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Last update: November 12, 2013.
1

Development of Thin-Film Battery Powered Transdermal Medical Devices  

SciTech Connect

Research carried out at ORNL has led to the development of solid state thin-film rechargeable lithium and lithium-ion batteries. These unique devices can be fabricated in a variety of shapes and to any required size, large or small, on virtually any type of substrate. Because they have high energies per unit of volume and mass and because they are rechargeable, thin-film lithium batteries have potentially many applications as small power supplies in consumer and special electronic products. Initially, the objective of this project was to develop thin-film battery powered products. Initially, the objective of this project was to develop thin-film battery powered transdermal electrodes for recording electrocardiograms and electroencephalograms. These ''active'' electrode would eliminate the effect of interference and improve the reliability in diagnosing heart or brain malfunctions. Work in the second phase of this project was directed at the development of thin-film battery powered implantable defibrillators.

Bates, J.B.; Sein, T.

1999-07-06

2

A portable and programmable iontophoresis device for transdermal drug delivery and transdermal extraction  

Microsoft Academic Search

Iontophoresis for transdermal drug delivery or for non-invasive monitoring of patients could allow a new generation of medical devices to be developed for low-cost healthcare. The existing iontophoresis systems today are bulky, expensive or non-programmable. Therefore, a miniature, low-cost and programmable device was developed and evaluated. A circuit is described herein which provides a variety of waveforms (DC, pulsed DC,

C. T. S. Ching; I. Camilleri; P. Connolly

2004-01-01

3

Medical Device Safety  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety - Section Contents ... Medical Product Safety Network Emergency Situations (Medical Devices) - Medical Device Safety Search the Medical Device Safety Section Medical ...

4

Medical Device Recalls  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device ... Learn more about medical device recalls here . - Recent Medical Device Recalls Listed by date posted on FDA website. ...

5

Implantable Medical Devices  

MedlinePLUS

Implantable Medical Devices Updated:May 1,2012 In certain cases, your doctor may prescribe an implantable device to assist your ... maintain the pumping ability of your heart. Implantable Medical Devices Left Ventricular Assist Device (Also known as LVAD) ...

6

Transdermal Patch Medication Delivery Systems and Pediatric Poisonings, 2002-2006  

Microsoft Academic Search

Transdermal drug delivery systems are an increasingly popular method of medication delivery containing large quantities of medication and presenting new opportunities for toxicity. To provide a description of exposures to transdermal medications in a pediatric population, we studied exposures in individuals less than 12 years of age. This is a retrospective database study in which the Texas Poison Center Network

Dina Parekh; Michael A. Miller; Doug Borys; Paresh R. Patel; Marc E. Levsky

2008-01-01

7

Medical Device Safety  

MedlinePLUS

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

8

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

9

Medication timing device  

US Patent & Trademark Office Database

A medication regime control device employs a plurality of liquid crystal displays controlled by a preprogrammed electronic circuit to display to a patient the number of doses of selected identified medications to be consumed at the time of display and any special instructions with respect thereto. The device acts as a watch and personal identifier between displays of the need to take medication.

1998-02-17

10

Section 8700: Medical Devices  

Center for Biologics Evaluation and Research (CBER)

... SOPP 8717: Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices Effective Date: Jan. ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/proceduressopps

11

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

PubMed

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, the fabrication of dense microneedle arrays from silk with different drug release kinetics is reported. 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 are 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

2013-05-01

12

Optomechanical medical devices (instruments)  

Microsoft Academic Search

Optomechanical Medical Devices (Instruments) use lightwaves (UV, Visible, IR) for one or more of the following functions; to observe, to measure, to record, to test (align) and or to cut\\/repair. The evolution of Optomechanical Medical Devices probably started when the first torch or candle or petrochemical lamp used a polished reflector (possibly with a concave configuration) to examine a part

Roger S. Reiss

2004-01-01

13

Immunotoxicity of Medical Devices  

Microsoft Academic Search

Determination of the ability of a medical device to interact with the immune system currently involves assessment of the immunogenic potential and biocompatibility of the device or an extract of the device. However, implants are often in the body for extended periods of time and\\/or are placed by a surgical procedure that in and of itself will generate an acute

Kathleen Rodgers; Paal Klykken; Joshua Jacobs; Carmelita Frondoza; Vesna Tomazic; Judith Zelikoff

1997-01-01

14

Modeling and design of transdermal drug delivery patches containing an external heating device  

Microsoft Academic Search

Process modeling and design concepts were implemented to aid in the manufacturing of heat-enhanced transdermal drug-delivery systems. The simulated prototype consists of a corticosterone-loaded polymer patch applied to the skin and connected to a heating device in which an exothermic reaction occurs. To achieve a desired transdermal flux of 1.2×10?5mg\\/cm2h, this contribution focuses on the influences of the (1) initial

Kwang Seok Kim; Laurent Simon

2011-01-01

15

Microwave medical devices  

Microsoft Academic Search

This article describes several new microwave medical devices that either were or are being developed at MMTC, Inc. in cooperation with the following institutions: Celsion Corporation, Columbia, Maryland (microwave balloon catheters); Montefiore Medical Center (MMC), Bronx, New York (microwave balloon catheters, dual microwave antennas, and microwave poration); and the University of California at San Francisco (conformal array antennas). The individuals

F. Sterzer

2002-01-01

16

Microbiology Devices Panel Medical Devices Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Microbiology Devices Panel Medical Devices Advisory Committee Proposal for the reclassification of rapid influenza detection devices Page 2. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

17

Registration of Medical Devices  

PubMed Central

Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries.

George, Bobby

2010-01-01

18

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

19

Fourier transform Raman microscopic study of drug distribution in a transdermal drug delivery device  

Microsoft Academic Search

The mapping facility of a Fourier transform Raman microscope was used to construct a profile of oestradiol distribution in a transdermal drug delivery device (Hormone Replacement Therapy patch). Mapping was performed across a region of the patch which contained crystallised material for characterisation. The spectra acquired using the microscope facility were compared with those obtained of pure oestradiol and of

Clare L. Armstrong; Howell G. M. Edwards; Dennis W. Farwell; Adrian C. Williams

1996-01-01

20

Design and fabrication of a sonophoresis device with a flat flextensional transducer for transdermal drug delivery  

Microsoft Academic Search

The development of ultrasound enhanced transdermal drug delivery technology (or sonophoresis) has received increasing attention over the recent years. Significant enhanced transportation of model drugs such as insulin and mannitol has been demonstrated using commercial sonicators. However, its practical use is hindered by its large size and weight of the conventional ultrasound transducer devices. In this research work, a sonophoresis

H. Y. Zhang; S. H. Yeo

2004-01-01

21

Medical Device Reporting: An Overview.  

National Technical Information Service (NTIS)

This document is intended to help manufacturers and user facilities understand the basic requirements for reporting adverse events involving medical devices as required by the Medical Device Reporting (MDR) Regulation (Title 21, Code of Federal Regulation...

1996-01-01

22

Body Implanted Medical Device Communications  

Microsoft Academic Search

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

Kamya Yekeh Yazdandoost; Ryuji Kohno

2009-01-01

23

Transdermal Power Transfer for Implanted Drug Delivery Devices using a Smart Needle and Refill Port  

Microsoft Academic Search

This paper describes a pair of micromachined components that work together for transdermal power (and data) transfer into implantable drug delivery devices. In particular, it describes a smart refill port that is electrically accessed with a mating, multi-pole, plug-in needle. These components are fabricated entirely from molded PDMS, Parylene, Kapton, and micro-electro-discharge machined stainless steel. The component pair demonstrates power

A. T. Evans; S. Chiravuri; Y. B. Gianchandani

2009-01-01

24

Advances in Medical Devices and Medical Electronics  

Microsoft Academic Search

Medical devices and medical electronics are areas that had little to offer 100 years ago. However, there were three important existing technologies that led to many further developments over the following 100 years. These are the stethoscope, electrocardiography, and X-ray medical imaging. Although these technologies had been described and were available to some extent when the Proceedings of the IEEE

Michael R. Neuman; Gail D. Baura; Stuart Meldrum; Orhan Soykan; Max E. Valentinuzzi; Ron S. Leder; Silvestro Micera; Yuan-Ting Zhang

2012-01-01

25

Reprocessing of Reusable Medical Devices  

MedlinePLUS

... Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Public Workshop - Reprocessing of Reusable Medical ... 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) ...

26

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

27

Medical Devices Dispute Resolution Panel  

Center for Biologics Evaluation and Research (CBER)

... The Medical Devices Dispute Resolution Panel provides advice to the Center Director on complex or contested scientific issues between the FDA ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices

28

Medical Device Review at CBER  

Center for Biologics Evaluation and Research (CBER)

Text Version... ways, several different times, trying to describe the areas that they ... SLIDE 51 This concludes the presentation, "Medical Device Review at CBER". ... More results from www.fda.gov/downloads/biologicsbloodvaccines/internationalactivities

29

Medical Device Reporting for Manufacturers, March 1997.  

National Technical Information Service (NTIS)

This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the fi...

1997-01-01

30

78 FR 15878 - Taxable Medical Devices; Correction  

Federal Register 2010, 2011, 2012, 2013

...9604] RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY: Internal...imposed on the sale of certain medical devices, enacted by the Health Care...Sec. 48.4191-2 Taxable medical device. * * * * * (b) * * *...

2013-03-13

31

Nitinol medical devices and implants  

Microsoft Academic Search

Summary Superelastic Nitinol is now a common and well-known engineering materi al in the medical industry. While the greater flexibility of the alloy drives many of its applications, there are also a large number of lesser- known advantages of Niti nol in medical devices. This paper reviews 7 of these less-obvious but very important reasons for Nitinol's success, bot h

D. Stoeckel

2000-01-01

32

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

2012-03-12

33

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

34

["Medical devices and European regulations"].  

PubMed

In order to put on the European Market, the medical devices shall be in conformity with two European Directives transcribed in national regulation: Directive 90/385/CEE--20 June 1990: concerning the implantable active medical devices, mandatory since the 1/01/95; Directive 93/42/CEE--13 June 1993: concerning the medical devices, applicable since the 1/01/95 and mandatory the 14/06/98. Both impose the conformity to essential requirements which can be proved by different procedures of evaluation verified by notify bodies. Then, the CE mark, technical passport, can be apposed. To demonstrate this conformity, the manufacturers can use harmonized european standards without obligation. The "Safety clause" allows to follow the "well-founded" of the CE marking and the national systems of vigilance to register and evaluate the incidents and to define corrective actions. PMID:9181704

Fleur, F

1997-01-01

35

New Medical Devices: Invention, Development and Use,  

National Technical Information Service (NTIS)

A reference text for health professionals and the medical device industry presents 11 expert overview papers on innovations in the development of medical devices in the rapidly changing health care environment. The papers are grouped among three principal...

K. B. Ekelman

1988-01-01

36

Medical device electromagnetic interference-ANSI issues  

Microsoft Academic Search

Medical Device Electromagnetic Interference (EMI) is an interaction that may occur between electrical medical devices and other sources of electromagnetic energy. The United States Food and Drug Administration (FDA) has federal responsibility for the safety and efficacy of electrical medical devices and is deeply involved in the subject interaction. The American National Standards Institute (ANSI) has administered and coordinated the

DANIEL D. HOOLIHAN

1997-01-01

37

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

2009-07-14

38

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

39

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2010 CFR

... 2010-04-01 false Medical image communications device. 892.2020 Section...SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic...medical image data between medical devices. It may include a...

2010-04-01

40

Security and Privacy for Implantable Medical Devices  

Microsoft Academic Search

Protecting implantable medical devices against attack without compromising patient health requires balancing security and privacy goals with traditional goals such as safety and utility. Implantable medical devices monitor and treat physiological conditions within the body. These devices - including pacemakers, implantable cardiac defibrillators (ICDs), drug delivery systems, and neurostimulators - can help manage a broad range of ailments, such as

Daniel Halperin; Thomas S. Heydt-benjamin; Kevin Fu; Tadayoshi Kohno; William H. Maisel

2008-01-01

41

Overview of quality assurance for medical devices  

Microsoft Academic Search

Medical devices can have very stringent performance requirements. The life of a critically ill patient can be determined by the quality of the monitoring and therapeutic devices being used in his or her treatment. But how is quality guaranteed? What are the characteristics of a medical device that determine its quality? The author discusses the methods used for designing quality

H. Troy Nagle

1992-01-01

42

Investigational Device Exemptions: Regulatory Requirements for Medical Devices.  

National Technical Information Service (NTIS)

The publication is Chapter 7 of the 'Regulatory Requirements for Medical Devices - A Workshop Manual.' It covers regulatory requirements for investigational device exemptions, which are granted for purposes of conducting clinical studies. Exemption from c...

1989-01-01

43

Engineering high confidence medical device software  

Microsoft Academic Search

The increasing complexity of medical device software has created new challenges in ensuring that a medical device operates correctly. This paper discusses how two technologies---model-based development and static analysis---may be used to facilitate the successful engineering of medical software and some possible regulatory side benefits.

Arnab Ray; Raoul Jetley; Paul Jones

2009-01-01

44

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 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...

2010-04-01

45

Import of Medical Devices: A Workshop Manual.  

National Technical Information Service (NTIS)

The manual covers the range of basic regulatory requirements that all manufacturers must consider when they begin to import a medical device. The materials it contains are useful for guidance and reference on establishment registration, device listing, la...

R. Parr A. Barcome

1993-01-01

46

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.

2013-06-19

47

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

48

Medical Device Legislation -- Its Impact on Hospitals.  

National Technical Information Service (NTIS)

Proceedings of a seminar on medical device legislation and its impact on hospitals, held April 3, 1975 in Atlanta, Georgia, are presented. The seminar discussants included experts in the field of hospital research and testing, law, medical technology, and...

1975-01-01

49

NEUROLOGICAL DEVICES PANEL OF THE MEDICAL ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE TO ... Foundation for Medical Care Denver ... and Associates Consulting Roseville, MN ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

50

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

51

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2010 CFR

...2009-04-01 2009-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

2009-04-01

52

FDA Launches System to Label Medical Devices  

MedlinePLUS

... please enable JavaScript. FDA Launches System to Label Medical Devices Goal is to improve patient safety, identify items ... 2013) Friday, September 20, 2013 Related MedlinePlus Page Medical Device Safety FRIDAY, Sept. 20 (HealthDay News) -- A new ...

53

FDA rules for the medical device engineer  

Microsoft Academic Search

Since enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in 1976, the US Food and Drug Administration has implemented rules that impinge on the design and testing of virtually all medical devices. These rules are described. The availability of FDA staff for informal guidance is noted

R. F. Munzner

1988-01-01

54

Efficacy of silver-coated medical devices  

Microsoft Academic Search

Silver coating of medical devices is believed to prevent device-associated infection. Several in-vitro and in-vivo studies, as well as clinical observations on silver—nylon, silver-intramedullary pins, silver oxide Foley catheters and silver-coated vascular prostheses have been performed during the past 30 years. Nevertheless, randomized clinical studies showing efficacy of such coated medical devices in high-risk patient populations are rare, have dealt

J. M. Schierholz; L. J. Lucas; A. Rump; G. Pulverer

1998-01-01

55

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

56

Mobile Medical Device Connectivity: Real World Solutions  

Microsoft Academic Search

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

D. C. Pettus

2004-01-01

57

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

58

Transdermal iontophoresis.  

PubMed

Iontophoresis is a technique used to enhance the transdermal delivery of compounds through the skin via the application of a small electric current. By the process of electromigration and electro-osmosis, iontophoresis increases the permeation of charged and neutral compounds, and offers the option for programmed drug delivery. Interest in this field of research has led to the successful delivery of both low (lidocaine) and high molecular drugs, such as peptides (e.g., luteinising hormone releasing hormone, nafarelin and insulin). Combinations of iontophoresis with chemical enhancers, electroporation and sonophoresis have been tested in order to further increase transdermal drug permeation and decrease possible side effects. In addition, rapid progress in the fields of microelectronics, nanotechnology and miniaturisation of devices is leading the way to more sophisticated iontophoretic devices, allowing improved designs with better control of drug delivery. Recent successful designing of the fentanyl E-TRANS iontophoretic system have provided encouraging results. This review will discuss basic concepts, principles and applications of this delivery technique. PMID:16370945

Batheja, Priya; Priya, Batheja; Thakur, Rashmi; Rashmi, Thakur; Michniak, Bozena; Bozena, Michniak

2006-01-01

59

EMC (Electromagnetic Compatibility) Standard for Medical Devices.  

National Technical Information Service (NTIS)

The report fulfills requirements of FDA Contract 223-74-5246 to research, evaluate, and document performance parameters and methods of test for use in an electromagnetic compatibility (EMC) standard for medical devices. The objectives were met by performi...

1976-01-01

60

Home Healthcare Medical Devices: A Checklist  

MedlinePLUS

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

61

Inhibition of Bacterial Adhesion on Medical Devices  

Microsoft Academic Search

\\u000a Microbial infections resulting from bacterial adhesion to biomaterial surfaces have been observed on almost all medical devices.\\u000a Biofilm infections pose a number of clinical challenges due to their resistance to immune defence mechanisms and antimicrobials,\\u000a and, regardless of the sophistication of the implant, all medical devices are susceptible to microbial colonisation and infection.\\u000a Research efforts are currently directed towards eliminating

Lígia R. Rodrigues

62

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2013 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

2013-04-01

63

Feasibility of retroreflective transdermal optical wireless communication.  

PubMed

There is an increasing demand for transdermal high-data-rate communication for use with in-body devices, such as pacemakers, smart prostheses, neural signals processors at the brain interface, and cameras acting as artificial eyes as well as for collecting signals generated within the human body. Prominent requirements of these communication systems include (1) wireless modality, (2) noise immunity and (3) ultra-low-power consumption for the in-body device. Today, the common wireless methods for transdermal communication are based on communication at radio frequencies, electrical induction, or acoustic waves. In this paper, we will explore another alternative to these methods--optical wireless communication (OWC)--for which modulated light carries the information. The main advantages of OWC in transdermal communication, by comparison to the other methods, are the high data rates and immunity to external interference availed, which combine to make it a promising technology for next-generation systems. In this paper, we present a mathematical model and experimental results of measurements from direct link and retroreflection link configurations with Gallus gallus domesticus derma as the transdermal channel. The main conclusion from this work is that an OWC link is an attractive communication solution in medical applications. For a modulating retroreflective link to become a competitive solution in comparison with a direct link, low-energy-consumption modulating retroreflectors should be developed. PMID:22722303

Gil, Yotam; Rotter, Nadav; Arnon, Shlomi

2012-06-20

64

Medical device development: The challenge for ergonomics  

Microsoft Academic Search

High quality, well-designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the user requirements of users and incorporating these into design is an essential component of this. The field of ergonomics has an opportunity to assist, not only with

Jennifer L. Martin; Beverley J. Norris; Elizabeth Murphy; John A. Crowe

2008-01-01

65

A platform for implantable medical device validation  

Microsoft Academic Search

Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. In the 20-year period from 1985 to 2005, the US Food and Drug Administration's (FDA) Maude database records almost 30,000 deaths and almost 600,000 injuries from device failures [8]. There is currently no formal methodology or open experimental platform to validate

Miroslav Pajic; Zhihao Jiang; Allison Connolly; Sanjay Dixit; Rahul Mangharam

2010-01-01

66

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

67

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

PubMed Central

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.

2011-01-01

68

Medical Device Notification: TERUFLEX CPDA-1 Blood Bag ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System-Terumo Medical Corporation. DATE INITIATED: ... Terumo Medical Corporation. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

69

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...  

Federal Register 2010, 2011, 2012, 2013

...Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain...IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain...facilitate early feasibility studies of medical devices, using appropriate risk...

2013-10-01

70

78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...  

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2013-M-0042] Medical Devices; General Hospital and Personal...the date of enactment of the Medical Device Amendments of 1976), generally...of Subjects in 21 CFR Part 880 Medical devices. Therefore, under the...

2013-05-16

71

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

Federal Register 2010, 2011, 2012, 2013

...Drug Administration [Docket No. FDA-2010-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices...

2010-09-23

72

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

Federal Register 2010, 2011, 2012, 2013

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

2011-11-21

73

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

Federal Register 2010, 2011, 2012, 2013

...Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices...

2012-03-28

74

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

Federal Register 2010, 2011, 2012, 2013

...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee...Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee...

2011-09-07

75

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

Federal Register 2010, 2011, 2012, 2013

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...a Disease or Condition That a Device Is Intended to Treat, Diagnose...of readily available pediatric medical device information as a part of...

2010-07-20

76

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...  

Code of Federal Regulations, 2010 CFR

...SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.63 Medical devices; warning statements for devices...in the upper atmosphere. CONSULT WITH YOUR PHYSICIAN,...

2009-04-01

77

21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...  

Code of Federal Regulations, 2010 CFR

...SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.63 Medical devices; warning statements for devices...in the upper atmosphere. CONSULT WITH YOUR PHYSICIAN,...

2010-04-01

78

75 FR 55803 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013

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

2010-09-14

79

Drug releasing coatings for medical devices  

US Patent & Trademark Office Database

The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, an antioxidant, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In some embodiments, the additive is a liquid. In other embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide or ester groups.

2013-04-09

80

Advertising and promotion of medical devices.  

PubMed

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties. PMID:17002234

Portnoy, Stuart

2006-01-01

81

Graphical process design tools for iontophoretic transdermal drug-delivery devices.  

PubMed

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 the electric field. Analysis was conducted using Laplace-transformed variables and did not require time-domain solutions. Simulation results show that a current density of 0.044 mA/cm(2) and a loading of 3500 ?g/ml of dexamethasone sodium m-sulfobenzoate were necessary to achieve an equilibrium plasma concentration of 1.254 ng/cm(3) with a time constant of 8.34 h. PMID:21345513

Simon, Laurent

2011-02-22

82

Development of super devices for medical applications  

Microsoft Academic Search

In the medical field, demands and expectations are growing for portable equipment that is small, low power, high performance and reliable in order to improve the quality of life of patients. We therefore developed super devices for medical applications by using micro 3D processing technology. This project should help to nurture R&D style business enterprises and help create knowledge-building industrial

M. Akiyama

2000-01-01

83

76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2011-N-0097] Medical Device Reporting; Malfunction Reporting...including class I and those class II devices that are not permanently implantable...in full compliance with FDA's Medical Device Reporting regulation,...

2011-03-08

84

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.

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

2010-01-01

85

Medical Device with Infection Preventing Feature.  

National Technical Information Service (NTIS)

This patent application discloses a flexible medical device which is intended to be disposed in the opening or the incision in the skin tissue of an animal includes a thin, flexible, adherent film coating of a bioactive ceramic material at least at a poin...

C. M. Cotell D. B. Chrisey P. M. Zabetakis

1993-01-01

86

Using Medical Devices to Teach Formal Modeling  

Microsoft Academic Search

Formal modeling can be used as an effective technique to improve the quality and reliability of software-intensive systems in general, and medical devices in particular. However, for formal modeling to be accessible to practicing engineers and domain specialists, suitable educational materials need to be developed. We report on the development of educational materials designed to give students the necessary experience

Orieta Celiku; David Garlan

2007-01-01

87

Technology needs of the medical device industry  

Microsoft Academic Search

With fast-rising health-care costs, reimbursement and outcomes considerations are now key to the technology needs of new products in the medical device industry. Healthcare spending in the United States has grown from $280 billion in 1981 to $1 trillion in 1994, and accounts for 14% of the total gross domestic product. With healthcare costs now increasing at a rate of

D. T. Achord

1996-01-01

88

Production of Medical Device Using MIM Technique  

Microsoft Academic Search

Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medical devices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 mum and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at

M. A. Omar; M. Mustapha; E. A. G. E. Ali; I. Subuki; B. Meh

2010-01-01

89

Efficacy of silver-coated medical devices.  

PubMed

Silver coating of medical devices is believed to prevent device-associated infection. Several in-vitro and in-vivo studies, as well as clinical observations on silver-nylon, silver-intramedullary pins, silver oxide Foley catheters and silver-coated vascular prostheses have been performed during the past 30 years. Nevertheless, randomized clinical studies showing efficacy of such coated medical devices in high-risk patient populations are rare, have dealt with very small numbers of patients or are controversial. Physico-chemical, pharmacological and microbiological data explaining the antimicrobial efficacy of silver in prophylaxis of implants are presented here, as well as the scientific background for the established clinical benefits of silver-preparations in burns. PMID:9868616

Schierholz, J M; Lucas, L J; Rump, A; Pulverer, G

1998-12-01

90

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section...HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL...Miscellaneous Devices § 880.6310 Medical device data system. (a)...

2013-04-01

91

Process-based derivation of requirements for medical devices  

Microsoft Academic Search

One goal of medical device certification is to show that a given medical device satisfies its requirements. The requirements that should be met by a device, however, depend on the medical processes in which the device is to be used. Such processes may be complex and, thus, critical requirements may be specified inaccurately or incompletely, or even missed altogether. We

Heather M. Conboy; George S. Avrunin; Lori A. Clarke

2010-01-01

92

Learning from adverse incidents involving medical devices  

PubMed Central

Problem The NHS is perceived to have a poor record of learning from incidents. Despite efforts of the Medical Devices Agency, which issues safety warnings, adverse incidents with medical devices continue to occur, some of which result in serious injury or death through device failures, user errors, and organisational problems. Design Introduction of feedback notes on a supportive investigation that seeks to determine latent factors, immediate triggers, causes, and positive actions taken by staff that minimised adverse consequences. Background and setting Medical physics department providing equipment management services in a major NHS teaching trust. Key measures for improvement Reduction in repetitions of adverse incidents and improved staff competency in using devices. Strategy for change A feedback note was developed to describe the incident and generic details of the equipment, summarise the investigation (focusing on latent causes and immediate triggers), and describe lessons to be learnt and positive actions by staff. Effects of change Feedback notes have been used in teaching sessions and given to ward link nurses. Despite being new, the positive supportive approach has encouraged an open reporting culture. Lessons learnt Adverse incidents are typically caused by alignment of different factors, but good practice can prevent errors becoming incidents. Careful analysis of incidents reveals both the multifactorial causes and the good practices that can help minimise repetitions.

Amoore, John; Ingram, Paula

2002-01-01

93

78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...  

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices...will be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical...

2013-02-27

94

Microbattery technologies for miniaturized implantable medical devices.  

PubMed

Implanted medical devices (IMDs), in particular neuro-stimulators, drug delivery chips and cochlear implants are undergoing miniaturization. Some of these miniaturized IMDs are "active" in the sense that they require a power source for operation. In most cases, the ideal power source needs to be an implanted battery of dimensions similar to that of the device. The state-of-the-art of battery miniaturization is reviewed with emphasis on novel Li and Li-ion two- and three-dimensional thin-film microbatteries. It is shown that three-dimensional thin-film batteries may provide a solution to the power requirements of miniaturized IMDs. PMID:20199378

Nathan, Menachem

2010-06-01

95

Medical Device Notification Transfer Set with 150 Micron Filter ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Device Notification Transfer Set with 150 Micron Filter-Charter Medical. DATE NOTIFICATION INITIATED: October 13, 2005. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

96

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

97

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

98

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

99

Model-Based Development of Medical Devices  

Microsoft Academic Search

Model-based development can offer many advantages compared to other techniques. This paper will demonstrate how models are\\u000a used to develop safe systems in a medical devices company. The approach described uses a combination of model-driven analysis,\\u000a model-driven design, model-driven test and model-driven safety analysis. Different approaches have been developed and followed\\u000a in the past. The approach presented has been developed

Uwe Becker

2009-01-01

100

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

101

Improving acute care through use of medical device data  

Microsoft Academic Search

The Medical Information Bus (MIB) is a data communications standard for bedside patient connected medical devices. It is formally titled IEEE 1073 Standard for Medical Device Communications. MIB defines a complete seven layer communications stack for devices in acute care settings. All of the design trade-offs in writing the standard were taken to optimize performance in acute care settings. The

Robert J Kennelly

1998-01-01

102

Determination of Compounds Inhibiting Bacterial Growth in Sterilized Medical Devices  

Microsoft Academic Search

Summary Medical devices must be sterilized before shipping. During sterilization the quality of the medical device must be maintained. Polysulfone (PS) and polycarbonate (PC) are often used as materials for medical devices. It has been observed that compounds inhibiting bacterial growth are produced when PS or PC are sterilized by autoclaving or by use of ozone gas, especially when ozone

H. Shintani; E. Suzuki; M. Sakurai

2003-01-01

103

A platform for implantable medical device validation: demo abstract  

Microsoft Academic Search

We present the design of an integrated modeling platform to investigate efficient methodologies for certifying medical device software. The outcome of this research has the potential to expedite medical device software certification for safer operation. Our specific focus in this study is on our ongoing research in artificial pacemaker software. Designing bug-free medical device software is difficult, especially in complex

Zhihao Jiang; Miroslav Pajic; Allison Connolly; Sanjay Dixit; Rahul Mangharam

2010-01-01

104

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.

105

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

Federal Register 2010, 2011, 2012, 2013

...Strengthening the National Medical Device Postmarket Surveillance System...Strengthening the National Medical Device Postmarket Surveillance System...public feedback regarding the medical device postmarket surveillance...

2012-08-30

106

77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...  

Federal Register 2010, 2011, 2012, 2013

...Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer...This notice solicits comments on medical device reporting (MDR); manufacturer...forms of information technology. Medical Device Reporting: Manufacturer,...

2012-02-14

107

The new collaborative path in medical device development: The medical device innovation consortium.  

PubMed

The United States medical device market is the world's largest with over $100billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. PMID:23578741

Kampfrath, Thomas; Cotten, Steven W

2013-04-08

108

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

109

Ask the Experts: Transdermal drug delivery.  

PubMed

Transdermal drug delivery, an arena currently worth several billions of US dollars, is a highly favored route of drug administration due to its convenience for patients and medical professionals alike. However, given the high costs in bringing new technologies to the market, as well as the technical issues of delivering drugs past the stratum corneum, the transdermal field needs to overcome a number of obstacles before it can realize its true potential. James Potticary, Assistant Commissioning Editor, spoke with three experts, discussing the challenges faced within the transdermal community, their motivations for becoming involved in the field and their visions for the future of transdermal drug delivery. PMID:24116908

2013-10-01

110

Patenting medical devices: the economic implications of ethically motivated reform.  

PubMed

This article explores whether the current patent system strikes the optimal balance between providing incentives to inventors to bring new medical devices to the marketplace and promoting public health by ensuring that these medical devices are widely available at a reasonable price. After providing an overview of the relationship of patent law to medical devices, the author explains how ethical and economic considerations suggest the need for an alternative patent system for medical devices and notes the difficulties with this proposal. The author concludes that a combination of alternatives to the current system most equitably account for the interests and needs of both healthcare device consumers and producers. PMID:18365652

Nugent, Kristen

2008-01-01

111

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

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures Home ... Consumer Products Home Use Devices - Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your ...

112

Missing Data in the Regulation of Medical Devices  

Microsoft Academic Search

Handling missing data is an important consideration in the analysis of data from all kinds of medical device studies. Missing data in medical device studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point

Gregory Campbell; Gene Pennello; Lilly Yue

2011-01-01

113

Using usability heuristics to evaluate patient safety of medical devices  

Microsoft Academic Search

Objective. To modify the traditional heuristic evaluation method of assessing software usability so that it can be applied to medical devices and used to evaluate the patient safety of those devices through the identification and assessment of usability problems.Design. Heuristic evaluation, a usability inspection method commonly used for software usability evaluation, was modified and extended for medical devices. The modified

Jiajie Zhang; Todd R. Johnson; Vimla L. Patel; Danielle L. Paige; Tate Kubose

2003-01-01

114

Medical Device Communication: A Standards based Conformance Testing Approach  

Microsoft Academic Search

NIST researchers are collaborating with medical device experts to facilitate the development and adoption of standards for medical device communications throughout the healthcare enterprise as well as integrating it into the electronic health record. We have developed test tools and corresponding electronic representation of an international standard's information model that provides several important capabilities leading toward device interoperability. We describe

John J. Garguilo; Sandra Martinez; Maria Cherkaoui

115

Proximity-based access control for implantable medical devices  

Microsoft Academic Search

We proposea proximity-based access control scheme forimplantable medical devices (IMDs). Ourscheme is based onultrasonic distance- bounding and enables an implanted medical device to grant access to its resources only to those devices that are in its close proxim- ity. We demonstrate the feasibility of our approach through tests in an emulated patient environment. We show that, although im- planted, IMDs

Kasper Bonne Rasmussen; Claude Castelluccia; Thomas S. Heydt-benjamin; Srdjan Capkun

2009-01-01

116

Security and interconnection of medical devices to healthcare networks  

Microsoft Academic Search

The introduction of medical devices onto healthcare facility networks presents a myriad of problems, both for the medical device or system being connected to the network, as well as other information technology devices on the network. The current state of security in healthcare, specifically security planning, is not as effective as other business areas. The value of the equipment associated

Dennis M. Seymour; Keith R. Mccall; Louis Dipaola

2004-01-01

117

Vibration analysis of medical devices with a calibrated FEA model  

Microsoft Academic Search

This study presents vibration analysis of medical devices by a finite element analysis (FEA) model calibrated with test data. The medical device under investigation is the Lifepak500 automated external defibrillator (AED), a product that is frequently exposed to vibration and shock in transportation means such as ambulances and medical-evacuation helicopters. In structure, the AED is a plastic case that contains

Jingshu Wu; Ray Ruichong Zhang; Steve Radons; Xiaole Long; Karl K Stevens

2002-01-01

118

Production of Medical Device Using MIM Technique  

NASA Astrophysics Data System (ADS)

Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medical devices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 ?m and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at 160° C using a sigma-blade mixer for one hour to prepare the feedstock of the fracture fixation plates. The fracture fixation plate component was injection molded using vertical injection moulding machine with the nozzle temperature of 200° C. Prior to sintering, the specimens were debound using a combination of solvent extraction and thermal pyrolysis method. The specimens were then sintered under vacuum. The properties of the fracture fixation plates such as physical and mechanical properties were presented and discussed. The in-vitro biocompatibility study on the fracture plates produced was examined.

Omar, M. A.; Mustapha, M.; Ali, E. A. G. E.; Subuki, I.; Meh, B.

2010-03-01

119

Education and training in regulatory science for medical device development.  

PubMed

Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed. PMID:24110397

Sakuma, Ichiro

2013-07-01

120

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

Federal Register 2010, 2011, 2012, 2013

...or plan to use the custom device exemption for treatment of a sufficiently rare condition. 3. Product areas other than orthopedic and dental devices where the custom device exemption may be useful. 4. The type of information manufacturers intend to...

2012-11-19

121

An update on mobile phones interference with medical devices.  

PubMed

Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. PMID:23559585

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-04-04

122

June 13, 2013: Microbiology Devices Panel of the Medical ...  

Center for Biologics Evaluation and Research (CBER)

... The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the Medical Devices Advisory Committee. ... More results from www.fda.gov/advisorycommittees/calendar/ucm351035.htm

123

Panel Roster Dental Products Panel of the Medical Devices ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. Panel Roster Dental Products Panel of the Medical Devices Advisory Committee Device Classification Panel Name Affiliation Role ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

124

Medical Devices: FDA Should Enhance Its Oversight of Recalls.  

National Technical Information Service (NTIS)

Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The Food and Drug Administration (FDA), an ag...

2011-01-01

125

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2013 CFR

...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

2013-04-01

126

Regulatory Requirements for Medical Devices: A Workshop Manual (Fifth Edition).  

National Technical Information Service (NTIS)

The manual covers the range of basic regulatory requirements that all manufacturers must consider when they begin marketing a medical device. The materials it contains are useful for guidance and reference on establishment registration, device listing, an...

1992-01-01

127

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

128

Premarket Notification: 510(k). Regulatory Requirements for Medical Devices.  

National Technical Information Service (NTIS)

The publication covers premarket notification procedures under Section 510(k) of the Food, Drug, and Cosmetic Act (Medical Device Amendments). Manufacturers intending to market a new or significantly modified device are required to submit a premarket noti...

1990-01-01

129

Medical Device Notification: Hotline L-10 Gas Vent-Smiths ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Device Notification: Hotline L-10 Gas Vent-Smiths Medical ASD, Inc. DATE NOTIFICATION INITIATED: August 2, 2005. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

130

Analysis of Corporate Acquisitions by Medical Device Manufacturers.  

National Technical Information Service (NTIS)

To investigate conditions under which corporate acquisitions in the medical device industry have enhanced or eroded shareholder wealth and financial accounting performance. One emphasis is whether building product lines within medical specialties (e.g., c...

R. A. DeGraaff

2002-01-01

131

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...  

Federal Register 2010, 2011, 2012, 2013

...FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug...entitled ``Drugs & Medical Device Supplier Management Forum...marketing of drugs and/or devices. Topics for discussion...following: Regulating Medical Products in the...

2010-04-09

132

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2010-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...

2010-08-16

133

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

Federal Register 2010, 2011, 2012, 2013

...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

134

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

Federal Register 2010, 2011, 2012, 2013

...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

135

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

Federal Register 2010, 2011, 2012, 2013

...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

136

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

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2010-08-06

137

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

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2011-10-20

138

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

Federal Register 2010, 2011, 2012, 2013

...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

139

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

Federal Register 2010, 2011, 2012, 2013

...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

140

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

Federal Register 2010, 2011, 2012, 2013

...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

141

Transdermal drug delivery system exposure outcomes 2 1 Some of the data contained herein were used by Dr. Roberge in a graduate essay as partial fulfillment of requirements for a master of public health degree. 2 2 Original Contributions is coordinated by John A. Marx, MD, of Carolinas Medical Center, Charlotte, North Carolina  

Microsoft Academic Search

Transdermal drug delivery systems are increasingly popular, yet few data exist regarding medical outcomes after exposures. Using data collected through a Regional Poison Information System, this retrospective study identified 61 cases of transdermal drug delivery system exposures reported over a recent 5-year period. Exposure routes included dermal (48 patients), oral (10 patients), combined oral and dermal (one patient), parenteral use

Raymond J Roberge; Edward P Krenzelok; Rita Mrvos

2000-01-01

142

78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers...the draft guidance entitled ``Medical Device Reporting for Manufacturers...applicable to manufacturers of medical devices for certain device-related...

2013-07-09

143

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

Federal Register 2010, 2011, 2012, 2013

...Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food...requirements for the tracking of medical devices. DATES: Submit either electronic...emphasized the importance of medical device tracking and supported the...

2010-11-12

144

Evaluation of MEMS materials of construction for implantable medical devices  

Microsoft Academic Search

Medical devices based on microelectro-mechanical systems (MEMS) platforms are currently being proposed for a wide variety of implantable applications. However, biocompatibility data for typical MEMS materials of construction and processing, obtained from standard tests currently recognized by regulatory agencies, has not been published. Likewise, the effects of common sterilization techniques on MEMS material properties have not been reported. Medical device

Geoffrey Kotzar; Mark Freas; Phillip Abel; Aaron Fleischman; Shuvo Roy; Christian Zorman; James M. Moran; Jeff Melzak

2002-01-01

145

Effective bandwidth allocation algorithm for medical device wireless network  

Microsoft Academic Search

Wireless sensor network (WSN) is proposed to be implemented in telemedicine. However, there are some requirements for WSN design in order to be implemented in this area. One of the requirements is data reliability in term of congestion management. For medical device network, there are other parameters to be counted besides data rate; congestion degree, medical device priority, and emergency

Indra H Mulyadi; N. M. A. Sumarang; Norlaili M Safri; Eko Supriyanto

2011-01-01

146

Development of wearable medical device for Bio-MEMS  

Microsoft Academic Search

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

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

2006-01-01

147

78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...  

Federal Register 2010, 2011, 2012, 2013

...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule...

2013-04-02

148

Digital Watermarking of Medical Images for Mobile Devices  

Microsoft Academic Search

Mobile devices are widely available to both consumers and businesses at affordable prices. These devices have the computational power to achieve tasks that were infeasible a few years ago. In medical facilities, mobile devices provide the medium for remote diagnosis and information retrieval. However, there are strict privacy issues that must be met. We investigate digital watermarking and information hiding

Christopher N. Gutierrez; Gautam Kakani; Ramesh C. Verma

2010-01-01

149

Cyber–Physical Modeling of Implantable Cardiac Medical Devices  

Microsoft Academic Search

The design of bug-free and safe medical device software is challenging, especially in complex implantable devices that control and actuate organs in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators between 1990 and 2000 affected over 600 000 devices. Of these, 200 000 or 41% were due to firmware issues and their effect continues to increase in frequency.

Zhihao Jiang; Miroslav Pajic; Rahul Mangharam

2012-01-01

150

Toward patient safety in closed-loop medical device systems  

Microsoft Academic Search

A model-driven design and validation of closed-loop medical device systems is presented. Currently, few if any medical systems on the market support closed-loop control of interconnected medical devices, and mechanisms for regulatory approval of such systems are lacking. We present a system implementing a clinical scenario where closed-loop control may reduce the possibility of human error and improve safety of

David Arney; Miroslav Pajic; Julian M. Goldman; Insup Lee; Rahul Mangharam; Oleg Sokolsky

2010-01-01

151

The economic evaluation of medical devices: challenges ahead.  

PubMed

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medical devices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices. PMID:23329383

Kirisits, Andreas; Redekop, W Ken

2013-02-01

152

Need for harmonization of labeling of medical devices: a review.  

PubMed

Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements. PMID:22247840

Songara, Raiendra K; Sharma, Ganesh N; Gupta, Vipul K; Gupta, Promila

2010-04-01

153

NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW  

PubMed Central

Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.

Songara, Raiendra K.; Sharma, Ganesh N.; Gupta, Vipul K.; Gupta, Promila

2010-01-01

154

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

Federal Register 2010, 2011, 2012, 2013

...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

155

Legal framework conditions for the reprocessing of medical devices.  

PubMed

The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM).For medical devices in the category "critical C", the RKI/BfArM-recommendation provides that the processor's quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007.On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. PMID:20204096

Großkopf, Volker; Jäkel, Christian

2008-09-03

156

Summary of the Medical Device Dispute Resolution Panel ...  

Center for Biologics Evaluation and Research (CBER)

... a review by the Medical Devices Dispute Resolution Panel was granted. ... Transcripts may be purchased from: (written requests only) Neal R. Gross ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices

157

Urgent Medical Device Recall / Field Safety Notice - Micro ...  

Center for Biologics Evaluation and Research (CBER)

... Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing Trays. ... Micro SSP™ DNA Typing Trays. Affected Product Details. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

158

510k Summary - imExpress, Medical Device Consultants, Inc.  

Center for Biologics Evaluation and Research (CBER)

Text Version... of concern as outlined in FDA's “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” Documentation ... More results from www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts

159

Medical Device Notification (PSN-08-09)-Sunquest Laboratory ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Device Notification (PSN-08-09)-Sunquest Laboratory Blood Bank and ... situations, the system will save result(s) with incorrect records. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

160

Medical Device Notification (PSN-08-08) - Sunquest ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules-Sunquest Information Systems, Inc. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/recalls

161

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

Federal Register 2010, 2011, 2012, 2013

...Collection; Comment Request; Medical Device Recall Authority AGENCY: Food...information collection requirements for medical device recall authority. DATES: Submit...forms of information technology. Medical Device Recall Authority--21 CFR...

2011-11-16

162

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

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2011-P-0882] Medical Devices; Exemption From Premarket Notification...and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments...as amended by the Safe Medical Devices Act of 1990 (SMDA)...

2012-06-01

163

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

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2011-P-0804] Medical Devices; Exemption From Premarket Notification...and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments...as amended by the Safe Medical Devices Act of 1990 (SMDA)...

2012-06-01

164

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

Federal Register 2010, 2011, 2012, 2013

...Formerly Docket No. 2006N-0109) Medical Devices; Reclassification of the Topical...FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA),...

2011-04-25

165

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

Federal Register 2010, 2011, 2012, 2013

...Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA...on Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which...be submitted along with certain medical device product applications,...

2012-06-06

166

75 FR 77647 - Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2010-N-0389] Medical Device User Fee Program; Meetings on...meetings on reauthorization of the Medical Device User Fee Amendments of 2007...continue collecting user fees for the medical device program. The Federal Food,...

2010-12-13

167

FDA's Home Use Medical Device Initiative  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 16. Negative Pressure Wound Therapy (NPWT) Survey • Learn about potential risks • Device issues at home faced by: ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

168

FDA's Home Use Medical Device Initiative  

Center for Drug Evaluation (CDER)

Text Version... 8 Page 9. Surgical Robots • Pre-1976: – Traditional laparoscopes and accessories ... Reports of significant human experience with a marketed device ... More results from www.fda.gov/downloads/drugs/newsevents

169

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

Federal Register 2010, 2011, 2012, 2013

...No. FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct...CFR part 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR...

2010-11-10

170

Ensuring the Safety of Marketed Medical Devices:  

Center for Biologics Evaluation and Research (CBER)

Text Version... the Center's regulatory mission and public health portfolio 6 Page 7. ... Computational modeling - Medical countermeasures - Personalized medicine ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

171

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.

2013-01-01

172

Improving patient care by reporting problems with medical devices.  

PubMed

Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices. PMID:9866489

White, G G; Weick-Brady, M D; Goldman, S A; Gross, T P; Kennedy, D L; Lucas, B S; Merritt, K; Naschinski, C

1998-11-01

173

Low invasive propulsion of medical devices by traction using mucus  

Microsoft Academic Search

This paper presents a new low invasive method to drive a medical device in an organic tube. The device has a spiral ribbed impeller which converts rotation to axial motion hydrodynamically using mucus. Generated thrust and drag were estimated according to linearized hydrodynamic lubrication theory. The optimum rib shape which makes thrust force maximum is predicted theoretically. As the proposed

Ken Ikeuchi; Kiyoshi Yoshinaka; Naohide Tomita

1997-01-01

174

Power and Information Transmission to Implanted Medical Device Using Ultrasonic  

Microsoft Academic Search

Using ultrasonic, we propose here a novel method of transmitting power and information to implanted medical equipment. The proposed system is composed of two piezo oscillators and has the following functions: transmission of power and control information to an implanted device, and transmission of the information acquired by an implanted device to the outside of a living body. With amplitude

Hideyuki Kawanabe; Tamotsu Katane; Hideo Saotome; Osami Saito; Kazuhito Kobayashi

2001-01-01

175

Use of standards in the review of medical devices  

Microsoft Academic Search

In keeping with its mandate to provide the least burdensome means of product regulation, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include providing a set of common requirements and test protocols to

Charles Ho; Donald Jensen; Frank Lacy; Neal Muni; Sabina Reilly; Elias Mallis

2005-01-01

176

A taxonomy of vulnerabilities in implantable medical devices  

Microsoft Academic Search

Once the domain of science fiction, devices connecting biological systems with computers have become reality. Security vulnerabilities that might be exploited in such systems by malicious parties or by inadvertent manipulation are also now a reality. Where previous research has described certain categories of attacks against and countermeasures for implantable medical devices (IMDs), we construct a loose vulnerability taxonomy useful

Jeremy A. Hansen; Nicole M. Hansen

2010-01-01

177

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

178

Risk evaluation of medical and industrial radiation devices.  

National Technical Information Service (NTIS)

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 ...

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

1994-01-01

179

Collaborative architecture framework for the design & manufacturing of medical devices  

Microsoft Academic Search

The purpose of this project is to develop a modular architecture framework for the design and manufacture of medical devices. This modular framework aims to incorporate design variables and criteria that are unique to the medical domain to facilitate reliable operation, easier maintenance, and faster product development time. Central to this research effort is the need for inputs from range

Celestine Aguwa; Leslie Monplaisir

2009-01-01

180

The CE mark for implantable medical devices.  

PubMed

A vital aspect of device and implant regulation is continual surveillance of performance after approval. Most permanent implants seldom reveal their strengths and weaknesses until they have been in clinical use for a number of years. It is vital that clinicians report problems to the manufacturers and regulatory authorities to enable emerging hazards to be promptly identified. PMID:11436437

Randall, H; Croft, R J

2001-06-01

181

Do medical devices have enhanced placebo effects?  

Microsoft Academic Search

Although the placebo in a clinical trial is often considered simply a baseline against which to evaluate the efficacy of a clinical intervention, there is evidence that the magnitude of placebo effect may be a critical factor in determining the results of a trial. This article examines the question of whether devices have enhanced placebo effects and, if so, what

Ted J Kaptchuk; Peter Goldman; David A Stone; William B Stason

2000-01-01

182

Medical device industry efforts to increase healthcare value.  

PubMed

Although governmental healthcare reform initiatives have come to a stop in Washington, DC, the healthcare delivery system is, nevertheless, being transformed. Change is being driven by managed care organizations, which are looking for increased cost-effectiveness, and by providers of care and suppliers of medical products, who are trying to differentiate themselves from their competitors on the basis of service and quality. The efforts of one medical device company, Medtronic, are indicative of what the medical device industry is doing to increase the value (cost and quality) of healthcare. PMID:8526682

Nelson, G D

1995-11-01

183

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

184

Enhancing medical device training with hybrid physical-virtual simulators: smart peripherals for virtual devices.  

PubMed

We introduce a novel platform for medical device training: hybrid physical-virtual simulators of medical devices, combining touchscreen-enabled virtual emulations of real devices with sensorized physical peripherals to enable tactile, hands-on interaction between the trainee, simulated device and standardized patients or mannequins. The system enables objective measurement and recording of trainee performance, including interactions with both the virtual device elements and the physical components, and can include metrics and feedback not available in the real device. The system also includes an integrated wireless signaling device for use with standardized patients. We present the implementation of an example system, a virtual defibrillator with sensorized paddles and wireless signaling of successful defibrillator operation. PMID:23400187

Samosky, Joseph T; Thornburg, Andrew; Karkhanis, Tushar; Petraglia, Frank; Strickler, Elise; Nelson, Douglas A; Weaver, Robert A; Robinson, Evan

2013-01-01

185

Does switching from oral extended-release methylphenidate to the methylphenidate transdermal system affect health-related quality-of-life and medication satisfaction for children with attention-deficit\\/hyperactivity disorder?  

Microsoft Academic Search

BACKGROUND: To evaluate health-related quality of life (HRQL) and medication satisfaction after switching from a stable dose of oral extended-release methylphenidate (ER-MPH) to methylphenidate transdermal system (MTS) via a dose-transition schedule in children with attention-deficit\\/hyperactivity disorder (ADHD). METHODS: In a 4-week, multisite, open-label study, 171 children (164 in the intent-to-treat [ITT] population) aged 6-12 years diagnosed with ADHD abruptly switched

Oscar G Bukstein; L Eugene Arnold; Jeanne M Landgraf; Paul Hodgkins

2009-01-01

186

Intravascular foreign bodies: danger of unretrieved fragmented medical devices.  

PubMed

A warning on the danger of unretrieved device fragments and recommendations to mitigate the danger were issued by the Food and Drug Administration in January 2008. The causes of intravascular foreign bodies are classified into three main categories: improper manipulation and usage, device defects, and others, such as patient and anatomical factors. Device failure after long-term use is rarely predicted at the time of approval, since device abnormality is rarely experienced in animal studies and clinical trials conducted during development of the device. Stent fracture due to metal fatigue is one example. Complex complications could occur from simultaneous use of two or more devices with diverse characteristics. The success rate of percutaneous retrieval of intravascular foreign bodies has improved with the advances in commercially available devices. However, the procedure is not always successful and sometimes surgical removal becomes necessary. Appropriate device selection and acquisition of experience in using the device are important. When an intravascular foreign body cannot be retrieved, the risk of complication could be high. Magnetic resonance imaging examination sometimes causes adverse events, including burns due to the heat generated by metal movement. Such information should be correctly recorded. Furthermore, it is necessary to provide patients with adequate information about the characteristics of implanted devices and unretrieved fragments. We reviewed the literature on unretrieved medical device fragments and include articles that describe the Japanese experience. PMID:19536624

Tateishi, Minori; Tomizawa, Yasuko

2009-06-18

187

Risk management in the design of medical device software systems.  

PubMed

The safety of any medical device system is dependent on the application of a disciplined, well-defined, risk management process throughout the product life cycle. Hardware, software, human, and environmental interactions must be assessed in terms of intended use, risk, and cost/benefit criteria. This article addresses these issues in the context of medical devices that incorporate software. The article explains the principles of risk management, using terminology and examples from the domain of software engineering. It may serve as a guide to those new to the concepts of risk management and as an aide-memoire for medical device system/software engineers who are more familiar with the topic. PMID:12162111

Jones, Paul L; Jorgens, Joseph; Taylor, Alford R; Weber, Markus

188

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

189

The medical device data language for the P1073 medical information bus standard  

Microsoft Academic Search

Summary  A new object-oriented Medical Device Data Language (MDDL) has been developed by the P1073 Medical Information Bus (MIB) Standard\\u000a Committee, under the auspices of the Engineering in Biology and Medicine Society (EMBS) of the Institute of Electronic and\\u000a Electrical Engineers (IEEE). The MDDL treats devices, host computers, persons and parameters as objects, and provides methods\\u000a for describing and passing messages

Jan Wittenber; M. Michael Shabot

1991-01-01

190

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

191

Battery power comparison to charge medical devices in developing countries.  

PubMed

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. PMID:19964250

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

2009-01-01

192

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

Federal Register 2010, 2011, 2012, 2013

...Orphan Products Development is announcing...workshop: FDA Pediatric Medical Devices...challenges in pediatric device development--namely...2012. The FDA Pediatric Medical Devices...Orphan Product Development and will...

2012-07-26

193

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

Federal Register 2010, 2011, 2012, 2013

...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

194

Risk evaluation of medical and industrial radiation devices  

SciTech Connect

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 techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis.

Jones, E.D. [Lawrence Livermore National Lab., CA (United States); Cunningham, R.E.; Rathbun, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Office of Nuclear Material Safety and Safeguards

1994-03-01

195

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

Federal Register 2010, 2011, 2012, 2013

...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

196

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

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...an amendment to the notice of a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

2010-01-11

197

Cutaneous reactions to transdermal therapeutic systems.  

PubMed

Transdermal therapeutic systems (TTSs) are commonly used to treat many diverse medical conditions. There are several advantages to this form of drug delivery; however, adverse cutaneous reactions are common. This review article provides an update on skin reactions due to TTSs containing medications newly available in TTS form, including buprenorphine, diclofenac, lidocaine, oxybutynin, rotigotine, methylphenidate, rivastigmine, teriparatide, and nicardipine. PMID:21781635

Bershow, Andrea; Warshaw, Erin

198

European medical device regulatory law and product liability  

Microsoft Academic Search

The regulatory system for medical devices is quite different from that for pharmaceuticals and may catch many people unawares. For instance, it does not involve the grant of a marketing authorization by a medicines agency. Instead, a ‘declaration of conformity’ is made by the manufacturer, but in many instances this is subject to approval by an independent certification house (known

J. Bright

1999-01-01

199

From concept to exit strategies--medical device innovation.  

PubMed

It's quite a rollercoaster ride when you are part of a medical device start-up team. There are often many partners and processes that are not often taught in school or in the training to do research . For example, how does one obtain financing, protect intellectual property, set up a business, work with contract designers and/or manufacturers? Bringing a medical device business into existence is challenging and generally, only one in 10 medical device start ups make it. This lively 2-hour session brings together panelists with many years of start-up experience to give the audience a perspective of the many facets and ways to successfully (and sometimes not so successfully) bring a product to market. This is a panel discussion on the "nuts and bolts" of medical device innovation, how to do it, what to watch out for, a sharing of experience and lessons learned. The panelists include: Amir Belson M. D.--Neoguide Systems Thomas Conn--consultant Tom Goff, Kerberos MD; Eric Goldfarb--Evalve Sorin Grunwald, Ph.D./MBA--BC Tech Nicole Walker--Onset Ventures D.J. Williams, PhD--Loughborough University. PMID:17271480

Kermit, Eben L

2004-01-01

200

Applied ergonomics: Determining user needs in medical device design  

Microsoft Academic Search

This paper describes methodology for determining user needs within the design process currently being used by the University of Cincinnati's Medical Device Innovation and Entrepreneurship Program. Topics such as ethnography (user observation and interviews), task analysis, and human factors for product embodiment are discussed. Specific tools for data gathering, analysis and synthesis towards determining design considerations, requirements and specifications are

Mary Beth Privitera; D. L. Murray

2009-01-01

201

Wireless energy transfer platform for medical sensors and implantable devices  

Microsoft Academic Search

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro

Fei Zhang; Steven A. Hackworth; Xiaoyu Liu; Haiyan Chen; Robert J. Sclabassi; Mingui Sun

2009-01-01

202

Export of Medical Devices. A Workshop Manual, August 1990.  

National Technical Information Service (NTIS)

The manual covers the basic regulatory requirements that manufacturers must consider when they prepare to export a medical device. The materials it contains are useful for guidance and reference on Food and Drug Administration and U.S. Department of Comme...

G. S. Clark L. L. Rice N. S. Lowe R. P. Parr

1990-01-01

203

MRI compatibility and visibility assessment of implantable medical devices  

Microsoft Academic Search

We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medical de- vices. The testing protocol consists of the evaluation of magnetic field-induced movement, electric current, heat- ing, image distortion, and device operation. In addition, current induction is evaluated with a finite element analy- sis simulation technique that models the effect of radiofre- quency fields on

Beth A. Schueler; Todd B. Parrish; Bruce E. Hammer; Brian J. Pangrle; E. Russell Ritenour; John Kucharczyk; Charles L. Truwit

1999-01-01

204

Lost in menuspace: user interactions with complex medical devices  

Microsoft Academic Search

The advent of fast-acting drugs has made the infusion pump the most pervasive electronic medical device in the acute care (hospital) environment. Despite the importance of its correct oper- ation, incident reports in the US Food and Drug Administration (FDA) database implicate interface programming as a significant aspect of adverse outcomes. This article describes a study of infu- sion pump-programming

Mark Nunnally; Christopher P. Nemeth; Valerie Brunetti; Richard I. Cook

2004-01-01

205

Biofilms in infectious disease and on medical devices  

Microsoft Academic Search

Microbial biofilms constitute a major reason for infections to occur and persist at various sites in the human body, especially in association with medical devices. The organisms invariably form these biofilms on surfaces which have host proteins and other substances coating them. Once adherent, the bacteria multiply and anchor themselves in quite intricate structures which appear to allow for communication

G Reid

1999-01-01

206

Towards automated assistance for operating home medical devices  

Microsoft Academic Search

To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human

Zan Gao; Marcin Detyniecki; Ming-yu Chen; Wen Wu; Alexander G. Hauptmann; Howard D. Wactlar

2010-01-01

207

Design and execution of clinical studies for medical devices  

Microsoft Academic Search

Summary form only give. You have a great new medical device that had good results in your animal studies and now you want to test it in a clinical study on human subjects. What are the key steps in designing and executing human subject studies so you can use the data to support your regulatory submissions? Some aspects that will

G. T. Bartoo

2004-01-01

208

Perspectives on In Vitro Toxicity for Medical Devices  

Microsoft Academic Search

In vitro toxicity testing has found widespread application in its use for screening materials for medical devices. Cytotoxicity tests, which have been in use for nearly 20 years, have been validated for intralaboratory repeatability, interlaboratory reproducibility, and correlation with acute animal toxicity assays. The three primary cytotoxicity assays, i.e., direct contact, agar diffusion, and elution tests, allow a selection between

Sharon J. Northup

1988-01-01

209

IMDGuard: Securing implantable medical devices with the external wearable guardian  

Microsoft Academic Search

Recent studies have revealed security vulnerabilities in implantable medical devices (IMDs). Security design for IMDs is complicated by the requirement that IMDs remain operable in an emergency when appropriate security credentials may be unavailable. In this paper, we introduce IMDGuard, a compre- hensive security scheme for heart-related IMDs to fulfill this requirement. IMDGuard incorporates two techniques tailored to provide desirable

Fengyuan Xu; Zhengrui Qin; Chiu C. Tan; Baosheng Wang; Qun Li

2011-01-01

210

CASE STUDY: Safety assessment for new medical device  

Microsoft Academic Search

Noveko, a leading manufacturer of medical devices, wanted to market a new surgical mask that contained several plastic additives, including two antimicrobial compounds. The registration of products with antimicrobial properties can be very challenging in the US and all claims of performance, efficacy and labeling are closely scrutinized by the EPA and FDA. The safety of such articles must also

211

Secure Method for Software Upgrades for Implantable Medical Devices  

Microsoft Academic Search

A non-invasive software upgrade method for permanent implantable medical devices was developed to alleviate patients' suffering due to malfunctions because of software faults, which may cause serious adverse health consequences or require enhancements with new software. The programs distributed to the internal implantable pulse generator (IPG) from the external programmer have been developed so that the upgrade service program in

Yang Cao; Chunhua Hu; Bozhi Ma; Hongwei Hao; Luming Li; Weiming Wang

2010-01-01

212

New trends in biological evaluation of medical devices.  

PubMed

More extensive material characterisation and increased determination of toxicological risks are now required when evaluating new medical devices. The new requirements together with other changes in the ISO 10993 series described here suggest how companies can adjust their approach. PMID:15984539

Bollen, L S

2005-06-01

213

A quantitative approach for medical device Health Hazard Analysis  

Microsoft Academic Search

Health Hazard Analysis (HHA) is one major type of patient health risk assessment for medical device field performance issue. U.S. Food and Drug Administration (FDA) has an online form, listing the needed information for HHA. In this paper, we will illustrate a quantitative HHA approach, which is structured in a rigorous risk assessment framework, with several critical steps, concepts and

Mingxiao Jiang; Kathy Herzog; Thomas Pepin; Michael D. Baca

2011-01-01

214

Career development of biomedical engineers in medical device industry  

Microsoft Academic Search

With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper

Quan Ni; Yachuan Pu

2009-01-01

215

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

Federal Register 2010, 2011, 2012, 2013

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

2010-07-28

216

Transdermal patch drug delivery interactions with exercise.  

PubMed

Transdermal drug delivery systems, such as the transdermal patch, continue to be a popular and convenient way to administer medications. There are currently several medications that use a transdermal patch drug delivery system. This article describes the potential untoward side effects of increased drug absorption through the use of a transdermal patch in individuals who exercise or participate in sporting events. Four studies have been reported that demonstrate a significant increase in the plasma concentration of nitroglycerin when individuals exercise compared with rest. Likewise, several case reports and two studies have been conducted that demonstrate nicotine toxicity and increased plasma nicotine while wearing a nicotine patch in individuals who exercise or participate in sporting events compared with rest. Healthcare providers, trainers and coaches should be aware of proper transdermal patch use, especially while exercising, in order to provide needed information to their respective patients and athletes to avoid potential untoward side effects. Particular caution should be given to individuals who participate in an extreme sporting event of long duration. Further research that includes more medications is needed in this area. PMID:21395361

Lenz, Thomas L; Gillespie, Nicole

2011-03-01

217

The radiation resistance of the bioburden from medical devices  

NASA Astrophysics Data System (ADS)

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 manufactured in these centres were studied. A total of 3742 unselected isolates were obtained, of which 197 failed to survive long enough for subsequent radiation resistance studies. The remainder were subjected to an initial screen test to identify those organisms that were sensitive to the lethal effects of radiation with a D10 of < 1.5kGy. The 465 isolates that survived the screen doses were then tested for survival in an incremental series of radiation doses using methods similar to those of Whitby (1979) and Yan and Tallentire (1995). The isolates from ``dry'' devices were more resistant than those obtained from the one water filled (``wet'') device studied. The overall distribution of radiation resistance among the isolates was considered to be similar to that forming the ``Standard Distribution of Resistance'' (SDR) included in the ISO International Standard 11137 ``Sterilization of Health Care Products - Requirements for validation and routine control - Radiation sterilization''.

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

1998-06-01

218

A publish-subscribe architecture and component-based programming model for medical device interoperability  

Microsoft Academic Search

Medical devices historically have been monolithic units --- developed, validated, and approved by regulatory authorities as standalone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single customizable displays, and coordinate the actions of groups of cooperating devices to realize \\

Andrew King; Sam Procter; Dan Andresen; John Hatcliff; Steve Warren; William Spees; Raoul Jetley; Paul Jones; Sandy Weininger

2009-01-01

219

Prototyping closed loop physiologic control with the medical device coordination framework  

Microsoft Academic Search

Medical devices historically have been monolithic units --- developed, validated, and approved by regulatory authorities as standalone entities. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to electronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices

Andrew King; Dave Arney; Insup Lee; Oleg Sokolsky; John Hatcliff; Sam Procter

2010-01-01

220

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

221

Design of medical devices--a home perspective.  

PubMed

Health care services are moving out to the community and into the home; e-health services, remote monitoring technology and self-management are replacing hospitalization and visits to medical clinics and custom-tailored medicines are making inroads into normative treatment. These developments have great implications for the scope and design of home health care equipment. The paper discusses the unique nature of home medical devices, from a human-environment-machine perspective, focusing on the nature of users, environment and tasks performed. We call for increased awareness and active continuous involvement of health care personnel together with bioengineers, human factors experts, architects, designers and end users--patients and caregivers--in defining the objectives of health care devices and services at home in terms of "all family" use, integrated into the overall surroundings ("smart home"), and as part of a collaborative patient-physician disease management team. PMID:21238891

Bitterman, Noemi

2010-10-30

222

Wireless energy transfer platform for medical sensors and implantable devices.  

PubMed

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power. PMID:19964948

Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

2009-01-01

223

Polymeric biomaterials for load-bearing medical devices  

Microsoft Academic Search

This paper aims to give a broad overview of the challenges that are faced in load-bearing medical devices and focuses specifically\\u000a on the challenges faced in utilizing polymeric materials in such applications. Three specific cases are given in the field\\u000a of polymeric biomaterials. These cases build in complexity and initiate with examination of the evolution of intravascular\\u000a catheter design in

Lisa Pruitt; Jevan Furmanski

2009-01-01

224

Industrial Design and Human Factors: Design Synergy for Medical Devices  

Microsoft Academic Search

Research has shown the impact design may have on apparent, as well as inherent, usability. Through collaboration, Industrial\\u000a Designers and Human Factors Engineers can design medical devices that address emotional design and thus contribute to apparent\\u000a usability. This collaboration must overcome challenges common in the industry including design influences and standards, business\\u000a factors, and regulatory processes. Integrating the two disciplines,

Merrick Kossack; Andrew Gellatly; Alice Jandrisits

2007-01-01

225

State of the Art Batteries for Implantable Medical Devices  

Microsoft Academic Search

th anniversary of the first im plant of a pacemaker powered by a lithium battery. 1 Thirty y ears later, lithium-based batteries remain at the forefront of power source technology for implantable medical devices, with many recent developments in the specialized chemistries for these applications. Early pacemakers used zinc\\/mercury cells, but by the early 1970's it was clear that an

Randolph A. Leising; Esther S. Takeuchi

226

Flex Technology for Foldable Medical Flip Chip Devices  

Microsoft Academic Search

Highest functionality in increasingly smaller volumes, both for implanted and non- implanted medical devices, requires extreme miniaturization. An approach using ultrathin highly flexible substrate technology, flip chip reflow soldering of thin IC's thereon and subsequent 3D-folding has been developed in the framework of the European project SHIFT. The concept and results will be presented in this paper. With the HiCoFlex

Barbara Pahl; Thomas Loeher; Hans Burkard; Josef Link; A. Petersen; R. Aschenbrenner

227

Improving Software Risk Management Practices in a Medical Device Company  

Microsoft Academic Search

Software is becoming an increasingly important aspect of medical devices (MDs) and MD regulation. MDs can only be marketed\\u000a if compliance and approval is achieved from the appropriate regulatory bodies. MD companies must produce a design history\\u000a file detailing the processes undertaken in the design and development of their MD software. The safety of all MD software\\u000a produced is of

John Burton; Fergal Mccaffery; Ita Richardson

2008-01-01

228

Medical device interoperability a standards-based testing approach.  

PubMed

Abstract We present a black-box messaging test approach employed to achieve a level of rigor which improves-if not assures, given no optionality-correct data exchange. In particular, we verify that physiological information derived and communicated via messaging from a source medical device (e.g., an infusion pump) or healthcare information system, to another medical device (e.g., a patient monitor) or healthcare information system, which consumes or makes use of the data, is syntactically and semantically correct. In other words, the structure of information exchanged within the healthcare system is compliant to a defined specification(s) and the information meaning conveyed and interpreted by the consumer is exactly the same and as intended by the source. Our approach for developing a test system to validate messages is based on constraining identified and recognized specifications. The test system validation performed uses codified assertions derived from the specifications and constraints placed upon those specifications. To first show conformance-which subsequently enables interoperability-these assertions, which are atomic requirements traceable by clause to the base specifications, are employed by our medical device test tools to rigorously enforce standards to facilitate safe and effective plug-and-play information exchange. PMID:21639776

Garguilo, John J; Martinez, Sandra; Cherkaoui, Maria

229

[Comments on the interpretation of the term "medical devices"].  

PubMed

The Court of Justice of the European Union made a decision on medical devices as non-medicinal products for intended use in interpreting the concept of free movement of goods, such as operating principles concerning the subject matter of the interpretation of Directive 93/42/ EEC - in preliminary ruling according to article 267 of TFEU - on 22 November 2012. With its decision, given assigned explained the concept of the scope of medical devices. The decision of the Court is binding not only for the national court initiating a request for the preliminary ruling, but also for all courts of the Member States. Official reference: Dated judgement 22 November 2012 of the Court of Justice of the European Union to C-219/ Case no. 11 - in preliminary ruling according to article 267 of TFEU. Interpreted provisions: Directive 2007/47/EC of The European Parliament and of the Council of 5 September 2007 as amended by the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 1st (2) a) first, second and third indent. PMID:23461981

Ferge, Zsigmond

2013-03-10

230

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

231

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?  

Microsoft Academic Search

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and

Gerald Robert Goodman

1999-01-01

232

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

233

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

Code of Federal Regulations, 2010 CFR

...2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices. 419...OUTPATIENT DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices....

2010-10-01

234

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

Code of Federal Regulations, 2010 CFR

...2009-10-01 2009-10-01 false Transitional pass-through payments: Medical devices. 419...OUTPATIENT DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices....

2009-10-01

235

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

Federal Register 2010, 2011, 2012, 2013

...Comment Request; Medical Devices; Third-Party Review Under the Food and Drug...associated with medical devices third-party review under the Food and Drug...records, or provide information to a third party. Section...

2013-07-09

236

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

Federal Register 2010, 2011, 2012, 2013

...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

237

61 FR 12075 - ``Medical Device Design Control Guidance'' and ``Do It By Design;'' Draft Guidance; Availability  

Federal Register 2010, 2011, 2012, 2013

...Docket No. 96D-0065] ``Medical Device Design Control Guidance'' and ``Do It By Design;'' Draft Guidance; Availability AGENCY...guidance documents entitled, ``Medical Device Design Control Guidance'' and ``Do It By...

1996-03-25

238

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

Federal Register 2010, 2011, 2012, 2013

...a similar course of a disease or condition or a similar effect of...and effective pediatric medical devices continues to steadily increase. Pediatric medical devices treat or diagnose diseases and conditions occurring from birth...

2011-11-01

239

Baseline Data on the Availability of Medical Devices and In-Vitro Diagnostic Products.  

National Technical Information Service (NTIS)

Following enactment of the Medical Device Amendments of 1976, FDA initiated a series of studies to assess the 'baseline' conditions in the medical device industry. Those studies are designed to (1) provide the basis for informed regulation and (2) supply ...

1980-01-01

240

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

Federal Register 2010, 2011, 2012, 2013

...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

241

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

Federal Register 2010, 2011, 2012, 2013

...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

242

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

Federal Register 2010, 2011, 2012, 2013

...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

243

Transmitting patient and device data via GSM--central management for decentral mobile medical devices.  

PubMed

Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system. PMID:12451860

Bachmor, T; Schöchlin, J; Bolz, A

2002-01-01

244

Improvised explosive devices: pathophysiology, injury profiles and current medical management.  

PubMed

The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management. PMID:20397601

Ramasamy, A; Hill, A M; Clasper, J C

2009-12-01

245

Nanostructured selenium for preventing biofilm formation on polycarbonate medical devices.  

PubMed

Biofilms are a common cause of persistent infections on medical devices as they are easy to form and hard to treat. The objective of this study was for the first time to coat selenium (a natural element in the body) nanoparticles on the surface of polycarbonate medical devices (such as those used for medical catheters) and to examine their effectiveness at preventing biofilm formation. The size and distribution of selenium coatings were characterized using scanning electron microscopy and atomic force microscopy. The strength of the selenium coating on polycarbonate was assessed by tape-adhesion tests followed by atomic absorption spectroscopy. Results showed that selenium nanoparticles had a diameter of 50-100 nm and were well distributed on the polycarbonate surface. In addition, more than 50% of the selenium coating survived the tape-adhesion test as larger nanoparticles had less adhesion strength to the underlying polycarbonate substrate than smaller selenium nanoparticles. Most significantly, the results of this in vitro study showed that the selenium coatings on polycarbonate significantly inhibited Staphylococcus aureus growth to 8.9% and 27% when compared with an uncoated polycarbonate surface after 24 and 72 h, respectively. Importantly, this was accomplished without using antibiotics but rather with an element (selenium) that is natural to the human body. Thus, this study suggests that coating polymers (particularly, polycarbonate) with nanostructured selenium is a fast and effective way to reduce bacteria functions that lead to medical device infections. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 100A: 3205-3210, 2012. PMID:22707390

Wang, Qi; Webster, Thomas J

2012-06-15

246

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

247

75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2010-N-0363] Medical Device User Fee Rates for Fiscal Year...rates and payment procedures for medical device user fees for fiscal year (FY...the act), as amended by the Medical Device User Fee Amendments of...

2010-08-03

248

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

Microsoft Academic Search

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 of a safe and effective method of thermally actuating various device geometries in vivo. A novel scheme of actuation by Curie-thermoregulated inductive heating is presented. Prototype medical

Patrick R. Buckley; Gareth H. McKinley; Thomas S. Wilson; Ward Small; William J. Benett; Jane P. Bearinger; Michael W. McElfresh; Duncan J. Maitland

2006-01-01

249

Testing of Domestic and Imported Medical Devices for Interference Stability Requirements  

Microsoft Academic Search

Medical devices work in the presence of significant electromagnetic interference. Therefore, interference stability is a very important parameter of medical devices and systems because it contributes substantially to safety and reliability requirements [2]. Electromagnetic compatibility (EMC) is determined by the requirements of interference emission and interference stability. All electrical devices are routinely tested for interference emission, whereas tests of medical

B. N. Faizulaev; K. S. Oraevskii; I. N. Porfir'ev; V. V. Logachev; I. P. Gorshkova

2001-01-01

250

Electromagnetic Environmental Effects Testing of Medical Devices Including Those Used for the Treatment of Diabetes  

Microsoft Academic Search

Background: Electromagnetic emissions from technologies that surround us can produce interference with implanted and externally worn medical devices. Electromagnetic environmental effects (E3) testing of medical devices at the Georgia Tech Research Institute (GTRI) began almost four decades ago and continues to incorporate new devices and new sources of electromagnetic emissions as they are developed and become available. The GTRI Medical

Ralph M. Herkert

2008-01-01

251

Safety Evaluation of Medical Devices: US Food and Drug Administration and International Standards Organization Guidelines  

Microsoft Academic Search

During the last 20 years, safety evaluation of medical devices has evolved from screening assays to the “pharmaceutical model” of preclinical testing. Biocompatibility testing guidelines for medical devices are published in the International Organization for Standardization (ISO) document 10993–1: Biological evaluation of medical devices—Part 1: Evaluation and testing. These guidelines are recognized by most national regulatory bodies and supplement, but

Sharon J. Northup

1999-01-01

252

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

Microsoft Academic Search

Human errors in medical device use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical device use is critical for developing interventions to reduce such errors either by redesigning the devices or, if redesign is not an option,

Jiajie Zhang; Vimla L. Patel; Todd R. Johnson; Philip Chung; James P. Turley

253

Estradiol Transdermal Patch  

MedlinePLUS

Most brands of estradiol transdermal patches are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or vaginal ... that does not contain estrogen. Most brands of estradiol transdermal patches are also sometimes used as a source ...

254

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

Federal Register 2010, 2011, 2012, 2013

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

2010-08-06

255

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

Federal Register 2010, 2011, 2012, 2013

...Medical Devices; Neurological and Physical Medicine Device Guidance Documents...guidance documents for 11 neurological and physical medicine devices. FDA has developed...achieves ``aesthetic effects through physical change to the structure of the...

2010-04-05

256

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

Code of Federal Regulations, 2013 CFR

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

2013-04-01

257

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

2010-07-01

258

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

2009-07-01

259

77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...  

Federal Register 2010, 2011, 2012, 2013

...and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit...availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit...guidance document entitled ``Medical Device ISO 13485:2003 Voluntary...

2012-03-19

260

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...

2009-04-01

261

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

262

75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...  

Federal Register 2010, 2011, 2012, 2013

...and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit...the draft guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit...guidance document entitled ``Medical Device ISO 13485:2003 Voluntary...

2010-05-20

263

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

Federal Register 2010, 2011, 2012, 2013

...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

264

78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...  

Federal Register 2010, 2011, 2012, 2013

...Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY...entitled ``eCopy Program for Medical Device Submissions.'' The purpose...electronic copy (eCopy) Program for medical device submissions, which is...

2013-01-02

265

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

Federal Register 2010, 2011, 2012, 2013

...2006D-0504) Radio Frequency Wireless Technology in Medical Devices; Guidance...entitled ``Radio Frequency Wireless Technology in Medical Devices; Guidance...of radio frequency (RF) wireless technology in medical devices....

2013-08-14

266

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

Federal Register 2010, 2011, 2012, 2013

...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

267

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

Code of Federal Regulations, 2012 CFR

...2 2012-10-01 2012-10-01 false Medical supplies, appliances, and devices: Scope...HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.36...

2012-10-01

268

Empowering patients: total product life cycle for medical devices.  

PubMed

Patients today demand a stake in the care of their own health. The expectation is that patients who take responsibility for their own care will communicate more effectively with their health care team and be productive citizens in our society. Medical technology today and those products visible on the horizon, coupled in a telehealth network, provide promise to empower patients to participate fully in the management of their own health. Technology alone, however, will not integrate the elements required for an effective telehealth system. This chapter considers the non-technical matters of this issue such as trends in the medical device industry, trends in the point of care, public health care policies, and the role of government regulation, working together to achieve these public health goals. PMID:15455843

Ciarkowski, Arthur A

2003-01-01

269

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

270

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

271

BioIntraface®: The Next Quantum in Medical Devices.  

PubMed

BioIntraface®, Inc., located in Riverside, Rhode Island, was formed in February of 2009 to commercialize its biomaterials surface treatment technologies. The platform technologies involve the creation of economical, multifunctional metal oxide and polymer materials and coatings to control the bioactivity and antimicrobial properties of medical devices and implants. Biointraface® has continued optimizing and validating coatings for promising applications in orthopaedics, dentistry, catheters, wound dressings, topical antimicrobial products, and cosmetics applications. It has also obtained third-party verification of ISO biocompatibility testing for eight coatings with increasing levels of antimicrobial agents, where no cytotoxicity was indicated and similar tests showing long lasting antimicrobial efficacy against multiple strains of bacteria. PMID:23641423

Jarrell, John D

2013-02-01

272

What the Internet means for the medical device industry.  

PubMed

The Internet is dramatically changing the structure of the industry. For the first time, direct communication between all suppliers and all hospitals is available. The Internet-based electronic market place not only provides the ability to choose products from a standardized catalogue, but also to send orders direct to suppliers' enterprise resource planning systems. One-to-one marketing is also becoming a reality. Medical device manufacturers are advised to test the different electronic sales and marketing initiatives that are now available. PMID:11200157

Frank, T

2000-12-01

273

Gordonia araii Infection Associated with an Orthopedic Device and Review of the Literature on Medical Device-Associated Gordonia Infections  

Microsoft Academic Search

Gordonia infections in humans are rare and usually affect immunocompromised patients. We present the first case of Gordonia araii infection associated with a medical device in an immunocompetent patient. Sequencing was required for conclusive identification. We compared our case to the 16 Gordonia species- associated medical device infections reported to date.

Deanna P. Jannat-Khah; Eric S. Halsey; Brent A. Lasker; Arnold G. Steigerwalt; Hans P. Hinrikson; June M. Brown

2009-01-01

274

US FDA perspective on the regulations of medical-grade polymers: cyanoacrylate polymer medical device tissue adhesives.  

PubMed

This article provides a brief description of the uses and clinical applications of medical-grade polymers, in particular synthetic cyanoacrylate adhesive/glue devices that have been cleared and/or approved as medical devices by the US FDA since the Medical Device Amendments of 1976 were enacted. This includes Class I cyanoacrylate devices (e.g., liquid bandages), Class II cyanoacrylate devices (e.g., dental cements), and Class III (premarket approval) cyanoacrylate devices such as Dermabond, Indermil Tissue Adhesive, Histoacryl and Histoacryl Blue Topical Skin Adhesive, and Trufill n-Butyl Cyanoacrylate Embolic Agent. By citing an example of FDA approved Class III devices in the cyanoacrylate technology, the article provides a brief discussion of the FDA approval process of medical devices. It includes the FDA issues regarding the published guidance document for 'Cyanoacrylate Topical Tissue Adhesives' that will provide guidance to regulatory personnel and manufacturers in the preparation of investigational device exception applications and in the development of valid scientific evidence to support premarket approval applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. The article provides a short regulatory description of the US FDA; under what laws its operates, how the FDA evaluates new devices for marketing, and how the device regulatory system works, for example, Class I, Class II, and Class III cyanoacrylate medical devices. PMID:18095895

Mattamal, George J

2008-01-01

275

Surgical hemostatic agents: assessment of drugs and medical devices.  

PubMed

Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished several particular settings (mouth and dental care in patients under antiagregant or anticoagulation therapy, central nervous system surgery or acute aortic dissection). Comparative data are insufficient to determine if one product is superior to another for a specific use. To evaluate the clinical value of these products, methodologically sound clinical studies are necessary. PMID:22136914

Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C

2011-12-01

276

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125...Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A device...

2013-04-01

277

Transdermal Drug Delivery  

Microsoft Academic Search

\\u000a Transdermal drug delivery is a validated technology contributing significantly to global pharmaceutical care. Since 1980,\\u000a impressive growth in this field has been observed with many commercial successes; importantly, a new chemical entity was recently\\u000a developed and approved for transdermal administration without having first been given as an injectable or oral dosage form.\\u000a The progress achieved has been based on the

Richard H. Guy

278

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

279

Achromatic handpiece and laser delivery device for cutaneous medical application  

NASA Astrophysics Data System (ADS)

A fiber handpiece developed for dermatological and vascular medical applications is discussed in detail. The handpiece can be zoomed such that it can deliver output spot diameters ranging from 2 mm to 10 mm when connected to a fiber optic with a 365 micrometer diameter core size. The spot diameter is invariant at the treatment plane over a continuous wavelength spectrum between 532 nm to 1064 nm and exhibits a spot diameter variation of less than 10% over the depth of focus of plus or minus 5 mm at each spot size setting. In these regards, the handpiece can be considered 'achromatic' and 'telecentric.' Details of the optical design, the design process, and important delivery device considerations will be discussed.

Angeley, David G.

2000-05-01

280

Nanobionics: the impact of nanotechnology on implantable medical bionic devices  

NASA Astrophysics Data System (ADS)

The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.

Wallace, G. G.; Higgins, M. J.; Moulton, S. E.; Wang, C.

2012-07-01

281

Identifying, Understanding, and Communicating Medical Device Use Errors: Observations from an FDA Pilot Program.  

National Technical Information Service (NTIS)

The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe u...

M. Flack T. Reed J. Crowley S. Gardner

2005-01-01

282

Medical Devices: FDA Can Improve Oversight of Tracking and Recall Systems.  

National Technical Information Service (NTIS)

The authors met with officials from (FDA's) Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs who oversee the implementation of the medical device tracking regulation to discuss and the methods used to inspect the tracking...

1998-01-01

283

Medical Device Tracking: Questions and Answers Based on the Final Rule.  

National Technical Information Service (NTIS)

The tracking requirements of the Safe Medical Devices Act became effective on August 29, 1993. The purpose of device tracking is to assure that manufacturers of certain devices (i.e., devices subject to tracking under section 519(e) of the Food, Drug, and...

N. Lowe N. Pressly

1993-01-01

284

The Role of Postmarket Surveillance in the Medical Device Risk Management System  

Microsoft Academic Search

The primary vehicles of medical device risk management are the threat and actuality of product liability plus federal regulation by FDA's Center for Devices and Radiological Health (CDRH). CDRH regulates devices using varying degrees of stringency, including premarket approval. Even after premarket approval, subsequent failures of several devices have led to widespread litigation. This litigation often results in gag orders

Henry R. Piehler; Allen A. Hughes

285

47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.  

Code of Federal Regulations, 2010 CFR

...Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the 608-614...

2010-10-01

286

47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.  

Code of Federal Regulations, 2010 CFR

...Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the 608-614...

2009-10-01

287

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...  

Code of Federal Regulations, 2010 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2010-10-01

288

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...  

Code of Federal Regulations, 2012 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2012-10-01

289

47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 MHz and...  

Code of Federal Regulations, 2010 CFR

...Specific requirements for wireless medical telemetry devices operating in the 1395-1400...PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions...Specific requirements for wireless medical telemetry devices operating in the...

2009-10-01

290

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.

Smith, Nadine Barrie

2007-01-01

291

Mobile devices management system in the medical field  

Microsoft Academic Search

Mobile devices location systems for remote objects are increasingly used today by several enterprises. Many systems use positioning devices such as GPS and communication devices to send remote location data. These systems suffer from many constraints related to the precision of the location at any point of time, the availability of specified devices, their high cost and the periodical expensive

Hamid Mcheick; Joumana Dargham

2011-01-01

292

Transdermal treatment options for neurological disorders: impact on the elderly.  

PubMed

As people grow old, their need for medications increases dramatically because of the higher incidence of chronic pain, diabetes mellitus, cardiovascular and neurological diseases in the elderly population. Furthermore, the elderly require special consideration with respect to drug delivery, drug interactions and adherence. In particular, patients with chronic neurological diseases often require multiple administration of drugs during the day to maintain constant plasma medication levels, which in turn increases the likelihood of poor adherence. Consequently, several attempts have been made to develop pharmacological preparations that can achieve a constant rate of drug delivery. For example, transdermal lisuride and apomorphine have been shown to reduce motor fluctuations and duration of 'off' periods in advanced Parkinson's disease, while rotigotine allows significant down-titration of levodopa without severe adverse effects. Thus, parkinsonian patients with long-term levodopa syndrome or motor disorders during sleep could benefit from use of transdermal lisuride and apomorphine. Moreover, transdermal dopaminergic drugs, particularly rotigotine, seem the ideal treatment for patients experiencing restless legs syndrome or periodic limb movement disorder during sleep, disorders that are quite common in elderly people or in association with neurodegenerative diseases. Unlike dopaminergic drugs, transdermal treatments for the management of cognitive and behavioural dysfunction in patients with Parkinson's disease and Alzheimer's disease have inconsistent effects and no clearly established role. Nevertheless, because of their favourable pharmacological profile and bioavailability, the cholinesterase inhibitors tacrine and rivastigmine are expected to show at least the same benefits as oral formulations of these drugs, but with fewer severe adverse effects. Transdermal delivery systems play an important role in the management of neuropathic pain. The transdermal lidocaine (lignocaine) patch is recommended as first-line therapy for the treatment of postherpetic neuralgia. Furthermore, in patients with severe persistent pain, transdermal delivery systems using the opioids fentanyl and buprenorphine are able to achieve satisfactory analgesia with good tolerability, comparable to the benefits seen with oral formulations. Transdermal administration is the ideal therapeutic approach for chronic neurological disorders in elderly people because it provides sustained therapeutic plasma levels of drugs, is simple to use, and may reduce systemic adverse effects. Several transdermal delivery systems are currently under investigation for the treatment of Parkinson's disease, Alzheimer's disease and neuropathic pain. Although most transdermal delivery systems treatments cannot be considered as first-line therapy at present, some of them provide clear advantages compared with other routes of administration and may become the preferred treatment in selected patients. In general, however, most transdermal treatments still require long-term evaluation in large patient groups in order to optimise dosages and evaluate the actual incidence of local and systemic adverse effects. PMID:16823990

Priano, Lorenzo; Gasco, Maria Rosa; Mauro, Alessandro

2006-01-01

293

Safety evaluation of a Medical Device Data System.  

PubMed

Our hospital became interested in the extraction of electronic data from our bedside monitor network to enrich clinical care, and enable various quality improvement projects, research projects, and future applications involving advanced decision-support. We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly to provide electronic data extraction and storage from networked General Electric Healthcare bedside patient monitors. We conducted a series of tests examining the changes in network performance when the BedMaster system was on our isolated patient monitor network. We found that use of BedMaster led to measurable, but trivial increases in network traffic and latency. We did not identify any failure scenarios in our analysis and testing. The major value of this report is to highlight potential challenges inherent in data and electronic device integration within the healthcare setting. In describing our strategy for testing the BedMaster system, it is our intention to present one testing protocol and to generate thought and discussion in the broader community about what types of problems can arise with inter-operability, and what types of testing are necessary to mitigate against these risks. Standards for inter-operability would surely reduce the inherent risks. PMID:23367271

Liddle, Stephanie; Grover, Lata; Zhang, Rachel; Khitrov, Maxim; Brown, Joan C; Cobb, J Perren; Goldman, Julian; Chou, Joseph; Yagoda, Daniel; Westover, Brandon; Reisner, Andrew T

2012-01-01

294

78 FR 23940 - Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1...  

Federal Register 2010, 2011, 2012, 2013

...document is limited to the biological evaluation of sterile and...Standard ISO-10993, ``Biological Evaluation of Medical Devices...International Standard ISO-10993, `Biological Evaluation of Medical Devices...have been approved under OMB control number 0910-0120; the...

2013-04-23

295

Natural bioburden levels detected on rigid lumened medical devices before and after cleaning  

Microsoft Academic Search

Controversy exists concerning the degree of microbial contamination associated with the us of rigid lumened medical devices, the efficacy of standard cleaning techniques used to remove pathogenic microorganisms from lumen channels, and whether patients are placed at risk of cross infection because of microbial contamination. In this study the level and types of microorganisms found on rigid lumened medical devices

Harriet Chan-Myers; David McAlister; Patricia Antonoplos

1997-01-01

296

Benefits and challenges of using ionic polymer metal composites in medical device applications  

Microsoft Academic Search

Ionic Polymer Metal Composites (IPMCs) have several unique characteristics such as, low driving voltage, no moving parts, etc., that allow the material to fulfill specific needs for medical device applications. However, there are numerous challenges that must be addressed in order to utilize IPMC in medical devices. The research presented is a culmination of efforts that address a number of

Charisse Yung; Doyeon Kim; Nikhil Bhat

2007-01-01

297

Projecting the impact of the 1976 Medical Device Amendments on innovation in clinical chemistry tests  

Microsoft Academic Search

This paper is concerned with the impact of the Medical Device Amendments of 1976 and its implications in terms of innovation. With this objective the paper first describes the Medical Device Amendments of 1976. The paper then reports empirical evidence on the sources of a subset of innovations regulated by the Amendment's clinical chemistry diagnostic products. Finally, based on the

Stan N. Finkelstein; Eric von. Hippel; Jeffrey R. Scott

1980-01-01

298

Facing the Challenges of Electromagnetic Interference With Medical Devices in the Wireless World  

Microsoft Academic Search

Electro magnetic interference (EMI) with medical devices has been confirmed through testing and linked with patient injury and death (1-8). For example, EMI from cellular telephones recently caused drug infusion pumps to overdose patients (8). FDA has championed the electromagnetic compatibility (EMC) of electrically powered medical devices, and performed research to help develop standardized testing methods and national and international

Donald Witters

299

Hand-held metal detectors and medical devices: measurements and testing for electromagnetic compatibility  

Microsoft Academic Search

This work examines the electromagnetic compatibility (EMC) of several priority medical devices, such as implanted cardiac pacemakers and implanted nerve stimulators, with the emissions from 28 different hand-held metal detectors (HHMDs). The HHMD emissions were measured and mapped to assess the waveforms, magnitude, and distribution of emission field strengths. Testing with the sample medical devices was performed using a saline

Donald Witters; V. Buzduga; S. Seidman; W. Kainz; J. Casamento; P. Ruggera

2005-01-01

300

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

301

Bayesian Approaches in Medical Device Clinical Trials: A Discussion with Examples in the Regulatory Setting  

Microsoft Academic Search

Challenging statistical issues often arise in the design and analysis of clinical trials to assess safety and effectiveness of medical devices in the regulatory setting. The use of Bayesian methods in the design and analysis of medical device clinical trials has been increasing significantly in the past decade, not only due to the availability of prior information, but mainly due

Pablo Bonangelino; Telba Irony; Shengde Liang; Xuefeng Li; Vandana Mukhi; Shiling Ruan; Yunling Xu; Xiting Yang; Chenguang Wang

2011-01-01

302

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

Federal Register 2010, 2011, 2012, 2013

...D) of the Federal Food, Drug, and Cosmetic Act (the FD...creates requirements for specific medical devices under 21 U.S.C...collection of information. Title: Medical Devices; Exception From General...and certify in writing certain facts concerning the need for...

2011-06-24

303

A Review of the Design Process for Implantable Orthopedic Medical Devices  

PubMed Central

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

Aitchison, G.A; Hukins, D.W.L; Parry, J.J; Shepherd, D.E.T; Trotman, S.G

2009-01-01

304

Integrating a Risk-based Approach and ISO 62304 into a Quality System for Medical Devices  

NASA Astrophysics Data System (ADS)

A recent standard for medical device software lifecycle processes, ISO/IEC 62304 (ISO 2006), assumes and specifies a software safety classification scheme, where documentation, verification and validation tasks to be carried out depend on the safety classification. This means that a risk-driven approach has become an accepted standard for medical devices.

Bianco, Celestina

305

[The research and implementation of DICOM interface of medical imaging devices].  

PubMed

PACS (Picture Archiving and Communication Systems) is the hot spot of hospital information construction research and DICOM (Digital Imaging and Communication in Medicine) is the international standard about data compression and translation of medical image and relational information. Supporting DICOM standard is the necessary condition for medical image devices to join into PACS net. In making reforms in the old fashioned medical devices in hospitals, it is necessary to add DICOM interface for medical image devices. In this paper, DICOM information model is introduced and software system is implemented with Visual C + + programming, especially the writing, reading and C-STORE service in communication function are introduced in detail. PMID:17899737

Li, Xiaoning; Li, Lvzhou; Tong, Bin; Xing, Haoyang

2007-08-01

306

Medical Device Software Development - A Perspective from a Lean Manufacturing Plant  

Microsoft Academic Search

\\u000a Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety\\u000a and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which\\u000a includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the\\u000a device. With the increasing complexity

Oisín Cawley; Ita Richardson; Xiaofeng Wang

307

Transdermal Therapy for Overactive Bladder: Present and Future  

PubMed Central

Transdermal delivery of certain pharmacologic agents offers distinct advantages, including the ability to bypass the gastrointestinal environment, fewer side effects, and increased bioavailability. For many patients with overactive bladder (OAB), transdermal therapy is more convenient than oral therapy, and the altered drug metabolism offers the advantages of an improved side-effect profile and enhanced steady-state plasma concentrations. The “newness” of transdermal delivery to physicians treating OAB is a potential limitation; however, much insight can be gained from the successful use of transdermal systems for delivery of other therapies, such as agents for chronic pain, hormone replacement therapy, and contraceptives. The transdermal oxybutynin system for OAB reduces the level of oxybutynin metabolites, resulting in a low incidence of anticholinergic side effects, and provides efficacy similar to that of standard doses of currently available oral preparations. However, there is room for improvement of the transdermal system, especially with respect to providing increased efficacy over currently available oral medications and reducing and treating local skin reactions at the application site.

Nitti, Victor W

2003-01-01

308

Practical Techniques for Limiting Disclosure of RF-Equipped Medical Devices  

Microsoft Academic Search

The use of radio for communication with medical devices provides important convenience and safety features. However, devices that respond to unauthorized queries may inadvertently disclose their presence. It is reasonable for users to expect that their devices' detectability by third parties to be limited, and thus even eavesdroppers to an authorized conversation (e.g. a command sent to an insulin pump)

E. Freudenthal; R. Spring; L. Estevez

2007-01-01

309

Implantable medical devices: current status and future developments within the healthy-aims project.  

PubMed

This paper describes the current situation concerning medical implants and suggests why the number of available devices is so limited. It then goes on to describe how a consortium was established from an EU network focussing specifically on Medical Devices. This consortium was successful in obtaining EU funding for the development of a range of medical implants that will help patients with specific disabilities relating to the nervous system, including deafness, blindness, lack of limb motion and urinary incontinence. PMID:15718649

Hodgins, Diana

2004-01-01

310

The transdermal revolution  

Microsoft Academic Search

Historically, developments in transdermal drug delivery have been incremental, focusing on overcoming problems associated with the barrier properties of the skin, reducing skin irritation rates and improving the aesthetics associated with passive patch systems. More-recent advances have concentrated on the development of non-passive systems to aid delivery of larger drug molecules, such as proteins and nucleotides, as the trend for

Beverley J. Thomas; Barrie C. Finnin

2004-01-01

311

Safety problems with the use of medical equipment\\/devices  

Microsoft Academic Search

In the past decennia medical technology has rapidly developed. Nowadays it plays an important\\u000arole in all medical fields. It introduced technologic solutions for many medical problems and it\\u000adefinitely increased the possibilities in the medical field to increase the quality of life. However\\u000awith this rapid development also new problems came up. Only since the last decennium the\\u000agovernment

C. Rademakers

2009-01-01

312

Intravascular foreign bodies: danger of unretrieved fragmented medical devices  

Microsoft Academic Search

A warning on the danger of unretrieved device fragments and recommendations to mitigate the danger were issued by the Food\\u000a and Drug Administration in January 2008. The causes of intravascular foreign bodies are classified into three main categories:\\u000a improper manipulation and usage, device defects, and others, such as patient and anatomical factors. Device failure after\\u000a long-term use is rarely predicted

Minori Tateishi; Yasuko Tomizawa

2009-01-01

313

February 10, 2012: Neurological Devices Panel of the Medical ...  

Center for Biologics Evaluation and Research (CBER)

... Contact Person: Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. ... More results from www.fda.gov/advisorycommittees/calendar

314

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

2012-02-01

315

March 23, 2012: Neurological Devices Panel of the Medical ...  

Center for Biologics Evaluation and Research (CBER)

... Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis" (SAMMPRIS), published in the New England Journal of Medicine ... More results from www.fda.gov/advisorycommittees/calendar

316

Retrofitting Software Safety in an Implantable Medical Device  

Microsoft Academic Search

Regulatory agencies are requiring companies to systematically demonstrate software safety in their implantable devices, even those already developed. The authors devised a rigorous software safety analysis technique and applied it to a nearly-completed cardiac rhythm management device. They were able to identify safety faults, modify the software to mitigate them, and verify overall safety

Ramin Mojdehbakhsh; Wei-tek Tsai; Shekhar H. Kirani; Lynn Elliott

1994-01-01

317

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

318

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

Code of Federal Regulations, 2010 CFR

...will I know if you require more information about my medical device report? 803.15 Section 803.15 Food and...DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.15...

2009-04-01

319

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

Code of Federal Regulations, 2010 CFR

...will I know if you require more information about my medical device report? 803.15 Section 803.15 Food and...DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.15...

2010-04-01

320

Mobile Devices and Data Synchronization Assisting Medical Diagnosis  

Microsoft Academic Search

In order to be able to establish the m ost accurate diagnostics as quick as possible, medical doctors need fast access not only to the current patient state and test results but also to its historical medical data. With the diversity of the malady symptoms today a correct diagnostic often requires a valuable time that is not always available due

ADRIAN SERGIU DARABANT; HOREA TODORAN

321

Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.  

National Technical Information Service (NTIS)

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination. This guidance p...

2013-01-01

322

[Analysis for the common problems of the product standards for medical devices' registeration].  

PubMed

The product standards for medical devices' registration are important technical document for production and supervision. Up to now, some problems still exist in these product standards. This paper analyzes common issues according to the standard writing specifications. PMID:22571157

Yu, Dong; Li, Genchi

2012-01-01

323

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

Federal Register 2010, 2011, 2012, 2013

...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

324

Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting.  

National Technical Information Service (NTIS)

Certain characteristics unique to pediatric populations including physiological differences from adult patients and challenges with recruiting pediatric participants for clinical trialsare barriers to developing medical devices for pediatric use cited by ...

2011-01-01

325

Approved Medical Devices for the Treatment of Complications of HIV/AIDS  

MedlinePLUS

... Cure Research Blood Donor Deferral Timeline / History - Approved medical devices for the treatment of complications of HIV/AIDS Product Name Generic Name Manufacturer Name Approval Date Time to Approval Sculptra (for facial ... months - - Page ...

326

21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?  

Code of Federal Regulations, 2010 CFR

...reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food...DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Generally Applicable...

2009-04-01

327

21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?  

Code of Federal Regulations, 2010 CFR

...reporting codes for adverse events that I use with medical device reports? 803.21 Section 803.21 Food...DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Generally Applicable...

2010-04-01

328

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

Federal Register 2010, 2011, 2012, 2013

...1\\ See ``510(k) and Science Report Recommendations: Summary...Implementation of 510(k) and Science Recommendations,'' available...innovative devices safely and based on sound science. These actions are as...

2011-02-09

329

Gastroenterology and Urology Devices Panel of the Medical ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... The results of these trials show real-world clinical success, and ... (UADEs). A serious adverse event (SAE) related to the device or implantation ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

330

Ultra-flexible and ultra-thin embedded medical devices on large area panels  

Microsoft Academic Search

Medical devices need a maximum of miniaturization for highest functionality in smallest volumes. An approach using ultra-thin highly flexible substrate technology, flip chip reflow soldering of thinned IC dies thereon and 3D-folding and stacking has been tested in the framework of the European project TIPS. The concepts of ultra-flexible and ultra-thin embedded medical devices on large area panels are proposed

Gerhard Kunkel; Tomasz Debski; Hans Burkard; Josef Link; Anders E. Petersen; W. Christiaens; J. Vanfleteren

2010-01-01

331

Clinical and pharmacokinetic properties of a transdermal nicotine patch  

Microsoft Academic Search

We examined the pharmacokinetics of a transdermal nicotine patch and evaluated the usefulness of such a patch in a pilot smoking-cessation program. Use of the patch was associated with plasma nicotine concentrations that were comparable to smoking or to the use of other smoking-cessation devices. However, these plasma concentrations were maintained for 24 hours, and the patch appeared to be

Seamus C Mulligan; Joseph G Masterson; John G Devane; John G Kelly

1990-01-01

332

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

333

The safety of medical devices: the tools of your working day.  

PubMed

You are trained and skilled in the practice of safe clinical procedures. Are you aware however that the safety of the medical devices, which includes medical equipment, that you use routinely in your clinical working day have been designed to be safe for both you and for patients? This is a legal requirement of the Medical Device Regulations by which manufacturers of medical devices and medical equipment are required to design and manufacture their products. That they conform to these regulations is designated by the CE Mark that has to be displayed on the product or on its labelling. This article will outline the legislative requirements of the regulations with which manufacturers have to comply. PMID:18828455

Cutler, Ian

2008-09-01

334

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

Federal Register 2010, 2011, 2012, 2013

...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

335

76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...  

Federal Register 2010, 2011, 2012, 2013

...Docket No. FDA-2011-N-0002] Obstetrics and Gynecology Devices Panel of the...amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the...FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of...

2011-08-15

336

In vivo transdermal delivery using a shock tube  

NASA Astrophysics Data System (ADS)

A shock tube was utilized for transdermal delivery in fuzzy rats. Rhodamine-B dextran, 10 kDa molecular weight, was used as the probe molecule. Shock waves were generated by a two-stage shock tube. A single shock wave was applied onto the skin to permeabilize the stratum corneum. Subsequently, the dextran solution diffused through the stratum corneum into the epidermis. Fluorescence microscopy of biopsies showed that the dextran was delivered to a depth of $30-60\\mum into the skin. Thus, the shock tube could become an inexpensive device for transdermal drug delivery.

Lee, S.; McAuliffe, D. J.; Kodama, T.; Doukas, A. G.

337

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

338

Transdermal drug delivery: Microfabrication insights  

Microsoft Academic Search

The paper presented an enhancement solution for transdermal drug delivery using microneedles array with biodegradable tips. The microneedles array was fabricated by using deep reactive ion etching (DRIE) and the biodegradable tips were made to be porous by electrochemical etching process. The porous silicon microneedle tips can greatly enhance the transdermal drug delivery in a minimum invasion, painless, and convenient

Ciprian Iliescu; Bangtao Chen; Jiashen Wei; Zhilian Yue

2009-01-01

339

Transdermal hyoscine induced unilateral mydriasis.  

PubMed

The authors present a case of unilateral mydriasis in a teenager prescribed transdermal hyoscine hydrobromide (scopolamine) for chemotherapy induced nausea and vomiting. The authors discuss the ocular side-effects associated with this particular drug and delivery system and the potential use of transdermal hyoscine as an antiemetic agent in this group. PMID:22605696

Hannon, Breffni; Jennings, Valerie; Twomey, Marie; O'Reilly, Maeve

2012-03-20

340

Microneedles for transdermal drug delivery  

Microsoft Academic Search

The success of transdermal drug delivery has been severely limited by the inability of most drugs to enter the skin at therapeutically useful rates. Recently, the use of micron-scale needles in increasing skin permeability has been proposed and shown to dramatically increase transdermal delivery, especially for macromolecules. Using the tools of the microelectronics industry, microneedles have been fabricated with a

Mark R Prausnitz

2004-01-01

341

Virtual worlds are an innovative tool for medical device training in a simulated environment.  

PubMed

Medical infusion devices are an integral component within the delivery of healthcare management. The aim of this study was to develop a training simulation in the virtual world of Second Life for the management of adverse events associated with infusion devices. Forty nurses were subsequently recruited to participate within the simulation and assess its feasibility. PMID:22357014

Patel, Vishal; Lee, Henry; Taylor, Dave; Aggarwal, Rajesh; Kinross, James; Darzi, Ara

2012-01-01

342

A fully integrated low-power BPSK demodulator for implantable medical devices  

Microsoft Academic Search

During the past decades, research has progressed on the biomedical implantable electronic devices that require power and data communication through wireless inductive links. In this paper, we present a fully integrated binary phase-shift keying (BPSK) demodulator, which is based on a hard-limited COSTAS loop topology, dedicated to such implantable medical devices. The experimental results of the proposed demodulator show a

Yamu Hu; Mohamad Sawan

2005-01-01

343

Factors and Interactions Affecting the Performance of Polyurethane Elastomers in Medical Devices  

Microsoft Academic Search

Polyurethanes offer the greatest versatility in compositions and properties of any family of polymers. For implantable medical devices, a few specific elastomeric polyurethane compositions have demonstrated a combination of toughness, durability, biocompatibility and biostability not achieved by any other available material.Because of the complex behavior of implantable polyurethanes in the body environment, designers and fabricators of polyurethane-containing devices must pay

Arthur J. Coury; Paul C. Slaikeu; Patrick T. Cahalan; Kenneth B. Stokes; Christopher M. Hobot

1988-01-01

344

Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals  

Microsoft Academic Search

Medical devices play a vital role in people's lives as these products are revolutionizing medicine with breathtaking advances in both the treatment and the detection of many diseases. While a similar, primarily therapeutic, revolution is ongoing in the pharmaceutical world; the focus here is the effect this device revolution is having on the statistical world. The similarities and differences between

Gregory Campbell

2007-01-01

345

Established Cell Lines and Primary Cultures in Testing Medical Devices In Vitro  

Microsoft Academic Search

In testing for the cytotoxicity of medical devices, crucial parameters are the type of cells, the duration of the exposure, the physical form of the device and the method of evaluation. Using cell cultures the changes of cell functions induced by artificial materials may be evaluated. In screening tests the effect of biomaterials on functions common to all cell types

E Cenni; G Ciapetti; D Granchi; C. R Arciola; L Savarino; S Stea; L Montanaro; A Pizzoferrato

1999-01-01

346

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

347

A system for ultrasonic beacon-guidance of catheters and other minimally-invasive medical devices  

Microsoft Academic Search

Catheters and other interventional medical devices are presently guided by X-ray imaging, despite the advantages of ultrasound imaging over X-ray imaging in cost, safety, and availability. X-ray imaging is used because ultrasound reflects specularly from catheters and similar devices; their visibility is highly angle-dependent. With an omni-directional receiver mounted on a device, the receiver's location in the ultrasound image can

David Vilkomerson; David Lyons

1997-01-01

348

Determination of Sensitivity and Specificity Parameters of Interpretation Rules in Medical Device Testing  

Microsoft Academic Search

Testing of the efficiency of software for an interpretation medical device includes both instrumental measurement of typical parameters of quality of measurement and calculation of signal parameters and interpretation quality assessment. At present, such assessment is performed by experts during medical testing of equipment or (mostly in industrially developed countries) using databases compiled and annotated on the basis of the

V. P. Bulygin; A. G. Chepaikin

2003-01-01

349

Rationale for practical medical device accelerated aging programs in AAMI TIR 17  

Microsoft Academic Search

A Technical Information Report, TIR 17, entitled, “Radiation Sterilization Material Qualification” has been published by the Association for the Advancement of Medical Instrumentation (AAMI) to provide guidance in order to increase the quality and reduce the cost and amount of time required for performing medical device material qualifications. It contains four sections that cover the fundamentals of material selection, processing,

Byron J Lambert; Fuh-Wei Tang

2000-01-01

350

Software quality in medical devices-a top-down approach  

Microsoft Academic Search

The development of highly reliable software is key to the success of many of today's medical devices and instruments. The development of such software is achieved through a phased development process that starts with requirements and ends when the product reaches the market. Quality medical software is achieved by applying verification and validation techniques throughout he different development phases. Verification

D. A. Leggingwell; B. Norman

1993-01-01

351

Rationale for practical medical device accelerated aging programs in AAMI TIR 17  

Microsoft Academic Search

A Technical Information Report, TIR 17, entitled, ``Radiation Sterilization Material Qualification'' has been published by the Association for the Advancement of Medical Instrumentation (AAMI) to provide guidance in order to increase the quality and reduce the cost and amount of time required for performing medical device material qualifications. It contains four sections that cover the fundamentals of material selection, processing,

B. J. Lambert; F.-W. Tang

2000-01-01

352

An open trial of transdermal nicotine replacement therapy for smoking cessation among alcohol- and drug-dependent inpatients  

Microsoft Academic Search

An open trial of transdermal nicotine replacement for smoking cessation was conducted. Over a 7-month period, all patients admitted to the inpatient alcohol and drug treatment unit of the Seattle Veterans Affairs Medical Center (n = 207) were offered the opportunity to participate in an open trial of transdermal nicotine replacement for smoking cessation. Forty-nine (23.7%) elected to attempt cessation

Andrew J. Saxon; Robert McGuffin; R. Dale Walker

1997-01-01

353

Effect of Transdermal Nitroglycerin or N-Acetylcysteine, or Both, in the Long-Term Treatment of Unstable Angina Pectoris  

Microsoft Academic Search

Objectives. This study was designed to evaluate whether the addition of transdermal nitroglycerin or oral N-acetylcysteine, or both, to conventional medical therapy improves the natural history of unstable angina pectoris.Background. Transdermal nitroglycerin is widely used to treat angina pectoris, but the development of tolerance is a major problem that may reduce its clinical efficacy. It has been suggested that the

Diego Ardissino; Piera Angelica Merlini; Stefano Savonitto; Gloria Demicheli; Paola Zanini; Federico Bertocchi; Colomba Falcone; Stefano Ghio; Giampiero Marinoni; Carlo Montemartini; Antonio Mussini

1997-01-01

354

Adhoc electromagnetic compatibility testing of non-implantable medical devices and radio frequency identification  

PubMed Central

Background The use of radiofrequency identification (RFID) in healthcare is increasing and concerns for electromagnetic compatibility (EMC) pose one of the biggest obstacles for widespread adoption. Numerous studies have documented that RFID can interfere with medical devices. The majority of past studies have concentrated on implantable medical devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). This study examined EMC between RFID systems and non-implantable medical devices. Methods Medical devices were exposed to 19 different RFID readers and one RFID active tag. The RFID systems used covered 5 different frequency bands: 125–134 kHz (low frequency (LF)); 13.56 MHz (high frequency (HF)); 433 MHz; 915 MHz (ultra high frequency (UHF])) and 2.4 GHz. We tested three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs), and one ventilator. The testing procedure is modified from American National Standards Institute (ANSI) C63.18, Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. Results For syringe pumps, we observed electromagnetic interference (EMI) during 13 of 60 experiments (22%) at a maximum distance of 59 cm. For infusion pumps, we observed EMI during 10 of 60 experiments (17%) at a maximum distance of 136 cm. For AEDs, we observed EMI during 18 of 75 experiments (24%) at a maximum distance of 51 cm. The majority of the EMI observed was classified as probably clinically significant or left the device inoperable. No EMI was observed for all medical devices tested during exposure to 433 MHz (two readers, one active tag) or 2.4 GHz RFID (two readers). Conclusion Testing confirms that RFID has the ability to interfere with critical medical equipment. Hospital staff should be aware of the potential for medical device EMI caused by RFID systems and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medical devices in an RFID environment. The methods presented in this paper are time-consuming and burdensome and suggest the need for standard test methods for assessing the immunity of medical devices to RFID systems.

2013-01-01

355

Innovative delivery systems for migraine: the clinical utility of a transdermal patch for the acute treatment of migraine.  

PubMed

Migraine is a disabling, painful primary headache disorder that is associated with various combinations of neurological, gastrointestinal, autonomic and pain symptoms. Gastrointestinal disturbances associated with migraine, including nausea and vomiting, affect a majority of migraineurs and often result in a delay in taking or avoidance of pharmacological intervention. Gastric stasis and vomiting may lead to delayed or inconsistent absorption of orally administered medications. Many migraineurs awake early in the morning with their attack progressing and already associated with nausea and vomiting. As a result, there is a need for a novel, non-invasive, non-oral delivery system for fast and effective acute treatment of migraine. There are two non-oral delivery systems currently available in the US for the acute treatment of migraine: three nasal sprays and two injectable formulations. Although nasal sprays depend partially on nasal mucosal absorption, a significant amount of drug is swallowed, transits the stomach and is absorbed in the small intestine, which is not as rapid or effective a route of delivery for those migraineurs with gastric stasis. Sumatriptan is rapidly absorbed by subcutaneous injection with or without a needle, but the invasiveness and discomfort of the delivery, the high incidence of adverse events and the high recurrence rate all limit its use for many patients. Iontophoretic delivery of medication is a non-invasive transdermal approach that uses small amounts of electrical current to promote rapid movement of the ionized drug through the skin and into the systemic circulation. This delivery bypasses hepatic first-pass metabolism and also avoids gastric transit delay and slowing of small intestinal absorption associated with gastrointestinal stasis in migraineurs. Two pharmacokinetic studies have demonstrated that iontophoretic transdermal delivery of sumatriptan results in rapid and consistent achievement of therapeutic plasma concentrations. These studies also suggest that, by avoiding patient exposure to a rapid rise in and high plasma concentrations of sumatriptan as seen with injectable sumatriptan, transdermal delivery using iontophoresis may significantly reduce typical triptan-related adverse events. A large, randomized, double-blind, placebo-controlled, multicentre clinical trial showed statistically significant efficacy, good tolerability and virtually no triptan-related adverse events. Iontophoretic delivery of sumatriptan, with a novel transdermal patch device, offers patients a migraine-specific medication that is non-invasive and non-oral. Clinically, transdermal delivery provides rapid and effective relief of migraine while bypassing the gastrointestinal tract, with minimal classic triptan-related adverse effects. This unique approach facilitates the rapid absorption of this migraine-specific triptan, which should improve the chances of consistently achieving a therapeutic plasma concentration of sumatriptan, resulting in effective migraine relief. PMID:20932065

Rapoport, Alan M; Freitag, Fred; Pearlman, Starr H

2010-11-01

356

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

357

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

358

Resolution of epileptic encephalopathy following treatment with transdermal nicotine.  

PubMed

We report resolution of an epileptic encephalopathy by administration of transdermal nicotine patches in an adolescent with severe nonlesional refractory frontal lobe epilepsy. The 18.5-year-old female patient had refractory epilepsy from the age of 11. Recurrent electroencephalography (EEG) recordings showed mostly generalized activity, albeit with right frontal predominance. Almost all antiepileptic medications failed to provide benefit. She developed an encephalopathic state with cognitive decline. The nonlesional frontal lobe epilepsy and a family history of a cousin with nocturnal epilepsy with frontal origin suggested genetic etiology. Transdermal nicotine patches brought complete resolution of the seizures, normalization of the EEG, and a significant improvement in her thinking process and speech organization. Sequencing of the CHRNB2 and CHRNA4 genes did not detect a mutation. Transdermal nicotine patches should be considered in severe pharmacoresistant frontal lobe epilepsy. PMID:23061632

Zerem, Ayelet; Nishri, Daniella; Yosef, Yael; Blumkin, Lubuv; Lev, Dorit; Leshinsky-Silver, Esther; Kivity, Sara; Lerman-Sagie, Tally

2012-10-12

359

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

360

Electromagnetic near field interference with implantable medical devices  

Microsoft Academic Search

The paper describes the methodology used to detect interference phenomena in vitro caused by digital and analog cellular phones placed in the close vicinity of implantable cardiac pacemakers. All four pacemakers tested exhibited some kind of interference; there was inhibition of the pacemaker function in two devices, when these were located at less than 2.5 cm from the antenna. The

Roger Carrillo; O. Garay; Q. Balzano; M. Pickels

1995-01-01

361

Placebo Responses to Medical Device Therapy for Pain  

Microsoft Academic Search

Placebo response to a functionless machine was tested in 58 patients with chronic pain. Thirteen discontinued treatment before the planned trials were complete: 5 did so because sham therapy worsened their pain. Forty-five patients completed three trials of treatment with a magnetic device, one trial of which was a sham. Thirteen percent of patients undergoing sham therapy experienced relief of

Don M. Long; Sumio Uematsu; Richard B. Kouba

1989-01-01

362

Role of Usability Testing and Documentation in Medical Device Safety.  

National Technical Information Service (NTIS)

Usability testing is a technique that can be used to identify problems users have with a device. If usability testing is employed early in the development cycle it can identify potential use-related problems and hazards so that they can be addressed early...

S. G. Feinberg B. N. Feinberg

2001-01-01

363

Integration of human factors and ergonomics during medical device design and development: It's all about communication.  

PubMed

Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability. PMID:23778022

Vincent, Christopher James; Li, Yunqiu; Blandford, Ann

2013-06-15

364

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.

Gittard, Shaun D; Narayan, Roger J

2010-01-01

365

Biocompatibility: meeting a key functional requirement of next-generation medical devices.  

PubMed

The array of polymeric, biologic, metallic, and ceramic biomaterials will be reviewed with respect to their biocompatibility, which has traditionally been viewed as a requirement to develop a safe medical device. With the emergence of combination products, a paradigm shift is occurring that now requires biocompatibility to be designed into the device. In fact, next-generation medical devices will require enhanced biocompatibility by using, for example, pharmacological agents, bioactive coatings, nano-textures, or hybrid systems containing cells that control biologic interactions to have desirable biologic outcomes. The concept of biocompatibility is moving from a "do no harm" mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing "good," that is, encouraging positive healing responses. These new devices will promote the formation of normal healthy tissue as well as the integration of the device into adjacent tissue. In some contexts, biocompatibility can become a disruptive technology that can change therapeutic paradigms (e.g., drug-coated stents). New database tools to access biocompatibility data of the materials of construction in existing medical devices will facilitate the use of existing and new biomaterials for new medical device designs. PMID:18337223

Helmus, Michael N; Gibbons, Donald F; Cebon, David

2008-01-01

366

Guide to the EU In vitro Diagnostic Medical Devices Directive.  

National Technical Information Service (NTIS)

This guide (prepared under contract by Helen Delaney and Rene van de Zande, DVZ Joint Ventures) is an easy-to-use introductory reference for industry and government officials on the requirements of the European Union's (EU) In vitro Diagnostic Medical Dev...

H. Delaney R. van de Zande

2001-01-01

367

Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.  

PubMed

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k). PMID:23476998

2013-03-01

368

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

2013-08-28

369

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

2013-03-13

370

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

2013-06-05

371

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.

White, Judith; Carolan-Rees, Grace

2013-01-01

372

Poly(lactide- co-glycolide) nanoparticle assembly for highly efficient delivery of potent therapeutic agents from medical devices  

Microsoft Academic Search

Controlled delivery of therapeutic agents from medical devices can improve their safety and effectiveness in vivo, by ameliorating the surrounding tissue responses and thus maintaining the functional integrity of the devices. Previously, we presented a new method for providing simultaneous controlled delivery from medical devices, by surface assembly of biodegradable polymer nanoparticles (NPs) encapsulating fluorescent dyes. Here, we continue our

Catherine T. Lo; Paul R. Van Tassel; W. Mark Saltzman

2010-01-01

373

77 FR 32125 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment...  

Federal Register 2010, 2011, 2012, 2013

...There are no other changes. FOR FURTHER INFORMATION CONTACT: Avena Russell, Center for Devices and Radiological Health, Food...1535, Silver Spring, MD 20993-0002, 301-796-3805, Avena.Russell@fda.hhs.gov, or please use the FDA...

2012-05-31

374

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

Federal Register 2010, 2011, 2012, 2013

...Devices; Classification of the Focused Ultrasound Stimulator System for Aesthetic Use...Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use...Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic...

2011-07-20

375

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

Federal Register 2010, 2011, 2012, 2013

...Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use AGENCY...Administration (FDA) is classifying the contact cooling system for aesthetic use into...II Special Controls Guidance Document: Contact Cooling System for Aesthetic...

2011-02-07

376

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

377

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

378

Medical student access to multimedia devices: most have it, some don't and what's next?  

PubMed

In recent years, the rise in total student intake of medical schools across England has not been met by an increase in medical teachers. Computer aided learning (CAL) has the potential to address this disequilibrium. We conducted a survey of clinical medical students at our institution to ascertain the level of access to media devices capable of delivering vision and/or audio. The aim was to establish a baseline to assist CAL providers plan for appropriate modes of content delivery. A questionnaire was emailed to all clinical medical students at UCL. To validate the email survey, an identical paper questionnaire was distributed to a compulsory class for third year clinical medical students. The e-questionnaire and validation questionnaire response rate was 46 and 100% respectively. Eighty-six percent of students had home access to broadband Internet, and 85% of home computers were suitable for a full multimedia experience. Seventy-four percent of students indicated that their primary place of access was at home. Sixty-three percent of students had portable MP3 devices and over 50% owned an iPod. The hardware environment appears favourable for the introduction of complex multimedia teaching programs to medical students, but access is not universal. In addition to personal computers, inexpensive portable multimedia players might offer the opportunity to deliver 'on demand' learning. Medical schools planning for delivery of CAL should consider student access to desktop and portable media devices when designing an e-learning curriculum. PMID:19437179

Khan, Nasser; Coppola, William; Rayne, Tim; Epstein, Owen

2009-03-01

379

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

PubMed

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

2011-07-01

380

Rationale for practical medical device accelerated aging programs in AAMI TIR 17  

NASA Astrophysics Data System (ADS)

A Technical Information Report, TIR 17, entitled, ``Radiation Sterilization Material Qualification'' has been published by the Association for the Advancement of Medical Instrumentation (AAMI) to provide guidance in order to increase the quality and reduce the cost and amount of time required for performing medical device material qualifications. It contains four sections that cover the fundamentals of material selection, processing, testing and accelerated aging programs. The last of these sections, entitled ``Accelerating Aging Programs,'' provides step-by-step guidance for simple, empirical accelerated programs of use to the medical device industry. The methods are based on van't Hoff's observation that the rate of chemical reactions increases by a factor of two for every 10°C increase in temperature, the Q10=2 rule. With critical patient safety concerns in the medical device industry, it is appropriate for both device manufacturers and regulators to ask if simple, empirical methods such as those outlined in TIR 17 are reasonable and responsible. One reason for confidence in the methods is their success when used in aging environments that are much more severe than those commonly used in the medical device industry. Another reason for confidence in the methods is found from the observation that the working equations of the method can be derived from theory. This paper provides an overview of the thermal accelerated aging theory that forms the basis for the working equations of the accelerated aging programs of TIR 17. Assumptions used are examined and found reasonable; the theoretical foundation is established. While this foundation provides added confidence for the application of the methods of TIR 17 to the medical device industry, it is emphasized that application of the methods within appropriate boundaries is critical. Theoretical boundaries are explained and demonstrated by means of Arrhenius plots, and practical boundaries discussed.

Lambert, B. J.; Tang, F.-W.

2000-03-01

381

Medication Records in the Emergency Department: Agreement Between Paper-Based Charts and Automated Dispensing Device  

PubMed Central

Background: Research exploring the agreement between traditional medication records and electronic records generated by an automated dispensing device has been limited. Objective: To evaluate the extent of agreement between medication administration records written in paper-based emergency department charts and records generated by an automated dispensing device with regard to the presence or absence of a single, prespecified medication. Methods: Medication administration records in paper-based emergency department charts and medication dispensation records generated by an automated dispensing device were evaluated for concordance. The primary outcome measure was agreement between the 2 sources with regard to the presence or absence of a record for salbutamol by metered-dose inhaler (MDI) for randomly selected patients who presented to a pediatric emergency department with wheeze-related illness from January 1, 2008, to December 31, 2009. Results: In total, 1172 patient visits met the inclusion criteria. Of these, records for 1013 visits showed agreement between the paper-based emergency department chart and the dispensation record of the automated dispensing device (kappa = 0.71, 95% confidence interval 0.67–0.75). This value did not meet the target kappa of 0.80. Stratification by time of day, day of week, month, season, or year of presentation at triage or by triage level or disposition (whether or not the patient was admitted to the hospital ward) did not significantly affect the level of agreement between the 2 sources. Conclusions: Agreement between records of salbutamol MDI administration in paper-based charts and dispensation records from an automated dispensing device was substantial, but discrepancies were present. There are significant quality management, legal, clinical, and research reasons to strive for concordance between multiple records with respect to medication use in the emergency department. Data generated by automated dispensing devices have potential value for research, but their strengths and limitations need to be understood.

Wing, Andrew; Hill-Taylor, Barbara; Sketris, Ingrid; Smith, Jeanne; Stewart, Sam; Hurley, Katrina F

2012-01-01

382

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

2012-09-20

383

OpenMDC: an open-source framework for medical device communication.  

PubMed

We have developed an extensible, open source framework for collecting data from bedside medical devices which support RS-232 serial output. The system uses inexpensive hardware to convert RS-232 signals to Universal Serial Bus (USB) format, enabling "plug-and-play" device communication at low cost. A prototype of the system has been created and tested with Puritan-Bennett 840 ventilators. PMID:18998864

Vawdrey, David K; Hum, R Stanley

2008-11-06

384

Nosocomial infections in the intensive care unit associated with invasive medical devices  

Microsoft Academic Search

Modern day health care has become synonymous with cutting-edge, high-tech medicine, which includes a large and growing number\\u000a of invasive medical devices, especially in intensive care units. The most widely used of these devices—intravascular catheters\\u000a of many types and urinary catheters—account for more than one half of all institutionally acquired infections. Growing knowledge\\u000a of the pathogenesis and epidemiology of these

Nasia Safdar; Christopher J. Crnich; Dennis G. Maki

2001-01-01

385

A flexible tri-axis contact force sensor for tubular medical device applications  

Microsoft Academic Search

A capacitive, tube-shaped tri-axis contact force sensor is fabricated and characterized in this paper. The sensor is inserted into a tubular medical device just like a small section of tube in order to sense the applied contact force on the tip of this tubular device. It comprises two SU-8 plates, wherein the outer and inner rims of the plates with

Miao Lu; Jijun Xiong; Tianhong Cui

2011-01-01

386

Microtox System, a New Approach to the Safety Evaluation of Medical Devices  

Microsoft Academic Search

Medical devices of both intra- and extra-corporeal applications may contain leachable toxicants that warrant routine testing using internationally recognized\\/practiced protocols. An in vitro Microtox system comprising a selected bioluminescence strain of bacteria—Photobacterium phosphorium which emits light as an end product of its respiration, is used to screen out toxicants from biomaterials\\/devices. A Microtox system was standardized and validated in our

K. Rathinam; P. V. Mohanan

1998-01-01

387

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

Microsoft Academic Search

Objective  To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.\\u000a \\u000a \\u000a \\u000a Design  We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development,\\u000a clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2)\\u000a a scenario in which medical devices are subject to the same

Shelby D. Reed; Alisa M. Shea; Kevin A. Schulman

2008-01-01

388

Characterization of Bacterial Etiologic Agents of Biofilm Formation in Medical Devices in Critical Care Setup  

PubMed Central

Background. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim. Critical care units of any healthcare institute follow various interventional strategies with use of medical devices for the management of critical cases. Bacteria contaminate medical devices and form biofilms. Material and Methods. The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate. All the isolates were subjected to antibiotic susceptibility testing by VITEK 2 compact automated systems. Results. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. A 16–20-hour incubation period was found to be optimum for biofilm development. 85% isolates were multidrug resistants and different mechanisms of bacterial drug resistance like ESBL, carbapenemase, and MRSA were found among isolates. Conclusion. Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Time and availability of glucose are important factors for assessment of biofilm progress. It is an alarm for those who are associated with invasive procedures and indwelling medical devices especially in patients with low immunity.

Revdiwala, Sangita; Rajdev, Bhaumesh M.; Mulla, Summaiya

2012-01-01

389

Questions and Answers for the FDA Reviewer Guidance: Labeling Reuseable Medical Devices for Reprocessing in Health Care Facilities.  

National Technical Information Service (NTIS)

This guidance provides recommendations regarding the content of reuse instructions in labeling for reusable medical devices. the recommendations are also applicable to the initial processing of single-use only and reusable devices that are supplied nonste...

M. O'Lone

1996-01-01

390

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

391

Reactive component selection for TET powered medical devices.  

PubMed

Transcutaneous energy transfer (TET) is capable of supplying power across the skin to implantable devices and avoids the risk of infection associated with wires passing through the skin. These systems rely on a high frequency magnetic field to overcome the relatively low coupling between a coil located outside the body, and a coil implanted within the body. This paper introduces a new optimisation procedure to choose tuning capacitors that minimises the amount of power dissipated in the power transfer coils of an implantable TET system. The frequency of operation is determined by the selection of the resonant reactive components. By analysing the overall circuit impedance it is possible to observe that a Zero Voltage Switched TET system may dissipate different amounts of power in the power transfer coils while delivering the same amount of power. In this study an objective function was developed to determine the best configuration of resonant capacitors for any particular set of TET coils in order to minimize power loss. The method is used to find the value of the resonant capacitors for a system delivering 15 W over a coupling range of k=0.1 to 0.55 (corresponding to a separation of up to 20mm). PMID:22254950

Leung, Ho Yan; Budgett, David M; Hu, Patrick

2011-01-01

392

Wearable medical devices for tele-home healthcare.  

PubMed

The world's ageing population and prevalence of chronic diseases have lead to high demand for tele-home healthcare, in which vital-signs monitoring is essential. An overview of state-of-art wearable technologies for remote patient-monitoring is presented, followed by case studies on a cuffless blood pressure meter, ring-type heart rate monitor, and Bluetoothtrade mark-based ECG monitor. Aim of our project is to develop a tele-home healthcare system which utilizes wearable devices, wireless communication technologies, and multisensor data fusion methods. As an important part of this system, a cuffless BP meter has been developed and tested on 30 subjects in a total of 71 trials over a period of five months. Preliminary results show a mean error (ME) of 1.82 mmHg and standard deviation of error (SDE) of 7.62 mmHg in systolic pressure; while ME and SDE in diastolic pressure are 0.45 mmHg and 5.27 mmHg, respectively. PMID:17271560

Hung, K; Zhang, Y T; Tai, B

2004-01-01

393

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

Federal Register 2010, 2011, 2012, 2013

...hotel telephone number is (301) 977-8900. Contact Person: Avena Russell, Center for Devices and Radiological Health, Food...Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov, (301) 796-3805, or FDA...

2011-11-16

394

75 FR 9422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...  

Federal Register 2010, 2011, 2012, 2013

...March 23, 2010, the committee will discuss and make recommendations on issues relevant to FDA's reevaluation of the ReGen Collagen Scaffold (CS) device (marketed as the Menaflex[reg]), which FDA cleared in K082079 on December 18, 2008,...

2010-03-02

395

Electromagnetic Compatibility of WiFi Technology with Life-Supporting Medical Devices  

Microsoft Academic Search

\\u000a In this paper we investigated the EMI phenomenon on 45 critical care medical devices (infusion pumps, defibrillators, monitors,\\u000a lung ventilators, anesthesia machines) by several types of WiFi terminals. The potential interference was evaluated by performing\\u000a “ad-hoc” tests, according to the ANSI C63.18 standard. The behavior of the devices during the test was monitored using patient\\u000a simulators\\/device testers, specific for each

G. Calcagnini; E. Mattei; F. Censi; M. Triventi; R. Lo Sterzo; E. Marchetta; P. Bartolini

396

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

397

On the experimental testing of fine Nitinol wires for medical devices  

Microsoft Academic Search

Nitinol, a nickel titanium alloy, is widely used as a biocompatible metal with applications in high strain medical devices. The alloy exhibits both superelasticity and thermal shape memory behaviour. Basic mechanical properties can be established and are provided by suppliers; however the true stress–strain response under repeated load is not fully understood. It is essential to know this behaviour in

E. Henderson; D. H. Nash; W. M. Dempster

2011-01-01

398

Ion beam modification of polymers for the application of medical devices  

Microsoft Academic Search

Polymeric materials have contributed significantly to the development and improvement of medical devices and systems. Various interactions take place between biomaterials and a body when polymeric biomaterials come into contact with a living organism. Ion implantation is a physicochemical surface modification process that results from the impingement of a high-energy ion beam. The chemical characteristics of a material surface are

Y. Suzuki

2003-01-01

399

Relative Risk Analysis in Regulating the Use of Radiation-Emitting Medical Devices. A Preliminary Application.  

National Technical Information Service (NTIS)

The 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 u...

E. D. Jones W. W. Banks T. J. Altenbach L. E. Fischer

1995-01-01

400

In vitro and in vivo studies on wireless powering of medical sensors and implantable devices  

Microsoft Academic Search

This paper investigates wireless electricity (witricity) and its application to medical sensors and implantable devices. Several coupling scenarios of resonators are analyzed theoretically. In vitro experiments are conducted in open air and through an agar phantom of the human head. An in vivo animal experiment is also carried out. Our studies indicate that witricity is a suitable tool for providing

Fei Zhang; Xiaoyu Liu; Steven A. Hackworth; Robert J. Sclabassi; Mingui Sun

2009-01-01

401

Standards for Medical Device Communication: X73 PoC-MDC  

Microsoft Academic Search

When using a number of medical devices from very different manufacturers with different proprietary formats the problem of a lack of interoperability emerges. Connectivity and communications are then limited and the systems and users can not exploit all the possibilities that Information and Communication Technologies offer today. The use and application of standards can be the solution to bring light

Miguel GALARRAGA; Luis SERRANO; Ignacio MARTÍNEZ; Paula de TOLEDO

402

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

Code of Federal Regulations, 2013 CFR

...or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION...Administrative Requirements § 35.49 Suppliers for sealed sources or...accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of...

2013-01-01

403

Development of a Mechatronical Device to Measure Plantar Pressure for Medical Prevention of Gait Issues  

Microsoft Academic Search

A medically helpful mechatronical device for natural gait analysis is proposed. This consists of an instrumented shoe equipped with eight force sensors. The instantaneous plantar pressures are recorded by a personal digital assistant (PDA) belted on the patient hips. This article describes this original concept and the first results of its use

Fany Chedevergne; Arnaud Faivre; Marc Dahan

2006-01-01

404

Laser welding assembling of an implantable bio-medical device: investigation of temperature field  

Microsoft Academic Search

Laser welding is a commonly used process to assemble medical devices. The heat produced during the laser welding process may have an adverse effect on the mechanical integrity of the case assembly and the functionality of heat sensitive electronic components. In order to maintain the mechanical integrity of the case assembly and to protect the subcomponents, it is important to

Yaomin Lin; Guangqiang Jiang; Joseph L. Calderon

2011-01-01

405

A Formal Approach to Pre-Market Review for Medical Device Software  

Microsoft Academic Search

Formal methods have long been proposed as an effective technique for developing safety-critical software. However, few medical device manufacturers employ such methods. One way to encourage the use of formal methods is to leverage these techniques in such a way as to enhance the review process for regulatory bodies, such as the U.S. Food and Drug Administration. In this paper

Raoul Praful Jetley; S. Purushothaman Iyer; Paul L. Jones; William Spees

2006-01-01

406

FAILURE MODES IN MEDICAL DEVICE SOFTWARE: AN ANALYSIS OF 15 YEARS OF RECALL DATA  

Microsoft Academic Search

1 This author performed the work while an employee of NIST and is now working for Unisys at the NASA Goddard Space Flight Center . Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This paper presents an analysis of software-related failures of medical devices

DOLORES R. WALLACE; D. RICHARD KUHN

2001-01-01

407

Global Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices. Sixth Edition.  

National Technical Information Service (NTIS)

This is the sixth edition of Global Import Regulations for Pre-Owned Medical Devices, which was first issued in May 1999. This report seeks to collect and compile information on the regulations relating to the importation of pre-owned (used and refurbishe...

2008-01-01

408

Learning to Use a Home Medical Device: Mediating Age-Related Differences with Training  

Microsoft Academic Search

We examined the differential benefits of instructional materials for younger and older adults learning to use a home medical device. Participants received training on use of a blood glucose meter via either a user manual (a text guide with pictures) or an instructional video. Performance was measured immediately and then after a 2-week retention interval. Type of instruction was critical

Amy L. Mykityshyn; Arthur D. Fisk; Wendy A. Rogers

2002-01-01

409

Globus MEDICUS - Federation of DICOM Medical Imaging Devices into Healthcare Grids  

Microsoft Academic Search

The Digital Imaging and Communications in Medicine (DICOM) standard defines Radiology medical device interoperability and image data exchange between modalities, image databases - Picture Archiving and Communication Systems (PACS) - and image review end-points. However the scope of DICOM and PACS technology is currently limited to the trusted and static environment of the hospital. In order to meet the demand

Stephan G. ERBERICHa; Jonathan C. SILVERSTEINc; Robert SCHULER; Marvin D. NELSON; Carl KESSELMAN

410

Outpatient Information System And Medical User: An I\\/O Device Evaluation  

Microsoft Academic Search

An experiment for evaluating some relevant factors in human-computer interaction with health care information systems is described. The results concern the comparison among three lnpuVOutput devices that can be used by the staff who manipulate medical records during outpatient care. A data entry activity, based on item selections and (short string) typing, has been considered as the basic task to

A. Bernabei; A. D'Atri; V. Curro

1991-01-01

411

Novel experimental platform for evaluating newly developed medical devices using patient companion animals  

Microsoft Academic Search

This study firstly describes current status of surgical robot development and various social barriers for clinical application such as pre-clinical evaluation study, governmental authorization, and commercialization. And then a novel experimental platform as an evaluation environment of newly developed medical devices is proposed. As model cases of evaluation study, MR scanning and surgeries were conducted in “intelligent animal operating room”.

Takashi Suzuki; Kitaro Yoshimitsu; Akihide Wada; Hiroshi Ishii; Yoshihiro Muragaki; Hiroshi Iseki

2010-01-01

412

Disability, Technology, and Place: Social and Ethical Implications of Long-Term Dependency on Medical Devices  

Microsoft Academic Search

Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and\\/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple

B. E. Gibson; R. E. G. Upshur; N. L. Young; P. McKeever

2007-01-01

413

77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...  

Federal Register 2010, 2011, 2012, 2013

...Administration [Docket No. FDA-2012-N-0001] Educational...the FDA Medical Device Industry Coalition (FMDIC...QSR) to the regulated industry, particularly small...be held on June 15, 2012, from 8 a.m. to 5...75207. Directions and lodging information are...

2012-05-07

414

Medical Device Safety and Efficacy Testing for Cutaneous Oxygen Monitors and Digoxin Diagnostic Products.  

National Technical Information Service (NTIS)

This report is the second in a series of three commissioned by FDA to obtain baseline information on already-marketed medical device products. The other two reports studied the development processes for arrhythmia monitors and artificial knees and CPK-Iso...

L. M. Firth L. A. Couvillon M. Charest L. Gordon S. Somes

1981-01-01

415

E3 testing of implantable medical devices-past and present  

Microsoft Academic Search

Electromagnetic environmental effects (E3) testing of implantable medical devices began about 30 years ago but is still expanding into new arenas today. The initial issues and concerns led to an E3 test protocol that evolved into the test procedures in the first published “standard”. E3 tests based on these test procedures, adapted to accommodate the characteristics of additional electromagnetic environments,

R. M. Herkert; J. A. Woody; H. W. Denny

1997-01-01

416

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

417

MATCH: A NEW INDUSTRY-FOCUSED APPROACH TO MEDICAL DEVICE DEVELOPMENT  

Microsoft Academic Search

MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the prod- uct lifecycle in order to achieve

Jennifer L. Martin; Michael P. Craven; Beverley J. Norris

418

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.

Hwang, Jeeseong; Ramella-Roman, Jessica C.; Nordstrom, Robert

2012-01-01

419

[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

420

The future of lithium and lithium-ion batteries in implantable medical devices  

Microsoft Academic Search

New implantable medical devices and applications are being developed at a rapid rate. Many of these applications have higher power and\\/or energy requirements than existing applications. These needs will drive the development of new primary lithium chemistries and the implementation of rechargeable lithium-ion technology.

Craig L. Schmidt; Paul M. Skarstad

2001-01-01

421

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

422

Risk Assessment of Dithiocarbamate Accelerator Residues in Latex-based Medical Devices: Genotoxicity Considerations  

Microsoft Academic Search

The Medical Devices Agency (MDA) has investigated potential human health hazards arising from the presence of dithiocarbamate vulcanization accelerators in latex products (mainly gloves). After collection of manufacturer's data on usage and residues of these accelerators, an independent investigation of solvent extractable residues and dithiocarbamate migration into aqueous simulants was commissioned, to complement equivalent “in-house” test data from two major

J Tinkler; D Gott; J Bootman

1998-01-01

423

Definition of Information Technology Architectures for Continuous Data Management and Medical Device Integration in Diabetes  

Microsoft Academic Search

The growing availability of continuous data from medical devices in diabetes management makes it crucial to define novel information technology architectures for efficient data storage, data transmission, and data visualization. The new paradigm of care demands the sharing of information in interoperable systems as the only way to support patient care in a continuum of care scenario. The technological platforms

M. Elena Hernando; Mario Pascual; Carlos H. Salvador; Gema García-Sáez; Agustín Rodríguez-Herrero; Iñaki Martínez-Sarriegui; Enrique J. Gómez

2008-01-01

424

Securing wireless communication with implanted medical devices using reciprocal carrier-phase quantization  

Microsoft Academic Search

Securing wireless communication with resource- constrained implanted medical devices is considered. A method for refreshing symmetric encryption keys by reciprocal quantization of the phase between local oscillators is proposed and analyzed. The method relies on simple low cost implementation and demands virtually no computation power or memory. These properties make the proposed method an attractive alternative to traditional symmetric key

Gill R. Tsouri

2009-01-01

425

Suitability of a thermoelectric power generator for implantable medical electronic devices  

Microsoft Academic Search

Embedding a thermoelectric generator (TEG) in a biological body is a promising way to supply electronic power in the long term for an implantable medical device (IMD). The unique merit of this method lies in its direct utilization of the temperature difference intrinsically existing throughout the whole biological body. However, little is known about the practicability of such a power

Yang Yang; Xiao-Juan Wei; Jing Liu

2007-01-01

426

Risk assessment of medical devices: Evaluation of microbiological and toxicological safety  

Microsoft Academic Search

Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

J. W. Dorpema

1995-01-01

427

Risk assessment of medical devices: evaluation of microbiological and toxicological safety  

Microsoft Academic Search

Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

J. W. Dorpema

1995-01-01

428

On the experimental testing of fine Nitinol wires for medical devices.  

PubMed

Nitinol, a nickel titanium alloy, is widely used as a biocompatible metal with applications in high strain medical devices. The alloy exhibits both superelasticity and thermal shape memory behaviour. Basic mechanical properties can be established and are provided by suppliers; however the true stress-strain response under repeated load is not fully understood. It is essential to know this behaviour in order to design devices where failure by fatigue may be possible. The present work develops an approach for characterising the time varying mechanical properties of fine Nitinol wire and investigates processing factors, asymmetric stress-strain behaviour, temperature dependency, strain rate dependency and the material response to thermal and repeated mechanical loading. Physically realistic and accurately determined mechanical properties are provided in a format suitable for use in finite element analysis for the design of medical devices. Guidance is also given as to the most appropriate experimental set up procedures for gripping and testing thin Nitinol wire. PMID:21316613

Henderson, E; Nash, D H; Dempster, W M

2010-10-17

429

Microtox system, a new approach to the safety evaluation of medical devices.  

PubMed

Medical devices of both intra- and extra-corporeal applications may contain leachable toxicants that warrant routine testing using internationally recognized/practiced protocols. An in vitro Microtox system comprising a selected bioluminescence strain of bacteria-Photobacterium phosphorium which emits light as an end product of its respiration, is used to screen out toxicants from biomaterials/devices. A Microtox system was standardized and validated in our laboratory conditions. Our experiences with extract of pyrogenic cardiotomy reservoir, blood filter and systemically toxic (in mice) Barium methacrylate (monomer), and CIBA epoxy polymer materials established a positive correlation with Microtox system. Hence, the Microtox system gives adequate evidence as an alternative in vitro method to evaluate the toxicity of biomaterials and medical devices. PMID:9777466

Rathinam, K; Mohanan, P V

1998-10-01

430

Relative risk analysis of the use of radiation-emitting medical devices: A preliminary application  

SciTech Connect

This report describes the development of a risk analysis approach for evaluating the use of radiation-emitting medial devices. This effort was performed by Lawrence Livermore National Laboratory for the US Nuclear Regulatory Commission (NRC). The assessment approach has bee applied to understand the risks in using the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step to evaluate the potential role of risk analysis for developing regulations and quality assurance requirements in the use of nuclear medical devices. The risk approach identifies and assesses the most likely risk contributors and their relative importance for the medical system. The approach uses expert screening techniques and relative risk profiling to incorporate the type, quality, and quantity of data available and to present results in an easily understood form.

Jones, E.D.

1996-06-01

431

Transferosomes - A vesicular transdermal delivery system for enhanced drug permeation  

PubMed Central

Transdermal administration of drugs is generally limited by the barrier function of the skin. Vesicular systems are one of the most controversial methods for transdermal delivery of active substances. The interest in designing transdermal delivery systems was relaunched after the discovery of elastic vesicles like transferosomes, ethosomes, cubosomes, phytosomes, etc. This paper presents the composition, mechanisms of penetration, manufacturing and characterization methods of transferosomes as transdermal delivery systems of active substances. For a drug to be absorbed and distributed into organs and tissues and eliminated from the body, it must pass through one or more biological membranes/barriers at various locations. Such a movement of drug across the membrane is called as drug transport. For the drugs to be delivered to the body, they should cross the membranous barrier. The concept of these delivery systems was designed in an attempt to concentrate the drug in the tissues of interest, while reducing the amount of drug in the remaining tissues. Hence, surrounding tissues are not affected by the drug. In addition, loss of drug does not happen due to localization of drug, leading to get maximum efficacy of the medication. Therefore, the phospholipid based carrier systems are of considerable interest in this era.

Rajan, Reshmy; Jose, Shoma; Mukund, V. P. Biju; Vasudevan, Deepa T.

2011-01-01

432

Microneedle-mediated transdermal bacteriophage delivery.  

PubMed

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 × 10(6)PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0 × 10(3)PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13 × 10(3)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 24h, 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

2012-06-30

433

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.

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

434

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 false Medical devices; name and place of business of manufacturer...Provisions § 801.1 Medical devices; name and place of business of manufacturer...package form shall specify conspicuously the name and place of business of the...

2013-04-01

435

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

436

Investigation of the Application of Process Analytical Technology for a Laser Welding Process in Medical Device Manufacturing  

Microsoft Academic Search

In FDA regulated medical device manufacturing, real time inspection of manufactured product is limited by the requirement to destructively test random samples of the product post production. Infra Red thermography offers the ability to non-destructively test, key critical to quality attributes of medical devices during laser welding and facilitates real time statistical process control for enhanced product quality and yield.

Sean Moore; Alan Conneely; Eric Stenzel; Eamonn Murphy

2011-01-01

437

Ad hoc test protocols for determination of electromagnetic interference caused by cell phones on electro-medical devices  

Microsoft Academic Search

Electromagnetic interference (EMI) can cause malfunctions on electro-medical devices, and it is a difficult task to determine it. EMI can be caused by RF mobile transceivers like cell phones. Clinical engineers can perform ad hoc EMI test protocols to determine EMI caused by cell phones on electro-medical devices. In this paper, four ad hoc EMI test protocols are introduced (Mayo

G. N. Nogueira-Neto; P. Nohama; M. A. de Moural; S. B. de Paula

2003-01-01

438

Design and manufacture of a multiple material sample for implantation testing of thermoplastic materials used in a medical device  

Microsoft Academic Search

Submissions to regulatory bodies for approval of medical devices must include the results of biological evaluation. This evaluation determines whether contact with the materials used in the medical device has any effect on the user. Implantation testing is one particular evaluation that involves implanting a sample into living tissue. This can be an expensive test and must be carried out

Paul Dunne

2005-01-01

439

Medical hypnosis device for controlling the administration of a hypnosis experience  

US Patent & Trademark Office Database

A medical hypnosis device (20) for controlling the administration of a hypnosis experience to a user is described. The device comprises a stimulus output module (24) for outputting a first type of content via one or more media channels to a sensory output device (28a, 28b) for presentation to the user and a sensor data receiver (26) for receiving physiological feedback data from a sensor (32a, 32b, 32c) sensing a physiological parameter of the user. The device also comprises a processor (22) for comparing the received physiological feedback data with predetermined physiological data to detect a change in a neurological state of the user. The processor is arranged, on detection of such a change, to trigger the provision of a second type of content to the user via the stimulus output module.

Clare; Jon (Kent, GB)

2013-08-27

440

Guidance note: risk management of workers with medical electronic devices and metallic implants in electromagnetic fields.  

PubMed

Medical electronic devices and metallic implants are found in an increasing number of workers. Industrial applications requiring intense electromagnetic fields (EMF) are growing and the potential risk of injurious interactions arising from EMF affecting devices or implants needs to be managed. Potential interactions include electromagnetic interference, displacement, and electrostimulation or heating of adjacent tissue, depending on the device or implant and the frequency of the fields. A guidance note, which uses a risk management framework, has been developed to give generic advice in (a) risk identification--implementing procedures to identify workers with implants and to characterise EMF exposure within a workplace; (b) risk assessment--integrating the characteristics of devices, the anatomical localisation of implants, occupational hygiene data, and application of basic physics principles; and (c) risk control--advising the worker and employer regarding safety and any necessary changes to work practices, while observing privacy. PMID:18534156

Hocking, Bruce; Mild, Kjell Hansson

2008-01-01

441

A compact and disposable transdermal drug delivery system  

Microsoft Academic Search

This work presents a portable transdermal drug delivery system that combines a magnetically actuated micro gear pump with a microneedle array. Micropart fabrication is performed through DXRL and LIGA techniques. The manufacturing process of both micropump and microneedle array are described together with wear issues. Results show that the assembled device can deliver rates that go from 0.1 to 1.2ml\\/min

M. Matteucci; M. Casella; M. Bedoni; E. Donetti; M. Fanetti; F. De Angelis; F. Gramatica; E. Di Fabrizio

2008-01-01

442

Transdermal methylphenidate, behavioral, and combined treatment for children with ADHD.  

PubMed

Stimulant medication and behavioral treatments are evidence-based for children with attention-deficit/hyperactivity disorder, but the combination of the 2 treatments has been understudied. In this investigation, methylphenidate (MPH) was crossed with 2 levels of behavior modification (BMOD) in a summer treatment program. Twenty-seven children with attention-deficit/hyperactivity disorder, aged 6-12, participated. Children received placebo and 3 doses of transdermal MPH (12.5 cm(2), 25.0 cm(2), and 37.5 cm(2)). BMOD was implemented on alternating weeks. Both treatments produced large and significant effects. Combined treatment was superior to either treatment alone. The effects of transdermal MPH were comparable to those found in this setting in previous studies with multiple stimulant medications and formulations. Consistent with other research, low doses of MPH--even lower than in previous studies--yielded enhanced effects in combination with behavior modification. PMID:15943544

Pelham, William E; Burrows-Maclean, Lisa; Gnagy, Elizabeth M; Fabiano, Gregory A; Coles, Erika K; Tresco, Katy E; Chacko, Anil; Wymbs, Brian T; Wienke, Amber L; Walker, Kathryn S; Hoffman, Martin T

2005-05-01

443

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

PubMed Central

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

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

2007-01-01

444

[Authorization procedure of clinical trials with medical devices. First practical analysis of the BfArM].  

PubMed

The 4th amendment of the Medical Device Law introduced the authorization procedure for clinical trials with medical devices. The Federal Institute for Drugs and Medical Devices ("Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM) has now drawn the first substantial interim balance on the basis of daily practice in order to describe results achieved by applications of clinical trials with medical devices. Overall, realization of the new authorization procedure of clinical trials is well underway. This empirical practical analysis of the first 405 applications points out further possibilities for improvements for future applicants. Furthermore, initial figures demonstrate the cooperative relationship with national and international applicants. Because the by far largest percentage of the premarket clinical trials with medical devices in the European Community are conducted in Germany (28%), the analysis also provides a comparison with other European countries in order to detect differences in specific areas as the result of the implementation of Directive 2007/47/EC. PMID:22290172

Fischer, T; Renisch, B; Broich, K

2012-02-01

445

Real-time volume rendering of digital medical images on an iOS device  

NASA Astrophysics Data System (ADS)

Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

Noon, Christian; Holub, Joseph; Winer, Eliot

2013-03-01

446

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.

2012-01-01

447

Harmonized Medical Device Regulation: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia  

PubMed Central

Medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. Despite the fact that Asia has 60% of the world population providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The accelerated ageing population and increasing prevalence of chronic disease are the key drivers that contribute toward the increase in the total healthcare expenditure on medical devices in the region. Several policies clearly showed the eagerness of the government to provide better healthcare infrastructure with better medical devices and facilities. The fundamental objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive. After the era of liberalization and globalization, the desires of developing economies is to ensure safety and performance of the product brought to their markets and for this harmonized regulation is an important tool for strengthening the same. If we talk about the industry need, then this approach will eliminate redundant requirements that do not contribute to safety and effectiveness. In addition, Asia is diverse in many respects and with it come the various challenges to harmonizing the regulation which includes diversity in culture, politics, economy, historical issues, etc. If, by any reason, the regulation of medical devices is not harmonized and consequently, the harmonized regulation is not adopted, then it leads to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of medical therapies, etc. So this issue is written to attract all stakeholders to move toward the concept of harmonization, keeping in mind their need, challenges, and risks of not harmonizing the regulation as well.

Kaushik, A; Saini, KS; Anil, B; Rambabu, S

2010-01-01

448

Programmable transdermal drug delivery of nicotine using carbon nanotube membranes  

PubMed Central

Carbon nanotube (CNT) membranes were employed as the active element of a switchable transdermal drug delivery device that can facilitate more effective treatments of drug abuse and addiction. Due to the dramatically fast flow through CNT cores, high charge density, and small pore dimensions, highly efficient electrophoretic pumping through functionalized CNT membrane was achieved. These membranes were integrated with a nicotine formulation to obtain switchable transdermal nicotine delivery rates on human skin (in vitro) and are consistent with a Fickian diffusion in series model. The transdermal nicotine delivery device was able to successfully switch between high (1.3 ± 0.65 ?mol/hr-cm2) and low (0.33 ± 0.22 ?mol/hr-cm2) fluxes that coincide with therapeutic demand levels for nicotine cessation treatment. These highly energy efficient programmable devices with minimal skin irritation and no skin barrier disruption would open an avenue for single application long-wear patches for therapies that require variable or programmable delivery rates.

Wu, Ji; Paudel, Kalpana S.; Strasinger, Caroline; Hammell, Dana; Stinchcomb, Audra L.; Hinds, Bruce J.

2010-01-01

449

Medical Devices  

Center for Biologics Evaluation and Research (CBER)

... These persons are not regular employees of FDA, but are paid as "special government employees" for the days they participate as members of a ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevices

450

Transdermal Methylphenidate, Behavioral, and Combined Treatment for Children With ADHD  

Microsoft Academic Search

Stimulant medication and behavioral treatments are evidence-based for children with attention-deficit\\/hyperactivity disorder, but the combination of the 2 treatments has been understudied. In this investigation, methylphenidate (MPH) was crossed with 2 levels of behavior modification (BMOD) in a summer treatment program. Twenty-seven children with attention-deficit\\/hyperactivity disorder, aged 6–12, participated. Children received placebo and 3 doses of transdermal MPH (12.5 cm2,

William E. Pelham; Lisa Burrows-MacLean; Elizabeth M. Gnagy; Gregory A. Fabiano; Erika K. Coles; Katy E. Tresco; Anil Chacko; Brian T. Wymbs; Amber L. Wienke; Kathryn S. Walker; Martin T. Hoffman

2005-01-01

451

US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?  

PubMed Central

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.

Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

2012-01-01

452

The transdermal delivery of fentanyl.  

PubMed

The fentanyl patch is one of the great commercial successes in transdermal drug delivery. The suitability of this molecule for delivery through skin had been identified in the 1970s, and subsequently, a number of transdermal formulations became available on the market. This article reviews the development of fentanyl patch technology with particular emphasis on the pharmacokinetics and disposition of the drug when delivered through the skin. The various patch designs are considered as well as the bioequivalence of the different designs. The influence of heat on fentanyl permeation is highlighted. Post-mortem redistribution of fentanyl is discussed in light of the reported discrepancies in serum levels reported in patients after death compared with therapeutic levels in living subjects. Finally, alternatives to patch technology are considered, and recent novel transdermal formulations are highlighted. PMID:23419814

Lane, Majella E

2013-02-16

453

Principles of transdermal nitroglycerin administration.  

PubMed

The currently marketed delivery systems for transdermal nitroglycerin (GTN) develop fairly constant GTN plasma concentrations throughout the 24-h application period. This may be associated with tolerance, particularly when higher doses are employed. Because of this problem, a new GTN transdermal delivery system (TDS) has been developed which provides a time-dependent, non-constant drug delivery rate. This system was engineered to provide high GTN plasma concentrations during the first 12h of application which should prevent exercise-induced angina and low nitroglycerin levels during the second 12-h period to prevent tolerance. This GTN TDS with a phasic release profile is described and the in vitro and in vivo release rates and resulting plasma concentrations are contrasted with those of conventional GTN transdermal patches. PMID:2501091

Wolff, H M; Bonn, R

1989-05-01

454

Advances in Microbial Biofilm Prevention on Indwelling Medical Devices with Emphasis on Usage of Acoustic Energy  

PubMed Central

Microbial biofilms are a major impediment to the use of indwelling medical devices, generating device-related infections with high morbidity and mortality. Major efforts directed towards preventing and eradicating the biofilm problem face difficulties because biofilms protect themselves very effectively by producing a polysaccharide coating, reducing biofilm sensitivity to antimicrobial agents. Techniques applied to combating biofilms have been primarily chemical. These have met with partial and limited success rates, leading to current trends of eradicating biofilms through physico-mechanical strategies. Here we review the different approaches that have been developed to control biofilm formation and removal, focusing on the utilization of acoustic energy to achieve these objectives.

Dror, Naama; Mandel, Mathilda; Hazan, Zadik; Lavie, Gad

2009-01-01

455

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

456

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

457

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

458

Transdermal rotigotine for the perioperative management of Parkinson's disease.  

PubMed

Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid 'off'-symptom complications in surgical patients with concomitant Parkinson's disease (PD). Fourteen PD patients undergoing surgery under general anesthesia were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg/24 h) for the perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists with good control of PD symptoms and easy switching and re-switching of PD medication. PMID:20535621

Wüllner, Ullrich; Kassubek, Jan; Odin, Per; Schwarz, Michael; Naumann, Markus; Häck, Hermann-Josef; Boroojerdi, Babak; Reichmann, Heinz

2010-06-10

459

Transdermal rotigotine for the perioperative management of Parkinson's disease  

PubMed Central

Continuous delivery of antiparkinsonian medication during a perioperative period is desirable to avoid ‘off’-symptom complications in surgical patients with concomitant Parkinson’s disease (PD). Fourteen PD patients undergoing surgery under general anesthesia were switched from oral dopaminergic medication to transdermally delivered 24-h rotigotine (median dose 12 mg/24 h) for the perioperative period. Rotigotine treatment was considered feasible by patients, their anesthesiologists and neurologists with good control of PD symptoms and easy switching and re-switching of PD medication.

Kassubek, Jan; Odin, Per; Schwarz, Michael; Naumann, Markus; Hack, Hermann-Josef; Boroojerdi, Babak; Reichmann, Heinz

2010-01-01

460

Definition of Information Technology Architectures for Continuous Data Management and Medical Device Integration in Diabetes  

PubMed Central

The growing availability of continuous data from medical devices in diabetes management makes it crucial to define novel information technology architectures for efficient data storage, data transmission, and data visualization. The new paradigm of care demands the sharing of information in interoperable systems as the only way to support patient care in a continuum of care scenario. The technological platforms should support all the services required by the actors involved in the care process, located in different scenarios and managing diverse information for different purposes. This article presents basic criteria for defining flexible and adaptive architectures that are capable of interoperating with external systems, and integrating medical devices and decision support tools to extract all the relevant knowledge to support diabetes care.

Hernando, M. Elena; Pascual, Mario; Salvador, Carlos H.; Garcia-Saez, Gema; Rodriguez-Herrero, Agustin; Martinez-Sarriegui, Inaki; Gomez, Enrique J.

2008-01-01

461

Prevention of plasticizer leaching from PVC medical devices by using organic–inorganic hybrid coatings  

Microsoft Academic Search

?,?-triethoxysilane terminated poly(ethylene oxide) (PEO-Si) was prepared and used to produce organic\\/inorganic hybrids by the sol–gel approach. These hybrids were used as coatings for flexible PVC tubes in order to reduce the plasticizer leaching from PVC medical devices. Extraction tests carried out with hexane indicated that all coating composition investigated are able to strongly reduce (about one order of magnitude)

M. Messori; M. Toselli; F. Pilati; E. Fabbri; P. Fabbri; L. Pasquali; S. Nannarone

2004-01-01

462

Antibacterial coatings for medical devices based on glass polyalkenoate cement chemistry  

Microsoft Academic Search

A biofilm is an accumulation of micro-organisms and their extracellular products forming a structured community on a surface.\\u000a Biofilm formation on medical devices has severe health consequences as bacteria growing in this lifestyle are tolerant to\\u000a both host defense mechanisms and antibiotic therapies. However, silver and zinc ions inhibit the attachment and proliferation\\u000a of immature biofilms. The objective of this

A. Coughlan; D. Boyd; C. W. I. Douglas; M. R. Towler

2008-01-01

463

A collaboration leading to the introduction of an innovative medical device to the international market  

Microsoft Academic Search

Development of a medical device is a multi-disciplinary activity. This is particularly the case for laser-based instruments which encompass mechanical, optical, hardware, and software sub-systems, together with the essential industrial design process. In this field, as in many others, small companies are highly innovative. However, the broad range of expertise needed to realise any innovation can be beyond the company's

Ian Walsh; Marc Clement

464

Medical Devices Put to Test - How Safe and Intuitive are Blood Sugar Meters?  

Microsoft Academic Search

\\u000a Use errors caused by insufficient usability of a medical device for patient self-control can pose serious risks to health\\u000a and safety. Under this aspect, 14 blood sugar meters from different manufacturers (Roche Diagnostics, LifeScan, Bayer Healthcare,\\u000a A. Menarini, Abott) were evaluated in detail according to standardized design guidelines and involving patients of type 2\\u000a diabetes aging between 45 and 77

Maike Reichel; Alexander Steffen

465

Issues in using databases of pre-recorded physiological signals to test medical devices.  

PubMed

Bench testing with databases of pre-recorded physiological signals is a common step in the verification and validation of medical devices. For example, in the case of an electrocardiographic (ECG) monitor to be tested, the physiological signals are ECG tracings that have previously been recorded from patients using other ECG monitors. Human overreaders then annotate the tracings to determine the occurrence of significant clinical events such as ventricular tachycardia. These annotations can be used to determine the sensitivity and specificity of the ECG monitor to be tested. This article aims to highlight some issues associated with such bench testing, such as the way the pre-recorded signals are presented to the medical device to be tested, the adequacy of single channel versus dual channel versus multi-channel testing in the bench testing, and the need for the human overreaders and the medical device to use the same set of rules for determining the occurrence of a clinical event. These issues are also applicable to other monitors such as the apnea monitor. Some suggestions for addressing the issues are presented. PMID:12724888

Ho, Charles; Kurtzman, Steven B

2003-01-01

466

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance  

PubMed Central

Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

2012-01-01

467

System-level design trade-offs for truly wearable wireless medical devices.  

PubMed

Power and current management in emerging wearable medical devices, intended to continuously monitor physiological signals, are crucial design issues. The overall size of the electronic part of these systems is generally going to be dominated by the size of the batteries. Unfortunately, the options of smaller batteries do not only come at the expense of a lower capacity and hence shorter operation time. It also significantly constrains the amount of available current that can be used by different electronic blocks, as well as their operating power supply voltage. This paper discusses all the typical power and current management system level issues in the design of a typical miniature wearable wireless medical device. The discussion is illustrated with experimental results obtained with two devices built using two of the currently most popular low power commercial transceivers in the market, the Texas Instruments (TI) CC2500 and the Nordic Semiconductor nRF24L01+. The numbers presented can be used as a more realistic guidance of the energy per bit required in a real system implementation, as opposed to the ideal figures normally quoted by the manufacturers. Furthermore the analysis in this paper can also be extrapolated to the design of future wireless monitoring wearable devices with further optimized radio transceivers. PMID:21096352

Chen, Guangwei; Rodriguez-Villegas, Esther

2010-01-01

468

Chitosan microneedle patches for sustained transdermal delivery of macromolecules.  

PubMed

This paper introduces a chitosan microneedle patch for efficient and sustained transdermal delivery of hydrophilic macromolecules. Chitosan microneedles have sufficient mechanical strength to be inserted in vitro into porcine skin at approximately 250 ?m in depth and in vivo into rat skin at approximately 200 ?m in depth. Bovine serum albumin (BSA, MW=66.5 kDa) was used as a model protein to explore the potential use of chitosan microneedles as a transdermal delivery device for protein drugs. In vitro drug release showed that chitosan microneedles can provide a sustained release of BSA for at least 8 days (approximately 95% of drugs released in 8 days). When the Alexa Fluor 488-labeled BSA (Alexa 488-BSA)-loaded microneedles were applied to the rat skin in vivo, confocal microscopic images showed that BSA can gradually diffuse from the puncture sites to the dermal layer and the fluorescence of Alexa 488-BSA can be observed at the depth of 300 ?m. In addition, encapsulation of BSA within the microneedle matrix did not alter the secondary structure of BSA, indicating that the gentle nature of the fabrication process allowed for encapsulation of fragile biomolecules. These results suggested that the developed chitosan microneedles may serve as a promising device for transdermal delivery of macromolecules in a sustained manner. PMID:23116140

Chen, Mei-Chin; Ling, Ming-Hung; Lai, Kuan-Ying; Pramudityo, Esar

2012-11-14

469

Ultrasound and transdermal drug delivery  

Microsoft Academic Search

Transdermal drug delivery offers an attractive alternative to the conventional drug delivery methods of oral administration and injection. However, the stratum corneum acts as a barrier that limits the penetration of substances through the skin. Application of ultrasound to the skin increases its permeability (sonophoresis) and enables the delivery of various substances into and through the skin. This review presents

Ilana Lavon; Joseph Kost

2004-01-01

470

Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.  

PubMed

While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. PMID:22032398

Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

2013-01-01

471

Critical factors in the translation of improved antimicrobial strategies for medical implants and devices.  

PubMed

Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medical device technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medical device innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively addressed by biomedical innovation. PMID:24034505

Grainger, David W; van der Mei, Henny C; Jutte, Paul C; van den Dungen, Jan J A M; Schultz, Marcus J; van der Laan, Bernard F A M; Zaat, Sebastian A J; Busscher, Henk J

2013-09-11

472

Impact of assay selection and study design on the outcome of cytotoxicity testing of medical devices: The case of multi-purpose vision care solutions  

Microsoft Academic Search

Medical device biocompatibility testing usually includes a cytotoxicity component. Assay selection and protocol design often depend on a specific testing standard rather than on the characteristics of the medical device. To better understand the impact of assay selection on study outcome of unstructured medical devices, we evaluated contact lens multi-purpose solutions (MPS) in the agar diffusion, direct contact and two

David M. Lehmann; Mary E. Richardson

2010-01-01

473

How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review  

PubMed Central

Background Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n?=?9), studies of device recalls (n?=?8), and surveys of device manufacturers (n?=?3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting. Please see later in the article for the Editors' Summary.

Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

2012-01-01

474

[International expert group for safety in medical device reprocessing (smdr)--patient safety has the foremost priority].  

PubMed

Unsafe reprocessing of medical device carries severe health hazards. Definite guidelines for reprocessing were drawn up by the german supreme federal authorities Robert-Koch-Institute (RKI) and Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Their joint statement covers both the devices declared for single and multi use. But however, there are problems in safety, resulting from ignorance or non-application of these guidelines especially in the ambulatory/outpatient area. To improve this deficiency, the international expert group for safety in medical device reprocessing (smdr) was founded at the end of 2006 by medical, technical and legal experts from Europe and Asia. PMID:18671180

Koczorek, Michael

2008-07-01

475

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

NASA Astrophysics Data System (ADS)

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 wideband signals. However, the propagation velocity inside the human body differs in each tissue and each frequency. Furthermore, the human body is formed of various tissues with complex structures. For this reason, propagation velocity is different at a different point inside human body and the received signal so distorted through the channel inside human body. In this paper, we apply an adaptive template synthesis method in multipath channel for calculate the propagation time accurately based on the output of the correlator between the transmitter and the receiver. Furthermore, we propose a position estimation method using an estimation of the propagation velocity inside the human body. In addition, we show by computer simulation that the proposal method can perform accurate positioning with a size of medical implanted devices such as a medicine capsule.

Kawasaki, Makoto; Kohno, Ryuji

476

Design and development of low-loss transformer for powering small implantable medical devices.  

PubMed

Small implantable medical devices, such as wireless capsule endoscopes, that can be swallowed have previously been developed. However, these devices cannot continuously operate for more than 8 h because of battery limitations; moreover, additional functionalities cannot be introduced. This paper proposes a design method for a high-efficiency energy transmission transformer (ETT) that can transmit energy transcutaneously to small implantable medical devices using electromagnetic induction. First, the authors propose an unconventional design method to develop such a high-efficiency ETT. This method can be readily used to calculate the exact transmission efficiency for changes in the material and design parameters (i.e., the magnetic material, transmission frequency, load resistance, etc.). Next, the ac-to-ac energy transmission efficiency is calculated and compared with experimental measurements. Then, suitable conditions for practical transmission are identified. A maximum efficiency of 33.1% can be obtained at a transmission frequency of 500 kHz and a receiving power of 100 mW for a receiving coil size of ¿5 mm × 20 mm. Future design optimization is possible by using this method. PMID:23853315

Shiba, K; Morimasa, A; Hirano, H

2010-04-01

477

Transdermal nicotine patches for eosinophilic pustular folliculitis.  

PubMed

We previously reported the clinical effectiveness of transdermal nicotine patches for the treatment of skin disorders with eosinophilic infiltration such as Kimura's disease, erythema nodosum and eosinophilic pustular folliculitis (EPF). We assessed the efficacy and safety of transdermal nicotine patches for EPF. We treated eight patients with EPF with transdermal nicotine patches and evaluated the treatment response by performing overall lesional assessment. Excellent 77and good responses were obtained in five and one patient(s), respectively. In the other two patients, the lesions remained unchanged. No severe adverse effects were observed. Our results suggest that transdermal nicotine patches may be useful and safe in the treatment of EPF. PMID:23802575

Yoshifuku, Asuka; Higashi, Yuko; Matsushita, Shigeto; Kawai, Kazuhiro; Kanekura, Takuro

2013-06-27

478

Radiological safety of medical devices sterilized with X-rays at 7.5 MeV  

Microsoft Academic Search

The induced radioactivity in medical devices when sterilized with 7.5MeV X-rays has been investigated theoretically and verified by dedicated experiments. The experimental setup has been chosen to simulate closely the situation in a commercial irradiation facility. The purpose of this study is twofold: compare activation of medical devices with regulatory limits and evaluate corresponding dose exposure of persons in contact

O. Grégoire; M. R. Cleland; J. Mittendorfer; M. Vander Donckt; J. Meissner

2003-01-01

479

Medical and Audiological Protocol for Selection and Evaluation of Vibrant Soundbridge® Device Implant in the Middle Ear  

Microsoft Academic Search

Currently, individuals with moderate to severe hearing loss, sensorineural type, mixed or conductive can benefit from different types of hearing devices, external or surgically implantable to their rehabilitation. The benefits of implantable hearing device are directly related to an accurate evaluation of pre-operative medical and audiological criteria. Objective: To describe the protocol of ENT and audiological evaluation of the candidates

Isabela de Souza Jardim; Graziela Queiroz Martins; Mariana Pedreiras Hausen

480

Methods of rapid microbiological assay and their application to pharmaceutical and medical device fabrication.  

PubMed

There are several well-developed rapid microbiological methods now becoming available that may have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended. PMID:21467625

Shintani, Hideharu; Sakudo, Akikazu; McDonnel, Gerald E

2011-03-01

481

Optimised design and development of a bio-medical healthcare device through quality function deployment (QFD).  

PubMed

Technology is major stimulus for change and is imbibed in various forms; especially in the field of medical devices and bio-medical instruments used in life and death situations. Cardiotocograph (CTG), a foetal heart rate and uterine contraction monitoring and measurement machine, is a valuable tool in the process of childbirth. The Quality Function Deployment (QFD) is an engineering technique with the number one priority being to satisfy the customer. The aim of using QFD in this paper is to highlight the limitations and complexities of the present instrument. The paper attempts to first discuss out the operational details of the instrument along with a brief review of the relevant literature. Following this, its functional analysis is carried out through QFD - a TQM tool. The resultant outcome enlists CTG functions with their Raw Weight and Priority Score. A detailed theoretical analysis of results pinpoints basic functional limitation of exiting machine. PMID:23008844

Sharma, Jitendra

2012-01-01

482

Issues in Wearable Computing for Medical Monitoring Applications: A Case Study of a Wearable ECG Monitoring Device  

Microsoft Academic Search

In this paper we discuss issues surrounding wearable computers used as intelligent health monitors. Unlike existing health monitors (for example, ECG and EEG holters), that are used mainly for data acquisition, the devices we discuss provide real-time feedback to the patient, either as a warning of impending medical emergency or as a monitoring aid during exercise. These medical applications are

Thomas L. Martin; Emil Jovanov; Dejan Raskovic

2000-01-01

483

Rivastigmine Transdermal Patch  

MedlinePLUS

... disease (a brain disease that slowly destroys the memory and the ability to think, learn, communicate and ... movement, muscle weakness, shuffling walk, and loss of memory). Rivastigmine is in a class of medications called ...

484

What do you mean you can't sterilize it? The reusable medical device matrix.  

PubMed

Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medical device manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada. PMID:21366000

Stephens, Anne; Assang, AnnMarie

2010-12-01

485

The Selegiline Transdermal System (Emsam)  

PubMed Central

Although monoamine oxidase inhibitors (MAOIs) at one time represented the mainstay of therapy for major depressive disorder (MDD), the risk of acute hypertensive reactions following the ingestion of tyramine-rich foods and the consequent need to restrict dietary tyramine represent a barrier to their use. In this article, we present an overview of the efficacy and safety of a transdermal formulation of the MAOI selegiline for the treatment of MDD. Transdermal delivery of selegiline at the effective dose of 6 mg every 24 hours eliminates the need for a tyramine-restricted diet. Our emphasis on potential drug–drug interactions and contraindications should be useful to prescribers who counsel patients with MDD.

Jessen, Lois; Kovalick, Lawrence J.; Azzaro, Albert J.

2008-01-01

486

TRICARE; off-label uses of devices; partial list of examples of unproven drugs, devices, medical treatments or procedures. Final rule.  

PubMed

The Department of Defense is publishing this final rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device.'' This provision codifies the coverage of those medically necessary indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective and in accordance with nationally accepted standards of practice in the medical community. Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed in TRICARE regulations. We are removing the partial list from the regulation but will maintain the partial list in the TRICARE Policy Manual at www.tricare.mil. PMID:22737762

2012-06-27

487

Synergistic Effect of Enhancers for Transdermal Drug Delivery  

Microsoft Academic Search

Transdermal drug delivery offers a non-invasive route of drug administration, although its applications are limited by low skin permeability. Various enhancers including iontophoresis, chemicals, ultrasound, and electroporation have been shown to enhance transdermal drug transport. Although all these meth- ods have been individually shown to enhance transdermal drug transport, their combinations have often been found to enhance transdermal transport more

Samir Mitragotri

2000-01-01

488

Synergistic Effect of Enhancers for Transdermal Drug Delivery  

Microsoft Academic Search

Transdermal drug delivery offers a non-invasive route of drug administration, although its applications are limited by low skin permeability. Various enhancers including iontophoresis, chemicals, ultrasound, and electroporation have been shown to enhance transdermal drug transport. Although all these methods have been individually shown to enhance transdermal drug transport, their combinations have often been found to enhance transdermal transport more effectively

Samir Mitragotri

2000-01-01

489

Transdermal nicotine effects on attention  

Microsoft Academic Search

Nicotine has been shown to improve attentiveness in smokers and attenuate attentional deficits in Alzheimer’s disease patients,\\u000a schizophrenics and adults with attention-deficit\\/hyperactivity disorder (ADHD). The current study was conducted to determine\\u000a whether nicotine administered via transdermal patches would improve attentiveness in non-smoking adults without attentional\\u000a deficits. The subjects underwent the nicotine and placebo exposure in a counterbalanced double-blind manner. Measures

E. D. Levin; C. Keith Conners; Donna Silva; Sean C. Hinton; Warren H. Meck; John March; Jed E. Rose

1998-01-01

490

Noninvasive Transdermal Chemical Collection. II. In vitro and in vivo Skin Permeability Studies  

Microsoft Academic Search

In vitro and in vivo skin permeability studies were conducted to investigate properties of several candidate transdermal chemical collection devices (TCDs). The TCD consists of a binding reservoir of activated charcoal suspended in a gel medium which is occlusively placed in direct contact with the skin. Binding of three model compounds (theophylline, methotrexate, and parathion) was studied in hydrophilic (agarose

Charles R. Bradley; Ramona G. Almirez; Dale P. Conner; Patricia R. Rhyne; Carl C. Peck

1990-01-01

491

BAYESIAN META-ANALYSIS ON MEDICAL DEVICES: APPLICATION TO IMPLANTABLE CARDIOVERTER DEFIBRILLATORS  

PubMed Central

Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device. Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies.

Youn, Ji-Hee; Lord, Joanne; Hemming, Karla; Girling, Alan; Buxton, Martin

2012-01-01

492

[Recommendations for documentation of incidents with medical devices in orthopaedic surgery].  

PubMed

The growing number of revisions in orthopaedic surgery as well as the multifactorial reasons for implant failure give cause for taking a closer look at the clinical documentation of adverse events. Based on our long-term experience it is our goal to present recommendations for an adequate documentation and filing. In the framework of the introduction of a quality management system (ISO 9001:2008) in our hospital, a process was developed for reportable incidents with medical devices regulating adequate documentation. Therefore, specific forms were developed. The retrievals are stored for subsequent damage analyses and are available for possible legal claims and tracking. A file should be opened for each reportable incident containing information about the event, a copy of the obligatory BfArM report, surgery report, medical device labels, radiographs and photographs. Declarations of agreement as well as handover certificates should be maintained in order to keep record of the retrievals. In order to assure consistent documentation, we recommend use of specific forms as presented in this paper. Identification of risk factors for implant failure and a long-term reduction of damage cases will only be possible under consequent incident reporting and responsible documentation of adverse events. Processing of cases of damage is accelerated and simplified by the presented recommendations and forms. Together with the newly established joint replacement registry, a higher quality of patient treatment and implant safety should be obtained. PMID:23296561

Kluess, D; Bader, R; Zenk, K; Mittelmeier, W

2013-01-07

493

Ultrasound Mediated Transdermal Insulin Delivery in Pigs Using a Lightweight Transducer  

Microsoft Academic Search

Purpose  In previous studies, ultrasound mediated transdermal drug delivery has shown a promising potential as a method for noninvasive\\u000a drug administration. For prospective future human application, this study was designed to determine the feasibility of lightweight\\u000a cymbal transducer array as a practical device for noninvasive transdermal insulin delivery in large pigs.\\u000a \\u000a \\u000a \\u000a Materials and Methods  Six Yorkshire pigs (100–140 lbs) were divided into two

E. J. Park; Jacob Werner; Nadine Barrie Smith

2007-01-01

494

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

495

Cutaneous reactions to transdermal therapeutic systems.  

PubMed

Transdermal therapeutic systems have been increasingly used in the past two decades. However, cutaneous side effects are fairly common and may result in poor patient compliance. This review article summarizes the spectrum of reactions due to transdermal therapeutic systems and provides a current list of known allergens. PMID:16956462

Musel, Andrea L; Warshaw, Erin M

2006-09-01

496

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

497

Kinetic Analysis of Transdermal Nitroglycerin Delivery  

Microsoft Academic Search

The current success of transdermal nitroglycerin delivery systems has focussed much attention upon the skin as a portal of drug entry into the systemic circulation. Although there are multiple potential problems associated with this administration route to elicit central effects, considerable efforts are being made to identify transdermal drug delivery candidates and to determine whether a sufficient percutaneous input rate

Richard H. Guy; Jonathan Hadgraft

1985-01-01

498

NANOMAGNETIC PARTICLES FOR TRANSDERMAL DRUG DELIVERY  

Microsoft Academic Search

Nowadays drug administration through the transdermal route has emphasized for comfort of patient and easy application. However, the limitations of transdermal drug delivery are governed largely by high impermeability of the human skin, which acts as a natural selective barrier impeding the penetration of foreign molecules and minimizing water losses. Recent advances on improvement of drug transport through the skin

M. H. A. Santana; R. M. Barbosa

499

A Review on Terpenes as Skin Penetration Enhancers in Transdermal Drug Delivery  

Microsoft Academic Search

The skin itself hinders the widespread use of transdermal drug delivery (TDD) for administration of medication. Despite the different strategies devised and employed to reversibly overcome the skin barrier, this non-invasive delivery mode is restricted to potent, low molar mass therapeutic agents. The use of chemical penetration enhancers is the conventional approach to modify the skin structure and lower its

Perry Fung Chye Lim; Xiang Yang Liu; Sui Yung Chan

2009-01-01

500

A fatality involving an unusual route of fentanyl delivery: Chewing and aspirating the transdermal patch  

Microsoft Academic Search

We recently encountered a subject who died from an uncommon misuse of a fentanyl transdermal patch, chewing, followed by complications of aspiration of the patch. We report this case to alert medical examiners to the troubling trend of increased fentanyl patch abuse and its expanding range of misuses and associated morbidities. The decedent was a 28-year-old white male with a

Henry J. Carson; Laura D. Knight; Mary H. Dudley; Uttam Garg

2010-01-01