18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

18 CFR 12.42 - Warning and safety devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Warning and safety devices. 12.42 Section 12.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.42 Warning and safety devices. To the...

Nuclear reactor safety device

DOEpatents

Hutter, Ernest

1986-01-01

A safety device is disclosed for use in a nuclear reactor for axially repositioning a control rod with respect to the reactor core in the event of an upward thermal excursion. Such safety device comprises a laminated helical ribbon configured as a tube-like helical coil having contiguous helical turns with slidably abutting edges. The helical coil is disclosed as a portion of a drive member connected axially to the control rod. The laminated ribbon is formed of outer and inner laminae. The material of the outer lamina has a greater thermal coefficient of expansion than the material of the inner lamina. In the event of an upward thermal excursion, the laminated helical coil curls inwardly to a smaller diameter. Such inward curling causes the total length of the helical coil to increase by a substantial increment, so that the control rod is axially repositioned by a corresponding amount to reduce the power output of the reactor.

Principles and Benefits of Explicitly Designed Medical Device Safety Architecture.

PubMed

Larson, Brian R; Jones, Paul; Zhang, Yi; Hatcliff, John

The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly. This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

The Role of Patient Safety in the Device Purchasing Process

DTIC Science & Technology

2005-05-01

Juliana J. Brixey, Danielle Paige, James P. Turley Abstract To examine how patient safety considerations are incorporated into medical device...Despite the general awareness of patient safety, its importance, and its role in medical device comparisons and purchasing decisions, this study...into the medical device purchasing process. We presently have a set of guidelines in development to help hospitals better emphasize patient safety

Police accident report forms: safety device coding and enacted laws.

PubMed

Brock, K; Lapidus, G

2008-12-01

Safety device coding on state police accident report (PAR) forms was compared with provisions in state traffic safety laws. PAR forms were obtained from all 50 states and the District of Columbia (states/DC). For seat belts, 22 states/DC had a primary seat belt enforcement law vs 50 with a PAR code. For car seats, all 51 states/DC had a law and a PAR code. For booster seats, 39 states/DC had a law vs nine with a PAR code. For motorcycle helmets, 21 states/DC had an all-age rider helmet law and another 26 a partial-age law vs 50 with a PAR code. For bicycle helmets, 21 states/DC had a partial-age rider helmet law vs 48 with a PAR code. Therefore gaps in the ability of states to fully record accident data reflective of existing state traffic safety laws are revealed. Revising the PAR forms in all states to include complete variables for safety devices should be an important priority, independent of the laws.

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

14 CFR 29.1413 - Safety belts: passenger warning device.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Safety belts: passenger warning device. 29.1413 Section 29.1413 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF....1413 Safety belts: passenger warning device. (a) If there are means to indicate to the passengers when...

33 CFR 159.127 - Safety coliform count: Recirculating devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety coliform count....127 Safety coliform count: Recirculating devices. Thirty-eight of forty samples of flush fluid from a recirculating device must have less than 240 fecal coliform bacteria per 100 milliliters. These samples must be...

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.

PubMed

Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R

2017-12-28

Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive

76 FR 45860 - In the Matter of Certain Electronic Devices, Including Wireless Communication Devices, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... electronic devices, including wireless communication devices, portable music and data processing devices, and... electronic devices, including wireless communication devices, portable music and data processing devices, and...

78 FR 34669 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... importing wireless communication devices, portable music and data processing devices, and tablet computers... certain electronic devices, including wireless communication devices, portable music and data processing...

EX-PRESS Glaucoma Filtration Device: efficacy, safety, and predictability

PubMed Central

Chan, Jessica E; Netland, Peter A

2015-01-01

Trabeculectomy has been the traditional primary surgical therapy for open-angle glaucoma. While trabeculectomy is effective in lowering intraocular pressure, complications associated with the procedure have motivated the development of alternative techniques and devices, including the EX-PRESS Glaucoma Filtration Device. This review describes the efficacy, safety, complication rates, and potential advantages and disadvantages of the EX-PRESS Glaucoma Filtration Device. EX-PRESS implantation is technically simpler compared with that of trabeculectomy, with fewer surgical steps. Vision recovery has been more rapid after EX-PRESS implantation compared with trabeculectomy. Intraocular pressure variation is lower during the early postoperative period, indicating a more predictable procedure. While efficacy of the EX-PRESS implant has been comparable to trabeculectomy, postoperative complications appear less common after EX-PRESS implantation compared with trabeculectomy. The EX-PRESS Glaucoma Filtration Device appears to be safe and effective in the surgical management of open-angle glaucoma. PMID:26366105

Materials for electrochemical device safety

DOEpatents

Vissers, Daniel R.; Amine, Khalil; Thackeray, Michael M.; Kahaian, Arthur J.; Johnson, Christopher S.

2015-04-07

An electrochemical device includes a thermally-triggered intumescent material or a gas-triggered intumescent material. Such devices prevent or minimize short circuits in a device that could lead to thermal run-away. Such devices may include batteries or supercapacitors.

78 FR 16865 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... certain electronic devices, including wireless communication devices, portable music and data processing...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND... and safety relief devices. (a) Each cylinder shall have a manually operated screw-down shutoff valve...

30 CFR 250.801 - Subsurface safety devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... conditions, hydrate formation, or paraffins, an alternate setting depth of the subsurface safety device may... conditions such as permafrost, unstable bottom conditions, hydrate formations, and paraffins. (g) Subsurface...

Complying with the Occupational Safety and Health Administration's Bloodborne Pathogens Standard: implementing needleless systems and intravenous safety devices.

PubMed

Marini, Michelle A; Giangregorio, Maeve; Kraskinski, Joanna C

2004-03-01

Preventing the transmission of bloodborne pathogens to healthcare workers has been a mission and a challenge of the healthcare industry for over 20 years. The development of the Occupational Safety and Health Administration Bloodborne Pathogens Standard in 1991 and the passing of the Needlestick Safety Act in 2000 mandated hospitals to develop an Exposure Control Plan to protect workers from these pathogens. Children's Hospital Boston began implementation of a needleless system in 1993. Employees readily accepted these systems into practice, because they were convenient and easy to use. A marked decrease in exposures to bloodborne pathogens naturally followed, which is consistent with the national data. The transition to intravenous (i.v.) safety devices at Children's Hospital began in 2000 and proved to be more of a challenge. First, the clinicians must choose a safety product, which requires developing and implementing a trial plan with potential catheters. This selection process is especially difficult in pediatrics where successful placement of the smallest-gauge catheter, no. 24, is imperative. After choosing an i.v. safety product, successful transition is dependent upon the thoroughness of i.v. safety device training and a commitment by the clinicians to the use of these products. Although the number of needlestick injuries and subsequent transmission of bloodborne pathogens have been further reduced with the use of i.v. safety devices, needlestick injuries still occur. This results from a lack of familiarity with the engineering of the device and therefore poor technique or a failure to activate the safety mechanism. Staff resistance due to loss of expertise with the new device and patient care concerns are additional barriers to the use of these new products. Addressing these obstacles and providing adequate training for all clinicians were required for successful implementation of these i.v. safety devices.

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety

PubMed Central

Sackner-Bernstein, Jonathan

2017-01-01

Background: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware. PMID:27837161

Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.

PubMed

Sackner-Bernstein, Jonathan

2017-03-01

The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

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

78 FR 1247 - Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... Wireless Communication Devices, Tablet Computers, Media Players, and Televisions, and Components Thereof... devices, including wireless communication devices, tablet computers, media players, and televisions, and... wireless communication devices, tablet computers, media players, and televisions, and components thereof...

Stakeholder challenges in purchasing medical devices for patient safety.

PubMed

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

Commercial vehicle (CV) retrofit safety device (RSD) kits project.

DOT National Transportation Integrated Search

2014-07-01

Retrofit Safety Device (RSD) kits were developed and deployed on commercial vehicles as part of the U.S. DOT Connected Vehicle Safety Pilot to gain insight into the unique aspects of deploying connected vehicle technology in a commercial vehicle envi...

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

PubMed

Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

2013-09-01

In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

77 FR 60720 - Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data Processing Devices, and Tablet Computers... communication devices, portable music and data processing devices, and tablet computers, imported by Apple Inc...

33 CFR 159.127 - Safety coliform count: Recirculating devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety coliform count: Recirculating devices. 159.127 Section 159.127 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159...

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.

Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…

Electrical safety device

DOEpatents

White, David B.

1991-01-01

An electrical safety device for use in power tools that is designed to automatically discontinue operation of the power tool upon physical contact of the tool with a concealed conductive material. A step down transformer is used to supply the operating power for a disconnect relay and a reset relay. When physical contact is made between the power tool and the conductive material, an electrical circuit through the disconnect relay is completed and the operation of the power tool is automatically interrupted. Once the contact between the tool and conductive material is broken, the power tool can be quickly and easily reactivated by a reset push button activating the reset relay. A remote reset is provided for convenience and efficiency of operation.

10 CFR 32.31 - Certain industrial devices containing byproduct material: Safety criteria.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Certain industrial devices containing byproduct material: Safety criteria. (a) An applicant for a license... 10 Energy 1 2014-01-01 2014-01-01 false Certain industrial devices containing byproduct material: Safety criteria. 32.31 Section 32.31 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO...

10 CFR 32.31 - Certain industrial devices containing byproduct material: Safety criteria.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Certain industrial devices containing byproduct material: Safety criteria. (a) An applicant for a license... 10 Energy 1 2013-01-01 2013-01-01 false Certain industrial devices containing byproduct material: Safety criteria. 32.31 Section 32.31 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO...

Effect of electronic device use on pedestrian safety : a literature review.

DOT National Transportation Integrated Search

2016-04-01

This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

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.

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the

Safety devices for neonatal intensive care.

PubMed

Neuman, M R; Flammer, C M; O'Connor, E

1982-01-01

Three relatively simple devices for improving safety in neonatal intensive care are described. When umbilical artery catheters are used, an inexpensive pressure switch is utilized to detect abnormally low pressures associated with catheter withdrawal or excessive fluid leakage from the catheter system. A capacitive, intravenous-line air bubble detector, consisting of a section of the intravenous line as the dielectric of a capacitor, is used to alert the clinical staff when air bubbles pass between the capacitor plates. An electronic temperature controller maintains the temperature of neonatal breathing gases to avoid temperature variations which occur with presently used techniques. These are relatively simple and inexpensive devices which can be fabricated by most hospital clinical engineering services.

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices.

PubMed

Vernick, J S; O'Brien, M; Hepburn, L M; Johnson, S B; Webster, D W; Hargarten, S W

2003-12-01

To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Information about all unintentional and undetermined firearm deaths from 1991-98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0-17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year.

Launch Lock Assemblies Including Axial Gap Amplification Devices and Spacecraft Isolation Systems Including the Same

NASA Technical Reports Server (NTRS)

Barber, Tim Daniel (Inventor); Hindle, Timothy (Inventor); Young, Ken (Inventor); Davis, Torey (Inventor)

2014-01-01

Embodiments of a launch lock assembly are provided, as are embodiments of a spacecraft isolation system including one or more launch lock assemblies. In one embodiment, the launch lock assembly includes first and second mount pieces, a releasable clamp device, and an axial gap amplification device. The releasable clamp device normally maintains the first and second mount pieces in clamped engagement; and, when actuated, releases the first and second mount pieces from clamped engagement to allow relative axial motion there between. The axial gap amplification device normally residing in a blocking position wherein the gap amplification device obstructs relative axial motion between the first and second mount pieces. The axial gap amplification device moves into a non-blocking position when the first and second mount pieces are released from clamped engagement to increase the range of axial motion between the first and second mount pieces.

Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries.

PubMed

Davis, Niall F; Cunnane, Eoghan M; Mooney, Rory O'C; Forde, James C; Walsh, Michael T

2018-05-01

To evaluate the feasibility of a novel "safety-valve" device for preventing catheter related urethral trauma during urethral catheterization (UC). To assess the opinions of clinicians on the performance of the safety-valve device. A validated prototype "safety-valve" device for preventing catheter balloon inflation related urethral injuries was prospectively piloted in male patients requiring UC in a tertiary referral teaching hospital (n = 100). The device allows fluid in the catheter system to decant through an activated safety threshold pressure valve if the catheter anchoring balloon is misplaced. Users evaluated the "safety-valve" with an anonymous questionnaire. The primary outcome measurement was prevention of anchoring balloon inflation in the urethra. Secondary outcome measurement was successful inflation of urinary catheter anchoring balloon in the bladder. Patient age was 76 ± 12 years and American Society of Anaesthesiologists grade was 3 ± 1.4. The "safety-valve" was utilized by 34 clinicians and activated in 7% (n = 7/100) patients during attempted UC, indicating that the catheter anchoring balloon was incorrectly positioned in the patient's urethra. In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 31 of 34 (91%) clinicians completed the questionnaire. Ten percent (n = 3/31) of respondents had previously inflated a urinary catheter anchoring balloon in the urethra and 100% (n = 31) felt that a safety mechanism for preventing balloon inflation in the urethra should be compulsory for all UCs. The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries. Copyright © 2018 Elsevier Inc. All rights reserved.

Unintentional and undetermined firearm related deaths: a preventable death analysis for three safety devices

PubMed Central

Vernick, J; O'Brien, M; Hepburn, L; Johnson, S; Webster, D; Hargarten, S

2003-01-01

Objective: To determine the proportion of unintentional and undetermined firearm related deaths preventable by three safety devices: personalization devices, loaded chamber indicators (LCIs), and magazine safeties. A personalized gun will operate only for an authorized user, a LCI indicates when the gun contains ammunition, and a magazine safety prevents the gun from firing when the ammunition magazine is removed. Design: Information about all unintentional and undetermined firearm deaths from 1991–98 was obtained from the Office of the Chief Medical Examiner for Maryland, and from the Wisconsin Firearm Injury Reporting System for Milwaukee. Data regarding the victim, shooter, weapon, and circumstances were abstracted. Coding rules to classify each death as preventable, possibly preventable, or not preventable by each of the three safety devices were also applied. Results: There were a total of 117 firearm related deaths in our sample, 95 (81%) involving handguns. Forty three deaths (37%) were classified as preventable by a personalized gun, 23 (20%) by a LCI, and five (4%) by a magazine safety. Overall, 52 deaths (44%) were preventable by at least one safety device. Deaths involving children 0–17 (relative risk (RR) 3.3, 95% confidence interval (CI) 2.1 to 5.1) and handguns (RR 8.1, 95% CI 1.2 to 53.5) were more likely to be preventable. Projecting the findings to the entire United States, an estimated 442 deaths might have been prevented in 2000 had all guns been equipped with these safety devices. Conclusion: Incorporating safety devices into firearms is an important injury intervention, with the potential to save hundreds of lives each year. PMID:14693889

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).

Safety of railroad employees' use of personal electronic devices

DOT National Transportation Integrated Search

2014-06-01

This report describes two studies sponsored by the Federal Railroad Administration that examined distraction from personal electronic device (PED) usage among safety-critical railroad employees. Study I considered railroad rules, railroad efficiency ...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.

PubMed

Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis

2013-11-25

Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction

Electric drive systems including smoothing capacitor cooling devices and systems

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

Dede, Ercan Mehmet; Zhou, Feng

An electric drive system includes a smoothing capacitor including at least one terminal, a bus bar electrically coupled to the at least one terminal, a thermoelectric device including a first side and a second side positioned opposite the first side, where the first side is thermally coupled to at least one of the at least one terminal and the bus bar, and a cooling element thermally coupled to the second side of the thermoelectric device, where the cooling element dissipates heat from the thermoelectric device.

FDA working to ensure the safety of medical devices used in the pediatric population.

PubMed

Flack, Marilyn Neder; Gross, Thomas P; Reid, Joy Samuels; Mills, Thalia T; Francis, Jacqueline

2012-12-01

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. Published by Elsevier Inc.

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Safety relief devices and pressure regulators. 179... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

49 CFR 179.103-4 - Safety relief devices and pressure regulators.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and 120...

An examination of safety reports involving electronic flight bags and portable electronic devices

DOT National Transportation Integrated Search

2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

30 CFR 250.611 - Traveling-block safety device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Traveling-block safety device. 250.611 Section 250.611 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS... operation weekly and after each drill-line slipping operation. The results of the operational check shall be...

30 CFR 250.511 - Traveling-block safety device.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Traveling-block safety device. 250.511 Section 250.511 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS... after each drill-line slipping operation. The results of the operational check must be entered in the...

VIEW OF WEST BANK OF “SAFETY ROD PACKAGE,” INCLUDING SAFETY ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

VIEW OF WEST BANK OF “SAFETY ROD PACKAGE,” INCLUDING SAFETY ROD MOTOR DRIVES (B AND C), DRUMS, AND CLUTCHES, IN A THREE-TIERED RACK IN THE PDP ROOM AT LEVEL +27’, LOOKING SOUTHWEST - Physics Assembly Laboratory, Area A/M, Savannah River Site, Aiken, Aiken County, SC

VIEW OF EAST BANK OF “SAFETY ROD PACKAGE,” INCLUDING SAFETY ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

VIEW OF EAST BANK OF “SAFETY ROD PACKAGE,” INCLUDING SAFETY ROD MOTOR DRIVES (B AND C), DRUMS, AND CLUTCHES, IN A THREE-TIERED RACK IN THE PDP ROOM AT LEVEL +27’, LOOKING SOUTHEAST - Physics Assembly Laboratory, Area A/M, Savannah River Site, Aiken, Aiken County, SC

Energy storage device including a redox-enhanced electrolyte

DOEpatents

Stucky, Galen; Evanko, Brian; Parker, Nicholas; Vonlanthen, David; Auston, David; Boettcher, Shannon; Chun, Sang-Eun; Ji, Xiulei; Wang, Bao; Wang, Xingfeng; Chandrabose, Raghu Subash

2017-08-08

An electrical double layer capacitor (EDLC) energy storage device is provided that includes at least two electrodes and a redox-enhanced electrolyte including two redox couples such that there is a different one of the redox couples for each of the electrodes. When charged, the charge is stored in Faradaic reactions with the at least two redox couples in the electrolyte and in a double-layer capacitance of a porous carbon material that comprises at least one of the electrodes, and a self-discharge of the energy storage device is mitigated by at least one of electrostatic attraction, adsorption, physisorption, and chemisorption of a redox couple onto the porous carbon material.

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...

Point-of-Care Detection Devices for Food Safety Monitoring: Proactive Disease Prevention.

PubMed

Wu, Marie Yung-Chen; Hsu, Min-Yen; Chen, Shih-Jen; Hwang, De-Kuang; Yen, Tzung-Hai; Cheng, Chao-Min

2017-04-01

Food safety has become an increasingly significant public concern in both developed and under-developed nations around the world; it increases morbidity, mortality, human suffering, and economic burden. This Opinion focuses on (i) examining the influence of pathogens and chemicals (e.g., food additives and pesticide residue) on food-borne illnesses, (ii) summarizing food hazards that are present in Asia, and (iii) summarizing the array of current point-of-care (POC) detection devices that have potential applications in food safety monitoring. In addition, we provide insight into global healthcare issues in both developing and under-developed nations with a focus on bridging the gap between food safety issues in the public sector (associated with relevant clinical cases) and the use of POC detection devices for food safety monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety lock-out device for electrical appliances

DOEpatents

Cliff, P.L. Jr.

1996-07-09

A safety lock-out device prevents the insertion of an electrical power cord into an electrical power cord receptacle of an electrical appliance. The device comprises a mounting plate fastened to the appliance and a hinged cover plate attached to the appliance. The cover plate is movable between a first position and a second position such that, in the first position, the cover plate covers and prevents insertion of a power cord into the appliance receptacle. In said second position, the appliance receptacle is uncovered to permit insertion of a power cord into the receptacle. Extending a lock shank through aligned openings formed in flange members extending from the mounting plate, the cover plate locks the cover plate in the first position. 15 figs.

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence.

PubMed

Ziv, Elan; Stanton, Stuart L; Abarbanel, Joseph

2008-05-01

The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women. Sixty women with severe SUI were recruited from 2 sites in Israel to wear preweighed pads during a 7-day control period followed by a 28-day device usage period in which the device and preweighed pads were worn daily for 8 hours. The primary endpoint was the percentage of women who achieved a > or = 70% reduction in pad weight gain (PWG) from the control period to the last 14 days of device usage. Sixty women who enrolled into the study and used the device for any period of time were included in the intent to treat (ITT) population. Eighty-five percent of them achieved a > or = 70% reduction in PWG (P = .01). Improvements in overall quality of life, subjective perception of incontinence, and satisfaction with the device were observed. The intravaginal device is easy to use, well-tolerated, and effective in reducing SUI.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

DTIC Science & Technology

2005-01-01

have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

The safety of non-incineration waste disposal devices in four hospitals of Tehran.

PubMed

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

The safe management of hospital waste is a challenge in many developing countries. The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries.

The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

PubMed

Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

2014-04-01

The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

Thermal-Responsive Polymers for Enhancing Safety of Electrochemical Storage Devices.

PubMed

Yang, Hui; Leow, Wan Ru; Chen, Xiaodong

2018-03-01

Thermal runway constitutes the most pressing safety issue in lithium-ion batteries and supercapacitors of large-scale and high-power density due to risks of fire or explosion. However, traditional strategies for averting thermal runaway do not enable the charging-discharging rate to change according to temperature or the original performance to resume when the device is cooled to room temperature. To efficiently control thermal runaway, thermal-responsive polymers provide a feasible and reversible strategy due to their ability to sense and subsequently act according to a predetermined sequence when triggered by heat. Herein, recent research progress on the use of thermal-responsive polymers to enhance the thermal safety of electrochemical storage devices is reviewed. First, a brief discussion is provided on the methods of preventing thermal runaway in electrochemical storage devices. Subsequently, a short review is provided on the different types of thermal-responsive polymers that can efficiently avoid thermal runaway, such as phase change polymers, polymers with sol-gel transitions, and polymers with positive temperature coefficients. The results represent the important development of thermal-responsive polymers toward the prevention of thermal runaway in next-generation smart electrochemical storage devices. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Nuclear reactor safety device

DOEpatents

Hutter, E.

1983-08-15

A safety device is described for use in a nuclear reactor for axially repositioning a control rod with respect to the reactor core in the event of a thermal excursion. It comprises a laminated strip helically configured to form a tube, said tube being in operative relation to said control rod. The laminated strip is formed of at least two materials having different thermal coefficients of expansion, and is helically configured such that the material forming the outer lamina of the tube has a greater thermal coefficient of expansion than the material forming the inner lamina of said tube. In the event of a thermal excursion the laminated strip will tend to curl inwardly so that said tube will increase in length, whereby as said tube increases in length it exerts a force on said control rod to axially reposition said control rod with respect to said core.

Modern traffic control devices to improve safety at rural intersections.

DOT National Transportation Integrated Search

2011-12-01

"Engineers with the Texas Department of Transportation (TxDOT) frequently make changes to traffic control devices : (TCDs) to improve intersection safety. To use available funds judiciously, engineers make incremental changes in : order to select the...

75 FR 10502 - In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-667; Investigation No. 337-TA-673] In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices; Notice of... Entirety AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that...

The Safety of Cardiac and Thoracic Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices.

PubMed

Dandamudi, Sanjay; Collins, Jeremy D; Carr, James C; Mongkolwat, Pat; Rahsepar, Amir A; Tomson, Todd T; Verma, Nishant; Arora, Rishi; Chicos, Alex B; Kim, Susan S; Lin, Albert C; Passman, Rod S; Knight, Bradley P

2016-12-01

Studies reporting the safety of magnetic resonance imaging (MRI) in patients with a cardiac implantable electronic device (CIED) have mostly excluded examinations with the device in the magnet isocenter. The purpose of this study was to describe the safety of cardiac and thoracic spine MRI in patients with a CIED. The medical records of patients with a CIED who underwent a cardiac or thoracic spine MRI between January 2011 and December 2014 were reviewed. Devices were interrogated before and after imaging with reprogramming to asynchronous pacing in pacemaker-dependent patients. The clinical interpretability of the MRI and peak and average specific absorption rates (SARs, W/kg) achieved were determined. Fifty-eight patients underwent 51 cardiac and 11 thoracic spine MRI exams. Twenty-nine patients had a pacemaker and 29 had an implantable cardioverter defibrillator. Seventeen percent (n = 10) were pacemaker dependent. Fifty-one patients (89%) had non-MRI-conditional devices. There were no clinically significant changes in atrial and ventricular sensing, impedance, and threshold measurements. There were no episodes of device mode changes, arrhythmias, therapies delivered, electrical reset, or battery depletion. One study was prematurely discontinued due to a patient complaint of chest pain of which the etiology was not determined. Across all examinations, the average peak SAR was 2.0 ± 0.85 W/kg with an average SAR of 0.35 ± 0.37 W/kg. Artifact significantly limiting the clinical interpretation of the study was present in 33% of cardiac MRI studies. When a comprehensive CIED magnetic resonance safety protocol is followed, the risk of performing 1.5-T magnetic resonance studies with the device in the magnet isocenter, including in patients who are pacemaker dependent, is low. Copyright © 2016. Published by Elsevier Inc.

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

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

PubMed

Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

2011-06-01

Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

75 FR 21567 - Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment; Denial... Motor Vehicle Safety Standard (FMVSS) No. 108; Lamps, reflective devices, and associated equipment... physical filaments in the lamp. Specifically, BMW requested that paragraph S10.17.1.1.2 \\4\\ of the...

The safety of non-incineration waste disposal devices in four hospitals of Tehran

PubMed Central

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

Background: The safe management of hospital waste is a challenge in many developing countries. Objectives: The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. Methods: VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. Results: There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. Conclusions: There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries. PMID:25000113

Microfluidic devices and methods including porous polymer monoliths

DOEpatents

Hatch, Anson V; Sommer, Gregory J; Singh, Anup K; Wang, Ying-Chih; Abhyankar, Vinay V

2014-04-22

Microfluidic devices and methods including porous polymer monoliths are described. Polymerization techniques may be used to generate porous polymer monoliths having pores defined by a liquid component of a fluid mixture. The fluid mixture may contain iniferters and the resulting porous polymer monolith may include surfaces terminated with iniferter species. Capture molecules may then be grafted to the monolith pores.

Microfluidic devices and methods including porous polymer monoliths

DOEpatents

Hatch, Anson V.; Sommer, Gregory j.; Singh, Anup K.; Wang, Ying-Chih; Abhyankar, Vinay

2015-12-01

Microfluidic devices and methods including porous polymer monoliths are described. Polymerization techniques may be used to generate porous polymer monoliths having pores defined by a liquid component of a fluid mixture. The fluid mixture may contain iniferters and the resulting porous polymer monolith may include surfaces terminated with iniferter species. Capture molecules may then be grafted to the monolith pores.

Technology assessment of medical devices at the Center for Devices and Radiological Health.

PubMed

Kessler, L; Richter, K

1998-09-25

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

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 ...

FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

MedlinePlus

... Consumers Home For Consumers Consumer Updates FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts ... Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888- ...

Safety considerations for wireless delivery of continuous power to implanted medical devices.

PubMed

Lucke, Lori; Bluvshtein, Vlad

2014-01-01

Wireless power systems for use with implants are referred to as transcutaneous energy transmission systems (TETS) and consist of an implanted secondary coil and an external primary coil along with supporting electronics. A TETS system could be used to power ventricular assist systems and eliminate driveline infections. There are both direct and indirect safety concerns that must be addressed when continuously transferring power through the skin. Direct safety concerns include thermal tissue damage caused by exposure to the electromagnetic fields, coil heating effects, and potential unwanted nerve stimulation. Indirect concerns are those caused by potential interference of the TETS system with other implanted devices. Wireless power systems are trending towards higher frequency operation. Understanding the limits for safe operation of a TETS system across a range of frequencies is important. A low frequency and a high frequency implementation are simulated to demonstrate the impact of this trend for a VAD application.

Safety of capsule endoscopy using human body communication in patients with cardiac devices.

PubMed

Chung, Joo Won; Hwang, Hye Jin; Chung, Moon Jae; Park, Jeong Youp; Pak, Hui-Nam; Song, Si Young

2012-06-01

The MiroCam (IntroMedic, Ltd., Seoul, Korea) is a small-bowel capsule endoscope that uses human body communication to transmit data. The potential interactions between cardiac devices and the capsule endoscope are causes for concern, but no data are available for this matter. This clinical study was designed to evaluate the potential influence of the MiroCam capsules on cardiac devices. Patients with cardiac pacemakers or implantable cardiac defibrillators referred for evaluation of small bowel disease were prospectively enrolled in this study. Before capsule endoscopy, a cardiologist checked baseline electrocardiograms and functions of the cardiac devices. Cardiac rhythms were continuously monitored by 24-h telemetry during capsule endoscopy in the hospital. After completion of procedures, functions of the cardiac devices were checked again for interference. Images from the capsule endoscopy were reviewed and analyzed for technical problems. Six patients, three with pacemakers and three with implantable cardiac defibrillators, were included in the study. We identified no disturbances in the cardiac devices and no arrhythmias detected on telemetry monitoring during capsule endoscopy. No significant changes in the programmed parameters of the cardiac devices were noted after capsule endoscopy. There were no imaging disturbances from the cardiac devices on capsule endoscopy. Capsule endoscopy using human body communication to transmit data was safely performed in patients with cardiac pacemakers or implantable cardiac defibrillators. Images from the capsule endoscopy were not affected by cardiac devices. A further large-scale study is required to confirm the safety of capsule endoscopy with various types of cardiac devices.

46 CFR 58.16-15 - Valves and safety relief devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Valves and safety relief devices. 58.16-15 Section 58.16-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MAIN AND AUXILIARY MACHINERY AND RELATED SYSTEMS Liquefied Petroleum Gases for Cooking and Heating § 58.16-15 Valves...

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.

Virtual Humans for Implantable Device Safety Assessment in MRI: Mitigating Magnetic Resonance Imaging Hazards for Implanted Medical Devices.

PubMed

Brown, James E; Qiang, Rui; Stadnik, Paul J; Stotts, Larry J; Von Arx, Jeffrey A

2017-01-01

Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation [1]. In recent years, AIMD manufacturers, such as Biotronik, have assessed the conditional safety of devices in MRI.

Passive safety device and internal short tested method for energy storage cells and systems

DOEpatents

Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad

2015-09-22

A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.

Electrolyte solutions including a phosphoranimine compound, and energy storage devices including same

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

Klaehn, John R.; Dufek, Eric J.; Rollins, Harry W.

An electrolyte solution comprising at least one phosphoranimine compound and a metal salt. The at least one phosphoranimine compound comprises a compound of the chemical structure ##STR00001## where X is an organosilyl group or a tert-butyl group and each of R.sup.1, R.sup.2, and R.sup.3 is independently selected from the group consisting of an alkyl group, an aryl group, an alkoxy group, or an aryloxy group. An energy storage device including the electrolyte solution is also disclosed.

A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI

PubMed Central

Kabil, J.; Belguerras, L.; Trattnig, S.; Pasquier, C.; Missoffe, A.

2016-01-01

Summary Objectives To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. Methods A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Results Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Conclusions Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges. PMID:27830244

Analysis of car-to-bicycle approach patterns for developing active safety devices.

PubMed

Matsui, Yasuhiro; Oikawa, Shoko; Hitosugi, Masahito

2016-05-18

To reduce the severity of injuries and the number of cyclist deaths in traffic accidents, active safety devices providing cyclist detection are considered to be effective countermeasures. The features of car-to-bicycle collisions need to be known in detail to develop such safety devices. The study investigated near-miss situations captured by drive recorders installed in passenger cars. Because similarities in the approach patterns between near-miss incidents and real-world fatal cyclist accidents in Japan were confirmed, we analyzed the 229 near-miss incident data via video capturing bicycles crossing the road in front of forward-moving cars. Using a video frame captured by a drive recorder, the time to collision (TTC) was calculated from the car's velocity and the distance between the car and bicycle at the moment when the bicycle initially appeared. The average TTC in the cases where bicycles emerged from behind obstructions was shorter than that in the cases where drivers had unobstructed views of the bicycles. In comparing the TTC of car-to-bicycle near-miss incidents to the previously obtained results of car-to-pedestrian near-miss incidents, it was determined that the average TTC in car-to-bicycle near-miss incidents was significantly longer than that in car-to-pedestrian near-miss incidents. When considering the TTC in the test protocol of evaluation for safety performance of active safety devices, we propose individual TTCs for evaluation of cyclist and pedestrian detections, respectively. In the test protocols, the following 2 scenarios should be employed: bicycle emerging from behind an unobstructed view and bicycle emerging from behind obstructions.

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...

Blood transfer devices for malaria rapid diagnostic tests: evaluation of accuracy, safety and ease of use.

PubMed

Hopkins, Heidi; Oyibo, Wellington; Luchavez, Jennifer; Mationg, Mary Lorraine; Asiimwe, Caroline; Albertini, Audrey; González, Iveth J; Gatton, Michelle L; Bell, David

2011-02-08

Malaria rapid diagnostic tests (RDTs) are increasingly used by remote health personnel with minimal training in laboratory techniques. RDTs must, therefore, be as simple, safe and reliable as possible. Transfer of blood from the patient to the RDT is critical to safety and accuracy, and poses a significant challenge to many users. Blood transfer devices were evaluated for accuracy and precision of volume transferred, safety and ease of use, to identify the most appropriate devices for use with RDTs in routine clinical care. Five devices, a loop, straw-pipette, calibrated pipette, glass capillary tube, and a new inverted cup device, were evaluated in Nigeria, the Philippines and Uganda. The 227 participating health workers used each device to transfer blood from a simulated finger-prick site to filter paper. For each transfer, the number of attempts required to collect and deposit blood and any spilling of blood during transfer were recorded. Perceptions of ease of use and safety of each device were recorded for each participant. Blood volume transferred was calculated from the area of blood spots deposited on filter paper. The overall mean volumes transferred by devices differed significantly from the target volume of 5 microliters (p < 0.001). The inverted cup (4.6 microliters) most closely approximated the target volume. The glass capillary was excluded from volume analysis as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures (23/225, 10%); exposures ranged from 2% to 6% for the other four devices. The inverted cup was considered easiest to use in blood collection (206/226, 91%); the straw-pipette and calibrated pipette were rated lowest (143/225 [64%] and 135/225 [60%] respectively). Overall, the inverted cup was the most preferred device (72%, 163/227), followed by the loop (61%, 138/227). The performance of blood transfer devices varied in this evaluation of accuracy

Using mobile devices to improve the safety of medication administration processes.

PubMed

Navas, H; Graffi Moltrasio, L; Ares, F; Strumia, G; Dourado, E; Alvarez, M

2015-01-01

Within preventable medical errors, those related to medications are frequent in every stage of the prescribing cycle. Nursing is responsible for maintaining each patients safety and care quality. Moreover, nurses are the last people who can detect an error in medication before its administration. Medication administration is one of the riskiest tasks in nursing. The use of information and communication technologies is related to a decrease in these errors. Including mobile devices related to 2D code reading of patients and medication will decrease the possibility of error when preparing and administering medication by nurses. A cross-platform software (iOS and Android) was developed to ensure the five Rights of the medication administration process (patient, medication, dose, route and schedule). Deployment in November showed 39% use.

78 FR 34132 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... INTERNATIONAL TRADE COMMISSION [Docket No 2958] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Correction to Notice of Receipt of Complaint; Solicitation... of complaint entitled Certain Portable Electronic Communications Devices, Including Mobile Phones and...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

PubMed

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices

PubMed Central

Kraft, Marc

2008-01-01

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority. PMID:20204095

Separating semiconductor devices from substrate by etching graded composition release layer disposed between semiconductor devices and substrate including forming protuberances that reduce stiction

DOEpatents

Tauke-Pedretti, Anna; Nielson, Gregory N; Cederberg, Jeffrey G; Cruz-Campa, Jose Luis

2015-05-12

A method includes etching a release layer that is coupled between a plurality of semiconductor devices and a substrate with an etch. The etching includes etching the release layer between the semiconductor devices and the substrate until the semiconductor devices are at least substantially released from the substrate. The etching also includes etching a protuberance in the release layer between each of the semiconductor devices and the substrate. The etch is stopped while the protuberances remain between each of the semiconductor devices and the substrate. The method also includes separating the semiconductor devices from the substrate. Other methods and apparatus are also disclosed.

[Comparison of port needle with safety device between Huber Plus (HP) and Poly PERF Safe (PPS)].

PubMed

Shimono, Chigusa; Tanaka, Atsuko; Fujita, Ai; Ishimoto, Miki; Oura, Shoji; Yamaue, Hiroki; Sato, Morio

2010-05-01

An embedded port is frequently used for outpatients with advanced cancer in central venous chemotherapy or hepatic arterial chemoinfusion. The port needle with a safety device in an ambulatory treatment center is indispensable for medical employees and patient plus family to reduce the risk of a needle puncture accident and to prevent iatrogenic infection. The port needle with safety system has been already introduced in our chemotherapy center. There are two types of port needle with safety device; Huber Plus (HP, Medicon Co., Ltd.) and POLY PERF Safe (PPS, Pyolax Device, Co., Ltd.). The comparison of the feasibility between HP and PPS was conducted by both medical employees and patients plus family using an inquiry score method. HP was highly regarded for its stability plus fixation and PPS for its usefulness in puncture and extraction of the needle. PPS was found to be preferable to HP based on the overall evaluation.

Device Driver Safety Through a Reference Validation Mechanism

DTIC Science & Technology

2008-05-01

microkernels and other research operat- ing systems [2, 9, 21, 24] run device drivers in user space ∗Supported by NICECAP cooperative agreement FA8750...device driver architecture in the Nexus trusted operating system [28], which has many similarities to traditional microkernels , including hardware... microkernel operating sys- tems, every flaw in a device driver is a potential secu- rity hole given the absence of mechanisms to contain the (mis

Safety Outcomes Using a Proximal Protection Device in Carotid Stenting of Long Carotid Stenoses

PubMed Central

Atchaneeyasakul, Kunakorn; Khandelwal, Priyank; Ambekar, Sudheer; Ramdas, Kevin; Guada, Luis; Yavagal, Dileep

2016-01-01

Background Embolic protection devices can prevent atherosclerotic emboli during carotid stenting. Newer proximal protection devices reverse flow in the internal carotid artery (ICA), leading to reduction in perioperative microemboli. The risk of stroke is high for carotid stenting of ICA lesions with a length >10 mm and/or angiographic string sign. Objective We aimed to evaluate the safety outcomes of proximal embolic protection device usage in this high-risk group. Methods This is a retrospective analysis of patients who underwent carotid stenting procedures with proximal embolic protection devices at a tertiary care center. High-risk features for adverse events with carotid stenting were identified. Peri- and postprocedural outcomes were recorded. We further compared outcomes in patients with a carotid stenosis length >10 mm to those with shorter stenosis. Results From January 2011 to December 2014, we included 27 patients; 96.3% were symptomatic and 3.7% were asymptomatic. There was a stent placement technical success rate of 100%. No major stroke or coronary events were recorded. One minor stroke event developed in one patient. A carotid lesion length >10 mm and/or angiographic string sign was noted in 21/27 patients, with an average lesion length of 14.4 mm. One patient (4.8%) in this group developed a minor stroke event. Neither a coronary nor a major stroke event was recorded in this group. There was no significant difference in the complication rate between the long lesion and the control group. Conclusion In our patient cohort, it was found that a proximal embolic protection device is safe for patients with carotid stenosis, including those with a carotid lesion length >10 mm and/or angiographic string sign. PMID:27781040

The Challenges of Balancing Safety and Security in Implantable Medical Devices.

PubMed

Katzis, Konstantinos; Jones, Richard W; Despotou, George

2016-01-01

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

10 CFR 32.101 - Schedule B-prototype tests for luminous safety devices for use in aircraft.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Schedule B-prototype tests for luminous safety devices for... thermometer. (d) Shock test. The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to equivalent treatment in a test device simulating such a free fall...

Alerts and Notices (Devices)

MedlinePlus

... Medical Devices Medical Device Safety Safety Communications Safety Communications Share Tweet Linkedin Pin it More sharing options ... Older safety communications are listed below. Older Safety Communications 2016 Safety Communications 2015 Safety Communications 2014 Safety ...

Ionic liquids, electrolyte solutions including the ionic liquids, and energy storage devices including the ionic liquids

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

Gering, Kevin L.; Harrup, Mason K.; Rollins, Harry W.

2015-12-08

An ionic liquid including a phosphazene compound that has a plurality of phosphorus-nitrogen units and at least one pendant group bonded to each phosphorus atom of the plurality of phosphorus-nitrogen units. One pendant group of the at least one pendant group comprises a positively charged pendant group. Additional embodiments of ionic liquids are disclosed, as are electrolyte solutions and energy storage devices including the embodiments of the ionic liquid.

Understanding safety-critical interactions with a home medical device through Distributed Cognition.

PubMed

Rajkomar, Atish; Mayer, Astrid; Blandford, Ann

2015-08-01

As healthcare shifts from the hospital to the home, it is becoming increasingly important to understand how patients interact with home medical devices, to inform the safe and patient-friendly design of these devices. Distributed Cognition (DCog) has been a useful theoretical framework for understanding situated interactions in the healthcare domain. However, it has not previously been applied to study interactions with home medical devices. In this study, DCog was applied to understand renal patients' interactions with Home Hemodialysis Technology (HHT), as an example of a home medical device. Data was gathered through ethnographic observations and interviews with 19 renal patients and interviews with seven professionals. Data was analyzed through the principles summarized in the Distributed Cognition for Teamwork methodology. In this paper we focus on the analysis of system activities, information flows, social structures, physical layouts, and artefacts. By explicitly considering different ways in which cognitive processes are distributed, the DCog approach helped to understand patients' interaction strategies, and pointed to design opportunities that could improve patients' experiences of using HHT. The findings highlight the need to design HHT taking into consideration likely scenarios of use in the home and of the broader home context. A setting such as home hemodialysis has the characteristics of a complex and safety-critical socio-technical system, and a DCog approach effectively helps to understand how safety is achieved or compromised in such a system. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Safety lock-out device for electrical appliances

DOEpatents

Cliff, Jr., Paul L.

1996-01-01

A safety lock-out device prevents the insertion of an electrical power cord into an electrical power cord receptacle of an electrical appliance. The devise comprises a mounting plate fastened to the appliance and a cover plate hingedly attached to the appliance. The cover plate is movable between a first position and a second position such that, in the first position, the cover plate covers and prevents insertion of a power cord into the appliance receptacle. In said second position, the appliance receptacle is uncovered to permit insertion of a power cord into the receptacle. Extending a lock shank through aligned openings formed in flange members extending from the mounting plate and the cover plate locks the cover plate in the first position.

Leaving patients to their own devices? Smart technology, safety and therapeutic relationships.

PubMed

Ho, Anita; Quick, Oliver

2018-03-06

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices.

Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices

PubMed Central

Strom, Jordan B.; Whelan, Jill B.; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J.; Kramer, Daniel B.

2017-01-01

BACKGROUND Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. OBJECTIVE The purpose of this study was to define major and minor adverse events with off-label MRI scans. METHODS We prospectively evaluated patients with non–MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). RESULTS A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 37.0% [70] patients with implantable cardioverter-defibrillators; 21.8% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01–2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3–4.6). Nearly all studies (98.4% [186]) were interpretable, while 74.9% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. CONCLUSION Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. PMID:28385671

Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices.

PubMed

Strom, Jordan B; Whelan, Jill B; Shen, Changyu; Zheng, Shuang Qi; Mortele, Koenraad J; Kramer, Daniel B

2017-08-01

Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility. The purpose of this study was to define major and minor adverse events with off-label MRI scans. We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months). A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories. Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2014 CFR

2014-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

30 CFR 585.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2012 CFR

2012-07-01

..., COPs and GAPs Safety Management Systems § 585.810 What must I include in my Safety Management System? You must submit a description of the Safety Management System you will use with your COP (provided...

Meta-structure and tunable optical device including the same

DOEpatents

Han, Seunghoon; Papadakis, Georgia Theano; Atwater, Harry

2017-12-26

A meta-structure and a tunable optical device including the same are provided. The meta-structure includes a plurality of metal layers spaced apart from one another, an active layer spaced apart from the plurality of metal layers and having a carrier concentration that is tuned according to an electric signal applied to the active layer and the plurality of metal layers, and a plurality of dielectric layers spaced apart from one another and each having one surface contacting a metal layer among the plurality of metal layers and another surface contacting the active layer.

78 FR 47410 - Certain Wireless Devices, Including Mobile Phones and Tablets Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Mobile Phones and Tablets Institution of Investigation AGENCY: U.S. International Trade Commission... importation of certain wireless devices, including mobile phones and tablets by reason of infringement of... sale within the United States after importation of certain wireless devices, including mobile phones...

Thermovoltaic semiconductor device including a plasma filter

DOEpatents

Baldasaro, Paul F.

1999-01-01

A thermovoltaic energy conversion device and related method for converting thermal energy into an electrical potential. An interference filter is provided on a semiconductor thermovoltaic cell to pre-filter black body radiation. The semiconductor thermovoltaic cell includes a P/N junction supported on a substrate which converts incident thermal energy below the semiconductor junction band gap into electrical potential. The semiconductor substrate is doped to provide a plasma filter which reflects back energy having a wavelength which is above the band gap and which is ineffectively filtered by the interference filter, through the P/N junction to the source of radiation thereby avoiding parasitic absorption of the unusable portion of the thermal radiation energy.

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

ERIC Educational Resources Information Center

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States.

PubMed

Frost, Karen L; van Roosmalen, Linda; Bertocci, Gina; Cross, Douglas J

2012-01-01

An overview of the current status of wheelchair transportation safety in fixed route and demand-responsive, non-rail, public transportation vehicles within the US is presented. A description of each mode of transportation is provided, followed by a discussion of the primary issues affecting safety, accessibility, and usability. Technologies such as lifts, ramps, securement systems, and occupant restraint systems, along with regulations and voluntary industry standards have been implemented with the intent of improving safety and accessibility for individuals who travel while seated in their wheeled mobility device (e.g., wheelchair or scooter). However, across both fixed route and demand-responsive transit systems a myriad of factors such as nonuse and misuse of safety systems, oversized wheeled mobility devices, vehicle space constraints, and inadequate vehicle operator training may place wheeled mobility device (WhMD) users at risk of injury even under non-impact driving conditions. Since WhMD-related incidents also often occur during the boarding and alighting process, the frequency of these events, along with factors associated with these events are described for each transit mode. Recommendations for improving WhMD transportation are discussed given the current state of

Minority carrier device comprising a passivating layer including a Group 13 element and a chalcogenide component

NASA Technical Reports Server (NTRS)

Barron, Andrew R. (Inventor); Hepp, Aloysius F. (Inventor); Jenkins, Phillip P. (Inventor); MacInnes, Andrew N. (Inventor)

1999-01-01

A minority carrier device includes at least one junction of at least two dissimilar materials, at least one of which is a semiconductor, and a passivating layer on at least one surface of the device. The passivating layer includes a Group 13 element and a chalcogenide component. Embodiments of the minority carrier device include, for example, laser diodes, light emitting diodes, heterojunction bipolar transistors, and solar cells.

77 FR 27078 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... Phones and Tablet Computers, and Components Thereof; Notice of Receipt of Complaint; Solicitation of... entitled Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... the United States after importation of certain electronic devices, including mobile phones and tablet...

Apollo Spacecraft and Saturn V Launch Vehicle Pyrotechnics/Explosive Devices

NASA Technical Reports Server (NTRS)

Interbartolo, Michael

2009-01-01

The Apollo Mission employs more than 210 pyrotechnic devices per mission.These devices are either automatic of commanded from the Apollo spacecraft systems. All devices require high reliability and safety and most are classified as either crew safety critical or mission critical. Pyrotechnic devices have a wide variety of applications including: launch escape tower separation, separation rocket ignition, parachute deployment and release and electrical circuit opening and closing. This viewgraph presentation identifies critical performance, design requirements and safety measures used to ensure quality, reliability and performance of Apollo pyrotechnic/explosive devices. The major components and functions of a typical Apollo pyrotechnic/explosive device are listed and described (initiators, cartridge assemblies, detonators, core charges). The presentation also identifies the major locations and uses for the devices on: the Command and Service Module, Lunar Module and all stages of the launch vehicle.

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Code of Federal Regulations, 2010 CFR

2010-10-01

... output terminal(s) of the device terminated by a resistance equal to the rated output impedance. The... ohms) matching the rated output impedance of the TV interface device, shall not exceed the following... during maximum amplitude peaks across a resistance (R in ohms) matching the rated output impedance of the...

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Code of Federal Regulations, 2011 CFR

2011-10-01

... output terminal(s) of the device terminated by a resistance equal to the rated output impedance. The... ohms) matching the rated output impedance of the TV interface device, shall not exceed the following... during maximum amplitude peaks across a resistance (R in ohms) matching the rated output impedance of the...

A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility.

PubMed

Pavelec, Vaclav; Rotenberg, Brian W; Maurer, Joachim T; Gillis, Edward; Verse, Thomas

2016-01-01

Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans. A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period. Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report. Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally

Safety control circuit for a neutronic reactor

DOEpatents

Ellsworth, Howard C.

2004-04-27

A neutronic reactor comprising an active portion containing material fissionable by neutrons of thermal energy, means to control a neutronic chain reaction within the reactor comprising a safety device and a regulating device, a safety device including means defining a vertical channel extending into the reactor from an aperture in the upper surface of the reactor, a rod containing neutron-absorbing materials slidably disposed within the channel, means for maintaining the safety rod in a withdrawn position relative to the active portion of the reactor including means for releasing said rod on actuation thereof, a hopper mounted above the active portion of the reactor having a door disposed at the bottom of the hopper opening into the vertical channel, a plurality of bodies of neutron-absorbing materials disposed within the hopper, and means responsive to the failure of the safety rod on actuation thereof to enter the active portion of the reactor for opening the door in the hopper.

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices.

PubMed

Gad, Shayne C; Schuh, JoAnn C L

2018-06-01

Safety ("biocompatibility") assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited-almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2010 CFR

2010-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... experimental studies and tests, required by the Commission to facilitate a determination of the safety of the... contact by any person with it; (3) The device is so designed that it cannot easily be disassembled; and (4...

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2011 CFR

2011-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... experimental studies and tests, required by the Commission to facilitate a determination of the safety of the... contact by any person with it; (3) The device is so designed that it cannot easily be disassembled; and (4...

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2012 CFR

2012-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... experimental studies and tests, required by the Commission to facilitate a determination of the safety of the... contact by any person with it; (3) The device is so designed that it cannot easily be disassembled; and (4...

The risk of a safety-critical event associated with mobile device use in specific driving contexts.

PubMed

Fitch, Gregory M; Hanowski, Richard J; Guo, Feng

2015-01-01

We explored drivers' mobile device use and its associated risk of a safety-critical event (SCE) in specific driving contexts. Our premise was that the SCE risk associated with mobile device use increases when the driving task becomes demanding. Data from naturalistic driving studies involving commercial motor vehicle drivers and light vehicle drivers were partitioned into subsets representative of specific driving contexts. The subsets were generated using data set attributes that included level of service and relation to junction. These attributes were selected based on exogenous factors known to alter driving task demands. The subsets were analyzed using a case-cohort approach, which was selected to complement previous investigations of mobile device SCE risk using naturalistic driving data. Both commercial motor vehicle and light vehicle drivers varied as to how much they conversed on a mobile device but did not vary their engagement in visual-manual subtasks. Furthermore, commercial motor vehicle drivers conversed less frequently as the driving task demands increased, whereas light vehicle drivers did not. The risk of an SCE associated with mobile device use was dependent on the subtask performed and the driving context. Only visual-manual subtasks were associated with an increased SCE risk, whereas conversing was associated with a decreased risk in some driving contexts. Drivers' engagement in mobile device subtasks varies by driving context. The SCE risk associated with mobile device use is dependent on the types of subtasks performed and the driving context. The findings of this exploratory study can be applied to the design of driver-vehicle interfaces that mitigate distraction by preventing visual-manual subtasks while driving.

Electra-optical device including a nitrogen containing electrolyte

DOEpatents

Bates, J.B.; Dudney, N.J.; Gruzalski, G.R.; Luck, C.F.

1995-10-03

Described is a thin-film battery, especially a thin-film microbattery, and a method for making same having application as a backup or primary integrated power source for electronic devices. The battery includes a novel electrolyte which is electrochemically stable and does not react with the lithium anode and a novel vanadium oxide cathode. Configured as a microbattery, the battery can be fabricated directly onto a semiconductor chip, onto the semiconductor die or onto any portion of the chip carrier. The battery can be fabricated to any specified size or shape to meet the requirements of a particular application. The battery is fabricated of solid state materials and is capable of operation between {minus}15 C and 150 C.

Photovoltaic Device Including A Boron Doping Profile In An I-Type Layer

DOEpatents

Yang, Liyou

1993-10-26

A photovoltaic cell for use in a single junction or multijunction photovoltaic device, which includes a p-type layer of a semiconductor compound including silicon, an i-type layer of an amorphous semiconductor compound including silicon, and an n-type layer of a semiconductor compound including silicon formed on the i-type layer. The i-type layer including an undoped first sublayer formed on the p-type layer, and a boron-doped second sublayer formed on the first sublayer.

Electronic cigarette devices and oro-facial trauma (Literature review)

NASA Astrophysics Data System (ADS)

Ghazali, A. F.; Ismail, A. F.; Daud, A.

2017-08-01

Detrimental effects of cigarette smoking have been well described and recognized globally. With recent advancement of technology, electronic cigarette has been introduced and gained its popularity and became a global trend, especially among young adults. However, the safety of the electronic devices remains debatable. This paper aimed to compile and review the reported cases of oro-facial trauma related to the usage of electronic cigarette devices. A literature search was conducted using PubMed/Medline in December 2016. The search terms used were a combination of “oral trauma”, “dental trauma”, “oral injury” and “electronic cigarette”. The search included all abstract published from the inception of the database until December 2016. Abstract that was written in English, case report, letter to editors, clinical and human studies were included for analysis. All selected abstract were searched for full articles. A total of 8 articles were included for review. All of the articles were published in 2016 with mostly case reports. The sample size of the studies ranged from 1 to 15 patients. Seven of the included articles are from United States of America and one from Mexico. Our review concluded that the use of electronic cigarette devices posed not only a safety concern but also that the devices were mostly unregulated. There should be a recognized authority body to regulate the safety and standard of the electronic devices.

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2013 CFR

2013-01-01

... accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v... source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct...) Instructions for handling and storing the source or device from the radiation safety standpoint; these...

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2014 CFR

2014-01-01

... accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v... source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct...) Instructions for handling and storing the source or device from the radiation safety standpoint; these...

Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

PubMed Central

Wang, Jingen; Zhou, Yongfei; Xia, Shuxia; Zhu, Zunwei; Jia, Linghua; Liu, Yong; Jiang, Min

2014-01-01

Background We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd. Material/Methods Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted. Results Intraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05). Conclusions This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT. PMID:24647226

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

PubMed

Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S

2018-06-12

To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. Copyright © 2018 John Wiley & Sons, Ltd.

Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness

NASA Astrophysics Data System (ADS)

Hughes, Allen A.

1994-12-01

Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.

Electra-optical device including a nitrogen containing electrolyte

DOEpatents

Bates, John B.; Dudney, Nancy J.; Gruzalski, Greg R.; Luck, Christopher F.

1995-01-01

Described is a thin-film battery, especially a thin-film microbattery, and a method for making same having application as a backup or primary integrated power source for electronic devices. The battery includes a novel electrolyte which is electrochemically stable and does not react with the lithium anode and a novel vanadium oxide cathode Configured as a microbattery, the battery can be fabricated directly onto a semiconductor chip, onto the semiconductor die or onto any portion of the chip carrier. The battery can be fabricated to any specified size or shape to meet the requirements of a particular application. The battery is fabricated of solid state materials and is capable of operation between -15.degree. C. and 150.degree. C.

Abdomen Impact Testing of the Hybrid III Rail Safety (H3-RS) Anthropomorphic Test Device

DOT National Transportation Integrated Search

2017-09-01

The Hybrid III Rail Safety (H3-RS) anthropomorphic test device (ATD) is a crash test dummy that was developed in the UK to evaluate abdomen and lower thorax injuries that occur when passengers impact workstation tables during train accidents. The H3-...

Evaluating the Performance of the NASA LaRC CMF Motion Base Safety Devices

NASA Technical Reports Server (NTRS)

Gupton, Lawrence E.; Bryant, Richard B., Jr.; Carrelli, David J.

2006-01-01

This paper describes the initial measured performance results of the previously documented NASA Langley Research Center (LaRC) Cockpit Motion Facility (CMF) motion base hardware safety devices. These safety systems are required to prevent excessive accelerations that could injure personnel and damage simulator cockpits or the motion base structure. Excessive accelerations may be caused by erroneous commands or hardware failures driving an actuator to the end of its travel at high velocity, stepping a servo valve, or instantly reversing servo direction. Such commands may result from single order failures of electrical or hydraulic components within the control system itself, or from aggressive or improper cueing commands from the host simulation computer. The safety systems must mitigate these high acceleration events while minimizing the negative performance impacts. The system accomplishes this by controlling the rate of change of valve signals to limit excessive commanded accelerations. It also aids hydraulic cushion performance by limiting valve command authority as the actuator approaches its end of travel. The design takes advantage of inherent motion base hydraulic characteristics to implement all safety features using hardware only solutions.

78 FR 32689 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

..., Including Mobile Phones and Components Thereof Notice of Receipt of Complaint; Solicitation of Comments... Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof, DN... mobile phones and components thereof. The complaint names as respondents HTC Corporation of China and HTC...

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

Measurement, testing, and safety technology: A compilation

NASA Technical Reports Server (NTRS)

1974-01-01

Methods and techniques in the related areas of measurement, testing, and safety are presented. Measuring techniques and devices and testing methods and devices are described. Articles on equipment modifications or procedures are included. Patent information is presented.

Consumers' Use of Personal Electronic Devices in the Kitchen.

PubMed

Lando, Amy M; Bazaco, Michael C; Chen, Yi

2018-02-23

Smartphones, tablets, and other personal electronic devices have become ubiquitous in Americans' daily lives. These devices are used by people throughout the day, including while preparing food. For example, a device may be used to look at recipes and therefore be touched multiple times during food preparation. Previous research has indicated that cell phones can harbor bacteria, including opportunistic human pathogens such as Staphylococcus and Klebsiella spp. This investigation was conducted with data from the 2016 Food Safety Survey (FSS) and from subsequent focus groups to determine the frequency with which consumers use personal electronic devices in the kitchen while preparing food, the types of devices used, and hand washing behaviors after handling these devices. The 2016 FSS is the seventh wave of a repeated cross-sectional survey conducted by the U.S. Food and Drug Administration in collaboration with the U.S. Department of Agriculture. The goal of the FSS is to evaluate U.S. adult consumer attitudes, behaviors, and knowledge about food safety. The FSS included 4,169 adults that were contacted using a dual-frame (land line and cell phone interviews) random-digit-dial sampling process. The personal electronics module was the first of three food safety topics discussed by each of eight consumer focus groups, which were convened in four U.S. cities in fall 2016. Results from the 2016 FSS revealed that of those individuals who use personal electronic devices while cooking, only about one third reported washing hands after touching the device and before continuing cooking. This proportion is significantly lower than that for self-reported hand washing behaviors after touching risky food products such as raw eggs, meat, chicken, or fish. Results from the focus groups highlight the varied usage of these devices during food preparation and the related strategies consumers are using to incorporate personal electric devices into their cooking routines.

Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

PubMed

Ramanathan, Aparna; Eckardt, Melody J; Nelson, Brett D; Guha, Moytrayee; Oguttu, Monica; Altawil, Zaid; Burke, Thomas

2018-05-15

Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

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 48468 - Delphi Corporation, Electronics and Safety Division, Including On-Site Leased Workers From...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

..., Electronics and Safety Division, Including On-Site Leased Workers From Securitas, Bartech, Flint Janitorial... Adjustment Assistance on May 20, 2013, applicable to workers of Delphi Corporation, Electronics and Safety... on- site at the Flint, Michigan location of Delphi Corporation, Electronics and Safety Division. The...

A method for safety testing of radiofrequency/microwave-emitting devices using MRI.

PubMed

Alon, Leeor; Cho, Gene Y; Yang, Xing; Sodickson, Daniel K; Deniz, Cem M

2015-11-01

Strict regulations are imposed on the amount of radiofrequency (RF) energy that devices can emit to prevent excessive deposition of RF energy into the body. In this study, we investigated the application of MR temperature mapping and 10-g average specific absorption rate (SAR) computation for safety evaluation of RF-emitting devices. Quantification of the RF power deposition was shown for an MRI-compatible dipole antenna and a non-MRI-compatible mobile phone via phantom temperature change measurements. Validation of the MR temperature mapping method was demonstrated by comparison with physical temperature measurements and electromagnetic field simulations. MR temperature measurements alongside physical property measurements were used to reconstruct 10-g average SAR. The maximum temperature change for a dipole antenna and the maximum 10-g average SAR were 1.83°C and 12.4 W/kg, respectively, for simulations and 1.73°C and 11.9 W/kg, respectively, for experiments. The difference between MR and probe thermometry was <0.15°C. The maximum temperature change and the maximum 10-g average SAR for a cell phone radiating at maximum output for 15 min was 1.7°C and 0.54 W/kg, respectively. Information acquired using MR temperature mapping and thermal property measurements can assess RF/microwave safety with high resolution and fidelity. © 2014 Wiley Periodicals, Inc.

A Method for Safety Testing of Radiofrequency/Microwave-Emitting Devices Using MRI

PubMed Central

Alon, Leeor; Cho, Gene Y.; Yang, Xing; Sodickson, Daniel K.; Deniz, Cem M.

2015-01-01

Purpose Strict regulations are imposed on the amount of radiofrequency (RF) energy that devices can emit to prevent excessive deposition of RF energy into the body. In this study, we investigated the application of MR temperature mapping and 10-g average specific absorption rate (SAR) computation for safety evaluation of RF-emitting devices. Methods Quantification of the RF power deposition was shown for an MRI-compatible dipole antenna and a non–MRI-compatible mobile phone via phantom temperature change measurements. Validation of the MR temperature mapping method was demonstrated by comparison with physical temperature measurements and electromagnetic field simulations. MR temperature measurements alongside physical property measurements were used to reconstruct 10-g average SAR. Results The maximum temperature change for a dipole antenna and the maximum 10-g average SAR were 1.83° C and 12.4 W/kg, respectively, for simulations and 1.73° C and 11.9 W/kg, respectively, for experiments. The difference between MR and probe thermometry was <0.15° C. The maximum temperature change and the maximum 10-g average SAR for a cell phone radiating at maximum output for 15 min was 1.7° C and 0.54 W/kg, respectively. Conclusion Information acquired using MR temperature mapping and thermal property measurements can assess RF/microwave safety with high resolution and fidelity. PMID:25424724

A novel safety device with metal counter meshing gears discriminator directly driven by axial flux permanent magnet micromotors based on MEMS technology

NASA Astrophysics Data System (ADS)

Zhang, Weiping; Chen, Wenyuan; Zhao, Xiaolin; Li, Shengyong; Jiang, Yong

2005-08-01

In a novel safety device based on MEMS technology for high consequence systems, the discriminator consists of two groups of metal counter meshing gears and two pawl/ratchet wheel mechanisms. Each group of counter meshing gears is onepiece and driven directly by an axial flux permanent magnet micromotor respectively. The energy-coupling element is an optical shutter with two collimators and a coupler wheel. The safety device's probability is less than 1/106. It is fabricated by combination of an LiGA-like process and precision mechanical engineering. The device has simple structure, few dynamic problems, high strength and strong reliability.

76 FR 31983 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-701] In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and Computers; Notice of Commission... States after importation of certain electronic devices, including mobile phones, portable music players...

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

PubMed

Gagliardi, Anna R; Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia; Urbach, David R

2017-01-01

Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and

Portable Bio/Chemosensoristic Devices: Innovative Systems for Environmental Health and Food Safety Diagnostics.

PubMed

Dragone, Roberto; Grasso, Gerardo; Muccini, Michele; Toffanin, Stefano

2017-01-01

This mini-review covers the newly developed biosensoristic and chemosensoristic devices described in recent literature for detection of contaminants in both environmental and food real matrices. Current needs in environmental and food surveillance of contaminants require new simplified, sensitive systems, which are portable and allow for rapid and on-site monitoring and diagnostics. Here, we focus on optical and electrochemical bio/chemosensoristic devices as promising tools with interesting analytical features that can be potentially exploited for innovative on-site and real-time applications for diagnostics and monitoring of environmental and food matrices (e.g., agricultural waters and milk). In near future, suitably developed and implemented bio/chemosensoristic devices will be a new and modern technological solution for the identification of new quality and safety marker indexes as well as for a more proper and complete characterization of abovementioned environmental and food matrices. Integrated bio/chemosensoristic devices can also allow an "holistic approach" that may prove to be more suitable for diagnostics of environmental and food real matrices, where the copresence of more bioactive substances is frequent. Therefore, this approach can be focused on the determination of net effect (mixture effect) of bioactive substances present in real matrices.

Effect of current federal regulations on handgun safety features.

PubMed

Milne, John S; Hargarten, Stephen W; Kellermann, Arthur L; Wintemute, Garen J

2003-01-01

In the late 1960s, the Bureau of Alcohol, Tobacco, and Firearms implemented the "factoring criteria," a set of minimum size and safety standards required for any handgun imported into the United States. These standards, however, were not applied to guns manufactured domestically. We determine whether extending the factoring criteria to all handguns sold in the United States, as has been proposed in Congress, would increase the likelihood that safety devices would be included in new handgun designs. Imported and domestic handgun models produced in 1996 were examined to determine the prevalence of 4 passively acting safety devices on pistols and 1 passive safety device on revolvers. Domestic models were also scored against the factoring criteria. Compared with domestic pistol models, imported pistols were more likely to include a firing pin block (odds ratio [OR] 2.43; 95% confidence interval [CI] 1.54 to 3.85) and a loaded chamber indicator (OR 1.59; 95% CI 0.98 to 2.56). Domestic pistol models that already met the factoring criteria were more likely to include a loaded chamber indicator (OR 12.05; 95% CI 2.74 to 53.02), a grip safety (OR 24.12; 95% CI 7.8 to 74.33), and a firing pin block (OR 4.92; 95% CI 2.35 to 10.29) than domestic models that did not meet the criteria. Although pistol models that meet the factoring criteria are more likely to contain safety devices than those that do not, the net effect is modest. Thus, the factoring criteria alone are insufficient to ensure consistent incorporation of safety features into new handgun designs.

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

PubMed

Venkataraman, Ganesh; Strickberger, S Adam; Doshi, Shephal; Ellis, Christopher R; Lakkireddy, Dhanunjaya; Whalen, S Patrick; Cuoco, Frank

2018-01-01

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm. Thirty-two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA 2 DS 2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m 2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14-16) and 23.2 ± 4.5 mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm. © 2017 Wiley Periodicals, Inc.

78 FR 49684 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-15

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Safety and severity of accelerations delivered from whole body vibration exercise devices to standing adults.

PubMed

Muir, Jesse; Kiel, Douglas P; Rubin, Clinton T

2013-11-01

Whole body vibration devices are used as a means to augment training, and their potential to treat a range of musculoskeletal diseases and injuries is now being considered. The goal of this work is to determine the degree to which acceleration delivered by whole body vibration devices at the plantar surfaces of a standing human is transmitted through the axial and appendicular skeleton, and how this mechanical challenge corresponds to the safety threshold limit values established by the International Standards Organization ISO-2631. Non-blinded laboratory assessment of a range of whole body vibration devices as it pertains to acceleration transmission to healthy volunteers. Using skin and bite-bar mounted accelerometers, transmissibility to the tibia and cranium was determined in six healthy adults standing on a programmable whole body vibration device as a function of frequency and intensity. Measures of transmissibility were then made from three distinct types of whole body vibration platforms, which delivered a 50-fold range of peak-to-peak acceleration intensities (0.3-15.1 gp-p; where 1g is Earth's gravitational field). For a given frequency, transmissibility was independent of intensity when below 1g. Transmissibility declined non-linearly with increasing frequency. Depending on the whole body vibration device, vibration ranged from levels considered safe by ISO-2631 for up to 8h each day (0.3 gp-p @ 30 Hz), to levels that were seven times higher than what is considered a safe threshold for even 1 min of exposure each day (15.1 gp-p @ 30 Hz). Transmissibility to the cranium was markedly attenuated by the degree of flexion in the knees. Vibration can have adverse effects on a number of physiologic systems. This work indicates that readily accessible whole body vibration devices markedly exceed ISO guidelines for safety, and extreme caution must be practiced when considering their use. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All

77 FR 65478 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

77 FR 60044 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River...

78 FR 65874 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including...

Influence of Steering Control Devices Mounted in Cars for the Disabled on Passive Safety

NASA Astrophysics Data System (ADS)

Masiá, J.; Eixerés, B.; Dols, J. F.; Colomina, F. J.

2009-11-01

The purpose of this research is to analyze the influence of steering control devices for disabled people on passive safety. It is based on the advances made in the modelling and simulation of the driver position and in the suit verification test. The influence of these devices is studied through airbag deployment and/or its influence on driver safety. We characterize the different adaptations that are used in adapted cars that can be found mounted in vehicles in order to generating models that are verified by experimental test. A three dimensional design software package was used to develop the model. The simulations were generated using a dynamic simulation program employing LSDYNA finite elements. This program plots the geometry and assigns materials. The airbag is shaped, meshed and folded just as it is mounted in current vehicles. The thermodynamic model of expansion of gases is assigned and the contact interfaces are defined. Static tests were carried out on deployment of the airbag to contrast with and to validate the computational models and to measure the behaviour of the airbag when there are steering adaptations mounted in the vehicle.

23 CFR 970.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2011 CFR

2011-04-01

...) An inventory of safety appurtenances such as signs, delineators, and guardrails (including terminals... upgrading safety appurtenances including highway-rail crossing warning devices, signs, highway elements, and... standards) for low volume roads may be tailored to be consistent with the functional classification of the...

23 CFR 970.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2012 CFR

2012-04-01

...) An inventory of safety appurtenances such as signs, delineators, and guardrails (including terminals... upgrading safety appurtenances including highway-rail crossing warning devices, signs, highway elements, and... standards) for low volume roads may be tailored to be consistent with the functional classification of the...

23 CFR 970.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2013 CFR

2013-04-01

...) An inventory of safety appurtenances such as signs, delineators, and guardrails (including terminals... upgrading safety appurtenances including highway-rail crossing warning devices, signs, highway elements, and... standards) for low volume roads may be tailored to be consistent with the functional classification of the...

23 CFR 970.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2014 CFR

2014-04-01

...) An inventory of safety appurtenances such as signs, delineators, and guardrails (including terminals... upgrading safety appurtenances including highway-rail crossing warning devices, signs, highway elements, and... standards) for low volume roads may be tailored to be consistent with the functional classification of the...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2011 CFR

2011-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2013 CFR

2013-07-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

Do safety engineered devices reduce needle-stick injuries?

PubMed

Schuurmans, J; Lutgens, S P; Groen, L; Schneeberger, P M

2018-05-05

Needle stick injuries (NSIs) are one of the most common health hazards facing health care workers (HCWs) across the globe. Needles with safety engineered devices (SEDs) have been developed to minimize the risk of exposure to blood-borne infections such as Hepatitis B virus (HBV), Hepatitis C virus (HCV) and human immunodeficiency virus (HIV) associated with NSIs. To assess the effect of the introduction of SEDs in preventing NSIs among HCWs in the Jeroen Bosch Hospital (JBH), the Netherlands. We compared the incidence of reported NSIs before and after the introduction of SEDs. All HCWs who reported a NSI with a SED were interviewed in order to understand the underlying causes of the NSIs. Despite the introduction of SEDs the incidence of NSIs increased from 1.9/100 HCWs before the introduction of SEDs to 2.2/100 HCWs after the introduction of SEDs. The registration of reported SED related NSIs showed a significant decrease in the number of NSIs related to injection needles and blood sugar needles, while an unexpected significant increase in NSIs with nadroparin calcium needles and infusion needles was found. The most common causes reported for NSIs were unsafe disposal of the needles and problems with the safety feature. The application of SEDs has not led to a reduction of NSIs. The majority of NSIs caused by a needle with a SED can be prevented by stimulation of safe needle disposal, proper use of SEDs and provision of feedback to manufacturers to keep improving product design. Copyright © 2018. Published by Elsevier Ltd.

Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment

PubMed Central

Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.

2007-01-01

Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices? Conclusions Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes. PMID:18095046

Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices.

PubMed

Elder, Alexander; Paterson, Caron

2006-12-01

To review the literature on sharps injuries and occupational bloodborne virus transmission in health care in the UK and the worldwide evidence for injury prevention of sharps safety devices. Literature review by online database and Internet resource search. Twenty-four relevant publications were identified regarding UK reported sharps injury rates. UK studies showed as much as a 10-fold difference between injuries reported through standard reporting systems (0.78-5.15 per 100 person-years) and rates estimated from retrospective questionnaires of clinical populations (30-284 per 100 person-years). National surveillance data from England, Wales and Northern Ireland gives a rate of 1.43 known hepatitis C virus or human immunodeficiency virus (HIV) transmissions to health care workers per annum. When extrapolated, this suggests an approximate rate of 0.009 such viral transmissions per 1000 hospital beds per annum. Risk of infection from sources with no risk factors is extremely small (less than one in one million for HIV transmission based on Scottish data). Thirty-one studies on the efficacy of sharps safety devices showed evidence of a reduction in injuries, with the greatest reductions achieved by blunt suture needles and safety cannulae. Although injuries remain common, confirmed viral transmission in the UK has been relatively rare. The degree of under-reporting of sharps injuries may be as much as 10-fold. Safety-engineered devices are likely to be effective at injury reduction.

Training the elderly in pedestrian safety: Transfer effect between two virtual reality simulation devices.

PubMed

Maillot, Pauline; Dommes, Aurélie; Dang, Nguyen-Thong; Vienne, Fabrice

2017-02-01

A virtual-reality training program has been developed to help older pedestrians make safer street-crossing decisions in two-way traffic situations. The aim was to develop a small-scale affordable and transportable simulation device that allowed transferring effects to a full-scale device involving actual walking. 20 younger adults and 40 older participants first participated in a pre-test phase to assess their street crossings using both full-scale and small-scale simulation devices. Then, a trained older group (20 participants) completed two 1.5-h training sessions with the small-scale device, whereas an older control group received no training (19 participants). Thereafter, the 39 older trained and untrained participants took part in a 1.5-h post-test phase again with both devices. Pre-test phase results suggested significant differences between both devices in the group of older participants only. Unlike younger participants, older participants accepted more often to cross and had more collisions on the small-scale simulation device than on the full-scale one. Post-test phase results showed that training older participants on the small-scale device allowed a significant global decrease in the percentage of accepted crossings and collisions on both simulation devices. But specific improvements regarding the way participants took into account the speed of approaching cars and vehicles in the far lane were notable only on the full-scale simulation device. The findings suggest that the small-scale simulation device triggers a greater number of unsafe decisions compared to a full-scale one that allows actual crossings. But findings reveal that such a small-scale simulation device could be a good means to improve the safety of street-crossing decisions and behaviors among older pedestrians, suggesting a transfer of learning effect between the two simulation devices, from training people with a miniature device to measuring their specific progress with a full-scale one

Safety of a progesterone-releasing intravaginal device as assessed from vaginal mucosal integrity and indicators of systemic inflammation in postpartum dairy cows

PubMed Central

Walsh, Robert B.; LeBlanc, Stephen J.; Vernooy, Erin; Leslie, Kenneth E.

2008-01-01

A clinical trial was conducted to investigate the animal safety of a progesterone-releasing intravaginal device (PRID). Anestrus cows at a mean of 63 ± 3.5 d in milk were randomly assigned to an ovulation-synchronization protocol that included placement of either a PRID or a placebo intravaginal device (PID) or no such treatment. At enrolment and at device removal 7 d later, blood samples were collected. The outcomes of interest included the vaginal reaction to the device, the vaginal mucosal integrity, and the results of bacterial culture of swabs of the vaginal mucosa. In addition, the leukocyte and haptoglobin responses were measured. Although only 5% of the PRID-treated animals compared with 19% of the PID-treated animals had a copious purulent vaginal discharge at the time of device removal, there was no significant difference in the proportions; furthermore, there was no evidence of vaginal mucosal damage associated with either device. The total blood leukocyte count was significantly lower in both the PRID-treated cows and the PID-treated cows after device removal compared with the start of treatment (P < 0.05) and compared with no treatment (P < 0.001); there was no difference in leukocyte response between the 2 device-treated groups. The decrease in leukocyte count was attributed to a significant reduction in the numbers of circulating neutrophils and lymphocytes, a pattern consistent with the luteal phase of the bovine estrus cycle. There was no significant difference in the circulating haptoglobin concentration between the 3 groups of cows. Culture revealed commensal bacterial growth in the vagina of all the cows. PMID:18214161

Portable Bio/Chemosensoristic Devices: Innovative Systems for Environmental Health and Food Safety Diagnostics

PubMed Central

Dragone, Roberto; Grasso, Gerardo; Muccini, Michele; Toffanin, Stefano

2017-01-01

This mini-review covers the newly developed biosensoristic and chemosensoristic devices described in recent literature for detection of contaminants in both environmental and food real matrices. Current needs in environmental and food surveillance of contaminants require new simplified, sensitive systems, which are portable and allow for rapid and on-site monitoring and diagnostics. Here, we focus on optical and electrochemical bio/chemosensoristic devices as promising tools with interesting analytical features that can be potentially exploited for innovative on-site and real-time applications for diagnostics and monitoring of environmental and food matrices (e.g., agricultural waters and milk). In near future, suitably developed and implemented bio/chemosensoristic devices will be a new and modern technological solution for the identification of new quality and safety marker indexes as well as for a more proper and complete characterization of abovementioned environmental and food matrices. Integrated bio/chemosensoristic devices can also allow an “holistic approach” that may prove to be more suitable for diagnostics of environmental and food real matrices, where the copresence of more bioactive substances is frequent. Therefore, this approach can be focused on the determination of net effect (mixture effect) of bioactive substances present in real matrices. PMID:28529937

Clinician-Driven Design of VitalPAD–An Intelligent Monitoring and Communication Device to Improve Patient Safety in the Intensive Care Unit

PubMed Central

Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter

2018-01-01

The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425

Clinician-Driven Design of VitalPAD-An Intelligent Monitoring and Communication Device to Improve Patient Safety in the Intensive Care Unit.

PubMed

Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter; Gorges, Matthias

2018-01-01

The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD , to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings.

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.

PubMed

Van den Branden, Ben J; Post, Martijn C; Plokker, Herbert W; ten Berg, Jurriën M; Suttorp, Maarten J

2010-09-01

The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts). Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices. All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography. Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up. Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

“We can’t get along without each other”: Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety

PubMed Central

Lehoux, Pascale; Ducey, Ariel; Easty, Anthony; Ross, Sue; Bell, Chaim; Trbovich, Patricia

2017-01-01

Objectives Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. Design A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. Results Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. Conclusions Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives

76 FR 35106 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago..., DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent safety zone from Brandon... Safety Zones; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary...

Batteries used to Power Implantable Biomedical Devices

PubMed Central

Bock, David C.; Marschilok, Amy C.; Takeuchi, Kenneth J.; Takeuchi, Esther S.

2012-01-01

Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease. PMID:24179249

Batteries used to Power Implantable Biomedical Devices.

PubMed

Bock, David C; Marschilok, Amy C; Takeuchi, Kenneth J; Takeuchi, Esther S

2012-12-01

Battery systems have been developed that provide years of service for implantable medical devices. The primary systems utilize lithium metal anodes with cathode systems including iodine, manganese oxide, carbon monofluoride, silver vanadium oxide and hybrid cathodes. Secondary lithium ion batteries have also been developed for medical applications where the batteries are charged while remaining implanted. While the specific performance requirements of the devices vary, some general requirements are common. These include high safety, reliability and volumetric energy density, long service life, and state of discharge indication. Successful development and implementation of these battery types has helped enable implanted biomedical devices and their treatment of human disease.

30 CFR 77.808 - Disconnecting devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Surface High-Voltage Distribution § 77.808 Disconnecting devices. Disconnecting devices shall be installed at the...

Medical Device Guidebook: A browser information resource for medical device users.

PubMed

Clarkson, Douglas M

2017-03-01

A web based information resource - the 'Medical Device Guidebook' - for the enabling of safe use of medical devices is described. Medical devices are described within a 'catalogue' of specific models and information on a specific model is provided within a consistent set of information 'keys'. These include 'user manuals', 'points of caution', 'clinical use framework', 'training/assessment material', 'frequently asked questions', 'authorised user comments' and 'consumables'. The system allows identification of known risk/hazards associated with specific devices, triggered, for example, by national alerts or locally raised safety observations. This provides a mechanism for more effective briefing of equipment users on the associated hazards of equipment. A feature of the system is the inclusion of a specific 'Operational Procedure' for each device, where the lack of this focus is shown in the literature to often be a key factor in equipment misuse and associated patient injury. The 'Guidebook' provides a mechanism for the development of an information resource developed within local clinical networks and encourages a consistent approach to medical device use. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

Safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion.

PubMed

Chen, Qiang; Cao, Hua; Zhang, Gui-Can; Chen, Liang-Wan; Chen, Dao-Zhong

2012-01-01

The study aims to evaluate the safety and feasibility of intra-operative device closure of atrial septal defect with transthoracic minimal invasion. From May 2006 to June 2009, 252 patients with secundum-type atrial septal defect closure were enrolled in our institution. The patients were divided into two groups, with 182 patients in group I with intra-operative device closure and 72 in group II with surgical closure. In group I, the patients' age ranged from 3 months to 62 years (mean±standard deviation, 19.0±16.7 years). This approach involved a transthoracic minimal invasion that was performed after full evaluation of the atrial septal defect by transthoracic echocardiography, deploying the device through the delivery sheath to occlude the atrial septal defect. In group I, 180 patients were occluded successfully under this approach. The size of the occluder device implanted ranged from 6 to 48 mm. Minor complications occurred, which included transient arrhythmias (n=23) and pleural effusion (n=15). Two patients with postoperative cardiac arrest were successfully cardiopulmonary resuscitated. Another two patients with occluder dislodged back into the right atrium were turned to surgical repair with cardiopulmonary bypass on the postoperative day. In group II, all patients were occluded successfully, and almost all patients needed blood transfusion and suffered from various minor complications. All discharged patients were followed up for 1-5 years. During this period, we found no recurrence, no thrombosis, even no device failure. In our comparative studies, group II had significantly longer intensive care unit (ICU) stay and hospital stay than group I (p<0.05). The cost for group I was less than group II (p<0.05). Intra-operative device closure of atrial septal defect with transthoracic minimal invasion is a safe and feasible technique. It had the advantages of cost savings, yielding better cosmetic results, and leaving less trauma than surgical closure.

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?

PubMed Central

Ghaly, Ramsis F.; Tverdohleb, Tatiana; Candido, Kenneth D.; Knezevic, Nebojsa Nick

2016-01-01

Background: Spinal cord stimulation is currently approved to treat chronic intractable pain of the trunk and limbs. However, such implantable electronic devices are vulnerable to external electrical currents and magnetic fields. Within the hospitals and modern operating rooms (ORs), there is an abundance of electrical devices and other types of equipment that could interfere with such devices. Despite the increasing number of patients with neuromodulation implantable devices, there are no written guidelines available or consensus of cautions for such patients undergoing unrelated surgery. Case Descriptions: A 60-year-old female with a permanent St. Jude's spinal cord stimulator (SCS) presented for open total abdominal hysterectomy. Both the anesthesia and gynecology staffs were aware of the device presence, but were unaware of any precautions regarding intraoperative management. The device was found to be nonmagnetic resonance imaging compatible, and bipolar cautery was used instead of monopolar cautery. A 59-year-old female with a 9-year-old permanent Medtronic SCS, presented for right total hip arthroplasty. The device was switched off prior to entering the OR, bipolar cautery was used, and grounding pads were placed away from her battery site. In each case, the manufacturer's representative was contacted preoperative. Both surgeries proceeded uneventfully. Conclusions: The Food and Drug Administration safety information manual warns about the use of diathermy, concomitant implanted stimulation devices, lithotripsy, external defibrillation, radiation therapy, ultrasonic scanning, and high-output ultrasound, all of which can lead to permanent implant damage if not turned off prior to undertaking procedures. Lack of uniform guidelines makes intraoperative management, as well as remote anesthesia care of patients with previously implanted SCSs unsafe. PMID:26958424

41 CFR 102-34.250 - Do Federal employees in Government motor vehicles have to use all safety devices and follow all...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section 102-34.250 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATIO...

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

NASA Astrophysics Data System (ADS)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Crashworthiness Design of the Shear Bolts for Light Collision Safety Devices

NASA Astrophysics Data System (ADS)

Kim, Jin Sung; Huh, Hoon; Kwon, Tae Soo

This paper introduces the jig set for the crash test and the crash test results of shear bolts which are designed to fail at train crash conditions. The tension and shear bolts are attached to Light Collision Safety Devices(LCSD) as a mechanical fuse when tension and shear bolts reach their failure load designed. The kinetic energy due to the crash is absorbed by the secondary energy absorbing device after LCSD are detached from the main body by the fracture of shear bolts. A single shear bolt was designed to fail at the load of 250 kN. The jig set designed to convert a compressive loading to a shear loading was installed to the high speed crash tester for dynamic shear tests. Two strain gauges were attached at the parallel section of the jig set to measure the load responses acting on the shear bolts. Crash tests were performed with a carrier whose mass was 250 kg and the initial speed of the carrier was 9 m/sec. From the quasi-static and dynamic experiments as well as the numerical analysis, the capacity of the shear bolts were accurately predicted for the crashworthiness design.

Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting.

PubMed

Jewell, Mark L; Baxter, Richard A; Cox, Sue Ellen; Donofrio, Lisa M; Dover, Jeffrey S; Glogau, Richard G; Kane, Michael A; Weiss, Robert A; Martin, Patrick; Schlessinger, Joel

2011-07-01

High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks. Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm (141 J/cm total), 59 J/cm (177 J/cm), or 0 J/cm (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations. For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm (-2.44; p = 0.01) but not the 47-J/cm treatment group (-2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm (-2.52 cm; p = 0.002) and the 47-J/cm treatment groups (-2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable. Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol). Therapeutic, II.(Figure is included in full-text article.).

Including safety-net providers in integrated delivery systems: issues and options for policymakers.

PubMed

Witgert, Katherine; Hess, Catherine

2012-08-01

Health care reform legislation has spurred efforts to develop integrated health care delivery systems that seek to coordinate the continuum of health services. These systems may be of particular benefit to patients who face barriers to accessing care or have multiple health conditions. But it remains to be seen how safety-net providers, including community health centers and public hospitals--which have long experience in caring for these vulnerable populations--will be included in integrated delivery systems. This issue brief explores key considerations for incorporating safety-net providers into integrated delivery systems and discusses the roles of state and federal agencies in sup­porting and testing models of integrated care delivery. The authors conclude that the most important principles in creating integrated delivery systems for vulnerable populations are: (1) an emphasis on primary care; (2) coordination of all care, including behavioral, social, and public health services; and (3) accountability for population health outcomes.

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

Effectiveness of Existing Eye Safety Legislation in Arizona.

ERIC Educational Resources Information Center

Gillaspy, Roy Eugene

This study was designed to ascertain the current practices of eye safety in Arizona high school industrial education laboratories, including the enforcement of eye safety legislation, use of eye protection devices, how the eye ware meets the American National Standards Institute specifications, and the teachers' interpretations of the existing eye…

Safety by design: effects of operating room floor marking on the position of surgical devices to promote clean air flow compliance and minimise infection risks.

PubMed

de Korne, Dirk F; van Wijngaarden, Jeroen D H; van Rooij, Jeroen; Wauben, Linda S G L; Hiddema, U Frans; Klazinga, Niek S

2012-09-01

To evaluate the use of floor marking on the positioning of surgical devices within the clean air flow in an operating room (OR) to minimise infection risk. Laminar flow clean air systems are important in preventing infection in ORs but, for optimal results, surgical devices must be correctly positioned. The authors evaluated floor marking in four ORs at an eye hospital using time series analysis. Through observations during 829 surgeries over a 20-month period, the positions of surgical devices were determined. Eight semistructured interviews with surgical staff were conducted to assess user experiences and team dynamics. Before marking, the instrument table was positioned completely within the laminar flow in only 6.1% of the cases. This increased to 36.1% and finally 53.8%. Mayo stands were increasingly positioned within the laminar flow: from 74.2% to 84.7%. The surgical lamp decreasingly obstructed flow: from 41.8% to 28.7%. At T3 (20 months), however, in 48.6% of the applicable cases the lamp was positioned in the flow again. Discussions and site visits between airside operators and surgical staff resulted in increasing awareness of specific risk areas in the OR. OR floor markings facilitated and stimulated safety awareness and resulted in significantly increased compliance with the positioning of surgical devices in the clean air flow. Safety and quality approaches in hospital care, therefore, should include a human factors approach that focuses on system design in addition to teaching clinical and non-technical skills.

75 FR 26094 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... establishing a temporary safety zone from Brandon Road Lock and Dam to Lake Michigan. This temporary safety...

75 FR 64673 - Safety Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... Zone, Brandon Road Lock and, Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and... Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Ship and...: The Coast Guard will enforce Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des...

Practice of Regulatory Science (Development of Medical Devices).

PubMed

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

Child-safety Containers/Devices and Compounding.

PubMed

Allen, Loyd V

2017-01-01

The U.S. Consumer Product Safety Commission has been around since it was created in 1972 through the Consumer Product Safety Act. Its purpose is to protect "against unreasonable risks of injuries associated with consumer products." Manufactured drugs must meet the standards unless specifically exempted. Dispensing and compounding pharmacists must also meet the standards. Due to a smaller market size, compliant products to meet the U.S. Consumer Product Safety Commission's standards to aid compounding pharmacists have been slow in coming. However, now there are numerous different products, some introduced recently, which make it easier for compounding pharmacists to comply with the standards. The new technologies are innovative and serve a great need. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

30 CFR 285.810 - What must I include in my Safety Management System?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Activities Conducted Under SAPs, COPs and GAPs Safety Management Systems § 285.810 What must I include in my... your COP (provided under § 285.627(d)) and, when required by this part, your SAP (as provided in § 285...

Reductions in invasive device use and care costs after institution of a daily safety checklist in a pediatric critical care unit.

PubMed

Tarrago, Rod; Nowak, Jeffrey E; Leonard, Christopher S; Payne, Nathaniel R

2014-06-01

In the critical care unit, complexity of care can contribute to both medical errors and increased costs, particularly when clinicians are forced to rely on memory. Checklists can be used to improve safety and reduce cost. A number of omission-related adverse events in 2010 prompted the development of a checklist to reduce the possibility of similar future events. The PICU Safety Checklist was implemented in the pediatric ICU (PICU) at Children's Hospitals and Clinics of Minnesota. During a 21-month period, the checklist was used to prompt the care team to address quality and safety items during rounds. The initial checklist was paper, with two subsequent versions being incorporated into the electronic medical record (EMR). The daily safety checklist was successfully implemented in the PICU. Work-flow improvements based on regular multidisciplinary feedback led to more consistent use of the checklist. Improvements on all quality and safety metrics were identified, including invasive device use, medication costs, antibiotic and laboratory test use, and compliance with standards of care. Staff satisfaction rates were > 80% for safety, communication, and collaboration. By using a daily safety checklist in the pediatric critical care unit, we improved quality and safety, as well as the collaborative culture among all clinicians. Incorporating the checklist into the EMR improved compliance and accountability, ensuring its application to all patients. Clinicians now often individually address many checklist items outside the formal rounding process, indicating that the checklist content has become part of their usual practice. A successful implementation showing tangible clinical improvements can lead to interest and adoption in other clinical areas within the institution.

Safety and Efficacy of a New Bipolar Energy Device for Parenchymal Dissection in Laparoscopic Liver Resection.

PubMed

Dural, Cem; Akyuz, Muhammet; Yazici, Pinar; Aksoy, Erol; Aucejo, Federico; Quintini, Cristiano; Miller, Charles; Fung, John; Berber, Eren

2016-02-01

Despite emerging technologies, parenchymal transection still remains challenging in liver resection. The aim of this study is to assess the safety and efficacy of a new articulating vessel sealer for laparoscopic hepatectomy. Our hypothesis was that this new device would facilitate parenchymal transection and reduce intraoperative costs in laparoscopic hepatectomy. Within 18 months, a 5 cm bipolar articulating vessel sealer was used in 32 laparoscopic liver resections (LLR). By excluding 4 patients who underwent concomitant colorectal resections, the outcomes of the remaining 28 patients (group 1) were compared with 28 patients who underwent LLR by the same surgical group using other energy devices (group 2). Tumor type was malignant in 71% of patients (n=20) in group 1 and 89% of the patients (n=25) in group 2 (P=0.360). The number and size of tumors were similar in both groups, as well as the type of resections performed. In group 1, there was a less number of adjunctive devices (ie, energy, clip appliers, staplers) used (median 2) compared with group 2 (median 3, P=0.032). Parenchymal transection time (mean±SEM 28.2±3.5 vs. 55.2±4.1 min, respectively, P<0.001) and total operative time (200.1±13.7 vs. 242.7±14.4 min, respectively, P=0.036) were shorter for group 1 versus group 2. Estimated blood loss, transfusion rate, margin status, and length of stay were similar between the groups. There was no mortality. Morbidity was 11% (n=3) in group 1 and 18% (n=5) in group 2 (P=NS). The overall intraoperative costs were an average of $3000 less in group 1 (95% confidence interval, $1090-$4930, P=0.0029) compared with group 2. This study demonstrates the safety and efficacy of a new energy device for LLR. Our experience suggested that this new device provided the functionality of both a vessel sealer and a stapler with its large jaw and articulation.

Digital Device Architecture and the Safe Use of Flash Devices in Munitions

NASA Technical Reports Server (NTRS)

Katz, Richard B.; Flowers, David; Bergevin, Keith

2017-01-01

Flash technology is being utilized in fuzed munition applications and, based on the development of digital logic devices in the commercial world, usage of flash technology will increase. Digital devices of interest to designers include flash-based microcontrollers and field programmable gate arrays (FPGAs). Almost a decade ago, a study was undertaken to determine if flash-based microcontrollers could be safely used in fuzes and, if so, how should such devices be applied. The results were documented in the Technical Manual for the Use of Logic Devices in Safety Features. This paper will first review the Technical Manual and discuss the rationale behind the suggested architectures for microcontrollers and a brief review of the concern about data retention in flash cells. An architectural feature in the microcontroller under study will be discussed and its use will show how to screen for weak or failed cells during manufacture, storage, or immediately prior to use. As was done for microcontrollers a decade ago, architectures for a flash-based FPGA will be discussed, showing how it can be safely used in fuzes. Additionally, architectures for using non-volatile (including flash-based) storage will be discussed for SRAM-based FPGAs.

76 FR 23524 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... safety zone from Brandon Road Lock and Dam to Lake Michigan. This proposed safety zone will cover 77.... This TIR established a 77 mile long safety zone from Brandon Road Lock to Lake Michigan in Chicago, IL...

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... times the square root of (R) for the video signal and 155 times the square root of (R) for the audio... and 77.5 times the square root of (R) for the audio signal. (2) At any RF output terminal, the maximum... video cassette recorders continue to be subject to the provisions for general TV interface devices. (c...

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... times the square root of (R) for the video signal and 155 times the square root of (R) for the audio... and 77.5 times the square root of (R) for the audio signal. (2) At any RF output terminal, the maximum... video cassette recorders continue to be subject to the provisions for general TV interface devices. (c...

47 CFR 15.115 - TV interface devices, including cable system terminal devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... times the square root of (R) for the video signal and 155 times the square root of (R) for the audio... and 77.5 times the square root of (R) for the audio signal. (2) At any RF output terminal, the maximum... video cassette recorders continue to be subject to the provisions for general TV interface devices. (c...

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

PubMed

Becker, Lillian C; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

30 CFR 57.14100 - Safety defects; examination, correction and records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... NONMETAL MINES Machinery and Equipment Safety Devices and Maintenance Requirements § 57.14100 Safety defects; examination, correction and records. (a) Self-propelled mobile equipment to be used during a... persons, the defective items including self-propelled mobile equipment shall be taken out of service and...

76 FR 24051 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

..., Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components Thereof... certain electronic devices, including mobile phones, mobile tablets, portable music players, and computers... mobile phones, mobile tablets, portable music players, and computers, and components thereof that...

Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

PubMed

2015-11-20

The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Operating room fire prevention: creating an electrosurgical unit fire safety device.

PubMed

Culp, William C; Kimbrough, Bradly A; Luna, Sarah; Maguddayao, Aris J

2014-08-01

To reduce the incidence of surgical fires. Operating room fires represent a potentially life-threatening hazard and are triggered by the electrosurgical unit (ESU) pencil. Carbon dioxide is a fire suppressant and is a routinely used medical gas. We hypothesize that a shroud of protective carbon dioxide covering the tip of the ESU pencil displaces oxygen, thereby preventing fire ignition. Using 3-dimensional modeling techniques, a polymer sleeve was created and attached to an ESU pencil. This sleeve was connected to a carbon dioxide source and directed the gas through multiple precisely angled ports, generating a cone of fire-suppressive carbon dioxide surrounding the active pencil tip. This device was evaluated in a flammability test chamber containing 21%, 50%, and 100% oxygen with sustained ESU activation. The sleeve was tested with and without carbon dioxide (control) until a fuel was ignited or 30 seconds elapsed. Time to ignition was measured by high-speed videography. Fires were ignited with each control trial (15/15 trials). The control group median ± SD ignition time in 21% oxygen was 3.0 ± 2.4 seconds, in 50% oxygen was 0.1 ± 1.8 seconds, and in 100% oxygen was 0.03 ± 0.1 seconds. No fire was observed when the fire safety device was used in all concentrations of oxygen (0/15 trials; P < 0.0001). The exact 95% confidence interval for absolute risk reduction of fire ignition was 76% to 100%. A sleeve creating a cone of protective carbon dioxide gas enshrouding the sparks from an ESU pencil effectively prevents fire in a high-flammability model. Clinical application of this device may reduce the incidence of operating room fires.

P and n-type microcrystalline semiconductor alloy material including band gap widening elements, devices utilizing same

DOEpatents

Guha, Subhendu; Ovshinsky, Stanford R.

1988-10-04

An n-type microcrystalline semiconductor alloy material including a band gap widening element; a method of fabricating p-type microcrystalline semiconductor alloy material including a band gap widening element; and electronic and photovoltaic devices incorporating said n-type and p-type materials.

33 CFR 159.95 - Safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety. 159.95 Section 159.95... SANITATION DEVICES Design, Construction, and Testing § 159.95 Safety. (a) Each device must— (1) Be free of... explosion or over pressurization as a result of an accumulation of gases; and (3) Meet all other safety...

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

PubMed

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

30 CFR 56.14100 - Safety defects; examination, correction and records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... MINES Machinery and Equipment Safety Devices and Maintenance Requirements § 56.14100 Safety defects; examination, correction and records. (a) Self-propelled mobile equipment to be used during a shift shall be... defective items including self-propelled mobile equipment shall be taken out of service and placed in a...

Organizational Culture and Safety

NASA Technical Reports Server (NTRS)

Adams, Catherine A.

2003-01-01

'..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

75 FR 4583 - In the Matter of: Certain Electronic Devices, Including Mobile Phones, Portable Music Players...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

..., Including Mobile Phones, Portable Music Players, and Computers; Notice of Investigation AGENCY: U.S... music players, and computers, by reason of infringement of certain claims of U.S. Patent Nos. 6,714,091... importation of certain electronic devices, including mobile phones, portable music players, or computers that...

Counterfeit esthetic devices and patient safety in dermatology.

PubMed

Wang, Jordan V; Zachary, Christopher B; Saedi, Nazanin

2018-06-01

This study addresses the dilemma concerned with meeting patients who may have encountered counterfeit esthetic devices in the marketplace. Over the past several years, we have witnessed a rise in counterfeit injectables and medical devices in our field. Often times, the procedures are marketed to patients at significantly reduced prices compared to competitors. Patients may be unaware that counterfeit devices exist and may unknowingly have procedures completed using untested and uncertified devices. It is important for clinicians to recognize when their patients may be encountering counterfeit devices, know what to do in this situation, and offer the best recommendations. © 2018 Wiley Periodicals, Inc.

Magnetic Resonance Safety

PubMed Central

Sammet, Steffen

2016-01-01

Magnetic Resonance Imaging (MRI) has a superior soft-tissue contrast compared to other radiological imaging modalities and its physiological and functional applications have led to a significant increase in MRI scans worldwide. A comprehensive MRI safety training to protect patients and other healthcare workers from potential bio-effects and risks of the magnetic fields in an MRI suite is therefore essential. The knowledge of the purpose of safety zones in an MRI suite as well as MRI appropriateness criteria is important for all healthcare professionals who will work in the MRI environment or refer patients for MRI scans. The purpose of this article is to give an overview of current magnetic resonance safety guidelines and discuss the safety risks of magnetic fields in an MRI suite including forces and torque of ferromagnetic objects, tissue heating, peripheral nerve stimulation and hearing damages. MRI safety and compatibility of implanted devices, MRI scans during pregnancy and the potential risks of MRI contrast agents will also be discussed and a comprehensive MRI safety training to avoid fatal accidents in an MRI suite will be presented. PMID:26940331

Extraglottic airway devices: technology update.

PubMed

Sharma, Bimla; Sahai, Chand; Sood, Jayashree

2017-01-01

Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS) formed the Airway Device Evaluation Project Team (ADEPT) to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues.

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... chains or cables are used as the safety device for that vehicle, at least two safety chains or cables... safety chains or cables are used as the safety device, the required strength shall be the combined strength of the combination of chains and cables. (ii) If chains or cables are used as the safety device...

49 CFR 393.71 - Coupling devices and towing methods, driveaway-towaway operations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... chains or cables are used as the safety device for that vehicle, at least two safety chains or cables... safety chains or cables are used as the safety device, the required strength shall be the combined strength of the combination of chains and cables. (ii) If chains or cables are used as the safety device...

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

Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

PubMed

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this 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 respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

78 FR 63492 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-847] Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is...

Model-based engineering for medical-device software.

PubMed

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

Tornadoes: Nature's Most Violent Storms. A Preparedness Guide Including Safety Information for Schools.

ERIC Educational Resources Information Center

American National Red Cross, Washington, DC.

This preparedness guide explains and describes tornadoes, and includes safety information for schools. A tornado is defined as a violently rotating column of air extending from a thunderstorm to the ground. The guide explains the cause of tornadoes, provides diagrams of how they form, describes variations of tornadoes, and classifies tornadoes by…

Study of magnetic nanoparticles and overcoatings for biological applications including a sensor device

NASA Astrophysics Data System (ADS)

Grancharov, Stephanie G.

I. A general introduction to the field of nanomaterials is presented, highlighting their special attributes and characteristics. Nanoparticles in general are discussed with respect to their structure, form and properties. Magnetic particles in particular are highlighted, especially the iron oxides. The importance and interest of integrating these materials with biological media is discussed, with emphasis on transferring particles from one medium to another, and subsequent modification of surfaces with different types of materials. II. A general route to making magnetic iron oxide nanoparticles is explained, both as maghemite and magnetite, including properties of the particles and characterization. A novel method of producing magnetite particles without a ligand is then presented, with subsequent characterization and properties described. III. Attempts to coat iron oxide nanoparticles with a view to creating biofunctional magnetic nanoparticles are presented, using a gold overcoating method. Methods of synthesis and characterization are examined, with unique problems to core-shell structures analyzed. IV. Solubility of nanoparticles in both aqueous and organic media is discussed and examined. The subsequent functionalization of the surface of maghemite and magnetite nanoparticles with a variety of biomaterials including block copolypeptides, phospholipids and carboxydextran is then presented. These methods are integral to the use of magnetic nanoparticles in biological applications, and therefore their properties are examined once tailored with these molecules. V. A new type of magnetic nanoparticle sensor-type device is described. This device integrates bio-and DNA-functionalized nanoparticles with conjugate functionalized silicon dioxide surfaces. These techniques to pattern particles to a surface are then incorporated into a device with a magnetic tunnel junction, which measures magnetoresistance in the presence of an external magnetic field. This configuration

Energy star compliant voice over internet protocol (VoIP) telecommunications network including energy star compliant VoIP devices

DOEpatents

Kouchri, Farrokh Mohammadzadeh

2012-11-06

A Voice over Internet Protocol (VoIP) communications system, a method of managing a communications network in such a system and a program product therefore. The system/network includes an ENERGY STAR (E-star) aware softswitch and E-star compliant communications devices at system endpoints. The E-star aware softswitch allows E-star compliant communications devices to enter and remain in power saving mode. The E-star aware softswitch spools messages and forwards only selected messages (e.g., calls) to the devices in power saving mode. When the E-star compliant communications devices exit power saving mode, the E-star aware softswitch forwards spooled messages.

Introduction to FPGA Devices and The Challenges for Critical Application - A User's Perspective

NASA Technical Reports Server (NTRS)

Berg, Melanie; LaBel, Kenneth

2015-01-01

This presentation is an introduction to Field Programmable Gate Array (FPGA) devices and the challenges of critical application including: safety, reliability, availability, recoverability, and security.

Thermodynamic Analysis of TEG-TEC Device Including Influence of Thomson Effect

NASA Astrophysics Data System (ADS)

Feng, Yuanli; Chen, Lingen; Meng, Fankai; Sun, Fengrui

2018-01-01

A thermodynamic model of a thermoelectric cooler driven by thermoelectric generator (TEG-TEC) device is established considering Thomson effect. The performance is analyzed and optimized using numerical calculation based on non-equilibrium thermodynamic theory. The influence characteristics of Thomson effect on the optimal performance and variable selection are investigated by comparing the condition with and without Thomson effect. The results show that Thomson effect degrades the performance of TEG-TEC device, it decreases the cooling capacity by 27 %, decreases the coefficient of performance (COP) by 19 %, decreases the maximum cooling temperature difference by 11 % when the ratio of thermoelectric elements number is 0.6, the cold junction temperature of thermoelectric cooler (TEC) is 285 K and the hot junction temperature of thermoelectric generator (TEG) is 450 K. Thomson effect degrades the optimal performance of TEG-TEC device, it decreases the maximum cooling capacity by 28 % and decreases the maximum COP by 28 % under the same junction temperatures. Thomson effect narrows the optimal variable range and optimal working range. In the design of the devices, limited-number thermoelectric elements should be more allocated appropriately to TEG when consider Thomson effect. The results may provide some guidelines for the design of TEG-TEC devices.

The effects, safety and acceptability of compact, pre-filled, autodisable injection devices when delivered by lay health workers.

PubMed

Glenton, Claire; Khanna, Rajesh; Morgan, Chris; Nilsen, Elin Strømme

2013-08-01

To systematically assess (i) the effects and safety and (ii) the acceptability of using lay health workers (LHWs) to deliver vaccines and medicines to mothers and children through compact pre-filled autodisable devices (CPADs). We searched electronic databases and grey literature. For the systematic review of effects and safety, we sought randomised and non-randomised controlled trials, controlled before-after studies and interrupted time series studies. For the systematic review of acceptability, we sought qualitative studies. Two researchers independently carried out data extraction, study quality assessment and thematic analysis of the qualitative data. No studies met our criteria for the review exploring the effects and safety of using LHWs to deliver CPADs. For the acceptability review, six qualitative studies assessed the acceptability of using LHWs to deliver hepatitis B vaccine, tetanus toxoid vaccine, gentamicin or oxytocin using Uniject™ devices. All studies took place in low- or middle-income countries and explored the perceptions of community members, LHWs, supervisors, health professionals or programme managers. Most of the studies were of low quality. Recipients generally accepted the intervention. Most health professionals were confident that LHWs could deliver the intervention with sufficient training and supervision, but some had problems delivering supervision. The LHWs perceived Uniject™ as effective and important and were motivated by positive responses from the community. However, some LHWs feared the consequences if harm should come to recipients. Evidence of the effects and safety of using CPADs delivered by LHWs is lacking. Evidence regarding acceptability suggests that this intervention may be acceptable although LHWs may feel vulnerable to blame. © 2013 John Wiley & Sons Ltd.

Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices.

PubMed

Sezdi, Mana

2016-01-01

A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices.

Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices

PubMed Central

Sezdi, Mana

2016-01-01

A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices. PMID:27195666

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

PubMed

Waldman, Abigail; Bolotin, Diana; Arndt, Kenneth A; Dover, Jeffrey S; Geronemus, Roy G; Chapas, Anne; Iyengar, Sanjana; Kilmer, Suzanne L; Krakowski, Andrew C; Lawrence, Naomi; Prather, Heidi B; Rohrer, Thomas E; Schlosser, Bethanee J; Kim, John Y S; Shumaker, Peter R; Spring, Leah K; Alam, Murad

2017-10-01

Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

33 CFR 165.930 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety Zone, Brandon Road Lock... Guard District § 165.930 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY REGULATED NAVIGATION...

34 CFR 668.49 - Institutional fire safety policies and fire statistics.

Code of Federal Regulations, 2011 CFR

2011-07-01

... fire. Fire safety system: Any mechanism or system related to the detection of a fire, the warning resulting from a fire, or the control of a fire. This may include sprinkler systems or other fire extinguishing systems, fire detection devices, stand-alone smoke alarms, devices that alert one to the presence...

34 CFR 668.49 - Institutional fire safety policies and fire statistics.

Code of Federal Regulations, 2012 CFR

2012-07-01

... fire. Fire safety system: Any mechanism or system related to the detection of a fire, the warning resulting from a fire, or the control of a fire. This may include sprinkler systems or other fire extinguishing systems, fire detection devices, stand-alone smoke alarms, devices that alert one to the presence...

34 CFR 668.49 - Institutional fire safety policies and fire statistics.

Code of Federal Regulations, 2014 CFR

2014-07-01

... fire. Fire safety system: Any mechanism or system related to the detection of a fire, the warning resulting from a fire, or the control of a fire. This may include sprinkler systems or other fire extinguishing systems, fire detection devices, stand-alone smoke alarms, devices that alert one to the presence...

34 CFR 668.49 - Institutional fire safety policies and fire statistics.

Code of Federal Regulations, 2013 CFR

2013-07-01

... fire. Fire safety system: Any mechanism or system related to the detection of a fire, the warning resulting from a fire, or the control of a fire. This may include sprinkler systems or other fire extinguishing systems, fire detection devices, stand-alone smoke alarms, devices that alert one to the presence...

Recommended safety guides for industrial laboratories and shops

NASA Technical Reports Server (NTRS)

Allison, W. W.

1971-01-01

Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

33 CFR 159.97 - Safety: inspected vessels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety: inspected vessels. 159.97...) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.97 Safety: inspected vessels. The Commanding Officer, USCG Marine Safety Center, approves the design and construction of devices to...

Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.

PubMed

Gold, Michael H; Biron, Julie; Levi, Liora; Sensing, Whitney

2017-03-01

The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation. This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance. Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end. Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P < 0.001). Analysis revealed improvement (downgrade of at least 1 score) in almost all subjects. No unexpected adverse events were reported. Post-treatment erythema was seen in all subjects and disappeared within 1 h. In some subjects, post-treatment edema was detected and resolved within 24 h. High satisfaction with the device operation, ease of treatments, safety, and wrinkle reduction was reported. The Silk'n Home Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles. © 2016 Wiley Periodicals, Inc.

Lithium Ion Battery Design and Safety

NASA Technical Reports Server (NTRS)

Au, George; Locke, Laura

2001-01-01

This viewgraph presentation makes several recommendations to ensure the safe and effective design of Lithium ion cell batteries. Large lithium ion cells require pressure switches and small cells require pressure disconnects and other safety devices with the ability to instantly interrupt flow. Other suggestions include specifications for batteries and battery chargers.

Safety assessment of modified terephthalate polymers as used in cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

Protection and Safety.

ERIC Educational Resources Information Center

American School Board Journal, 1964

1964-01-01

Several aspects of school safety and protection are presented for school administrators and architects. Among those topics discussed are--(1) life safety, (2) vandalism controlled through proper design, (3) personal protective devices, and (4) fire alarm systems. Another critical factor in providing a complete school safety program is proper…

Fast-acting nuclear reactor control device

DOEpatents

Kotlyar, Oleg M.; West, Phillip B.

1993-01-01

A fast-acting nuclear reactor control device for moving and positioning a fety control rod to desired positions within the core of the reactor between a run position in which the safety control rod is outside the reactor core, and a shutdown position in which the rod is fully inserted in the reactor core. The device employs a hydraulic pump/motor, an electric gear motor, and solenoid valve to drive the safety control rod into the reactor core through the entire stroke of the safety control rod. An overrunning clutch allows the safety control rod to freely travel toward a safe position in the event of a partial drive system failure.

33 CFR 159.95 - Safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety. 159.95 Section 159.95 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.95 Safety. (a) Each device must— (1) Be free of...

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...

Electrical safety for high voltage arrays

NASA Technical Reports Server (NTRS)

Marshall, N. A.

1983-01-01

A number of key electrical safety requirements for the high voltage arrays of central station photovoltaic power systems are explored. The suitability of representative industrial DC power switchgear for control and fault protection was evaluated. Included were AC/DC circuit breakers, electromechanical contactors and relays, load interruptors, cold disconnect devices, sectionalizing switches, and high voltage DC fuses. As appropriate, steady state and transient characteristics were analyzed. Failure modes impacting upon operation and maintenance safety were also identified, as were the voltage withstand and current interruption levels.

77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

[Industry regulation and its relationship to the rapid marketing of medical devices].

PubMed

Matsuoka, Atsuko

2012-01-01

In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

NASA Technical Reports Server (NTRS)

1972-01-01

Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

76 FR 41522 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-771] In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components... certain mobile phones, mobile tablets, portable music players, and computers. 76 FR 24051 (Apr. 29, 2011...

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy.

PubMed

Steinhaus, Daniel A; Waks, Jonathan W; Collins, Robert; Kleckner, Karen; Kramer, Daniel B; Zimetbaum, Peter J

2015-07-01

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of <0.5 V in 77% of patients and <1 V in 95%. Device longevity analysis showed that the use of a 0.5-V safety margin increased average battery longevity by 0.62 years (95% confidence interval 0.61 to 0.63) compared with a safety margin of 1.5 V. Patients with LV PCTs >1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. Copyright © 2015 Elsevier Inc. All rights reserved.

Medina® Embolization Device for the Treatment of Intracranial Aneurysms: Safety and Angiographic Effectiveness at 6 Months.

PubMed

Sourour, Nader-Antoine; Vande Perre, Saskia; Maria, Federico Di; Papagiannaki, Chrysanthi; Gabrieli, Joseph; Pistocchi, Silvia; Bartolini, Bruno; Degos, Vincent; Carpentier, Alexandre; Chiras, Jacques; Clarençon, Frédéric

2018-02-01

The Medina Embolization Device (MED) is a new concept device that combines the design of a detachable coil and the one of an intrasaccular flow disruption device. To evaluate the feasibility, safety, and 6- to 9-mo effectiveness of this new device for the treatment of intracranial wide-necked aneurysms. Twelve patients (10 females, mean age = 56 yr) with 13 wide-necked intracranial aneurysms (3 ruptured; 10 unruptured) were treated by means of the MED from January 2015 to October 2015. In 15% of the cases, MEDs were used in a standalone fashion; in 85% of the cases, additional regular coils were used. Adjunctive compliant balloon was used in 4 of 13 cases (31%). Procedure-related complications were systematically recorded; discharge and 6- to 9-mo follow-up modified Rankin Scale was assessed. Angiographic follow-up was performed with a mean delay of 5.5 ± 1.7 mo. Occlusion rate was evaluated in postprocedure and at midterm follow-up using the Roy-Raymond scale. The deployment of the MED was feasible in all cases. No perforation was recorded. One case of thromboembolic complication was observed in a ruptured anterior communicating artery aneurysm, without any clinical consequence at follow-up. Grade A occlusion rate was 61.5% in postprocedure and 83% at 6-mo follow-up. Two cases (17%) of recanalization were documented angiographically. The MED is a new generation device combining the design of a detachable coil and an intrasaccular flow disruption device. According to our early experience, this device is safe and provides a satisfactory occlusion rate at angiographic follow-up of 6 mo. Copyright © 2017 by the Congress of Neurological Surgeons

Evolution and update on current devices for prosthetic breast reconstruction

PubMed Central

2015-01-01

Over the past decade, the leading breast reconstruction modality has shifted from autologous tissue to implants. This trend reversal is multi-factorial but includes increasing bilateral mastectomies and the more widespread acceptance of implants due to stringent quality and safety regulatory surveillance by the US Food and Drug Administration (FDA). Since 2012, the US FDA has approved several new implant styles, shapes and textures, increasing the choices for patients and surgeons. Predictable, superior aesthetic results after prosthetic breast reconstruction are attainable, but require thoughtful planning, precise surgical technique and appropriate device selection based on several different patient and surgeon parameters, such as patient desires, body mass index, breast shape, mastectomy flap quality and tissue based bio-dimensional assessment. This article briefly reviews historic devices used in prosthetic breast reconstruction beginning in the 1960s through the modern generation devices used today. We reflect on the rigorous hurdles endured over the last several decades leading to the approval of silicone gel devices, along with their well-established safety and efficacy. The various implant characteristics can affect feel and performance of the device. The many different styles and features of implants and expanders are described emphasizing surgical indications, advantages and disadvantages of each device. PMID:26005642

75 FR 17511 - Coal Mine Dust Sampling Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Part III Department of Labor Mine Safety and Health Adminisration 30 CFR Parts 18, 74, and 75 Coal Mine Dust Sampling Devices; High-Voltage Continuous Mining Machine Standard for Underground Coal Mines...-AB61 Coal Mine Dust Sampling Devices AGENCY: Mine Safety and Health Administration, Labor. ACTION...

The strain capacitor: A novel energy storage device

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

Deb Shuvra, Pranoy; McNamara, Shamus, E-mail: shamus.mcnamara@louisville.edu

2014-12-15

A novel electromechanical energy storage device is reported that has the potential to have high energy densities. It can efficiently store both mechanical strain energy and electrical energy in the form of an electric field between the electrodes of a strain-mismatched bilayer capacitor. When the charged device is discharged, both the electrical and mechanical energy are extracted in an electrical form. The charge-voltage profile of the device is suitable for energy storage applications since a larger portion of the stored energy can be extracted at higher voltage levels compared to a normal capacitor. Its unique features include the potential formore » long lifetime, safety, portability, wide operating temperature range, and environment friendliness. The device can be designed to operate over varied operating voltage ranges by selecting appropriate materials and by changing the dimensions of the device. In this paper a finite element model of the device is developed to verify and demonstrate the potential of the device as an energy storage element. This device has the potential to replace conventional energy storage devices.« less

78 FR 40171 - Certain Wireless Devices, Including Mobile Phones and Tablets; Notice Of Receipt of Complaint...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

... INTERNATIONAL TRADE COMMISSION [Docket No. 2964] Certain Wireless Devices, Including Mobile Phones... Phones and Tablets, DN 2964; the Commission is soliciting comments on any public interest issues raised... mobile phones and tablets. The complaint names as respondents Pantech Co., Ltd. of South Korea and...

Regulatory science based approach in development of novel medical devices.

PubMed

Sakuma, Ichiro

2015-08-01

For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

Fundamental Use of Surgical Energy (FUSE): An Essential Educational Program for Operating Room Safety

PubMed Central

Jones, Stephanie B; Munro, Malcolm G; Feldman, Liane S; Robinson, Thomas N; Brunt, L Michael; Schwaitzberg, Steven D; Jones, Daniel B; Fuchshuber, Pascal R

2017-01-01

Operating room (OR) safety has become a major concern in patient safety since the 1990s. Improvement of team communication and behavior is a popular target for safety programming at the institutional level. Despite these efforts, essential safety gaps remain in the OR and procedure rooms. A prime example is the use of energy-based devices in ORs and procedural areas. The lack of fundamental understanding of energy device function, design, and application contributes to avoidable injury and harm at a rate of approximately 1 to 2 per 1000 patients in the US. Hundreds of OR fires occur each year in the US, some causing severe injury and even death. Most of these fires are associated with the use of energy-based surgical devices. In response to this safety issue, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed the Fundamental Use of Surgical Energy (FUSE) program. This program includes a standardized curriculum targeted to surgeons, other physicians, and allied health care professionals and a psychometrically designed and validated certification test. A successful FUSE certification documents acquisition of the basic knowledge needed to safely use energy-based devices in the OR. By design FUSE fills a void in the curriculum and competency assessment for surgeons and other procedural specialists in the use of energy-based devices in patients. PMID:28241913

Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

PubMed

Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

2017-12-15

Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

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.

A Detection Device for the Signs of Human Life in Accident

NASA Astrophysics Data System (ADS)

Ning, Li; Ruilan, Zhang; Jian, Liu; Ruirui, Cheng; Yuhong, Diao

2017-12-01

A detection device for the signs of human life in accidents is a device used in emergency situations, such as the crash site. the scene of natural disasters, the battlefield ruins. it designed to detect the life signs of the distress under the injured ambulance vital signs devices. The device can on human vital signs, including pulse, respiration physiological signals to make rapid and accurate response. After some calculations, and after contrast to normal human physiological parameters given warning signals, in order for them to make timely ambulance judgment. In this case the device is required to do gymnastics convenience, ease of movement, power and detection of small flexible easy realization. This device has the maximum protection of the wounded safety significance.

Do Undergraduate Engineering Faculty Include Occupational and Public Health and Safety in the Engineering Curriculum?

ERIC Educational Resources Information Center

Farwell, Dianna; And Others

1995-01-01

The purpose of this study was to determine whether and, if so, why engineering faculty include occupational and public health and safety in their undergraduate engineering courses. Data were collected from 157 undergraduate engineering faculty from 65 colleges of engineering in the United States. (LZ)

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Safety and Efficacy of Microinvasive Glaucoma Surgery

PubMed Central

Chen, David Z.

2017-01-01

Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations. PMID:28512578

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

30 CFR 57.9311 - Anchoring stationary sizing devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Loading, Hauling, and Dumping Safety Devices, Provisions, and Procedures for Roadways, Railroads, and Loading and...

A UK medical devices regulator's perspective on registries.

PubMed

Wilkinson, John; Crosbie, Andy

2016-04-01

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

Eat-by-light fiber-optic and micro-optic devices for food quality and safety assessment

NASA Astrophysics Data System (ADS)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Grimaldi, M. F.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-06-01

A selection is presented of fiber-optic and micro-optic devices that have been designed and tested for guaranteeing the quality and safety of typical foods, such as extra virgin olive oil, beer, and milk. Scattered colorimetry is used to authenticate various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids, which are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma that is capable of distinguishing different ageing levels of extra virgin olive oil is also presented. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer for the rapid monitoring of the carcinogenic M1 aflatoxin in milk, is experimented.

Eat-by-light: fiber-optic and micro-optic devices for food safety and quality assessment

NASA Astrophysics Data System (ADS)

Mignani, A. G.; Ciaccheri, L.; Cucci, C.; Mencaglia, A. A.; Cimato, A.; Attilio, C.; Thienpont, H.; Ottevaere, H.; Paolesse, R.; Mastroianni, M.; Monti, D.; Buonocore, G.; Del Nobile, A.; Mentana, A.; Dall'Asta, C.; Faccini, A.; Galaverna, G.; Dossena, A.

2007-07-01

A selection of fiber-optic and micro-optic devices is presented designed and tested for monitoring the quality and safety of typical foods, namely the extra virgin olive oil, the beer, and the milk. Scattered colorimetry is used for the authentication of various types of extra virgin olive oil and beer, while a fiber-optic-based device for UV-VIS-NIR absorption spectroscopy is exploited in order to obtain the hyperspectral optical signature of olive oil. This is done not only for authentication purposes, but also so as to correlate the spectral data with the content of fatty acids that are important nutritional factors. A micro-optic sensor for the detection of olive oil aroma is presented. It is capable of distinguishing different ageing levels of extra virgin olive oil. It shows effective potential for acting as a smart cap of bottled olive oil in order to achieve a non-destructive olfactory perception of oil ageing. Lastly, a compact portable fluorometer is experimented for the rapid monitoring of the carcinogenic M1 aflatoxin in milk.

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2012 CFR

2012-01-01

... pertinent to an evaluation of its radiation safety, including: (i) The byproduct material contained, its... maintain its integrity under stresses likely to be encountered in normal use and accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v) Details of quality...

10 CFR 32.74 - Manufacture and distribution of sources or devices containing byproduct material for medical use.

Code of Federal Regulations, 2011 CFR

2011-01-01

... pertinent to an evaluation of its radiation safety, including: (i) The byproduct material contained, its... maintain its integrity under stresses likely to be encountered in normal use and accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v) Details of quality...

Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.

PubMed

Chatterjee, Saurav; Herrmann, Howard C; Wilensky, Robert L; Hirshfeld, John; McCormick, Daniel; Frankel, David S; Yeh, Robert W; Armstrong, Ehrin J; Kumbhani, Dharam J; Giri, Jay

2015-07-01

The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. Procedural adverse events and procedural success. In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA

A Smartphone-Based Driver Safety Monitoring System Using Data Fusion

PubMed Central

Lee, Boon-Giin; Chung, Wan-Young

2012-01-01

This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416

Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

PubMed

2017-12-20

The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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

Maintaining ocular safety with light exposure, focusing on devices for optogenetic stimulation

PubMed Central

Yan, Boyuan; Vakulenko, Maksim; Min, Seok-Hong; Hauswirth, William W.; Nirenberg, Sheila

2016-01-01

Optogenetics methods are rapidly being developed as therapeutic tools for treating neurological diseases, in particular, retinal degenerative diseases. A critical component of the development is testing the safety of the light stimulation used to activate the optogenetic proteins. While the stimulation needs to be sufficient to produce neural responses in the targeted retinal cell class, it also needs to be below photochemical and photothermal limits known to cause ocular damage. The maximal permissible exposure is determined by a variety of factors, including wavelength, exposure duration, visual angle, pupil size, pulse width, pulse pattern, and repetition frequency. In this paper, we develop utilities to systematically and efficiently assess the contributions of these parameters in relation to the limits, following directly from the 2014 American National Standards Institute (ANSI). We also provide an array of stimulus protocols that fall within the bounds of both safety and effectiveness. Additional verification of safety is provided with a case study in rats using one of these protocols. PMID:26882975

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

29 CFR 1926.1415 - Safety devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Cranes and Derricks in Construction § 1926.1415... this subpart, unless otherwise specified: (1) Crane level indicator. (i) The equipment must have a crane level indicator that is either built into the equipment or is available on the equipment. (ii) If...

Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement.

PubMed

Zanon, Francesco; Martignani, Cristian; Ammendola, Ernesto; Menardi, Endrj; Narducci, Maria Lucia; DE Filippo, Paolo; Santamaria, Matteo; Campana, Andrea; Stabile, Giuseppe; Potenza, Domenico Rosario; Pastore, Gianni; Iori, Matteo; LA Rosa, Concetto; Biffi, Mauro

2016-07-01

The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life. Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons). Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers. © The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.

Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review.

PubMed

Batty, Lachlan M; Norsworthy, Cameron J; Lash, Nicholas J; Wasiak, Jason; Richmond, Anneka K; Feller, Julian A

2015-05-01

The role of synthetic devices in the management of the cruciate ligament-injured knee remains controversial. The aim of this systematic review was to assess the safety and efficacy of synthetic devices in cruciate ligament surgery. A systematic review of the electronic databases Medline, Embase, and The Cochrane Library (issue 1, 2014) on January 13, 2014, was performed to identify controlled and uncontrolled trials. Trials that assessed the safety and efficacy of synthetic devices for cruciate ligament surgery were included. The main variables assessed included rates of failure, revision, and noninfective effusion and synovitis. Patient-reported outcome assessments and complications were also assessed where reported. From 511 records screened, we included 85 articles published between 1985 and 2013 reporting on 6 synthetic devices (ligament augmentation and reconstruction system [Ligament Augmentation and Reconstruction System (LARS; Surgical Implants and Devices, Arc-sur-Tille, France)]; Leeds-Keio [Xiros (formerly Neoligaments), Leeds, England]; Kennedy ligament augmentation device [3M, St Paul, MN]; Dacron [Stryker, Kalamazoo, MI]; Gore-Tex [W.L. Gore and Associates, Flagstaff, AZ]; and Trevira [Telos (limited liability company), Marburg, Germany]). The heterogeneity of the included studies precluded meta-analysis. The results were analyzed by device and then type of reconstruction (anterior cruciate ligament [ACL]/posterior cruciate ligament [PCL]/combined ACL and PCL). The lowest cumulative rates of failure were seen with the LARS device (2.6% for ACL and 1% for PCL surgery). The highest failure rate was seen in the Dacron ACL group (cumulative rate, 33.6%). Rates of noninfective synovitis and effusion ranged from 0.2% in the LARS ACL group to 27.6% in the Gore-Tex ACL group. Revision rates ranged from 2.6% (LARS) to 11.8% (Trevira-Hochfest; Telos). Recent designs, specifically the LARS, showed good improvement in the outcome scores. The mean preoperative and

76 FR 40930 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-701] In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and Computers; Notice of Commission... music players, and computers by reason of infringement of various claims of United States Patent Nos. 6...

30 CFR 56.14208 - Warning devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Warning devices. 56.14208 Section 56.14208... Safety Practices and Operational Procedures § 56.14208 Warning devices. (a) Visible warning devices shall... feet beyond the rear of the equipment shall have a warning flag at the end of the projection. Under...

30 CFR 56.14208 - Warning devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Warning devices. 56.14208 Section 56.14208... Safety Practices and Operational Procedures § 56.14208 Warning devices. (a) Visible warning devices shall... feet beyond the rear of the equipment shall have a warning flag at the end of the projection. Under...

30 CFR 56.14208 - Warning devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Warning devices. 56.14208 Section 56.14208... Safety Practices and Operational Procedures § 56.14208 Warning devices. (a) Visible warning devices shall... feet beyond the rear of the equipment shall have a warning flag at the end of the projection. Under...

30 CFR 56.14208 - Warning devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Warning devices. 56.14208 Section 56.14208... Safety Practices and Operational Procedures § 56.14208 Warning devices. (a) Visible warning devices shall... feet beyond the rear of the equipment shall have a warning flag at the end of the projection. Under...

30 CFR 56.14208 - Warning devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Warning devices. 56.14208 Section 56.14208... Safety Practices and Operational Procedures § 56.14208 Warning devices. (a) Visible warning devices shall... feet beyond the rear of the equipment shall have a warning flag at the end of the projection. Under...

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

PubMed

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

PubMed

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Connected commercial vehicles — retrofit safety device kit project : safety applications and development plan.

DOT National Transportation Integrated Search

2014-03-01

Connected vehicle wireless data communications can enable safety applications that may reduce injuries and fatalities. Cooperative vehicle-to-vehicle (V2V) safety applications will be effective only if a high fraction of vehicles are equipped. Deploy...

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration.

PubMed

Dodd, Erin M; Winter, Margo A; Hordinsky, Maria K; Sadick, Neil S; Farah, Ronda S

2018-06-01

The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium. AGA, androgenetic alopecia; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; LED, light-emitting diode; PBMT, photobiomodulation therapy.

Promoting child passenger safety in children served by a health maintenance organization.

PubMed

Chang, A; Hearey, C D; Gallagher, K D; English, P; Chang, P C

1989-06-01

A patient education program, based on the health belief model, promoting child passenger safety was developed and implemented at a health maintenance organization. The program included individual counseling by pediatricians, use of audiovisual materials and pamphlets, and (for newborn infants) a home visit by a child safety specialist. Based on parking lot observations, child safety device use increased to greater than 60% in both intervention and comparison-group children 1-4 years of age. During the child health supervision visit, pediatricians can play a leadership role in promoting child passenger safety.

Effectiveness of Direct Safety Regulations on Manufacturers and Users of Industrial Machines: Its Implications on Industrial Safety Policies in Republic of Korea.

PubMed

Choi, Gi Heung

2017-03-01

Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

PubMed

Reddy, Viraj K; Lavoie, Marie-Claude; Verbeek, Jos H; Pahwa, Manisha

2017-11-14

Percutaneous exposure injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood borne infections such as hepatitis B and C, and human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness. To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions. We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until 11 November 2016). We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs of the effect of safety engineered medical devices on percutaneous exposure injuries in healthcare staff. Two of the authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a fixed-effect or random-effects model meta-analysis where appropriate. We included six RCTs with 1838 participants, two cluster-RCTs with 795 participants and 73,454 patient days, five CBAs with approximately 22,000 participants and eleven ITS with an average of 13.8 data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices, sharps containers and legislation on the implementation of safe devices. We estimated the needlestick injury (NSI) rate in the control groups to be about one to five NSIs per 1000 person-years. There were only two studies from low- or middle-income countries. The risk of bias was high in 20 of 24 studies. Safe blood collection systems:We found one RCT that found a safety engineered blood gas syringe having no considerable effect on NSIs (Relative Risk (RR) 0.2, 95

78 FR 36091 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Unified theory for inhomogeneous thermoelectric generators and coolers including multistage devices.

PubMed

Gerstenmaier, York Christian; Wachutka, Gerhard

2012-11-01

A novel generalized Lagrange multiplier method for functional optimization with inclusion of subsidiary conditions is presented and applied to the optimization of material distributions in thermoelectric converters. Multistaged devices are considered within the same formalism by inclusion of position-dependent electric current in the legs leading to a modified thermoelectric equation. Previous analytical solutions for maximized efficiencies for generators and coolers obtained by Sherman [J. Appl. Phys. 31, 1 (1960)], Snyder [Phys. Rev. B 86, 045202 (2012)], and Seifert et al. [Phys. Status Solidi A 207, 760 (2010)] by a method of local optimization of reduced efficiencies are recovered by independent proof. The outstanding maximization problems for generated electric power and cooling power can be solved swiftly numerically by solution of a differential equation-system obtained within the new formalism. As far as suitable materials are available, the inhomogeneous TE converters can have increased performance by use of purely temperature-dependent material properties in the thermoelectric legs or by use of purely spatial variation of material properties or by a combination of both. It turns out that the optimization domain is larger for the second kind of device which can, thus, outperform the first kind of device.

Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

PubMed

2004-03-16

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

76 FR 72888 - Federal Motor Vehicle Safety Standards; Small Business Impacts of Motor Vehicle Safety

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... pedestrian safety devices. 571.217 Bus emergency exits and window retention and release. 571.220 School bus... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2011-0160] Federal Motor Vehicle Safety Standards; Small Business Impacts of Motor...

Guideline Implementation: Energy-Generating Devices, Part 2-Lasers.

PubMed

Burlingame, Byron L

2017-04-01

Lasers have been used in the OR for many years and are essential tools in many different types of procedures. However, laser beams that come into contact with unintended targets directly or via reflection can cause injury to patients or personnel or pose other hazards, such as fires. The new AORN "Guideline for safe use of energy-generating devices" provides guidance on the use of all energy-generating devices in the OR. This article focuses on key points of the guideline that address the safe use of lasers. These include the components of the laser safety program, the responsibilities of the personnel in roles specific to use of a laser, laser safety measures, and documentation of laser use. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

76 FR 13432 - In the Matter of Certain Display Devices, Including Digital Televisions and Monitors II; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-765] In the Matter of Certain Display Devices, Including Digital Televisions and Monitors II; Notice of Investigation AGENCY: U.S. International Trade... that a complaint was filed with the U.S. International Trade Commission on February 9, 2011, under...

30 CFR 75.1107 - Fire suppression devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Provisions] On and after March 30, 1971, fire-suppression devices meeting specifications prescribed by the... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Fire suppression devices. 75.1107 Section 75... HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107 - Fire suppression devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Provisions] On and after March 30, 1971, fire-suppression devices meeting specifications prescribed by the... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Fire suppression devices. 75.1107 Section 75... HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107 - Fire suppression devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Provisions] On and after March 30, 1971, fire-suppression devices meeting specifications prescribed by the... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Fire suppression devices. 75.1107 Section 75... HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107 - Fire suppression devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Provisions] On and after March 30, 1971, fire-suppression devices meeting specifications prescribed by the... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Fire suppression devices. 75.1107 Section 75... HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107 - Fire suppression devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Provisions] On and after March 30, 1971, fire-suppression devices meeting specifications prescribed by the... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Fire suppression devices. 75.1107 Section 75... HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

76 FR 2829 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

77 FR 20295 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

77 FR 35854 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 52462 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

75 FR 73966 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including Des Plaines...

Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.

PubMed

Ross, Sue; Robert, Magali; Harvey, Marie-Andrée; Farrell, Scott; Schulz, Jane; Wilkie, David; Lovatsis, Danny; Epp, Annette; Easton, Bill; McMillan, Barry; Schachter, Joyce; Gupta, Chander; Weijer, Charles

2008-06-01

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health

Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

PubMed

Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

2017-12-01

To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged <16 years with uncontrolled intraocular pressure (IOP) refractory to medical treatment and considered at high risk of failure following trabeculectomy were recruited. Eligible children were implanted with the AADI. Those completing minimum 6-month follow-up were included. Main outcome measures were IOP reduction from preoperative values and postoperative complications. 34 eyes of 31 patients were analysed. Average follow-up was 18.3±6.9 months. Mean IOP reduced from 27.4±7.5 mm Hg on maximum medication to 14.6±10.74 mm Hg, 13.8±7.5 mm Hg, 12.8±5.6 mm Hg and 14.7±5.8 mm Hg at 1 week, 6 months, 1 year (32 eyes of 29 children) and 2 years (25 eyes of 22 children) postoperatively, respectively (p<0.001). The cumulative probability of success was 91.18% at 6 months and 81.7% at 18-24 months. Mean number of topical medications decreased from 3.1±0.6 to 1.8±1.3 at 6 months and 1.6±1.1 at 24 months (p<0.001). Preoperatively, 25 patients required systemic acetazolamide, decreasing to three patients at 2 years. There was no tube erosion or infection. One eye developed retinal detachment. The AADI appears to be a viable low-cost GDD with effectiveness and safety profile comparable with published reports of the BGI and Ahmed glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Safety systems in gamma irradiation facilities.

PubMed

Drndarevic, V

1997-08-01

A new electronic device has been developed to guard against individuals gaining entry through the product entry and exit ports into our irradiation facility for industrial sterilization. This device uses the output from electronic sensors and pressure mats to assure that only the transport cabins may pass through these ports. Any intention of personnel trespassing is detected, the process is stopped by the safety system, and the source is placed in safe position. Owing to a simple construction, the new device enables reliable operation, is inexpensive, easy to implement, and improves the existing safety systems.

Summary of safety and effectiveness data from FDA: a valuable source of information on the performance of global endometrial ablation devices.

PubMed

Cooper, Jay; Gimpelson, Richard J

2004-04-01

To provide an overview of the approved second-generation endometrial ablation technologies. Data from the FDA Summary of Safety and Effectiveness Data were compared for Thermachoice, HydroThermablator, Her Option and Novasure devices. At 12 months' follow-up, Novasure and HydroThermablator had the highest amenorrhea rates. Thermochoice and Novasure had the highest success rates at 12 months. Novasure had the lowest adverse event rates in the first 24 hours, between 24 hours and 2 weeks and between 2 weeks and 1 year of follow-up. Summary of Safety and Effectiveness Data, obtainable on the FDA Web site, offers objective data for comparing second-generation endometrial ablation technologies.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

PubMed

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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.

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

PubMed

1998-11-03

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

Nuclear reactor melt arrest and coolability device

DOEpatents

Theofanous, Theo G.; Dinh, Nam Truc; Wachowiak, Richard M.

2016-06-14

Example embodiments provide a Basemat-Internal Melt Arrest and Coolability device (BiMAC) that offers improved spatial and mechanical characteristics for use in damage prevention and risk mitigation in accident scenarios. Example embodiments may include a BiMAC having an inclination of less than 10-degrees from the basemat floor and/or coolant channels of less than 4 inches in diameter, while maintaining minimum safety margins required by the Nuclear Regulatory Commission.

Features and selection of vascular access devices.

PubMed

Sansivero, Gail Egan

2010-05-01

To review venous anatomy and physiology, discuss assessment parameters before vascular access device (VAD) placement, and review VAD options. Journal articles, personal experience. A number of VAD options are available in clinical practice. Access planning should include comprehensive assessment, with attention to patient participation in the planning and selection process. Careful consideration should be given to long-term access needs and preservation of access sites. Oncology nurses are uniquely suited to perform a key role in VAD planning and placement. With knowledge of infusion therapy, anatomy and physiology, device options, and community resources, nurses can be key leaders in preserving vascular access and improving the safety and comfort of infusion therapy. Copyright 2010 Elsevier Inc. All rights reserved.

Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill.

PubMed

Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

2016-09-01

Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty.

Flexible barrier film, method of forming same, and organic electronic device including same

DOEpatents

Blizzard, John; Tonge, James Steven; Weidner, William Kenneth

2013-03-26

A flexible barrier film has a thickness of from greater than zero to less than 5,000 nanometers and a water vapor transmission rate of no more than 1.times.10.sup.-2 g/m.sup.2/day at 22.degree. C. and 47% relative humidity. The flexible barrier film is formed from a composition, which comprises a multi-functional acrylate. The composition further comprises the reaction product of an alkoxy-functional organometallic compound and an alkoxy-functional organosilicon compound. A method of forming the flexible barrier film includes the steps of disposing the composition on a substrate and curing the composition to form the flexible barrier film. The flexible barrier film may be utilized in organic electronic devices.

Enabling Medical Device Interoperability for the Integrated Clinical Environment

DTIC Science & Technology

2013-08-01

include the unique device identifier (UDI) as specified by the FDA , a logical timestamp as described above, and the data. 17 Existing adverse event...failure or malfunction that led to an adverse effect during a medical procedure. User: clinical and legal experts, IT-experts, biomed experts...diagnosis, treatment, research, safety and quality improvements, equipment management, and adverse event detection and reporting . The Medical

The inverted cup device for blood transfer on malaria RDTs: ease of use, acceptability and safety in routine use by health workers in Nigeria.

PubMed

Incardona, Sandra; Mwancha-Kwasa, Magoma; Rees-Channer, Roxanne R; Albertini, Audrey; Havumaki, Joshua; Chiodini, Peter; Oyibo, Wellington; Gonzalez, Iveth J

2018-01-15

Malaria rapid diagnostic tests (RDTs) are becoming widely adopted for case management at community level. However, reports and anecdotal observations indicate that the blood transfer step poses a significant challenge to many users. This study sought to evaluate the inverted cup device in the hands of health workers in everyday clinical practice, in comparison with the plastic pipette, and to determine the volume accuracy of the device made of a lower-cost plastic. The volume accuracy of inverted cup devices made of two plastics, PMMA and SBC, was compared by transferring blood 150 times onto filter paper and comparing the blood spot areas with those produced by 20 reference transfers with a calibrated micropipette. The ease of use, safety and acceptability of the inverted cup device and the pipette were evaluated by 50 health workers in Nigeria. Observations were recorded on pre-designed questionnaires, by the health workers themselves and by trained observers. Focus group discussions were also conducted. The volume accuracy assessment showed that the device made from the low-cost material (SBC) delivered a more accurate volume (mean 5.4 μL, SD 0.48 μL, range 4.5-7.0 μL) than the PMMA device (mean 5.9 μL, SD 0.48 μL, range 4.9-7.2 μL). The observational evaluation demonstrated that the inverted cup device performed better than the pipette in all aspects, e.g. higher proportions of health workers achieved successful blood collection (96%, vs. 66%), transfer of the required blood volume (90%, vs. 58%), and blood deposit without any loss (95%, vs. 50%). Majority of health workers also considered it' very easy' to use (81%),'very appropriate' for everyday use (78%), and 50% of them reported that it was their preferred BTD. The good volume accuracy and high acceptability of the inverted cup device shown in this study, along with observed ease of use and safety in hands of health workers, further strengthens prior findings which demonstrated its higher

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

PubMed

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Further Development of a Robotic-Assisted Transfer Device

PubMed Central

Burkman, Jessica; Grindle, Garrett; Wang, Hongwu; Kelleher, Annmarie

2017-01-01

Background: The task of performing transfers, such as from a wheelchair to a bed, has a high risk of injury to both the caregiver and the person being transferred. Although mechanical transfer devices can reduce these risks, these devices are not meant for use in the community and they still place strain on the caregiver when used. Purpose: The aim of this study is to describe feedback gathered from focus groups of potential users of the Robotic-Assisted Transfer Device (RATD) and describe design changes aimed at preparing the device for the next step in the development process. Method: The RATD was transferred to a newer electric-powered wheelchair (EPW), key components were redesigned, and the control program was updated to increase the safety of the device. Two focus groups, one consisting of people with disabilities and the other consisting of clinicians and caregivers, were conducted to gather feedback from potential users. Results: Error checking, safety zones, a motor brake, and a new track helped increase the safety of the device. Sixty-three percent of the people with disabilities and 83% of caregivers surveyed said they would use the device. Conclusions: The results from the focus groups were positive and the design changes were successful, but more development is needed before the RATD can be marketed. PMID:29339890

Development of non-keyboard input device checklists through assessments.

PubMed

Woods, Valerie; Hastings, Sarah; Buckle, Peter; Haslam, Roger

2003-11-01

An assessment of non-keyboard input devices (NKID) was conducted to identify factors for good design in relation to operation, performance and comfort. Twenty-seven NKID users, working in health and safety, evaluated eight devices that included mice, trackballs and a joystick mouse. The factors considered important for good design were: (1) comfortable hand and finger position, (2) adequate control, (3) intuitive and easy to use, (4) ease of device, button and trackball movement, (5) good interaction with software, (6) provision of suitable accessories. Mice were rated more favourably than trackballs or the joystick mouse. The design of the standard 2-button mouse (D4) was considered most desirable to use; the 3-button mouse (D1) and 3-button curved mouse (D8) were also favoured. Assessment data and comments were drawn together with previously published research to produce useful tools for NKID purchasing (i.e. Device Purchasing Checklist) and assessment (i.e. Device Assessment Checklist).

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

Evolution of atherectomy devices.

PubMed

Al Khoury, G; Chaer, R

2011-08-01

Percutaneous atherectomy provides an alternative approach to the endovascular treatment of peripheral atherosclerotic occlusive disease beyond angioplasty and stenting, and has the theoretical advantage of lesion debulking and minimizing barotrauma to the vessel wall. Atherectomy has evolved greatly during the last decade, with currently four FDA approved devices for the treatment of peripheral arterial disease. Several reports have focused on the initial technical success rates, and demonstrated the safety and short as well as mid-term efficacy of atherectomy devices. This article will review the evolution of current atherectomy devices and the associated literature.

Stability-Augmentation Devices for Miniature Aircraft

NASA Technical Reports Server (NTRS)

Wood, RIchard M.

2005-01-01

Non-aerodynamic mechanical devices are under consideration as means to augment the stability of miniature autonomous and remotely controlled aircraft. Such aircraft can be used for diverse purposes, including military reconnaissance, radio communications, and safety-related monitoring of wide areas. The need for stability-augmentation devices arises because adverse meteorological conditions generally affect smaller aircraft more strongly than they affect larger aircraft: Miniature aircraft often become uncontrollable under conditions that would not be considered severe enough to warrant grounding of larger aircraft. The need for the stability-augmentation devices to be non-aerodynamic arises because there is no known way to create controlled aerodynamic forces sufficient to counteract the uncontrollable meteorological forces on miniature aircraft. A stability-augmentation device of the type under consideration includes a mass pod (a counterweight) at the outer end of a telescoping shaft, plus associated equipment to support the operation of the aircraft. The telescoping shaft and mass pod are stowed in the rear of the aircraft. When deployed, they extend below the aircraft. Optionally, an antenna for radio communication can be integrated into the shaft. At the time of writing this article, the deployment of the telescoping shaft and mass pod was characterized as passive and automatic, but information about the deployment mechanism(s) was not available. The feasibility of this stability-augmentation concept was demonstrated in flights of hand-launched prototype aircraft.

Graphene device and method of using graphene device

DOEpatents

Bouchiat, Vincent; Girit, Caglar; Kessler, Brian; Zettl, Alexander K.

2015-08-11

An embodiment of a graphene device includes a layered structure, first and second electrodes, and a dopant island. The layered structure includes a conductive layer, an insulating layer, and a graphene layer. The electrodes are coupled to the graphene layer. The dopant island is coupled to an exposed surface of the graphene layer between the electrodes. An embodiment of a method of using a graphene device includes providing the graphene device. A voltage is applied to the conductive layer of the graphene device. Another embodiment of a method of using a graphene device includes providing the graphene device without the dopant island. A dopant island is placed on an exposed surface of the graphene layer between the electrodes. A voltage is applied to the conductive layer of the graphene device. A response of the dopant island to the voltage is observed.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

PubMed

Schvartzman, Javier A; Krupitzki, Hugo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; Nguyen, My Huong; Vayena, Effy; Fiorillo, Angel E; Gadow, Enrique C; Vizcaino, Francisco M; von Petery, Felicitas; Marroquin, Victoria; Cafferata, María Luisa; Mazzoni, Agustina; Vannevel, Valerie; Pattinson, Robert C; Gülmezoglu, A Metin; Althabe, Fernando; Bonet, Mercedes

2018-03-12

A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

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

47 CFR 95.1125 - RF safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...

47 CFR 95.1125 - RF safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...

Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

PubMed

2014-10-22

The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

Soft robotic devices for hand rehabilitation and assistance: a narrative review.

PubMed

Chu, Chia-Ye; Patterson, Rita M

2018-02-17

The debilitating effects on hand function from a number of a neurologic disorders has given rise to the development of rehabilitative robotic devices aimed at restoring hand function in these patients. To combat the shortcomings of previous traditional robotics, soft robotics are rapidly emerging as an alternative due to their inherent safety, less complex designs, and increased potential for portability and efficacy. While several groups have begun designing devices, there are few devices that have progressed enough to provide clinical evidence of their design's therapeutic abilities. Therefore, a global review of devices that have been previously attempted could facilitate the development of new and improved devices in the next step towards obtaining clinical proof of the rehabilitative effects of soft robotics in hand dysfunction. A literature search was performed in SportDiscus, Pubmed, Scopus, and Web of Science for articles related to the design of soft robotic devices for hand rehabilitation. A framework of the key design elements of the devices was developed to ease the comparison of the various approaches to building them. This framework includes an analysis of the trends in portability, safety features, user intent detection methods, actuation systems, total DOF, number of independent actuators, device weight, evaluation metrics, and modes of rehabilitation. In this study, a total of 62 articles representing 44 unique devices were identified and summarized according to the framework we developed to compare different design aspects. By far, the most common type of device was that which used a pneumatic actuator to guide finger flexion/extension. However, the remainder of our framework elements yielded more heterogeneous results. Consequently, those results are summarized and the advantages and disadvantages of many design choices as well as their rationales were highlighted. The past 3 years has seen a rapid increase in the development of soft robotic

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment].

PubMed

Bohnet-Joschko, Sabine; Zippel, Claus; Siebert, Hartmut

2015-01-01

The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment. Copyright © 2015. Published by Elsevier GmbH.

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

CIRSE Vascular Closure Device Registry

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

Reekers, Jim A., E-mail: j.a.reekers@amc.uva.nl; Mueller-Huelsbeck, Stefan; Libicher, Martin

2011-02-15

Purpose: Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods: The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results: Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (Pmore » = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion: The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.« less

CIRSE Vascular Closure Device Registry

PubMed Central

Müller-Hülsbeck, Stefan; Libicher, Martin; Atar, Eli; Trentmann, Jens; Goffette, Pierre; Borggrefe, Jan; Zeleňák, Kamil; Hooijboer, Pieter; Belli, Anna-Maria

2010-01-01

Purpose Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology. Methods The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry. Results Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0–14.5] for antegrade access and 1.8% (95% CI 1.1–2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions. Conclusion The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters. PMID:20981425

OPERATING PARAMETERS TO MINIMIZE EMISSIONS DURING ROTARY KILN EMERGENCY SAFETY VENT OPENINGS

EPA Science Inventory

Certain designs of hazardous waste incinerator systems include emergency safety vents (ESVs). ESVs (also called dump stacks, vent stacks, emergency by-pass stacks, thermal relief valves, and pressure relief valves) are regarded as true emergency devices. Their purpose is to vent ...

78 FR 36092 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

78 FR 40635 - Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... Zone; Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship...; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal... Coast Guard will enforce a segment of the Safety Zone; Brandon Road Lock and Dam to Lake Michigan...

Detection of fecal contamination on beef meat surfaces using handheld fluorescence imaging device (HFID)

USDA-ARS?s Scientific Manuscript database

Current meat inspection in slaughter plants, for food safety and quality attributes including potential fecal contamination, is conducted through by visual examination human inspectors. A handheld fluorescence-based imaging device (HFID) was developed to be an assistive tool for human inspectors by ...

Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill

PubMed Central

Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

2016-01-01

Abstract Background: Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. Methods: A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. Results: No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. Conclusion: The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty. PMID:27631268

Using Mobile Devices in Nursing Education.

PubMed

Day-Black, Crystal; Merrill, Earlene B

2015-01-01

The use of mobile device technology in nursing education is growing. These devices are becoming more important in the health care environment with an advantage of providing a compendium of drug, nursing procedures and treatments, and disease information to nursing students. Senior baccalaureate nursing students traditionally are prohibited from medication administration during psychiatric-mental health clinical rotations, but they are required to participate in simulated medication discussions and administration experiences. The incorporation of this mobile device technology to augment clinical learning experiences has advantages including potential reduction of medication errors, and improved patient safety during students' clinical rotation. The purpose of this project is to explain how the mobile device (iPod Touch, 4th generation wireless media player) may be used to enhance and augment comprehensive nursing care in a psychiatric-mental health clinical setting. Thirty-four (34) baccalaureate senior nursing students enrolled in a clinical psychiatric-mental nursing course at a mid-Atlantic public university school of nursing were used. Each student was provided a loaner mobile device with appropriate software and the necessary training. Data were collected on the student's ability to simulate medication administration to a psychiatric-mental health client. Surveys were administered before distribution, at mid-point and at the end of two (2) seven week semesters.

Communication devices in the operating room.

PubMed

Ruskin, Keith J

2006-12-01

Effective communication is essential to patient safety. Although radio pagers have been the cornerstone of medical communication, new devices such as cellular telephones, personal digital assistants (PDAs), and laptop or tablet computers can help anesthesiologists to get information quickly and reliably. Anesthesiologists can use these devices to speak with colleagues, access the medical record, or help a colleague in another location without having to leave a patient's side. Recent advances in communication technology offer anesthesiologists new ways to improve patient care. Anesthesiologists rely on a wide variety of information to make decisions, including vital signs, laboratory values, and entries in the medical record. Devices such as PDAs and computers with wireless networking can be used to access this information. Mobile telephones can be used to get help or ask for advice, and are more efficient than radio pagers. Voice over Internet protocol is a new technology that allows voice conversations to be routed over computer networks. It is widely believed that wireless devices can cause life-threatening interference with medical devices. The actual risk is very low, and is offset by a significant reduction in medical errors that results from more efficient communication. Using common technology like cellular telephones and wireless networks is a simple, cost-effective way to improve patient care.

Low cost charged-coupled device (CCD) based detectors for Shiga toxins activity analysis

USDA-ARS?s Scientific Manuscript database

To improve food safety there is a need to develop simple, low-cost sensitive devices for detection of foodborne pathogens and their toxins. We describe a simple and relatively low-cost webcam-based detector which can be used for various optical detection modalities, including fluorescence, chemilumi...

Nanocomposites for ultra high density information storage, devices including the same, and methods of making the same

DOEpatents

Goyal, Amit; Shin, Junsoo

2014-04-01

A nanocomposite article that includes a single-crystal or single-crystal-like substrate and heteroepitaxial, phase-separated layer supported by a surface of the substrate and a method of making the same are described. The heteroepitaxial layer can include a continuous, non-magnetic, crystalline, matrix phase, and an ordered, magnetic magnetic phase disposed within the matrix phase. The ordered magnetic phase can include a plurality of self-assembled crystalline nanostructures of a magnetic material. The phase-separated layer and the single crystal substrate can be separated by a buffer layer. An electronic storage device that includes a read-write head and a nanocomposite article with a data storage density of 0.75 Tb/in.sup.2 is also described.

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

30 CFR 75.1107-7 - Water spray devices; capacity; water supply; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Water spray devices; capacity; water supply; minimum requirements. 75.1107-7 Section 75.1107-7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and...

Texas curve margin of safety.

DOT National Transportation Integrated Search

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

Patient Safety Threat - Syringe Reuse

MedlinePlus

... Fingerstick Devices Clinical Reminder: Insulin Pens Publications Infection Control Assessment of Ambulatory Surgical Centers Meetings Insurance Stakeholders Meeting – December 2011 Ambulatory Surgical Centers – October 2010 Safety by Design – May 2010 Sticking with Safety – May 2010 Injection ...

A study of medical device regulation management model in Asia.

PubMed

Wu, Yi-Hui; Li, Fong-An; Fan, Yin-Ting; Tu, Pei-Weng

2016-06-01

With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.

Body Implanted Medical Device Communications

NASA Astrophysics Data System (ADS)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

30 CFR 56.19095 - Location of signal devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Location of signal devices. 56.19095 Section 56.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Signaling § 56.19095 Location of signal devices. Hoisting signal devices shall be positioned within easy...

30 CFR 57.19095 - Location of signal devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Location of signal devices. 57.19095 Section 57.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Hoisting Signaling § 57.19095 Location of signal devices. Hoisting signal devices shall be positioned...

30 CFR 56.19006 - Automatic hoist braking devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 56.19006 Section 56.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 56.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

30 CFR 57.19006 - Automatic hoist braking devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Automatic hoist braking devices. 57.19006 Section 57.19006 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND... Hoisting Hoists § 57.19006 Automatic hoist braking devices. Automatic hoists shall be provided with devices...

30 CFR 56.19095 - Location of signal devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Location of signal devices. 56.19095 Section 56.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Signaling § 56.19095 Location of signal devices. Hoisting signal devices shall be positioned within easy...

30 CFR 57.19095 - Location of signal devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Location of signal devices. 57.19095 Section 57.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Hoisting Signaling § 57.19095 Location of signal devices. Hoisting signal devices shall be positioned...

30 CFR 56.19095 - Location of signal devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Location of signal devices. 56.19095 Section 56.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Signaling § 56.19095 Location of signal devices. Hoisting signal devices shall be positioned within easy...

30 CFR 57.19095 - Location of signal devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Location of signal devices. 57.19095 Section 57.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Hoisting Signaling § 57.19095 Location of signal devices. Hoisting signal devices shall be positioned...

30 CFR 57.19095 - Location of signal devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Location of signal devices. 57.19095 Section 57.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Hoisting Signaling § 57.19095 Location of signal devices. Hoisting signal devices shall be positioned...

30 CFR 56.19095 - Location of signal devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Location of signal devices. 56.19095 Section 56.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Signaling § 56.19095 Location of signal devices. Hoisting signal devices shall be positioned within easy...

30 CFR 56.19095 - Location of signal devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Location of signal devices. 56.19095 Section 56.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Signaling § 56.19095 Location of signal devices. Hoisting signal devices shall be positioned within easy...

30 CFR 57.19095 - Location of signal devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Location of signal devices. 57.19095 Section 57.19095 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL... Hoisting Signaling § 57.19095 Location of signal devices. Hoisting signal devices shall be positioned...

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2014 CFR

2014-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... information, including experimental studies and tests, required by the Commission to facilitate a... direct physical contact by any person with it; (3) The device is so designed that it cannot easily be...

10 CFR 32.53 - Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble...

Code of Federal Regulations, 2013 CFR

2013-01-01

... maximum quantity of tritium or promethium-147 in each device; (2) Details of construction and design; (3... information, including experimental studies and tests, required by the Commission to facilitate a... direct physical contact by any person with it; (3) The device is so designed that it cannot easily be...

Overview of Robotic Devices for Nursing Care Project.

PubMed

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

76 FR 69321 - Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety... previously approved antitheft device. SUMMARY: On May 25, 1989, the National Highway Traffic Safety...

Safety belt usage among drivers. Use of child restraint devices, passenger safety belts and position of passengers in cars. Motorcycle helmet usage.

DOT National Transportation Integrated Search

1980-05-01

This report presents findings from three observation studies conducted by Opinion Research Corporation under a contract with the National Highway Traffic Safety Administration. The report is organized into three sections. Each section includes the fo...

30 CFR 75.1107-13 - Approval of other fire suppression devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Fire Protection Fire Suppression Devices and Fire-Resistant Hydraulic Fluids on Underground Equipment § 75.1107-13 Approval of... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval of other fire suppression devices. 75...

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

PubMed

Doyle, Brendan J; Godfrey, Michael J; Lennon, Ryan J; Ryan, James L; Bresnahan, John F; Rihal, Charanjit S; Ting, Henry H

2007-02-01

The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications. (c) 2006 Wiley-Liss, Inc.

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.

77 FR 64827 - Certain Lighting Control Devices Including Dimmer Switches and Parts Thereof (IV); Final...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-23

...Notice is hereby given that the U.S. International Trade Commission has terminated the above-captioned investigation with a finding of violation of section 337, and has issued a general exclusion order directed against infringing lighting control devices including dimmer switches and parts thereof, and cease and desist orders directed against respondents American Top Electric Corp. (``American Top'') and Big Deal Electric Corp. (``Big Deal''), both of Santa Ana, California; Elemental LED, LLC d/b/a Diode LED (``Elemental'') of Emeryville, California; and Zhejiang Yuelong Mechanical and Electrical Co. (``Zhejiang Yuelong'') of Zhejiang, China.

How can cardiothoracic and vascular medical devices stay in the market?

PubMed

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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.

Automatic safety rod for reactors

DOEpatents

Germer, John H.

1988-01-01

An automatic safety rod for a nuclear reactor containing neutron absorbing material and designed to be inserted into a reactor core after a loss-of-core flow. Actuation is based upon either a sudden decrease in core pressure drop or the pressure drop decreases below a predetermined minimum value. The automatic control rod includes a pressure regulating device whereby a controlled decrease in operating pressure due to reduced coolant flow does not cause the rod to drop into the core.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

30 CFR 57.14208 - Warning devices.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Warning devices. 57.14208 Section 57.14208... Equipment Safety Practices and Operational Procedures § 57.14208 Warning devices. (a) Visible warning... four feet beyond the rear of the equipment shall have a warning flag at the end of the projection...

30 CFR 57.14208 - Warning devices.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Warning devices. 57.14208 Section 57.14208... Equipment Safety Practices and Operational Procedures § 57.14208 Warning devices. (a) Visible warning... four feet beyond the rear of the equipment shall have a warning flag at the end of the projection...

30 CFR 57.14208 - Warning devices.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Warning devices. 57.14208 Section 57.14208... Equipment Safety Practices and Operational Procedures § 57.14208 Warning devices. (a) Visible warning... four feet beyond the rear of the equipment shall have a warning flag at the end of the projection...

30 CFR 57.14208 - Warning devices.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Warning devices. 57.14208 Section 57.14208... Equipment Safety Practices and Operational Procedures § 57.14208 Warning devices. (a) Visible warning... four feet beyond the rear of the equipment shall have a warning flag at the end of the projection...

30 CFR 57.14208 - Warning devices.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Warning devices. 57.14208 Section 57.14208... Equipment Safety Practices and Operational Procedures § 57.14208 Warning devices. (a) Visible warning... four feet beyond the rear of the equipment shall have a warning flag at the end of the projection...

Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.

PubMed

2018-01-02

The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Use of consumer wireless devices by South Africans with severe communication disability

PubMed Central

Bryen, Diane Nelson; Moolman, Enid; Morris, John

2016-01-01

Background Advancements in wireless technology (e.g. cell phones and tablets) have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. Objectives To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Method Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC) technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. Results All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3%) needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends), for leisure activities (e.g. listening to music, watching videos, playing games), and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance). Conclusion These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population. PMID:28730045

Use of consumer wireless devices by South Africans with severe communication disability.

PubMed

Bornman, Juan; Bryen, Diane Nelson; Moolman, Enid; Morris, John

2016-01-01

Advancements in wireless technology (e.g. cell phones and tablets) have opened new communication opportunities and environments for individuals with severe communication disabilities. The advancement of these technologies poses challenges to ensuring that these individuals enjoy equal access to this increasingly essential technology. However, a paucity of research exists. To describe the nature and frequency with which South African adults with severe communication disabilities have access to and use wireless devices, as well as the types of activities for which wireless devices are used. Survey research was conducted with 30 individuals who use augmentative and alternative communication (AAC) technology using the Survey of User Needs Questionnaire developed in the United States, and localized to the South African context. All participants, despite their limited education, unemployment and low economic status, owned and/or used mainstream wireless devices. Slightly more than half of the participants (53.3%) needed adaptations to their wireless devices. Advantages of using wireless devices were highlighted, including connecting with others (through using text messaging, social networking, making plans with others, sharing photos and videos with friends), for leisure activities (e.g. listening to music, watching videos, playing games), and for safety purposes (e.g. to navigate when lost, using the device when in trouble and needing immediate assistance). These wireless devices offer substantial benefits and opportunities to individuals with disabilities who rely on AAC in terms of independence, social participation, education and safety/security. However, they still do not enjoy equal opportunity to access and use wireless devices relative to the non-disabled population.

Evaluation Of The Vehicle Radar Safety Systems Rashid Radar Safety Brake Collision Warning System, Final Report

DOT National Transportation Integrated Search

1988-02-01

THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... DEPARTMENT OF LABOR Mine Safety and Health Administration Coal Mine Dust Sampling Devices; Correction AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: On April 30, 2013, Mine Safety and Health Administration (MSHA) published a notice in the Federal Register...

Long-term efficacy of an ergonomics program that includes patient-handling devices on reducing musculoskeletal injuries to nursing personnel.