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1

Medical Device Safety  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Print this page Share this page E-mail this page Home Medical Devices Medical Device Safety Medical Device Safety Search the Medical Device Safety Section Medical ...

2

Recent Medical Device Recalls  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Print this page Share this page E-mail this page Home Medical Devices Medical Device Safety Medical Device Recalls List of ...

3

Transdermal estrogen with a levonorgestrel-releasing intrauterine device for climacteric complaints: Clinical and endometrial responses  

Microsoft Academic Search

OBJECTIVE: Our purpose was to study the effects of intrauterine release of a daily dose of 20 ?g levonorgestrel by an intrauterine device on climacteric symptoma, bleeding pattern, and endometrial histologic features in postmenopausal women receiving transdermal estrogen replacement therapy.STUDY DESIGN: Forty parous postmenopausal women were randomly allocated into two groups for 1 year: 20 women receiving a continuous transdermal

Tytti H. Raudaskoski; Eija I. Lahti; Antti J. Kauppila; Meeri A. Apaja-Sarkkinen; Timo J. Laatikainen

1995-01-01

4

Medical Device Safety  

MedlinePLUS

A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...

5

Transdermal Delivery Devices: Fabrication, Mechanics and Drug Release from Silk**  

PubMed Central

Microneedles are a relatively simple, minimally invasive and painless approach to deliver drugs across the skin. However, there remain limitations with this approach because of the materials most commonly utilized for such systems. Silk protein, with tunable and biocompatibility properties, is a useful biomaterial to overcome the current limitations with microneedles. Silk devices preserve drug activity, offer superior mechanical properties and biocompatibility, can be tuned for biodegradability, and can be processed under aqueous, benign conditions. In the present work, we report the fabrication of dense microneedle arrays from silk with different drug release kinetics. The mechanical properties of the microneedle patches are tuned by post-fabrication treatments or by loading the needles with silk microparticles to increase capacity and mechanical strength. Drug release is further enhanced by the encapsulation of the drugs in the silk matrix and coating with a thin dissolvable drug layer. The microneedles are used on human cadaver skin and drugs were delivered successfully. The various attributes demonstrated suggest that silk-based microneedle devices can provide significant benefit as a platform material for transdermal drug delivery. PMID:23653252

Raja, Waseem K.; MacCorkle, Scott; Diwan, Izzuddin M.; Abdurrob, Abdurrahman; Lu, Jessica; Omenetto, Fiorenzo G.; Kaplan, David L.

2013-01-01

6

Reprocessing of Reusable Medical Devices  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Print this page Share this page E-mail ... Reprocessing of Reusable Medical Devices Reprocessing of Reusable Medical Devices Reusable medical devices are devices that health care ...

7

Medical device incident investigation.  

PubMed

FDA Medical Device Reporting regulations require investigation and reporting of certain device-related incidents. Medical device incident investigation is also a key component of risk management for healthcare delivery organizations. However, the fundamental objective of incident investigation is to identify the root cause of an incident and mitigate the risk (probability x severity) of recurrence. PMID:17487098

Baretich, Matthew F

2007-01-01

8

Medical Device Interoperability The lack of interoperability between medical devices  

E-print Network

integration of medical devices in operating rooms, emergency rooms and intensive care units. The research medical devices. · Medical Device Communication Project - NIST researchers are collaborating with medicalMedical Device Interoperability The lack of interoperability between medical devices can lead

9

Medical Device Reliability BIOMATERIALS  

E-print Network

, and consistency of active implantable medical devices. These devices, including pacemakers, cardiac defibrillators million life-saving cardiac-assist devices have been implanted. Improved acceptance testing will reduce-El, Advanced Bionics, Vishay, AVX, and Kemet. Approach Materials Science and Engineering Laboratory Our bodies

10

Coupledfield microfluidic analysis of integrated MEMS based device for transdermal drug delivery applications  

Microsoft Academic Search

In this paper, we present design, fabrication and coupled multifield analysis of hollow out-of-plane silicon microneedle array with piezoelectrically actuated microfluidic device for transdermal drug delivery (TDD) applications. The mask layout design and fabrication process of silicon microneedle array is first done by series of combined isotropic and anisotropic etching process using inductively coupled plasma (ICP) etching technology. Then coupled

Muhammad Waseem Ashraf; Shahzadi Tayyaba; Asim Nisar; Nitin Afzulpurkar; Adisorn Tuantranont

2009-01-01

11

Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system  

PubMed Central

Objective A few cases of adverse reactions linked to erroneous use of transdermal opioid patches have been reported in the literature. The aim of this study was to describe and characterize medication errors (MEs) associated with use of transdermal fentanyl and buprenorphine. Methods All events concerning transdermal opioid patches reported between 2004 and 2011 to a regional incident reporting system and assessed as MEs were scrutinized and characterized. MEs were defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient”. Results In the study 151 MEs were identified. The three most common error types were wrong administration time 67 (44%), wrong dose 34 (23%), and omission of dose 20 (13%). Of all MEs, 118 (78%) occurred in the administration stage of the medication process. Harm was reported in 26 (17%) of the included cases, of which 2 (1%) were regarded as serious harm (nausea/vomiting and respiratory depression). Pain was the most common adverse reaction reported. Conclusions Of the reported MEs related to transdermal fentanyl and buprenorphine, most occurred during administration. Improved routines to ascertain correct and timely administration and educational interventions to reduce MEs for these drugs are warranted. PMID:24912424

2014-01-01

12

Combating medical device fouling.  

PubMed

When interfaced with the biological environment, biomedical devices are prone to surface biofouling due to adhesion of microbial or thrombotic agents as a result of the foreign body response. Surface biofouling of medical devices occurs as a result of nonspecific adhesion of noxious substrates to the surface. Approaches for biofouling-resistant surfaces can be categorized as either the manipulation of surface chemical functionalities or through the incorporation of regulatory biomolecules. This review summarizes current strategies for creating biofouling-resistant surfaces based on surface hydrophilicity and charge, biomolecule functionalization, and drug elution. Reducing the foreign body response and restoring the function of cells around the device minimizes the risk of device rejection and potentially integrates devices with surrounding tissues and fluids. In addition, we discuss the use of peptides and NO as biomolecules that not only inhibit surface fouling, but also promote the integration of medical devices with the biological environment. PMID:24438709

Harding, Jacqueline L; Reynolds, Melissa M

2014-03-01

13

78 FR 18233 - Medical Devices; Technical Amendment  

Federal Register 2010, 2011, 2012, 2013, 2014

...No. FDA-2013-N-0011] Medical Devices; Technical Amendment AGENCY...certain regulations regarding medical devices. Publication of this document...Confidential business information, Medical devices, Medical research,...

2013-03-26

14

Medical device regulation for manufacturers.  

PubMed

Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices. PMID:14702983

McAllister, P; Jeswiet, J

2003-01-01

15

[Medical device use errors].  

PubMed

Medical devices define our everyday patient treatment processes. But despite the beneficial effect, every use can also lead to damages. Use errors are thus often explained by human failure. But human errors can never be completely extinct, especially in such complex work processes like those in medicine that often involve time pressure. Therefore we need error-tolerant work systems in which potential problems are identified and solved as early as possible. In this context human engineering uses the TOP principle: technological before organisational and then person-related solutions. But especially in everyday medical work we realise that error-prone usability concepts can often only be counterbalanced by organisational or person-related measures. Thus human failure is pre-programmed. In addition, many medical work places represent a somewhat chaotic accumulation of individual devices with totally different user interaction concepts. There is not only a lack of holistic work place concepts, but of holistic process and system concepts as well. However, this can only be achieved through the co-operation of producers, healthcare providers and clinical users, by systematically analyzing and iteratively optimizing the underlying treatment processes from both a technological and organizational perspective. What we need is a joint platform like medilab V of the TU Berlin, in which the entire medical treatment chain can be simulated in order to discuss, experiment and model--a key to a safe and efficient healthcare system of the future. PMID:19213452

Friesdorf, Wolfgang; Marsolek, Ingo

2008-01-01

16

Barriers to medical device innovation  

PubMed Central

The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. PMID:24966699

Bergsland, Jacob; Elle, Ole Jakob; Fosse, Erik

2014-01-01

17

Micro- and nanofabrication methods in nanotechnological medical and pharmaceutical devices  

PubMed Central

Micro- and nanofabrication techniques have revolutionized the pharmaceutical and medical fields as they offer the possibility for highly reproducible mass-fabrication of systems with complex geometries and functionalities, including novel drug delivery systems and bionsensors. The principal micro- and nanofabrication techniques are described, including photolithography, soft lithography, film deposition, etching, bonding, molecular self assembly, electrically induced nanopatterning, rapid prototyping, and electron, X-ray, colloidal monolayer, and focused ion beam lithography. Application of these techniques for the fabrication of drug delivery and biosensing systems including injectable, implantable, transdermal, and mucoadhesive devices is described. PMID:17722281

Betancourt, Tania; Brannon-Peppas, Lisa

2006-01-01

18

Medical devices; Medical Device Data Systems. Final rule.  

PubMed

The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. PMID:21351676

2011-02-15

19

Human Factors and Medical Devices  

SciTech Connect

Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright.

Dick Sawyer

1998-12-31

20

Transdermal delivery using a novel electrochemical device, part 2: in vivo study in humans.  

PubMed

A single-center, open-label, and dose-escalation clinical trial has been performed using a novel electrochemical transdermal patch comprising a drug-loaded hydrogel sandwiched between two silver electrodes. The lower electrode is attached flatly to skin via an adhesive layer. This noniontophoretic device produces flux enhancement via voltage-induced electrolysis of the water in the hydrogel. A voltage application of 2 V over 60 s produced release of approximately 315 to 340 ?g of fentanyl from a patch. A single-voltage application at t = 16 h produced a maximum plasma level of approximately 200 pg/mL before patch removal at t = 41 h. Consecutive voltage applications at t = 16 h and t = 40 h produced a maximum plasma level of approximately 730 pg/mL. The lag time between voltage application and achievement of a plasma profile plateau is longer than that reported for an iontophoretic patch. The patch's advantage is production of an on-demand plasma profile without the use of potentially irritating iontophoresis. In contrast to a passive transdermal system, it is possible to adjust the plasma profile by using voltage application. It is not necessary to apply a continual current, in contrast to iontophoretic systems. PMID:22411742

Schröder, Britta; Nickel, Ulrich; Meyer, Elisabeth; Lee, Geoffrey

2012-06-01

21

MEDIC: Medical embedded device for individualized care  

Microsoft Academic Search

Summary Objective: Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabil- ities, and commercially available microelectronic components, sensors and conven- tional personal digital assistant (PDA) (or a cell phone). Methods and materials: In this paper, we present

Winston H. Wu; Alex A. T. Bui; Maxim A. Batalin; Lawrence K. Au; Jonathan D. Binney; William J. Kaiser

2008-01-01

22

[Benefit assessment of medical devices].  

PubMed

Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers. PMID:25566843

Zens, Yvonne; Fujita-Rohwerder, N; Windeler, J

2015-03-01

23

Implantable medical devices MRI safe.  

PubMed

Pacemakers, ICDs, neurostimulators like deep brain stimulator electrodes, spiral cord stimulators, insulin pumps, cochlear implants, retinal implants, hearing aids, electro cardio gram (ECG) leads, or devices in interventional MRI such as vascular guide wires or catheters are affected by MRI magnetic and electromagnetic fields. Design of MRI Safe medical devices requires computer modeling, bench testing, phantom testing, and animal studies. Implanted medical devices can be MRI unsafe, MRI conditional or MRI safe (see glossary). In the following paragraphs we will investigate how to design implanted medical devices MRI safe. PMID:23739365

Dal Molin, Renzo; Hecker, Bertrand

2013-01-01

24

Estradiol Transdermal Patch  

MedlinePLUS

... periods). Transdermal estradiol is also used to prevent osteoporosis (a condition in which the bones become thin ... Women who only need a medication to prevent osteoporosis may benefit more from a different medication that ...

25

Nanocoatings on implantable medical devices.  

PubMed

The global medical device industry has experienced significant growth over the past 5 years. The surge of patent publications in the field bears testimony to this fact. The advent of nanotechnology has opened up newer unexplored vistas in the field of medical devices. This review summarizes patents employing the principles of nanotechnology in the formulation of coatings for implantable medical devices. Patents selected have at least one entity or structure with dimensions in the nanometer range, which results in a therapeutic value addition. The strategies reviewed pertain to tackling issues such as restenosis and thrombosis in addition to improving the overall acceptability of the implantable medical device, particularly those placed in the vasculature. PMID:24237126

Arsiwala, Ammar M; Raval, Ankur J; Patravale, Vandana B

2013-07-01

26

Selegiline Transdermal System: An Examination of the Potential for CYP450- Dependent Pharmacokinetic Interactions With 3 Psychotropic Medications  

Microsoft Academic Search

Selegiline transdermal system (STS) is a recently approved monoamine oxidase inhibitor antidepressant. This article reports results from 3 studies examining the potential for cytochrome P450-dependent pharmacokinetic interactions between STS and 3 psychotropic medications that might be coadministered. Three open-label, randomized, Latin square, 3-sequence crossover design studies were conducted with healthy volunteers to determine the pharmacokinetic parameters of STS 6 mg\\/24

Albert J. Azzaro; John Ziemniak; Eva Kemper; Bryan J. Campbell; Chad VanDenBerg

2007-01-01

27

Body Implanted Medical Device Communications  

NASA Astrophysics Data System (ADS)

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.

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

28

Methylphenidate Transdermal Patch  

MedlinePLUS

Methylphenidate transdermal patches are used as part of a treatment program to control symptoms of attention deficit ... than other people who are the same age). Methylphenidate is in a class of medications called central ...

29

Recent medical devices for tonsillectomy  

PubMed Central

The most frequent and probably the earliest described surgical intervention of ENT field is tonsillectomy. Various methods were described and devices were invented up to now in order to increase safety and decrease time consumption and complications. All new created devices promises lower intraoperative blood loss, intraoperative time, postoperative pain and bleeding. But with their widely use it is seen that they cannot fulfill what they promise. Debate also continues as to which technique yields the best outcome. This study reports a summary for common medical devices which were previously used in tonsillectomy. PMID:23930051

Sayin, I; Cingi, C

2012-01-01

30

Transdermal drug delivery  

Microsoft Academic Search

Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, noncavitational ultrasound and iontophoresis have also resulted

Mark R Prausnitz; Robert Langer

2008-01-01

31

Polymer Tribology in Safety Medical Devices: Retractable  

E-print Network

Polymer Tribology in Safety Medical Devices: Retractable Syringes WITOLD BROSTOW, DOROTA ABSTRACT: We analyze an example of the application of polymer tribology to create a safety medical device years development of safety medical devices has continued to progress. The problem is of considerable

North Texas, University of

32

Metrological Reliability of Medical Devices  

NASA Astrophysics Data System (ADS)

The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

Costa Monteiro, E.; Leon, L. F.

2015-02-01

33

Medical Device Industry Educatinon Cosortium  

NSDL National Science Digital Library

The Medical Device Industry Education Consortium (MDIEC) was formed to build a learning and innovation network to develop and deliver industry-endorsed solutions that address critical industry-defined technical education and training needs. St. Petersburg College (SPC) led a group of Eight Community Colleges and Fifteen Industry partners to co-found the consortium. A Department of Education (DOE) Grant funded the initial formation and curriculum development. SPC along with Anoka-Ramsey Community College in Minnesota and Edmonds Community College in Washington State was awarded a National Science Foundation (NSF) Grant to further MDIEC and develop curriculum in three critical training areas: quality systems, information management and clinical data management.

Sullivan, Michael

34

Lithium ion batteries for medical devices  

Microsoft Academic Search

Lithium-ion batteries are being developed for nonimplantable and implantable medical devices. The high voltage, energy density and unique characteristics of this battery system are, in some cases, an enabling technology for the medical device. In other cases, the lithium-ion system provides additional convenience to the patients who use these devices. Especially for implantable medical devices, lithium-ion batteries must be designed

David M. Spillman; Esther S. Takeuchi

1999-01-01

35

Graphical process design tools for iontophoretic transdermal drug-delivery devices  

Microsoft Academic Search

A graphical procedure was proposed for the optimum design of transdermal drug-delivery systems enhanced by iontophoresis. Contour plots displayed the relationships among steady-state plasma level, current density and initial drug concentration in a vehicle. This information was combined with a closed-form expression of the process time constant, estimated as the medicament in the blood reaches a plateau after application of

Laurent Simon

36

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that...

2011-04-01

37

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that...

2014-04-01

38

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that...

2013-04-01

39

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that...

2012-04-01

40

77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting...Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Submit either...Rehabilitation Devices Panel of the Medical Devices Advisory Committee....

2012-03-30

41

Food and Drug Administration (FDA) Medical Devices  

NSDL National Science Digital Library

On this site, visitors can learn about the regulations and standards for the production of medical devices in the US. The site is divided into five broad areas: Products and Medical Procedures, Medical Device Safety, Device Advice: Comprehensive Regulatory Assistance, Science and Research, News and Events, and Resources for You. There are also, along the right side of the screen, helpful guides to current recalls and alerts, approvals and clearances, and tools and resources.

42

Microeconomics of Competitiveness Minnesota Medical Device Cluster  

E-print Network

1 Microeconomics of Competitiveness Minnesota Medical Device Cluster Team Members: Adam Wipperfurth........................................................................................................................ 24 Short-Term Action Descriptions...................................................................................................... 35 Medium-Term Action Descriptions

Levinson, David M.

43

Using Zigbee to Integrate Medical Devices  

Microsoft Academic Search

Wirelessly enabling medical devices such as vital signs monitors, ventilators and infusion pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present

Paul Frehill; Desmond Chambers; Cosmin Rotariu

2007-01-01

44

TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their  

E-print Network

and diagnostic medical devices. The next stage of the research project is to explore the use of imagingTECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their users, whether it be healthcare professionals or patients, is an important

Oakley, Jeremy

45

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2010 CFR

...DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892...electronic transfer of medical image data between medical devices. It may include a physical communications...

2010-04-01

46

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

2012-04-01

47

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

2013-04-01

48

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

2011-04-01

49

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

2014-04-01

50

E3 TEST PROTOCOL MEDICAL DEVICES  

E-print Network

E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY AND LOGISTICAL SYSTEMS Ver 5.1 August 2007 Ralph M.1 August 2007 GTRI MDTC TEST PROTOCOL Page 2 E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY or externally worn by the patient. They include Cardiac Pulse Generators (pacemakers and implantable

Bennett, Gisele

51

Medical Devices Policy and the Humanities: Examining Implantable Cardiac Devices  

Microsoft Academic Search

Medical devices are ubiquitous: eyeglasses and intraocular lenses enhance vision; artificial limbs restore mobility; and implanted\\u000a pacemakers and defibrillators treat otherwise debilitating or fatal heart rhythms. Despite the critically important role of\\u000a medical devices in health care, their development, testing, and use raise significant practical and normative issues.\\u000a \\u000a For the most part addressing these issues in the context of medical

Jeremy Sugarman; Courtney S. Campbell; Paul Citron; Susan Bartlett Foote; Nancy M. P. King

52

A novel non-imaging optics based Raman spectroscopy device for transdermal blood analyte measurement  

NASA Astrophysics Data System (ADS)

Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests.

Kong, Chae-Ryon; Barman, Ishan; Dingari, Narahara Chari; Kang, Jeon Woong; Galindo, Luis; Dasari, Ramachandra R.; Feld, Michael S.

2011-09-01

53

[Information safety test of digital medical device].  

PubMed

According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices. PMID:25330611

Liu, Jiong

2014-07-01

54

[The "Global Medical Device Nomenclature": a standard nomenclature for medical devices].  

PubMed

The Global Medical Device Nomenclature is the first European nomenclature available for medical devices. The purpose of a medical device nomenclature system is to facilitate identifying, medical devices. It is a registry composed by 7000 generic terms (preferred terms) for describing and identifying medical devices in an unambiguous manner. Terms are built according to pre-established rules and are assigned with a unique code and a definition. GMDN is the result of a collaborative international work own by the European community also used in USA, Japan or Australia. The main goal of GMDN is to facilitate regulatory data exchange on vigilance. PMID:16142130

Ventura, M; Chambrin, P-Y

2005-08-01

55

Privacy Challenges for Wireless Medical Devices  

SciTech Connect

Implantable medical devices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, we examine existing privacy enhancing algorithms and discuss their applicability to implantable medical devices.

Lagesse, Brent J [ORNL] [ORNL

2010-01-01

56

Anti-malware software and medical devices.  

PubMed

Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices. PMID:21306047

2010-10-01

57

Transdermal drug delivery  

PubMed Central

Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine. PMID:18997767

Prausnitz, Mark R.; Langer, Robert

2009-01-01

58

Mobile medical device connectivity: real world solutions.  

PubMed

Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in developing connectivity for such system based on actual experience with the implementation of wired, wireless, and hybrid systems in active medical environments. PMID:17271027

Pettus, Dan

2004-01-01

59

78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...regulations on premarket approval of medical devices to include requirements relating...purpose of the regulation of medical devices. Furthermore, the comment...

2013-02-19

60

75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...regulations on premarket approval of medical devices to include requirements relating...Premarket Assessment of Pediatric Medical Devices (May 14, 2004);...

2010-04-01

61

76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System  

Federal Register 2010, 2011, 2012, 2013, 2014

...No. FDA-2011-M-0570] Medical Devices; Ophthalmic Devices; Classification...requirements'' for specific medical devices under 21 U.S.C. 360k, even...of Subjects in 21 CFR Part 886 Medical devices. Therefore, under the...

2011-08-19

62

75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...regulations on premarket approval of medical devices to include requirements relating...Premarket Assessment of Pediatric Medical Devices (May 14, 2004);...

2010-04-01

63

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices; expiration of exemptions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.127 Medical devices; expiration of...

2010-04-01

64

76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0294] Reprocessing of Reusable Medical Devices; Public Workshop AGENCY: Food...Reprocessing of Reusable Medical Devices Workshop.'' The purpose of...the reprocessing of reusable medical devices and FDA's plans to...

2011-05-02

65

76 FR 45268 - Reprocessing of Reusable Medical Devices  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0294] Reprocessing of Reusable Medical Devices AGENCY: Food and Drug Administration...the reprocessing of reusable medical devices, including reprocessing quality...the reprocessing of reusable medical devices, reprocessing...

2011-07-28

66

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices; misleading statements. 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements....

2010-04-01

67

76 FR 7220 - Medical Device Innovation Initiative; Request for Comments  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0063] Medical Device Innovation Initiative; Request for Comments AGENCY...comment entitled ``Medical Device Innovation Initiative'' (the report). The...the global leader in medical device innovation and CDRH is committed to assuring...

2011-02-09

68

Medical devices for the anesthetist: current perspectives.  

PubMed

Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use. PMID:24707188

Ingrande, Jerry; Lemmens, Hendrikus Jm

2014-01-01

69

Medical devices for the anesthetist: current perspectives  

PubMed Central

Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use. PMID:24707188

Ingrande, Jerry; Lemmens, Hendrikus JM

2014-01-01

70

Acquisition of medical device start-ups  

E-print Network

Introduction: In the medical device space, a large proportion of the breakthrough inventions are developed by small firms that use private equity to bring their technologies from concept to varying stages of development. ...

Nair, Ganesh R

2006-01-01

71

Using Zigbee to integrate medical devices.  

PubMed

Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors. PMID:18003568

Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

2007-01-01

72

Seal strength models for medical device trays  

E-print Network

OF PHILOSOPHY May 2008 Major Subject: Industrial Engineering SEAL STRENGTH MODELS FOR MEDICAL DEVICE TRAYS A Dissertation by PATRICIA MAYS Submitted to the Office of Graduate Studies of Texas A&M University in partial... Major Subject: Industrial Engineering iii ABSTRACT Seal Strength Models for Medical Device Trays. (May 2008) Patricia Mays, B.S., University of Arkansas at Fayetteville; M.S., University of Arkansas at Fayetteville Chair of Advisory Committee...

Mays, Patricia Faye

2009-05-15

73

A Medical Device Safety Supervision over Wireless  

Microsoft Academic Search

\\u000a Interoperability of medical devices is a growing need in modern healthcare systems, not just for convenience, but also to\\u000a preclude potential human errors during medical procedures. Caregivers, as end users, strongly prefer the use of wireless networks\\u000a for such interconnections between clinical devices due to its seamless connectivity and ease of use\\/maintenance. In [KSM+10], we introduced a Network-Aware Safety Supervisior

Cheolgi Kim; Mu Sun; Heechul Yun; Lui Sha

74

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2010 CFR

...892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a)...

2010-04-01

75

Handheld Diagnostic Device Delivers Quick Medical Readings  

NASA Technical Reports Server (NTRS)

To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

2014-01-01

76

Metrological Support of Medical Laser Devices  

Microsoft Academic Search

The history of laser medicine dates back to the 1970ís. Since that time laser medicine and medical laser engineering have become individual branches of medicine and medical industry. Laser medicine has three main directions: laser therapy, laser surgery, and laser diagnosis. About 100,000 laser devices are presently used in Russia. Therapeutic, surgical, and diagnostic lasers account for 80, 15, and

A. P. Romashkov; A. I. Glazov; S. V. Tikhomirov

2001-01-01

77

Use of mobile devices for medical imaging.  

PubMed

Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. PMID:25467905

Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

2014-12-01

78

Selegiline transdermal system: an examination of the potential for CYP450-dependent pharmacokinetic interactions with 3 psychotropic medications.  

PubMed

Selegiline transdermal system (STS) is a recently approved monoamine oxidase inhibitor antidepressant. This article reports results from 3 studies examining the potential for cytochrome P450-dependent pharmacokinetic interactions between STS and 3 psychotropic medications that might be coadministered. Three open-label, randomized, Latin square, 3-sequence crossover design studies were conducted with healthy volunteers to determine the pharmacokinetic parameters of STS 6 mg/24 h and test drug (alprazolam, olanzapine, or risperidone) when administered alone and concomitantly. All pharmacokinetic parameters of interest were unaltered following selegiline or test drug monotherapy when compared to concomitant therapy. This was confirmed by least squares mean ratios and their 90% confidence intervals of log(e)-transformed C(max) and AUC(tau) values, using either standard bioequivalence criteria of 80% to 125% or study-defined 70% to 143% boundary criteria. These results demonstrate that STS 6 mg/24 h may provide an antidepressant option that is unlikely to result in CYP450-mediated pharmacokinetic drug-drug interactions. PMID:17244765

Azzaro, Albert J; Ziemniak, John; Kemper, Eva; Campbell, Bryan J; VanDenBerg, Chad

2007-02-01

79

Designing Medical Devices for the Ear  

NSDL National Science Digital Library

Students are introduced to engineering, specifically to biomedical engineering and the engineering design process, through a short lecture and an associated hands-on activity in which they design their own medical devices for retrieving foreign bodies from the ear canal. Through the lesson, they learn the basics of ear anatomy and how ear infections occur and are treated. Besides antibiotic treatment, the most common treatment for chronic ear infections is the insertion of ear tubes to drain fluid from the middle ear space to relieve pressure on the ear drum. Medical devices for this procedure, a very common children's surgery, are limited, sometimes resulting in unnecessary complications from a simple procedure. Thus, biomedical engineers must think creatively to develop new solutions (that is, new and improved medical devices/instruments) for inserting ear tubes into the ear drum. The class learns the engineering design process from this ear tube example of a medical device design problem. In the associated activity, students explore biomedical engineering on their own by designing prototype medical devices to solve another ear problem commonly experienced by children: the lodging of a foreign body (such as a pebble, bead or popcorn kernel) in the ear canal. The activity concludes by teams sharing and verbally analyzing their devices.

Biomedical Engineering,

80

Medical ice slurry production device  

DOEpatents

The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

Kasza, Kenneth E. (Palos Park, IL); Oras, John (Des Plaines, IL); Son, HyunJin (Naperville, IL)

2008-06-24

81

Residual ethylene oxide in medical devices and device material.  

PubMed

Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body. With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined. Next, the effect of various extraction conditions and extraction solutions on these polymers and medical devices was evaluated. The results showed different polymers desorb EO differently. One polyurethane (PU 75D) had much higher EO residue than a different polyurethane (PU 80A). Repeated extraction of the PU 75D was necessary to quantify total EO residue levels. Different extraction solutions influence the amount and reproducibility of EO detected, whereas multiple resterilizations showed no difference in amount of residual EO. Bioavailability of EO was estimated by extracting the devices and polymers in water. Comparison of total EO residues to EO that was bioavailable showed no difference for some polymers and devices, while others had an almost eightfold difference. Some standard biocompatibility tests were run on extracts and devices, but no significant effects were observed. PMID:12861606

Lucas, Anne D; Merritt, Katharine; Hitchins, Victoria M; Woods, Terry O; McNamee, Scott G; Lyle, Dan B; Brown, Stanley A

2003-08-15

82

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...  

Federal Register 2010, 2011, 2012, 2013, 2014

...The Medical Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide efficient yet thorough...medical devices quality management systems and other specific regulatory...and will accept the resulting audit reports as a substitute...

2013-11-15

83

Evaluating and Predicting Patient Safety for Medical Devices with  

E-print Network

in medical device use account for a large portion of medical errors. Most of these errors are due safety in medical device use is critical for developing interventions to reduce such errors either errors in medical device use. EHTA divides the task space between the external world of the device

Zhang, Jiajie

84

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee...The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical Devices Advisory...

2011-08-09

85

76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-1997-N-0040] (formerly Docket No. 1997N-0484P) Medical Devices; Neurological Devices; Clarification of Classification...nonsubstantive. List of Subjects in 21 CFR Part 882 Medical devices, Neurological devices. Therefore, under the...

2011-06-24

86

78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2013-02-15

87

76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2011-09-12

88

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2011-06-22

89

76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2011-09-19

90

78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2013-09-09

91

78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2013-11-12

92

77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2012-03-28

93

75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2010-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2010-02-18

94

78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2013-08-13

95

77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2012-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2012-04-27

96

76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2011-10-14

97

77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2012-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2012-03-19

98

75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2010-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

2010-12-27

99

78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2013-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2013-05-02

100

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2010-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2010-09-23

101

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2011-11-21

102

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice...open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee....

2012-03-28

103

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2014 CFR

...a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the...iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical...

2014-04-01

104

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2011 CFR

...a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the...iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical...

2011-04-01

105

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2012 CFR

...a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the...iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical...

2012-04-01

106

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2013 CFR

...a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the...iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical...

2013-04-01

107

Global medical device nomenclature: the concept for reducing device-related medical errors.  

PubMed

In the medical device field, there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process, there is a need for a common method for describing and identifying these medical devices in an unambiguous manner. The Global Medical Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and used locally or nationally for special purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had no impact on improving the overall situation of providing a common platform, whereby, medical devices could be correctly identified and the related data safely exchanged between the involved parties. Work by standard organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature, for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we also make an attempt to explain various aspects of the GMDN system, such as, the process of development of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification (UDI) System. Finally, the current area of focus and vision for the future are also mentioned. PMID:21264103

Anand, K; Saini, Sk; Singh, Bk; Veermaram, C

2010-10-01

108

Global Medical Device Nomenclature: The Concept for Reducing Device-Related Medical Errors  

PubMed Central

In the medical device field, there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process, there is a need for a common method for describing and identifying these medical devices in an unambiguous manner. The Global Medical Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and used locally or nationally for special purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had no impact on improving the overall situation of providing a common platform, whereby, medical devices could be correctly identified and the related data safely exchanged between the involved parties. Work by standard organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature, for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we also make an attempt to explain various aspects of the GMDN system, such as, the process of development of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification (UDI) System. Finally, the current area of focus and vision for the future are also mentioned. PMID:21264103

Anand, K; Saini, SK; Singh, BK; Veermaram, C

2010-01-01

109

Donating and selling used medical equipment. International Medical Device Group.  

PubMed

This position paper was issued by the International Medical Device Group (IMDG) in June 1992. The group includes representatives from Finland, France, Germany, Hungary, Italy, Norway, Sweden, the United Kingdom, and the United States. ECRI is the United States representative and a founding member of IMDG. PMID:1428899

1992-09-01

110

Medical device vigilance systems: India, US, UK, and Australia  

PubMed Central

The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices. PMID:22915923

Gupta, Pooja; Janodia, Manthan D; Jagadish, Puralea C; Udupa, Nayanabhirama

2010-01-01

111

75 FR 16351 - Medical Devices; Technical Amendment  

Federal Register 2010, 2011, 2012, 2013, 2014

...entirety of the regulation at Sec. 1002...amending its regulations at part 1002...Act) (Public Law 90-602...The Safe Medical Devices Act of...SMDA) (Public Law 101- 629...an inadvertent error that this technical...Code of Federal Regulations. FDA...

2010-04-01

112

Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?  

PubMed

It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

Kelley, Peter

2010-01-01

113

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2010 CFR

...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2010-07-01

114

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2014 CFR

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2014-07-01

115

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2012-07-01

116

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2011-07-01

117

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2012-07-01

118

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2012 CFR

...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2012-07-01

119

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2010 CFR

...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2010-07-01

120

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2013-07-01

121

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2014 CFR

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2014-07-01

122

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2014 CFR

...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2014-07-01

123

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

2011-07-01

124

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2010 CFR

...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2010-07-01

125

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2013-07-01

126

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2013 CFR

...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2013-07-01

127

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

2011-07-01

128

78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator  

Federal Register 2010, 2011, 2012, 2013, 2014

...CFR Part 890 [Docket No. FDA-2011-P-0882] Medical Devices; Exemption From Premarket Notification; Class II...not required. List of Subjects in 21 CFR Part 890 Medical devices, Physical medicine devices. Therefore, under...

2013-03-04

129

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices...Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...the public. Name of Committee: Microbiology Devices Panel of the Medical...

2011-03-16

130

Strategic inventory management of externally sourced medical devices  

E-print Network

The purpose of this research was to determine inventory strategies for externally sourced medical devices. In the medical device industry, the desire for high levels of customer service often results in less than optimal ...

Hillstrom, Nichole L. (Nichole Leigh)

2013-01-01

131

Characterization of Therapeutic Coatings on Medical Devices  

NASA Astrophysics Data System (ADS)

Therapeutic coatings on medical devices such as catheters, guide wires, and stents improve biocompatibility by favorably altering the chemical nature of the device/tissue or device/blood interface. Such coatings often minimize tissue damage (reduce friction), decrease chances for blood clot formation (prevent platelet adsorption), and improve the healing response (deliver drugs). Confocal Raman microscopy provides valuable information about biomedical coatings by, for example, facilitating the measurement of the thickness and swelling of frictionreducing hydrogel coatings on catheters and by determining the distribution of drug within a polymer-based drug-eluting coatings on stents. This chapter explores the application of Raman microscopy to the imaging of thin coatings of cross-linked poly(vinyl pyrrolidone) gels, parylene films, mixtures of dexamethasone with various polymethacrylates, and mixtures of rapamycin with hydrolysable (biodegradable) poly(lactide-co-glycolide) polymers. Raman microscopy measures the thickness and swelling of coatings, reveals the degree of mixing of drug and polymer, senses the hydrolysis of biodegradable polymers, and determines the polymorphic forms of drug present within thin therapeutic coatings on medical devices.

Wormuth, Klaus

132

Electrospun PVP-indomethacin constituents for transdermal dressings and drug delivery devices.  

PubMed

A method in layering dressings with a superficial active layer of sub-micrometer scaled fibrous structures is demonstrated. For this, polyvinylpyrolidone (PVP)-indomethacin (INDO) fibres (5% w/v PVP, 5% w/w indomethacin, using a 50:50 ethanol-methanol solvent system) were produced at different flow rates (50 ?L/min and 100 ?L/min) via a modified electrospinning device head (applied voltage varied between 15 ± 2 kV). We further assessed these structures for their morphological, physical and chemical properties using SEM, AFM, DSC, XRD, FTIR and HPLC-UV. The average diameter of the resulting 3D (ca. 500 nm in height) PVP-INDO fibres produced at 50 ?L/min flow rate was 2.58 ± 0.30 ?m, while an almost two-fold increase in the diameter was observed (5.22 ± 0.83 ?m) when the flow rate was doubled. However, both of these diameters were appreciably smaller than the existing dressing fibres (ca. 30 ?m), which were visible even when layered with the active spun fibres. Indomethacin was incorporated in the amorphous state. The encapsulation efficiency was 75% w/w, with complete drug release in 45 min. The advantages are the ease of fabrication and deposition onto any existing normal or functionalised dressing (retaining the original fabric functionality), elimination of topical product issues (application, storage and transport), rapid release of active and controlled loading of drug content (fibre layer). PMID:24997411

Rasekh, Manoochehr; Karavasili, Christina; Soong, Yi Ling; Bouropoulos, Nikolaos; Morris, Mhairi; Armitage, David; Li, Xiang; Fatouros, Dimitrios G; Ahmad, Zeeshan

2014-10-01

133

The Museum of Questionable Medical Devices  

NSDL National Science Digital Library

Featuring items on loan from the U.S. Food and Drug Administration, the American Medical Association, and others, the Minneapolis-based Museum of Questionable Medical Devices is an interesting resource about the history of medicine. From frightening turn-of-the-century phrenology machines to the vibrating "Relaxicisor," taken off the market in 1971, and even an electric shock contraption, "The Stimulator," introduced in 1996, the site features a wide array of machines. Visitors can click on a machine's name and go to a page that includes a photo or illustration, a bit of history of the machine including the date and manufacturer, and a series of related links both to other pages on the museum's site and to outside sites. The links take readers to interesting, informative quackery sites such as Quackwatch.com, Internet Hoax Watch, and the National Council for Reliable Health Information. Well-organized, lively, and information-rich, the Museum of Questionable Medical Devices Website provides a worthwhile diversion.

134

76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Device Recall Authority AGENCY...information collection requirements for medical device recall authority. DATES...and other forms of information technology. Medical Device Recall...

2011-11-16

135

Hacking medical devices a review - biomed 2013.  

PubMed

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as ?hacking?. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (?buggy?) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States. PMID:23686179

Frenger, Paul

2013-01-01

136

75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2010-N-0001] Medical Device Epidemiology Network: Developing Partnership Between...workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership...academic researchers with expertise in epidemiology and health services research on...

2010-03-24

137

The regulation of medical devices and the role of the Medical Devices Agency.  

PubMed

This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the 'New Approach' policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are relatively recent beginning in 1993 for Active Implantable Devices and concluding with the In Vitro Diagnostic Directive implemented in June 2000. The article describes how the directives have been implemented in the UK, the role of the Notified Bodies and the role of the Medical Device Agency (MDA) as the competent authority. In particular the Agency's compliance and standards work is described along with the strategy and post marketing surveillance and adverse incident scheme. The MDA is a key international device regulatory agency and its international role is discussed. So too is its device evaluation programme for the NHS and how this complements the work of NICE. The article also considers the future direction of the MDA and changes in the device sector. PMID:11560554

Jefferys, D B

2001-09-01

138

The regulation of medical devices and the role of the Medical Devices Agency  

PubMed Central

This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the ‘New Approach’ policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are relatively recent beginning in 1993 for Active Implantable Devices and concluding with the In Vitro Diagnostic Directive implemented in June 2000. The article describes how the directives have been implemented in the UK, the role of the Notified Bodies and the role of the Medical Device Agency (MDA) as the competent authority. In particular the Agency's compliance and standards work is described along with the strategy and post marketing surveillance and adverse incident scheme. The MDA is a key international device regulatory agency and its international role is discussed. So too is its device evaluation programme for the NHS and how this complements the work of NICE. The article also considers the future direction of the MDA and changes in the device sector. PMID:11560554

Jefferys, D B

2001-01-01

139

Integrated Microbatteries for Implantable Medical Devices  

NASA Technical Reports Server (NTRS)

Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

Whitacre, Jay; West, William

2008-01-01

140

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare  

E-print Network

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer to receive health care through the use of pervasive medical devices, sensors, and applications, even outside Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer- Communication Networks]: General

Bishop, Matt

141

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare  

E-print Network

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer to receive health care through the use of pervasive medical devices, sensors, and applications, even outside Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer­ Communication Networks]: General

Bishop, Matt

142

Literature Review of Testing Techniques for Medical Device Software  

E-print Network

failures. Finally, we suggest improvements that can help future research studies of complex medical devices Class I recalls? Can research stud- ies on more complicated Medical Cyber-Physical Systems (MCPS) better the SLR method used to query research literature for investigating failures related to medical devices

Xie, Tao

143

Certification and regulatory challenges in medical device software development  

Microsoft Academic Search

The critical nature of safety in medical device software requires a repeatable and compliant software engineering process. This process should take into account the whole development life cycle, risk management, and software verification and validation activities that would commensurate with the device's complexity and risk. This paper discusses some of the key challenges medical device manufacturers are facing in the

Nadica Hrgarek

2012-01-01

144

The radiation resistance of the bioburden from medical devices  

Microsoft Academic Search

An extensive study of the radiation resistance of microbial species constituting the bioburden of a number of different medical devices obtained from Japanese medical device manufacturers has been carried out. A standard protocol for determining radiation resistance was used and validated at the fourteen centres involved in the study. Individual microbial isolates from the bioburden obtained from seven different devices

M. Takehisa; H. Shintani; M. Sekiguchi; T. Koshikawa; T. Oonishi; M. Tsuge; K. Sou; Y. Yamase; S. Kinoshita; H. Tsukamoto; T. Endo; K. Yashima; M. Nagai; K. Ishigaki; Y. Sato; J. L. Whitby

1998-01-01

145

75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food...requirements for the tracking of medical devices. DATES: Submit either electronic...currently undertaking this effort. Medical Devices; Device Tracking--21...

2010-11-12

146

77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Neurological Devices Panel of the Medical Devices Advisory Committee...multilumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

2012-11-16

147

77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Neurological Devices Panel of the Medical Devices Advisory Committee...multi-lumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

2012-10-11

148

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices...FDA) is postponing the meeting of the Immunology Devices Panel of the Medical Devices...meeting is postponed so that FDA can review and consider additional information...

2011-09-07

149

MEDEMAS -Medical Device Management and Maintenance System Architecture  

NASA Astrophysics Data System (ADS)

In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the service technician to carry out and report maintenance/repair processes via remote access. Thus predicted future failures are possible to prevent or minimize. Maintenance and repair is essential for patient safety and proper functioning of the medical devices, as it prevents performance decrease of the devices, deterioration of the equipment, and detrimental effects on the health of a patient, the user or other interacting people. The study aims to make the maintenance process more accurate, more efficient, faster and easier to manage and organize; and much less confusing. The accumulated history of medical devices and maintenance personnel helps efficient facility planning.

Dogan, Ülkü Balc?; Dogan, Mehmet Ugur; Ülgen, Yekta; Özkan, Mehmed

150

Medical-device complication reporting. A quality assurance mechanism.  

PubMed

As the primary users of medical devices, nurses have a responsibility to report device-related problems to the federal government's Device Experience Network (DEN). The procedures for reporting these problems are described. Nurses wishing to conduct research into problems with medical devices may wish to access the DEN data base. A Food and Drug Administration study using DEN data to study central venous catheter complications is offered as an example of this data base's role in research. PMID:2341963

Scott, W L

1990-01-01

151

Medical device reporting: electronic submission requirements. Final rule.  

PubMed

The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). PMID:24611205

2014-02-14

152

AC electrokinetic platform for iontophoretic transdermal drug delivery  

Microsoft Academic Search

Iontophoretic and electroporation transdermal delivery modes of ionic drugs have been utilized in a number of clinical and biomedical devices. However, applications of these methods have been found challenging for the delivery of many non polar and high molecular weight clinically important drugs. The main goal of the present study is to investigate whether transdermal transport of non polar macromolecular

Vadim F. Lvovich; Ellen Matthews; Alan T. Riga; Lakshmi Kaza

2010-01-01

153

77 FR 72924 - Taxable Medical Devices  

Federal Register 2010, 2011, 2012, 2013, 2014

...that 21 CFR part 876 (Gastroenterology- Urology Devices) be removed from the list of...21 CFR part 876 (Gastroenterology--Urology Devices), 21 CFR part 878 (General...21 CFR part 876 (Gastroenterology--Urology Devices) and product code EXH. The...

2012-12-07

154

76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0754] Pediatric Medical Devices; Public Workshop; Request for...establish pediatric indications for medical devices. The topics to be discussed...pediatric effectiveness claims for medical devices and pediatric device...

2011-11-01

155

77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2012-04-05

156

78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2013-03-18

157

76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2011-07-07

158

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2013-05-23

159

76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2011-10-07

160

76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2011-03-16

161

Medical device regulations and testing for toxicologic pathologists.  

PubMed

Awareness of the regulatory environment is fundamental to understanding the biological assessment of biomaterials and medical devices. Medical devices are a diverse and heterogeneous group of medical products and technologies defined by the lack of chemical action or requirement for metabolism. Regional activity and the Global Harmonization Task Force are now working on harmonizing the categorization and testing of medical devices. The International Organization for Standardization (ISO) has published 19 standards for biological evaluation. ISO 10993 standards are generally accepted outright or as an alternative to most national regulatory directives or acts, although Japan and the United States require more stringency in some tests. Type of materials, intended use, and risk are the basis for drafting testing programs for biomaterials and medical devices. With growth of the medical device industry and advent of new biomaterials and technologies, the need for toxicologic pathologists in safety (biocompatibility) and efficacy (conditions of use) evaluation of moderate- to high-risk devices is expanding. Preclinical evaluation of biomaterials and medical devices increasingly requires a basic understanding of materials science and bioengineering to facilitate interpretation of complex interface reactions between biomaterials, cellular and secretory factors, and vascular and tissue responses that modulate success or failure of medical devices. PMID:18337222

Schuh, Joann C L

2008-01-01

162

[Comparison of the software safety evaluation methods in medical devices].  

PubMed

The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe. PMID:21179714

Yu, Sicong; Pan, Ying; Yu, Xiping; Zhu, Yinfeng

2010-09-01

163

The regulation of cognitive enhancement devices: extending the medical model  

PubMed Central

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. PMID:25243073

Maslen, Hannah; Douglas, Thomas; Cohen Kadosh, Roi; Levy, Neil; Savulescu, Julian

2014-01-01

164

Component-Based App Design for Platform-Oriented Devices in a Medical Device Coordination Framework*  

E-print Network

, a set of reconfigurable, component- based software apps was developed to address medical devicesComponent-Based App Design for Platform-Oriented Devices in a Medical Device Coordination Framework and reconfigurable hardware/software components will allow these systems to adapt to changing patient/provider needs

Huth, Michael

165

Home Healthcare Medical Devices: A Checklist  

MedlinePLUS

... know how your device works. * Read your patient education information. * Ask your doctor or supplier questions about your device and take notes. * Ask what you need to operate your device. - Do you need electricity, running water, telephone, or computer connections to operate your device? * Check to see ...

166

Extraction and stability of ethylene oxide residue in medical devices.  

PubMed

Ethylene oxide (EO) gas is commonly used to sterilize medical devices. A major concern is the amount of residue that may remain on or in the device and be available in the body. Some standards (ASTMF619 and ISO 10993-12) recommend using two different extraction solutions (one polar, one nonpolar), for sample preparation prior to testing medical devices. However, ISO 10993-7 recommends water to process medical devices to determine EO residual levels. To address this, EO residual levels were examined in different extraction solutions. EO residual levels from devices and materials extracted with different solutions were evaluated. Results from this study indicate little difference between extraction solutions of water, cell culture media, and serum (less than 30% difference). Given the increased cost and increased background noise of media or serum over water, using only water to process medical devices and materials for EO residues appears adequate. PMID:18257644

Lucas, Anne D; Stratmeyer, Melvin E

2008-01-01

167

Transdermal patches: history, development and pharmacology.  

PubMed

Transdermal patches are now widely used as cosmetic, topical and transdermal delivery systems. These patches represent a key outcome from the growth in skin science, technology and expertise developed through trial and error, clinical observation and evidence-based studies that date back to the first existing human records. This review begins with the earliest topical therapies and traces topical delivery to the present-day transdermal patches, describing along the way the initial trials, devices and drug delivery systems that underpin current transdermal patches and their actives. This is followed by consideration of the evolution in the various patch designs and their limitations as well as requirements for actives to be used for transdermal delivery. The properties of and issues associated with the use of currently marketed products, such as variability, safety and regulatory aspects, are then described. The review concludes by examining future prospects for transdermal patches and drug delivery systems, such as the combination of active delivery systems with patches, minimally invasive microneedle patches and cutaneous solutions, including metered-dose systems. PMID:25560046

Pastore, Michael N; Kalia, Yogeshvar N; Horstmann, Michael; Roberts, Michael S

2015-05-01

168

MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 121 Biological, Medical Devices  

E-print Network

MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 121 Biological, Medical Devices and Systems........................................................................................143 #12;122 Biological & Medical MTL ANNUAL RESEARCH REPORT 2014 #12;MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 123 Vital signs such as heart rate, blood pressure, blood ox- ygenation, cardiac output

Reif, Rafael

169

75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 [Docket No. FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer...

2010-07-20

170

77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR...Medical Devices; Immunology and Microbiology Devices; Classification of...Reagents; Correction AGENCY: Food and Drug Administration, HHS...2012 (76 FR 14272), the Food and Drug Administration...

2012-04-02

171

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...  

Federal Register 2010, 2011, 2012, 2013, 2014

...OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR...Medical Devices; Immunology and Microbiology Devices; Classification of...System; Correction AGENCY: Food and Drug Administration, HHS...SUMMARY: The Food and Drug Administration...

2011-04-21

172

78 FR 15878 - Taxable Medical Devices; Correction  

Federal Register 2010, 2011, 2012, 2013, 2014

...Clinical Toxicology Devices) and product code NBW. The FDA classifies the lancets under 21 CFR part 878 (General and Plastic Surgery Devices) and product code FMK. The blood glucose monitors and test strips are included in the FDA's online...

2013-03-13

173

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices...the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical...

2011-07-19

174

Assuring the Safety, Security, and Reliability of Medical-Device Cyber-  

E-print Network

Assuring the Safety, Security, and Reliability of Medical-Device Cyber- Physical Systems (MDCPS Finance Healthcare Transportation Energy Large-scale Infrastructure ... #12;Monitoring Medical Devices Treatment Delivery Medical Devices Smart Alarm Caregiver Patient Smart Controller Decision Support (ICE

Hu, Fei

175

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...Use § 801.125 Medical devices for use in teaching, law enforcement, research, and...

2011-04-01

176

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...Use § 801.125 Medical devices for use in teaching, law enforcement, research, and...

2012-04-01

177

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...Use § 801.125 Medical devices for use in teaching, law enforcement, research, and...

2013-04-01

178

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...Use § 801.125 Medical devices for use in teaching, law enforcement, research, and...

2014-04-01

179

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices for processing, repacking...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.122 Medical devices for processing,...

2010-04-01

180

78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...  

Federal Register 2010, 2011, 2012, 2013, 2014

...and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and...and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and...parties of the development of medical devices for the treatment of morbid...

2013-11-20

181

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.125 Medical devices for use in teaching, law...

2010-04-01

182

78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic...and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic...parties of the development of medical devices for the treatment of morbid...

2013-09-13

183

21 CFR 801.5 - Medical devices; adequate directions for use.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices; adequate directions for use...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for...

2010-04-01

184

21 CFR 801.15 - Medical devices; prominence of required label statements.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices; prominence of required label...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required...

2010-04-01

185

76 FR 22805 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities  

Federal Register 2010, 2011, 2012, 2013, 2014

...Formerly Docket No. 2006N-0109) Medical Devices; Reclassification of the Topical...1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and...system for the regulation of medical devices intended for human use....

2011-04-25

186

75 FR 36092 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Devices: Current Good Manufacturing...recordkeeping requirements related to the medical devices current good manufacturing practice...forms of information technology. Medical Devices: Current Good...

2010-06-24

187

78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Devices; Third-Party Review Under...information collection associated with medical devices third-party review under the...forms of information technology. Medical Devices; Third-Party Review...

2013-07-09

188

76 FR 36989 - Medical Devices; Exception From General Requirements for Informed Consent  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. 2003N-0355)] Medical Devices; Exception From General Requirements...final rule (IFR) entitled ``Medical Devices; Exception From General Requirements...creates requirements for specific medical devices under 21 U.S.C. 360k....

2011-06-24

189

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices having commonly known directions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.116 Medical devices having commonly known...

2010-04-01

190

77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop  

Federal Register 2010, 2011, 2012, 2013, 2014

...Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop...following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended...events/FDA_OOPD_Pediatric_Medical_Devices_Workshop. Please note...

2012-07-26

191

78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Devices Current Good Manufacturing Practice...recordkeeping requirements related to the medical devices current good manufacturing practice...forms of information technology. Medical Devices Current Good Manufacturing...

2013-07-31

192

75 FR 57801 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Collection; Comment Request; Medical Devices Third-Party Review Under the...information collection in ``Medical Devices Third- Party Review under the...forms of information technology. Medical Devices Third-Party Review Under...

2010-09-22

193

42 CFR 419.66 - Transitional pass-through payments: Medical devices.  

Code of Federal Regulations, 2010 CFR

...Transitional pass-through payments: Medical devices. 419.66 Section 419...Transitional pass-through payments: Medical devices. (a) General rule. CMS...treatment. (3) Except for medical devices identified in paragraph...

2010-10-01

194

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2011 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2011-07-01

195

31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2011 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 538.526...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices to the...

2011-07-01

196

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2014 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2014-07-01

197

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2013 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2013-07-01

198

31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2010 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 538.526...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices to the...

2010-07-01

199

31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2010 CFR

...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

2010-07-01

200

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2013 CFR

... Calculation of patent term extension for a medical device. 1.777 Section... Calculation of patent term extension for a medical device. (a) If a...321). (b) The term of the patent for a medical device will be...

2013-07-01

201

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2014 CFR

... Calculation of patent term extension for a medical device. 1.777 Section... Calculation of patent term extension for a medical device. (a) If a...321). (b) The term of the patent for a medical device will be...

2014-07-01

202

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2010 CFR

... Calculation of patent term extension for a medical device. 1.777 Section... Calculation of patent term extension for a medical device. (a) If a...321). (b) The term of the patent for a medical device will be...

2010-07-01

203

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2011 CFR

... Calculation of patent term extension for a medical device. 1.777 Section... Calculation of patent term extension for a medical device. (a) If a...321). (b) The term of the patent for a medical device will be...

2011-07-01

204

37 CFR 1.777 - Calculation of patent term extension for a medical device.  

Code of Federal Regulations, 2012 CFR

... Calculation of patent term extension for a medical device. 1.777 Section... Calculation of patent term extension for a medical device. (a) If a...321). (b) The term of the patent for a medical device will be...

2012-07-01

205

76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0062] Medical Device Innovation Initiative; Public Meeting; Request...entitled ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The...CDRH) document, ``Medical Device Innovation Initiative'' (report). FDA is...

2011-02-09

206

78 FR 58316 - Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Issues in Developing Medical Devices for Pediatric...Issues in Developing Medical Devices for Pediatric...Drug Evaluation and Research's workshop entitled...the following broad topics associated with medical devices for the...

2013-09-23

207

77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...  

Federal Register 2010, 2011, 2012, 2013, 2014

...this mission is to monitor medical devices and radiological products...challenges of rapidly evolving medical devices and the changing nature...care delivery and information technology. In their report entitled ``Medical Devices and the...

2012-08-30

208

Green manufacturing in the medical device industry : a case study  

E-print Network

Introduction: Med Dev (name changed to protect confidentiality), is a medical device start-up using tissue engineering and drug delivery techniques to help combat the negative effects associated with secondary injury. Med ...

Gautreau, Leigh (Leigh Ann)

2009-01-01

209

Characteristics of disruptive innovation within the medical device industry  

E-print Network

Innovation within the medical device industry had led to tremendous advances in the provision of care for patients worldwide. Continued progress in the treatment of disease will require effective processes for managing and ...

Berlin, David B. (David Benjamin)

2011-01-01

210

Modeling medical devices for plug-and-play interoperability  

E-print Network

One of the challenges faced by clinical engineers is to support the connectivity and interoperability of medical-electrical point-of-care devices. A system that could enable plug-and-play connectivity and interoperability ...

Hofmann, Robert Matthew

2007-01-01

211

Quality management for the processing of medical devices  

PubMed Central

Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

Klosz, Kerstin

2008-01-01

212

A system theoretic approach to design safety into medical device  

E-print Network

The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic ...

Song, Qingyang S.M. Massachusetts Institute of Technology

2012-01-01

213

Integrated programmable current source for implantable medical devices  

Microsoft Academic Search

In this paper an integrated current source is presented. The source is digitally programmable and can be used on implantable medical devices. It was designed in AMI C5 (0.5 mum) technology, and it is currently under fabrication.

Juan Osta; Julio Suárez; Matías Miguez; Alfredo Arnaud

2009-01-01

214

Factors influencing FDA clearance time for medical device 510(k)  

E-print Network

Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review ...

Koert, Andrew J. (Andrew James)

2010-01-01

215

Factors influencing the time for FDA review of medical devices  

E-print Network

Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application ...

Singh, Inder Raj, S.M. Massachusetts Institute of Technology

2007-01-01

216

77 FR 69488 - Medical Devices; Custom Devices; Request for Comments  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA) is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the...in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for...

2012-11-19

217

Buying Medical Devices and Diagnostic Tests Online  

MedlinePLUS

... opportunities for consumers to receive new information and new offers of legitimate medical products. Unfortunately, it is difficult to examine an Internet business in the same way as you would a ...

218

Development of Implantable Medical Devices: From an Engineering Perspective  

PubMed Central

From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

2013-01-01

219

78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance...Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers...

2013-06-14

220

75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility...announced the public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and...

2010-09-01

221

Risk evaluation of medical and industrial radiation devices  

Microsoft Academic Search

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis

E. D. Jones; R. E. Cunningham; P. A. Rathbun

1994-01-01

222

Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration  

E-print Network

The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July ...

Wolf, Daniel W. (Daniel William)

2010-01-01

223

Current and proposed EMC tests for medical devices  

Microsoft Academic Search

As the electromagnetic spectrum becomes more congested the need for electromagnetic compatibility (EMC) among electrical and electronic equipment becomes more and more important. Also, because of the proliferation of electronic devices, these devices must work in close proximity to, and with each other. By virtue of its usage, electrical and electronic medical equipment must perform as intended and not emit

G. Fenical

1994-01-01

224

Medical device electromagnetic interference problems: A limited review  

Microsoft Academic Search

Incidents of degraded medical device performance caused by electromagnetic interference (EMI) continue to be reported to the Food and Drug Administration (FDA). The reasons for renewed efforts at the FDA to reduce device susceptibility are listed. Case studies describing the effects of EMI, magnetic fields, and electrostatic discharge (ESD) are presented.

William H. Midgette; Jeffrey L. Silberberg

1992-01-01

225

Dynamic Service Composition for Plug-and-Play Medical Devices  

Microsoft Academic Search

\\u000a Object: Clinical environments are crowded with technology where devices from multiple vendors run into interoperability barriers.\\u000a Systems of integrated medical devices support improvements in workflow and reductions in medical errors and healthcare costs\\u000a to the benefit of patients throughout the continuum of care.\\u000a \\u000a \\u000a Methods: Interoperability is achieved using a middleware for ubiquitous computing based on a service-oriented architecture.\\u000a Connected devices

F. C. Pop; M. F. Vaida; M. Cremene; M. Riveill; C. Puia

226

Medical devices in dermatology using DLP technology from Texas Instruments  

NASA Astrophysics Data System (ADS)

The market of medical devices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

Kock, M.; Lüllau, F.

2012-03-01

227

Development of wearable medical device for Bio-MEMS  

NASA Astrophysics Data System (ADS)

Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medical device used for blood sugar control. The new type compact medical device comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 ?m in internal diameter, was measured. The wearable medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 ?l/sec. If the wearable medical device extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15?l/sec.

Nakanishi, Naoyuki; Yamamoto, Hidetake; Tsuchiya, Kazuyoshi; Uetsuji, Yasutomo; Nakamachi, Eiji

2006-01-01

228

Transdermal Photopolymerization for Minimally Invasive Implantation  

NASA Astrophysics Data System (ADS)

Photopolymerizations are widely used in medicine to create polymer networks for use in applications such as bone restorations and coatings for artificial implants. These photopolymerizations occur by directly exposing materials to light in "open" environments such as the oral cavity or during invasive procedures such as surgery. We hypothesized that light, which penetrates tissue including skin, could cause a photopolymerization indirectly. Liquid materials then could be injected s.c. and solidified by exposing the exterior surface of the skin to light. To test this hypothesis, the penetration of UVA and visible light through skin was studied. Modeling predicted the feasibility of transdermal polymerization with only 2 min of light exposure required to photopolymerize an implant underneath human skin. To establish the validity of these modeling studies, transdermal photopolymerization first was applied to tissue engineering by using "injectable" cartilage as a model system. Polymer/chondrocyte constructs were injected s.c. and transdermally photopolymerized. Implants harvested at 2, 4, and 7 weeks demonstrated collagen and proteoglycan production and histology with tissue structure comparable to native neocartilage. To further examine this phenomenon and test the applicability of transdermal photopolymerization for drug release devices, albumin, a model protein, was released for 1 week from photopolymerized hydrogels. With further study, transdermal photpolymerization potentially could be used to create a variety of new, minimally invasive surgical procedures in applications ranging from plastic and orthopedic surgery to tissue engineering and drug delivery.

Elisseeff, J.; Anseth, K.; Sims, D.; McIntosh, W.; Randolph, M.; Langer, R.

1999-03-01

229

Medical device development: managing conflicts of interest encountered by physicians.  

PubMed

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary report of those discussions. PMID:17390305

Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

2007-04-01

230

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter  

E-print Network

of device data into medical records. In addition, large-scale research projects such as the Medical DeviceAn Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter Dan.Spees,Raoul.Jetley,PaulL.Jones, Sandy.Weininger}@fda.hhs.gov March 7, 2009 Abstract Medical devices historically have been monolithic

Huth, Michael

231

Assessment of cardiovascular and noncardiovascular medical device recalls.  

PubMed

Medical device recalls have called attention to the device approval process in the United States. The premarket approval (PMA) process requires clinical trials to evaluate safety and effectiveness, whereas the expedited 510(k) process does not. The 510(k) process has been considered a source of increased recalls. This study aimed to assess the relative safety of medical device approval pathways based on the numbers of approvals and recalls. Data on recalls in the United States from January 2005 to December 2012 were collected from the Food and Drug Administration Web site. Over 8 years, 30,002 devices were approved, 5,728 by PMA (19%) and 24,274 (81%) by 510(k). There were 249 recalls due to serious risks, 0.45% of PMA approvals, and 0.92% of 510(k)-cleared devices, p <0.001. Over 1/2 of the recalls were during the first 2 years on the market. Percentage of recalled PMA devices was unchanged over the 8 years, whereas 510(k) recalls increased in 2010 to 2012 (from 0.65% to 1.39%, p <0.001). Cardiovascular devices represent the largest class of recalls (27%). The proportions of recalled PMA and 510(k) cardiovascular devices were the same as for all medical devices until 2011, but 510(k) recalls dramatically decreased in 2012 to the lowest recall rate seen (0.73%). In conclusion, recall rates were the same for 510(k)- and PMA-approved devices in 2005 to 2009 and increased for 510(k) devices subsequently. Modifying the 510(k) process with more rigorous performance testing, a conditional 2-year approval and a mandatory registry may be an approach to reduce recalls. PMID:24837271

Somberg, John C; McEwen, Pauline; Molnar, Janos

2014-06-01

232

Component-based app design for platform-oriented devices in a medical device coordination framework  

Microsoft Academic Search

Frameworks that promote the intelligent coordination of medical devices are required in ubiquitous health care environments. Such environments are essential to achieve closed-loop behavior, and an emphasis on interoperability standards and reconfigurable hardware\\/software components will allow these systems to adapt to changing patient\\/provider needs and technologies. Intelligent medical system design often focuses on smart, complex on-device algorithms. This paper addresses

Kejia Li; Steve Warren; John Hatcliff

2012-01-01

233

Implantable photonic devices for improved medical treatments  

NASA Astrophysics Data System (ADS)

An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

2014-10-01

234

Implantable photonic devices for improved medical treatments.  

PubMed

An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient’s body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment. PMID:25279540

Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

2014-01-01

235

76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA/Xavier University Global Medical Device Conference.'' This 3-day...those engaged in FDA-regulated medical devices (for humans) with information...Market Access. Using Electronic Medical Records. Cooperative Research...

2011-03-22

236

Battery power comparison to charge medical devices in developing countries  

Microsoft Academic Search

Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution.

Alesia M. Casanova; Andrew S. Bray; Taylor A. Powers; Amit J. Nimunkar; John G. Webster

2009-01-01

237

77 FR 41417 - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices  

Federal Register 2010, 2011, 2012, 2013, 2014

...Considerations for Medical Countermeasure Radiation Biodosimetry Devices AGENCY: Food and...Considerations for Medical Countermeasure (MCM) Radiation Biodosimetry Devices.'' The purpose...challenges for performance validation of radiation biodosimetry devices. Date and...

2012-07-13

238

Aspects of serial communication in a network of medical devices  

Microsoft Academic Search

Patient treatment in any hospital may require perfusion devices. Modern technology in this area is related to electronic-controlled devices that can be remotely accessed from a central place (guarding room). Because electromagnetic radiation is a big issue in medical world, remote access solutions must be wire-based, and RS485 serial communication is an effective solution. As part of a research project

Andrei Drumea; Alexandru Vasile

2006-01-01

239

Medical devices and procedures in the hyperbaric chamber.  

PubMed

The aim of this paper is to present current controversies concerning the safety of medical devices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medical devices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medical devices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers. PMID:25596835

Kot, Jacek

2014-12-01

240

Medical Devices Assess, Treat Balance Disorders  

NASA Technical Reports Server (NTRS)

You may have heard the phrase as difficult as walking and chewing gum as a joking way of referring to something that is not difficult at all. Just walking, however, is not all that simple physiologically speaking. Even standing upright is an undertaking requiring the complex cooperation of multiple motor and sensory systems including vision, the inner ear, somatosensation (sensation from the skin), and proprioception (the sense of the body s parts in relation to each other). The compromised performance of any of these elements can lead to a balance disorder, which in some form affects nearly half of Americans at least once in their lifetimes, from the elderly, to those with neurological or vestibular (inner ear) dysfunction, to athletes with musculoskeletal injuries, to astronauts returning from space. Readjusting to Earth s gravity has a significant impact on an astronaut s ability to balance, a result of the brain switching to a different "model" for interpreting sensory input in normal gravity versus weightlessness. While acclimating, astronauts can experience headaches, motion sickness, and problems with perception. To help ease the transition and study the effects of weightlessness on the body, NASA has conducted many investigations into post-flight balance control, realizing this research can help treat patients with balance disorders on Earth as well. In the 1960s, the NASA-sponsored Man Vehicle Laboratory at the Massachusetts Institute of Technology (MIT) studied the effects of prolonged space flight on astronauts. The lab s work intrigued MIT doctoral candidate Lewis Nashner, who began conducting NASA-funded research on human movement and balance under the supervision of Dr. Larry Young in the MIT Department of Aeronautics and Astronautics. In 1982, Nashner s work resulted in a noninvasive clinical technique for assessing the cooperative systems that allow the body to balance, commonly referred to as computerized dynamic posturography (CDP). CDP employs a series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.

2009-01-01

241

Microscale metal additive manufacturing of multi-component medical devices  

Microsoft Academic Search

Purpose – The purpose of this paper is to familiarize the reader with the capabilities of EFAB technology, a unique additive manufacturing process which yields fully assembled, functional mechanisms from metal on the micro to millimeter scale, and applications in medical devices. Design\\/methodology\\/approach – The process is based on multi-layer electrodeposition and planarization of at least two metals: one structural

Adam Cohen; Richard Chen; Uri Frodis; Ming-Ting Wu; Chris Folk

2010-01-01

242

MEMS integration for smart medical devices: opportunities and challenges  

Microsoft Academic Search

In the insatiable quest for miniaturization, improved performance, novel sensing and treatments capabilities, implantable medical devices are now required to integrate micro-nano systems. As they enter the biomedical world, MEMS are facing new challenges such as biocompatibility, perpetual reliability and extended life span. We will discuss how these disciplines are now converging to broaden the scope of perspectives for healthcare

Martin Deterre; Sorin CRM SAS

2012-01-01

243

Medical Devices: The Therac25 \\Lambda Nancy Leveson  

E-print Network

on the Therac­25 software development, management, and quality control procedures are not available. What reserved. 1 #12; App. A -- Medical Devices: The Therac­25 2 healthy tissue. Relatively shallow tissue in the Therac­20 and that CGR developed the initial software. Software functionality was limited in both

Leveson, Nancy

244

Defending Resource Depletion Attacks on Implantable Medical Devices  

E-print Network

Defending Resource Depletion Attacks on Implantable Medical Devices Xiali Hei, Xiaojiang Du, Jie Wu and storage. In this research, we identify a new kind of attacks on IMDs - Resource Depletion (RD) attacks that could deplete IMD resources (e.g., battery power) quickly. The RD attacks could reduce the lifetime

Wu, Jie

245

Defending Resource Depletion Attacks on Implantable Medical Devices  

Microsoft Academic Search

Implantable Medical Devices (IMDs) have been widely used to treat chronic diseases such as cardiac arrhythmia and diabetes. Many IMDs are enabled with wireless communication capabilities and can communicate with an outside programmer\\/reader wirelessly. With the rapid growth of IMDs, IMD security becomes a critical issue since attacks on IMDs may directly harm the patient. Typical IMDs have very limited

Xiali Hei; Xiaojiang Du; Jie Wu; Fei Hu

2010-01-01

246

Perinatal Staff Nurse Medical Device Use and Education.  

ERIC Educational Resources Information Center

Survey responses from 48 perinatal nurses found that most learned about medical devices by reading manuals; 75% had received inservice training; and 95% learned from other staff. Inadequate knowledge was related to fear of causing patient harm. Initial learning method influenced what was learned, and hands-on experience was considered efficacious.…

McConnell, Edwina A.

1998-01-01

247

The 1995 Medical Device Technology raw materials survey.  

PubMed

Using information supplied by manufacturers, this article reports on the use of raw materials and compounding and conversion practices in the European medical device manufacturing industry. The findings of the survey provide an indication of which materials are being used and how frequently, and the process of selecting suppliers. PMID:10155397

Pearson, L S

1995-09-01

248

The future with the UK Medical Devices Agency.  

PubMed

The medical device industry is facing a period of profound change and opportunity. This is partly arising from rapid developments in various fields of science and technology and partly from sociological and perceptual changes in society. One regulatory agency describes how it is responding to the challenge. PMID:11317870

Jefferys, D

2001-01-01

249

MATCH Guide towards User Involvement in Medical Device Technology  

E-print Network

MATCH Guide towards User Involvement in Medical Device Technology Assessment P3 D10 V1 050429 Ian Multidisciplinary Assessment of Technology Centre for Health #12;EXECUTIVE SUMMARY Introduction This guide provides of published literature drawing on engineering, ergonomics, healthcare and social sciences. Aims · Map

Oakley, Jeremy

250

78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...and Drug Administration [Docket No. FDA-2013-N-0001] Ear, Nose and Throat Devices Panel of the Medical Devices Advisory...The meeting will be open to the public. Name of Committee: Ear, Nose and Throat Devices Panel of the Medical Devices...

2013-10-23

251

Image Quality Characteristics of Handheld Display Devices for Medical Imaging  

PubMed Central

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10?5 mm2 at 1 mm?1, while handheld displays have values lower than 3.7×10?6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

2013-01-01

252

75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...documents for 11 neurological and physical medicine devices. FDA is reopening the comment...documents for 11 neurological and physical medicine devices. Interested persons were...

2010-07-28

253

Perspectives on transdermal ultrasound mediated drug delivery  

PubMed Central

The use of needles for multiple injection of drugs, such as insulin for diabetes, can be painful. As a result, prescribed drug noncompliance can result in severe medical complications. Several noninvasive methods exist for transdermal drug delivery. These include chemical mediation using liposomes and chemical enhancers or physical mechanisms such as microneedles, iontophoresis, electroporation, and ultrasound. Ultrasound enhanced transdermal drug delivery offers advantages over traditional drug delivery methods which are often invasive and painful. A broad review of the transdermal ultrasound drug delivery literature has shown that this technology offers promising potential for noninvasive drug administration. From a clinical perspective, few drugs, proteins or peptides have been successfully administered transdermally because of the low skin permeability to these relatively large molecules, although much work is underway to resolve this problem. The proposed mechanism of ultrasound has been suggested to be the result of cavitation, which is discussed along with the bioeffects from therapeutic ultrasound. For low frequencies, potential transducers which can be used for drug delivery are discussed, along with cautions regarding ultrasound safety versus efficacy. PMID:18203426

Smith, Nadine Barrie

2007-01-01

254

[The EU medical device market process and enlightenment for the review].  

PubMed

European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer. PMID:25241519

Luo, Qingfeng

2014-05-01

255

Transdermal iontophoresis. Part I: Basic principles and considerations.  

PubMed

The skin has increasingly become a route for the delivery of drugs with a range of compounds being considered for transdermal delivery generating a great deal of interest in this area of research. The passive delivery of most compounds across the skin is limited due to the barrier properties afforded by stratum corneum, the outermost layer of the skin. Transdermal iontophoresis is an effective technique for physically facilitating the transport of permeants across the skin by using electromotive force. It is being extensively explored as a potential means for delivery of hydrophilic, large and charged molecules and is also believed to be a future method of choice for peptides and proteins. In this context, this review focuses mainly on the basic principles and considerations of transdermal iontophoresis with particular emphasis on modeling, devices and parameters influencing transdermal iontophoresis. PMID:10327395

Nair, V; Pillai, O; Poduri, R; Panchagnula, R

1999-03-01

256

Management information system of medical equipment using mobile devices  

NASA Astrophysics Data System (ADS)

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

Núñez, C.; Castro, D.

2011-09-01

257

The role of the user within the medical device design and development process: medical device manufacturers' perspectives  

PubMed Central

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised. PMID:21356097

2011-01-01

258

Ethylene oxide sterilization of medical devices: a review.  

PubMed

Ethylene oxide (EO) is a well-known sterilizing agent. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development and sterilization. This paper describes the progress in terms of EO sterilization and concludes that it remains a promising field to explore and develop. The EO action mechanism and toxicity are analyzed, and a critical analysis is made on how it is possible to use EO sterilization for medical devices advantageously, with emphasis on cycle design and validation. One huge challenge is related with the development of mathematical models to integrate lethality to allow a continuous increase of process flexibility, without compromising its safety. The scientific community should also focus on other important issues, such as EO diffusion in different substrates, taking into account different environmental conditions both for sterilization and aeration. PMID:17980234

Mendes, Gisela C C; Brandão, Teresa R S; Silva, Cristina L M

2007-11-01

259

Antimicrobial selenium nanoparticle coatings on polymeric medical devices  

NASA Astrophysics Data System (ADS)

Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

Tran, Phong A.; Webster, Thomas J.

2013-04-01

260

Printable thermoelectric devices and conductive patterns for medical applications  

NASA Astrophysics Data System (ADS)

Remote point-of-care is expected to revolutionize the modern medical practice, and many efforts have been made for the development of wireless health monitoring systems for continuously detecting the physiological signals of patients. To make the remote point-of-care generally accepted and widely used, it is necessary to develop cost-effective and durable wireless health monitoring systems. Printing technique will be helpful for the fabrication of high-quality and low-cost medical devices and systems because it allows high-resolution and high-speed fabrication, low material consumption and nano-sized patterning on both flexible and rigid substrates. Furthermore, application of thermoelectric generators can replace conventional batteries as the power sources for wireless health monitoring systems because thermoelectric generators can convert the wasted heat or the heat from nature into electricity which is required for the operation of the wireless health monitoring systems. In this research, we propose the concept of printable thermoelectric devices and conductive patterns for the realization of more portable and cost-effective medical devices. To print thermoelectric generators and conductive patterns on substrates, printing inks with special characteristics should be developed. For the development of thermoelectric inks, nano-structured thermoelectric materials are synthesized and characterized; and for the development of conductive inks, two kinds of surface treated carbon nanotubes are used as active materials.

Lee, Jungmin; Kim, Hyunjung; Chen, Linfeng; Choi, Sang H.; Varadan, Vijay K.

2012-10-01

261

Inductively Heated Shape Memory Polymer for the Magnetic Actuation of Medical Devices  

E-print Network

Presently there is interest in making medical devices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medical devices is the implementation ...

Buckley, Patrick R.

2007-01-23

262

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.  

Code of Federal Regulations, 2011 CFR

... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

2011-04-01

263

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.  

Code of Federal Regulations, 2010 CFR

... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

2010-04-01

264

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-P-0804] Medical Devices; Exemption From Premarket Notification: Powered...Pub. L. 94-295)), as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101- 629)),...

2012-06-01

265

21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.  

Code of Federal Regulations, 2010 CFR

...false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs...42 Restrictions on use for further manufacture of medical devices. (a) In addition to labeling requirements...

2010-04-01

266

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration [Docket No. FDA-2011-P-0882] Medical Devices; Exemption From Premarket Notification: Wheelchair...Pub. L. 94-295)), as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101- 629)),...

2012-06-01

267

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2013 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2013-07-01

268

31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2012 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 560.533 Section 560.533 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2012-07-01

269

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2014 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2014-07-01

270

31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.  

Code of Federal Regulations, 2012 CFR

... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

2012-07-01

271

42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.  

Code of Federal Regulations, 2011 CFR

...Services § 410.36 Medical supplies, appliances, and devices...for the following medical supplies, appliances and devices...including colostomy bags and supplies directly related to colostomy...section requires a written physician order before delivery of...

2011-10-01

272

75 FR 61494 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use...requirements for the collection ``Recommended Glossary and Educational Outreach to Support Use...technology. Medical Devices: Recommended Glossary and Educational Outreach to Support...

2010-10-05

273

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.  

Code of Federal Regulations, 2011 CFR

21 Food and Drugs 8 2011-04-01... Medical devices for processing, repacking, or manufacturing... Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION... Medical devices for processing, repacking, or...

2011-04-01

274

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.  

Code of Federal Regulations, 2013 CFR

21 Food and Drugs 8 2013-04-01... Medical devices for processing, repacking, or manufacturing... Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION... Medical devices for processing, repacking, or...

2013-04-01

275

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.  

Code of Federal Regulations, 2012 CFR

21 Food and Drugs 8 2012-04-01... Medical devices for processing, repacking, or manufacturing... Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION... Medical devices for processing, repacking, or...

2012-04-01

276

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.  

Code of Federal Regulations, 2014 CFR

21 Food and Drugs 8 2014-04-01... Medical devices for processing, repacking, or manufacturing... Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION... Medical devices for processing, repacking, or...

2014-04-01

277

21 CFR 801.150 - Medical devices; processing, labeling, or repacking.  

Code of Federal Regulations, 2010 CFR

21 Food and Drugs 8 2010-04-01...Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Other Exemptions...

2010-04-01

278

21 CFR 801.150 - Medical devices; processing, labeling, or repacking.  

Code of Federal Regulations, 2013 CFR

21 Food and Drugs 8 2013-04-01...Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Other Exemptions...

2013-04-01

279

21 CFR 801.150 - Medical devices; processing, labeling, or repacking.  

Code of Federal Regulations, 2011 CFR

21 Food and Drugs 8 2011-04-01...Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Other Exemptions...

2011-04-01

280

21 CFR 801.150 - Medical devices; processing, labeling, or repacking.  

Code of Federal Regulations, 2014 CFR

21 Food and Drugs 8 2014-04-01...Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Other Exemptions...

2014-04-01

281

21 CFR 801.150 - Medical devices; processing, labeling, or repacking.  

Code of Federal Regulations, 2012 CFR

21 Food and Drugs 8 2012-04-01...Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Other Exemptions...

2012-04-01

282

77 FR 24716 - Scientific Information Request on Medical Devices To Treat Otitis Media With Effusion  

Federal Register 2010, 2011, 2012, 2013, 2014

...Request on Medical Devices To Treat Otitis Media With Effusion AGENCY: Agency for Healthcare...submissions from manufacturers of otitis media with effusion medical devices, such as...Comparative Effectiveness Review of Otitis Media with Effusion (OME) Treatments,...

2012-04-25

283

75 FR 8375 - Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public...Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging.'' The...unnecessary patient exposure to ionizing radiation during CT and fluoroscopic...

2010-02-24

284

78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2013-N-0007] Medical Device User Fee Rates for Fiscal Year 2014 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal...

2013-08-02

285

77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2012-N-0785] Medical Device User Fee Rates for Fiscal Year 2013 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2013. The Federal...

2012-07-31

286

76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal...

2011-08-01

287

76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0002] Medical Device Epidemiology Network 2011: Second Annual Public...workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second...all stakeholders with expertise in epidemiology and health services research on...

2011-03-30

288

76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices  

Federal Register 2010, 2011, 2012, 2013, 2014

...Quality Scientific Information Request on Pressure Ulcer Treatment Medical Devices AGENCY...information submissions from manufacturers of pressure ulcer treatment medical devices, such...Ultrasonic wound care systems, negative pressure therapy units, turning &...

2011-12-01

289

[The management of implantable medical device and the application of the internet of things in hospitals].  

PubMed

Implantable medical device is a special product which belongs to medical devices. It not only possesses product characteristics in common, but also has specificity for safety and effectiveness. Implantable medical device must be managed by the relevant laws and regulations of the State Food and Drug Administration. In this paper, we have used cardiac pacemakers as an example to describe the significance of the management of implantable medical device products and the application of the internet of things in hospitals. PMID:22379772

Zhou, Li; Xu, Liang

2011-11-01

290

78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2013-N-0118] Extreme Weather Effects on Medical Device Safety and Quality...studying the potential effects of extreme weather and natural disasters on medical device...request for comments on the topic of extreme weather effects on medical device safety and...

2013-02-21

291

77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug...entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with...technology. Medical Device User Fee Cover Sheet--Form FDA 3601 (OMB Control...

2012-06-06

292

Not a minor problem: involving adolescents in medical device design research  

Microsoft Academic Search

This article outlines how adolescents are currently overlooked as a specific user group of medical devices and positions the contribution that ergonomics (human factors) can make in mitigating this issue. Details are provided of the current barriers to adolescent inclusion in medical device design research. The discussion then provides guidance and suggested strategies for researchers, clinical staff and medical device

Alexandra R. Lang; Jennifer L. Martin; Sarah Sharples; John A. Crowe; Elizabeth Murphy

2012-01-01

293

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory...meeting of the Molecular and Clinical Genetics Panel (the panel) of the Medical Devices...meeting of the Molecular and Clinical Genetics Panel of the Medical Devices...

2011-04-01

294

A Systems Theoretic Application to Design for the Safety of Medical Diagnostic Devices  

E-print Network

A Systems Theoretic Application to Design for the Safety of Medical to Design for the Safety of Medical Diagnostic Devices by Vincent H, there is a need for a new approach to design safety into medical systems

Leveson, Nancy

295

78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food...Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food...RF) wireless technology in medical devices. This guidance discusses...

2013-08-14

296

77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...  

Federal Register 2010, 2011, 2012, 2013, 2014

...and Drug Administration Staff; Medical Devices: The Pre-Submission Program...the draft guidance entitled ``Medical Devices: The Pre- Submission Program...Exemption (IDE) program) for medical devices reviewed in the Center for...

2012-07-13

297

34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.  

Code of Federal Regulations, 2010 CFR

...components of surgically implanted medical devices. 300.113 Section 300...components of surgically implanted medical devices. (a) Hearing aids. ...components of surgically implanted medical devices. (1) Subject to...

2010-07-01

298

21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Medical devices; name and place of business...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of...

2010-04-01

299

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2010 CFR

...alternatives to labeling requirements for medical devices held by the Strategic National...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...alternatives to labeling requirements for medical devices held by the Strategic...

2010-04-01

300

76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods...

2011-05-02

301

Transdermal delivery of therapeutic agent  

NASA Technical Reports Server (NTRS)

A device for the transdermal delivery of a therapeutic agent to a biological subject that includes a first electrode comprising a first array of electrically conductive microprojections for providing electrical communication through a skin portion of the subject to a second electrode comprising a second array of electrically conductive microprojections. Additionally, a reservoir for holding the therapeutic agent surrounding the first electrode and a pulse generator for providing an exponential decay pulse between the first and second electrodes may be provided. A method includes the steps of piercing a stratum corneum layer of skin with two arrays of conductive microprojections, encapsulating the therapeutic agent into biocompatible charged carriers, surrounding the conductive microprojections with the therapeutic agent, generating an exponential decay pulse between the two arrays of conductive microprojections to create a non-uniform electrical field and electrokinetically driving the therapeutic agent through the stratum corneum layer of skin.

Kwiatkowski, Krzysztof C. (Inventor); Hayes, Ryan T. (Inventor); Magnuson, James W. (Inventor); Giletto, Anthony (Inventor)

2008-01-01

302

A systems approach to improving patient safety through medical device purchasing  

E-print Network

safety from a systems perspective, acknowledging that medical device errors are not only directly related to device design, but to the design of the healthcare delivery service system in which the device operates. Little evidence exists of successfully...

Hinrichs, Saba

2010-10-12

303

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and...controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls...

2010-04-05

304

75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction...of draft guidance documents for 11 neurological and physical medicine devices. The document was published with an inadvertent...

2010-08-06

305

Assessment and Non-clinical Impact of Medical Devices.  

PubMed

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion. PMID:25747839

Dervaux, Benoît; Szwarcensztein, Karine; Josseran, Anne; Barna, Alexandre; Carbonneil, Cédric; Chevrie, Karine; Debroucker, Frédérique; Grumblat, Anne; Grumel, Olivier; Massol, Jacques; Maugendre, Philippe; Méchin, Hubert; Orlikowski, David; Roussel, Christophe; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Vicaut, Eric

2015-01-01

306

Development of medical electronic devices in the APL space department  

NASA Technical Reports Server (NTRS)

Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.

Newman, A. L.

1985-01-01

307

Challenges to validation of a complex nonsterile medical device tray.  

PubMed

Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers. PMID:25046511

Prince, Daniel; Mastej, Jozef; Hoverman, Isabel; Chatterjee, Raja; Easton, Diana; Behzad, Daniela

2014-01-01

308

Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices  

NASA Astrophysics Data System (ADS)

Atmospheric pressure plasma sources produce a multiplicity of different antimicrobial agents and are applicable to even complicated geometries as well as to heat sensitive materials. Thus, atmospheric pressure plasmas have a huge potential for the decontamination of even complex medical devices like central venous catheters and endoscopes. In this paper we present practicable realizations of atmospheric pressure plasma sources, namely plasma jet, dielectric barrier discharge and microwave driven discharge that are able to penetrate fine lumen or are adaptable to difficult geometries. Furthermore, the antimicrobial efficacy of these sources is given for one example setup in each case.

Weltmann, Klaus-Dieter; Winter, Jörn; Polak, Martin; Ehlbeck, Jörg; von Woedtke, Thomas

309

Polymeric biomaterials for load-bearing medical devices  

NASA Astrophysics Data System (ADS)

This paper aims to give a broad overview of the challenges that are faced in load-bearing medical devices and focuses specifically on the challenges faced in utilizing polymeric materials in such applications. Three specific cases are given in the field of polymeric biomaterials. These cases build in complexity and initiate with examination of the evolution of intravascular catheter design in which the materials, properties, and processing have been optimized to develop a system that can be used in an angioplasty procedure with little concern of clinical failure.

Pruitt, Lisa; Furmanski, Jevan

2009-09-01

310

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

PubMed

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"). PMID:23243983

Matsuoka, Atsuko

2012-01-01

311

Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging  

NASA Astrophysics Data System (ADS)

Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun

2014-02-01

312

A wireless network sensor and server architecture for legacy medical devices  

Microsoft Academic Search

Modern medical devices have the facility to output data such as device settings and readings. Such devices include vital signs monitors, ventilators and infusion pumps to name a few. Wirelessly networking these types of devices has the advantages of patient mobility, device mobility and central data storage. This has led us to develop wireless sensors, gateways, servers and clients to

Paul Frehill; Desmond Chambers; Cosmin Rotariu

2008-01-01

313

Managing equipment failures: nursing practice requirements for meeting the challenges of the Safe Medical Devices Act.  

PubMed

The Safe Medical Devices Act (SMDA) has two major effects for the user facilities: the reporting of specific medical device-related incidents and the tracking of medical devices through the user facility. As the final ruling becomes effective in 1996, it is imperative that healthcare professionals take an active role in identifying the effects of the SMDA and the impact that it poses on healthcare facilities. This article supports nursing's role in developing a medical device tracking process. Included in the overall plan to promote the user supporting system successfully are such ideas as employee education about medical equipment safety, development of unit-based medical device resource materials for employees to access, and promotion of the steps for reporting a medical device malfunction. PMID:9060352

Cuthrell, P

1996-01-01

314

MEDICAL TECHNOLOGY ASSESSMENT: THE USE OF THE ANALYTIC HIERARCHY PROCESS AS A TOOL FOR MULTIDISCIPLINARY EVALUATION OF MEDICAL DEVICES  

Microsoft Academic Search

Most types of medical technology assessments are performed after the technology has been developed. Consequently, they have only minor effects on changes in clinical practice. Our study introduces a new method of constructive medical technology assessment that can change the development and diffusion of a medical device to improve its later effectiveness in clinical practice. The method, based on Saaty's

HUMMEL JM

315

Transdermal delivery of ketorolac.  

PubMed

A reservoir type transdermal patch for delivery of ketorolac, a potent analgesic agent was studied. The low permeability of skin is the rate-limiting step for delivery of most of the drugs. Studies were carried out to investigate the effect of permeation enhancers on the in vitro permeation of ketorolac across rat skin. The reservoir type transdermal patch was fabricated and the core was filled with gel system of a non ionic polymer HPMC (hydroxypropyl methyl cellulose) formulated in PBS (phosphate buffer saline) solution of pH of 5.4 along with isopropyl alcohol at 25% w/w concentration. Various permeation enhancers' viz. dimethyl sulphoxide, d-limonene, eucalyptus oil and transcutol (diethylene glycol monoethyl ether) were incorporated into the gel system. Permeation enhancement of ketorolac with different enhancers followed the order eucalyptus oil> transcutol> DMSO> d-limonene. Cyclic terpene containing eucalyptus oil was found to be the most promising chemical permeation enhancer for transdermal delivery of ketorolac. The increase in concentration of eucalyptus oil further enhanced drug permeation with maximum flux being achieved at 10% w/w of 66.38 microg/cm(2)/h. Further enhancement of permeation rate of ketorolac across skin was attained by application of abrading gel containing crushed apricot seed onto the skin. There was 5.16 times enhancement and flux of 93.10 microg/cm(2)/h was attained. A reservoir type transdermal patch for delivery of ketorolac thus appears to be feasible of delivering ketorolac across skin. PMID:19252396

Amrish, Chandra; Kumar, Sharma Pramod

2009-03-01

316

Current status and future potential of transdermal drug delivery  

Microsoft Academic Search

The past twenty five years have seen an explosion in the creation and discovery of new medicinal agents. Related innovations in drug delivery systems have not only enabled the successful implementation of many of these novel pharmaceuticals, but have also permitted the development of new medical treatments with existing drugs. The creation of transdermal delivery systems has been one of

Mark R. Prausnitz; Samir Mitragotri; Robert Langer

2004-01-01

317

Transdermal Therapeutic Systems with Indomethacin  

Microsoft Academic Search

Several years ago we developed a hydrophilic matrix for the transdermal supply of drugs to the organism through intact skin. Most of the matrices employed in the commercial transdermal therapeutic systems (TTSs) are of a hydrophobic nature (silicon, rubber, etc.). The proposed hydrophilic matrix offers a number of significant advantages over hydrophobic counterparts. The material exhibits a higher biocompatibility and

A. E. Vasil'ev; I. I. Krasnyuk; S. Ravikumar; O. O. Maksimenko

2001-01-01

318

Varying the Wear Time of the Methylphenidate Transdermal System in Children with Attention-Deficit/Hyperactivity Disorder  

ERIC Educational Resources Information Center

A study investigated the impact of variable wear times of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder (ADHD). It was concluded that duration of medication effect was directly related to the wear time of the methylphenidate transdermal system patch.

Wilens, Timothy E.; Boellner, Samuel W.; Lopez, Frank A.; Turnbow, John M.; Wigal, Sharon B.; Childress, Ann C.; Abikoff, Howard B.; Manos, Michael J.

2008-01-01

319

EDI system definition for a European medical device vigilance system.  

PubMed

EDI is expected to be the dominant form of business communication between organizations moving to the Electronic Commerce era of 2000. The healthcare sector is already using EDI in the hospital supply function as well as in the clinical area and the reimbursement process. In this paper, we examine the use of EDI in the healthcare administration sector and more specifically its application to the Medical Device Vigilance System. Firstly, the potential of this approach is examined, followed by the definition of the EDI System Reference Model and the specification of the required system architecture. Each of the architecture's components are then explained in more detail, followed by the most important implementation options relating to them. PMID:9062886

Doukidis, G; Pallikarakis, N; Pangalos, G; Vassilacopoulos, G; Pramataris, K

1996-01-01

320

Pressure-sensitive adhesives for transdermal drug delivery systems  

Microsoft Academic Search

Adhesives are a critical component in transdermal drug delivery (TDD) devices. In addition to the usual requirements of functional adhesive properties, adhesives for TDD applications must have good biocompatibility with the skin, chemical compatibility with the drug, various components of the formulation, and provide consistent, effective delivery of the drug. This review discusses the three most commonly used adhesives (polyisobutylenes,

Hock S Tan; William R Pfister

1999-01-01

321

Evaluation of the medical device approval lag between the United States and the European Union  

E-print Network

The United States is the world leader in development and manufacture of medical devices. Even with this leadership position, there is evidence that the US is often not the first country to have new medical technology ...

Dhavale, Todd V

2011-01-01

322

Safety-Ensured Coordination of Networked Medical Devices in MDPnP  

E-print Network

to generate medical errors [2]. As revealed in [2], medical errors are the leading cause of death and injury the human error-induced ac- cidents. This increasing demand has led to the establishment of the MedicalSafety-Ensured Coordination of Networked Medical Devices in MDPnP Tao Li, and Jiannong Cao

Hu, Fei

323

Effective use of transdermal drug delivery in children.  

PubMed

Transdermal administration offers a non-invasive and convenient method for paediatric drug delivery. The competent skin barrier function in term infants and older children limits both water loss and the percutaneous entry of chemicals including drugs; but the smaller doses required by children eases the attainment of therapeutic concentrations. Transdermal patches used in paediatrics include fentanyl, buprenorphine, clonidine, scopolamine, methylphenidate, oestrogens, nicotine and tulobuterol. Some patches have paediatric labelling supported by clinical trials whereas others are used unlicensed. Innovative drug delivery methods, such as microneedles and sonophoresis are being tested for their safety and efficacy; needleless injectors are primarily used to administer growth hormone; and two iontophoretic devices were approved for paediatrics. In contrast, the immature and rapidly evolving skin barrier function in premature neonates represents a significant formulation challenge. Unfortunately, this population group suffers from an absence of approved transdermal formulations, a shortcoming exacerbated by the significant risk of excessive drug exposure via the incompletely formed skin barrier. PMID:24333231

Delgado-Charro, M Begoña; Guy, Richard H

2014-06-01

324

Mn-porphyrin derivatives as an antioxidant for medical devices.  

PubMed

It is well known that reactive oxygen species such as O*2- and H2O2 induce the biodegradation or cracking of medical devices in vivo or that they are released from inflammatory cells activated by devices to oxidize low-density lipoprotein. Therefore, the development of a novel antioxidant is required to eliminate the reactive oxygen species. In this paper, we report that Mn-porphyrin derivatives containing a macromolecular Mn-porphyrin are relatively stable compounds that can eliminate O*2- and/or H2O2. The dismutation of O*2- in the porphyrins was determined using a cytochrome c-assay by the xanthine/xanthine oxidase system and using the stopped-flow kinetic analysis technique. The possibility of porphyrins as scavengers of H2O2 was evaluated by in situ measurement with a Clark electrode. As a result, it has been found that Mn-porphyrin derivatives may be a vastly better scavenger of reactive oxygen species in vivo. PMID:10574608

Ohse, T; Kawakami, H; Morita, A; Nagaoka, S

1999-01-01

325

Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump  

MedlinePLUS

... Home Use Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump ... therapy. What do you do before using your infusion pump? Read your pump's Instructions for Use and ...

326

Biologically inspired artificial haircell sensors Today's engineering systems, such as machines, vehicles, robots, medical devices, home  

E-print Network

, such as machines, vehicles, robots, medical devices, home appliances and entertainment devices, are often sensor and system engineering. I will illustrate a few examples of sensors inspired by nature, including biomimetic

Valero-Cuevas, Francisco

327

77 FR 27234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2012-N-0427] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY: Food and Drug Administration, HHS. ACTION:...

2012-05-09

328

Encryption on the air : non-Invasive security for implantable medical devices  

E-print Network

Modern implantable medical devices (IMDs) including pacemakers, cardiac defibrillators and nerve stimulators feature wireless connectivity that enables remote monitoring and post-implantation adjustment. However, recent ...

Al-Hassanieh, Haitham (Haitham Zuhair)

2011-01-01

329

Skin tolerability associated with transdermal drug delivery systems: an overview  

Microsoft Academic Search

As transdermal patches become more widely prescribed, it is important that clinicians understand: (a) the common causes of\\u000a skin reactions with these medications; (b) how to minimize these reactions; and (c) how to manage the signs and symptoms.\\u000a Here we review published data for skin reactions with patch medications approved within the past decade. Overall, the most\\u000a common application site

Iris Ale; Jean-Marie Lachapelle; Howard I. Maibach

2009-01-01

330

Methodological choices for the clinical development of medical devices.  

PubMed

Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the clinical development of MDs. PMID:25285025

Bernard, Alain; Vaneau, Michel; Fournel, Isabelle; Galmiche, Hubert; Nony, Patrice; Dubernard, Jean Michel

2014-01-01

331

Devices for medical diagnosis with GaN lasers  

NASA Astrophysics Data System (ADS)

This paper presents laser-induced fluroescence method (LIF) employing endogenous ("autofluroescence") and exogenous fluorophores. LIF is applied for clinical diagnosis in dermatology, gynaecology, urology, lung tumors as well as for early dentin caries. We describe the analysers with He-Ne, He-Cd, and SHG Nd:YAG lasers and new generation systems based on blue semiconductor GaN lasers that have been implemented into clinical practice till now. The LIF method, fundamental one for many medical applications, with excitation radiation of wavelength 400 nm could be appl,ied only using tunable dye lasers or titanium lasers adequte for laboratory investigations. Development of GaN laser shows possibility to design portable, compact diagnostic devices as multi-channel analysers of fluorescence spectra and surface imaging devoted to clinical application. The designed systems used for spectra measurement and registration of fluorescence images include lasers of power 5-30 mW and generate wavelengths of 405-407 nm. They are widely used in PDT method for investigation of superficial distribution of accumulation kinetics of all known photosensitizers, their elimination, and degradation as well as for treatment of superficial lesions of mucosa and skin. Excitation of exogenous porphrins in Soret band makes possible to estimate their concentration and a period of healthy skin photosensitivity that occurs after photosensitiser injections. Due to high sensitivity of spectrum analysers, properties of photosensitisers can be investigated in vitro (e.g. their aggregation, purity, chromatographic distributions) when their concentrations are 2-3 times lower in comparison to concentrations investigated with typical spectrofluorescence methods. Dentistry diagnosis is a new field in which GaN laser devices can be applied. After induction with blue light, decreased autofluorescence intensity can be observed when dentin caries occur and strong characteristic bands of endogenous porphyrines when parodentosis or dental plaque are present.

Kwasny, Miroslaw; Mierczyk, Zygmunt

2003-10-01

332

26 CFR 48.4191-2 - Taxable medical device.  

Code of Federal Regulations, 2013 CFR

...and Throat Devices), 21 CFR part 876 (Gastroenterology—Urology Devices), 21 CFR part 878 (General and Plastic Surgery...ileostomy bags under 21 CFR part 876 (Gastroenterology—Urology Devices) and product code EXH. The urinary ileostomy...

2013-04-01

333

Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device  

PubMed Central

Purpose This study investigates the psychosocial aspects of adolescent medical device use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medical device use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medical device use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medical devices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents’ needs to form their own identity and have autonomy. Conclusion This study shows that adolescent needs regarding medical device use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals. PMID:24669187

Lang, Alexandra R; Martin, Jennifer L; Sharples, Sarah; Crowe, John A

2014-01-01

334

A risk management capability model for use in medical device companies  

Microsoft Academic Search

Medical device software is a risky business. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. It is therefore no surprise that regulators throughout the world are penalising medical device manufacturers that do not demonstrate that sufficient attention is devoted to the areas of hazard analysis and risk management (RM) throughout the

John Burton; Fergal McCaffery; Ita Richardson

2006-01-01

335

21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.  

Code of Federal Regulations, 2011 CFR

... 2010-04-01 true Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food...Disease Agents § 610.42 Restrictions on use for further manufacture of medical devices. (a) In addition to...

2011-04-01

336

Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method  

Technology Transfer Automated Retrieval System (TEKTRAN)

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially life-threatening infections. Other types of medical devices such as bronchoscopes and duod...

337

75 FR 33315 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2010-N-0268] Dental Products Panel of the Medical Devices...open to the public. Name of Committee: Dental Products Panel of the Medical Devices...the final rule on the classification of dental amalgam, which published in the...

2010-06-11

338

10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.  

Code of Federal Regulations, 2010 CFR

...10 Energy 1 2010-01-01 2010-01-01 false Suppliers for sealed sources or devices for medical use. 35.49...MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For...

2010-01-01

339

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December 1, 2011. The meeting was announced in the Federal Register of Friday, October 7, 2011 (76 FR 62419). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future......

2011-10-20

340

Dosing considerations with transdermal formulations of fentanyl and buprenorphine for the treatment of cancer pain  

PubMed Central

Opioids continue to be first-line pharmacotherapy for patients suffering from cancer pain. Unfortunately, subtherapeutic dosage prescribing of pain medications remains common, and many cancer patients continue to suffer and experience diminished quality of life. A large variety of therapeutic options are available for cancer pain patients. Analgesic pharmacotherapy is based on the patient’s self-report of pain intensity and should be tailored to meet the requirements of each individual. Most, if not all, cancer pain patients will ultimately require modifications in their opioid pharmacotherapy. When changes in a patient’s medication regimen are needed, adequate pain control is best maintained through appropriate dosage conversion, scheduling immediate release medication for withdrawal prevention, and providing as needed dosing for breakthrough pain. Transdermal opioids are noninvasive, cause less constipation and sedation when compared to oral opioids, and may improve patient compliance. A relative potency of 100:1 is recommended when converting the patient from oral morphine to transdermal fentanyl. Based on the limited data available, there is significant interpatient variability with transdermal buprenorphine and equipotency recommendations from oral morphine of 75:1–110:1 have been suggested. Cancer patients may require larger transdermal buprenorphine doses to control their pain and may respond better to a more aggressive 75–100:1 potency ratio. This review outlines the prescribing of transdermal fentanyl and transdermal buprenorphine including how to safely and effectively convert to and use them for those with cancer pain. PMID:25170278

Skaer, Tracy L

2014-01-01

341

On a microfabricated Ti-alloy-based microneedle array for transdermal drug delivery  

Microsoft Academic Search

Transdermal drug delivery is a promising approach that allows controlled release of drug over time while avoiding possible degradation due to the gastrointestinal tract or first-pass liver effect. Of many different methods have been employed in transdermal drug delivery, microneedle is a widely explored MEMS-based device that can conveniently penetrate the skin and thus create micrometer-scale openings for drug absorption.

Wensheng Hou; B. Das; Yingtao Jiang; Shizhi Qian; Xiaolin Zheng; Jun Yang; Xitian Pi; Hongying Liu; Jun Zheng; Yi Zhang

2008-01-01

342

Pharmacokinetics of transdermally delivered clonidine  

Microsoft Academic Search

We detail a series of pharmacokinetic investigations to determine the dose linearity, the effect of site of application, the duration of steady-state plasma concentrations, and the effect of chronic application when clonidine is administered transdermally. Dose linearity was assessed in six subjects with normotension after application of increasing sizes of transdermal clonidine systems (3.5, 7.0, and 10.5 cm2 size) to

Thomas R MacGregor; Kandace M Matzek; James J Keirns; Rudolf G A van Wayjen; Abraham van den Ende; Rudolf G L van Tol

1985-01-01

343

How New Technologies Can Help Create Better UI's for Medical Devices  

Microsoft Academic Search

Since medical devices are often linked to the alarmingly high rate of medical accidents, it is speculated that newer advanced\\u000a user interface related technologies might mitigate some accidents. This paper describes some positive as well as negative\\u000a consequences of incorporating advanced technologies with particular emphasis on technologies that directly impact the design\\u000a and usability of medical device user interfaces. Notably,

William H. Muto; Edmond W. Israelski

2007-01-01

344

Technology Advances and Challenges in Hermetic Packaging for Implantable Medical Devices  

Microsoft Academic Search

\\u000a Many implantable medical devices contain sophisticated electronic circuits. Hermetic packaging is required to provide the\\u000a implant’s electronic circuitry with protection from the harsh environment of the human body. This chapter provides a review\\u000a of available hermetic sealing methods and their applications. General considerations of implantable medical device packaging\\u000a are discussed. Various testing methods applicable to the packaging of implantable medical

Guangqiang Jiang; David D. Zhou

2010-01-01

345

75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2010-N-0389] Medical Device User Fees; Public Meeting...notice, FDA requested input and comments from interested...the Agency's medical user fee program and requested...public docket to seek input and comments from interested...the Agency's medical user fee program and...

2010-10-18

346

Medication Reminder Device for the Elderly Patients With Mild Cognitive Impairment  

Microsoft Academic Search

Reminder devices reportedly improve medication adherence in the elderly patients with mild dementia; however, the efficacy of such devices remains unexplored. Therefore, a 3-month before and after study with convenience sampling was conducted to determine the efficacy of a medication reminder device used by 18 participants (aged 81.2 ± 6.2 years) with Clinical Dementia Rating scores of 0.5 or 1.

Tomoko Kamimura; Rina Ishiwata; Takenobu Inoue

2012-01-01

347

Silicone surface with drug nanodepots for medical devices.  

PubMed

An ideal surface of poly(dimethylsiloxane) (PDMS) medical devices requires sustained drug release to combat various tissue responses and infection. At present, a noncovalent surface coating with drug molecules using binders possesses a detachment problem, while covalently linking drug molecules to the surface provides no releasable drug. Here, a platform that allows the deposition of diverse drugs onto the PDMS surface in an adequate quantity with reliable attachment and a sustained-release character is demonstrated. First, a PDMS surface with carboxyl functionality (PDMS-COOH) is generated by subjecting a PDMS piece to an oxygen plasma treatment to obtain silanol moieties on its surface, then condensing the silanols with (3-aminopropyl)triethoxysilane molecules to generate amino groups, and finally reacting the amino groups with succinic anhydride. The drug-loaded carriers with hydroxyl groups on their surface can then be esterified to PDMS-COOH, resulting in a PDMS surface covalently grafted with drug-filled nanocarriers so that the drugs inside the securely grafted carriers can be released. Demonstrated here is the covalent linking of the surface of a PDMS endotracheal tube with budesonide-loaded ethylcellulose nanoparticles. A secure and high drug accumulation at the surface of the tubes (0.025 mg/cm2) can be achieved without changes in its bulk property such as hardness (Shore-A), and sustained release of budesonide with a high release flux during the first week followed by a reduced release flux over the subsequent 3 weeks can be obtained. In addition, the grafted tube possesses more hydrophilic surface and thus is more tissue-compatible. The grafted PDMS pieces show a reduced in vitro inflammation in cell culture and a lower level of in vivo tissue responses, including a reduced level of inflammation, compared to the unmodified PDMS pieces, when implanted in rats. Although demonstrated with budesonide and a PDMS endotracheal tube, this platform of grafting a PDMS surface with drug-loaded particles can be applied to other drugs and other devices. PMID:25314005

Mokkaphan, Jiratchaya; Banlunara, Wijit; Palaga, Tanapat; Sombuntham, Premsuda; Wanichwecharungruang, Supason

2014-11-26

348

MedMon: securing medical devices through wireless monitoring and anomaly detection.  

PubMed

Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices. PMID:24473551

Zhang, Meng; Raghunathan, Anand; Jha, Niraj K

2013-12-01

349

Simulating acceleration from stereophotogrammetry for medical device design.  

PubMed

When designing a medical device based on lightweight accelerometers, the designer is faced with a number of questions in order to maximize performance while minimizing cost and complexity: Where should the inertial unit be located? How many units are required? How is performance affected if the unit is not correctly located during donning? One way to answer these questions is to use position data from a single trial, captured with a nonportable measurement system (e.g., stereophotogrammetry) to simulate measurements from multiple accelerometers at different locations on the body. In this paper, we undertake a thorough investigation into the applicability of these simulated acceleration signals via a series of interdependent experiments of increasing generality. We measured the dynamics of a reference coordinate frame using stereophotogrammetry over a number of trials. These dynamics were then used to simulate several "virtual" accelerometers at different points on the body segment. We then compared the simulated signals with those directly measured to evaluate the error under a number of conditions. Finally, we demonstrated an example of how simulated signals can be employed in a system design application. In the best case, we may expect an error of 0.028 m/s2 between a derived virtual signal and that directly measured by an accelerometer. In practice, however, using centripetal and tangential acceleration terms (that are poorly estimated) results in an error that is an order of magnitude greater than the baseline. Furthermore, nonrigidity of the limb can increase error dramatically, although the effects can be reduced considerably via careful modeling. We conclude that using simulated signals has definite benefits when an appropriate model of the body segment is applied. PMID:19449956

Tresadern, Philip A; Thies, Sibylle B; Kenney, Laurence P J; Howard, David; Smith, Christine; Rigby, Julie; Goulermas, John Y

2009-06-01

350

Polymeric microdevices for transdermal and subcutaneous drug delivery.  

PubMed

Low cost manufacturing of polymeric microdevices for transdermal and subcutaneous drug delivery is slated to have a major impact on next generation devices for administration of biopharmaceuticals and other emerging new formulations. These devices range in complexity from simple microneedle arrays to more complicated systems incorporating micropumps, micro-reservoirs, on-board sensors, and electronic intelligence. In this paper, we review devices currently in the market and those in the earlier stages of research and development. We also present two examples of the research in our laboratory towards using phase change liquids in polymeric structures to create disposable micropumps and the development of an elastomeric reservoir for MEMS-based transdermal drug delivery systems. PMID:23000744

Ochoa, Manuel; Mousoulis, Charilaos; Ziaie, Babak

2012-11-01

351

[Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application].  

PubMed

Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context. PMID:25370170

Lauer, Wolfgang; Stößlein, E; Brinker, A; Broich, K

2014-12-01

352

JAMA Patient Page: FDA Authorization of Medical Devices  

MedlinePLUS

... standards. • Class II devices usually undergo a 510(k) review , which focuses on determining whether the new ... is “substantially equivalent” to an existing device. 510(k) reviews usually do not require clinical trials to ...

353

Transdermal Opioids for Cancer Pain Management  

Microsoft Academic Search

•The prevalence of pain in cancer is up to 90%, more than 45% of this can be adequately managed using the World Health Organisation three step analgesic ladder.•Transdermal opioids are safe, effective, and produce significantly fewer side effects than oral morphine when used for moderate to severe cancer pain.•Transdermal buprenorphine has a lower incidence of systemic side effects than transdermal

Rohan Hasmukh Vithlani; Ganesan Baranidharan

2010-01-01

354

78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...encourage public comments regarding standard content and format for medical device labeling...during the general session. Standard content and format of full labeling and a...

2013-01-07

355

21 CFR 803.15 - How will I know if you require more information about my medical device report?  

Code of Federal Regulations, 2010 CFR

...803.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.15 How will I know if you require more information...

2010-04-01

356

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2014 CFR

...false Exceptions or alternatives to labeling requirements for medical devices... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate...

2014-04-01

357

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2013 CFR

...false Exceptions or alternatives to labeling requirements for medical devices... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate...

2013-04-01

358

21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...  

Code of Federal Regulations, 2012 CFR

...false Exceptions or alternatives to labeling requirements for medical devices... 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION...CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate...

2012-04-01

359

76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...to the public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. General...

2011-02-07

360

UbiMMS: an ubiquitous medication monitoring system based on remote device management methods.  

PubMed

Medication adherence is one of the most important factors in treating chronic diseases. However, current medication dispensers, which are devices that deliver medication to chronic disease patients according to predetermined schedules, are not equipped with internal remote management functions. Here, we propose a ubiquitous medication monitoring system (UbiMMS) that provides remote functions for medication status transmission, configuration management, software management, and real-time error management. We provide an overview and performance evaluation of the UbiMMS, and show that the proposed system is adequate for remotely monitoring and managing a medication dispenser in real time. PMID:22754967

Pak, JuGeon; Park, KeeHyun

2012-01-01

361

Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method  

NASA Astrophysics Data System (ADS)

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

2012-03-01

362

Evaluation of the Potential for Pharmacodynamic and Pharmacokinetic Drug Interactions Between Selegiline Transdermal System and Two Sympathomimetic Agents (Pseudoephedrine and Phenylpropanolamine) in Healthy Volunteers  

Microsoft Academic Search

Selegiline transdermal system is a recently approved monoamine oxidase inhibitor antidepressant. Medications that inhibit monoamine oxidase type A can augment the pressor effects of sympathomimetic amines, increasing the potential for hypertensive crisis. This study examined the potential for drug?drug interactions during treatment with selegiline transdermal system and pseudoephedrine or phenylpropanolamine. Two studies were conducted with 25 healthy volunteers to assess

Albert J. Azzaro; Chad M. VanDenBerg; John Ziemniak; Eva M. Kemper; Lawrence F. Blob; Bryan J. Campbell

2007-01-01

363

Fentanyl Transdermal Patch  

MedlinePLUS

Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication ... and who cannot be treated with other medications. Fentanyl is in a class of medications called opiate ( ...

364

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2010-N-0202] Medical Device Use in the Home Environment: Implications for the Safe and Effective...entitled Medical Device Use in the Home Environment: Implications for the Safe and Effective...medical device technology in the home environment. FDA seeks input and comments on...

2010-04-21

365

77 FR 52741 - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Partnership for Building Global Medical Device Epidemiology...Partnership for Building Global Medical Device Epidemiology...partnership for building global medical device epidemiology...partnership structure and governance; (3) MDEpiNet as a...expansion of the postmarket risk identification and...

2012-08-30

366

77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2012-N-0001] Circulatory System Devices Panel of the...Name of Committee: Circulatory System Devices Panel of the...III devices. These systems typically consist of...provide noninvasive circulatory support by...

2012-11-07

367

A proposed framework to improve the safety of medical devices in a Canadian hospital context  

PubMed Central

Purpose Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital. Materials and methods The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services. Results The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined. Conclusion The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility. PMID:24876796

Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

2014-01-01

368

Implantable Medical Devices with Electric Current Retrieval Assist  

Cancer.gov

Implantable devices, such as filters and stents, typically include structures that anchor to surrounding tissue. To prevent blood clots from reaching the heart, an IVC filter may be implanted into the patient. While generally effective at preventing movement post-implantation, traditional anchors present challenges when attempting to remove the device from the subject. In particular, the tissue to which the device is anchored may grow around the anchors making removal difficult.

369

Effect of transdermal scopolamine on salivation.  

PubMed

The effect of transdermal scopolamine on salivary flow and composition was analyzed in 21 healthy volunteers. The flow rate of whole saliva was significantly lowered by transdermal scopolamine. Significant positive correlations were found between the placebo rate of flow and both the quantity and percentage decreases in response to transdermal scopolamine. The magnesium concentration was significantly increased during transdermal scopolamine administration, whereas the sodium, potassium, and calcium concentrations were not consistently altered. Accordingly, the magnesium secretion rate was unaltered, whereas sodium, potassium, and calcium secretion rates were significantly lowered by transdermal scopolamine administration. PMID:4056076

Gordon, C; Ben-Aryeh, H; Attias, J; Szargel, R; Gutman, D

1985-09-01

370

A review of the economic tools for assessing new medical devices.  

PubMed

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices. PMID:25139635

Craig, Joyce A; Carr, Louise; Hutton, John; Glanville, Julie; Iglesias, Cynthia P; Sims, Andrew J

2015-02-01

371

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

PubMed

In order to study new methods of telemedicine usage in the context of emergency medical services, researchers need to prototype integrated telemedicine systems. To conduct a one-year trial phase-intended to study a new application of telemedicine in German emergency medical services-we used off-the-shelf medical devices and software to realize real-time patient monitoring within an integrated telemedicine system prototype. We demonstrate its feasibility by presenting the integrated real-time patient monitoring solution, by studying signal delay and transmission robustness regarding changing communication channel characteristics, and by evaluating issues reported by the physicians during the trial phase. Where standards like HL7 and the IEEE 11073 family are intended to enable interoperability of product grade medical devices, we show that research prototypes benefit from the use of web technologies and simple device interfaces, as they simplify product development for a manufacturer and ease integration efforts for research teams. Embracing this approach for the development of new medical devices eases the constraint to use off-the-shelf products for research trials investigating innovative use of telemedicine. PMID:25312967

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

2015-01-01

372

Microneedle-mediated transdermal bacteriophage delivery  

PubMed Central

Interest in bacteriophages as therapeutic agents has recently been reawakened. Parenteral delivery is the most routinely-employed method of administration. However, injection of phages has numerous disadvantages, such as the requirement of a health professional for administration and the possibility of cross-contamination. Transdermal delivery offers one potential means of overcoming many of these problems. The present study utilized a novel poly (carbonate) (PC) hollow microneedle (MN) device for the transdermal delivery of Escherichia coli-specific T4 bacteriophages both in vitro and in vivo. MN successfully achieved bacteriophage delivery in vitro across dermatomed and full thickness skin. A concentration of 2.67 × 106 PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0 × 103 PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13 × 103 PFU/ml being detected in blood 30 min following initial MN-mediated phage administration. Clearance occurred rapidly, with phages being completely cleared from the systemic circulation within 24 h, which was expected in the absence of infection. We have shown here that MN-mediated delivery allows successful systemic phage absorption. Accordingly, bacteriophage-based therapeutics may now have an alternative route for systemic delivery. Once fully-investigated, this could lead to more widespread investigation of these interesting therapeutic viruses. PMID:22750416

Ryan, Elizabeth; Garland, Martin J.; Singh, Thakur Raghu Raj; Bambury, Eoin; O’Dea, John; Migalska, Katarzyna; Gorman, Sean P.; McCarthy, Helen O.; Gilmore, Brendan F.; Donnelly, Ryan F.

2012-01-01

373

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 17, 2009 (74 FR 59194). The amendment is being made to reflect a change in the Contact Person and Procedure portions of the document, and to provide......

2010-01-11

374

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August 26, 2010, is postponed. The meeting was announced in the Federal Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future meeting date will be announced in the Federal Register......

2010-08-06

375

75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...No. FDA-2009-M-0513] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries...for Biologics Evaluation and Research (CBER). This list is intended...for Biologics Evaluation and Research (HFM-17), Food and...

2010-02-09

376

Developing an Asia-Pacific manufacturing footprint strategy in the medical device industry  

E-print Network

As medical device manufacturers operating in the Asia-Pacific region are planning for increased demand in the near future, they must evaluate their manufacturing footprint strategies to determine if they are getting the ...

Dev, Nishanth K. (Nishanth Krishna)

2013-01-01

377

Production system improvement at a medical devices company : floor layout reduction and manpower analysis  

E-print Network

Due to the low demand and the need to introduce other production lines in the floor, the medical devices company wants to optimize the utilization of space and manpower for the occlusion system product. This thesis shows ...

AlEisa, Abdulaziz A. (Abdulaziz Asaad)

2012-01-01

378

Actuation of shape memory polymer using magnetic fields for applications in medical devices  

E-print Network

A novel approach to the heating and actuation of shape memory polymer using dispersed Curie temperature thermo-regulated particles is proposed. Such a material has potential applications in medical devices which are delivered ...

Buckley, Patrick Regan, 1981-

2004-01-01

379

76 FR 29153 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction  

Federal Register 2010, 2011, 2012, 2013, 2014

...2006N-0109] Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction AGENCY: Food and Drug...The document announced that FDA is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class...

2011-05-20

380

Preventive maintenance scheduling based on failure data in a medical device manufacturing facility  

E-print Network

This study was conducted at a medical device production facility where analysis was done on the reliability of Product S barrel molds for the purpose of predicting preventive maintenance (PM) schedule. Pareto Rule was ...

Mohd Fauzi, Mohammed Faizal B

2009-01-01

381

77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period  

Federal Register 2010, 2011, 2012, 2013, 2014

...medical devices; and methods to overcome the pitfalls and data gaps, including statistical approaches and modeling...research data, and 3. The methods to overcome the pitfalls and data gaps, including statistical approaches and...

2012-01-25

382

Mergers & acquisitions in the medical device industry : an exploration of factors influencing valuation  

E-print Network

Valuing medical device companies and technologies is a complex process. Several different approaches and models are often used in combination to determine a transaction valuation. This research uses the Enterprise Value ...

Robins, Jason S

2008-01-01

383

Systems Theoretic Accident Model and Process application : quality control in medical device manufacturing  

E-print Network

The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, ...

Li, Tieyu

2013-01-01

384

FDA Offers Tips about Medical Devices and Hurricane Disasters  

MedlinePLUS

... Safety Keep your device and supplies clean and dry. If you depend on your device to keep you alive, seek emergency services immediately. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events. Always use battery powered flashlights or lanterns ...

385

Modeling and Simulation of SMA Medical Devices Undergoing complex Thermo-mechanical Loadings  

NASA Astrophysics Data System (ADS)

There are SMA medical applications which undergo complex thermo-mechanical loading paths to meet specific and accurate requirements. In this work, a 3D model and its implementation techniques are presented. This model is currently deployed to design and model SMA medical devices subjected to multi-axial loading in both isothermal and dynamic regimes. Some of these devices are introduced and studied as examples to show the efficiency of the proposed platform.

Taheri Andani, Masood; Elahinia, Mohammad

2014-07-01

386

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2012 CFR

...a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers. (b) Classification. Class II (special controls; voluntary standards—Digital Imaging and...

2012-04-01

387

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2013 CFR

...a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers. (b) Classification. Class II (special controls; voluntary standards—Digital Imaging and...

2013-04-01

388

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2014 CFR

...a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers. (b) Classification. Class II (special controls; voluntary standards—Digital Imaging and...

2014-04-01

389

Transdermal innovations in diabetes management.  

PubMed

Diabetes mellitus, an endocrine disorder affecting glucose metabolism, has been crippling mankind for the past two centuries. Despite the advancements in the understanding pertaining to its pathogenesis and treatment, the currently available therapeutic options are far from satisfactory. The growing diabetic population increases the gravity of the situation. The shortcomings of the conventional drug delivery systems necessitate the need to delve into other routes. On account of its merits over other routes, the transdermal approach has drawn the interest of the researchers around the world. The transdermal drug delivery systems are aimed to achieve therapeutic concentrations of the drug through skin. These systems are designed so that the drug can be delivered at a pre-determined and controlled rate. This makes it particularly conducive to treat chronic disorders like diabetes. Correspondingly, the adverse effects and inconvenience concomitant with oral and parentral route are circumvented. This article attempts to outline the development of transdermal drug delivery systems to optimize diabetes pharmacotherapy. It not only covers the transdermal approaches adopted to fine-tune insulin delivery, but also, discusses various transdermal drug delivery systems fabricated to improve the therapeutic performance of oral hypoglycaemic agents. Such formulations include the advanced drug delivery systems, namely, transferosomal gels, microemulsions, self-dissolving micropiles, nanoparticles, insulin pumps, biphasic lipid systems, calcium carbonate nanoparticles, lecithin nanoparticles; physical techniques such as iontophoresis and microneedles and, drugs formulated as transdermal patches. In addition to this, the authors have also shed light on the future prospects and patented and commercial formulations of antidiabetic agents. PMID:25418713

Rao, Rekha; Mahant, Sheefali; Chhabra, Lovely; Nanda, Sanju

2014-01-01

390

A Device for Metrological Support of Medical Techniques for Diagnostic Contact Thermography  

Microsoft Academic Search

A device for the metrological support of medical techniques for diagnostic contact thermography is described. The device contains\\u000a an experimental setup for calibration and testing of precision skin temperature sensors. These sensors are based on diagnostic\\u000a contact thermography with a volume thermal diagraph.

S. V. Mikheev

2011-01-01

391

Position Estimation Method of Medical Implanted Devices Using Estimation of Propagation Velocity inside Human Body  

Microsoft Academic Search

Wireless communication devices in the field of medical implant, such as cardiac pacemakers and capsule endoscopes, have been studied and developed to improve healthcare systems. Especially it is very important to know the range and position of each device because it will contribute to an optimization of the transmission power. We adopt the time-based approach of position estimation using ultra

Makoto Kawasaki; Ryuji Kohno

2009-01-01

392

Towards Formal Modeling and Analysis of Networks of Embedded Medical Devices in Real-Time Maude  

Microsoft Academic Search

With the increasing number of medical devices and of accidents resulting from them being used in isolation in a hectic operating room, there is a trend towards integrating such devices into networks. This paper describes the appli- cation of the Real-Time Maude tool to the formal modeling and analysis of a network integrating an x-ray machine, a ventilation machine, and

Peter Csaba

393

Towards Formal Modeling and Analysis of Networks of Embedded Medical Devices in Real-Time Maude  

Microsoft Academic Search

With the increasing number of medical devices and of accidents resulting from them being used in isolation in a hectic operating room, there is a trend towards integrating such devices into networks. This paper describes the application of the Real-Time Maude tool to the formal modeling and analysis of a network integrating an x-ray machine, a ventilation machine, and a

Peter Csaba Ölveczky

2008-01-01

394

Kinetic and thermal energy harvesters for implantable medical devices and biomedical autonomous sensors  

NASA Astrophysics Data System (ADS)

Implantable medical devices usually require a battery to operate and this can represent a severe restriction. In most cases, the implantable medical devices must be surgically replaced because of the dead batteries; therefore, the longevity of the whole implantable medical device is determined by the battery lifespan. For this reason, researchers have been studying energy harvesting techniques from the human body in order to obtain batteryless implantable medical devices. The human body is a rich source of energy and this energy can be harvested from body heat, breathing, arm motion, leg motion or the motion of other body parts produced during walking or any other activity. In particular, the main human-body energy sources are kinetic energy and thermal energy. This paper reviews the state-of-art in kinetic and thermoelectric energy harvesters for powering implantable medical devices. Kinetic energy harvesters are based on electromagnetic, electrostatic and piezoelectric conversion. The different energy harvesters are analyzed highlighting their sizes, energy or power they produce and their relative applications. As they must be implanted, energy harvesting devices must be limited in size, typically about 1 cm3. The available energy depends on human-body positions; therefore, some positions are more advantageous than others. For example, favorable positions for piezoelectric harvesters are hip, knee and ankle where forces are significant. The energy harvesters here reported produce a power between 6 nW and 7.2 mW; these values are comparable with the supply requirements of the most common implantable medical devices; this demonstrates that energy harvesting techniques is a valid solution to design batteryless implantable medical devices.

Cadei, Andrea; Dionisi, Alessandro; Sardini, Emilio; Serpelloni, Mauro

2014-01-01

395

Improving Medical Device Regulation: The United States and Europe in Perspective  

PubMed Central

Context:?Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods:?We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings:?The two regulatory systems differ in their mandate and orientation, organization, pre-and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions:?Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium-and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices. PMID:24597558

SORENSON, CORINNA; DRUMMOND, MICHAEL

2014-01-01

396

Selecting medical devices and materials for development in Korea: the analytic hierarchy process approach.  

PubMed

Recently, the health industry in Korea has been given greater emphasis. Amid budgetary restrictions, setting the priorities for effective and efficient investment in medical devices and materials has been a key issue in the government sector. This paper shows how the analytic hierarchy process (AHP) can be used in assessing selected medical devices and materials for grants by the Korean Ministry of Health and Welfare. The final results show that unabsorbable suture is the most attractive medical product among 88 evaluated products, followed by i.v. cannula and central venous catheter. PMID:12841155

Cho, Keun-Tae; Kim, Sung-Min

2003-01-01

397

Clinical use of medical devices in the 'Bermuda Triangle'.  

PubMed

The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case. PMID:15002643

Kessler, Larry; Ramsey, Scott D; Tunis, Sean; Sullivan, Sean D

2004-01-01

398

77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...discuss, make recommendations, and vote on information related to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U-Systems, Inc. The ABUS scanning device is intended to increase breast...

2012-02-28

399

69 FR 26036 - Medical Devices; Immunology and Microbiology Devices; Classification of the Immunomagnetic...  

Federal Register 2010, 2011, 2012, 2013, 2014

...and count circulating cancer cells in a prepared sample of whole blood. This device is intended...monitoring or predicting cancer disease progression...and count circulating cancer cells in a prepared sample of whole blood. This device is...

2004-05-11

400

An Evaluation of a NiTiCo Alloy and its Suitability for Medical Device Applications  

NASA Astrophysics Data System (ADS)

Development of a superelastic material with higher stiffness and plateau stresses than binary nitinol is of interest to the medical device industry because it may allow for lower profile, less intrusive devices without compromising the material's characteristics. This project studied the effect of cobalt (Co) alloying additions on the stiffness and plateau stresses of a superelastic nickel-titanium alloy. In addition, the general physical, mechanical, corrosion, and biocompatibility properties of the alloy were compared to binary nitinol. The results of this study showed Co to be an interesting alloying addition that should be considered for future medical devices in applications, where stiffness is of concern.

Fasching, Audrey; Norwich, D.; Geiser, T.; Paul, Graeme W.

2011-07-01

401

IEC80001 and Future Ramifications for Health Systems not currently classed as Medical Devices  

NASA Astrophysics Data System (ADS)

Traditionally a medical device is viewed as a standalone hospital system with a carefully segregated private network running on specialist bespoke equipment, managed by highly skilled medical technicians. The regulations in force implementing the Medical Devices Directive support this view. The emerging reality in the modern health organisation is a patient-centric shared electronic record, networked over the organisation's local area network, with medical devices hanging as endpoints off that shared network and contributing to the central pool of patient data - all the time reliant on the shared network services. The IEC80001 standard has been developed to provide guidance on the measures that the medical devices community considers are required best practice in order to ensure that the integrity and safety of the interconnected medical device is not compromised. This in itself is both a laudable and pragmatic action. The question that it immediately prompts for those left with the new and very real task of 'compliance' with the new standards - primarily the over worked health organisation's IT department, is 'what impact does this have on me?'. A number of papers exist prepared from a health-system-supplier standpoint. This paper is principally focused on examining the ramifications of IEC80001 from a health organisation stand point. This paper seeks to identify the areas where a health organisation may expect to have their business-as-usual IT processes impacted, and offers a simple framework to address these challenges.

Harrison, Ian

402

Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology  

PubMed Central

Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls—most notably related to underperforming ICD leads—have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a “least burdensome” approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in post-market surveillance and comparative effectiveness research remains imperative. PMID:24760423

Rome, Benjamin N.; Kramer, Daniel B.

2014-01-01

403

78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport  

Federal Register 2010, 2011, 2012, 2013, 2014

...notification for powered patient transport devices commonly...890.5150), Powered patient transport. On May 3...to assess whether the risks posed by this type of...FDA agrees that the risks posed by the device and...Defines a subset of powered patient transport devices...

2013-03-04

404

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Devices; Immunology and Microbiology Devices; Classification...Serological Reagents AGENCY: Food and Drug Administration...to the Commissioner of Food and Drugs, 21 CFR part...866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The...

2012-03-09

405

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...  

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...Devices; Immunology and Microbiology Devices; Classification...Test System AGENCY: Food and Drug Administration...to the Commissioner of Food and Drugs, 21 CFR part...866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The...

2011-03-23

406

Medical devices; immunology and microbiology devices; classification of tryptase test system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying tryptase test system 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. PMID:25233536

2014-09-18

407

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) 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: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.''......

2010-11-17

408

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device......

2010-11-10

409

Laser direct writing of micro- and nano-scale medical devices  

PubMed Central

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Gittard, Shaun D; Narayan, Roger J

2010-01-01

410

Laser direct writing of micro- and nano-scale medical devices.  

PubMed

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Gittard, Shaun D; Narayan, Roger J

2010-05-01

411

Medical device procurement in low- and middle-income settings: protocol for a systematic review  

PubMed Central

Background Medical device procurement processes for low- and middle-income countries (LMICs) are a poorly understood and researched topic. To support LMIC policy formulation in this area, international public health organizations and research institutions issue a large body of predominantly grey literature including guidelines, manuals and recommendations. We propose to undertake a systematic review to identify and explore the medical device procurement methodologies suggested within this and further literature. Procurement facilitators and barriers will be identified, and methodologies for medical device prioritization under resource constraints will be discussed. Methods/design Searches of both bibliographic and grey literature will be conducted to identify documents relating to the procurement of medical devices in LMICs. Data will be extracted according to protocol on a number of pre-specified issues and variables. First, data relating to the specific settings described within the literature will be noted. Second, information relating to medical device procurement methodologies will be extracted, including prioritization of procurement under resource constraints, the use of evidence (e.g. cost-effectiveness evaluations, burden of disease data) as well as stakeholders participating in procurement processes. Information relating to prioritization methodologies will be extracted in the form of quotes or keywords, and analysis will include qualitative meta-summary. Narrative synthesis will be employed to analyse data otherwise extracted. The PRISMA guidelines for reporting will be followed. Discussion The current review will identify recommended medical device procurement methodologies for LMICs. Prioritization methods for medical device acquisition will be explored. Relevant stakeholders, facilitators and barriers will be discussed. The review is aimed at both LMIC decision makers and the international research community and hopes to offer a first holistic conceptualization of this topic. PMID:25336161

2014-01-01

412

Mechatronics in medical engineering: advanced control of a ventilation device  

Microsoft Academic Search

A typical mechatronics system consists of a mechanical process, electromechanical actuators, electronic sensors and a controller unit with the corresponding software. In this paper a microcontroller-based digital feedback control of a positioning device for a ventilation machine is presented. This kind of machine should allow either a volume- or a pressure-based controlled ventilation. The interdependence between the two important physiological

F. Simon; I. Jenayeh; H. Rake

2000-01-01

413

Towards a Better Corrosion Resistance and Biocompatibility Improvement of Nitinol Medical Devices  

NASA Astrophysics Data System (ADS)

Haemocompatibility of Nitinol implantable devices and their corrosion resistance as well as resistance to fracture are very important features of advanced medical implants. The authors of the paper present some novel methods capable to improve Nitinol implantable devices to some marked degree beyond currently used electropolishing (EP) processes. Instead, a magnetoelectropolishing process should be advised. The polarization study shows that magnetoelectropolished Nitinol surface is more corrosion resistant than that obtained after a standard EP and has a unique ability to repassivate the surface. Currently used sterilization processes of Nitinol implantable devices can dramatically change physicochemical properties of medical device and by this influence its biocompatibility. The Authors' experimental results clearly show the way to improve biocompatibility of NiTi alloy surface. The final sodium hypochlorite treatment should replace currently used Nitinol implantable devices sterilization methods which rationale was also given in our previous study.

Rokicki, Ryszard; Hryniewicz, Tadeusz; Pulletikurthi, Chandan; Rokosz, Krzysztof; Munroe, Norman

2015-04-01

414

Towards a Better Corrosion Resistance and Biocompatibility Improvement of Nitinol Medical Devices  

NASA Astrophysics Data System (ADS)

Haemocompatibility of Nitinol implantable devices and their corrosion resistance as well as resistance to fracture are very important features of advanced medical implants. The authors of the paper present some novel methods capable to improve Nitinol implantable devices to some marked degree beyond currently used electropolishing (EP) processes. Instead, a magnetoelectropolishing process should be advised. The polarization study shows that magnetoelectropolished Nitinol surface is more corrosion resistant than that obtained after a standard EP and has a unique ability to repassivate the surface. Currently used sterilization processes of Nitinol implantable devices can dramatically change physicochemical properties of medical device and by this influence its biocompatibility. The Authors' experimental results clearly show the way to improve biocompatibility of NiTi alloy surface. The final sodium hypochlorite treatment should replace currently used Nitinol implantable devices sterilization methods which rationale was also given in our previous study.

Rokicki, Ryszard; Hryniewicz, Tadeusz; Pulletikurthi, Chandan; Rokosz, Krzysztof; Munroe, Norman

2015-02-01

415

Modular reservoir concept for MEMS-based transdermal drug delivery systems  

NASA Astrophysics Data System (ADS)

While MEMS-based transdermal drug delivery device development efforts have typically focused on tightly-integrated solutions, we propose an alternate conception based upon a novel, modular drug reservoir approach. By decoupling the drug storage functionality from the rest of the delivery system, this approach seeks to minimize cold chain storage volume, enhance compatibility with conventional pharmaceutical practices, and allow independent optimization of reservoir device design, materials, and fabrication. Herein, we report the design, fabrication, and preliminary characterization of modular reservoirs that demonstrate the virtue of this approach within the application context of transdermal insulin administration for diabetes management.

Cantwell, Cara T.; Wei, Pinghung; Ziaie, Babak; Rao, Masaru P.

2014-11-01

416

Scientific evaluation and pricing of medical devices and associated procedures in France.  

PubMed

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented. PMID:23981256

Gilard, Martine; Debroucker, Frederique; Dubray, Claude; Allioux, Yves; Aper, Eliane; Barat-Leonhardt, Valérie; Brami, Michèle; Carbonneil, Cédric; Chartier-Kastler, Emmanuel; Coqueblin, Claire; Fare, Sandrine; Giri, Isabelle; Goehrs, Jean-Marie; Levesque, Karine; Maugendre, Philippe; Parquin, François; Sales, Jean-Patrick; Szwarcensztein, Karine

2013-01-01

417

Implantable Glucose BioFuel Cells for Medical Devices  

NASA Astrophysics Data System (ADS)

An Implantable BioFuel Cell (IBFC) is a device that produces power only from the chemicals that are naturally occurring inside the body. We have been working on two approaches to creating an IBFC. The first approach is to use chemicals such as glucose and oxygen to provide the fuel for an enzymatic IBFC. The second approach is to use electrolytes such as sodium to provide the fuel for a biomimetic IBFC.

Cinquin, P.; Cosnier, S.; Belgacem, N.; Cosnier, M. L.; Dal Molin, R.; Martin, D. K.

2013-12-01

418

Value driven innovation in medical device design: a process for balancing stakeholder voices.  

PubMed

The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features. PMID:23483372

de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P

2013-09-01

419

Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat headache 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. PMID:25016620

2014-07-01

420

Medical devices; gastroenterology-urology devices; classification of the implantable transprostatic tissue retractor system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the implantable transprostatic tissue retractor system 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. 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. PMID:25118368

2014-07-25

421

Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache 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 transcranial magnetic stimulator for headache 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. PMID:25016622

2014-07-01

422

Medical devices; gastroenterology-urology devices; classification of pancreatic drainage stent and delivery system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system 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 pancreatic drainage stent and delivery system 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. PMID:24873019

2014-05-29

423

Medical devices; gastroenterology-urology devices; classification of the colon capsule imaging system. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the colon capsule imaging system 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 colon capsule imaging system's 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. PMID:24839664

2014-05-16

424

Medical devices; physical medicine devices; classification of the powered exoskeleton. Final order.  

PubMed

: The Food and Drug Administration (FDA) is classifying the powered exoskeleton 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 powered exoskeleton's 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. PMID:25735053

2014-02-24

425

Postmarket surveillance of medical devices: current capabilities and future opportunities.  

PubMed

Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide. Premarket evaluation of CIEDs cannot be expected to eliminate all performance defects. Robust postmarket surveillance systems are needed to promote patient safety and reduce harm. Challenges impacting existing surveillance mechanisms include underreporting of defects, low rates of return of explanted CIEDs, lack of integration of surveillance into normal workflow, underutilization of existing resources including registries, a lack of capacity of aging resources, multiple proprietary platforms that lack interoperability, and the unmet need for common data variables as well as newer methods to generate, synthesize, analyze, and interpret evidence in order to respond rapidly to safety signals. Long-term solutions include establishing a unique device identification system; promoting expanded use of registries for surveillance and post-approval studies; developing additional methods to combine evidence from diverse data sources; creating tools and implementing strategies for universal automatic, triggered electronic event reporting; and refining methods to rapidly identify and interpret safety signals. Protection from litigation and creation of financial and other incentives by legislators, regulators, payers, accreditation organizations, and licensing boards can be expanded to increase participation in device surveillance by clinicians and health care facilities. Research to evaluate the comparative effectiveness of surveillance strategies is needed. Interim solutions to improve CIED surveillance while new initiatives are launched and the system strengthened are also presented. PMID:23479089

Blake, Kathleen

2013-03-01

426

[Assessment of the benefit of medical devices in surgical practice. Problems and possible solutions].  

PubMed

The market approval of medical devices in Germany does not yet require a benefit assessment. Thus, there is a lack of high quality studies that clearly prove the benefit of medical innovations. In the past, the Federal Joint Committee in Germany (G-BA) did not have the opportunity to adequately address this issue of lacking evidence. A law for the improvement of the care structure in the statutory health insurance offers the possibility for the G-BA to obtain evidence for the benefit of medical practice. With an integrated regulation for testing of medical devices the manufacturers have the option to apply for an assessment of new and established treatment methods and to provide scientific evidence for the benefit of medical devices as a requirement for inclusion in the catalogue of services of the statutory health insurance. However, this expanded scope of action is also a challenge for clinicians. The already existing problem of integrating multicenter clinical trials in the surgical routine will remain. The Surgical Study Network Germany (CHIR-Net) offers an ideal way to cope with the increased requirements on studies in the field of medical devices through established partnerships with methodological institutions and practitioners in clinical settings. PMID:24402570

Seidel, D; Braß, P; Sehnke, N; Jakob, V; Eglmeier, W; Neugebauer, E A M

2014-05-01

427

Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT  

PubMed Central

A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients’ healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299

White, Judith; Carolan-Rees, Grace

2013-01-01

428

Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT.  

PubMed

A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients' healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299

White, Judith; Carolan-Rees, Grace

2013-07-01

429

Medical devices; immunology and microbiology devices; classification of dengue virus serological reagents. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. 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. PMID:24881094

2014-05-30

430

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System  

Federal Register 2010, 2011, 2012, 2013, 2014

...fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular...fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an...

2012-02-14

431

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration...FDA-2013-N-0001] Microbiology Devices Panel of the...Notice of Meeting AGENCY: Food and Drug Administration...advisory committee of the Food and Drug Administration...Name of Committee: Microbiology Devices Panel of...

2013-05-08

432

Medical devices; physical medicine devices; classification of the nonpowered lower extremity pressure wrap. Final order.  

PubMed

The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25016621

2014-07-01

433

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

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use 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......

2011-04-14

434

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' The Agency is classifying the device into class II (special......

2011-07-20

435

76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...  

Federal Register 2010, 2011, 2012, 2013, 2014

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' The Agency is classifying the device into class II......

2011-02-07

436

SMPTE Test Pattern For Certification Of Medical Diagnostic Display Devices  

NASA Astrophysics Data System (ADS)

Since the invention of x-rays by Wilhelm Conrad Roentgen, rapid advances have been made in the radiological detection of body abnormalities. This was very evident in the 1960's and 70's when the marriage of computers to radiology gave birth to a new generation of imaging modalities such as computerized tomography, ultrasound, digital radiographic imaging, nuclear medicine, and nuclear magnetic resonance. Many of these devices employ digital computer techniques for signal manipulation, and the resultant analog diagnostic images are displayed on television monitors for viewing and on imaging cathode-ray tubes for a photographic hard copy.

Lisk, Kenneth G.

1984-08-01

437

Medical devices and conflict of interest: unique issues and an industry code to address them.  

PubMed

Development of medical devices requires interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development. Progress in procedure-based medicine would be stalled if this collaboration were eliminated. This degree of interaction, however, creates conflicts of interest that must be managed to avoid compromising trust, credibility, and patient care. AdvaMed, a trade association for the medical device industry, has developed a code of ethics to manage many of these conflicts and to guide its members' interactions with health care professionals. This article reviews the rationale for the AdvaMed code and provides a brief in terms of c overview of the code itself.onflict-of-interest cons iderations, the world of medical devices is significantly dif- PMID:17469470

LaViolette, Paul A

2007-03-01

438

Medical devices for the treatment of eye diseases.  

PubMed

Development of intraocular drug delivery systems (DDSs) is urgently required for the treatment of eye diseases, especially in the posterior segment of the eye (the vitreous cavity, retina, and choroid), most of which are refractory to conventional pharmacologic approaches; eye drops and systemically administered drugs cannot achieve therapeutic drug concentrations in the posterior segment of the eye. Repeated intravitreal injections of anti-angiogenic agents are effective in the treatment of age-related macular degeneration, but there remain risks of serious side effects such as endophthalmitis associated with repeated injections. Intraocular DDSs may address these problems. Intraocular sustained drug release from implantable or injectable devices has been investigated to treat vitreoretinal diseases. A reservoir-type nonbiodegradable implant was first launched in the market in 1996 for the treatment of cytomegalovirus retinitis secondary to the acquired immunodeficiency syndrome, followed by clinical trials for a variety of potent devices to treat other challenging eye diseases. An injectable rod-shaped insert releasing a steroid is presently being assessed in a phase III trial to treat macular edema secondary to diabetic retinopathy or retinal vein occlusion. Thus various types of intraocular DDSs will be commercially available to treat vision-threatening intraocular diseases in the near future. PMID:20217540

Yasukawa, Tsutomu; Ogura, Yuichiro

2010-01-01

439

A bioinspired omniphobic surface coating on medical devices prevents thrombosis and biofouling.  

PubMed

Thrombosis and biofouling of extracorporeal circuits and indwelling medical devices cause significant morbidity and mortality worldwide. We apply a bioinspired, omniphobic coating to tubing and catheters and show that it completely repels blood and suppresses biofilm formation. The coating is a covalently tethered, flexible molecular layer of perfluorocarbon, which holds a thin liquid film of medical-grade perfluorocarbon on the surface. This coating prevents fibrin attachment, reduces platelet adhesion and activation, suppresses biofilm formation and is stable under blood flow in vitro. Surface-coated medical-grade tubing and catheters, assembled into arteriovenous shunts and implanted in pigs, remain patent for at least 8 h without anticoagulation. This surface-coating technology could reduce the use of anticoagulants in patients and help to prevent thrombotic occlusion and biofouling of medical devices. PMID:25306244

Leslie, Daniel C; Waterhouse, Anna; Berthet, Julia B; Valentin, Thomas M; Watters, Alexander L; Jain, Abhishek; Kim, Philseok; Hatton, Benjamin D; Nedder, Arthur; Donovan, Kathryn; Super, Elana H; Howell, Caitlin; Johnson, Christopher P; Vu, Thy L; Bolgen, Dana E; Rifai, Sami; Hansen, Anne R; Aizenberg, Michael; Super, Michael; Aizenberg, Joanna; Ingber, Donald E

2014-11-01

440

Concordance of Adherence Measurement Using Self-Reported Adherence Questionnaires and Medication Monitoring Devices  

Microsoft Academic Search

The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the

Lizheng Shi; Jinan Liu; Yordanka Koleva; Vivian Fonseca; Anupama Kalsekar; Manjiri Pawaskar

2010-01-01

441

Nanomaterials and synergistic low-intensity direct current (LIDC) stimulation technology for orthopedic implantable medical devices.  

PubMed

Nanomaterials play a significant role in biomedical research and applications because of their unique biological, mechanical, and electrical properties. In recent years, they have been utilized to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopedic residual hardware devices (e.g., hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopedic implants is also discussed, the focus being on a low-intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The article concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these. PMID:23335493

Shirwaiker, Rohan A; Samberg, Meghan E; Cohen, Paul H; Wysk, Richard A; Monteiro-Riviere, Nancy A

2013-01-01

442

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states  

PubMed Central

With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC’s abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states. PMID:25429243

Howard, Jason J

2014-01-01

443

Wireless communication with implanted medical devices using the conductive properties of the body  

PubMed Central

Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications. PMID:21728728

Ferguson, John E; Redish, A David

2013-01-01

444

Critical appraisal of medical devices in the management of cerebrovascular disease  

PubMed Central

Medical devices may revolutionize the management of acute ischemic stroke and prevention of recurrent events. By comparison with pharmaceuticals, the device approval process and subsequent application of these devices in stroke treatment is founded on a paucity of Class I evidence-based clinical trial data. Thromboembolectomy for acute stroke, stenting of cervical or cerebral arteries for stroke prevention, and percutaneous closure of patent foramen ovale for prevention or recurrent cerebral ischemia are being done with an ever-increasing frequency despite few, if any, randomized clinical trials to confirm the appropriateness of the interventions. The current basis, or lack thereof, for these interventions for cerebrovascular disease is therefore discussed. As such, a critical appraisal of the available clinical data does not support widespread use of medical devices at this time outside of well-designed clinical trials. PMID:18728708

Schneck, Michael J

2008-01-01

445

75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for...

2010-06-22

446

76 FR 71045 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final,...

2011-11-16

447

77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector  

Federal Register 2010, 2011, 2012, 2013, 2014

...Devices; Classification of the Near Infrared Brain Hematoma Detector AGENCY: Food and Drug...is classifying the Near Infrared (NIR) Brain Hematoma Detector into class II (special...the generic name Near Infrared (NIR) Brain Hematoma Detector, and it is...

2012-03-23

448

75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...Notice of Meeting AGENCY: Food and Drug Administration, HHS...public advisory committee of the Food and Drug Administration (FDA...Devices and Radiological Health, Food and Drug Administration, 10903...approval application for the Deep Brain Stimulation System for...

2010-01-27

449

76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft. FDA intends to make background...

2011-03-29

450

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Classification of the Hemorrhoid Prevention Pressure Wedge AGENCY: Food and Drug Administration...classifying the hemorrhoid prevention pressure wedge into class II (special controls...the device. A hemorrhoid prevention pressure wedge provides support to the...

2011-04-15

451

Designing a program to assess potential induced radioactivity in electron beam sterilization of medical devices  

NASA Astrophysics Data System (ADS)

ISO 11137-1:2006 requires that the potential for induced radioactivity be evaluated for medical devices irradiated with electrons with energy more than 10 MeV. For a manufacturing operation where new devices are being developed, a practical program for making such an evaluation needs to be engrained in the process. A program was developed such that the induced radioactivity evaluation is imbedded in the development of the irradiation process.

Smith, Mark; Logar, John; Vrain, Olivier

2014-12-01

452

Towards fabrication of 3D printed medical devices to prevent biofilm formation.  

PubMed

The use of three-dimensional (3D) printing technologies is transforming the way that materials are turned into functional devices. We demonstrate in the current study the incorporation of anti-microbial nitrofurantoin in a polymer carrier material and subsequent 3D printing of a model structure, which resulted in an inhibition of biofilm colonization. The approach taken is very promising and can open up new avenues to manufacture functional medical devices in the future. PMID:24239831

Sandler, Niklas; Salmela, Ida; Fallarero, Adyary; Rosling, Ari; Khajeheian, Mohammad; Kolakovic, Ruzica; Genina, Natalja; Nyman, Johan; Vuorela, Pia

2014-01-01

453

A new hermetic antenna for wireless transmission systems of implantable medical devices  

Microsoft Academic Search

In implantable medical devices (IMDs), the need of telemetry systems able to provide wireless bidirectional communication to interrogate and remotely program the device, as well as to monitor the physiological status of the patient, is growing.The object of the present study was to evaluate a new hermetic antenna for wireless short-range transmission system for IMDs which would assure reliable long-term

E. Marcelli; F. Scalambra; L. Cercenelli; G. Plicchi

2007-01-01

454

Oxybutynin Transdermal Patch  

MedlinePLUS

... body to cool down when it gets very hot. Avoid exposure to extreme heat, and call your doctor or get emergency medical treatment if you have fever or other signs of heat stroke such as dizziness, upset stomach, ...

455

Josephson junction devices: Model quantum mechanical systems and medical applications  

NASA Astrophysics Data System (ADS)

In this dissertation, three experiments using Josephson junction devices are described. In Part I, the effect of dissipation on tunneling between charge states in a superconducting single-electron transistor (sSET) was studied. The sSET was fabricated on top of a semi-conductor heterostructure with a two-dimensional electron gas (2DEG) imbedded beneath the surface. The 2DEG acted as a dissipative ground plane. The sheet resistance of the 2DEG could be varied in situ by applying a large voltage to a gate on the back of the substrate. The zero-bias conductance of the sSET was observed to increase with increasing temperature and 2DEG resistance. Some qualitative but not quantitative agreement was found with theoretical calculations of the functional dependence of the conductance on temperature and 2DEG resistance. Part II describes a series of experiments performed on magnesium diboride point-contact junctions. The pressure between the MgB2 tip and base pieces could be adjusted to form junctions with different characteristics. With light pressure applied between the two pieces, quasiparticle tunneling in superconductor-insulator-superconductor junctions was measured. From these data, a superconducting gap of approximately 2 meV and a critical temperature of 29 K were estimated. Increasing the pressure between the MgB2 pieces formed junctions with superconductor-normal metal-superconductor characteristics. We used these junctions to form MgB2 superconducting quantum interference devices (SQUIDS). Noise levels as low as 35 fT/Hz1/2 and 4 muphi 0/Hz1/2 at 1 kHz were measured. In Part III, we used a SQUID-based instrument to acquire magnetocardiograms (MCG), the magnetic field signal measured from the human heart. We measured 51 healthy volunteers and 11 cardiac patients both at rest and after treadmill exercise. We found age and sex related differences in the MCG of the healthy volunteers that suggest that these factors should be considered when evaluating the MCG for disease. We also defined a spatio-temporal MCG parameter, the repolarization stabilization interval, which successfully discriminated our patients from our healthy controls.

Chen, Josephine

456

Transport numbers in transdermal iontophoresis.  

PubMed

Parameters determining ionic transport numbers in transdermal iontophoresis have been characterized. The transport number of an ion (its ability to carry charge) is key to its iontophoretic delivery or extraction across the skin. Using small inorganic ions, the roles of molar fraction and mobility of the co- and counterions present have been demonstrated. A direct, constant current was applied across mammalian skin in vitro. Cations were anodally delivered from either simple M(+)Cl(-) solutions (single-ion case, M(+) = sodium, lithium, ammonium, potassium), or binary and quaternary mixtures thereof. Transport numbers were deduced from ion fluxes. In the single-ion case, maximum cationic fluxes directly related to the corresponding ionic aqueous mobilities were found. Addition of co-ions decreased the transport numbers of all cations relative to the single-ion case, the degree of effect depending upon the molar fraction and mobility of the species involved. With chloride as the principal counterion competing to carry current across the skin (the in vivo situation), a maximum limit on the single or collective cation transport number was 0.6-0.8. Overall, these results demonstrate how current flowing across the skin during transdermal iontophoresis is distributed between competing ions, and establish simple rules with which to optimize transdermal iontophoretic transport. PMID:16443654

Mudry, Blaise; Guy, Richard H; Delgado-Charro, M Begoña

2006-04-15

457

A service protocol for post-processing of medical images on the mobile device  

NASA Astrophysics Data System (ADS)

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

458

Efficacy of a Methylphenidate Transdermal System versus t.i.d. Methylphenidate in a Laboratory Setting  

ERIC Educational Resources Information Center

Objective: To test the efficacy and tolerability of the methylphenidate transdermal formulation (MTS) against immediate-release methylphenidate (IR MPH) and placebo in a 12-hr analog classroom setting. Method: A total of nine boys ages 6 to 9 years, medicated with MPH for ADHD, complete a within-subject, double-blind study. For the purpose of the…

Pelham, William E.; Waxmonsky, James G.; Schentag, Jerome; Ballow, Charles H.; Panahon, Carlos J.; Gnagy, Elizabeth M.; Hoffman, Martin T.; Burrows-MacLean, Lisa; Meichenbaum, David L.; Forehand, Gregory L.; Fabiano, Gregory A.; Tresco, Katy E.; Lopez-Williams, Andy; Coles, Erika K.; Gonzalez, Mario A.

2011-01-01

459

Multiscale modeling of transdermal drug delivery  

Microsoft Academic Search

This study addresses the modeling of transdermal diffusion of drugs, to better understand the permeation of molecules through the skin, and especially the stratum corneum, which forms the main permeation barrier of the skin. In transdermal delivery of systemic drugs, the drugs diffuse from a patch placed on the skin through the epidermis to the underlying blood vessels. The epidermis

Jee Eun Rim

2006-01-01

460

Ultrasound-Mediated Transdermal Protein Delivery  

Microsoft Academic Search

Transdermal drug delivery offers a potential method of drug administration. However, its application has been limited to a few low molecular weight compounds because of the extremely low permeability of human skin. Low-frequency ultrasound was shown to increase the permeability of human skin to many drugs, including high molecular weight proteins, by several orders of magnitude, thus making transdermal administration

Samir Mitragotri; Daniel Blankschtein; Robert Langer

1995-01-01

461

Medical devices; ophthalmic devices; classification of the eyelid weight. Final rule.  

PubMed

The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). PMID:24754095

2014-04-21

462

Medical devices; ophthalmic devices; classification of the scleral plug. Final rule.  

PubMed

The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. PMID:24236336

2013-11-15

463

Product development of a device for manufacturing medical equipment for use in low-resource settings  

E-print Network

The objective of this paper is to describe the product design of a device that can be used to create medical supplies on-site in clinics in low-resource settings. The machine uses purely mechanical elements to cut and fold ...

Schlecht, Lisa (Lisa Anne)

2010-01-01

464

Introduction: Feature Issue on Phantoms for the Performance Evaluation and Validation of Optical Medical Imaging Devices  

PubMed Central

The editors introduce the Biomedical Optics Express feature issue on “Phantoms for the Performance Evaluation and Validation of Optical Medical Imaging Devices.” This topic was the focus of a technical workshop that was held on November 7–8, 2011, in Washington, D.C. The feature issue includes 13 contributions from workshop attendees. PMID:22741084

Hwang, Jeeseong; Ramella-Roman, Jessica C.; Nordstrom, Robert

2012-01-01

465

Use of Fiber Lasers for Micro Cutting Applications in the Medical Device Industry  

Microsoft Academic Search

The medical device industry has created a big demand for laser micro machining. Flash- lamp pump solid-state lasers are currently used for this application. Many of these lasers are configured to operate near the diffraction limited beam performance to maintain a very small kerf width. In order to meet yields and up-time requirements reliable laser operation and low maintenance are

K. F. Kleine; B. Whitney; K. G. Watkins

466

PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION A SOCIOLEGAL STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL  

E-print Network

AND PHARMACEUTICAL REGULATION IN EUROPE Nupur Chowdhury #12;Thesis Committee Members: Prof. Dr. Christa Altenstetter, School of Management and Governance, University of Twente, PO Box 217, 7500 AE, Enschede, The Netherlands STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL REGULATION IN EUROPE DISSERTATION to obtain the degree

Vellekoop, Michel

467

Plasma Sterilization: Opportunities and Microbial Assessment Strategies in Medical Device Manufacturing  

Microsoft Academic Search

Non-thermal gas discharge plasmas have significant potential as novel sterilization\\/decontamination agents in medical device manufacturing, and such agents may well be accepted by regulatory agencies. A number of aspects of plasma technology are currently under active investigation by many institutions and companies in order to obtain a thorough understanding of plasma sterilization as an alternative to conventional sterilization methods for

Ozlem Yardimci; Peter Setlow

2010-01-01

468

Design and test of a miniature 2.45 GHz antenna for implantable medical devices  

Microsoft Academic Search

A miniature 2.45 GHz microstrip antenna based on the short pin technique is presented. The antenna is designated for implantable medical devices which have extreme stringent requirements on componentspsila sizes. Theoretical analysis and implementation details of the antenna are presented in this paper. Direct measurement results show that the antenna achieves an impedance bandwidth of 104 MHz and a maximum

Xueyi Yu; Guolin Li; Lingwei Zhang; Zhihua Wang

2008-01-01

469

A study on radiation sterilization of medical devices in the South of China  

Microsoft Academic Search

In this paper, directing at the peculiarity of south China, the technique and quality control of Co-80 r radiation sterilization of medical devices have been studied. Radiation dose setting is determined by the AAMI method. Experiment shows that radiation treatment has no effect upon the attributes of the products. Under the same condition of packing and environment, storing time of

Wen Zhutang; Lou Riyou; Li Meilan; Liu Xueqin; Lin Najie; Zeng Mingsheng

1993-01-01

470

Impact of sanctions on procurement of medicine and medical devices in Iran; a technical response.  

PubMed

Following recent sanctions on foreign trade, financial and banking services, Iran has faced major difficulties for importing medicines (both finished products and pharmaceutical raw materials) and medical devices. Problems with money transfer have made it extremely lengthy in time to import medicine and medical devices and these have negatively affected access to and affordability of medicines. Quality of pharmaceuticals and treatment of patients have also been affected due to changing the sources of imported medicines and raw materials for locally produced pharmaceuticals. Several interventions have been employed during the past few months in Iran to overcome the effects imposed by recent sanctions and drug shortages have been managed to some extent with attempts made by Iran Food and Drug Organization (IRI FDO). As recommended by the experts, a specific Society for Worldwide Interbank Financial Telecommunication line should be allocated for transferring money for medicines and medical devices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medical device companies together with their foreign counterparts would facilitate this process. It appears that, in a public health prospective, ordinary people and patients are hurt and paying the cost for current sanctions. It remains the responsibility of the public health and international communities to separate public health from politics and to ease the pain of public from sanctions. PMID:24329148

Hosseini, Seyed Alireza

2013-12-01

471

Department of Mechanical Engineering Spring 2013 3D Printed Medical Device  

E-print Network

PENNSTATE Department of Mechanical Engineering Spring 2013 3D Printed Medical Device Overview This project aimed to develop a 3D-printed everting structure for use in conjunction with current endosurgical/concept and that our main form of manufacturing revolved around 3D-printing, which allowed us to quickly make

Demirel, Melik C.

472

[The SWOT analysis and strategic considerations for the present medical devices' procurement].  

PubMed

In this paper, the SWOT analysis method is used to find out the internal strength, weakness, exterior opportunities and threats of the present medical devices' procurements in hospitals and some strategic considerations are suggested as "one direction, two expansions, three changes and four countermeasures". PMID:16929781

Li, Bin; He, Meng-qiao; Cao, Jian-wen

2006-05-01

473

An Index of United States Federal Regulations and Guidelines which Cover Safety Surveillance of Medical Devices  

Microsoft Academic Search

An index is provided of relevant sections of Title 21 of the Code of Federal Regulations which cover the safety surveillance of medical devices which are required of manufactures in the United States. A relevant guideline prepared by the Food and Drug Administration is also indexed.

Charles F. Curran; Judith M. Sills

1998-01-01

474

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

Microsoft Academic Search

Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews

Richard Cookson; John Hutton

2003-01-01

475

Device helps with Sudden Infant Death Syndrome May 9th, 2012 in Medical research  

E-print Network

Device helps with Sudden Infant Death Syndrome detection May 9th, 2012 in Medical research' lives through improved and rapid detection of Sudden Infant Death Syndrome. Electrical Engineering infants are not expelling carbon dioxide ­ quickly enough to allow intervention. "This has the chance

Chiao, Jung-Chih

476

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels  

E-print Network

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels by David André Broniatowski S.B., Aeronautics and Astronautics, Massachusetts Institute of Technology, 2004 S.M., Aeronautics and Astronautics, Massachusetts Institute of Technology, 2006 S.M., Technology

de Weck, Olivier L.

477

Polymers for tissue engineering, medical devices, and regenerative medicine. Concise general review of recent studies  

Microsoft Academic Search

Recently investigated applications of polymeric materials for tissue engineering, regenerative medicine, implants, stents, and medical devices are described in the present review. Papers published during the last 2 years about polymeric materials used for preparation of various polymeric scaffolds, methods of fabrication of such scaffolds and their effectiveness in providing support for cell growth and development into various tissues and

Joseph Jagur-Grodzinski

2006-01-01

478

78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight  

Federal Register 2010, 2011, 2012, 2013, 2014

...is implanted into the upper eyelid. B. Recommended...demonstrating the sterility and shelf life of the device...the outer skin of the upper eyelid. (2) The implantable...is implanted into the upper eyelid. (b) Classification...demonstrating the sterility and shelf life of the...

2013-02-08

479

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug  

Federal Register 2010, 2011, 2012, 2013, 2014

...gold, silver, or titanium) from premarket notification...following steps: (1) Receives a recommendation...unless and until: (1) FDA reclassifies...gold, silver, or titanium coating. II. Regulatory...are as follows: (1) The device is exempt...gold, silver, or titanium coating. The...

2013-11-15

480

75 FR 9422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure. FDA intends to make background material available to the...

2010-03-02

481

78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013, 2014

...by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device...The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement...

2013-04-25

482

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug  

Federal Register 2010, 2011, 2012, 2013, 2014

...not necessary to assure the safety and effectiveness of the device...not necessary to assure the safety and effectiveness of scleral...after cataract and excimer laser refractive surgery (Ref. 2...reasonable assurance of the safety and effectiveness of the...

2013-01-25

483

Implantable and ingestible medical devices with wireless telemetry functionalities: A review of current status and challenges.  

PubMed

Wireless medical telemetry permits the measurement of physiological signals at a distance through wireless technologies. One of the latest applications is in the field of implantable and ingestible medical devices (IIMDs) with integrated antennas for wireless radiofrequency (RF) communication (telemetry) with exterior monitoring/control equipment. Implantable medical devices (MDs) perform an expanding variety of diagnostic and therapeutic functions, while ingestible MDs receive significant attention in gastrointestinal endoscopy. Design of such wireless IIMD telemetry systems is highly intriguing and deals with issues related to: operation frequency selection, electronics and powering, antenna design and performance, and modeling of the wireless channel. In this paper, we attempt to comparatively review the current status and challenges of IIMDs with wireless telemetry functionalities. Full solutions of commercial IIMDs are also recorded. The objective is to provide a comprehensive reference for scientists and developers in the field, while indicating directions for future research. Bioelectromagnetics. 35:1-15, 2014. © 2013 Wiley Periodicals, Inc. PMID:24115132

Kiourti, Asimina; Psathas, Konstantinos A; Nikita, Konstantina S

2014-01-01

484

Comparing Silicone Pressure-Sensitive Adhesives to Silicone Gels for Transdermal Drug Delivery  

Microsoft Academic Search

Transdermal, drug-delivery applications mandate the use of adequate adhesive systems to not only keep the pharmaceutical agent in contact with the intended surface, but to facilitate sustained, controlled delivery. An engineer who must determine which silicone chemistry is optimal for their device has a few options. This paper will investigate the differences in silicone pressure sensitive adhesives (PSAs) and silicone

Manfred Hof; Stephen Bruner; John Freedman

485

Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application  

SciTech Connect

This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC.

Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)

1995-09-01

486

Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context.  

PubMed

In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III. PMID:19999642

Bleicher, Ester W B

2009-01-01

487

Book review of “Joining and assembly of medical materials and devices” edited by Y. (Norman) Zhou and Mark D. Breyen  

PubMed Central

This article is a review of the book “Joining and assembly of medical materials and devices” edited by Y. (Norman) Zhou and Mark D. Breyen. This book (hardcover) was published by Woodhead Publishing, Cambridge, UK in 2013. The contents of the book and its relevance to medical device design and education are discussed in this invited review.

2013-01-01

488

Radiation sterilization of medical devices. Effects of ionizing radiation on ultra-high molecular-weight polyethylene  

Microsoft Academic Search

Sterilization by ionizing radiation has become, next to ethylene oxide treament, the most important “cold” sterilization process for medical devices made from plastics. The effects of ionizing radiation on the most important polymer for medical devices, ultra-high molecular-weight polyethylene, are briefly described in this review.

R. Buchalla; C. Schüttler; K. W. Bögl

1995-01-01

489

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

Microsoft Academic Search

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

Allen A. Hughes

1994-01-01

490

75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2010-N-0551] Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture...announcing the withdrawal of Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal,...

2010-12-07

491

An Evaluation of a Distributed Medical Device Safety Surveillance System: The DELTA Network Study  

PubMed Central

Background Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. Purpose To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. Methods This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology- National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. Results The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. Conclusion This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices. PMID:21356331

Vidi, Venkatesan D.; Matheny, Michael E.; Donnelly, Sharon; Resnic, Frederic S.

2011-01-01

492

Influence of Mobile Phones on the Quality of ECG Signal Acquired by Medical Devices  

NASA Astrophysics Data System (ADS)

Health aspects of the use of radiating devices, like mobile phones, are still a public concern. Stand-alone electrocardiographic systems and those built-in, more sophisticated, medical devices have become a standard tool used in everyday medical practice. GSM mobile phones might be a potential source of electromagnetic interference (EMI) which may affect reliability of medical appliances. Risk of such event is particularly high in places remote from GSM base stations in which the signal received by GSM mobile phone is weak. In such locations an increase in power of transmitted radio signal is necessary to enhance quality of the communication. In consequence, the risk of interference of electronic devices increases because of the high level of EMI. In the present paper the spatial, temporal, and spectral characteristics of the interference have been examined. The influence of GSM mobile phone on multilead ECG recordings was studied. It was observed that the electrocardiographic system was vulnerable to the interference generated by the GSM mobile phone working with maximum transmit power and in DTX mode when the device was placed in a distance shorter than 7.5 cm from the ECG electrode located on the surface of the chest. Negligible EMI was encountered at any longer distance.

Buczkowski, T.; Janusek, D.; Zavala-Fernandez, H.; Skrok, M.; Kania, M.; Liebert, A.

2013-10-01

493

Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.  

PubMed

Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health. PMID:24772683

Kramer, Daniel B; Tan, Yongtian T; Sato, Chiaki; Kesselheim, Aron S

2014-01-01

494

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

PubMed Central

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

2012-01-01

495

Real-time signal processing of accelerometer data for wearable medical patient monitoring devices.  

PubMed

Elderly and other people who live at home but required some physical assistance to do so are often more susceptible injury causing falls in and around their place of residence. In the event that a fall does occur, as a direct result of a previous medical condition or the fall itself, these people are typically less likely to be able to seek timely medical help without assistance. The goal of this research is to develop a wearable sensor device that uses an accelerometer for monitoring the movement of the person to detect falls after they have occurred in order to enable timely medical assistance. The data coming from the accelerometer is processed in real-time in the device and sent to a remote monitoring station where operators can attempt to make contact with the person and/or notify medical personnel of the situation. The ADXL330 accelerometer is contained within a Nintendo WiiMote controller, which forms the basis of the wearable medical sensor. The accelerometer data can then be sent via Bluetooth connection and processed by a local gateway processor. If a fall is detected, the gateway will then contact a remote monitoring station, on a cellular network, for example, via satellite, and/or through a hardwired phone or Internet connection. To detect the occurrence of ta fall, the accelerometer data is passed through a matched filter and the data is compared to benchmark analysis data that will define the conditions that represents the occurrence of a fall. PMID:19163185

Van Wieringen, Matt; Eklund, J

2008-01-01

496

The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act  

PubMed Central

Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.

Brannigan, Vincent

1986-01-01

497

US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?  

PubMed

Although radiation therapy is highly safe and effective in treating cancer, recent reports of dangerous radiation-related errors have focused a national spotlight on the field of radiation oncology and, more specifically, on the rapidly evolving and complex nature of radiation devices and how they are regulated. The purpose of this review is to explore the issues involved in medical device regulation in radiation oncology. We start with a general review of federal medical device regulation, including explanations of the legal and regulatory framework, and then discuss issues specific to radiation oncology with real-world examples. We also provide our thoughts on potential solutions and reforms to the current system, including better reporting of radiation-related errors in a centralized database, well-defined criteria for establishing substantial equivalence of a new device, and standard postmarket surveillance of radiation devices. Modern radiation therapy is a powerful tool that can help cure many patients' cancers and alleviate others' suffering with limited adverse effects. We must ensure that this promise is never compromised by avoidable mistakes. PMID:22548012

Hattangadi, Jona A; O'Reilly, James T; Recht, Abram

2012-01-01

498

An introduction to future truly wearable medical devices--from application to ASIC.  

PubMed

This talk will provide an introduction to the "Towards future truly wearable medical devices: from application to ASIC" mini-symposium. For user comfort and acceptance long term physiological sensors must be discrete, comfortable and easy to use. These requirements place stringent limits on all aspects of the system design: from the overall application aim, to power generation issues, to low power electronic design techniques. For successful devices design issues in all of these areas must be solved simultaneously. The work here presents an overview and introduction to these topics. PMID:21097253

Casson, Alexander J; Logesparan, Lojini; Rodriguez-Villegas, Esther

2010-01-01

499

Medical device-related hospital-acquired pressure ulcers in children: an integrative review.  

PubMed

The management, cost, physical and emotional suffering associated with pressure ulcers have a significant impact on the health status of patients-especially infants and children. The purpose of this integrative review was to identify factors associated with medical device-related (MDR) hospital acquired pressure ulcers (HAPUs) in the pediatric population. Pediatric MDR HAPUs are becoming more prevalent and require further exploration in terms of describing devices which cause injury and preventive interventions to improve patient outcomes. Opportunities to uncover new methods for addressing this important problem and to inform and advance the state of the science in this evolving area exist. PMID:23810813

Murray, John S; Noonan, Catherine; Quigley, Sandy; Curley, Martha A Q

2013-01-01

500

Case studies of innovative medical device companies from India: barriers and enablers to development  

PubMed Central

Background Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered. Methods Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources. Results In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market. Conclusions Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products. PMID:23721110

2013-01-01