversed order of front-side forward direct writing and back-side later membrane formation. Pros and cons of LEEPL technology are discussed based on the evaluation results and estimation from the memory device standpoint. We also propose a novel concept of stencil mask that can be helpful in memory device application.

Evaluation of a polymer implanted port access device.

PubMed

Brown, J M

1996-01-01

The implanted port vascular access system has provided many patients with safe and reliable vascular access. Its implanted design provides improved body image, reduced maintenance and a better quality of life. The Huber needle has been the standard means of accessing the implanted port system. Because of the problems associated with the Huber needle system, current standards recommend that the Huber needle be changed every 7 days. This evaluation examines the use of a polymer cannula to access the implanted port system. This polymer cannula eliminates many of the problems associated with the Huber needle and provides longer dwell times without increased complications. Seventy nine patients were accessed for a total of 1533 days with the mean dwell time being 19.4 days with no increase in complications associated with port access. To establish implanted port access times of greater than 7 days without increased complications. A multicenter voluntary enrollment evaluation of a medical device. Patients were offered the opportunity to participate in the evaluation if they had an implanted port and were going to be accessed for therapy for periods of 7 days or more. Patients were observed for adverse cutaneous reactions at the insertion site and any port access complications such as sepsis, leakage, changes in portal chamber integrity, and implant pocket integrity. From October 1994 through November 1995, 79 L-Cath for Ports (Luther Medical Products) polymer catheter port access devices (Illustration 1) were inserted in 54 patients. This polymer port access device was used instead of a rigid metal Huber needle for port access. The total number of access days was 1533 days with the mean duration of access being 19.4 days. Two patients experienced blood stream infections while they were accessed with the polymer port access device. These infections ensued with fever of unknown origin as the presenting symptom during neutropenic episodes after chemotherapy treatment. The port access device was removed and the port access device tip was cultured with culture results being negative. No other patients experienced complications related to the port access device. The polymer port access device provided a safe and effective means of extending port access times. This reduced the number of restarts for the patients and could extend portal septum life by exposing the portal septum to fewer accesses.

Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence.

PubMed

Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David

2016-01-01

Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.

Safe Eats - Eating Out and Bringing In

MedlinePlus

... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Resources for ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

The Measurement of Airflow Using Singing Helmet That Allows Free Movement of the Jaw.

PubMed

Jiang, Jack J; Hanna, Rewais B; Willey, Malachi V; Rieves, Adam

2016-11-01

Airflow measurement is a useful method of evaluating laryngeal physiology. We introduce a noninvasive device that measures airflow without restricting jaw movement or requiring phonation into a mouthpiece, thus facilitating measurement during singing and connected speech. Validation and human subject trials were conducted. Airflow measurements were obtained from 16 male and 16 female subjects during singing, speech, and constant vowel production tasks. A similar helmet was designed by Stevens and Mead in 1968. The new device validity was evaluated by comparing the measured volume of air to a known volume of administered air using a calibration syringe. Subjects were asked to voice sustained vowels at low, medium, and high vocal intensity, read two sentences at a conversational volume, and perform different singing exercises while airflow was recorded. The device accurately and reliably measured airflow with mean airflow values falling within previously published ranges. There was an experimentally determined response time of 0.173 ± 0.014 seconds. Subjects were able to comfortably perform speech and singing exercises. Male subjects had higher airflow for all sustained vowels (P < 0.05). Airflow was higher for abduction rather than adduction sentences (P < 0.05). No other portable device has been shown to measure airflow during singing and speech while allowing for free movement of the jaw. This device provides a more natural environment to measure airflow that could be used to help evaluate laryngeal function and aid in singing training. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

78 FR 15682 - Notification of Proposed Production Activity TTI, Inc.; Subzone 196A (Electromechanical and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... Activity TTI, Inc.; Subzone 196A (Electromechanical and Circuit Protection Devices Production/ Kitting... electromechanical and circuit protection device production/kitting for a variety of commercial, aerospace and... for crimping, insertion/extraction, and terminal removal, and electromechanical devices (duty rates...

77 FR 24738 - Certain Wireless Communication Devices and Systems, Components Thereof, and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... Devices and Systems, Components Thereof, and Products Containing Same; Notice of Commission Determination... certain wireless communication devices and systems, components thereof, and products containing the same..., California; Apple Inc. of Cupertino, California; Aruba Networks, Inc. of Sunnyvale, California; Meru Networks...

76 FR 69285 - Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-757] Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To Review An Initial Determination Granting... the United States after importation of certain game devices, components thereof, and products...

Design control considerations for biologic-device combination products.

PubMed

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting development of innovative, safe and effective combination products. It remains the manufacturer's responsibility to comply with the relevant requirements and regulations, and develop good business practices that clearly describe how these practices comply with FDA's final rule (21 CFR Part 4) and aligns with the company's already established quality system. Copyright © 2017 Elsevier B.V. All rights reserved.

Reconstituting factor concentrates: Defining Evidence of Coaching Non-Experts (DEVICE) in haemophilia--a prospective randomized feasibility study.

PubMed

Bidlingmaier, C; Kurnik, K; Hölscher, G; Kappler, M

2007-09-01

The introduction of new needleless devices as demanded by the US Department of Labor Occupational Safety and Health Administration (OSHA) has caused problems with the reconstitution of antihaemophilic factor in emergency situations. Our aim therefore was to evaluate the feasibility of a needleless device for reconstitution of antihaemophilic factor for non-haemophilia experts and to define evidence of the need for coaching these physicians via providing two additional photographs illustrating the two key points of the factor reconstitution process. Twenty-eight physicians of a tertiary care university children's hospital were randomized into two groups, either with no further explanation of the reconstitution device or with two additional photographs, showing the two key steps of the procedure. Reconstitution of dummy-factor concentrate was video-taped and evaluated by a blinded helper. Main outcome measure was the successful reconstitution of dummy-factor concentrate and procedure failure respectively. Of the group without explanation of the reconstitution device, only two of 14 physicians were able to reconstitute the dummy-factor concentrate. Of the group receiving two photographs, nine of 14 completed the task successfully (P = 0.0068). The needleless device is not self explaining to non-haemophilia physicians involved in emergency services. Coaching via short to the point instructions as provided by simple visual educational material therefore is crucial to enable these physicians to resolve the expensive emergency drug quickly and correctly. Companies concerned with the production of any devices to dissolve drugs, especially for treatment of rare diseases as haemophilia, therefore should take measures to simplify therapy.

Evaluation of the Spectra Optia apheresis system for mononuclear cell (MNC) collection in G-CSF mobilized and nonmobilized healthy donors: results of a multicenter study.

PubMed

Karafin, Matthew S; Graminske, Sharon; Erickson, Paulette; Walters, Mark C; Scott, Edward P; Carter, Scott; Padmanabhan, Anand

2014-10-01

The Spectra Optia apheresis system is a newer centrifugation-based device that in comparison with the COBE Spectra includes features that enhance procedure automation and usability. In this FDA-approved three-center two-arm observational study we characterized the performance of the Spectra Optia for collection of MNCs and CD34+ cells from nonmobilized and granulocyte-colony stimulating factor (G-CSF) mobilized healthy donors, respectively. There were a total of 15 evaluable subjects in each arm. Key performance indicators included collection efficiency of MNCs/CD34+ cells, product purity and cellular viability. For nonmobilized donors, median MNC collection efficiency, platelet collection efficiency, product hematocrit and granulocyte contamination were 57%, 12%, 4%, and 1.7%, respectively. For mobilized donors, median MNC collection efficiency, CD34+ cell collection efficiency, platelet collection efficiency, product hematocrit and granulocyte contamination were 61%, 77%, 19%, 4%, and 15%, respectively. Average WBC viability in the mobilized products was 99%. There was one severe (grade 3) adverse event related to citrate toxicity. This study demonstrates that the Spectra Optia can be used for safe and efficacious collection of MNCs, and results obtained are in line with expectations on collection efficiency and product characteristics. Adverse events were limited to those that are well documented in the stem-cell mobilization and leukapheresis process. As of the time of this writing, FDA 510(k) approval for use of the Spectra Optia device for MNC collection was achieved in the US based partly on the results of this study. © 2014 Wiley Periodicals, Inc.

Effectiveness of a personalized device in the evaluation of mandibular second molar periodontal healing after surgical extraction of adjacent third molar

PubMed Central

Pippi, Roberto

2013-01-01

Summary Aim The primary aim of the present study was to validate the effectiveness of a personalized device able to guide periodontal probing in evaluation of second molar periodontal healing after adjacent third molar surgical extraction. Secondarily, the study analyzed if any patient and tooth related factors affected the second molar periodontal healing as well as if they were able to affect the periodontal probing depth performed with or without the personalized device. Materials and methods Thirty-five lower second molars were evaluated after extraction of the adjacent third molar. Pre-operative as well as 3 and 12 month post-operative probing depths of the distal surface of the second molar were evaluated. All measurements were taken by two different methods: standard two-point and four-point probing using a personalized onlay-type guide. Periapical radiographs were also evaluated. The Pearson product moment and the general linear model with backward stepwise procedure were used for inferential statistics. Results The mean 12-month post-operative probing depth/mean pre-operative probing depth ratio obtained with the guided probing method showed a highly significant effect on the 12-month radiographic post-operative/pre-operative radiographic measure ratio. None of the examined patient- or tooth-related factors showed a significant effect on pre-operative/12-month post-operative radiographic measure ratio. Conclusions The use of the proposed personalized device seems to provide a more reliable estimate of second molar periodontal healing after adjacent third molar surgical extraction. No patient-or tooth-related factors seem to be able to affect either second molar periodontal healing or probing depth measures obtained with or without the personalized device in individuals younger than 25 years old. It can be therefore recommended that lower third molar surgical extraction be performed in young adults. PMID:24611086

Probability elicitation to inform early health economic evaluations of new medical technologies: a case study in heart failure disease management.

PubMed

Cao, Qi; Postmus, Douwe; Hillege, Hans L; Buskens, Erik

2013-06-01

Early estimates of the commercial headroom available to a new medical device can assist producers of health technology in making appropriate product investment decisions. The purpose of this study was to illustrate how this quantity can be captured probabilistically by combining probability elicitation with early health economic modeling. The technology considered was a novel point-of-care testing device in heart failure disease management. First, we developed a continuous-time Markov model to represent the patients' disease progression under the current care setting. Next, we identified the model parameters that are likely to change after the introduction of the new device and interviewed three cardiologists to capture the probability distributions of these parameters. Finally, we obtained the probability distribution of the commercial headroom available per measurement by propagating the uncertainty in the model inputs to uncertainty in modeled outcomes. For a willingness-to-pay value of €10,000 per life-year, the median headroom available per measurement was €1.64 (interquartile range €0.05-€3.16) when the measurement frequency was assumed to be daily. In the subsequently conducted sensitivity analysis, this median value increased to a maximum of €57.70 for different combinations of the willingness-to-pay threshold and the measurement frequency. Probability elicitation can successfully be combined with early health economic modeling to obtain the probability distribution of the headroom available to a new medical technology. Subsequently feeding this distribution into a product investment evaluation method enables stakeholders to make more informed decisions regarding to which markets a currently available product prototype should be targeted. Copyright © 2013. Published by Elsevier Inc.

Evaluating new health information technologies: expanding the frontiers of health care delivery and health promotion.

PubMed

Kreps, Gary L

2002-01-01

The modern health care system is being irrevocably changed by the development and introduction of new health information technologies (such as health information systems, decision-support tools, specialized websites, and innovative communication devices). While many of these new technologies hold the promise of revolutionizing the modern health system and facilitating improvements in health care delivery, health education, and health promotion, it is imperative to carefully examine and assess the effectiveness of these technological tools to determine which products are most useful to apply in specific contexts, as well as to learn how to best utilize these products and processes. Without good evaluative information about new technologies, we are unlikely to reap the greatest benefits from these powerful new tools. This chapter examines the demand for evaluating health information technologies and suggests several strategies for conducting rigorous and relevant evaluation research.

A comparison of sampling methods for a standing tree acoustic device

Treesearch

Jerry M. Mahon, Jr.; Lewis Jordan; Lawrence R. Schimleck; Alexander Clark, III; Richard F. Daniels

2009-01-01

One method of evaluating potential product performance is the use of acoustic tools for identifying trees with high stiffness. Acoustic velocities for 100 standing loblolly pine (Pinus taeda) trees, obtained with the transmitting and receiving probes placed on the same face and opposite faces, were compared. Significant differences in velocity between the two...

Defense Systems Modernization and Sustainment Initiative

DTIC Science & Technology

2014-03-31

research programs focus on sustainable production, sustainable energy, sustainable mobility , and ecologically friendly information technology systems...for Sustainable Mobility (CSM): focused on developing viable technologies for sustainable transportation systems and the support of complex equipment...utilization of mobile devices. The objective of the evaluation was to identify features that the new implementation of LEEDS would require, such as

Environmental Technology Verification Report and Statement for Baghouse Filtration Products, W. L. Gore & Associates, Inc. 5117 High Durability PPS Laminate Filtration Media (Tested March-April 2012)

EPA Science Inventory

Baghouses are air pollution control devices used to control particulate emissions from stationary sources and are among the technologies evaluated by the APCT Center. Baghouses and their accompanying filter media have long been one of the leading particulate control techniques fo...

77 FR 19933 - Bloodborne Pathogens Standard; Corrections and Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

... Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up...), or 1-2012 (77 FR 3912), as applicable, and 29 CFR 1911. All of subpart Z issued under section 6(b) of...) The type and brand of device involved in the incident, (B) The department or work area where the...

77 FR 31876 - Certain Consumer Electronics and Display Devices and Products Containing Same Determination Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-836] Certain Consumer Electronics and Display Devices and Products Containing Same Determination Not To Review Initial Determination To Amend... electronics and display devices and products containing the same by reason of infringement of U.S. Patent Nos...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2013 CFR

2013-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2010 CFR

2010-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2012 CFR

2012-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2014 CFR

2014-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

21 CFR 801.433 - Warning statements for prescription and restricted device products containing or manufactured...

Code of Federal Regulations, 2011 CFR

2011-04-01

... device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances... chlorofluorocarbons or other ozone-depleting substances. (a)(1) All prescription and restricted device products... environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible...

75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

...] Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life...), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide...

Cybersecurity and the Medical Device Product Development Lifecycle.

PubMed

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

77 FR 60721 - Certain Semiconductor Integrated Circuit Devices and Products Containing Same; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

... Circuit Devices and Products Containing Same; Notice of Commission Determination Not To Review an Initial... public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at http... certain semiconductor integrated circuit devices and products containing same by reason of infringement of...

Electrochromic devices and related products and methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

Snow, Timothy; McFadden, Judith; Tenent, Robert

2018-01-30

An electrochromic device may be switchable between a transparent state and at least one reflective state. A lithium-containing reflective feature may form when the electrochromic device is switched from the transparent state to the reflective state. Various products and methods may involve the electrochromic device.

The Evaluation of Efficiency of the Use of Machine Working Time in the Industrial Company - Case Study

NASA Astrophysics Data System (ADS)

Kardas, Edyta; Brožova, Silvie; Pustějovská, Pavlína; Jursová, Simona

2017-12-01

In the paper the evaluation of efficiency of the use of machines in the selected production company was presented. The OEE method (Overall Equipment Effectiveness) was used for the analysis. The selected company deals with the production of tapered roller bearings. The analysis of effectiveness was done for 17 automatic grinding lines working in the department of grinding rollers. Low level of efficiency of machines was affected by problems with the availability of machines and devices. The causes of machine downtime on these lines was also analyzed. Three basic causes of downtime were identified: no kanban card, diamonding, no operator. Ways to improve the use of these machines were suggested. The analysis takes into account the actual results from the production process and covers the period of one calendar year.

Evaluating a medical error taxonomy.

PubMed

Brixey, Juliana; Johnson, Todd R; Zhang, Jiajie

2002-01-01

Healthcare has been slow in using human factors principles to reduce medical errors. The Center for Devices and Radiological Health (CDRH) recognizes that a lack of attention to human factors during product development may lead to errors that have the potential for patient injury, or even death. In response to the need for reducing medication errors, the National Coordinating Council for Medication Errors Reporting and Prevention (NCC MERP) released the NCC MERP taxonomy that provides a standard language for reporting medication errors. This project maps the NCC MERP taxonomy of medication error to MedWatch medical errors involving infusion pumps. Of particular interest are human factors associated with medical device errors. The NCC MERP taxonomy of medication errors is limited in mapping information from MEDWATCH because of the focus on the medical device and the format of reporting.

Effectiveness of alternative listening devices to conventional hearing aids for adults with hearing loss: a systematic review protocol

PubMed Central

Barker, Alex B; Xia, Jun

2016-01-01

Introduction Hearing loss is a major public health concern, affecting over 11 million people in the UK. While hearing aids are the most common clinical intervention for hearing loss, the majority of people that would benefit from using hearing aids do not take them up. Recent technological advances have led to a rapid increase of alternative listening devices to conventional hearing aids. These include hearing aids that can be customised using a smartphone, smartphone-based ‘hearing aid’ apps, personal sound amplification products and wireless hearing products. However, no systematic review has been published evaluating whether alternative listening devices are an effective management strategy for people with hearing loss. Methods and analysis The objective of this systematic review is to assess whether alternative listening devices are an effective intervention for adults with hearing loss. Methods are reported according to the Preferred Reporting Items for Systematic reviews and Meta-analyses Protocols (PRISMA-P) 2015 checklist. Retrospective or prospective studies, randomised controlled trials, non-randomised controlled trials, and before-after comparison studies will be eligible for inclusion. We will include studies with adult participants (≥18 years) with a mild or moderate hearing loss. The intervention should be an alternative listening device to a conventional hearing aid (comparison). Studies will be restricted to outcomes associated with the consequences of hearing loss. We will search relevant databases to identify published, completed but unpublished and ongoing trials. The overall quality of included evidence will be evaluated using the GRADE system, and meta-analysis performed if appropriate. Ethics and dissemination No ethical issues are foreseen. The findings will be reported at national and international conferences, primarily audiology, and ear, nose and throat, and in a peer-reviewed journal using the PRISMA guidelines. Review registration number PROSPERO CRD4201502958. PMID:27789514

The development of neural stimulators: a review of preclinical safety and efficacy studies.

PubMed

Shepherd, Robert K; Villalobos, Joel; Burns, Owen; Nayagam, David

2018-05-14

Given the rapid expansion of the field of neural stimulation and the rigorous regulatory approval requirements required before these devices can be applied clinically, it is important that there is clarity around conducting preclinical safety and efficacy studies required for the development of this technology. The present review examines basic design principles associated with the development of a safe neural stimulator and describes the suite of preclinical safety studies that need to be considered when taking a device to clinical trial. Neural stimulators are active implantable devices that provide therapeutic intervention, sensory feedback or improved motor control via electrical stimulation of neural or neuro-muscular tissue in response to trauma or disease. Because of their complexity, regulatory bodies classify these devices in the highest risk category (Class III), and they are therefore required to go through a rigorous regulatory approval process before progressing to market. The successful development of these devices is achieved through close collaboration across disciplines including engineers, scientists and a surgical/clinical team, and the adherence to clear design principles. Preclinical studies form one of several key components in the development pathway from concept to product release of neural stimulators. Importantly, these studies provide iterative feedback in order to optimise the final design of the device. Key components of any preclinical evaluation include: in vitro studies that are focussed on device reliability and include accelerated testing under highly controlled environments; in vivo studies using animal models of the disease or injury in order to assess safety and, given an appropriate animal model, the efficacy of the technology under both passive and electrically active conditions; and human cadaver and ex vivo studies designed to ensure the device's form factor conforms to human anatomy, to optimise the surgical approach and to develop any specialist surgical tooling required. The pipeline from concept to commercialisation of these devices is long and expensive; careful attention to both device design and its preclinical evaluation will have significant impact on the duration and cost associated with taking a device through to commercialisation. Carefully controlled in vitro and in vivo studies together with ex vivo and human cadaver trials are key components of a thorough preclinical evaluation of any new neural stimulator. © 2018 IOP Publishing Ltd.

76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

...; formerly Docket No. 2007D-0290] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance...: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral...

76 FR 4375 - In the Matter of Certain MLC Flash Memory Devices and Products Containing Same; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-683] In the Matter of Certain MLC Flash Memory Devices and Products Containing Same; Notice of Commission Determination Not To Review an Initial... the United States after importation of certain MLC flash memory devices and products containing same...

Field evaluation of four spatial repellent devices against Arkansas rice-land mosquitoes.

PubMed

Dame, David A; Meisch, Max V; Lewis, Carolyn N; Kline, Daniel L; Clark, Gary G

2014-03-01

Four commercially available spatial repellent devices were tested in a rice-land habitat near Stuttgart, AR, after semi-field level assessments had been made at the Center for Medical, Agricultural, and Veterinary Entomology, Agricultural Research Service, US Department of Agriculture in Gainesville, FL. OFF! Clip-On(metofluthrin), Mosquito Cognito (linalool), No-Pest Strip (dichlorvos), and ThermaCELL (d-cisltrans allethrin) were selected for this study from >20 candidate products. The units based on metofluthrin, linalool, or d-cisltrans allethrin significantly reduced captures of 1 or more of the mosquito species at surrogate human sites (unlit Centers for Disease Control and Prevention traps with CO2 and octenol). Among the mosquito species analyzed statistically (Anopheles quadrimaculatus, Culex erraticus, and Psorophora columbiae), there were significantly different responses (up to 84% reduction) to individual products, suggesting that combinations of certain spatial repellents might provide significantly greater protection.

UWB EMI To Aircraft Radios: Field Evaluation on Operational Commercial Transport Airplanes. Volume 1

NASA Technical Reports Server (NTRS)

Oria, A. J. (Editor); Ely, Jay J.; Martin, Warren L.; Shaver, Timothy W.; Fuller, Gerald L.; Zimmerman, John; Fuschino, Robert L.; Larsen, William E.

2005-01-01

Ultrawideband (UWB) transmitters may soon be integrated into a wide variety of portable electronic devices (PEDs) that passengers routinely carry on board commercial airplanes. Airlines and the FAA will have difficulty controlling passenger use of UWB transmitters during flights with current airline policies and existing wireless product standards. The aeronautical community is concerned as to whether evolving FCC UWB rules are adequate to protect legacy and emerging aeronautical radio systems from electromagnetic interference (EMI) from emerging UWB products. To address these concerns, the NASA Office of Space Communications and Chief Spectrum Managers assembled a multidisciplinary team from NASA LaRC, NASA JPL, NASA ARC, FAA, United Airlines, Sky West Airlines, and Eagles Wings Inc. to carry out a comprehensive series of tests aimed at determining the nature and extent of any EMI to aeronautical communication and navigation systems from UWB devices meeting FCCapproved and proposed levels for unlicensed handheld transmitters.

Spectral tailoring device

DOEpatents

Brager, H.R.; Schenter, R.E.; Carter, L.L.; Karnesky, R.A.

1987-08-05

A spectral tailoring device for altering the neutron energy spectra and flux of neutrons in a fast reactor thereby selectively to enhance or inhibit the transmutation rate of a target metrical to form a product isotope. Neutron moderators, neutron filters, neutron absorbers and neutron reflectors may be used as spectral tailoring devices. Depending on the intended use for the device, a member from each of these four classes of materials could be used singularly, or in combination, to provide a preferred neutron energy spectra and flux of the neutrons in the region of the target material. In one embodiment of the invention, an assembly is provided for enhancing the production of isotopes, such as cobalt 60 and gadolinium 153. In another embodiment of the invention, a spectral tailoring device is disposed adjacent a target material which comprises long lived or volatile fission products and the device is used to shift the neutron energy spectra and flux of neutrons in the region of the fission products to preferentially transmute them to produce a less volatile fission product inventory. 6 figs.

NASA SBIR product catalog, 1991

NASA Technical Reports Server (NTRS)

1991-01-01

This catalog is a partial list of products of NASA SBIR (Small Business Innovation Research) projects that have advanced to some degree into Phase 3. While most of the products evolved from work conducted during SBIR Phase 1 and 2, a few advanced to commercial status solely from Phase 1 activities. The catalog presents information provided to NASA by SBIR contractors who wished to have their products exhibited at Technology 2001, a NASA-sponsored technology transfer conference held in San Jose, California, on December 4, 5, and 6, 1991. The catalog presents the product information in the following technology areas: computer and communication systems; information processing and AI; robotics and automation; signal and image processing; microelectronics; electronic devices and equipment; microwave electronic devices; optical devices and lasers; advanced materials; materials processing; materials testing and NDE; materials instrumentation; aerodynamics and aircraft; fluid mechanics and measurement; heat transfer devices; refrigeration and cryogenics; energy conversion devices; oceanographic instruments; atmosphere monitoring devices; water management; life science instruments; and spacecraft electromechanical systems.

Fabrication and evaluation of polymeric early-warning fire-alarm devices. [combustion products

NASA Technical Reports Server (NTRS)

Senturia, S. D.

1975-01-01

The electrical resistivities were investigated of some polymers known to be enhanced by the presence of certain gases. This was done to make a device capable of providing early warning to fire through its response with the gases produced in the early phases of combustion. Eight polymers were investigated: poly(phenyl acetylene), poly(p-aminophenyl acetylene), poly(p-nitrophenyl acetylene), poly(p-formamidophenyl acetylene), poly(ethynyl ferrocene), poly(ethynyl carborane), poly(ethynyl pyridine), and the polymer made from 1,2,3,6 tetramethyl pyridazine. A total of 40 usable thin-film sandwich devices and a total of 70 usable interdigitated-electrode lock-and-key devices were fabricated. The sandwich devices were used for measurements of contact linearity, polymer conductivity, and polymer dielectric constant. The lock-and-key devices were used to determine the response of the polymers to a spectrum of gases that included ammonia, carbon nonoxide, carbon dioxide, sulfur dioxide, ethylene, acrolein, water vapor, and normal laboratory air. Strongest responses were to water vapor, ammonia, and acrolein, and depending on the polymer, weaker responses to carbon dioxide, sulfur dioxide, and carbon monoxide were observed. A quantitative theory of device operation, capable of accounting for observed device leakage current and sensitivity, was developed. A prototype detection/alarm system was designed and built for use in demonstrating sensor performance.

A user-centred approach to requirements elicitation in medical device development: a case study from an industry perspective.

PubMed

Martin, Jennifer L; Clark, Daniel J; Morgan, Stephen P; Crowe, John A; Murphy, Elizabeth

2012-01-01

The healthcare industry is dependent upon the provision of well designed medical devices. To achieve this it is recommended that user-centred design should begin early, and continue throughout device development. This is a challenge, particularly for smaller companies who may lack the necessary expertise and knowledge. The aim of this study was to conduct a rigorous yet focused investigation into the user requirements for a new medical imaging device. Open-ended semi-structured interviews were conducted with potential clinical users of the device to investigate the clinical need for the device and the potential benefits for patients and clinical users. The study identified a number of new and significant clinical needs that suggested that the concept of the device should be fundamentally changed. The clinical and organisational priorities of the clinical users were identified, as well as a number of factors that would act as barriers to the safe and effective adoption of the device. The developers reported that this focused approach to early requirements elicitation would result in an improved product, reduce the time to market, and save the time and cost of producing and evaluating an inappropriate prototype. Copyright © 2011 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Drug-device combination products: regulatory landscape and market growth.

PubMed

Bayarri, L

2015-08-01

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

PubMed

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

A risk analysis for production processes with disposable bioreactors.

PubMed

Merseburger, Tobias; Pahl, Ina; Müller, Daniel; Tanner, Markus

2014-01-01

: Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.

Can Carbon Nanomaterials Improve CZTS Photovoltaic Devices? Evaluation of Performance and Impacts Using Integrated Life-Cycle Assessment and Decision Analysis.

PubMed

Scott, Ryan P; Cullen, Alison C; Fox-Lent, Cate; Linkov, Igor

2016-10-01

In emergent photovoltaics, nanoscale materials hold promise for optimizing device characteristics; however, the related impacts remain uncertain, resulting in challenges to decisions on strategic investment in technology innovation. We integrate multi-criteria decision analysis (MCDA) and life-cycle assessment (LCA) results (LCA-MCDA) as a method of incorporating values of a hypothetical federal acquisition manager into the assessment of risks and benefits of emerging photovoltaic materials. Specifically, we compare adoption of copper zinc tin sulfide (CZTS) devices with molybdenum back contacts to alternative devices employing graphite or graphene instead of molybdenum. LCA impact results are interpreted alongside benefits of substitution including cost reductions and performance improvements through application of multi-attribute utility theory. To assess the role of uncertainty we apply Monte Carlo simulation and sensitivity analysis. We find that graphene or graphite back contacts outperform molybdenum under most scenarios and assumptions. The use of decision analysis clarifies potential advantages of adopting graphite as a back contact while emphasizing the importance of mitigating conventional impacts of graphene production processes if graphene is used in emerging CZTS devices. Our research further demonstrates that a combination of LCA and MCDA increases the usability of LCA in assessing product sustainability. In particular, this approach identifies the most influential assumptions and data gaps in the analysis and the areas in which either engineering controls or further data collection may be necessary. © 2016 Society for Risk Analysis.

A model of user engagement in medical device development.

PubMed

Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal

2007-01-01

The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a "proving ground" study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions. A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds. Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n = 1 experimental design, generating quantitative outcomes data. There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.

Job Shop Scheduling Focusing on Role of Buffer

NASA Astrophysics Data System (ADS)

Hino, Rei; Kusumi, Tetsuya; Yoo, Jae-Kyu; Shimizu, Yoshiaki

A scheduling problem is formulated in order to consistently manage each manufacturing resource, including machine tools, assembly robots, AGV, storehouses, material shelves, and so on. The manufacturing resources are classified into three types: producer, location, and mover. This paper focuses especially on the role of the buffer, and the differences among these types are analyzed. A unified scheduling formulation is derived from the analytical results based on the resource’s roles. Scheduling procedures based on dispatching rules are also proposed in order to numerically evaluate job shop-type production having finite buffer capacity. The influences of the capacity of bottle-necked production devices and the buffer on productivity are discussed.

Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops.

PubMed

Craven, Michael P; Allsop, Matthew J; Morgan, Stephen P; Martin, Jennifer L

2012-09-03

With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one. This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.

Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops

PubMed Central

2012-01-01

Background With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. Methods A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. Results The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one. Conclusion This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE. PMID:22943625

Variability in syringe components and its impact on functionality of delivery systems.

PubMed

Rathore, Nitin; Pranay, Pratik; Eu, Bruce; Ji, Wenchang; Walls, Ed

2011-01-01

Prefilled syringes and autoinjectors are becoming increasingly common for parenteral drug administration primarily due to the convenience they offer to the patients. Successful commercialization of such delivery systems requires thorough characterization of individual components. Complete understanding of various sources of variability and their ranking is essential for robust device design. In this work, we studied the impact of variability in various primary container and device components on the delivery forces associated with syringe injection. More specifically, the effects of barrel size, needle size, autoinjector spring force, and frictional forces have been evaluated. An analytical model based on underlying physics is developed that can be used to fully characterize the design space for a product delivery system. Use of prefilled syringes (syringes prefilled with active drug) is becoming increasingly common for injectable drugs. Compared to vials, prefilled syringes offer higher dose accuracy and ease of use due to fewer steps required for dosage. Convenience to end users can be further enhanced through the use of prefilled syringes in combination with delivery devices such as autoinjectors. These devices allow patients to self-administer the drug by following simple steps such as pressing a button. These autoinjectors are often spring-loaded and are designed to keep the needle tip shielded prior to injection. Because the needle is not visible to the user, such autoinjectors are perceived to be less invasive than syringes and help the patient overcome the hesitation associated with self-administration. In order to successfully develop and market such delivery devices, we need to perform an in-depth analysis of the components that come into play during the activation of the device and dose delivery. Typically, an autoinjector is activated by the press of a button that releases a compressed spring; the spring relaxes and provides the driving force to push the drug out of the syringe and into the site of administration. Complete understanding of the spring force, syringe barrel dimensions, needle size, and drug product properties is essential for robust device design. It is equally important to estimate the extent of variability that exists in these components and the resulting impact it could have on the performance of the device. In this work, we studied the impact of variability in syringe and device components on the delivery forces associated with syringe injection. More specifically, the effect of barrel size, needle size, autoinjector spring force, and frictional forces has been evaluated. An analytical model based on underlying physics is developed that can be used to predict the functionality of the autoinjector.

Fiber optic lighting system for plant production

NASA Astrophysics Data System (ADS)

St. George, Dennis R.; Feddes, John J. R.

1991-02-01

Dennis St. George John Feddes (Dept. of Agricultural Engineering University of Alberta Edmonton AB Canada T6G 2Hl) A prototype light collection and transmission device was developed and evaluated for the potential of irradiating plants grown in an opague growth chamber. Results indicated that the device transmitted light with a photon flux of 130 1amol/s/m2 (4000-7000 nm) to the bottom of the growth chamber when direct solar radiation was 800 W/m2 (300-2500 nm) outside. The overall collection and transmission efficiency for photosynthetically active radiation is 19. 2. A growth trial with plants indicated that artificial lighting is required during cloudy periods. 1.

A Multimodal Deep Log-Based User Experience (UX) Platform for UX Evaluation

PubMed Central

Ali Khan, Wajahat; Hur, Taeho; Muhammad Bilal, Hafiz Syed; Ul Hassan, Anees; Lee, Sungyoung

2018-01-01

The user experience (UX) is an emerging field in user research and design, and the development of UX evaluation methods presents a challenge for both researchers and practitioners. Different UX evaluation methods have been developed to extract accurate UX data. Among UX evaluation methods, the mixed-method approach of triangulation has gained importance. It provides more accurate and precise information about the user while interacting with the product. However, this approach requires skilled UX researchers and developers to integrate multiple devices, synchronize them, analyze the data, and ultimately produce an informed decision. In this paper, a method and system for measuring the overall UX over time using a triangulation method are proposed. The proposed platform incorporates observational and physiological measurements in addition to traditional ones. The platform reduces the subjective bias and validates the user’s perceptions, which are measured by different sensors through objectification of the subjective nature of the user in the UX assessment. The platform additionally offers plug-and-play support for different devices and powerful analytics for obtaining insight on the UX in terms of multiple participants. PMID:29783712

A Multimodal Deep Log-Based User Experience (UX) Platform for UX Evaluation.

PubMed

Hussain, Jamil; Khan, Wajahat Ali; Hur, Taeho; Bilal, Hafiz Syed Muhammad; Bang, Jaehun; Hassan, Anees Ul; Afzal, Muhammad; Lee, Sungyoung

2018-05-18

The user experience (UX) is an emerging field in user research and design, and the development of UX evaluation methods presents a challenge for both researchers and practitioners. Different UX evaluation methods have been developed to extract accurate UX data. Among UX evaluation methods, the mixed-method approach of triangulation has gained importance. It provides more accurate and precise information about the user while interacting with the product. However, this approach requires skilled UX researchers and developers to integrate multiple devices, synchronize them, analyze the data, and ultimately produce an informed decision. In this paper, a method and system for measuring the overall UX over time using a triangulation method are proposed. The proposed platform incorporates observational and physiological measurements in addition to traditional ones. The platform reduces the subjective bias and validates the user's perceptions, which are measured by different sensors through objectification of the subjective nature of the user in the UX assessment. The platform additionally offers plug-and-play support for different devices and powerful analytics for obtaining insight on the UX in terms of multiple participants.

76 FR 55417 - In the Matter of Certain Dynamic Random Access Memory and Nand Flash Memory Devices and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... Access Memory and Nand Flash Memory Devices and Products Containing Same; Notice of Institution of... importation, and the sale within the United States after importation of certain dynamic random access memory and NAND flash memory devices and products containing same by reason of infringement of certain claims...

Postmarketing Surveillance for “Modified-Risk” Tobacco Products

PubMed Central

2012-01-01

Introduction: The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have “modified-risk” for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of marketing. Method: A narrative review approach was taken. The author searched and integrated publicly accessible literature on tobacco product surveillance as well as drug and medical device postmarket activities currently performed by FDA. Results: FDA relies on active and passive methods for postmarket surveillance and can require specific studies and risk evaluation and mitigation strategies for certain products, including those with abuse liability. Past efforts at examining the individual and population effects of reduced harm tobacco products provide an example of integrating different data streams. Discussion: Postmarket surveillance can be viewed in terms of the Agent–Host–Vector–Environment model, and concepts from diffusion of innovations are relevant to understanding factors associated with the adoption of new products by the population. Given that active and passive surveillance approaches have different strengths and weaknesses, multiple approaches may be necessary to evaluate population-level effects. Assuring that required studies are properly conducted and reported and that data indicating significant public health harms are quickly recognized will be important going forward. Conclusions: The advent of broad regulatory authority over tobacco provides opportunities for policy evaluation research. The research community can provide FDA with the independent science it needs to evaluate the public health impact of novel tobacco products. PMID:21330282

Evaluation of SAGE Electrochromic Devices: Cooperative Research and Development Final Report, CRADA Number CRD-15-579

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tenent, Robert C.

2017-12-06

NREL will conduct durability testing of Sage Electrochromics dynamic windows products using American Society for Testing and Materials (ASTM) standard methods and drive parameters as defined by Sage. Window units will be tested and standard analysis performed. Data will be summarized and reported back to Sage at the end of the testing period.

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

A methodology to emulate and evaluate a productive virtual workstation

NASA Technical Reports Server (NTRS)

Krubsack, David; Haberman, David

1992-01-01

The Advanced Display and Computer Augmented Control (ADCACS) Program at ACT is sponsored by NASA Ames to investigate the broad field of technologies which must be combined to design a 'virtual' workstation for the Space Station Freedom. This program is progressing in several areas and resulted in the definition of requirements for a workstation. A unique combination of technologies at the ACT Laboratory have been networked to effectively create an experimental environment. This experimental environment allows the integration of nonconventional input devices with a high power graphics engine within the framework of an expert system shell which coordinates the heterogeneous inputs with the 'virtual' presentation. The flexibility of the workstation is evolved as experiments are designed and conducted to evaluate the condition descriptions and rule sets of the expert system shell and its effectiveness in driving the graphics engine. Workstation productivity has been defined by the achievable performance in the emulator of the calibrated 'sensitivity' of input devices, the graphics presentation, the possible optical enhancements to achieve a wide field of view color image and the flexibility of conditional descriptions in the expert system shell in adapting to prototype problems.

Enhanced fuel production in thorium/lithium hybrid blankets utilizing uranium multipliers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pitulski, R.H.

1979-10-01

A consistent neutronics analysis is performed to determine the effectiveness of uranium bearing neutron multiplier zones on increasing the production of U/sup 233/ in thorium/lithium blankets for use in a tokamak fusion-fission hybrid reactor. The nuclear performance of these blankets is evaluated as a function of zone thicknesses and exposure by using the coupled transport burnup code ANISN-CINDER-HIC. Various parameters such as U/sup 233/, Pu/sup 239/, and H/sup 3/ production rates, the blanket energy multiplication, isotopic composition of the fuels, and neutron leakages into the various zones are evaluated during a 5 year (6 MW.y.m/sup -2/) exposure period. Although themore » results of this study were obtained for a tokomak magnetic fusion device, the qualitative behavior associated with the use of the uranium bearing neutron multiplier should be applicable to all fusion-fission hybrids.« less

Poly(lactic-co-glycolic acid) devices: Production and applications for sustained protein delivery.

PubMed

Lee, Parker W; Pokorski, Jonathan K

2018-03-13

Injectable or implantable poly(lactic-co-glycolic acid) (PLGA) devices for the sustained delivery of proteins have been widely studied and utilized to overcome the necessity of repeated administrations for therapeutic proteins due to poor pharmacokinetic profiles of macromolecular therapies. These devices can come in the form of microparticles, implants, or patches depending on the disease state and route of administration. Furthermore, the release rate can be tuned from weeks to months by controlling the polymer composition, geometry of the device, or introducing additives during device fabrication. Slow-release devices have become a very powerful tool for modern medicine. Production of these devices has initially focused on emulsion-based methods, relying on phase separation to encapsulate proteins within polymeric microparticles. Process parameters and the effect of additives have been thoroughly researched to ensure protein stability during device manufacturing and to control the release profile. Continuous fluidic production methods have also been utilized to create protein-laden PLGA devices through spray drying and electrospray production. Thermal processing of PLGA with solid proteins is an emerging production method that allows for continuous, high-throughput manufacturing of PLGA/protein devices. Overall, polymeric materials for protein delivery remain an emerging field of research for the creation of single administration treatments for a wide variety of disease. This review describes, in detail, methods to make PLGA devices, comparing traditional emulsion-based methods to emerging methods to fabricate protein-laden devices. This article is categorized under: Biology-Inspired Nanomaterials > Protein and Virus-Based Structures Implantable Materials and Surgical Technologies > Nanomaterials and Implants Biology-Inspired Nanomaterials > Peptide-Based Structures. © 2018 Wiley Periodicals, Inc.

Structural design of high-performance capacitive accelerometers using parametric optimization with uncertainties

NASA Astrophysics Data System (ADS)

Teves, André da Costa; Lima, Cícero Ribeiro de; Passaro, Angelo; Silva, Emílio Carlos Nelli

2017-03-01

Electrostatic or capacitive accelerometers are among the highest volume microelectromechanical systems (MEMS) products nowadays. The design of such devices is a complex task, since they depend on many performance requirements, which are often conflicting. Therefore, optimization techniques are often used in the design stage of these MEMS devices. Because of problems with reliability, the technology of MEMS is not yet well established. Thus, in this work, size optimization is combined with the reliability-based design optimization (RBDO) method to improve the performance of accelerometers. To account for uncertainties in the dimensions and material properties of these devices, the first order reliability method is applied to calculate the probabilities involved in the RBDO formulation. Practical examples of bulk-type capacitive accelerometer designs are presented and discussed to evaluate the potential of the implemented RBDO solver.

Optical surface analysis: a new technique for the inspection and metrology of optoelectronic films and wafers

NASA Astrophysics Data System (ADS)

Bechtler, Laurie; Velidandla, Vamsi

2003-04-01

In response to demand for higher volumes and greater product capability, integrated optoelectronic device processing is rapidly increasing in complexity, benefiting from techniques developed for conventional silicon integrated circuit processing. The needs for high product yield and low manufacturing cost are also similar to the silicon wafer processing industry. This paper discusses the design and use of an automated inspection instrument called the Optical Surface Analyzer (OSA) to evaluate two critical production issues in optoelectronic device manufacturing: (1) film thickness uniformity, and (2) defectivity at various process steps. The OSA measurement instrument is better suited to photonics process development than most equipment developed for conventional silicon wafer processing in two important ways: it can handle both transparent and opaque substrates (unlike most inspection and metrology tools), and it is a full-wafer inspection method that captures defects and film variations over the entire substrate surface (unlike most film thickness measurement tools). Measurement examples will be provided in the paper for a variety of films and substrates used for optoelectronics manufacturing.

Comparison between two portable devices for widefield PpIX fluorescence during cervical intraepithelial neoplasia treatment

NASA Astrophysics Data System (ADS)

Carbinatto, Fernanda M.; Inada, Natalia Mayumi; Lombardi, Welington; Cossetin, Natália Fernandez; Varoto, Cinthia; Kurachi, Cristina; Bagnato, Vanderlei Salvador

2015-06-01

The use of portable electronic devices, in particular mobile phones such as smartphones is increasing not only for all known applications, but also for diagnosis of diseases and monitoring treatments like topical Photodynamic Therapy. The aim of the study is to evaluate the production of the photosensitizer Protoporphyrin IX (PpIX) after topical application of a cream containing methyl aminolevulinate (MAL) in the cervix with diagnosis of Cervical Intraepithelial Neoplasia (CIN) through the fluorescence images captured after one and three hours and compare the images using two devices (a Sony Xperia® mobile and an Apple Ipod®. Was observed an increasing fluorescence intensity of the cervix three hours after cream application, in both portable electronic devices. However, because was used a specific program for the treatment of images using the Ipod® device, these images presented better resolution than observed by the Sony cell phone without a specific program. One hour after cream application presented a more selective fluorescence than the group of three hours. In conclusion, the use of portable devices to obtain images of PpIX fluorescence shown to be an effective tool and is necessary the improvement of programs for achievement of better results.

A Silicon Disk with Sandwiched Piezoelectric Springs for Ultra-low Frequency Energy Harvesting

NASA Astrophysics Data System (ADS)

Lu, J.; Zhang, L.; Yamashita, T.; Takei, R.; Makimoto, N.; Kobayashi, T.

2015-12-01

Exploiting the sporadic availability of energy by energy harvesting devices is an attractive solution to power wireless sensor nodes and many other distributed modules for much longer operation duration and much lower maintenance cost after they are deployed. MEMS energy harvesting devices exhibit unique advantageous of super-compact size, mass productivity, and easy-integration with sensors, actuators and other integrated circuits. However, MEMS vibration energy harvesting devices are rather difficult to be used practically due to their poor response to most of the ambient vibrations at ultra-low frequency range. In this paper, a micromachined silicon disk with sandwiched piezoelectric springs was successfully developed with resonant frequency of 15.36∼42.42 Hz and quality factor of 39∼55 for energy harvesting. Footprint size of the device was 6 mm × 6 mm, which is less than half of the piezoelectric cantilevers, while the device can scavenge reasonably high power of 0.57 μW at the acceleration of 0.1 g. The evaluation results also suggested that the device was quite sensitive as a sensor for selective monitoring of vibrations at a certain frequency.

Introducing the pro-coagulant contact system in the numerical assessment of device-related thrombosis.

PubMed

Méndez Rojano, Rodrigo; Mendez, Simon; Nicoud, Franck

2018-06-01

Thrombosis is a major concern in blood-coated medical devices. Contact activation, which is the initial part of the coagulation cascade in device-related thrombosis, is not considered in current thrombus formation models. In the present study, pro-coagulant reactions including the contact activation system are coupled with a fluid solver in order to evaluate the potential of the contact system to initiate thrombin production. The biochemical/fluid model is applied to a backward-facing step configuration, a flow configuration that frequently appears in medical devices. In contrast to the in vivo thrombosis models in which a specific thrombotic zone (injury region) is set a priori by the user to initiate the coagulation reaction, a reactive surface boundary condition is applied to the whole device wall. Simulation results show large thrombin concentration in regions related to recirculation zones without the need of an a priori knowledge of the thrombus location. The numerical results align well with the regions prone to thrombosis observed in experimental results reported in the literature. This approach could complement thrombus formation models that take into account platelet activity and thrombus growth to optimize a wide range of medical devices.

Biomaterial-induced alterations of neutrophil superoxide production.

PubMed

Kaplan, S S; Basford, R E; Mora, E; Jeong, M H; Simmons, R L

1992-08-01

Because periprosthetic infection remains a vexing problem for patients receiving implanted devices, we evaluated the effect of several materials on neutrophil free radical production. Human peripheral blood neutrophils were incubated with several sterile, lipopolysaccharide (LPS)-free biomaterials used in surgically implantable prosthetic devices: polyurethane, woven dacron, and velcro. Free radical formation as the superoxide (O2-) anion was evaluated by cytochrome c reduction in neutrophils that were exposed to the materials and then removed and in neutrophils allowed to remain in association with the materials. Neutrophils exposed to polyurethane or woven dacron for 30 or 60 min and then removed consistently exhibited an enhanced release of O2- after simulation via receptor engagement with formyl methionyl-leucyl-phenylalanine. Enhanced reactivity to stimulation via protein kinase C with phorbol myristate acetate, however, was not consistently observed. The cells evaluated for O2- release during continuous association with the biomaterials showed enhanced metabolic activity during short periods of association (especially with polyurethane and woven dacron). Although O2- release by neutrophils in association with these materials decreased with longer periods of incubation, it was not obliterated. These studies, therefore, show that several commonly used biomaterials activate neutrophils soon after exposure and that this activated state diminishes with prolonged exposure but nevertheless remains measurable. The diminishing level of activity with prolonged exposure, however, suggests that ultimately a depletion of reactivity may occur and may result in increased susceptibility to periprosthetic infection.

Noninvasive metabolic profiling using microfluidics for analysis of single preimplantation embryos.

PubMed

Urbanski, John Paul; Johnson, Mark T; Craig, David D; Potter, David L; Gardner, David K; Thorsen, Todd

2008-09-01

Noninvasive analysis of metabolism at the single cell level will have many applications in evaluating cellular physiology. One clinically relevant application would be to determine the metabolic activities of embryos produced through assisted reproduction. There is increasing evidence that embryos with greater developmental capacity have distinct metabolic profiles. One of the standard techniques for evaluating embryonic metabolism has been to evaluate consumption and production of several key energetic substrates (glucose, pyruvate, and lactate) using microfluorometric enzymatic assays. These assays are performed manually using constriction pipets, which greatly limits the utility of this system. Through multilayer soft-lithography, we have designed a microfluidic device that can perform these assays in an automated fashion. Following manual loading of samples and enzyme cocktail reagents, this system performs sample and enzyme cocktail aliquotting, mixing of reagents, data acquisition, and data analysis without operator intervention. Optimization of design and operating regimens has resulted in the ability to perform serial measurements of glucose, pyruvate, and lactate in triplicate with submicroliter sample volumes within 5 min. The current architecture allows for automated analysis of 10 samples and intermittent calibration over a 3 h period. Standard curves generated for each metabolite have correlation coefficients that routinely exceed 0.99. With the use of a standard epifluorescent microscope and CCD camera, linearity is obtained with metabolite concentrations in the low micromolar range (low femtomoles of total analyte). This system is inherently flexible, being easily adapted for any NAD(P)H-based assay and scaled up in terms of sample ports. Open source JAVA-based software allows for simple alterations in routine algorithms. Furthermore, this device can be used as a standalone device in which media samples are loaded or be integrated into microfluidic culture systems for in line, real time metabolic evaluation. With the improved throughput and flexibility of this system, many barriers to evaluating metabolism of embryos and single cells are eliminated. As a proof of principle, metabolic activities of single murine embryos were evaluated using this device.

FY 2017 Center Innovation Fund Annual Report - Highlights/Abstract section

NASA Technical Reports Server (NTRS)

Hintze, Paul; Youngquist, Robert C.; Massa, Gioia D.; Meier, Anne J.

2017-01-01

This project evaluated the feasibility of low pressure cold plasma (CP) for two applications: disinfection of produce grown in space and sterilization of medical equipment in space. Currently there is no ISS capability for disinfecting pick and eat crops, food utensils, food production areas, or medical devices. This deficit is extended to projected long duration missions. Small, portable, cold plasma devices would provide an enhanced benefit to crew health and address issues concerning microbial cross contamination. The technology would contribute to the reduction of solid waste since currently crews utilize benzalkonium chloride wet wipes for cleaning surfaces and might use PRO-SAN wipes for cleaning vegetables. CP cleaning/disinfection/sterilization can work on many surfaces, including all metals, most polymers, and this project evaluated produce. Therefore CP provides a simple system that has many different cleaning application in space: produce, medical equipment, cutlery, miscellaneous tools.

Mechanical evaluation of a ruptured Swedish adjustable gastric band.

PubMed

Reijnen, Michael M P J; Naus, J H; Janssen, Ignace M C

2004-02-01

Leakage of a laparoscopically placed Swedish adjustable gastric band (SAGB) was observed 2 1/2 years after placement. The band was evaluated for mechanical inaccuracies by a laboratory. The ruptured SAGB was investigated microscopically and wall thicknesses were measured. An unused SAGB was tested, both empty and filled, for mechanical deformity after exposure to saline solution. A permanent transformation of the silicone rubber was found, caused by bowing of the device. 2 tears were present at the end of a kink. The mean wall thickness was within acceptable limits. Exposure of the gastric band to saline solution did not cause any sign of permanent deformity of the silicone rubber. The rupture of the gastric band did not seem to be caused by a production error. Long-term deformity, in combination with a continuous dynamic load, may increase the risk of tearing. Long-term follow up is recommended for patients treated with this device.

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2012 CFR

2012-04-01

... human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... product listing for human blood and blood products and for medical devices. (a) Owners and operators of human blood and blood product establishments shall register and list their products with the Center for...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2014 CFR

2014-04-01

... human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... product listing for human blood and blood products and for medical devices. (a) Owners and operators of human blood and blood product establishments shall register and list their products with the Center for...

21 CFR 207.7 - Establishment registration and product listing for human blood and blood products and for medical...

Code of Federal Regulations, 2013 CFR

2013-04-01

... human blood and blood products and for medical devices. 207.7 Section 207.7 Food and Drugs FOOD AND DRUG... product listing for human blood and blood products and for medical devices. (a) Owners and operators of human blood and blood product establishments shall register and list their products with the Center for...

The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand.

PubMed

Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R

2006-04-03

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines.

Freeze-drying process monitoring using a cold plasma ionization device.

PubMed

Mayeresse, Y; Veillon, R; Sibille, P H; Nomine, C

2007-01-01

A cold plasma ionization device has been designed to monitor freeze-drying processes in situ by monitoring lyophilization chamber moisture content. This plasma device, which consists of a probe that can be mounted directly on the lyophilization chamber, depends upon the ionization of nitrogen and water molecules using a radiofrequency generator and spectrometric signal collection. The study performed on this probe shows that it is steam sterilizable, simple to integrate, reproducible, and sensitive. The limitations include suitable positioning in the lyophilization chamber, calibration, and signal integration. Sensitivity was evaluated in relation to the quantity of vials and the probe positioning, and correlation with existing methods, such as microbalance, was established. These tests verified signal reproducibility through three freeze-drying cycles. Scaling-up studies demonstrated a similar product signature for the same product using pilot-scale and larger-scale equipment. On an industrial scale, the method efficiently monitored the freeze-drying cycle, but in a larger industrial freeze-dryer the signal was slightly modified. This was mainly due to the positioning of the plasma device, in relation to the vapor flow pathway, which is not necessarily homogeneous within the freeze-drying chamber. The plasma tool is a relevant method for monitoring freeze-drying processes and may in the future allow the verification of current thermodynamic freeze-drying models. This plasma technique may ultimately represent a process analytical technology (PAT) approach for the freeze-drying process.

Integrating health economics into the product development cycle: a case study of absorbable pins for treating hallux valgus.

PubMed

Vallejo-Torres, Laura; Steuten, Lotte; Parkinson, Bonny; Girling, Alan J; Buxton, Martin J

2011-01-01

The probability of reimbursement is a key factor in determining whether to proceed with or abandon a product during its development. The purpose of this article is to illustrate how the methods of iterative Bayesian economic evaluation proposed in the literature can be incorporated into the development process of new medical devices, adapting them to face the relative scarcity of data and time that characterizes the process. A 3-stage economic evaluation was applied: an early phase in which simple methods allow for a quick prioritization of competing products; a mid-stage in which developers synthesize the data into a decision model, identify the parameters for which more information is most valuable, and explore uncertainty; and a late stage, in which all relevant information is synthesized. A retrospective analysis was conducted of the case study of absorbable pins, compared with metallic fixation, in osteotomy to treat hallux valgus. The results from the early analysis suggest absorbable pins to be cost-effective under the beliefs and assumptions applied. The outputs from the models at the mid-stage analyses show the device to be cost-effective with a high probability. Late-stage analysis synthesizes evidence from a randomized controlled trial and informative priors, which are based on previous evidence. It also suggests that absorbable pins are the most cost-effective strategy, although the uncertainty in the model output increased considerably. This example illustrates how the method proposed allows decisions in the product development cycle to be based on the best knowledge that is available at each stage.

Strong ion exchange in centrifugal partition extraction (SIX-CPE): effect of partition cell design and dimensions on purification process efficiency.

PubMed

Hamzaoui, Mahmoud; Hubert, Jane; Reynaud, Romain; Marchal, Luc; Foucault, Alain; Renault, Jean-Hugues

2012-07-20

The aim of this article was to evaluate the influence of the column design of a hydrostatic support-free liquid-liquid chromatography device on the process efficiency when the strong ion-exchange (SIX) development mode is used. The purification of p-hydroxybenzylglucosinolate (sinalbin) from a crude aqueous extract of white mustard seeds (Sinapis alba L.) was achieved on two types of devices: a centrifugal partition chromatograph (CPC) and a centrifugal partition extractor (CPE). They differ in the number, volume and geometry of their partition cells. The SIX-CPE process was evaluated in terms of productivity and sinalbin purification capability as compared to previously optimized SIX-CPC protocols that were carried out on columns of 200 mL and 5700 mL inner volume, respectively. The objective was to determine whether the decrease in partition cell number, the increase in their volume and the use of a "twin cell" design would induce a significant increase in productivity by applying higher mobile phase flow rate while maintaining a constant separation quality. 4.6g of sinalbin (92% recovery) were isolated from 25 g of a crude white mustard seed extract, in only 32 min and with a purity of 94.7%, thus corresponding to a productivity of 28 g per hour and per liter of column volume (g/h/LV(c)). Therefore, the SIX-CPE process demonstrates promising industrial technology transfer perspectives for the large-scale isolation of ionized natural products. Copyright © 2012 Elsevier B.V. All rights reserved.

Measuring the Impact of Cognitive Prosthetics on the Daily Life of People with Dementia and Their Carers

NASA Astrophysics Data System (ADS)

Meiland, Franka; Dröes, Rose-Marie; Sävenstedt, Stefan

Assistive technologies to support persons with dementia and their carers are used increasingly often. However, little is known about the effectiveness of most assistive devices. Much technology is put on the market without having been properly tested with potential end-users. To increase the chance that an assistive device is well accepted and useful for the target group, it is important, especially in the case of disabled persons, to involve potential users in the development process and to evaluate the impact of using the device on them before implementing it in the daily care and support. When evaluating the impact, decisions have to be made regarding the selection of measuring instruments. Important considerations in the selection process are the underlying domains to be addressed by the assistive technology, the target group and the availability of standardized instruments with good psychometric properties. In this chapter the COGKNOW project is used as a case example to explain how the impact of cognitive prosthetics on the daily lives of people with dementia and their carers can be measured. In COGKNOW a cognitive prosthetic device is being developed to improve the quality of life and autonomy of persons with dementia and to help them to remember and remind, to have social contact, to perform daily activities and to enhance feelings of safety. For all these areas, potential measuring instruments are described. Besides (standardized) measuring instruments, other data collection methods are used as well, such as semi-structured interviews and observations, diaries and in situ measurement. Within the COGKNOW project a first uncontrolled small-scale impact measurement takes place during the development process of the assistive device. However, it is recommended to perform a larger randomized controlled study as soon as the final product is ready to evaluate the impact of the device on persons with dementia and carers before it is released on the market.

27 CFR 479.24 - Destructive device determination.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Destructive device determination. 479.24 Section 479.24 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.24 - Destructive device determination.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Destructive device determination. 479.24 Section 479.24 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.24 - Destructive device determination.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Destructive device determination. 479.24 Section 479.24 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.24 - Destructive device determination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Destructive device determination. 479.24 Section 479.24 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

27 CFR 479.24 - Destructive device determination.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Destructive device determination. 479.24 Section 479.24 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES...

DD fusion neutron production at UW-Madison using IEC devices

NASA Astrophysics Data System (ADS)

Fancher, Aaron; Michalak, Matt; Kulcinski, Gerald; Santarius, John; Bonomo, Richard

2017-10-01

An inertial electrostatic confinement (IEC) device using spherical, gridded electrodes at high voltage accelerates deuterium ions, allowing for neutrons to be produced within the device from DD fusion reactions. The effects of the device cathode voltage (30-170 kV), current (30-100 mA), and pressure (0.15-1.25 mTorr) on the neutron production rate have been measured. New high voltage capabilities have resulted in the achievement of a steady state neutron production rate of 3.3x108 n/s at 175 kV, 100 mA, and 1.0 mTorr of deuterium. Applications of IEC devices include the production of DD neutrons to detect chemical explosives and special nuclear materials using active interrogation methods. Research supported by US Dept. of Homeland Security Grant 2015-DN-077-AR1095 and the Grainger Foundation.

High-Volume Production of Lightweight Multijunction Solar Cells

NASA Technical Reports Server (NTRS)

Youtsey, Christopher

2015-01-01

MicroLink Devices, Inc., has transitioned its 6-inch epitaxial lift-off (ELO) solar cell fabrication process into a manufacturing platform capable of sustaining large-volume production. This Phase II project improves the ELO process by reducing cycle time and increasing the yield of large-area devices. In addition, all critical device fabrication processes have transitioned to 6-inch production tool sets designed for volume production. An emphasis on automated cassette-to-cassette and batch processes minimizes operator dependence and cell performance variability. MicroLink Devices established a pilot production line capable of at least 1,500 6-inch wafers per month at greater than 80 percent yield. The company also increased the yield and manufacturability of the 6-inch reclaim process, which is crucial to reducing the cost of the cells.

Recent trends in the development and evaluation of assistive robotic manipulation devices.

PubMed

Allin, Sonya; Eckel, Emily; Markham, Heather; Brewer, Bambi R

2010-02-01

This review explores recent trends in the development and evaluation of assistive robotic arms, both prosthetic and externally mounted. Evaluations have been organized according to the CATOR taxonomy of assistive device outcomes, which takes into consideration device effectiveness, social significance, and impact on subjective well-being. Questions that have informed the review include: (1) Are robotic arms being comprehensively evaluated along axes of the CATOR taxonomy? (2) Are definitions of effectiveness in accordance with the priorities of users? (3) What gaps in robotic arm evaluation exist, and how might these best be addressed? (4) What further advances can be expected in the next 15 years? Results highlight the need for increased standardization of evaluation methods, increased emphasis on the social significance (i.e., social cost) of devices, and increased emphasis on device impact on quality of life. Several open areas for future research, in terms of both device evaluation and device development, are also discussed.

76 FR 70164 - Certain Devices With Secure Communication Capabilities, Components Thereof, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... capabilities, components thereof, and products containing the same. The complaint names Apple Inc. of Cupertino..., Components Thereof, and Products Containing the Same; Receipt of Complaint; Solicitation of Comments Relating... Certain Devices with Secure Communication Capabilities, Components Thereof, and Products Containing the...

78 FR 52211 - Certain Electronic Devices Having Placeshifting or Display Replication and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-878] Certain Electronic Devices Having Placeshifting or Display Replication and Products Containing Same; Commission Determination Not To Review an... States after importation of certain electronic devices having placeshifting or display replication...

Economic Implications of Potential Changes to Regulatory and Reimbursement Policies for Medical Devices

PubMed Central

Reed, Shelby D.; Shea, Alisa M.

2007-01-01

Objective To evaluate the impact of regulatory scenarios on the financial viability of medical device companies. Design We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be “reasonable and necessary” if the patients participate in clinical studies or registries. Measurements and Main results When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions. Conclusions The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies. PMID:18095045

Hearing Aids and Personal Sound Amplifiers: Know the Difference

MedlinePlus

... Devices and Personal Sound Amplification Products - Guidance for Industry and FDA Staff (PDF - 42KB) More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Rapid isolation of bone marrow mesenchymal stromal cells using integrated centrifuge-based technology.

PubMed

Meppelink, Amanda M; Wang, Xing-Hua; Bradica, Gino; Barron, Kathryn; Hiltz, Kathleen; Liu, Xiang-Hong; Goldman, Scott M; Vacanti, Joseph P; Keating, Armand; Hoganson, David M

2016-06-01

The use of bone marrow-derived mesenchymal stromal cells (MSCs) in cell-based therapies is currently being developed for a number of diseases. Thus far, the clinical results have been inconclusive and variable, in part because of the variety of cell isolation procedures and culture conditions used in each study. A new isolation technique that streamlines the method of concentration and demands less time and attention could provide clinical and economic advantages compared with current methodologies. In this study, we evaluated the concentrating capability of an integrated centrifuge-based technology compared with standard Ficoll isolation. MSCs were concentrated from bone marrow aspirate using the new device and the Ficoll method. The isolation capabilities of the device and the growth characteristics, secretome production, and differentiation capacity of the derived cells were determined. The new MSC isolation device concentrated the bone marrow in 90 seconds and resulted in a mononuclear cell yield 10-fold higher and with a twofold increase in cell retention compared with Ficoll. The cells isolated using the device were shown to exhibit similar morphology and functional activity as assessed by growth curves and secretome production compared to the Ficoll-isolated cells. The surface marker and trilineage differentiation profile of the device-isolated cells was consistent with the known profile of MSCs. The faster time to isolation and greater cell yield of the integrated centrifuge-based technology may make this an improved approach for MSC isolation from bone marrow aspirates. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Using colony monitoring devices to evaluate the impacts of land use and nutritional value of forage on honey bee health

USGS Publications Warehouse

Smart, Matthew; Otto, Clint R.; Cornman, Robert S.; Iwanowicz, Deborah

2018-01-01

Colony monitoring devices used to track and assess the health status of honey bees are becoming more widely available and used by both beekeepers and researchers. These devices monitor parameters relevant to colony health at frequent intervals, often approximating real time. The fine-scale record of hive condition can be further related to static or dynamic features of the landscape, such as weather, climate, colony density, land use, pesticide use, vegetation class, and forage quality. In this study, we fit commercial honey bee colonies in two apiaries with pollen traps and digital scales to monitor floral resource use, pollen quality, and honey production. One apiary was situated in low-intensity agriculture; the other in high-intensity agriculture. Pollen traps were open for 72 h every two weeks while scales recorded weight every 15 min throughout the growing season. From collected pollen, we determined forage quantity per day, species identity using DNA sequencing, pesticide residues, amino acid content, and total protein content. From scales, we determined the accumulated hive weight change over the growing season, relating to honey production and final colony weight going into winter. Hive scales may also be used to identify the occurrence of environmental pollen and nectar dearth, and track phenological changes in plant communities. We provide comparisons of device-derived data between two apiaries over the growing season and discuss the potential for employing apiary monitoring devices to infer colony health in the context of divergent agricultural land use conditions.

Comparison of roll-to-roll replication approaches for microfluidic and optical functions in lab-on-a-chip diagnostic devices

NASA Astrophysics Data System (ADS)

Brecher, Christian; Baum, Christoph; Bastuck, Thomas

2015-03-01

Economically advantageous microfabrication technologies for lab-on-a-chip diagnostic devices substituting commonly used glass etching or injection molding processes are one of the key enablers for the emerging market of microfluidic devices. On-site detection in fields of life sciences, point of care diagnostics and environmental analysis requires compact, disposable and highly functionalized systems. Roll-to-roll production as a high volume process has become the emerging fabrication technology for integrated, complex high technology products within recent years (e.g. fuel cells). Differently functionalized polymer films enable researchers to create a new generation of lab-on-a-chip devices by combining electronic, microfluidic and optical functions in multilayer architecture. For replication of microfluidic and optical functions via roll-to-roll production process competitive approaches are available. One of them is to imprint fluidic channels and optical structures of micro- or nanometer scale from embossing rollers into ultraviolet (UV) curable lacquers on polymer substrates. Depending on dimension, shape and quantity of those structures there are alternative manufacturing technologies for the embossing roller. Ultra-precise diamond turning, electroforming or casting polymer materials are used either for direct structuring or manufacturing of roller sleeves. Mastering methods are selected for application considering replication quality required and structure complexity. Criteria for the replication quality are surface roughness and contour accuracy. Structure complexity is evaluated by shapes producible (e.g. linear, circular) and aspect ratio. Costs for the mastering process and structure lifetime are major cost factors. The alternative replication approaches are introduced and analyzed corresponding to the criteria presented. Advantages and drawbacks of each technology are discussed and exemplary applications are presented.

Non- contacting capacitive diagnostic device

DOEpatents

Ellison, Timothy

2005-07-12

A non-contacting capacitive diagnostic device includes a pulsed light source for producing an electric field in a semiconductor or photovoltaic device or material to be evaluated and a circuit responsive to the electric field. The circuit is not in physical contact with the device or material being evaluated and produces an electrical signal characteristic of the electric field produced in the device or material. The diagnostic device permits quality control and evaluation of semiconductor or photovoltaic device properties in continuous manufacturing processes.

Characterization of nonplanar motion in MEMS involving scanning laser interferometry

NASA Astrophysics Data System (ADS)

Lawton, Russell A.; Abraham, Margaret H.; Lawrence, Eric

1999-08-01

A study to evaluate three processes used for the release of standard devices produced by MCNC using the MUMPS process was undertaken by Jet Propulsion Laboratory with the collaboration of The Aerospace Corporation, and Polytec PI. The processes used were developed at various laboratories and are commonly the final step in the production of micro- electro-mechanical systems prior to packaging. It is at this stage of the process when the devices become extremely delicate and are subject to yield losses due to handling errors or the phenomenon of stiction. The effects of post processing with HF on gain boundaries and subsequent thermal processing producing native oxide growth during packaging will require further investigation.

47 CFR 2.803 - Marketing of radio frequency devices prior to equipment authorization.

Code of Federal Regulations, 2010 CFR

2010-10-01

... device that is in the conceptual, developmental, design or pre-production stage is permitted prior to... operation takes place at the manufacturer's facilities during developmental, design, or pre-production... development, design or pre-production stages. A product operated under this provision shall be labelled, in a...

47 CFR 2.803 - Marketing of radio frequency devices prior to equipment authorization.

Code of Federal Regulations, 2012 CFR

2012-10-01

... device that is in the conceptual, developmental, design or pre-production stage is permitted prior to... operation takes place at the manufacturer's facilities during developmental, design, or pre-production... development, design or pre-production stages. A product operated under this provision shall be labelled, in a...

47 CFR 2.803 - Marketing of radio frequency devices prior to equipment authorization.

Code of Federal Regulations, 2011 CFR

2011-10-01

... device that is in the conceptual, developmental, design or pre-production stage is permitted prior to... operation takes place at the manufacturer's facilities during developmental, design, or pre-production... development, design or pre-production stages. A product operated under this provision shall be labelled, in a...

77 FR 26041 - Certain Computers and Computer Peripheral Devices and Components Thereof and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-841] Certain Computers and Computer Peripheral... after importation of certain computers and computer peripheral devices and components thereof and... computers and computer peripheral devices and components thereof and products containing the same that...

Evaluation of Thermoelectric Devices by the Slope-Efficiency Method

DTIC Science & Technology

2016-09-01

ARL-TR-7837 ● SEP 2016 US Army Research Laboratory Evaluation of Thermoelectric Devices by the Slope-Efficiency Method by...Evaluation of Thermoelectric Devices by the Slope-Efficiency Method by Patrick J Taylor Sensors and Electron Devices Directorate, ARL Jay R...

An Initial Evaluation of Tablet Devices & What Are the Next Steps?

ERIC Educational Resources Information Center

McKillen, Tracey

2016-01-01

This paper describes an evaluation of tablet devices for a Graduate Entry Medical School (GEMS). The purpose of this evaluation is to assess what type of tablet device could meet the needs of a GEMS student. GEMS requirements for the evaluation include; using the tablet device to replace paper teaching resources in lectures and tutorials and…

Laboratory and semi-field evaluations of two (transfluthrin) spatial repellent devices against Aedes aegypti (L.) (Diptera: Culicidae).

PubMed

McPhatter, Lee P; Mischler, Paula D; Webb, Meiling Z; Chauhan, Kamal; Lindroth, Erica J; Richardson, Alec G; Debboun, Mustapha

2017-01-01

Two transfluthrin-based spatial repellent products (Raid Dual Action Insect Repellent and Home Freshener and Raid Shield (currently not commercially available), SC Johnson, Racine WI) were evaluated for spatial repellent effects against female Aedes aegypti (L.) mosquitoes under laboratory (wind tunnel) and semi-field (outdoor enclosure) conditions. The placement of either product in the wind tunnel significantly reduced host-seeking behaviors. The mean baseline (control) landing counts for the Raid Dual Action and Raid Shield were reduced by 95% and 74% respectively. Mean probing counts for the Raid Dual Action were reduced by 95%, while the probing counts for the Raid Shield were decreased by 69%. Baseline blood-feeding success was significantly reduced for both treatments: Raid Dual Action (100%) and Raid Shield (96%). Semi-field evaluations were conducted in outdoor enclosures at the Navy Entomology Center of Excellence, Jacksonville, Florida. A moderate reduction in mosquito entry into military style tents resulted when either product was placed near the tent opening. The Raid Shield reduced mosquito entry into tents by 88%, while the Dual Action decreased entry by 66%.

Application of M-JPEG compression hardware to dynamic stimulus production.

PubMed

Mulligan, J B

1997-01-01

Inexpensive circuit boards have appeared on the market which transform a normal micro-computer's disk drive into a video disk capable of playing extended video sequences in real time. This technology enables the performance of experiments which were previously impossible, or at least prohibitively expensive. The new technology achieves this capability using special-purpose hardware to compress and decompress individual video frames, enabling a video stream to be transferred over relatively low-bandwidth disk interfaces. This paper will describe the use of such devices for visual psychophysics and present the technical issues that must be considered when evaluating individual products.

The feasibility of miniaturizing the versatile portable speech prosthesis: A market survey of commercial products

NASA Technical Reports Server (NTRS)

Walklet, T.

1981-01-01

The feasibility of a miniature versatile portable speech prosthesis (VPSP) was analyzed and information on its potential users and on other similar devices was collected. The VPSP is a device that incorporates speech synthesis technology. The objective is to provide sufficient information to decide whether there is valuable technology to contribute to the miniaturization of the VPSP. The needs of potential users are identified, the development status of technologies similar or related to those used in the VPSP are evaluated. The VPSP, a computer based speech synthesis system fits on a wheelchair. The purpose was to produce a device that provides communication assistance in educational, vocational, and social situations to speech impaired individuals. It is expected that the VPSP can be a valuable aid for persons who are also motor impaired, which explains the placement of the system on a wheelchair.

Determination of Pesticide Residues in Cannabis Smoke

PubMed Central

Sullivan, Nicholas; Elzinga, Sytze; Raber, Jeffrey C.

2013-01-01

The present study was conducted in order to quantify to what extent cannabis consumers may be exposed to pesticide and other chemical residues through inhaled mainstream cannabis smoke. Three different smoking devices were evaluated in order to provide a generalized data set representative of pesticide exposures possible for medical cannabis users. Three different pesticides, bifenthrin, diazinon, and permethrin, along with the plant growth regulator paclobutrazol, which are readily available to cultivators in commercial products, were investigated in the experiment. Smoke generated from the smoking devices was condensed in tandem chilled gas traps and analyzed with gas chromatography-mass spectrometry (GC-MS). Recoveries of residues were as high as 69.5% depending on the device used and the component investigated, suggesting that the potential of pesticide and chemical residue exposures to cannabis users is substantial and may pose a significant toxicological threat in the absence of adequate regulatory frameworks. PMID:23737769

Charge transport properties of intrinsic layer in diamond vertical pin diode

NASA Astrophysics Data System (ADS)

Shimaoka, Takehiro; Kuwabara, Daisuke; Hara, Asuka; Makino, Toshiharu; Tanaka, Manobu; Koizumi, Satoshi

2017-05-01

Diamond is hoped to be utilized in ultimate power electronic devices exhibiting ultra-high blocking voltages. For practical device formation, it is important to characterize the electric properties to precisely simulate carrier transport and to practically design optimum device structures. In this study, we experimentally evaluated the charge transport properties of intrinsic layers in diamond vertical pin diodes using alpha-particle induced charge distribution measurements. The charge collection efficiencies were 98.1 ± 0.6% for a {111} pin diode and 96.9 ± 0.6% for a {100} pin diode, which means that almost all generated charges are collected accordingly equivalent to conventional Silicon pin photodiodes. Mobility-lifetime (μτ) products of holes were (2.2 ± 0.3) × 10-6 cm2/V for {111} and (1.8 ± 0.1) × 10-5 cm2/V for {100} diamond pin diodes.

High-speed all-optical logic inverter based on stimulated Raman scattering in silicon nanocrystal.

PubMed

Sen, Mrinal; Das, Mukul K

2015-11-01

In this paper, we propose a new device architecture for an all-optical logic inverter (NOT gate), which is cascadable with a similar device. The inverter is based on stimulated Raman scattering in silicon nanocrystal waveguides, which are embedded in a silicon photonic crystal structure. The Raman response function of silicon nanocrystal is evaluated to explore the transfer characteristic of the inverter. A maximum product criterion for the noise margin is taken to analyze the cascadability of the inverter. The time domain response of the inverter, which explores successful inversion operation at 100 Gb/s, is analyzed. Propagation delay of the inverter is on the order of 5 ps, which is less than the delay in most of the electronic logic families as of today. Overall dimension of the device is around 755  μm ×15  μm, which ensures integration compatibility with the matured silicon industry.

Validity and reliability of isometric muscle strength measurements of hip abduction and abduction with external hip rotation in a bent-hip position using a handheld dynamometer with a belt.

PubMed

Aramaki, Hidefumi; Katoh, Munenori; Hiiragi, Yukinobu; Kawasaki, Tsubasa; Kurihara, Tomohisa; Ohmi, Yorikatsu

2016-07-01

[Purpose] This study aimed to investigate the relatedness, reliability, and validity of isometric muscle strength measurements of hip abduction and abduction with an external hip rotation in a bent-hip position using a handheld dynamometer with a belt. [Subjects and Methods] Twenty healthy young adults, with a mean age of 21.5 ± 0.6 years were included. Isometric hip muscle strength in the subjects' right legs was measured under two posture positions using two devices: a handheld dynamometer with a belt and an isokinetic dynamometer. Reliability was evaluated using an intra-class correlation coefficient (ICC); relatedness and validity were evaluated using Pearson's product moment correlation coefficient. Differences in measurements of devices were assessed by two-way ANOVA. [Results] ICC (1, 1) was ≥0.9; significant positive correlations in measurements were found between the two devices under both conditions. No main effect was found between the measurement values. [Conclusion] Our findings revealed that there was relatedness, reliability, and validity of this method for isometric muscle strength measurements using a handheld dynamometer with a belt.

77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...-0061] Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement... Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES: Effective Date... Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459...

77 FR 14422 - Certain Consumer Electronics and Display Devices and Products Containing Same; Notice of Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... INTERNATIONAL TRADE COMMISSION [DN 2882] Certain Consumer Electronics and Display Devices and... the U.S. International Trade Commission has received a complaint entitled Certain Consumer Electronics... importation of certain consumer electronics and display devices and products containing same. The complaint...

76 FR 72439 - Certain Consumer Electronics and Display Devices and Products Containing Same; Receipt of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... INTERNATIONAL TRADE COMMISSION [DN 2858] Certain Consumer Electronics and Display Devices and.... International Trade Commission has received a complaint entitled In Re Certain Consumer Electronics and Display... importation of certain consumer electronics and display devices and products containing same. The complaint...

76 FR 38417 - In the Matter of Certain Multimedia Display and Navigation Devices and Systems, Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-30

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-694] In the Matter of Certain Multimedia Display and Navigation Devices and Systems, Components Thereof, and Products Containing Same; Notice of... importation of certain multimedia display and navigation devices and systems, components thereof, and products...

76 FR 25707 - In The Matter of Certain Multimedia Display and Navigation Devices and Systems, Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-694] In The Matter of Certain Multimedia Display and Navigation Devices and Systems, Components Thereof, and Products Containing Same; Notice of... multimedia display and navigation devices and systems, components thereof, and products containing same by...

78 FR 17429 - Certain Balloon Dissection Devices and Products Containing Same; Commission Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-21

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-865] Certain Balloon Dissection Devices... importation, or sale in the United States after importation of certain balloon dissection devices and products...; Pajunk Medizintechnologie GmbH of Geisingen, Germany; and Pajunk Medical Systems LP of Norcross, Georgia...

27 CFR 19.188 - Measuring devices and proofing instruments.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Measuring devices and proofing instruments. 19.188 Section 19.188 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX..., and Security Requirements Measuring and Proofing Equipment Requirements § 19.188 Measuring devices and...

27 CFR 19.188 - Measuring devices and proofing instruments.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Measuring devices and proofing instruments. 19.188 Section 19.188 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX..., and Security Requirements Measuring and Proofing Equipment Requirements § 19.188 Measuring devices and...

27 CFR 19.188 - Measuring devices and proofing instruments.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Measuring devices and proofing instruments. 19.188 Section 19.188 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX..., and Security Requirements Measuring and Proofing Equipment Requirements § 19.188 Measuring devices and...

27 CFR 19.188 - Measuring devices and proofing instruments.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Measuring devices and proofing instruments. 19.188 Section 19.188 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX..., and Security Requirements Measuring and Proofing Equipment Requirements § 19.188 Measuring devices and...

78 FR 68861 - Certain Navigation Products, Including GPS Devices, Navigation and Display Systems, Radar Systems...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... Devices, Navigation and Display Systems, Radar Systems, Navigational Aids, Mapping Systems and Related... navigation products, including GPS devices, navigation and display systems, radar systems, navigational aids..., radar systems, navigational aids, mapping systems and related software by reason of infringement of one...

78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1295] Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for... draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound...

76 FR 73676 - Certain Dynamic Random Access Memory Devices, and Products Containing Same; Receipt of Complaint...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

... INTERNATIONAL TRADE COMMISSION [DN 2859] Certain Dynamic Random Access Memory Devices, and.... International Trade Commission has received a complaint entitled In Re Certain Dynamic Random Access Memory... certain dynamic random access memory devices, and products containing same. The complaint names Elpida...

Combustion products generating and metering device

NASA Technical Reports Server (NTRS)

Wiberg, R. E.; Klisch, J. A.

1974-01-01

Device simulates incipient fire conditions in closely-controlled adjustable manner, to give predetermined degree of intensity at selected locations throughout area, and to verify that detection system will respond. Device can be used with and for cross calibration and experimentation in conjunction with commercially available products of combustion analyzing meters.

9 CFR 312.9 - Official detention marks and devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Official detention marks and devices. 312.9 Section 312.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... INSPECTION AND CERTIFICATION OFFICIAL MARKS, DEVICES AND CERTIFICATES § 312.9 Official detention marks and...

77 FR 19032 - Certain Semiconductor Integrated Circuit Devices and Products Containing Same Notice of Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-29

... INTERNATIONAL TRADE COMMISSION [DN 2888] Certain Semiconductor Integrated Circuit Devices and... Integrated Circuit Devices and Products Containing Same, DN 2888; the Commission is soliciting comments on... Commission's electronic docket (EDIS) at http://edis.usitc.gov , and will be available for inspection during...

Histological evaluation and optimization of surgical vessel sealing systems

NASA Astrophysics Data System (ADS)

Lathrop, Robert; Ryan, Thomas; Gaspredes, Jonathan; Woloszko, Jean; Coad, James E.

2017-02-01

Surgical vessel sealing systems are widely used to achieve hemostasis and dissection in open surgery and minimally invasive, laparoscopic surgery. This enabling technology was developed about 17 years ago and continues to evolve with new devices and systems achieving improved outcomes. Histopathological assessment of thermally sealed tissues is a valuable tool for refining and comparing performance among surgical vessel sealing systems. Early work in this field typically assessed seal time, burst rate, and failure rate (in-situ). Later work compared histological staining methods with birefringence to assess the extent of thermal damage to tissues adjacent to the device. Understanding the microscopic architecture of a sealed vessel is crucial to optimizing the performance of power delivery algorithms and device design parameters. Manufacturers rely on these techniques to develop new products. A system for histopathological evaluation of vessels and sealing performance was established, to enable the direct assessment of a treatment's tissue effects. The parameters included the commonly used seal time, pressure burst rate and failure rate, as well as extensions of the assessment to include its likelihood to form steam vacuoles, adjacent thermal effect near the device, and extent of thermally affected tissue extruded back into the vessel lumen. This comprehensive assessment method provides an improved means of assessing the quality of a sealed vessel and understanding the exact mechanisms which create an optimally sealed vessel.

Lessons from innovation in drug-device combination products.

PubMed

Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

2012-01-01

Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

MEDICAL DEVICE PRICES IN ECONOMIC EVALUATIONS.

PubMed

Akpinar, Ilke; Jacobs, Philip; Husereau, Don

2015-01-01

Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices. We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective. We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions. Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

Mechanisms of toxicity and biomarkers of flavoring and flavor enhancing chemicals in emerging tobacco and non-tobacco products.

PubMed

Kaur, Gurjot; Muthumalage, Thivanka; Rahman, Irfan

2018-05-15

Tobacco products containing flavorings, such as electronic nicotine delivery devices (ENDS) or e-cigarettes, cigars/cigarillos, waterpipes, and heat-not-burn devices (iQOS) are continuously evolving. In addition to increasing the exposure of teenagers and adults to nicotine containing flavoring products and flavoring enhancers, chances of nicotine addiction through chronic use and abuse also increase. These flavorings are believed to be safe for ingestion, but little information is available about their effects on the lungs. In this review, we have discussed the in vitro and in vivo data on toxicity of flavoring chemicals in lung cells. We have further discussed the common flavoring agents, such as diacetyl and menthol, currently available detection methods, and the toxicological mechanisms associated with oxidative stress, inflammation, mucociliary clearance, and DNA damage in cells, mice, and humans. Finally, we present potential biomarkers that could be utilized for future risk assessment. This review provides crucial parameters important for evaluation of risk associated with flavoring agents and flavoring enhancers used in tobacco products and ENDS. Future studies can be designed to address the potential toxicity of inhaled flavorings and their biomarkers in users as well as in chronic exposure studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Novel Hyperspectral Sun Photometer for Satellite Remote Sensing Data Radiometeic Calibration and Atmospheric Aerosol Studies

NASA Technical Reports Server (NTRS)

Pagnutti, Mary; Ryan, Robert E.; Holekamp, Kara; Harrington, Gary; Frisbie, Troy

2006-01-01

A simple and cost-effective, hyperspectral sun photometer for radiometric vicarious remote sensing system calibration, air quality monitoring, and potentially in-situ planetary climatological studies, was developed. The device was constructed solely from off the shelf components and was designed to be easily deployable for support of short-term verification and validation data collects. This sun photometer not only provides the same data products as existing multi-band sun photometers but also the potential of hyperspectral optical depth and diffuse-to-global products. As compared to traditional sun photometers, this device requires a simpler setup, less data acquisition time and allows for a more direct calibration approach. Fielding this instrument has also enabled Stennis Space Center (SSC) Applied Sciences Directorate personnel to cross-calibrate existing sun photometers. This innovative research will position SSC personnel to perform air quality assessments in support of the NASA Applied Sciences Program's National Applications program element as well as to develop techniques to evaluate aerosols in a Martian or other planetary atmosphere.

An Evaluation of the Feasibility of Using Hand-Held Computers for Training.

DTIC Science & Technology

1982-05-30

approved. I FRANK E. GIUNTI F. A. NERONE Chief, Instructuinal Colonel, Infantry Development Division Director, Training Developments Institute...on electronic networks (PLATO) were initiated, and HHCs were borrowed and programmed. A number of Battelle experts were also consulted. Devices Noted...of a network . as an book. aide-memoire, a calculator, a word For outdoor use there is no processor, a financial planner and comparable product. From on

Evaluating the Tradeoffs Between Dollars Spent and Lives saved in Military Settings

DTIC Science & Technology

2013-11-18

data needed , and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this...Programs that improve workplace safety have costs. Firms may need to purchase additional equipment or protective devices, install machine guards...employers the costs may be slight. Because of the inherent dangers in production, firms in mining, logging, fishing, and construction will need to

Evaluation and quantification of reprocessing modification in single-use devices in interventional cardiology

NASA Astrophysics Data System (ADS)

Tessarolo, Francesco; Ferrari, Paolo; Silvia, Bortoluzzi; Motta, Antonella; Migliaresi, Claudio; Zennaro, Lucio; Rigo, Adelio; Guarrera, Giovanni Maria; Nollo, Giandomenico

2004-11-01

The increasing demand in interventional cardiology urges for reprocessing of single-use-labelled medical devices. To fulfil this aim, accurate and validated regeneration protocols are mandatory to guarantee sterility, functionality and safeness. The reprocessing protocol was realized by decontamination with chloro-donors, cleaning with enzymatic solutions and hydrogen peroxide gas plasma sterilization. Reprocessing effects on ablation and electrophysiology catheters were evaluated by assessing physical-chemical changes on surfaces and bulks, as a function of the reprocessing cycles number. Conventional optical microscopy and environmental scanning electron microscopy (ESEM) underlined the presence of micro-scratches on the polyurethane shaft surface. A clear correlation was found between surface damages and number of reprocessing cycles. Atomic force microscopy (AFM) confirmed the occurrence of physical-chemical etching of the polyurethane shaft caused by the hydrogen peroxide plasma sterilization, with increasing of nano-roughness at increasing number of the reprocessing cycles. UV-Vis spectra performed on the incubation solution of polymeric shaft sample, showed an absorbance increase at about 208 nm. This fact could be attributed to the water elution from the polymer of low molecular weight oligomers. The presence of hydrolysis products of the polymeric shaft after incubation demands both the characterization of the products released in the solution and the chemical characterization of the water exposed surface.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

78 FR 33447 - Draft Applications for Sealed Source and Device Evaluation and Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0104] Draft Applications for Sealed Source and Device... for sealed source and device evaluation and registration. The NRC is requesting public comment on... for Sealed Source and Device Evaluation and Registration.'' The document has been updated from the...

78 FR 27441 - NIJ Evaluation of Hand-Held Cell Phone Detector Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... Hand-Held Cell Phone Detector Devices AGENCY: National Institute of Justice, Department of Justice...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...

Performance analysis of InGaAs/GaAsP heterojunction double gate tunnel field effect transistor

NASA Astrophysics Data System (ADS)

Ahish, S.; Sharma, Dheeraj; Vasantha, M. H.; Kumar, Y. B. N.

2017-03-01

In this paper, analog/RF performance of InGaAs/GaAsP heterojunction double gate tunnel field effect transistor (HJTFET) has been explored. A highly doped n+ layer is placed at the Source-Channel junction in order to improve the horizontal electric field component and thus, improve the realiability of the device. The analog performance of the device is analysed by extracting current-voltage characteristics, transcondutance (gm), gate-to-drain capacitance (Cgd) and gate-to-source capacitance (Cgs). Further, RF performance of the device is evaluated by obtaining cut-off frequency (fT) and Gain Bandwidth (GBW) product. ION /IOFF ratio equal to ≈ 109, subthreshold slope of 27 mV/dec, maximum fT of 2.1 THz and maximum GBW of 484 GHz were achieved. Also, the impact of temperature variation on the linearity performance of the device has been investigated. Furthermore, the circuit level performance of the device is performed by implementing a Common Source (CS) amplifier; maximum gain of 31.11 dB and 3-dB cut-off frequency equal to 91.2 GHz were achieved for load resistance (RL) = 17.5 KΩ.

An unattended device for high-voltage sampling and passive measurement of thoron decay products.

PubMed

Gierl, Stefanie; Meisenberg, Oliver; Haninger, Thomas; Wielunski, Marek; Tschiersch, Jochen

2014-02-01

An integrating measurement device for the concentration of airborne thoron decay products was designed and calibrated. It is suitable for unattended use over up to several months also in inhabited dwellings. The device consists of a hemispheric capacitor with a wire mesh as the outer electrode on ground potential and the sampling substrates as the inner electrode on +7.0 kV. Negatively charged and neutral thoron decay products are accelerated to and deposited on the sampling substrates. As sampling substrates, CR39 solid-state nuclear track detectors are used in order to record the alpha decay of the sampled decay products. Nuclide discrimination is achieved by covering the detectors with aluminum foil of different thickness, which are penetrated only by alpha particles with sufficient energy. Devices of this type were calibrated against working level monitors in a thoron experimental house. The sensitivity was measured as 9.2 tracks per Bq/m(3) × d of thoron decay products. The devices were used over 8 weeks in several houses built of earthen material in southern Germany, where equilibrium equivalent concentrations of 1.4-9.9 Bq/m(3) of thoron decay products were measured.

9 CFR 316.1 - Authorization required to make devices bearing official marks.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authorization required to make devices bearing official marks. 316.1 Section 316.1 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... required to make devices bearing official marks. No brand manufacturer, printer or other person shall cast...

[Licensing of Pharmaceuticals and Medical Devices in Germany: Weaknesses and Opportunities].

PubMed

Reinhardt, D; Wildner, M

2016-12-01

The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified. Methods: To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11. The results were critically assessed by comparing them with the current academic literature. Results: A central market authorization for medical devices was mentioned often, but seems politically not viable. However, quality, methodology and depth of the analyses necessary for the licensing of medical devices, especially for high-risk devices, can and should strive for higher standards, comparable to those of pharmaceuticals. With regard to post-market surveillance, the systems for both pharmaceuticals and medical devices should be improved. Innovativeness and competitiveness of European medical device manufacturers should not be promoted by reduced evidence standards and patient safety. Subsidies or easier licensing procedures for small product lines with particular importance for public health, similar to orphan drug regulations, are more desirable. Conclusion: This study helps to identify areas of improvement for licensing of pharmaceuticals and medical devices. Concrete recommendations were developed. Higher evidence standards should be mandatory especially for high-risk devices, comparable to those of pharmaceuticals. Post-marketing surveillance should be improved for pharmaceuticals and medical devices. © Georg Thieme Verlag KG Stuttgart · New York.

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

PubMed

Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

2006-04-01

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review.

PubMed

Stamatakis, Emmanuel; Weiler, Richard; Ioannidis, John P A

2013-05-01

Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice. Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer's decisions. We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests. © 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by Blackwell Publishing Ltd.

First-in-human testing of a wirelessly controlled drug delivery microchip.

PubMed

Farra, Robert; Sheppard, Norman F; McCabe, Laura; Neer, Robert M; Anderson, James M; Santini, John T; Cima, Michael J; Langer, Robert

2012-02-22

The first clinical trial of an implantable microchip-based drug delivery device is discussed. Human parathyroid hormone fragment (1-34) [hPTH(1-34)] was delivered from the device in vivo. hPTH(1-34) is the only approved anabolic osteoporosis treatment, but requires daily injections, making patient compliance an obstacle to effective treatment. Furthermore, a net increase in bone mineral density requires intermittent or pulsatile hPTH(1-34) delivery, a challenge for implantable drug delivery products. The microchip-based devices, containing discrete doses of lyophilized hPTH(1-34), were implanted in eight osteoporotic postmenopausal women for 4 months and wirelessly programmed to release doses from the device once daily for up to 20 days. A computer-based programmer, operating in the Medical Implant Communications Service band, established a bidirectional wireless communication link with the implant to program the dosing schedule and receive implant status confirming proper operation. Each woman subsequently received hPTH(1-34) injections in escalating doses. The pharmacokinetics, safety, tolerability, and bioequivalence of hPTH(1-34) were assessed. Device dosing produced similar pharmacokinetics to multiple injections and had lower coefficients of variation. Bone marker evaluation indicated that daily release from the device increased bone formation. There were no toxic or adverse events due to the device or drug, and patients stated that the implant did not affect quality of life.

Improving car passengers' comfort and experience by supporting the use of handheld devices.

PubMed

van Veen, S A T; Hiemstra-van Mastrigt, S; Kamp, I; Vink, P

2014-01-01

There is a demand for interiors to support other activities in a car than controlling the vehicle. Currently, this is the case for the car passengers and--in the future--autonomous driving cars will also facilitate drivers to perform other activities. One of these activities is working with handheld devices. Previous research shows that people experience problems when using handheld devices in a moving vehicle and the use of handheld devices generally causes unwanted neck flexion [Young et al. 2012; Sin and Zu 2011; Gold et al.2011]. In this study, armrests are designed to support the arms when using handheld devices in a driving car in order to decrease neck flexion. Neck flexion was measured by attaching markers on the C7 and tragus. Discomfort was indicated on a body map on a scale 1-10. User experience was evaluated in a semi-structured interview. Neck flexion is significantly decreased by the support of the armrests and approaches a neutral position. Furthermore, overall comfort and comfort in the neck region specifically are significantly increased. Subjects appreciate the body posture facilitated by the armrests and 9 out of 10 prefer using handheld devices with the armrests compared to using handheld devices without the armrests. More efforts are needed to develop the mock-up into an established product, but the angles and dimensions presented in this study could serve as guidelines.

Screening method to evaluate point-of-care human chorionic gonadotropin (hCG) devices for susceptibility to the hook effect by hCG β core fragment: evaluation of 11 devices.

PubMed

Nerenz, Robert D; Song, Haowei; Gronowski, Ann M

2014-04-01

The predominant hCG variant in urine, hCG β core fragment (hCGβcf), has been demonstrated to cause false-negative results in qualitative point-of-care (POC) hCG devices. This is a major concern for healthcare professionals using POC pregnancy tests. We developed a screening method to evaluate qualitative POC hCG devices for their susceptibility to inhibition by hCGβcf. Using this method, we evaluated the performance of 11 commonly used devices. A wide range of purified hCG and hCGβcf concentrations were mixed and tested on 2 POC devices. By use of those results, a screening method was defined and 9 additional POC devices were evaluated. Two solutions containing (a) 500 pmol/L (171 IU/L) intact hCG with 0 pmol/L hCGβcf and (b) 500 pmol/L intact hCG with 500 000 pmol/L hCGβcf were used to screen all POC devices. The OSOM and Cen-Med Elite devices were found to be most susceptible to false-negative results due to hCGβcf. The BC Icon 20 and the Alere were the least susceptible. The remaining 7 were moderately affected. Devices that gave the strongest signal with hCGβcf alone were those that were least likely to show a hook effect. The screening method put forth here can be used by device users and manufacturers to evaluate POC devices for inhibition by hCGβcf. Of 11 devices evaluated, only 2 have been identified that exhibit minimal to no susceptibility to hCGβcf.

A product-service system approach to telehealth application design.

PubMed

Flores-Vaquero, Paul; Tiwari, Ashutosh; Alcock, Jeffrey; Hutabarat, Windo; Turner, Chris

2016-06-01

A considerable proportion of current point-of-care devices do not offer a wide enough set of capabilities if they are to function in any telehealth system. There is a need for intermediate devices that lie between healthcare devices and service networks. The development of an application is suggested that allows for a smartphone to take the role of an intermediate device. This research seeks to identify the telehealth service requirements for long-term condition management using a product-service system approach. The use of product-service system has proven to be a suitable methodology for the design and development of telehealth smartphone applications. © The Author(s) 2014.

Bioengineered Renal Cell Therapy Device for Clinical Translation

PubMed Central

Pino, Christopher J.; Westover, Angela J.; Buffington, Deborah A.; Humes, H. David

2016-01-01

The Bioartificial Renal Epithelial Cell System (BRECS), is a cell-based device to treat acute kidney injury through renal cell therapy from an extracorporeal circuit. To enable widespread implementation of cell therapy, the BRECS was designed to be cryopreserved as a complete device, cryostored, cryoshipped to an end-use site, thawed as a complete device, and employed in a therapeutic extracorporeal hemofiltration circuit. This strategy overcomes storage and distribution issues that have been previous barriers to cell therapy. Previous BRECS housings produced by Computer Numerical Control (CNC) machining, a slow process taking hours to produce one bioreactor, was also prohibitively expensive (>$600/CNC-BRECS); major obstacles to mass production. The goal of this study was to produce a BRECS to be mass produced by injection molding (IM-BRECS), decreasing cost (<$20/unit) and improving manufacturing speed (hundreds of units/hr), while maintaining the same cell therapy function as the previous CNC-BRECS, first evaluated through prototypes produced by stereolithography (SLA-BRECS). The finalized IM-BRECS design had a significantly lower fill volume (10 mL), mass (49 g) and footprint (8.5 cm×8.5 cm×1.5 cm), and was demonstrated to outperform the previous BRECS designs with respect to heat transfer, significantly improving control of cooling during cryopreservation and reducing thaw times during warming. During in vitro culture, IM-BRECS performed similarly to previous CNC-BRECS with respect to cell metabolic activity (lactate production, oxygen consumption and glutathione metabolism) and amount of cells supported. PMID:27922886

Use of controlled internal drug releasing (CIDR) devices to control reproduction in goats: A review.

PubMed

Knights, Marlon; Singh-Knights, Doolarie

2016-09-01

High reproductive rates are necessary in order to increase the productivity of goat operations. Progesterone and its analogues are widely used in other species to control the reproductive system to facilitate synchronized births, induce fertile estrus or to facilitate the use of assisted reproductive techniques with the goal of increasing productivity of livestock. Progesterone impregnated controlled internal drug releasing (CIDR) devices are approved for delivery of the natural hormone progesterone to synchronize and induce fertile estrus in sheep. A few studies have reported a high estrous response and pregnancy rates when CIDRs are used to induce estrus in goats. However, significant variation exists in the duration of treatment (5-16 days) and in the use of exogenous gonadotropins as part of the treatment protocol. As gonadotropins are not currently approved for commercial use in small ruminants in the USA, studies are needed to determine the necessity for exogenous gonadotropins and whether they can be replaced by enhancing endogenous secretion through photoperiodic manipulation of the doe and \\ or increase stimulation through the 'buck-effect'. Future studies must not only evaluate efficacy, but should consider the economic feasibility of using CIDRs in commercial production systems. © 2016 Japanese Society of Animal Science.

3DS-colorimeter based on a mobile phone camera for industrial applications

NASA Astrophysics Data System (ADS)

Miettinen, Jari; Martinkauppi, J. Birgitta; Suopajärvi, Pekka

2013-02-01

Colour gives an essential finishing touch to many products. Consumers find it as an important factor, for example, when selecting doors, furniture, parquet and coated metal products. Currently, colour evaluation is often carried out by looking at the product. Since people's memory for an exact colour is poor, this method often produces unsatisfactory results in industrial quality control. In this paper, we discuss how to solve this problem by the use of a colour measurement technology for mobile phones equipped with a suitable accessory. Mobile phones provide a suitable monitor platform even for laymen as people are increasingly using their mobile devices for purposes of entertainment, communication and business, thus making them a familiar device to use. Our 3DS-colorimeter is a new, handheld, low-cost consumer/industrial-level prototype combining both a colorimeter feature and 3D surface measurement feature. In this paper, we describe its colorimeter features shortly and demonstrate its performance in measurement repeatability and colorimetric accuracy. As an application example, we show its usefulness for monitoring the colour appearance of painted doors. This study indicates that the 3DS-colorimeter is applicable to industrial quality control.

9 CFR 312.3 - Official marks and devices to identify inspected and passed equine products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... inspected and passed equine products. 312.3 Section 312.3 Animals and Animal Products FOOD SAFETY AND... § 312.3 Official marks and devices to identify inspected and passed equine products. (a) The official... § 317.2 of this subchapter to identify inspected and passed mule and other (nonhorse) equine carcasses...

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

Improved model for detection of homogeneous production batches of electronic components

NASA Astrophysics Data System (ADS)

Kazakovtsev, L. A.; Orlov, V. I.; Stashkov, D. V.; Antamoshkin, A. N.; Masich, I. S.

2017-10-01

Supplying the electronic units of the complex technical systems with electronic devices of the proper quality is one of the most important problems for increasing the whole system reliability. Moreover, for reaching the highest reliability of an electronic unit, the electronic devices of the same type must have equal characteristics which assure their coherent operation. The highest homogeneity of the characteristics is reached if the electronic devices are manufactured as a single production batch. Moreover, each production batch must contain homogeneous raw materials. In this paper, we propose an improved model for detecting the homogeneous production batches of shipped lot of electronic components based on implementing the kurtosis criterion for the results of non-destructive testing performed for each lot of electronic devices used in the space industry.

A high-throughput core sampling device for the evaluation of maize stalk composition

PubMed Central

2012-01-01

Background A major challenge in the identification and development of superior feedstocks for the production of second generation biofuels is the rapid assessment of biomass composition in a large number of samples. Currently, highly accurate and precise robotic analysis systems are available for the evaluation of biomass composition, on a large number of samples, with a variety of pretreatments. However, the lack of an inexpensive and high-throughput process for large scale sampling of biomass resources is still an important limiting factor. Our goal was to develop a simple mechanical maize stalk core sampling device that can be utilized to collect uniform samples of a dimension compatible with robotic processing and analysis, while allowing the collection of hundreds to thousands of samples per day. Results We have developed a core sampling device (CSD) to collect maize stalk samples compatible with robotic processing and analysis. The CSD facilitates the collection of thousands of uniform tissue cores consistent with high-throughput analysis required for breeding, genetics, and production studies. With a single CSD operated by one person with minimal training, more than 1,000 biomass samples were obtained in an eight-hour period. One of the main advantages of using cores is the high level of homogeneity of the samples obtained and the minimal opportunity for sample contamination. In addition, the samples obtained with the CSD can be placed directly into a bath of ice, dry ice, or liquid nitrogen maintaining the composition of the biomass sample for relatively long periods of time. Conclusions The CSD has been demonstrated to successfully produce homogeneous stalk core samples in a repeatable manner with a throughput substantially superior to the currently available sampling methods. Given the variety of maize developmental stages and the diversity of stalk diameter evaluated, it is expected that the CSD will have utility for other bioenergy crops as well. PMID:22548834

Internet-based Advertising Claims and Consumer Reasons for Using Electronic Cigarettes by Device Type in the US.

PubMed

Pulvers, Kim; Sun, Jessica Y; Zhuang, Yue-Lin; Holguin, Gabriel; Zhu, Shu-Hong

2017-10-01

Important differences exist between closed-system and open-system e-cigarettes, but it is unknown whether online companies are marketing these devices differently and whether consumer reasons for using e-cigarettes vary by device type. This paper compares Internet-based advertising claims of closed- versus open-system products, and evaluates US consumers' reasons for using closed- versus open-system e-cigarettes. Internet sites selling exclusively closed (N = 130) or open (N = 129) e-cigarettes in December 2013-January 2014 were coded for advertising claims. Current users (≥18 years old) of exclusively closed or open e-cigarettes (N = 860) in a nationally representative online survey in February-March 2014 provided their main reason for using e-cigarettes. Internet sites that exclusively sold closed-system e-cigarettes were more likely to make cigarette-related claims such as e-cigarettes being healthier and cheaper than cigarettes (ps < .0001) compared to sites selling open systems. Many sites implied their products could help smokers quit. Exclusive users of both systems endorsed cessation as their top reason. Closed-system users were more likely to report their reason as "use where smoking is banned." Although promotion of e-cigarettes as cessation aids is prohibited, consumers of both systems endorsed smoking cessation as their top reason for using e-cigarettes.

Stretchable, Twisted Conductive Microtubules for Wearable Computing, Robotics, Electronics, and Healthcare.

PubMed

Do, Thanh Nho; Visell, Yon

2017-05-11

Stretchable and flexible multifunctional electronic components, including sensors and actuators, have received increasing attention in robotics, electronics, wearable, and healthcare applications. Despite advances, it has remained challenging to design analogs of many electronic components to be highly stretchable, to be efficient to fabricate, and to provide control over electronic performance. Here, we describe highly elastic sensors and interconnects formed from thin, twisted conductive microtubules. These devices consist of twisted assemblies of thin, highly stretchable (>400%) elastomer tubules filled with liquid conductor (eutectic gallium indium, EGaIn), and fabricated using a simple roller coating process. As we demonstrate, these devices can operate as multimodal sensors for strain, rotation, contact force, or contact location. We also show that, through twisting, it is possible to control their mechanical performance and electronic sensitivity. In extensive experiments, we have evaluated the capabilities of these devices, and have prototyped an array of applications in several domains of stretchable and wearable electronics. These devices provide a novel, low cost solution for high performance stretchable electronics with broad applications in industry, healthcare, and consumer electronics, to emerging product categories of high potential economic and societal significance.

The relation between patient discomfort and uncompensated forces of a patient support device for breast and regional lymph node radiotherapy.

PubMed

Boute, Bert; Veldeman, Liv; Speleers, Bruno; Van Greveling, Annick; Van Hoof, Tom; Van de Velde, Joris; Vercauteren, Tom; De Neve, Wilfried; Detand, Jan

2018-10-01

Although many authors stated that a user-centred design approach in medical device development has added values, the most common research approach within healthcare is evidence-based medicine, which tend to focus on functional data rather than patient wellbeing and comfort. End user comfort is well addressed in literature for commercial products such as seats and hand tools but no data was found for medical devices. A commercial patient support device for breast radiotherapy was analysed and a relation was found between discomfort and uncompensated internal body forces. Derived from CT-images, simplified patient free-body diagrams were analysed and pain and comfort evaluated. Subsequently, a new patient position was established and prototypes were developed. Patient comfort- and prototype optimization was done through iterative prototyping. With this approach, we were able to compensate all internal body forces and establish a force neutral patient free-body diagram. This resulted in comfortable patient positioning and favourable medical results. Copyright © 2018 Elsevier Ltd. All rights reserved.

Mechanism Development, Testing, and Lessons Learned for the Advanced Resistive Exercise Device

NASA Technical Reports Server (NTRS)

Lamoreaux, Christopher D.; Landeck, Mark E.

2006-01-01

The Advanced Resistive Exercise Device (ARED) has been developed at NASA Johnson Space Center, for the International Space Station (ISS) program. ARED is a multi-exercise, high-load resistive exercise device, designed for long duration, human space missions. ARED will enable astronauts to effectively maintain their muscle strength and bone mass in the micro-gravity environment more effectively than any other existing devices. ARED's resistance is provided via two, 20.3 cm (8 in) diameter vacuum cylinders, which provide a nearly constant resistance source. ARED also has a means to simulate the inertia that is felt during a 1-G exercise routine via the flywheel subassembly, which is directly tied to the motion of the ARED cylinders. ARED is scheduled to fly on flight ULF 2 to the ISS and will be located in Node 1. Presently, ARED is in the middle of its qualification and acceptance test program. An extensive testing program and engineering evaluation has increased the reliability of ARED by bringing potential design issues to light before flight production. Some of those design issues, resolutions, and design details will be discussed in this paper.

Development of Bipolar All-solid-state Lithium Battery Based on Quasi-solid-state Electrolyte Containing Tetraglyme-LiTFSA Equimolar Complex

PubMed Central

Gambe, Yoshiyuki; Sun, Yan; Honma, Itaru

2015-01-01

The development of high energy–density lithium-ion secondary batteries as storage batteries in vehicles is attracting increasing attention. In this study, high-voltage bipolar stacked batteries with a quasi-solid-state electrolyte containing a Li-Glyme complex were prepared, and the performance of the device was evaluated. Via the successful production of double-layered and triple-layered high-voltage devices, it was confirmed that these stacked batteries operated properly without any internal short-circuits of a single cell within the package: Their plateau potentials (6.7 and 10.0 V, respectively) were two and three times that (3.4 V) of the single-layered device, respectively. Further, the double-layered device showed a capacity retention of 99% on the 200th cycle at 0.5 C, which is an indication of good cycling properties. These results suggest that bipolar stacked batteries with a quasi-solid-state electrolyte containing a Li-Glyme complex could readily produce a high voltage of 10 V. PMID:25746860

Parachuting harnesses comparative evaluation on energy distribution grids.

PubMed

Hembecker, Paula Karina; Poletto, Angela Regina; Gontijo, Leila Amaral

2012-01-01

This research aims to make a comparative evaluation of three different parachuting harnesses to work at heights in the energy industry, from the electricians' point of view concerning these products under the optics of usability and ergonomic principles, and mainly justified by the high quantity of injuries at the energy industry due to high falls. According to its main target, this field research is classified as exploratory-descriptive transversal viewing study and, considering this perspective, the study was developed in four steps. Research results have enlightened the weakest spots and the potential improvement opportunities of these products, developed to assure safety of the work at heights to the energy industry, according to the opinion of the users. Still, results point that, regardless of the model, these devices have adapting issues to fulfill the electrical sector user's needs.

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems.

PubMed

Silva, Lenardo C; Almeida, Hyggo O; Perkusich, Angelo; Perkusich, Mirko

2015-10-30

Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage.

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems

PubMed Central

Silva, Lenardo C.; Almeida, Hyggo O.; Perkusich, Angelo; Perkusich, Mirko

2015-01-01

Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage. PMID:26528982

Artificial food lump from porous neoprene and the method of its use for the evaluation of adaptation patients to the dental constructions

NASA Astrophysics Data System (ADS)

Reshetnikov, A.; Urakov, A.; Kasatkin, A.; Soiher, M. G.; Kopylov, M.

2016-04-01

New dental product called artificial food lump is offered for dental practices. In its size and shape it is similar to the natural food bolus, which is formed in adult's mouth when chewing white bread. This innovative product resembles an inedible and non-swallowable chewing gum. Artificial lump is made of porous neoprene; it is elastic and has food flavor. It is not destroyed by chewing and has stable elasticity during chewing. Besides, artificial lump is manufactured in a way that it can be attached to the patient's clothes with a braid line. New medical device is intended to create the masticatory loading in patients' mouth in order to evaluate the quality of mounted dental restorations as well as patient's adaptation to it during the chewing process.

Towards fully spray coated organic light emitting devices

NASA Astrophysics Data System (ADS)

Gilissen, Koen; Stryckers, Jeroen; Manca, Jean; Deferme, Wim

2014-10-01

Pi-conjugated polymer light emitting devices have the potential to be the next generation of solid state lighting. In order to achieve this goal, a low cost, efficient and large area production process is essential. Polymer based light emitting devices are generally deposited using techniques based on solution processing e.g.: spin coating, ink jet printing. These techniques are not well suited for cost-effective, high throughput, large area mass production of these organic devices. Ultrasonic spray deposition however, is a deposition technique that is fast, efficient and roll to roll compatible which can be easily scaled up for the production of large area polymer light emitting devices (PLEDs). This deposition technique has already successfully been employed to produce organic photovoltaic devices (OPV)1. Recently the electron blocking layer PEDOT:PSS2 and metal top contact3 have been successfully spray coated as part of the organic photovoltaic device stack. In this study, the effects of ultrasonic spray deposition of polymer light emitting devices are investigated. For the first time - to our knowledge -, spray coating of the active layer in PLED is demonstrated. Different solvents are tested to achieve the best possible spray-able dispersion. The active layer morphology is characterized and optimized to produce uniform films with optimal thickness. Furthermore these ultrasonic spray coated films are incorporated in the polymer light emitting device stack to investigate the device characteristics and efficiency. Our results show that after careful optimization of the active layer, ultrasonic spray coating is prime candidate as deposition technique for mass production of PLEDs.

Description of MSFC engineering photographic analysis

NASA Technical Reports Server (NTRS)

Earle, Jim; Williams, Frank

1988-01-01

Utilizing a background that includes development of basic launch and test photographic coverage and analysis procedures, the MSFC Photographic Evaluation Group has built a body of experience that enables it to effectively satisfy MSFC's engineering photographic analysis needs. Combining the basic soundness of reliable, proven techniques of the past with the newer technical advances of computers and computer-related devices, the MSFC Photo Evaluation Group is in a position to continue to provide photo and video analysis service center-wide and NASA-wide to supply an improving photo analysis product to meet the photo evaluation needs of the future; and to provide new standards in the state-of-the-art of photo analysis of dynamic events.

Degradation of HTL layers during device operation in PhOLEDs

NASA Astrophysics Data System (ADS)

Sivasubramaniam, Varatharajan; Brodkorb, Florian; Hanning, Stephanie; Buttler, Oliver; Loebl, Hans Peter; van Elsbergen, Volker; Boerner, Herbert; Scherf, Ullrich; Kreyenschmidt, Martin

2009-11-01

Different analytical tools and methodologies are currently employed to determine degradation products of organic blue light emitting devices in order to identify the failure mechanisms which determine the lifetime of these devices. This article provides a deeper understanding of degradation mechanisms of organic light emitting diodes (OLEDs) during device operation. Degradation products of blue emitting devices containing 8% of the phosphorescent emitter iridium(III)bis(4,6-difluorophenyl)-pyridinato-N,C 2' picolinate (FIrpic) in a matrix containing bis(2-methyl-8-quinolinolato)(4-phenylphenolato)aluminium (BAlq) as electron transport layer (ETL), 4,4',4″-tri( N-carbazolyl)triphenylamine (TCTA) and N, N'-diphenyl- N, N'-bis(1-naphthyl)-1,1'-biphenyl-4,4″-diamine (α-NPD) were investigated using laser desorption ionization (LDI) coupled with a time of flight mass spectrometry (TOF/MS). Especially chemical degradation pathways of the hole transport materials TCTA and α-NPD were investigated. The comparison of experimental data of unstressed and stressed device revealed that new reaction products are formed during the device operation. The linkage of TCTA fragments to the α-NPD core in an interfacial reaction as well as a dimerization of TCTA itself was observed. Ten new reaction products could be characterized via LDI-TOF-MS. Some of these compounds might possess a negative influence on the drop of efficiency and lifetime of blue light emitting devices based on FIrpic.

21 CFR 872.3660 - Impression material.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3660 Impression material. (a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed... device is intended to provide models for study and for production of restorative prosthetic devices, such...

21 CFR 872.3660 - Impression material.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3660 Impression material. (a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed... device is intended to provide models for study and for production of restorative prosthetic devices, such...

78 FR 70306 - Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... for Devices and Radiological Health (CDRH) Food and Drug Administration, 10903 New Hampshire Ave...''). This guidance is intended to provide the current thinking of CDRH and CBER on when IVD products are... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device...

Toxicity of materials used in the manufacture of lithium batteries

DOE Office of Scientific and Technical Information (OSTI.GOV)

Archuleta, M.M.

1994-05-01

The growing interest in battery systems has led to major advances in high-energy and/or high-power-density lithium batteries. Potential applications for lithium batteries include radio transceivers, portable electronic instrumentation, emergency locator transmitters, night vision devices, human implantable devices, as well as uses in the aerospace and defense programs. With this new technology comes the use of new solvent and electrolyte systems in the research, development, and production of lithium batteries. The goal is to enhance lithium battery technology with the use of non-hazardous materials. Therefore, the toxicity and health hazards associated with exposure to the solvents and electrolytes used in currentmore » lithium battery research and development is evaluated and described.« less

Shot and bead peening control

NASA Astrophysics Data System (ADS)

John, R.

The merits of the peening effect in improving the fatigue resistance of ferrous and non-ferrous media is discussed. The machines that perform the peening task are also discussed, including the rotating-wheel plant, pressure-type air-assisted peening machines, and suction systems. The peening process itself is discussed briefly, and an outline of the parameters that affect the product specification is presented. The merits of the Almen test strip as a measure of correct treatment are evaluated, and the two types of devices are discussed for monitoring the flow of peening media. The two types of feed control devices (one for ferrous media and the other for non-ferrous media) for accurately controlling the feed of peening media are also briefly examined.

Combustion products generating and metering device

NASA Technical Reports Server (NTRS)

Wiberg, R. E.; Klisch, J. A. (Inventor)

1971-01-01

An apparatus for generating combustion products at a predetermined fixed rate, mixing the combustion products with air to achieve a given concentration, and distributing the resultant mixture to an area or device to be tested is described. The apparatus is comprised of blowers, a holder for the combustion product generating materials (which burn at a predictable and controlled rate), a mixing plenum chamber, and a means for distributing the air combustion product mixture.

Comparative ex vivo evaluation of two electronic percussive testing devices measuring the stability of dental implants.

PubMed

Geckili, Onur; Bilhan, Hakan; Cilingir, Altug; Bilmenoglu, Caglar; Ates, Gokcen; Urgun, Aliye Ceren; Bural, Canan

2014-12-01

A comparative ex vivo study was performed to determine electronic percussive test values (PTVs) measured by cabled and wireless electronic percussive testing (EPT) devices and to evaluate the intra- and interobserver reliability of the wireless EPT device. Forty implants were inserted into the vertebrae and forty into the pelvis of a steer, a safe distance apart. The implants were all 4.3 mm wide and 13 mm long, from the same manufacturer. PTV of each implant was measured by four different examiners, using both EPT devices, and compared. Additionally, the intra- and interobserver reliability of the wireless EPT device was evaluated. Statistically significant differences (P <0.05) were observed between PTVs made by the two EPT devices. PTVs measured by the wireless EPT device were significantly higher than the cabled EPT device (P <0.05), indicating lower implant stability. The intraobserver reliability of the wireless EPT device was evaluated as excellent for the measurements in type II bone and good-to-excellent in type IV bone; interobserver reliability was evaluated as fair-to-good in both bone types. The wireless EPT device gives PTVs higher than the cabled EPT device, indicating lower implant stability, and its inter- and intraobserver reliability is good and acceptable.

Evaluation of load transfer devices : final report.

DOT National Transportation Integrated Search

1975-11-01

This report describes the procedures and findings of a study conducted to evaluate two types of load transfer devices used in Louisiana--steel dowel bars and starlugs (a patented device). A statistical comparison was accomplished by evaluating existi...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

78 FR 6838 - Certain Balloon Dissection Devices and Products Containing Same; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-865] Certain Balloon Dissection Devices... the United States after importation of certain dissection balloons and products containing the same by... importation of certain dissection balloons and products containing the same that infringe one or more of...

Proposal of an innovative benchmark for comparison of the performance of contactless digitizers

NASA Astrophysics Data System (ADS)

Iuliano, Luca; Minetola, Paolo; Salmi, Alessandro

2010-10-01

Thanks to the improving performances of 3D optical scanners, in terms of accuracy and repeatability, reverse engineering applications have extended from CAD model design or reconstruction to quality control. Today, contactless digitizing devices constitute a good alternative to coordinate measuring machines (CMMs) for the inspection of certain parts. The German guideline VDI/VDE 2634 is the only reference to evaluate whether 3D optical measuring systems comply with the declared or required performance specifications. Nevertheless it is difficult to compare the performance of different scanners referring to such a guideline. An adequate novel benchmark is proposed in this paper: focusing on the inspection of production tools (moulds), the innovative test piece was designed using common geometries and free-form surfaces. The reference part is intended to be employed for the evaluation of the performance of several contactless digitizing devices in computer-aided inspection, considering dimensional and geometrical tolerances as well as other quantitative and qualitative criteria.

Evaluating transdermal alcohol measuring devices

DOT National Transportation Integrated Search

2007-11-01

This report is an evaluation study of two types of transdermal devices that detect alcohol at the skin surface representing two types of electrochemical sensing technology. The AMS SCRAM ankle device and the Giner WrisTAS wrist device were worn...

Growth and innovation in medical devices: a conversation with Stryker chairman John Brown. Interview by Lawton R. Burns.

PubMed

Brown, John

2007-01-01

John Brown, current chairman and past chief executive officer (CEO) of the Stryker Corporation, reviews the development of his device firm and the medical device industry over the past thirty years. Brown describes the trajectory of innovation in medical devices and the managerial and organizational strategy he pioneered at Stryker to achieve consistently high growth rates over the long term. He also shares his perspective on some of the current policy issues facing the device industry today, including product safety, conflicts of interest, rising product prices, and direct-to-consumer advertising.

MO-A-BRC-02: TG167 Report - Detailed Description

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rivard, M.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

MO-A-BRC-01: TG167 Report - Introduction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nath, R.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Medical devices manufactured from latex: European regulatory initiatives.

PubMed

De Jong, W H; Geertsma, R E; Tinkler, J J B

2002-05-01

In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities. Copyright 2002 Elsevier Science (USA).

An investigation into the effects of excipient particle size, blending techniques and processing parameters on the homogeneity and content uniformity of a blend containing low-dose model drug

PubMed Central

Alyami, Hamad; Dahmash, Eman; Bowen, James

2017-01-01

Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality. In this work the effect of excipient type and properties, blending technique and processing time on content uniformity was investigated. Powder characteristics for three commonly used excipients (starch, pregelatinised starch and microcrystalline cellulose) were initially explored using laser diffraction particle size analyser, angle of repose for flowability, followed by thorough evaluations of surface topography employing scanning electron microscopy and interferometry. Blend homogeneity was evaluated based on content uniformity analysis of the model API, ergocalciferol, using a validated analytical technique. Flowability of powders were directly related to particle size and shape, while surface topography results revealed the relationship between surface roughness and ability of excipient with high surface roughness to lodge fine API particles within surface groves resulting in superior uniformity of content. Of the two blending techniques, geometric blending confirmed the ability to produce homogeneous blends at low dilution when processed for longer durations, whereas manual ordered blending failed to achieve compendial requirement for content uniformity despite mixing for 32 minutes. Employing the novel dry powder hybrid mixer device, developed at Aston University laboratory, results revealed the superiority of the device and enabled the production of homogenous blend irrespective of excipient type and particle size. Lower dilutions of the API (1% and 0.5% w/w) were examined using non-sieved excipients and the dry powder hybrid mixing device enabled the development of successful blends within compendial requirements and low relative standard deviation. PMID:28609454

An investigation into the effects of excipient particle size, blending techniques and processing parameters on the homogeneity and content uniformity of a blend containing low-dose model drug.

PubMed

Alyami, Hamad; Dahmash, Eman; Bowen, James; Mohammed, Afzal R

2017-01-01

Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality. In this work the effect of excipient type and properties, blending technique and processing time on content uniformity was investigated. Powder characteristics for three commonly used excipients (starch, pregelatinised starch and microcrystalline cellulose) were initially explored using laser diffraction particle size analyser, angle of repose for flowability, followed by thorough evaluations of surface topography employing scanning electron microscopy and interferometry. Blend homogeneity was evaluated based on content uniformity analysis of the model API, ergocalciferol, using a validated analytical technique. Flowability of powders were directly related to particle size and shape, while surface topography results revealed the relationship between surface roughness and ability of excipient with high surface roughness to lodge fine API particles within surface groves resulting in superior uniformity of content. Of the two blending techniques, geometric blending confirmed the ability to produce homogeneous blends at low dilution when processed for longer durations, whereas manual ordered blending failed to achieve compendial requirement for content uniformity despite mixing for 32 minutes. Employing the novel dry powder hybrid mixer device, developed at Aston University laboratory, results revealed the superiority of the device and enabled the production of homogenous blend irrespective of excipient type and particle size. Lower dilutions of the API (1% and 0.5% w/w) were examined using non-sieved excipients and the dry powder hybrid mixing device enabled the development of successful blends within compendial requirements and low relative standard deviation.

Low emission turbo compound engine system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vuk,; Carl, T

2011-05-31

A diesel or HHCI engine has an air intake and an exhaust for products of combustion. A pair of turbochargers receive the products of combustion in a series relationship and an exhaust aftertreatment device receive the products of combustion from the downstream turbine. A power turbine receives the output from the exhaust aftertreatment device and an EGR system of the power turbine passes a selected portion of the output to a point upstream of the upstream turbocharger compressor. A device adds fuel to the aftertreatment device to regenerate the particulate filter and the power turbine recoups the additional energy. Themore » power turbine may be used to drive accessories or the prime output of the engine.« less

Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians.

PubMed

Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas

2016-06-01

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital-based health technology assessment has been developed to support decisions. However, little is known about the different perceptions of innovative medical devices among practitioners and how different perceptions may affect decision making. What does this paper add? This paper compares and understands the perceptions of two groups of health professionals concerning innovative devices in the university hospital environment. What are the implications for practitioners? Such a comparison of viewpoints could facilitate improvements in current practices and decision-making processes in local health technology assessment for these medical products.

E-tongue: a tool for taste evaluation.

PubMed

Gupta, Himanshu; Sharma, Aarti; Kumar, Suresh; Roy, Saroj K

2010-01-01

Taste has an important role in the development of oral pharmaceuticals. With respect to patient acceptability and compliance, taste is one of the prime factors determining the market penetration and commercial success of oral formulations, especially in pediatric medicine. Taste assessment is one important quality-control parameter for evaluating taste-masked formulations. Hence, pharmaceutical industries invest time, money and resources into developing palatable and pleasant-tasting products. The primary method for the taste measurement of a drug substance or a formulation is by human sensory evaluation, in which tasting a sample is relayed to inspectors. However, this method is impractical for early stage drug development because the test in humans is expensive and the taste of a drug candidate may not be important to the final product. Therefore, taste-sensing analytical devices, which can detect tastes, have been replacing the taste panelists. In the present review we are presenting different aspect of electronic tongue. The review article also discussed some useful patents and instrument with respect to E-tongue.

Medical Device Safety

MedlinePlus

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

Description of Ophthalmic Pharmaceutical and Device Start-Up Companies.

PubMed

Sharpe, R Allan; Austin, Jennifer P; Kruft, Bonnie; Nelson, Lindsay A; Stewart, Jeanette A; Stewart, William C

2015-01-01

To describe the number, type and location of ophthalmic companies and their associated product areas and indications. A retrospective, non-patient-based, observational review of ophthalmic pharmaceutical and device companies with a new product in development. Data was compiled by Internet searches. We identified 190 companies currently developing ophthalmic products: 134 (71%) were privately held and 56 (29%) publicly held, while 136 (72%) were in the United States and 53 (28%) were outside the United States. There were 436 total products of which 338 (78%) were pharmaceuticals and 98 (22%) devices. With pharmaceuticals we identified 46 separate indications with age-related macular degeneration (n = 75), glaucoma (n = 52) and dry eye (n = 46) as most common; anti-vascular endothelial growth factor, hormone therapy and anti-inflammatory products were also common classes. With devices there were 30 indications with glaucoma (n = 26), age-related macular degeneration (n = 19) and dry eye (n = 6) as most common; drug delivery, ocular implants and prostheses were less common classes. Ophthalmology as a specialty is benefited by a wide effort in new medicine and device development. However, a concentration of effort into relatively few indications suggests a potential lack of market analysis and possible difficulty for many companies in commercializing their product. © 2015 S. Karger AG, Basel.

Analytical Chemistry in the Regulatory Science of Medical Devices.

PubMed

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

A new submarine oil-water separation system

NASA Astrophysics Data System (ADS)

Cai, Wen-Bin; Liu, Bo-Hong

2017-12-01

In order to solve the oil field losses of environmental problems and economic benefit caused by the separation of lifting production liquid to offshore platforms in the current offshore oil production, from the most basic separation principle, a new oil-water separation system has been processed of adsorption and desorption on related materials, achieving high efficiency and separation of oil and water phases. And the submarine oil-water separation device has been designed. The main structure of the device consists of gas-solid phase separation device, period separating device and adsorption device that completed high efficiency separation of oil, gas and water under the adsorption and desorption principle, and the processing capacity of the device is calculated.

Product-based Safety Certification for Medical Devices Embedded Software.

PubMed

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

21 CFR 810.10 - Cease distribution and notification order.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

21 CFR 810.10 - Cease distribution and notification order.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

PubMed

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of MEDDEV 2.12-1 rev 8. However, there are differences between German and English FSN, e.g. regarding the distribution to persons needing awareness, missing statement that the Competent Authority was informed and missing customer confirmation. Due to the importance of FSN for reduction of product related risks in FSCA type and content of FSN should be further improved.

Scaled-Up Production and Transport Applications of Graphitic Carbon Nanomaterials

NASA Astrophysics Data System (ADS)

Saviers, Kimberly R.

Graphitic carbon nanomaterials enhance the performance of engineered systems for energy harvesting and storage. However, commercial availability remains largely cost-prohibitive due to technical barriers to mass production. This thesis examines both the scaled-up production and energy transport applications of graphitic materials. Cost driven-production of graphitic petals is developed, carbon nanotube array thermal interface materials enhance waste heat energy harvesting, and microsupercapacitors are visually examined using a new electroreflectance measurement method. Graphitic materials have previously been synthesized using batch-style processing methods with small sample sizes, limiting their commercial viability. In order to increase production throughput, a roll-to-roll radio-frequency plasma chemical vapor deposition method is employed to continuously deposit graphitic petals on carbon fiber tow. In consideration of a full production framework, efficient and informative characterization methods in the form of electrical resistance and electrochemical capacitance are highlighted. To co-optimize the functional characteristics of the material, the processing conditions are comprehensively varied using a data-driven predictive design of experiments method. Repeatable and reliable production of graphitic materials will enable a host of creative graphene-based devices to emerge into the marketplace. Two such applications are discussed in the remaining chapters. Waste heat is most efficiently harvested at high temperatures, such as vehicle exhaust systems near 600°C. However, the resistance to heat flux at the interfaces between the harvesting device and its surroundings is detrimental to the system-level performance. To study the performance of thermal interface materials up to 700°C, a reference bar measurement method was designed. Design considerations are discussed and compared to past implementations, particularly regarding radiation heat flux and thermal expansion at these elevated temperatures. The microscale roughness of the contacting measurement surface is fully characterized, as it fundamentally affects the resulting thermal interface resistance. This comprehensive method for determining thermal interface resistance at high temperatures includes the physical equipment, data acquisition system, and data analysis method. Thermomechanical evaluation of carbon nanotube arrays up to 700°C has shown that the arrays provide mechanical flexibility to accommodate thermal expansion in a thermomechanically mismatched interface. To demonstrate the application of the arrays for improving energy generation, they were evaluated in conjunction with a thermoelectric module. The system-level efficiency increases significantly when a carbon nanotube array is applied to the hot side of the thermoelectric module. Additional materials characterization suggests the presence of a strong thermal connection between the carbon nanotubes and their catalyst layers, due to covalent bonding between them. In another application of harvesting waste heat, the carbon nanotube arrays increase the performance of a thermo-magnetically actuated shuttle device for solar photovoltaic cells due to decreased thermal interface resistance. Vertically-oriented graphitic petals have previously enhanced supercapacitor power density. Here, a spatiotemporal characterization method is developed and utilized to study ageing phenomena in microsupercapacitor electrodes. The electroreflectance method captures images of charge accumulation in the electrodes at varying states during each charge-discharge cycle. The method was exploited by imaging each an ideal device and a device with defects over an extended period of over four million cycles. The charge accumulation patterns over the ageing period relate to the physical transport behavior. During a single discharge cycle, one may visually observe the electrons drifting out of the electrode. Overall, the investigations herein determine the following. Continuous production of graphitic petals is possible and is optimized by considering the effect of plasma conditions on the resulting functional performance of the material. Thermal interface resistance may be measured at high temperatures in order to understand the viability of interface materials for energy harvesting applications. Carbon nanotube array thermal interface materials lead to increased energy generation from thermoelectric modules. Spatial electroreflectance measurements of microsupercapacitors lead to observation of decreased physical wetting between the electrode and electrolyte, impacting device performance. Looking forward, creative application of graphitic carbon nanomaterials, coupled with cost-driven production capability, will launch them into the commercial marketplace.

42 CFR 405.213 - Re-evaluation of a device categorization.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Re-evaluation of a device categorization. 405.213... Decisions That Relate to Health Care Technology § 405.213 Re-evaluation of a device categorization. (a... experimental/investigational (Category A) may request re-evaluation of the categorization decision. (2) A...

42 CFR 405.213 - Re-evaluation of a device categorization.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Re-evaluation of a device categorization. 405.213... Decisions That Relate to Health Care Technology § 405.213 Re-evaluation of a device categorization. (a... experimental/investigational (Category A) may request re-evaluation of the categorization decision. (2) A...

Drug Development Process

MedlinePlus

... Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Patients Home For Patients Learn About Drug and Device Approvals The Drug Development Process The Drug Development Process Share Tweet Linkedin Pin ...

Evaluation of Underwater Adhesives and Friction Coatings for In Situ Attachment of Fiber Optic Sensor System for Subsea Applications

NASA Technical Reports Server (NTRS)

Tang, Henry H.; Le, Suy Q.; Orndoff, Evelyne S.; Smith, Frederick D.; Tapia, Alma S.; Brower, David V.

2012-01-01

Integrity and performance monitoring of subsea pipelines and structures provides critical information for managing offshore oil and gas production operation and preventing environmentally damaging and costly catastrophic failure. Currently pipeline monitoring devices require ground assembly and installation prior to the underwater deployment of the pipeline. A monitoring device that could be installed in situ on the operating underwater structures could enhance the productivity and improve the safety of current offshore operation. Through a Space Act Agreement (SAA) between the National Aeronautics and Space Administration (NASA) Johnson Space Center (JSC) and Astro Technology, Inc. (ATI), JSC provides technical expertise and testing facilities to support the development of fiber optic sensor technologies by ATI. This paper details the first collaboration effort between NASA JSC and ATI in evaluating underwater applicable adhesives and friction coatings for attaching fiber optic sensor system to subsea pipeline. A market survey was conducted to examine different commercial ]off ]the ]shelf (COTS) underwater adhesive systems and to select adhesive candidates for testing and evaluation. Four COTS epoxy based underwater adhesives were selected and evaluated. The adhesives were applied and cured in simulated seawater conditions and then evaluated for application characteristics and adhesive strength. The adhesive that demonstrated the best underwater application characteristics and highest adhesive strength were identified for further evaluation in developing an attachment system that could be deployed in the harsh subsea environment. Various friction coatings were also tested in this study to measure their shear strengths for a mechanical clamping design concept for attaching fiber optic sensor system. A COTS carbide alloy coating was found to increase the shear strength of metal to metal clamping interface by up to 46 percent. This study provides valuable data for assessing the feasibility of developing the next generation fiber optic senor system that could be retrofitted onto existing subsea pipeline structures.

Field evaluations of the VD max approach for substantiation of a 25 kGy sterilization dose and its application to other preselected doses

NASA Astrophysics Data System (ADS)

Kowalski, John B.; Herring, Craig; Baryschpolec, Lisa; Reger, John; Patel, Jay; Feeney, Mary; Tallentire, Alan

2002-08-01

The International and European standards for radiation sterilization require evidence of the effectiveness of a minimum sterilization dose of 25 kGy but do not provide detailed guidance on how this evidence can be generated. An approach, designated VD max, has recently been described and computer evaluated to provide safe and unambiguous substantiation of a 25 kGy sterilization dose. The approach has been further developed into a practical method, which has been subjected to field evaluations at three manufacturing facilities which produce different types of medical devices. The three facilities each used a different overall evaluation strategy: Facility A used VD max for quarterly dose audits; Facility B compared VD max and Method 1 in side-by-side parallel experiments; and Facility C, a new facility at start-up, used VD max for initial substantiation of 25 kGy and subsequent quarterly dose audits. A common element at all three facilities was the use of 10 product units for irradiation in the verification dose experiment. The field evaluations of the VD max method were successful at all three facilities; they included many different types of medical devices/product families with a wide range of average bioburden and sample item portion values used in the verification dose experiments. Overall, around 500 verification dose experiments were performed and no failures were observed. In the side-by-side parallel experiments, the outcomes of the VD max experiments were consistent with the outcomes observed with Method 1. The VD max approach has been extended to sterilization doses >25 and <25 kGy; verification doses have been derived for sterilization doses of 15, 20, 30, and 35 kGy. Widespread application of the VD max method for doses other than 25 kGy must await controlled field evaluations and the development of appropriate specifications/standards.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bouchier, F.; Ahrens, J.S.; Wells, G.

One thing that all access control applications have in common is the need to identify those individuals authorized to gain access to an area. Traditionally, the identification is based on something that person possesses, such as a key or badge, or something they know, such as a PIN or password. Biometric identifiers make their decisions based on the physiological or behavioral characteristics of individuals. The potential of biometrics devices to positively identify individuals has made them attractive for use in access control and computer security applications. However, no systems perform perfectly, so it is important to understand what a biometricmore » device`s performance is under real world conditions before deciding to implement one in an access control system. This paper will describe the evaluation of a prototype biometric identifier provided by IriScan Incorporated. This identifier was developed to recognize individual human beings based on the distinctive visual characteristics of the irises of their eyes. The main goal of the evaluation was to determine whether the system has potential as an access control device within the Department of Energy (DOE). The primary interest was an estimate of the accuracy of the system in terms of false accept and false reject rates. Data was also collected to estimate throughput time and user acceptability. The performance of the system during the test will be discussed. Lessons learned during the test which may aid in further testing and simplify implementation of a production system will also be discussed.« less

STS-43 Commander Blaha conducts DTO 1208 using laptop on OV-104's flight deck

NASA Image and Video Library

1991-08-11

STS043-03-009 (5 Aug 1991) ---- Astronaut John E. Blaha is pictured executing development test objective (DTO) 1208, Space Station Cursor Control Device Evaluation II and advanced applications. The purpose of the Cursor Control Device Experiment is to evaluate human performance under space flight conditions of cursor control devices which are similar to the devices under consideration for use onboard Space Station computers. Here, the mission commander uses a thumbball/handgrip control device. Each crewmember evaluated the different types of cursor control devices during the nine-day STS-43 mission. Other methods of cursor control evaluated were the built-in trackball, a side mounted trackball with restraints and an optical pad with mouse.

STS-43 MS Adamson conducts DTO 1208 using laptop on OV-104's flight deck

NASA Image and Video Library

1991-08-11

STS043-14-034 (2-11 Aug 1991) --- Astronaut James C. Adamson is pictured executing Development Test Objective (DTO) 1208, Space Station Cursor Control Device Evaluation II and Advanced Applications. The purpose of the Cursor Control Device Experiment is to evaluate human performance under space flight conditions of cursor control devices which are similar to the devices under consideration for use onboard space station computers. Here, the mission specialists uses a thumbball/handgrip control device. Each crewmember evaluated the different types of cursor control devices during the nine-day STS-43 mission. Other methods of cursor control evaluated were the built-in trackball, a side mounted trackball with restraints and an optical pad with mouse.

77 FR 3159 - Electronic Export Application and Certification Charge; Flexibility in the Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... Marks, Devices, and Certificates; Egg Products Export Certification AGENCY: Food Safety and Inspection... inspection marks, devices, and certificates. In addition, FSIS is proposing to amend the egg product export... possible under the current system. The Egg Products Inspection Act (EPIA) (21 U.S.C. 1031-1056) does not...

9 CFR 381.137 - Evidence of labeling and devices approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Evidence of labeling and devices approval. 381.137 Section 381.137 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION...

Economic content in medical journal advertisements for medical devices and prescription drugs.

PubMed

Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

2010-01-01

Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

Experimental evaluation of cooling efficiency of the high performance cooling device

NASA Astrophysics Data System (ADS)

Nemec, Patrik; Malcho, Milan

2016-06-01

This work deal with experimental evaluation of cooling efficiency of cooling device capable transfer high heat fluxes from electric elements to the surrounding. The work contain description of cooling device, working principle of cooling device, construction of cooling device. Experimental part describe the measuring method of device cooling efficiency evaluation. The work results are presented in graphic visualization of temperature dependence of the contact area surface between cooling device evaporator and electronic components on the loaded heat of electronic components in range from 250 to 740 W and temperature dependence of the loop thermosiphon condenser surface on the loaded heat of electronic components in range from 250 to 740 W.

Sensory and instrumental analysis for slipperiness and compliance of food during swallowing.

PubMed

Seo, H-S; Hwang, I K; Han, T R; Kim, I S

2007-11-01

In spite of its importance, there have been few attempts to evaluate the sensory attributes of the food bolus during swallowing. In the current study, the slipperiness, the degree of slide for the food bolus through the mucosal surface of the oro-pharynx, and the compliance, how easily the shape of a food bolus can be transformed for automatic and comfortable swallowing, were derived among several sensory attributes related to the swallowing. Therefore, the study aims were twofold: (1) to develop the methods of sensory and instrumental analyses for determining the slipperiness and compliance of the food bolus during swallowing and (2) to examine the appropriateness of the newly designed devices by correlating the data between the sensory and instrumental analyses. Six commercial food products were evaluated by 10 trained panelists for each attribute. The devices for assessing each attribute were developed in consideration of the oro-pharyngeal movements. The sensory and instrumental analyses showed high correlation and regression coefficients as well as intensity differences of the 6 samples for each attribute. In conclusion, the slipperiness and the compliance were suitable for acquiring a better understanding of the sensory attributes of the food bolus during swallowing, and the newly developed devices showed a high potential for determining those attributes.

16 CFR 1507.8 - Wheel devices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Wheel devices. 1507.8 Section 1507.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.8 Wheel devices. Drivers in fireworks devices commonly known as “wheels” shall be...

Bright conjugated polymer nanoparticles containing a biodegradable shell produced at high yields and with tuneable optical properties by a scalable microfluidic device.

PubMed

Abelha, T F; Phillips, T W; Bannock, J H; Nightingale, A M; Dreiss, C A; Kemal, E; Urbano, L; deMello, J C; Green, M; Dailey, L A

2017-02-02

This study compares the performance of a microfluidic technique and a conventional bulk method to manufacture conjugated polymer nanoparticles (CPNs) embedded within a biodegradable poly(ethylene glycol) methyl ether-block-poly(lactide-co-glycolide) (PEG 5K -PLGA 55K ) matrix. The influence of PEG 5K -PLGA 55K and conjugated polymers cyano-substituted poly(p-phenylene vinylene) (CN-PPV) and poly(9,9-dioctylfluorene-2,1,3-benzothiadiazole) (F8BT) on the physicochemical properties of the CPNs was also evaluated. Both techniques enabled CPN production with high end product yields (∼70-95%). However, while the bulk technique (solvent displacement) under optimal conditions generated small nanoparticles (∼70-100 nm) with similar optical properties (quantum yields ∼35%), the microfluidic approach produced larger CPNs (140-260 nm) with significantly superior quantum yields (49-55%) and tailored emission spectra. CPNs containing CN-PPV showed smaller size distributions and tuneable emission spectra compared to F8BT systems prepared under the same conditions. The presence of PEG 5K -PLGA 55K did not affect the size or optical properties of the CPNs and provided a neutral net electric charge as is often required for biomedical applications. The microfluidics flow-based device was successfully used for the continuous preparation of CPNs over a 24 hour period. On the basis of the results presented here, it can be concluded that the microfluidic device used in this study can be used to optimize the production of bright CPNs with tailored properties with good reproducibility.

75 FR 82410 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... Certain Game Devices, Components Thereof, and Products Containing the Same, DN 2776; the Commission is... United States after importation of certain game devices, components thereof, and products containing the...

78 FR 59370 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof, DN 2981; the... United States after importation of certain marine sonar imaging devices, products containing the same...

Advancements in DEPMOSFET device developments for XEUS

NASA Astrophysics Data System (ADS)

Treis, J.; Bombelli, L.; Eckart, R.; Fiorini, C.; Fischer, P.; Hälker, O.; Herrmann, S.; Lechner, P.; Lutz, G.; Peric, I.; Porro, M.; Richter, R. H.; Schaller, G.; Schopper, F.; Soltau, H.; Strüder, L.; Wölfel, S.

2006-06-01

DEPMOSFET based Active Pixel Sensor (APS) matrices are a new detector concept for X-ray imaging spectroscopy missions. They can cope with the challenging requirements of the XEUS Wide Field Imager and combine excellent energy resolution, high speed readout and low power consumption with the attractive feature of random accessibility of pixels. From the evaluation of first prototypes, new concepts have been developed to overcome the minor drawbacks and problems encountered for the older devices. The new devices will have a pixel size of 75 μm × 75 μm. Besides 64 × 64 pixel arrays, prototypes with a sizes of 256 × 256 pixels and 128 × 512 pixels and an active area of about 3.6 cm2 will be produced, a milestone on the way towards the fully grown XEUS WFI device. The production of these improved devices is currently on the way. At the same time, the development of the next generation of front-end electronics has been started, which will permit to operate the sensor devices with the readout speed required by XEUS. Here, a summary of the DEPFET capabilities, the concept of the sensors of the next generation and the new front-end electronics will be given. Additionally, prospects of new device developments using the DEPFET as a sensitive element are shown, e.g. so-called RNDR-pixels, which feature repetitive non-destructive readout to lower the readout noise below the 1 e - ENC limit.

Potential of connected devices to optimize cattle reproduction.

PubMed

Saint-Dizier, Marie; Chastant-Maillard, Sylvie

2018-05-01

Estrus and calving are two major events of reproduction that benefit from connected devices because of their crucial importance in herd economics and the amount of time required for their detection. The objectives of this review are to: 1) provide an update on performances reached by sensor systems to detect estrus and calving time; 2) discuss current economic issues related to connected devices for the management of cattle reproduction; 3) propose perspectives for these devices. The main physiological parameters monitored separately or in combination by connected devices are the cow activity, body temperature and rumination or eating behavior. The combination of several indicators in one sensor may maximize the performances of estrus and calving detection. An effort remains to be made for the prediction of calvings that will require human assistance (dystocia). The main reasons to invest in connected devices are to optimize herd reproductive performances and reduce labor on farm. The economic benefit was evaluated for estrus detection and depends on the initial herd performances, herd size, labor cost and price of the equipment. Major issues associated with the use of automated sensor systems are the weight of financial investment, the lack of economic analysis and limited skills of the users to manage associated technologies. In the near future, connected devices may allow a precise phenotyping of reproductive and health traits on animals and could help to improve animal welfare and public perception of animal production. Copyright © 2017 Elsevier Inc. All rights reserved.

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

PubMed

Terhechte, Arno

2018-03-01

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

Revealing Optical Components

NASA Technical Reports Server (NTRS)

2002-01-01

The Optical Vector Analyzer (OVA) 1550 significantly reduces the time and cost of testing sophisticated optical components. The technology grew from the research Luna Technologies' Dr. Mark Froggatt conducted on optical fiber strain measurement while working at Langley Research Center. Dr. Froggatt originally developed the technology for non- destructive evaluation testing at Langley. The new technique can provide 10,000 independent strain measurements while adding less than 10 grams to the weight of the vehicle. The OVA is capable of complete linear characterization of single-mode optical components used in high- bit-rate applications. The device can test most components over their full range in less than 30 seconds, compared to the more than 20 minutes required by other testing methods. The dramatically shortened measurement time results in increased efficiency in final acceptance tests of optical devices, and the comprehensive data produced by the instrument adds considerable value for component consumers. The device eliminates manufacturing bottlenecks, while reducing labor costs and wasted materials during production.

Steering the Properties of MoOx Hole Transporting Layers in OPVs and OLEDs: Interface Morphology vs. Electronic Structure

PubMed Central

Marchal, Wouter; Verboven, Inge; Kesters, Jurgen; Moeremans, Boaz; De Dobbelaere, Christopher; Bonneux, Gilles; Elen, Ken; Conings, Bert; Maes, Wouter; Boyen, Hans Gerd; Deferme, Wim; Van Bael, Marlies; Hardy, An

2017-01-01

The identification, fine-tuning, and process optimization of appropriate hole transporting layers (HTLs) for organic solar cells is indispensable for the production of efficient and sustainable functional devices. In this study, the optimization of a solution-processed molybdenum oxide (MoOx) layer fabricated from a combustion precursor is carried out via the introduction of zirconium and tin additives. The evaluation of the output characteristics of both organic photovoltaic (OPV) and organic light emitting diode (OLED) devices demonstrates the beneficial influence upon the addition of the Zr and Sn ions compared to the generic MoOx precursor. A dopant effect in which the heteroatoms and the molybdenum oxide form a chemical identity with fundamentally different structural properties could not be observed, as the additives do not affect the molybdenum oxide composition or electronic band structure. An improved surface roughness due to a reduced crystallinity was found to be a key parameter leading to the superior performance of the devices employing modified HTLs. PMID:28772483

Steering the Properties of MoOx Hole Transporting Layers in OPVs and OLEDs: Interface Morphology vs. Electronic Structure.

PubMed

Marchal, Wouter; Verboven, Inge; Kesters, Jurgen; Moeremans, Boaz; De Dobbelaere, Christopher; Bonneux, Gilles; Elen, Ken; Conings, Bert; Maes, Wouter; Boyen, Hans Gerd; Deferme, Wim; Van Bael, Marlies; Hardy, An

2017-01-30

The identification, fine-tuning, and process optimization of appropriate hole transporting layers (HTLs) for organic solar cells is indispensable for the production of efficient and sustainable functional devices. In this study, the optimization of a solution-processed molybdenum oxide (MoOx) layer fabricated from a combustion precursor is carried out via the introduction of zirconium and tin additives. The evaluation of the output characteristics of both organic photovoltaic (OPV) and organic light emitting diode (OLED) devices demonstrates the beneficial influence upon the addition of the Zr and Sn ions compared to the generic MoOx precursor. A dopant effect in which the heteroatoms and the molybdenum oxide form a chemical identity with fundamentally different structural properties could not be observed, as the additives do not affect the molybdenum oxide composition or electronic band structure. An improved surface roughness due to a reduced crystallinity was found to be a key parameter leading to the superior performance of the devices employing modified HTLs.

Fused Deposition Modeling 3D Printing for (Bio)analytical Device Fabrication: Procedures, Materials, and Applications

PubMed Central

2017-01-01

In this work, the use of fused deposition modeling (FDM) in a (bio)analytical/lab-on-a-chip research laboratory is described. First, the specifications of this 3D printing method that are important for the fabrication of (micro)devices were characterized for a benchtop FDM 3D printer. These include resolution, surface roughness, leakage, transparency, material deformation, and the possibilities for integration of other materials. Next, the autofluorescence, solvent compatibility, and biocompatibility of 12 representative FDM materials were tested and evaluated. Finally, we demonstrate the feasibility of FDM in a number of important applications. In particular, we consider the fabrication of fluidic channels, masters for polymer replication, and tools for the production of paper microfluidic devices. This work thus provides a guideline for (i) the use of FDM technology by addressing its possibilities and current limitations, (ii) material selection for FDM, based on solvent compatibility and biocompatibility, and (iii) application of FDM technology to (bio)analytical research by demonstrating a broad range of illustrative examples. PMID:28628294

Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C.

PubMed

Maynard, John D; Rohrscheib, Mark; Way, Jeffrey F; Nguyen, Catriona M; Ediger, Marwood N

2007-05-01

This study compared the performance of a novel noninvasive technology to fasting plasma glucose (FPG) and A1C tests for detecting undiagnosed diabetes and impaired glucose tolerance. The design was a head-to-head evaluation in a naïve population. Consented subjects received FPG and A1C tests and an oral glucose tolerance test (OGTT). Subjects were also measured by a noninvasive device that detects the fluorescence of skin advanced glycation end products. A total of 351 subjects participated. Subjects with 2-h OGTT values > or = 140 mg/dl defined the positive screening class. A total of 84 subjects (23.9% prevalence) screened positive. The performances of the noninvasive device, FPG, and A1C were evaluated for sensitivity and specificity against this classification. At the impaired fasting glucose threshold (FPG = 100 mg/dl), the FPG testing sensitivity was 58% and the specificity was 77.4%. At that same specificity, the sensitivity for A1C testing was 63.8%, while the noninvasive testing sensitivity was 74.7%. The sensitivity advantage of the noninvasive device over both blood tests for detecting diabetes and precursors was statistically significant (P < 0.05). The noninvasive technology showed clinical performance advantages over both FPG and A1C testing. The sensitivity differential indicated that the noninvasive device is capable of identifying 28.8% more individuals in the OGTT-defined positive screening class than FPG testing and 17.1% more than A1C testing. The combination of higher sensitivity and greater convenience--rapid results with no fasting or blood draws--makes the device well suited for opportunistic screening.

Vat rates on medical devices: foreign experience and Ukrainian practice.

PubMed

Pashkov, Vitalii; Hutorova, Nataliia; Harkusha, Andrii

2017-01-01

In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.

Combustion Products Monitor: Trade Study Testing

NASA Technical Reports Server (NTRS)

Wallace, William T.; Trowbridge, John B.

2011-01-01

Current combustion products monitoring on the International Space Station (ISS) uses a handheld device (Compound Specific Analyzer-Combustion Products, CSA-CP) containing electrochemical sensors used to measure the concentration of carbon monoxide (CO), hydrogen chloride (HCl), hydrogen cyanide (HCN), and oxygen (O2). The CO sensor in this device accounts for a well-known cross-sensitivity with hydrogen (H2), which is important, as ISS air can contain up to 100 ppm H2. Unfortunately, this current device is being discontinued, and due to space constraints, the new model cannot accommodate the size of the current CO sensor. Therefore, a trade study was conducted in order to determine which CO sensors on the market were available with compensation for H2, and which instruments used these sensors, while also measuring HCN, O2, and carbon dioxide (CO2). The addition of CO2 to the device is helpful, as current monitoring of this gas requires a second hand-held monitor. By providing a device that will monitor both combustion products and CO2, volume and up-mass can be reduced as these monitors are delivered to ISS.

Portable Intravenous Fluid Production Device for Ground Use

NASA Technical Reports Server (NTRS)

Scarpa, Philip J.; Scheuer, Wolfgang K.

2012-01-01

There are several medical conditions that require intravenous (IV) fluids. Limitations of mass, volume, storage space, shelf-life, transportation, and local resources can restrict the availability of such important fluids. These limitations are expected in long-duration space exploration missions and in remote or austere environments on Earth. Current IV fluid production requires large factory-based processes. Easy, portable, on-site production of IV fluids can eliminate these limitations. Based on experience gained in developing a device for spaceflight, a ground-use device was developed. This design uses regular drinking water that is pumped through two filters to produce, in minutes, sterile, ultrapure water that meets the stringent quality standards of the United States Pharmacopeia for Water for Injection (Total Bacteria, Conductivity, Endotoxins, Total Organic Carbon). The device weighs 2.2 lb (1 kg) and is 10 in. long, 5 in. wide, and 3 in. high (.25, 13, and 7.5 cm, respectively) in its storage configuration. This handheld device produces one liter of medical-grade water in 21 minutes. Total production capacity for this innovation is expected to be in the hundreds of liters.

iPhone in NASA Ground Operations

NASA Technical Reports Server (NTRS)

Benedict, Ashley; Byrd, Keena; Ignacio, Lalaine; Lagu, Amit; Palmer, Ralph Curtis, III; Savoy, April; Surabattula, Deepti; Vaitkunas, Samantha

2007-01-01

A comprehensive review of the literature and historical background of NASA established a need for an easy-to-implement technological improvement to displaying procedures which is cost effective and risk reducing. Previous unsuccessful attempts have led this team to explore the practicality of using a mobile handheld device. The major products, inputs, resources, constraints, planning and effort required for consideration of this type of solution were outlined. After analyzing the physical, environmental, life-cycle, functional, and socio-technical requirements, a Functional Analysis was performed to describe the top-level, second-level, and third-level functions of the system requirements. In addition, the risk/value proposition of conversion to a new technology was considered and gave a blueprint for transitioning along with the tasks necessary to implement the device into the Vehicle Assembly Building's (VAB) current infrastructure. A Work Breakdown Structure (WBS) described the elemental work items of the implementation. Once the viability of this system was confirmed, a device was selected through use of technical design comparison methods including the Pugh Matrix and House of Quality. Comparison and evaluation of the Apple iPhone, Motorola Q, Blackberry, PC Notebook, and PDA revealed that the iPhone is the most suitable device for this task. This paper outlines the device design/ architecture, as well as some of the required infrastructure.

Controlling release from 3D printed medical devices using CLIP and drug-loaded liquid resins.

PubMed

Bloomquist, Cameron J; Mecham, Michael B; Paradzinsky, Mark D; Janusziewicz, Rima; Warner, Samuel B; Luft, J Christopher; Mecham, Sue J; Wang, Andrew Z; DeSimone, Joseph M

2018-05-28

Mass customization along with the ability to generate designs using medical imaging data makes 3D printing an attractive method for the fabrication of patient-tailored drug and medical devices. Herein we describe the application of Continuous Liquid Interface Production (CLIP) as a method to fabricate biocompatible and drug-loaded devices with controlled release properties, using liquid resins containing active pharmaceutical ingredients (API). In this work, we characterize how the release kinetics of a model small molecule, rhodamine B-base (RhB), are affected by device geometry, network crosslink density, and the polymer composition of polycaprolactone- and poly (ethylene glycol)-based networks. To demonstrate the applicability of using API-loaded liquid resins with CLIP, the UV stability was evaluated for a panel of clinically-relevant small molecule drugs. Finally, select formulations were tested for biocompatibility, degradation and encapsulation of docetaxel (DTXL) and dexamethasone-acetate (DexAc). Formulations were shown to be biocompatible over the course of 175 days of in vitro degradation and the clinically-relevant drugs could be encapsulated and released in a controlled fashion. This study reveals the potential of the CLIP manufacturing platform to serve as a method for the fabrication of patient-specific medical and drug-delivery devices for personalized medicine. Copyright © 2018. Published by Elsevier B.V.

Summary of Research, Academic Departments, 1982-1983.

DTIC Science & Technology

1983-10-01

Office to pursue fur- - and the production of towing tank models is de - ther proof of concept tests and seek improvements ,’ scribed. The design...followed b" Haskind. Rci,,ncr. * as "Cable Fire Studies: Progress Report in Evaluation of Timman, van de Vooren and Greidanus. and Release Rate Apparatus...diameter of the in the capture chamber have been compared with a system is increased, the draft of the device is de - limited amount of experimental data

Safety and Efficacy of the BrainPort V100 Device in Individuals Blinded by Traumatic Injury

DTIC Science & Technology

2017-12-01

study was to investigate the impact of the BrainPort V200 on real-world functional task performance in persons who are profoundly blind (no better than...16 6. Products 16 7. Participants & Other Collaborating Organizations 16 8. Special Reporting Requirements 18 9. Appendix...environment. The purpose of this study was to evaluate the safety and effectiveness of the BrainPort V200 in individuals who have been medically

Production of radially and azimuthally polarized polychromatic beams

NASA Astrophysics Data System (ADS)

Shoham, A.; Vander, R.; Lipson, S. G.

2006-12-01

We describe a system that efficiently provides radially or azimuthally polarized radiation from a randomly polarized source. It is constructed from two conical reflectors and a cylindrical sheet of polarizing film. Envisaged applications include a microscope illuminator for high-resolution surface plasmon resonance microscopy, illumination for high-resolution microlithography, and efficient coupling of a laser source to hollow optical fibers. The angular coherence function of light polarized by the device was measured to evaluate its usefulness for these applications.

Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial.

PubMed

Ullman, Amanda J; Kleidon, Tricia; Gibson, Victoria; McBride, Craig A; Mihala, Gabor; Cooke, Marie; Rickard, Claire M

2017-08-30

Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. ACTRN12614000280606 ; prospectively registered on 17/03/2014.

Do single-use medical devices containing biopolymers reduce the environmental impacts of surgical procedures compared with their plastic equivalents?

PubMed

Unger, Scott R; Hottle, Troy A; Hobbs, Shakira R; Thiel, Cassandra L; Campion, Nicole; Bilec, Melissa M; Landis, Amy E

2017-01-01

Background While petroleum-based plastics are extensively used in health care, recent developments in biopolymer manufacturing have created new opportunities for increased integration of biopolymers into medical products, devices and services. This study compared the environmental impacts of single-use disposable devices with increased biopolymer content versus typically manufactured devices in hysterectomy. Methods A comparative life cycle assessment of single-use disposable medical products containing plastic(s) versus the same single-use medical devices with biopolymers substituted for plastic(s) at Magee-Women's Hospital (Magee) in Pittsburgh, PA and the products used in four types of hysterectomies that contained plastics potentially suitable for biopolymer substitution. Magee is a 360-bed teaching hospital, which performs approximately 1400 hysterectomies annually. Results There are life cycle environmental impact tradeoffs when substituting biopolymers for petroplastics in procedures such as hysterectomies. The substitution of biopolymers for petroleum-based plastics increased smog-related impacts by approximately 900% for laparoscopic and robotic hysterectomies, and increased ozone depletion-related impacts by approximately 125% for laparoscopic and robotic hysterectomies. Conversely, biopolymers reduced life cycle human health impacts, acidification and cumulative energy demand for the four hysterectomy procedures. The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects. However, the significant agricultural inputs associated with manufacturing biopolymers exacerbate environmental impacts of products and devices made using biopolymers. Conclusions The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects; however, the significant agricultural inputs associated with manufacturing biopolymers exacerbate environmental impacts.

Implications of scaling on static RAM bit cell stability and reliability

NASA Astrophysics Data System (ADS)

Coones, Mary Ann; Herr, Norm; Bormann, Al; Erington, Kent; Soorholtz, Vince; Sweeney, John; Phillips, Michael

1993-01-01

In order to lower manufacturing costs and increase performance, static random access memory (SRAM) bit cells are scaled progressively toward submicron geometries. The reliability of an SRAM is highly dependent on the bit cell stability. Smaller memory cells with less capacitance and restoring current make the array more susceptible to failures from defectivity, alpha hits, and other instabilities and leakage mechanisms. Improving long term reliability while migrating to higher density devices makes the task of building in and improving reliability increasingly difficult. Reliability requirements for high density SRAMs are very demanding with failure rates of less than 100 failures per billion device hours (100 FITs) being a common criteria. Design techniques for increasing bit cell stability and manufacturability must be implemented in order to build in this level of reliability. Several types of analyses are performed to benchmark the performance of the SRAM device. Examples of these analysis techniques which are presented here include DC parametric measurements of test structures, functional bit mapping of the circuit used to characterize the entire distribution of bits, electrical microprobing of weak and/or failing bits, and system and accelerated soft error rate measurements. These tests allow process and design improvements to be evaluated prior to implementation on the final product. These results are used to provide comprehensive bit cell characterization which can then be compared to device models and adjusted accordingly to provide optimized cell stability versus cell size for a particular technology. The result is designed in reliability which can be accomplished during the early stages of product development.

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

9 CFR 381.138 - Unauthorized use or disposition of approved labeling or devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labeling or devices. 381.138 Section 381.138 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION...

9 CFR 592.5 - Designation of official certificates, memoranda, marks, other identifications, and devices for...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Designation of official certificates, memoranda, marks, other identifications, and devices for purposes of the Agricultural Marketing Act. 592.5 Section 592.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY...

47 CFR 2.803 - Marketing of radio frequency devices prior to equipment authorization.

Code of Federal Regulations, 2014 CFR

2014-10-01

... device that is in the conceptual, developmental, design or pre-production stage may be offered for sale...) The following notice is included with the kit: FCC NOTICE: This kit is designed to allow: (1) Product... stations and that this product accept harmful interference. Unless the assembled kit is designed to operate...

Processing single-use medical devices for use in surgery - importance, status quo and potential.

PubMed

Krüger, Colin M

2008-09-03

In summary, it is possible with the technology and scientific knowledge currently available to allow products intended for single use to be reprocessed using validated and certified processing procedures, while maintaining the full function and without any loss in quality. How many times a product can be re-processed must be determined separately for each individual medical technology device; it is not possible to make any kind of blanket statement as to the permissible number of cycles. This is due to the differing construction, the various combinations of materials and the diverse demands made of each device during clinical use. The exigency of the reprocessing issue is evident both to the user and the primary manufacturer. For the user, where there is a correspondingly high-quality primary product with suitably costed, technically-sound and certified reprocessing procedures, repeat usage can mean real savings while maintaining full functionality in each use. For the primary manufacturers of highly specialised instruments, only part of which can be represented by the medical facility in terms of a corresponding DRG (Diagnosis-Related Group), it is reprocessing that opens the door to widespread routine clinical use. The patient, in turn, benefits greatly from this, since his demand for medical treatment using the most up-to-date technology is taken into account. If processing complies in full with medical technology and hygiene directives, from the medical point of view (without being able to definitively evaluate each individual case using this criterion) the specific advantages of the reprocessing procedure are obvious. In order to establish broad acceptance for the purposes of good marketing, corresponding controlling and quality instruments have to be developed to allow the decision-making process regarding the permissibility of the reprocessing of a certain device and the number of times it can be reprocessed using this procedure to be made transparent.Taking this a step further, possibilities arise for the establishment of corresponding quality-assurance instruments on the part of the clinical establishments involved, within which reprocessed products, in the interest of quality assurance, can be referred back to the processor in the event of defective function and can also be removed from clinical use prior to completing the intended number of processing cycles. Furthermore, it can be assumed that the widespread use of reprocessing procedures in today's high-cost single-use medical device sector will have a long-term cost/price-regulating effect for the primary products, to the benefit of the users. Thus, the heated debate regarding the safety of processing procedures that have already been certified and validated in accordance with current industry standards should be evaluated in particular from the point of view of the justified fears of the leading manufacturers with regard to their currently established market share. From a purely surgical point of view, the reprocessing of disposable products should be welcomed as a revolution. The main criteria for surgeons and medics should always be the benefit for the patient. If the quality is ensured through corresponding processing and validation procedures based on recognised certificates, then economic arguments take precedence. Cases in which a DRG (and thus a payment calculation) does not fully cover the use of medical devices are conceivable. Withholding medically necessary services on grounds of the costs, or making these services available to a limited extent only, is not acceptable from the medical point of view and furthermore goes beyond what is ethically acceptable. Each procedure, even the systematic use of reprocessing of suitable medical technology disposable items, should, where the quality is guaranteed, be supported unequivocally. Taken a step further, this branch of the economy will have a long-lasting price-regulating effect on the primary producers market.

Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters.

PubMed

Jeong, Tae-Dong; Cho, Eun-Jung; Ko, Dae-Hyun; Lee, Woochang; Chun, Sail; Hong, Ki-Sook; Min, Won-Ki

2016-12-01

The aim of this study was to report the experience of large-scale performance evaluation of 238 Accu-Chek Inform II point-of-care (POC) glucose meters in a single medical setting. The repeatability of 238 POC devices, the within-site imprecision of 12 devices, and the linearity of 49 devices were evaluated using glucose control solutions. The glucose results of 24 POC devices and central laboratory were compared using patient samples. Mean concentration of control solutions was 2.39 mmol/L for Level 1 and 16.52 mmol/L for Level 2. The pooled repeatability coefficient of variation (CV) of the 238 devices was 2.0% for Level 1 and 1.6% for Level 2. The pooled within-site imprecision CV and reproducibility CV of the 12 devices were 2.7% and 2.7% for Level 1, and 1.9%, and 1.9% for Level 2, respectively. The test results of all 49 devices were linear within analytical measurement range from 1.55-31.02 mmol/L. The correlation coefficient for individual POC devices ranged from 0.9967-0.9985. The total correlation coefficient for the 24 devices was 0.998. The Accu-Chek Inform II POC blood glucose meters performed well in terms of precision, linearity, and correlation evaluations. Consensus guidelines for the large-scale performance evaluations of POC devices are required.

Store-operate-coherence-on-value

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chen, Dong; Heidelberger, Philip; Kumar, Sameer

A system, method and computer program product for performing various store-operate instructions in a parallel computing environment that includes a plurality of processors and at least one cache memory device. A queue in the system receives, from a processor, a store-operate instruction that specifies under which condition a cache coherence operation is to be invoked. A hardware unit in the system runs the received store-operate instruction. The hardware unit evaluates whether a result of the running the received store-operate instruction satisfies the condition. The hardware unit invokes a cache coherence operation on a cache memory address associated with the receivedmore » store-operate instruction if the result satisfies the condition. Otherwise, the hardware unit does not invoke the cache coherence operation on the cache memory device.« less

A modified thickness extensional disk transducer.

PubMed

Trolier, S E; Xu, Q C; Newnham, R E

1988-01-01

Photolithography and chemical etching were investigated as a means of patterning miniature piezoelectric devices. Using a processing procedure analogous to that utilized in the production of integrated circuitry, concentrated hydrochloric acid and a commercially available photoresist were used to fabricate a number of complex structures from soft lead zirconate titanate (PZT) substrates. Among the devices produced in this manner was a modified thickness-mode resonator etched to destroy the simple geometry responsible for radial vibrations. The resultant transducer demonstrated significantly smaller amplitudes for lateral resonances and a marked reduction in the effective planar coupling coefficient over the unaltered disk. The results indicate that photolithographic patterning is useful both for eliminating spurious resonances from transducers for medical imaging or nondestructive evaluation and for engineering low planar coupling coefficients into a variety of substrate materials.

Degradable phosphate glass fiber reinforced polymer matrices: mechanical properties and cell response.

PubMed

Brauer, Delia S; Rüssel, Christian; Vogt, Sebastian; Weisser, Jürgen; Schnabelrauch, Matthias

2008-01-01

The development of biodegradable materials for internal fracture fixation is of great interest, as they would both eliminate the problem of stress shielding and obviate the need for a second operation to remove fixation devices. Preliminary investigations for the production of degradable fiber reinforced polymer composite materials are detailed. Composites were produced of phosphate invert glass fibers of the glass system P(2)O(5)-CaO-MgO-Na(2)O-TiO(2), which showed a low solubility in previous work. The fibers were embedded into a matrix of a degradable organic polymer network based on methacrylate-modified oligolactide. Fracture behavior, bending strength and elastic modulus were evaluated during 3-point bending tests and the fracture surface of the composites was investigated using a scanning electron microscope. Short-term biocompatibility was tested in an FDA/EtBr viability assay using MC3T3-E1 murine pre-osteoblast cells and showed a good cell compatibility of the composite materials. Results suggested that these composite materials are biocompatible and show mechanical properties which are of interest for the production of degradable bone fixation devices.

Insuring the unknown.

PubMed

Parsons, C

2015-12-01

Uncertainty is the central element in insurance. This article examines how insurers evaluate and price risks that can present very high levels of uncertainty, and which many underwriters regard as especially hazardous in insurance terms. These are the risks associated with new medical devices, new pharmaceutical products and others substances for human consumption, such as food additives. Insurance is likely to be needed for these products both during their research and development phases, including insurance for clinical trials, and also once the device, drug or other substance gains approval and is in regular use.The article examines the types of insurance that are available to cover these risks, the organizations that provide insurance and how the insurance is organised. It discusses the basic principles that insurers use to price insurance before considering the difficulties presented by novel and complex risks generally. The article concludes with a description of the techniques that insurers employ to analyse and price the particular risks that are our subject and a discussion of how underwriters seek to overcome the special problems associated with them. © The Author(s) 2015.

Regulatory aspects of total product life cycle.

PubMed

Hausman, Ethan D; Altaie, Sousan S

2004-12-01

Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.

40 CFR 63.1413 - Compliance demonstration procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... or operators are required to conduct a design evaluation for a small control device. An owner or... for small control devices shall be set based on the design evaluation required by paragraph (a)(3) of... efficiency for a control device or control technology, a design evaluation shall address the composition and...

Evaluation Of Traffic Control Devices For Rural High-Speed Maintenance Work Zones: Second Year Activities And Final Recommendations

DOT National Transportation Integrated Search

2000-10-01

This report documents the second year of a two-year project to evaluate the effectiveness of innovative work zone traffic control devices. Researchers evaluated these devices at short-term rural work zones. During the second year of the project, seve...