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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

Recent Medical Device Recalls  

MedlinePLUS

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

3

Medical Device Safety  

MedlinePLUS

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Print this page Share this page E-mail ... Medical Product Safety Network Emergency Situations (Medical Devices) Medical Device Safety Search the Medical Device Safety Section Medical ...

4

Medical Device Reliability BIOMATERIALS  

E-print Network

-generation packaging, where conformal coatings will serve as the primary interface between the deviceMedical Device Reliability BIOMATERIALS Our goal is to provide medical device manufacturers, and consistency of active implantable medical devices. These devices, including pacemakers, cardiac defibrillators

5

Taro corms mucilage/HPMC based transdermal patch: an efficient device for delivery of diltiazem hydrochloride.  

PubMed

The aim of this work is to examine the effectiveness of mucilage/hydroxypropylmethylcellulose (HPMC) based transdermal patch (matrix type) as a drug delivery device. We have successfully extracted mucilage from Colocasia esculenta (Taro) corms and prepared diltiazem hydrochloride incorporated mucilage/HPMC based transdermal patches using various wt% of mucilage by the solvent evaporation technique. Characterization of both mucilage and transdermal patches has been done by several techniques such as Molisch's test, organoleptic evaluation of mucilage, mechanical, morphological and thermal analysis of transdermal patches. Skin irritation test is studied on hairless Albino rat skin showing that transdermal patches are apparently free of potentially hazardous skin irritation. Fourier transform infrared analysis shows that there is no interaction between drug, mucilage and HPMC while scanning electron microscopy shows the surface morphology of transdermal patches. In vitro drug release time of mucilage-HPMC based transdermal patches is prolonged with increasing mucilage concentration in the formulation. PMID:24556117

Sarkar, Gunjan; Saha, Nayan Ranjan; Roy, Indranil; Bhattacharyya, Amartya; Bose, Madhura; Mishra, Roshnara; Rana, Dipak; Bhattacharjee, Debashis; Chattopadhyay, Dipankar

2014-05-01

6

Medical Device Safety  

MedlinePLUS

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

7

Micro-scale Devices for Transdermal Drug Delivery  

PubMed Central

Skin makes an excellent site for drug and vaccine delivery due to easy accessibility, immuno-surveillance functions, avoidance of macromolecular degradation in the gastrointestinal tract and possibility of self-administration. However, macromolecular drug delivery across the skin is primarily accomplished using hypodermic needles, which have several disadvantages including accidental needle-sticks, pain and needle phobia. These limitations have led to extensive research and development of alternative methods for drug and vaccine delivery across the skin. This review focuses on the recent trends and developments in this field of micro-scale devices for transdermal macromolecular delivery. These include liquid jet injectors, powder injectors, microneedles and thermal microablation. The historical perspective, mechanisms of action, important design parameters, applications and challenges are discussed for each method. PMID:18805472

Arora, Anubhav; Prausnitz, Mark; Mitragotri, Samir

2009-01-01

8

Reprocessing of Reusable Medical Devices  

MedlinePLUS

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

9

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

PubMed Central

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

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

2013-01-01

10

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

11

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

12

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

13

NVM Challenges in Medical Devices.  

E-print Network

??Electronic devices are gaining an increasing market share in the medical field. Medical devices are becoming more sophisticated, and encompassing more applications. Unlike consumer electronics,… (more)

Hag, Eslam E.

2010-01-01

14

Nicotine transdermal patch and atypical antipsychotic medications for smoking cessation in schizophrenia  

Microsoft Academic Search

OBJECTIVE: Schizophrenic patients have high rates of cigarette smoking. The authors compared the outcomes of two group psychotherapy programs for smoking cessation in patients with schizophrenia or schizoaffective disorder who were also treated with the nicotine transdermal patch and with either atypical or typical antipsychotic medications.\\u000aMETHOD: Forty-five subjects were randomly assigned to 1) the group therapy program of the

Tony P. George; Douglas M. Ziedonis; Alan Feingold; W. Thomas Pepper; Cheryl A. Satterburg; Justin Winkel; Bruce J. Rounsaville; Thomas R. Kosten

2000-01-01

15

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. PMID:21814626

George, Bobby

2010-01-01

16

Barriers to medical device innovation  

PubMed Central

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

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

2014-01-01

17

Human Factors and Medical Devices  

Microsoft Academic Search

Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design

Dick Sawyer

1998-01-01

18

Micro- and nanofabrication methods in nanotechnological medical and pharmaceutical devices  

PubMed Central

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

Betancourt, Tania; Brannon-Peppas, Lisa

2006-01-01

19

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

20

Implantable medical devices MRI safe.  

PubMed

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

Dal Molin, Renzo; Hecker, Bertrand

2013-01-01

21

78 FR 18233 - Medical Devices; Technical Amendment  

Federal Register 2010, 2011, 2012, 2013, 2014

...No. FDA-2013-N-0011] Medical Devices; Technical Amendment AGENCY...Administration (FDA) is amending certain medical device regulations to correct minor...certain regulations regarding medical devices. Publication of this...

2013-03-26

22

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

23

Reliable Design of Medical Devices  

Microsoft Academic Search

The development of a medical device is a complex process. It requires the integration of a range of diverse disciplines, activities, and regulatory requirements, all of which must be achieved to ensure that the final result is a safe, effective and competitive product. While much of the information required in the process of device development is already in the pubic

S J Meldrum

1998-01-01

24

A Computational Procedure for Assessing the Dynamic Performance of Diffusion-Controlled Transdermal Delivery Devices  

PubMed Central

The dynamic performances of two different controlled-release systems were analyzed. In a reservoir-type drug-delivery patch, the transdermal flux is influenced by the properties of the membrane. A constant thermodynamic drug activity is preserved in the donor compartment. Monolithic matrices are among the most inexpensive systems used to direct drug delivery. In these structures, the active pharmaceutical ingredients are encapsulated within a polymeric material. Despite the popularity of these two devices, to tailor the properties of the polymer and additives to specific transient behaviors can be challenging and time-consuming. The heuristic approaches often considered to select the vehicle formulation provide limited insight into key permeation mechanisms making it difficult to predict the device performance. In this contribution, a method to calculate the flux response time in a system consisting of a reservoir and a polymeric membrane was proposed and confirmed. Nearly 8.60 h passed before the metoprolol delivery rate reached ninety-eight percent of its final value. An expression was derived for the time it took to transport the active pharmaceutical ingredient out of the polymer. Ninety-eight percent of alpha-tocopherol acetate was released in 461.4 h following application to the skin. The effective time constant can be computed to help develop optimum design strategies. PMID:24310592

Simon, Laurent

2011-01-01

25

FDA Targets Risks from Reused Medical Devices  

MedlinePLUS

... Articulos en Espanol FDA Targets Risks From Reused Medical Devices Search the Consumer Updates Section These reusable medical ... how the clinic cleans and disinfects the reusable medical devices used in such procedures. Get Consumer Updates by ...

26

Recent medical devices for tonsillectomy.  

PubMed

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

Sayin, I; Cingi, C

2012-01-01

27

Safety Problems With Your Child's Medical Device?  

MedlinePLUS

... Articulos en Espanol Safety Problems With Your Child's Medical Device? Search the Consumer Updates Section Get Consumer Updates by E-mail Medical devices used by children range from simple to complex. ...

28

Microeconomics of Competitiveness Minnesota Medical Device Cluster  

E-print Network

1 Microeconomics of Competitiveness Minnesota Medical Device Cluster Team Members: Adam Wipperfurth. in 1949, Minnesota has enjoyed the benefits created by a critical mass of medical device firms that were

Levinson, David M.

29

E3 TEST PROTOCOL MEDICAL DEVICES  

E-print Network

E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY AND LOGISTICAL SYSTEMS Ver 5.1 August 2007 Ralph M. Herkert and Jimmy A. Woody GTRI Medical Device Test Center Georgia Tech Research Institute Atlanta, GA.1 August 2007 GTRI MDTC TEST PROTOCOL Page 2 E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY

Bennett, Gisele

30

Medical Devices and Systems PRECISE Center  

E-print Network

12/16/2008 1 Medical Devices and Systems Insup Lee PRECISE Center Department Computer and Information Science University of Pennsylvania 12/15/08 CPS Information Day Medical Devices Containing recognizes that the rapidly increasing software complexity of medical devices makes the development of high

Rajkumar, Ragunathan "Raj"

31

Value Modelling: Three examples for medical devices  

E-print Network

Value Modelling: Three examples for medical devices P1 D4 V1.0 050414 Martin Buxton Brunel techniques to the determination of value in the context of the medical device industry. The first two and implementation of new medical devices. In doing so, definite practical issues are addressed in all three projects

Oakley, Jeremy

32

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

33

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

34

Lithium ion batteries for medical devices  

Microsoft Academic Search

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

David M. Spillman; Esther S. Takeuchi

1999-01-01

35

A novel network module for medical devices  

Microsoft Academic Search

In order to allow medical devices to upload the vital signs to a server on a network without manually configuring for end-users, a new network module is proposed. The proposed network module, called Medical Hub (MH), functions as a bridge to fetch the data from all connecting medical devices, and then upload these data to the server. When powering on,

Ping-Yu Chen

2008-01-01

36

Design for reliability in medical devices  

Microsoft Academic Search

The challenges faced by medical device manufacturers in bringing safe, reliable, low overall life-cycle cost products to market in a timely manner is increasing rapidly. The global recession, the increasing complexity and criticality of medical devices and the increasing number of safety recalls is driving the need for a good design for reliability (DFR) program in the medical industry. However,

V. Hegde; D. Raheja

2010-01-01

37

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

38

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

Code of Federal Regulations, 2012 CFR

...In-kind donations of medicine, medical devices, and medical services. 597...In-kind donations of medicine, medical devices, and medical services...in-kind donations of medicine, medical devices, and medical services...

2012-07-01

39

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

Code of Federal Regulations, 2012 CFR

...In-kind donations of medicine, medical devices, and medical services. 595...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2012-07-01

40

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

Code of Federal Regulations, 2012 CFR

...In-kind donations of medicine, medical devices, and medical services. 594...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2012-07-01

41

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

Code of Federal Regulations, 2014 CFR

...In-kind donations of medicine, medical devices, and medical services. 595...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2014-07-01

42

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

Code of Federal Regulations, 2013 CFR

...In-kind donations of medicine, medical devices, and medical services. 595...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2013-07-01

43

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

Code of Federal Regulations, 2014 CFR

...In-kind donations of medicine, medical devices, and medical services. 594...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2014-07-01

44

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

Code of Federal Regulations, 2013 CFR

...In-kind donations of medicine, medical devices, and medical services. 594...In-kind donations of medicine, medical devices, and medical services. ...in-kind donations of medicine, medical devices, and medical services...

2013-07-01

45

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

Code of Federal Regulations, 2014 CFR

...In-kind donations of medicine, medical devices, and medical services. 597...In-kind donations of medicine, medical devices, and medical services...in-kind donations of medicine, medical devices, and medical services...

2014-07-01

46

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

Code of Federal Regulations, 2013 CFR

...In-kind donations of medicine, medical devices, and medical services. 597...In-kind donations of medicine, medical devices, and medical services...in-kind donations of medicine, medical devices, and medical services...

2013-07-01

47

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

48

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

49

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

50

[Buprenorphine transdermal patch (Norspan tape)].  

PubMed

Buprenorphine is a chemically synthesized opioid characterized as the partial mu agonist and kappa antagonist, and transdermal buprenorphine patch will be considered useful as a strong analgesic with fewer psychological side effects in the treatment of chronic non-cancer pain. Use of transdermal buprenorphine should be limited for pain relief of intractable muscle skeletal pain that cannot be alleviated with other analgesics. To avoid severe complication and drug abuse or addiction, assessment of pain and medical history including drug dependence by medical team are important before administration of transdermal buprenorphine. Moreover, side effects such as nausea, vomiting, constipation, erythema and itching, loss of appetite should be treated appropriately. When transdermal buprenorphine is administered to chronic pain patients, physicians must examine the condition of patients regularly at an outpatient clinic. Moreover, decreasing and discontinuation of opioid including transdermal buprenorphine should always be considered during the treatment. Most important objective of chronic pain treatment is to improve QOL and ADL of patients. PMID:23905402

Hamaguchi, Shinsuke; Ikeda, Tomohito

2013-07-01

51

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

52

21 CFR 892.2040 - Medical image hardcopy 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 § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2013-04-01

53

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2010 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2010-04-01

54

21 CFR 892.2010 - Medical image storage 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 § 892.2010 Medical image storage device. (a) Identification. A medical...

2013-04-01

55

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2014 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2014-04-01

56

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2014 CFR

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

2014-04-01

57

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2011 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2011-04-01

58

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2012 CFR

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

2012-04-01

59

21 CFR 892.2010 - Medical image storage device.  

Code of Federal Regulations, 2011 CFR

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

2011-04-01

60

21 CFR 892.2040 - Medical image hardcopy device.  

Code of Federal Regulations, 2012 CFR

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

2012-04-01

61

Precision assembly systems for medical devices  

Microsoft Academic Search

Purpose – The purpose of this paper is to describe the approach and technology of various companies making automated assembly equipment for medical devices. Design\\/methodology\\/approach – The structure of the medical device assembly market is introduced, and the expertise and applications of a small company working in the intermediate production market is described. The modular approach of Mikron Assembly Technology

Christine Connolly

2009-01-01

62

Computerized Medical Devices: Trends, Problems, and Safety  

Microsoft Academic Search

Virtually all of the medical devices utilizing electronics will contain a micro or minicomputer by 1990. These devices accounted for $7 billion in U.S. sales in 1984. Their capabilities can provide the means for new or greatly improved medical procedures, and ensure greater patient safety. However, these benefits can easily be compromised if ``computer safety'' is not practiced in the

H. Bassen; J. Silberberg; F. Houston; W. Knight; C. Christman; M. Greberman

1986-01-01

63

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; warning statements for devices...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements...Over-the-Counter Devices § 801.63 Medical devices; warning statements for...

2013-04-01

64

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; warning statements for devices...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements...Over-the-Counter Devices § 801.63 Medical devices; warning statements for...

2011-04-01

65

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; warning statements for devices...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements...Over-the-Counter Devices § 801.63 Medical devices; warning statements for...

2012-04-01

66

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; warning statements for devices...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements...Over-the-Counter Devices § 801.63 Medical devices; warning statements for...

2014-04-01

67

[Information safety test of digital medical device].  

PubMed

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

Liu, Jiong

2014-07-01

68

New Dependability Approach for Implanted Medical Devices  

E-print Network

New Dependability Approach for Implanted Medical Devices Fabien Soulier§, Fanny Le Floch§, Serge, this paper proposes a strategy for risk management at system level for FES medical implant. The idea a new strategy for risk manage- ment at system level for FES medical implant. The aim is to propose

Paris-Sud XI, Université de

69

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

70

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

PubMed

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

Ventura, M; Chambrin, P-Y

2005-08-01

71

Privacy Challenges for Wireless Medical Devices  

SciTech Connect

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

Lagesse, Brent J [ORNL] [ORNL

2010-01-01

72

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

NASA Astrophysics Data System (ADS)

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

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

2011-09-01

73

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. PMID:22125761

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

2011-01-01

74

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

75

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

Federal Register 2010, 2011, 2012, 2013, 2014

...includes the Agency for Healthcare Research and Quality, FDA, National...healthcare practitioners, medical device trade associations...Confidential business information, Medical devices, Medical research, Reporting and...

2010-04-01

76

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

Federal Register 2010, 2011, 2012, 2013, 2014

...includes the Agency for Healthcare Research and Quality, FDA, National...healthcare practitioners, medical device trade associations...Confidential business information, Medical devices, Medical research, Reporting and...

2010-04-01

77

Fumarate copolymers-based membranes overlooking future transdermal delivery devices: synthesis and properties.  

PubMed

Novel copolymers of vinyl acetate and dialkylfumarates, poly(VA-co-DRF) with R = isopropyl (DIPF) or octan-2-yl (DOF), were synthesized by radical copolymerization under microwave conditions. The products were characterized by (1)H NMR and FTIR spectroscopies, size exclusion chromatography and differential scanning calorimetry. Based on these copolymers three membranes supported on polyvinyl alcohol were prepared and their morphology, swelling and mechanical properties were studied. The swelling kinetic was analyzed and interpreted in light of the Fick transport model, showing that the water transport occurs through a non-Fickian diffusion mechanism. The results show that the membrane prepared of poly(VA-co-DOF) exhibited excellent properties as potential platform for transdermal delivery system: they exhibited good tensile strength, moderated swelling and form thin and transparent films. PMID:23588672

Pasqualone, Magalí; Oberti, Tamara G; Andreetta, Héctor A; Cortizo, M Susana

2013-07-01

78

Transdermal drug delivery  

PubMed Central

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

Prausnitz, Mark R.; Langer, Robert

2009-01-01

79

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

80

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; misleading statements. 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements....

2012-04-01

81

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; expiration of exemptions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.127 Medical devices; expiration of...

2011-04-01

82

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; misleading statements. 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements....

2011-04-01

83

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; expiration of exemptions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.127 Medical devices; expiration of...

2012-04-01

84

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; expiration of exemptions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.127 Medical devices; expiration of...

2014-04-01

85

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; expiration of exemptions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.127 Medical devices; expiration of...

2013-04-01

86

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; misleading statements. 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements....

2014-04-01

87

21 CFR 801.127 - Medical devices; expiration of exemptions.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

88

21 CFR 801.6 - Medical devices; misleading statements.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; misleading statements. 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements....

2013-04-01

89

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Background Various types of medical devices used in healthcare settings...The workshop will focus on medical devices that are intended for reuse after reprocessing, rather...reprocessing of single-use-only medical devices. Thousands of reusable...

2011-05-02

90

76 FR 45268 - Reprocessing of Reusable Medical Devices  

Federal Register 2010, 2011, 2012, 2013, 2014

...reprocessing of reusable medical devices, reprocessing methodologies...The workshop focused on medical devices that are intended for reuse after reprocessing, rather...reprocessing of single-use-only medical devices. FDA has a Web cast of...

2011-07-28

91

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

Federal Register 2010, 2011, 2012, 2013, 2014

...only improve the safety of medical devices but also increase...regulatory evaluation of innovative medical devices; Strengthen the U.S. research infrastructure and promote...breakthroughs. Part of the Medical Device Innovation...

2011-02-09

92

Acquisition of medical device start-ups  

E-print Network

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

Nair, Ganesh R

2006-01-01

93

Medical devices for the anesthetist: current perspectives  

PubMed Central

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

Ingrande, Jerry; Lemmens, Hendrikus JM

2014-01-01

94

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 ...

95

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

96

Handheld Diagnostic Device Delivers Quick Medical Readings  

NASA Technical Reports Server (NTRS)

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

2014-01-01

97

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

98

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Devices Panel of the Medical Devices Advisory Committee; Notice...of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General...recommendations regarding clinical trial design issues for devices...

2010-09-14

99

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

100

Designing Medical Devices for the Ear  

NSDL National Science Digital Library

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

2014-09-18

101

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

102

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

E-print Network

TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their users, whether it be healthcare professionals or patients, is an important developments in healthcare. This is the aim of this research project, which is researching user behaviours

Oakley, Jeremy

103

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

Federal Register 2010, 2011, 2012, 2013, 2014

...health services research on issues related...methodology for studying medical device performance...health services research with an interest in medical device outcome...Opportunities for medical device epidemiologic research and...

2010-03-24

104

Evaluating and Predicting Patient Safety for Medical Devices with  

E-print Network

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

Zhang, Jiajie

105

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

106

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-08-09

107

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-04-27

108

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-10-14

109

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-08-13

110

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-12-27

111

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-03-28

112

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-02-18

113

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-06-22

114

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-03-19

115

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

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...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

116

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-05-08

117

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2011 CFR

...device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. (b) Classification. Class I (general controls). The device is...

2011-04-01

118

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2012 CFR

...device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. (b) Classification. Class I (general controls). The device is...

2012-04-01

119

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2013 CFR

...device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. (b) Classification. Class I (general controls). The device is...

2013-04-01

120

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2010 CFR

...device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. (b) Classification. Class I (general controls). The device is...

2010-04-01

121

21 CFR 892.2020 - Medical image communications device.  

Code of Federal Regulations, 2014 CFR

...device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. (b) Classification. Class I (general controls). The device is...

2014-04-01

122

76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency  

Federal Register 2010, 2011, 2012, 2013, 2014

...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

123

Medical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study  

E-print Network

Medical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study Alena.demicheli@epfl.ch Abstract--Nowadays medical software is tightly coupled with medical devices that perform patient state as specification of a medical system that includes both software and electronic devices. However, often medical GLs

De Micheli, Giovanni

124

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

PubMed

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

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

2010-10-01

125

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

PubMed Central

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

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

2010-01-01

126

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

PubMed Central

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

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

2010-01-01

127

Quality assurance in production of medical devices  

Microsoft Academic Search

An introducing and development of the quality system at any production or service is necessary assumption to be prosperous in opened market. Special attention has to be devoted to tasks of the quality of medical devices production, because an incidental use of the technical of poor quality product, can be caused of the health loss or can directly endanger the

J. Kuba

2003-01-01

128

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

129

[Evaluation of new implantable medical devices].  

PubMed

Complex administrative procedures have gradually been established for the evaluation of implantable medical devices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty. PMID:23259342

Loisance, Daniel

2012-01-01

130

Literature Review of Testing Techniques for Medical Device Software  

E-print Network

Literature Review of Testing Techniques for Medical Device Software John J. Majikes Department As software-controlled medical devices evolve from monolithic de- vices to modular Medical Cyber existing software-testing techniques that expose failures in software-controlled medical devices. In par

Xie, Tao

131

Recent Results in Computer Security for Medical Devices  

E-print Network

Recent Results in Computer Security for Medical Devices Shane S. Clark and Kevin Fu Department with implantable medical devices and identified both existing flaws and new techniques to improve future devices factors affecting security and privacy solutions for implantable medical devices: fundamental tensions

Shenoy, Prashant

132

Gastric-fluid-utilizing micro battery for micro medical devices  

Microsoft Academic Search

A variety of micro medical devices have been developed to provide more advanced and less invasive medical treatment. An effective power supply is crucial to the operation of these devices. Currently, two types of power supply are used: small batteries or radio-power transmission. However, the former limits the operating time of the devices, while radio-power transmission affects other medical devices

Hikaru Jimbo; Norihisa Miki

2008-01-01

133

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

134

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

135

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

136

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

137

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

138

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

139

MEDEMAS Medical Device Management and Maintenance System Architecture  

Microsoft Academic Search

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

Ülkü Balci Dogan; Mehmet Ugur Dogan; Yekta Ülgen; Mehmed Özkan

2010-01-01

140

An open test bed for medical device integration and coordination  

Microsoft Academic Search

Medical devices historically have been monolithic units - developed, validated, and approved by regulatory authorities as stand-alone 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 ldquoclosed looprdquo scenarios

Andrew L. King; Sam Procter; Daniel Andresen; John Hatcliff; Steve Warren; William Spees; Raoul Praful Jetley; Paul L. Jones; Sandy Weininger

2009-01-01

141

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Panel of the Medical Devices Advisory Committee...Russell, Center for Devices and Radiological Health...general issues related to medical devices intended for obese patients...recommendations regarding trial design for clinical...

2012-03-28

142

Ocular prosthetic obturator: an innovative medical device.  

PubMed

The following article describes the methods, materials and techniques used in the long-term management of an anophthalmic patient. Following aggressive surgery to remove a squamous cell carcinoma, the patient had no orbital implant inserted at the time of surgery and remains reticent in regard to further surgery. She presented with a large orbital socket requiring imaginative and innovative ocular rehabilitation. This paper describes the materials and methods of fabricating this new and innovative medical device. PMID:24505037

Worrell, Emma

2014-07-01

143

Strategic inventory management of externally sourced medical devices  

E-print Network

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

Hillstrom, Nichole L. (Nichole Leigh)

2013-01-01

144

Medical Device Integration Copyright 2010 The University of Vermont  

E-print Network

Case Study Medical Device Integration Copyright© 2010 The University of Vermont Physiologic Monitor Vermont Healthcare Facility This facility consists of nearly 500 licensed beds and 13,000 medical devices

Hayden, Nancy J.

145

Overview of the US FDA medical device approval process.  

PubMed

Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities. PMID:24880920

Sastry, Ashwani

2014-01-01

146

MATCH Guide towards User Involvement in Medical Device Technology  

E-print Network

MATCH Guide towards User Involvement in Medical Device Technology Assessment P3 D10 V1 050429 Ian methodologies for medical device development and evaluation Implementation of New Methodologies Embedding users and end-users in medical device development and evaluation should be a `given' and a highly practical

Oakley, Jeremy

147

Balancing Security and Utility in Medical Devices? Masoud Rostami  

E-print Network

Balancing Security and Utility in Medical Devices? Masoud Rostami Rice University Houston, TX farinaz@rice.edu ABSTRACT Implantable Medical Devices (IMDs) are being embedded increas- ingly often and challenging areas of IMD security and medical-device security in general. Categories and Subject Descriptors J

148

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

149

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

150

Enabling National Education Networking For Medical Device Industry  

Microsoft Academic Search

Design and development of medical device using medical mechatronics (MM) technologies, is an important and emerging engineering discipline in the 21 century. However, training for R & D staff for medic al device industry becomes a critical issue in knowledge- based economics development plan in Taiwan. This paper describes a successful experience on planning and executing a government sponsored Medical

Ming-Yih Lee; Chung-Hsien Kuo

151

Medical device development practices: empirical survey and legal implications  

Microsoft Academic Search

Safety concerns relating to medical devices have been raised through recent failures of heart valves, breast implants and pacemaker leads. Under common law in Australia, people who are engaged in the provision of medical care are under a duty to disclose, fully and frankly, the risks associated with any medical treatment, including those associated with new medical devices. A study

L. K. Holley; C. F. Hughes

1998-01-01

152

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.

153

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

154

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

155

Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.  

PubMed

Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference. PMID:22702259

Censi, Federica; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

2012-05-01

156

Tracking medical devices to ensure patient safety.  

PubMed

Registered nurses in perioperative settings and managers of perioperative departments must work together to implement policies and procedures to ensure compliance with these very important federal regulations. If the information is not recorded in the proper manner and shared with the manufacturer, patients' safety is at risk. Without the ability to contact physicians and patients, manufacturers cannot alert individuals appropriately if problems arise with a certain device. Tracking devices in the correct manner ensures that patients can be notified expediently. Nurses and managers should examine their current practices to ensure that they are consistent with federal regulations. A regular assessment should be conducted to ensure that tracking forms are completed in an accurate, timely manner, that permission to release a patient's social security number is obtained, and that the hospital is compliant with the FDA's most up-to-date list of devices that must be tracked. All perioperative staff members must receive education about the tracking process in their particular institution and receive updates when the process or FDA regulations change. Maintain patient safety by ensuring that the medical device tracking process is followed accurately and meets federal regulations. PMID:12575634

Beyea, Suzanne C

2003-01-01

157

Hacking medical devices a review - biomed 2013.  

PubMed

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

Frenger, Paul

2013-01-01

158

Software as a medical device: regulatory critical issues.  

PubMed

The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them. PMID:23388310

Pelayo, Sylvia; Bras Da Costa, Sabrina; Leroy, Nicolas; Loiseau, Séverine; Beuscart-Zephir, Marie-Catherine

2013-01-01

159

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 $100 billion 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

2013-10-01

160

A DPWS-Based Architecture for Medical Device Interoperability  

Microsoft Academic Search

\\u000a Due to the fact that mature or upcoming standards like the ISO\\/IEEE 11073 are not adopted widely by medical device vendors\\u000a lack of interoperability between medical devices is still an issue. We propose an architecture for medical device interoperability\\u000a basically built on the Device Profile for Web services (DPWS) for syntactic interoperability. Mature data communication standards\\u000a like the domain information

S. Pöhlsen; S. Schlichting; M. Strähle; F. Franz; C. Werner

161

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity  

MedlinePLUS

... Handle Power Outages for Medical Devices that Require Electricity CDRH Home Use Devices: How to Prepare for ... Handle Power Outages for Medical Devices that Require Electricity iv As a home medical device user, it ...

162

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

Federal Register 2010, 2011, 2012, 2013, 2014

...for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration...for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human...

2013-10-01

163

Integrated Microbatteries for Implantable Medical Devices  

NASA Technical Reports Server (NTRS)

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

Whitacre, Jay; West, William

2008-01-01

164

MEDEMAS Medical Device Management and Maintenance System Architecture  

Microsoft Academic Search

\\u000a In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides\\u000a a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also\\u000a contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices\\u000a and enables the service technician to carry

Yekta Ülgen; Mehmed Özkan

165

SPECIAL ISSUE PAPER 1397 Swallowable medical devices for diagnosis  

E-print Network

SPECIAL ISSUE PAPER 1397 Swallowable medical devices for diagnosis and surgery: the state with a perspective on the future potential of swallowable medical devices to enable advanced diagnostics beyond the feasibility of achieving medical objectives deep within the human body from a swallowable, wireless platform

Webster III, Robert James

166

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

167

Medical Devices: Principles of Clinical Evaluation of Effectiveness and Safety  

E-print Network

Medical Devices: Principles of Clinical Evaluation of Effectiveness and Safety P1 D11 v2 050521 in trials including ethical issues. However, it goes on to indicate where trials of medical devices need studies (see section 2.3), bias (see section 2.4) and the more important role of the surgeon in device

Oakley, Jeremy

168

Medical Devices Competitiveness and Impact on Public Health Expenditure  

Microsoft Academic Search

This study provides an analytical overview of the state of the European Union medical device industry. The medical device industry sector encompasses an extremely large variety of products and technologies. It covers hundreds of thousands of products that range from more traditional products, such as bandages or syringes, to sophisticated devices that incorporate bioinformatics, nanotechnology and engineered cells. These are

Fabio Pammolli; Massimo Riccaboni; Claudia Oglialoro; Laura Magazzini; Gianluca Baio; Nicola Salerno

2005-01-01

169

Implementation of Risk Management in the Medical Device Industry  

Microsoft Academic Search

This study looks at the implementation and effectiveness of risk management (RM) activities in the medical device industry. An online survey was distributed to medical device professionals who were asked to identify RM-related activities performed during the device life cycle. RM activities and techniques included Establishing Risk Acceptance Criteria, Hazard Identification, Human Factors\\/Usability, Fault Tree Analysis (FTA), Design Failure Mode

Rachelo Dumbrique

2010-01-01

170

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

171

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

Federal Register 2010, 2011, 2012, 2013, 2014

...procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements...for conducting biomedical, regulatory, and medical product research. 0 4. In Sec. 814.20, redesignate...

2013-02-19

172

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

173

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

2013-10-01

174

Value-added medical-device risk management  

Microsoft Academic Search

The assessment of overall residual risk is the primary objective of performing risk-management activities and is required by ISO 14971:2000-Application of Risk Management to Medical Devices. Despite this requirement, much confusion remains among medical-device manufacturers and the various regulatory-approval bodies as to what is required. Today, many medical-device manufacturers do not formally address the subject. This paper will address the

C. Schmuland

2005-01-01

175

How Can Software SMEs Become Medical Device Software SMEs  

Microsoft Academic Search

\\u000a The amount of software content within medical devices has grown considerably over recent years and will continue to do so\\u000a as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce\\u000a sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software\\u000a development SMEs

Fergal McCaffery; Valentine Casey; Martin McHugh

176

Assessment of technical documentation of Annex II medical devices  

Microsoft Academic Search

An investigation was carried out on the availability and quality of the\\u000atechnical documentation (file) of medical devices. Manufacturers of\\u000amedical devices are obliged to prepare and maintain documentation\\u000acomplying with the provisions in the Medical Device Directive (MDD). \\u000aManufacturers are legally required to affix a CE mark to their medical\\u000adevices in order to gain access to the European

Roszek B; Drongelen AW van; Geertsma RE; Tienhoven EAE van

2007-01-01

177

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

178

Medical Devices of the Abdomen and Pelvis1  

Microsoft Academic Search

Medical devices in the abdomen and pelvis are probably less frequently seen than those in the chest or extremities, but they are important and should be recognized. These devices can be grouped into a few major categories: intestinal tubes, genitourinary devices, postoperative appa- ratus, and a wide variety of odds and ends. Many of these devices are used to monitor

Tim B. Hunter; Mihra S. Taljanovic

179

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety  

Microsoft Academic Search

G R Higson Bristol: Institute of Physics Publishing (2001) 272pp, price: £65.00, ISBN: 0-7503-0768-4Starting with a brief historical overview of the regulation of medical devices tracing early beginnings from pharmaceutical regulations, the author settles on three main focal points for in-depth examination of the current situation: the USA, Europe and Japan. The situation elsewhere in the world is then briefly

W J ODowd

2002-01-01

180

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

Microsoft Academic Search

Background  Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors\\u000a engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development\\u000a of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried\\u000a out to explore medical device manufacturers'

Arthur G Money; Julie Barnett; Jasna Kuljis; Michael P Craven; Jennifer L Martin; Terry Young

2011-01-01

181

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

Federal Register 2010, 2011, 2012, 2013, 2014

...University Global Medical Device Conference...University Global Medical Device Conference...affairs, and clinical research professionals, and... Using Electronic Medical Records. Cooperative Research Activities...

2011-03-22

182

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-11-12

183

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...  

Federal Register 2010, 2011, 2012, 2013, 2014

...FDA-2013-D-0114] Distinguishing Medical Device Recalls From Product Enhancements...guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements...potential change to a device is a medical device recall, distinguish those...

2013-02-22

184

Towards sustainable design for single-use medical devices  

Microsoft Academic Search

Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that

Jacob J. Hanson; Robert W. Hitchcock

2009-01-01

185

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

186

Supporting medical device development: a standard product design process model  

Microsoft Academic Search

This article describes the complex nature of the medical device development (MDD) process and presents a product design process model to aid designers engaged in MDD. Basically, the model serves as a conceptual framework and provides a set of formalisms to define the development landscape for medical devices. Specifically, the model describes the phases of MDD and their relationships, including

Lourdes A. Medina; Gül E. Okudan Kremer; Richard A. Wysk

2012-01-01

187

Using Storytelling to Elicit Design Guidance for Medical Devices  

Microsoft Academic Search

Medical device designers must understand the complex context of use within a health care environment to ensure product usability. Designers must overcome domain-specific obstacles during usability research, such as patient privacy standards, which prevent designers from observing practitioners in context. In this project, we investigated storytelling as an alternative elicitation method for medical device requirements when direct observations are limited

Kim Gausepohl; Woodrow W. Winchester; James D. Arthur; Tonya Smith-Jackson

2011-01-01

188

Medical devices for developing countries: Design constraints and approaches  

Microsoft Academic Search

Medical devices intended for use in developing countries have certain differences compared to those used in developed countries. Thus, many of the medical devices built for developed countries may not be compatible with the environment in developing countries. In this specific case study we consider the respiratory problems in India and elucidate design constraints and approaches for the development of

Amit J. Nimunkar; Jonathan Baran; David Van Sickle; Naresh Kumar Pagidimarry; J. G. Webster

2009-01-01

189

FMEA for rework reduction in software medical devices-experience  

Microsoft Academic Search

Safety and Effectiveness of the product is a crucial part of medical devices as it deals with human lives. In the case of software medical device it is important to establish processes, activities and tasks which assures that the software has been developed in a manner that is likely to produce highly reliable and safe products. It is proven that

Saraswathi Deora

2012-01-01

190

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

E-print Network

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer sources in networks of pervasive healthcare devices, sensors, and applications. Categories and Subject Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer­ Communication Networks]: General

Bishop, Matt

191

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

E-print Network

Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer sources in networks of pervasive healthcare devices, sensors, and applications. Categories and Subject Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer- Communication Networks]: General

Bishop, Matt

192

The regulation of cognitive enhancement devices: extending the medical model  

PubMed Central

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

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

2014-01-01

193

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-10-20

194

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-08-06

195

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-05-23

196

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-10-07

197

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-04-05

198

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-07-07

199

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-03-16

200

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-03-18

201

The role of biofilms in reprocessing medical devices.  

PubMed

Biofilms are communities of microorganisms within extracellular polymeric material attached to surfaces. Within a biofilm, cells have some protection from drying and other stress factors in their environment, including antimicrobial agents. In this article, the challenges to medical device reprocessing posed by biofilms are addressed. Biofilm formation on reusable medical device surfaces is a risk that can be controlled. By ensuring prompt device cleaning and reprocessing either by high-level disinfection or sterilization and proper drying, biofilms will not have a chance to form. Reusable medical devices like flexible endoscopes that are promptly cleaned and disinfected, rinsed and dried pose little risk to patients. PMID:23622755

Roberts, Charles G

2013-05-01

202

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-07-19

203

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

Federal Register 2010, 2011, 2012, 2013, 2014

...HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug...

2012-04-02

204

A biomedical device business plan for Medicraften Devices Inc. to develop a fluid medication dispenser  

E-print Network

This thesis surrounds an analysis to understand what it would take for a company to successfully launch a prescription fluid dispensing device. This device would in theory be able to dispense medication at any time daily ...

Louison, Charles Davidson

2006-01-01

205

The Headroom Method of early economic evaluation of medical devices: A useful tool for device developers?  

E-print Network

studies Primary Research Question: Is the Headroom Method a useful tool for device developers? DoesThe Headroom Method of early economic evaluation of medical devices: A useful tool for device Life Year] Headroom Determines the maximum reimbursable price of the new device Can the manufacturer

Oakley, Jeremy

206

Microbial colonization of medical devices and novel preventive strategies.  

PubMed

Upon implantation or insertion into patient's body for exerting the intended purpose like salvage of normal functions of vital organs, the medical devices are unfortunately becoming the sites of competition between host cell integration and microbial adhesion. Moreover, since there is an increased use of implanted medical devices, the incidence of biofilm-and medical devices-related nosocomial infections is also increasing progressively. To control microbial colonization and subsequent biofilm formation of the medical devices, different approaches either to enhance the efficiency of certain antimicrobial agents or to disrupt the basic physiology of the pathogenic microorganisms including novel small molecules and antipathogenic drugs are being explored. In addition, the various lipid-and polymer-based drug delivery carriers are also investigated for applying antibiofilm coating of the medical devices especially over catheters. The main intention of this review is therefore to summarize the major and/breakthrough inventions disclosed in patent literature as well as in research papers related to microbial colonization of medical devices and novel preventive strategies. This review starts with an overview of the preventive strategies followed by a short description about the potential of different lipidic-and polymeric-drug delivery carriers in eradicating the biofilm-associated infections from the medical devices. PMID:20236065

Shunmugaperumal, Tamilvanan

2010-06-01

207

Current Status of the Regulation for Medical Devices  

PubMed Central

In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical industry in India, guidelines for devices will encourage the much needed research in medical devices. Pharmacy personnel can certainly play an important role in the regulation of medical devices. Safety, risks, effectiveness and performance of the medial devices need to be well established and regulated properly. It is hoped that the guidelines are implemented and regulated properly with effective outcome. PMID:21369427

Shah, Anuja R.; Goyal, R. K.

2008-01-01

208

Reuse of medical devices: implications for infection control.  

PubMed

Reuse of both single-use and multiuse medical devices is a common practice and can result in transmission of infection when appropriate sterilization or reprocessing does not occur. Reuse of single-use devices can be problematic because there are no clear standards for reprocessing, although data regarding adverse outcomes are limited. Single-use devices are commonly reused, appropriately or inappropriately, in resource-limited settings because of cost constraints. Reuse of medical devices raises important legal and ethical questions. PMID:22284382

Shuman, Emily K; Chenoweth, Carol E

2012-03-01

209

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; adequate directions for use...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for...

2012-04-01

210

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

Code of Federal Regulations, 2012 CFR

...Suppliers for sealed sources or devices for medical use. 35.49 Section...Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured,...

2012-01-01

211

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

Code of Federal Regulations, 2014 CFR

...Suppliers for sealed sources or devices for medical use. 35.49 Section...Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured,...

2014-01-01

212

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices for use in teaching, law enforcement...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.125 Medical devices for use in teaching, law...

2014-04-01

213

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

Code of Federal Regulations, 2010 CFR

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

2010-04-01

214

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

Code of Federal Regulations, 2013 CFR

...Suppliers for sealed sources or devices for medical use. 35.49 Section...Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured,...

2013-01-01

215

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

Code of Federal Regulations, 2010 CFR

...Transitional pass-through payments: Medical devices. 419.66 Section 419...Transitional pass-through payments: Medical devices. (a) General rule. CMS...a pass-through payment for a medical device that meets the...

2010-10-01

216

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices having commonly known directions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.116 Medical devices having commonly known...

2012-04-01

217

77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...  

Federal Register 2010, 2011, 2012, 2013, 2014

...and Drug Administration Staff; Medical Device Classification Product Codes...the draft guidance entitled ``Medical Device Classification Product Codes...classification product codes for medical devices regulated by the Center for...

2012-01-03

218

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; prominence of required label...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required...

2012-04-01

219

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices having commonly known directions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.116 Medical devices having commonly known...

2011-04-01

220

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; prominence of required label...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required...

2011-04-01

221

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

Code of Federal Regulations, 2010 CFR

...2010-10-01 false Medical supplies, appliances, and devices: Scope. 410...Services § 410.36 Medical supplies, appliances, and devices: Scope. (a...for the following medical supplies, appliances and devices: (1)...

2010-10-01

222

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

Code of Federal Regulations, 2012 CFR

...Transitional pass-through payments: Medical devices. 419.66 Section 419...Transitional pass-through payments: Medical devices. (a) General rule. CMS...pass-through payment for a medical device that meets the...

2012-10-01

223

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; Spanish-language version...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language...

2014-04-01

224

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

225

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

Code of Federal Regulations, 2011 CFR

...Suppliers for sealed sources or devices for medical use. 35.49 Section...Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured,...

2011-01-01

226

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices for use in teaching, law enforcement...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.125 Medical devices for use in teaching, law...

2012-04-01

227

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices for use in teaching, law enforcement...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.125 Medical devices for use in teaching, law...

2011-04-01

228

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

Code of Federal Regulations, 2012 CFR

...2012-10-01 false Medical supplies, appliances, and devices: Scope. 410...Services § 410.36 Medical supplies, appliances, and devices: Scope. (a...for the following medical supplies, appliances and devices: (1)...

2012-10-01

229

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

Code of Federal Regulations, 2013 CFR

...2013-10-01 false Medical supplies, appliances, and devices: Scope. 410...Services § 410.36 Medical supplies, appliances, and devices: Scope. (a...for the following medical supplies, appliances and devices: (1)...

2013-10-01

230

21 CFR 801.18 - Format of dates provided on a medical device label.  

Code of Federal Regulations, 2014 CFR

... Format of dates provided on a medical device label. 801.18 Section 801...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling... Format of dates provided on a medical device label. (a) In...

2014-04-01

231

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...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.125 Medical devices for use in teaching, law...

2013-04-01

232

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

Code of Federal Regulations, 2010 CFR

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

2010-04-01

233

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

Code of Federal Regulations, 2011 CFR

...Transitional pass-through payments: Medical devices. 419.66 Section 419...Transitional pass-through payments: Medical devices. (a) General rule. CMS...a pass-through payment for a medical device that meets the...

2011-10-01

234

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2010 CFR

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

2010-04-01

235

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

Code of Federal Regulations, 2010 CFR

...Suppliers for sealed sources or devices for medical use. 35.49 Section...Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use— (a) Sealed sources or devices manufactured,...

2010-01-01

236

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

Code of Federal Regulations, 2011 CFR

...2011-10-01 false Medical supplies, appliances, and devices: Scope. 410...Services § 410.36 Medical supplies, appliances, and devices: Scope. (a...for the following medical supplies, appliances and devices: (1)...

2011-10-01

237

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices for processing, repacking...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.122 Medical devices for processing,...

2012-04-01

238

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; adequate directions for use...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for...

2011-04-01

239

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; adequate directions for use...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for...

2014-04-01

240

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-11-16

241

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; prominence of required label...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required...

2014-04-01

242

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; adequate directions for use...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for...

2013-04-01

243

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

244

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices having commonly known directions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.116 Medical devices having commonly known...

2013-04-01

245

21 CFR 801.116 - Medical devices having commonly known directions.  

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices having commonly known directions...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.116 Medical devices having commonly known...

2014-04-01

246

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices for processing, repacking...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.122 Medical devices for processing,...

2011-04-01

247

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices for processing, repacking...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From...Directions for Use § 801.122 Medical devices for processing,...

2013-04-01

248

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; Spanish-language version...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language...

2013-04-01

249

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

Code of Federal Regulations, 2013 CFR

...2013-04-01 2013-04-01 false Medical devices; prominence of required label...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required...

2013-04-01

250

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; Spanish-language version...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language...

2012-04-01

251

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

Code of Federal Regulations, 2013 CFR

...Transitional pass-through payments: Medical devices. 419.66 Section 419...Transitional pass-through payments: Medical devices. (a) General rule. CMS...pass-through payment for a medical device that meets the...

2013-10-01

252

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

253

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

254

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

255

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

256

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-06-24

257

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-07-09

258

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-09-22

259

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

Federal Register 2010, 2011, 2012, 2013, 2014

...The Medical Device Innovation Initiative...regulatory evaluation of innovative medical devices; Strengthen the U.S. research infrastructure and promote...breakthroughs. Part of the Medical Device Innovation...

2011-02-09

260

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

Code of Federal Regulations, 2010 CFR

...2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801...SERVICES (CONTINUED) MEDICAL DEVICES LABELING...Use § 801.125 Medical devices for use in teaching, law enforcement, research, and...

2010-04-01

261

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

Federal Register 2010, 2011, 2012, 2013, 2014

...of scientific research data to support pediatric medical device efficacy...ways scientific research data can be used...effectiveness claims for medical devices and pediatric...existing scientific research data to support...effectiveness claims for medical devices and...

2012-01-25

262

FDA Offers Tips about Medical Devices and Hurricane Disasters  

MedlinePLUS

... where exhaust can vent into an enclosed area. Water Contamination Some medical devices and equipment, such as dialyzers or IV pumps, require safe water in their use, cleaning, and maintenance. Hurricanes, especially ...

263

Mergers and acquisitions in the medical device industry  

E-print Network

Mergers and acquisitions in the Medical Device Industry are the primary mode of exit for early stage companies. The focus of this thesis is to examine factors which influence the value of these M&A transactions from the ...

Ohashi, Kevin Lee

2007-01-01

264

Modeling medical devices for plug-and-play interoperability  

E-print Network

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

Hofmann, Robert Matthew

2007-01-01

265

Factors influencing the time for FDA review of medical devices  

E-print Network

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

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

2007-01-01

266

Characteristics of disruptive innovation within the medical device industry  

E-print Network

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

Berlin, David B. (David Benjamin)

2011-01-01

267

Green manufacturing in the medical device industry : a case study  

E-print Network

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

Gautreau, Leigh (Leigh Ann)

2009-01-01

268

Computer-aided decision making for Medical Device Reporting  

E-print Network

COMPUTER ? AIDED DECISION MAKING FOR MEDICAL DEVICE REPORTING A Thesis By JIH ? HORN CHEN Submitted . to the Graduat. e College of Texas A &. M University in partial fulfillment of the requirements 1'or the degree of MASTER OF SCIENCE May... 1987 Ma, jor Sub?ject: Bioengineering COMPUTER ? AIDED DECISION MAKING FOR MEDICAL DEVICE REPORTING A Thesis By Jih ? Horn Chen Approved as to style and content by: William A rt Hyman (Chairman Committee) Hiller (Member) William cCain i ely...

Chen, Jih-Horn

2012-06-07

269

Post-approval studies in France, challenges facing medical devices.  

PubMed

Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance. PMID:25230354

Levesque, Karine; Coqueblin, Claire; Guillot, Bernard; Aubourg, Lucie; Avouac, Bernard; Carbonneil, Cédric; Cucherat, Michel; Descamps-Mandine, Patricia; Hanoka, Serge; Goldberg, Marcel; Josseran, Anne; Parquin, François; Pitel, Séverine; Ratignier, Christelle; Sechoy, Odile; Szwarcenstein, Karine; Tanti, André; Teiger, Emmanuel; Thevenet, Nicolas

2014-01-01

270

Development of Implantable Medical Devices: From an Engineering Perspective  

PubMed Central

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

2013-01-01

271

Development of implantable medical devices: from an engineering perspective.  

PubMed

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

Joung, Yeun-Ho

2013-09-01

272

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

E-print Network

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

Wolf, Daniel W. (Daniel William)

2010-01-01

273

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

274

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

275

Design of interactive medical devices: Feedback and its improvement  

Microsoft Academic Search

The design of medical devices directly affects the way healthcare practitioners carry out their daily tasks. Users welcome design that takes into account the clinical environment, in which the device is operated and is compatible with their workflow. However, if the design fails to fit, the likelihood of errors increases, which will put patient safety at risk. In this paper,

Yunqiu Li; Patrick Oladimeji; Carlos Monroy; Abigail Cauchi; Harold Thimbleby; Dominic Furniss; Chris Vincent; Ann Blandford

2011-01-01

276

In-the-spectacle-lens telescopic device Harvard Medical School  

E-print Network

successful telescopic devices to assist individuals with low vision vision impairment are bioptic telescopesIn-the-spectacle-lens telescopic device Eli Peli Harvard Medical School Schepens Eye Research, 30100 Spain Abstract. Spectacle-mounted telescopic systems are prescribed for in- dividuals with visual

Peli, Eli

277

Use of mobile devices for medical imaging.  

PubMed

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

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

2014-12-01

278

Portable, low-cost medical ultrasound device prototype  

Microsoft Academic Search

The first generation prototype of a portable, low-cost medical ultrasound device is described along with experimental results. The prototype system consists of a fully sampled 2D transducer array, sixteen custom receive circuitry chips multiplexed into two bandpass filter channels, and an onboard programmable logic device. A PC fitted with a commercially available data acquisition card is used for data collection

Michael I. Fuller; Karthik Ranganathan; Shiwei Zhou; Travis N. Blalock; John A. Hossack; William F. Walker

2004-01-01

279

Legal implications of single-use medical device reprocessing.  

PubMed

Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices. PMID:24034777

Larose, Emily

2013-01-01

280

MAOIs and transdermal delivery.  

PubMed

Although not currently considered a first-line treatment for depression due to safety and tolerability concerns, MAOIs are effective antidepressants, particularly for atypical or treatment-resistant depression. FDA-approved oral MAOIs inhibit both MAO-A and MAO-B; inhibition of MAO-A in the brain is required for an antidepressant effect, but inhibition in the intestinal tract can allow excessive absorption of tyramine, which can lead to hypertensive crisis. A transdermal formulation of selegiline delivers the medication directly into the circulatory system, bypassing the first-pass metabolism of the GI system and substantially reducing the risk for tyramine-related adverse events. The skin patch allows for a lower dose of the drug to achieve an antidepressant effect, maintains a steady dose of the medication over 24 hours, and avoids the need for dietary restrictions at the minimum effective dose of 6 mg/24 hours. MAOIs are useful treatment options for patients who have not responded to first-line treatments, and understanding their mechanism of action can help clinicians to accurately and safely prescribe these medications. PMID:23059160

Vandenberg, Chad M

2012-09-01

281

Medical devices in dermatology using DLP technology from Texas Instruments  

NASA Astrophysics Data System (ADS)

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

Kock, M.; Lüllau, F.

2012-03-01

282

Standards for medical devices in MRI: present and future.  

PubMed

The purpose of this review is to define the current standards addressing safety of medical devices in MRI and to describe ongoing standards development efforts. The American Society for Testing and Materials (ASTM International) began developing standard test methods for determining the MR safety of medical devices in MRI in 1997. To date, five ASTM standards addressing testing and marking medical devices and other items for use in the MR environment have been published. International Standards Organization (ISO) 14630, the general requirements standard for nonactive surgical implants, is currently being revised to include information about MR safety of passive implants and to reference the ASTM standards. To address the unique safety issues of active implants, and in particular, active implants with leads, like pacemakers and neurostimulators, a joint working group between ISO TC150/SC6 on active implants and International Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for medical diagnosis is working to develop a technical specification for active implantable medical devices (AIMDs) in MRI. While much progress has been made, work still needs to continue to develop a complete body of test methods to allow the evaluation of the safety of medical devices in the MR environment. PMID:17969160

Woods, Terry O

2007-11-01

283

Securing Legacy Mobile Medical Devices Vahab Pournaghshband, Majid Sarrafzadeh, and Peter Reiher  

E-print Network

Securing Legacy Mobile Medical Devices Vahab Pournaghshband, Majid Sarrafzadeh, and Peter Reiher Millions of people use mobile medical devices--more every day. But our under- standing of device security the Personal Security Device, a portable device to improve security for mobile medical systems. This device

California at Los Angeles, University of

284

Economic content in medical journal advertisements for medical devices and prescription drugs.  

PubMed

Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors. PMID:20402543

Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

2010-01-01

285

The use of medication compliance devices by district nursing services.  

PubMed

This article presents a critical review of the literature relating to medication compliance devices and the findings of a survey that examined the use of such devices by district nursing services. The UKCC (1992) does not regard the loading of compliance devices by nurses as safe practice; however, compliance devices continue to be used by district nurses. The evidence base concerning the value and use of medication compliance devices is examined and significant gaps in the literature relating to the use of such devices are identified. There is an absence of studies that focus on the effect of compliance devices on adherence among older patients and the nature and frequency of drug administration errors involving these devices. The survey findings show that nurse-loaded compliance devices are used in over one-third of the sample. Further research is necessary to assess the clinical effectiveness of, and clinical risk attached to, compliance devices for older patients in the community. It is suggested that this is an issue of serious concern for primary care groups considering the principles of clinical governance. PMID:12271220

McGraw, C; Drennan, V

2000-07-01

286

A PDMS interstitial fluid transdermal extraction tool  

Microsoft Academic Search

We present a microfluidic based interstitial fluid (ISF) transdermal extraction tool fabricated from polydimethylsiloxane (PDMS), designed towards the application of continuous glucose monitoring. This device consists of a Venturi Tube for vacuum generation, chambers for the introduction of ISF and normal saline solution, pneumatic valves for fluid control, and interconnected microchannels. Vacuum pressure is used for fluid manipulation and a

Haixia Yu; Robert C. Roberts; Dachao Li; Kexin Xu; Norman C. Tien

2010-01-01

287

77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting  

Federal Register 2010, 2011, 2012, 2013, 2014

...recommendations and vote on information regarding the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The proposed Indication for Use for the Argus II (as stated...

2012-07-19

288

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

Federal Register 2010, 2011, 2012, 2013, 2014

...glaucoma currently treated with ocular hypotensive medication. For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for phacoemulsification. The patient's glaucoma should be considered mild...

2010-06-22

289

Courses (15 credits) Course Name Semester BIOE 811 (3) Sterilization & Cleaning Engineering for Medical Devices Maymester  

E-print Network

for Medical Devices Maymester BIO 813 (3) Industrial Bioengineering Summer BIOE 814 (3) Medical Device Commercialization Fall BIOE 815 (3) Design, Manufacturing & Validation Methods for Reusable Medical Devices Spring BIOE 890 (3) Medical Device Recycling & Reprocessing Practicum By arrangement BioE Certificate Program

Duchowski, Andrew T.

290

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

291

Transdermal Photopolymerization for Minimally Invasive Implantation  

NASA Astrophysics Data System (ADS)

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

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

1999-03-01

292

Implantable photonic devices for improved medical treatments  

NASA Astrophysics Data System (ADS)

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

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

2014-10-01

293

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

Microsoft Academic Search

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

Kejia Li; Steve Warren; John Hatcliff

2012-01-01

294

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

295

[Harm related to medical device use - legal and organisational risks].  

PubMed

The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the system-atic exchange of much safety-relevant infor-mation. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk man-agement in health-care facilities without risk policy is dangerously incomplete. PMID:24824355

Hölscher, U M

2014-12-01

296

Medical devices and procedures in the hyperbaric chamber.  

PubMed

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

Kot, Jacek

2014-12-01

297

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

Federal Register 2010, 2011, 2012, 2013, 2014

...A. Marketed Devices Already in Use for Patient Care Medical devices in use for ongoing patient care may be damaged or prevented from functioning...medical devices that are essential to ongoing patient safety, treatment, or comfort need to...

2013-02-21

298

Analytical Challenges of Microbial Biofilms on Medical Devices Microbial colonization of medical devices is a widespread problem that tests the limits of conventional  

E-print Network

#12;Analytical Challenges of Microbial Biofilms on Medical Devices Microbial colonization of medical devices is a widespread problem that tests the limits of conventional analytical methods *S Supporting Information Robert Gates The use of medical devices is one of the fastest growing areas

Vertes, Akos

299

Standardized Device Services - A Design Pattern for Service Oriented Integration of Medical Devices  

Microsoft Academic Search

Service oriented device architecture (SODA) is a promising approach for enabling a continuous IT support of medical processes in hospitals. However, there is a lack of specific design patterns for realizing the concept in an effective and efficient way. This paper addresses this research gap by introducing the Standardized Device Service design pattern, as a first fundamental pattern for encapsulating

Christian Mauro; Ali; Sunyaev; Helmut Krcmar

2010-01-01

300

Deconvolving an estimate of breath measured blood alcohol concentration from biosensor collected transdermal ethanol data  

Microsoft Academic Search

Biosensor measurement of transdermal alcohol concentration in perspiration exhibits significant variance from subject to subject and device to device. Short duration data collected in a controlled clinical setting is used to calibrate a forward model for ethanol transport from the blood to the sensor. The calibrated model is then used to invert transdermal signals collected in the field (short or

M. A. Dumett; I. G. Rosen; J. Sabat; A. Shaman; L. Tempelman; C. Wang; R. M. Swift

2008-01-01

301

Medical Devices Assess, Treat Balance Disorders  

NASA Technical Reports Server (NTRS)

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

2009-01-01

302

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

303

Improving software Risk Management in a Medical Device Company  

Microsoft Academic Search

Software Risk Management (RM) within Medical Device (MD) companies is a critical area. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators penalise MD manufacturers that do not devote sufficient attention to the areas of hazard analysis and RM throughout the software lifecycle. This paper describes the experience of a

Fergal Mccaffery; John Burton; Ita Richardson

2009-01-01

304

Management information system of medical equipment using mobile devices  

Microsoft Academic Search

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

C. Núñez; D. Castro

2011-01-01

305

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

306

Perinatal Staff Nurse Medical Device Use and Education.  

ERIC Educational Resources Information Center

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

McConnell, Edwina A.

1998-01-01

307

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

308

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

309

From concept to exit strategies - medical device innovation  

Microsoft Academic Search

Summary form only given: 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

E. L. Kermit

2004-01-01

310

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

311

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

312

Quality and continuous improvement in medical device manufacturing  

Microsoft Academic Search

Purpose – The purpose of this paper is to compare a range of quality and continuous improvement strategies and to investigate whether there is a best choice of strategy for use within the medical devices sector. Design\\/methodology\\/approach – A brief literature-based review of a number of continuous improvement strategies. Comparison of these strategies and a subsequent discussion of the rationale

Alan Brown; Julie Eatock; Dorian Dixon; Brian J. Meenan; John Anderson

2008-01-01

313

A Formal Methods Approach to Medical Device Review  

Microsoft Academic Search

With software playing an increasingly important role in medical devices, regulatory agencies such as the US Food and Drug Administration need effective means for assuring that this software is safe and reliable. The FDA has been striving for a more rigorous engineering-based review strategy to provide this assurance. The use of mathematics-based techniques in the development of software might help

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

2006-01-01

314

The 1995 Medical Device Technology raw materials survey.  

PubMed

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

Pearson, L S

1995-09-01

315

Microscale metal additive manufacturing of multi-component medical devices  

Microsoft Academic Search

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

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

2010-01-01

316

Medical device EMI: FDA analysis of incident reports, and recent concerns for security systems and wireless medical telemetry  

Microsoft Academic Search

FDA has evaluated reports of medical device malfunctions caused by electromagnetic interference (EMI), performed device testing, and developed standardized test procedures. Over 500 incident reports are suspected to be attributable to EMI affecting cardiac devices. More than 80 of these reports involve cardiac and other medical device interactions with electronic security systems. EMI presents a risk to patient safety and

Donald Witters; Stuart Portnoy; Jon Casamento; Paul Ruggera; Howard Bassen

2001-01-01

317

The Use of Medical Devices in Self Monitoring of Chronic Diseases  

Microsoft Academic Search

\\u000a The range and complexity of medical devices used in homecare are increasing. Home medical devices must be safer, easier to\\u000a use and more accessible for all users. The safety and the efficiency of the medical device used depend on the device’s design,\\u000a users’ ability to operate with devices and the used environments for devices. In order to investigate the proper

S. Mirel; S. Pop; E. Onaca; S. Domnita; V. Mirel

318

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-01-11

319

Diclofenac Transdermal Patch  

MedlinePLUS

... transdermal diclofenac may cause swelling, ulcers, bleeding, or holes in the stomach or intestines. These problems may ... like coffee grounds, blood in the stool, or black and tarry stools.Keep all appointments with your ...

320

Rivastigmine Transdermal Patch  

MedlinePLUS

... also used to treat dementia in people with Parkinson's disease (a brain system disease with symptoms of slowing ... cure Alzheimer's disease or dementia in people with Parkinson's disease. Continue to use transdermal rivastigmine even if you ...

321

Informatica 38 (2014) 8188 81 Tricorder: Consumer Medical Device for Discovering Common  

E-print Network

Informatica 38 (2014) 81­88 81 Tricorder: Consumer Medical Device for Discovering Common Medical.stepan@gigodesign.com Technical Position Paper Keywords: diagnostic device, Tricorder, medical application, intelligent assistant or ambiental sensor or device through web of things, additional previous medical applications not set out

LuÂ?trek, Mitja

322

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...  

Federal Register 2010, 2011, 2012, 2013, 2014

...device studies. A medical device pivotal study is a definitive...effectiveness evaluation of the medical device for its intended use. Evidence...studies generally serves as the primary basis for the determination...effectiveness of the medical device of a premarket approval...

2013-11-07

323

Heart-to-Heart (H2H): Authentication for Implanted Medical Devices  

E-print Network

Heart-to-Heart (H2H): Authentication for Implanted Medical Devices Masoud Rostami Rice University to authenticate external medical device controllers and programmers to Implantable Medi- cal Devices (IMDs). IMDs, which include pacemakers and cardiac defibrillators, are therapeutic medical devices partially or wholly

324

Image quality characteristics of handheld display devices for medical imaging.  

PubMed

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2 × 10(-5) mm(2) at 1 mm(-1), while handheld displays have values lower than 3.7 × 10(-6) mm(2). Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

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

2013-01-01

325

Image Quality Characteristics of Handheld Display Devices for Medical Imaging  

PubMed Central

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

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

2013-01-01

326

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-07-28

327

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

PubMed

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

Luo, Qingfeng

2014-05-01

328

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

PubMed Central

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

2011-01-01

329

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

330

Quantitative risk analysis of medical devices: an endoscopic imaging example  

NASA Astrophysics Data System (ADS)

The performance of trained human observers in diagnosing a medical situation through an endoscope can be represented by a receiver operating characteristic (ROC) curve. When the ROC plot is related to a plot of signal to noise ratio (SNR) of the endoscope system display versus system resolution, the operator performance for a given size target object can be determined from the ROC. The ROC curve gives probability statistics associated with detection. When the costs of errors are assigned, this method would quantify the risks associated with the use of the device. It is proposed as a method which would allow a regulatory agency to judge imaging devices based on quantified cost/benefits.

Waynant, Ronald W.

1995-10-01

331

Application of the medical device directive to software: methodological challenges.  

PubMed

The European Union (EU) adopted the revised Medical Device Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medical device (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures. PMID:23920592

Pelayo, Sylvia; Bras Da Costa, Sabrina; Leroy, Nicolas; Loiseau, Séverine; MacKeon, Damien; Trancard, Delphine; Beuscart-Zéphir, Marie-Catherine

2013-01-01

332

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

333

Printable thermoelectric devices and conductive patterns for medical applications  

NASA Astrophysics Data System (ADS)

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

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

2012-10-01

334

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

Code of Federal Regulations, 2010 CFR

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

2010-04-01

335

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

Code of Federal Regulations, 2011 CFR

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

2011-04-01

336

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

E-print Network

to Design for the Safety of Medical Diagnostic Devices by Vincent HA Systems Theoretic Application to Design for the Safety of Medical Diagnostic Devices by Vincent H. Balgos B.S. Chemical Engineering B

Leveson, Nancy

337

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-07-31

338

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2013-08-02

339

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-08-01

340

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-10-05

341

A systems approach to improving patient safety through medical device purchasing  

E-print Network

applying systems approaches specifically to medical device purchasing practice. Medical device purchasing, because of its implications to patient safety on the one hand, and the uniqueness of the healthcare context, requires a unique approach...

Hinrichs, Saba

2010-10-12

342

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

E-print Network

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

Buckley, Patrick R.

2007-01-23

343

Transdermal iontophoresis. Part I: Basic principles and considerations.  

PubMed

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

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

1999-03-01

344

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

E-print Network

& Information Sciences 234 Nichols Hall Manhattan, KS 66506 hatcliff@ksu.edu ABSTRACT Frameworks that promote the intelligent coordination of medical devices are required in ubiquitous health care environments. Such environments are essential to achieve closed-loop behavior, and an emphasis on interoperability standards

Huth, Michael

345

MMEC Forward Focus Innovation Meets Standardization: Neuralynx Pursuing the Medical Device Market  

E-print Network

MMEC Forward Focus Innovation Meets Standardization: Neuralynx Pursuing the Medical Device Market, is on a journey to becoming a medical device manufacturer where its signature products may provide information for medical devices needed as the foundation to comply with U.S. Food and Drug Administration (FDA), CE

Dyer, Bill

346

Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare  

E-print Network

1 Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare. of Anesthesia and Biomedical Engineering Director, CIMIT Program on Interoperability and the Medical Device Plug be implemented due to the lack of interoperability of medical devices and systems, especially in high

Rajkumar, Ragunathan "Raj"

347

MLM Biologics Market-Driven, Evidence-Based Medical Devices for the Global Market  

E-print Network

MLM Biologics Market-Driven, Evidence-Based Medical Devices for the Global Market MLM Biologics is a Florida-based medical device company focusing on regenerative medicine (musculo- skeletal deficiencies and distribute medical devices, primarily a biologics platform, that are effective both clinically (evidence

Jawitz, James W.

348

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

E-print Network

An Open Test Bed for Medical Device Integration and Coordination Andrew King, Sam Procter Dan.Spees,Raoul.Jetley,PaulL.Jones, Sandy.Weininger}@fda.hhs.gov Abstract Medical devices historically have been monolithic units ­ de- veloped, validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices

Huth, Michael

349

Prototyping Closed Loop Physiologic Control with the Medical Device Coordination Framework  

E-print Network

Prototyping Closed Loop Physiologic Control with the Medical Device Coordination Framework Andrew authorities as stand- alone entities. Despite the fact that modern medical devices in- creasingly incorporate that could be used to quickly implement medical device coordina- tion applications ­ enabling a "systems

Hu, Fei

350

Low-Energy Encryption for Medical Devices: Security Adds an Extra Design Dimension  

E-print Network

Low-Energy Encryption for Medical Devices: Security Adds an Extra Design Dimension Junfeng Fan Smart medical devices will only be smart if they also in- clude technology to provide security, including location privacy, it is clear that medical devices need public key cryptography (PKC

Hu, Fei

351

MATCH Guide on Product Development Processes in the Medical Device Industry  

E-print Network

MATCH Guide on Product Development Processes in the Medical Device Industry P2 D9 V1.0 050506 of Technology Centre for Healthcare #12;EXECUTIVE SUMMARY This MATCH guide is aimed at SME medical device discussion, the NPD process for medical devices has been broken down in four main stages as shown in Figure 1

Oakley, Jeremy

352

Home Use Medical Devices: The Impact on the Lives of Older People  

E-print Network

Home Use Medical Devices: The Impact on the Lives of Older People Background Increased life were carried out with medical device users aged 65 or over. Five of these interviews included' illustrated the interaction of medical devices on the environment and context of its use. Conclusion

Oakley, Jeremy

353

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

354

An Approach to Reviewing Software in Medical Devices Raoul Jetley S. Purushothaman Iyer  

E-print Network

An Approach to Reviewing Software in Medical Devices Raoul Jetley S. Purushothaman Iyer Dept early and quick delivery of software in medical devices to field. Given these competing forces the US the process of reviewing software (in medical devices) easy. We discuss a methodology that is based on using

Young, R. Michael

355

Demonstration of a Medical Device Integration and Coordination Framework Andrew King, Sam Procter  

E-print Network

Demonstration of a Medical Device Integration and Coordination Framework Andrew King, Sam Procter and coordinating the activities of medical devices. The framework uses a publish-subscribe framework for com. The distribution of the framework includes a collection of mock medical devices, and instruc- tions for integrating

Huth, Michael

356

Modal Abstraction View of Requirements for Medical Devices Used in Healthcare Processes  

E-print Network

Modal Abstraction View of Requirements for Medical Devices Used in Healthcare Processes Heather M Amherst, Massachusetts 01003 Email: clarke@cs.umass.edu Abstract--Medical device requirements often depend, and thus appears to improve understandability. Index Terms--Requirement specifications, medical devices

Massachusetts at Amherst, University of

357

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

Federal Register 2010, 2011, 2012, 2013, 2014

...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

358

August 17, 1997 Using a Bayesian Approach in Medical Device Development *  

E-print Network

1 August 17, 1997 Using a Bayesian Approach in Medical Device Development * Donald A. Berry a Bayesian Approach in Medical Device Development Donald A. Berry Institute of Statistics & Decision Sciences attention to applying this approach to the development of medical devices. The eponym derives from

West, Mike

359

They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices  

E-print Network

General Terms Algorithms, Design, Performance, Security Keywords Full-duplex, Implanted Medical DevicesThey Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices Shyamnath}@cs.umass.edu ABSTRACT Wireless communication has become an intrinsic part of modern implantable medical devices (IMDs

360

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

361

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

Federal Register 2010, 2011, 2012, 2013, 2014

...for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate...for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate...medical devices for the treatment of morbid obesity and other metabolic diseases and...

2013-11-20

362

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

363

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

Code of Federal Regulations, 2012 CFR

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

2012-07-01

364

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

Code of Federal Regulations, 2011 CFR

...2011-04-01 2011-04-01 false Medical devices; name and place of business...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of...

2011-04-01

365

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

Code of Federal Regulations, 2011 CFR

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

2011-07-01

366

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

Code of Federal Regulations, 2010 CFR

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

2010-04-01

367

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

Code of Federal Regulations, 2014 CFR

...2014-04-01 2014-04-01 false Medical devices; name and place of business...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of...

2014-04-01

368

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

Code of Federal Regulations, 2012 CFR

...2012-04-01 2012-04-01 false Medical devices; name and place of business...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of...

2012-04-01

369

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

Code of Federal Regulations, 2014 CFR

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

2014-07-01

370

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

Code of Federal Regulations, 2013 CFR

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

2013-07-01

371

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

Code of Federal Regulations, 2011 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...

2011-04-01

372

78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...  

Federal Register 2010, 2011, 2012, 2013, 2014

...Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance...the draft guidance entitled ``Medical Device Development Tools.'' This document...CDRH) for qualification of medical device development tools (MDDT)...

2013-11-14

373

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

Code of Federal Regulations, 2014 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...

2014-04-01

374

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

Code of Federal Regulations, 2012 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...

2012-04-01

375

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 2013-04-01 false Medical devices; name and place of business...HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of...

2013-04-01

376

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

Code of Federal Regulations, 2012 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...

2012-04-01

377

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

Code of Federal Regulations, 2013 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...

2013-04-01

378

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

Code of Federal Regulations, 2011 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...

2011-04-01

379

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

2013-04-01

380

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

Code of Federal Regulations, 2010 CFR

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

2010-07-01

381

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

382

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2011-05-02

383

Capturing user requirements in medical device development: the role of ergonomics  

Microsoft Academic Search

Measuring and fulfilling user requirements during medical device development will result in successful products that improve patient safety, improve device effectiveness and reduce product recalls and modifications. Medical device users are an extremely heterogeneous group and for any one device the users may include patients and their carers as well as various healthcare professionals. There are a number of factors

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

2006-01-01

384

TOPICAL REVIEW: Capturing user requirements in medical device development: the role of ergonomics  

Microsoft Academic Search

Measuring and fulfilling user requirements during medical device development will result in successful products that improve patient safety, improve device effectiveness and reduce product recalls and modifications. Medical device users are an extremely heterogeneous group and for any one device the users may include patients and their carers as well as various healthcare professionals. There are a number of factors

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

2006-01-01

385

77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service  

Federal Register 2010, 2011, 2012, 2013, 2014

...allow medical devices to operate on a primary basis, on a secondary...spectrum with primary services successfully...shown that MMN devices can perform as...higher-powered primary uses may legitimately...intends that MMN devices will operate...

2012-01-27

386

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-08-06

387

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-04-05

388

New regulations on medical devices in Europe: what to expect?  

PubMed

Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes. PMID:24811927

Fouretier, Alice; Bertram, Delphine

2014-07-01

389

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

390

Challenges to validation of a complex nonsterile medical device tray.  

PubMed

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

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

2014-01-01

391

Dosimetric studies for gamma radiation validation of medical devices.  

PubMed

The delivery and validation of a specified dose to medical devices are key concerns to operators of gamma radiation facilities. The objective of the present study was to characterize the industrial gamma radiation facility and map the dose distribution inside the product-loading pattern during the validation and routine control of the sterilization process using radiochromic films. Cardboard phantoms were designed to achieve the homogeneity of absorbed doses. The uncertainty of the dose delivered during validation of the sterilization process was assessed. PMID:23079487

Soliman, Y S; Beshir, W B; Abdel-Fattah, A A; Abdel-Rehim, F

2013-01-01

392

Development of medical electronic devices in the APL space department  

NASA Technical Reports Server (NTRS)

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

Newman, A. L.

1985-01-01

393

Transdermal delivery of therapeutic agent  

NASA Technical Reports Server (NTRS)

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

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

2008-01-01

394

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

NASA Astrophysics Data System (ADS)

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

Saviola, James

2005-03-01

395

Practical pathology perspectives for minimally invasive hyperthermic medical devices  

NASA Astrophysics Data System (ADS)

Currently, hyperthermic-based minimally invasive medical devices are available for the treatment of dysfunctional and neoplastic tissues in a variety of organ systems. These therapies employ a spectrum of modalities for delivering heat energy to the targeted tissue, including radiofrequency/microwave, high intensity focused ultrasound, conductive/convective sources and others. While differences in energy transfer and organ systems exist, hyperthermic treatment sites show a spectrum of changes that intimately correlate with the thermal history generated in the tissue (temperature-time dependence). As a result, these hyperthermic medical technologies can be viewed using a "gradient" approach. First, the thermal applications themselves can be globally categorized along a high-dose ablation to low-dose ablation to lowdose non-ablative rejuvenating slope. Second, the resultant tissue changes can be viewed along a decreasing thermal dose gradient from thermally/heat-fixed tissue necrosis to coagulative tissue necrosis to partial tissue necrosis (transition zone) to subtle non-necrotizing tissue changes. Finally, a gradient of cellular and structural protein denaturation is present, especially within the transition zone and adjacent viable tissue region. A hyperthermic treatment's location along these gradients depends more on the overall thermal history it generates than the amount of energy it deposits into the tissue. The features of these gradients are highlighted to provide a better understanding of hyperthermic device associated tissue changes and their associated healing responses.

Coad, James E.

2011-03-01

396

Audible frequency vibration of puncture-access medical devices.  

PubMed

Ultrasonic vibration has been proven to help scalpels and puncture devices cut and cauterize, but creates a damaged tissue zone that may not be desirable. We have found that audible frequency vibration applied to a needle not only reduces puncture force more than ultrasonic vibration; it does not cause significant immediate tissue damage. Here we thus present a method for decreasing the force required to insert a puncture-access medical device and an analytical model for predicting performance of a hypodermic needle, which correlates well with tests and shows that needle insertion force is lowered not only by decreasing the outer diameter of the needle, but also by driving the device at its free state resonant (amplitude-maximizing) frequency. Finally, an in vivo histology study is conducted and suggests that audible frequency vibration results in the same degree of immediate local tissue damage as simple manually inserted needles, but that it causes significantly less immediate local tissue damage than ultrasonic vibration. PMID:24387905

Begg, Nikolai D M; Slocum, Alexander H

2014-03-01

397

Man-Machine Interaction in Medical Devices - Incorporating human factors to design safe, efficient and reliable medical products  

Microsoft Academic Search

This article describes relevant principles from human factors for use in the design of medical equipment. The main focus in the article has been to stress the importance of evaluating all elements involved in the interaction between users and medical devices in the design of such products. This can help the designer to develop medical equipment that is safe, efficient

Sidsel Sundvor

398

A Semantically-Adaptive Strategy for Energy-Efficiency in Wireless Medical Monitoring Devices  

E-print Network

A Semantically-Adaptive Strategy for Energy- Efficiency in Wireless Medical Monitoring Devices for energy-efficient operation of wireless monitoring devices under the premise that medical experts footsteps. Observations are atypical if application-specific medical metrics and biosignal features

Potkonjak, Miodrag

399

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels  

E-print Network

A Method for Analysis of Expert Committee Decision-Making Applied to FDA Medical Device Panels-Making Applied to FDA Medical Device Panels by David André Broniatowski Submitted to the Engineering Systems by which information is communicated in order to reach a decision. In particular, we focus on medical

de Weck, Olivier L.

400

Rules Modification on a Fuzzy-Based Modular Architecture for Medical Device Design and Development  

Microsoft Academic Search

Medical devices have a very high failure rate in their first prototype tests. According to the international testing body Intertek, out of every ten medical devices, nine fail in their first prototype tests—a 90% failure rate. In addition to the cost implication, quality is a key issue. To address this, we present an integrated, collaborative modular architecture method for medical

Celestine C. Aguwa; Leslie Monplaisir; Prasanth Achuthamenon Sylajakumari

2012-01-01

401

edical devices are essential for performing mod-ern-day clinical functions. Traditionally, medical  

E-print Network

,e.g.,aninsulininfusionpump.Asdevices begin to interoperate with other devices, the potential for harvest- ing medical information of the patient's health, much more so than any individual device can provide. Moreover, such information can aggregation. Some in the health-care industry are now considering the notion of medical device interoperation

Hu, Fei

402

oving a new drug or medical device from the laboratory to  

E-print Network

oving a new drug or medical device from the laboratory to the marketplace takes from five to 15 Director, Robin Ratkowski, MSJ, also teach courses. Taking new drugs and medical devices from of the new drug or device. On the way, reams of data are collected, analyzed and interpreted; study design

Garfunkel, Eric

403

Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots  

Microsoft Academic Search

Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as in the research and design phase of the device. Failing to take into account regulatory requirements

G. R. B. Romer; Harry J. A. Stuyt

2007-01-01

404

Hollow microneedle-based sensor for multiplexed transdermal electrochemical sensing.  

PubMed

The development of a minimally invasive multiplexed monitoring system for rapid analysis of biologically-relevant molecules could offer individuals suffering from chronic medical conditions facile assessment of their immediate physiological state. Furthermore, it could serve as a research tool for analysis of complex, multifactorial medical conditions. In order for such a multianalyte sensor to be realized, it must be minimally invasive, sampling of interstitial fluid must occur without pain or harm to the user, and analysis must be rapid as well as selective. Initially developed for pain-free drug delivery, microneedles have been used to deliver vaccines and pharmacologic agents (e.g., insulin) through the skin. Since these devices access the interstitial space, microneedles that are integrated with microelectrodes can be used as transdermal electrochemical sensors. Selective detection of glucose, glutamate, lactate, hydrogen peroxide, and ascorbic acid has been demonstrated using integrated microneedle-electrode devices with carbon fibers, modified carbon pastes, and platinum-coated polymer microneedles serving as transducing elements. This microneedle sensor technology has enabled a novel and sophisticated analytical approach for in situ and simultaneous detection of multiple analytes. Multiplexing offers the possibility of monitoring complex microenvironments, which are otherwise difficult to characterize in a rapid and minimally invasive manner. For example, this technology could be utilized for simultaneous monitoring of extracellular levels of, glucose, lactate and pH, which are important metabolic indicators of disease states (e.g., cancer proliferation) and exercise-induced acidosis. PMID:22688693

Miller, Philip R; Skoog, Shelby A; Edwards, Thayne L; Wheeler, David R; Xiao, Xiaoyin; Brozik, Susan M; Polsky, Ronen; Narayan, Roger J

2012-01-01

405

An electronic post market surveillance system for medical devices.  

PubMed

An important issue in the health care sector is the collection of information about adverse incidents relative to medical devices and the exchange of this information among Health Care Institutions, Manufacturers and Competent Authorities. We present an Electronic Post Market Surveillance System, which solves in an efficient and secure way the above problem and it is compliant to the International Standards. The system consists of the PMS Server Application installed in the manufacturers/suppliers premises and the PMS Client Application installed in the Health Care Institutions. The PMS applications are used for the management of the PMS Reports and Responses with important features such as the user-friendly interfaces, interoperability and different implementations depending on the performance and cost requirements. The messages are in XML format and the security is based on public-private key cryptography. The system was evaluated in a systematic way by a variety of users, who were satisfied by the system functionality and efficiency. PMID:12758134

Vlachos, I; Kalivas, D; Panou-Diamandi, O

2003-06-01

406

Large Eddy Simulation of FDA’s Idealized Medical Device  

PubMed Central

A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration’s (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo™), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered. PMID:24187599

Delorme, Yann T.; Anupindi, Kameswararao; Frankel, Steven H.

2013-01-01

407

Large Eddy Simulation of FDA's Idealized Medical Device.  

PubMed

A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered. PMID:24187599

Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

2013-12-01

408

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...Specific requirements for wireless medical telemetry devices operating in the...

2012-10-01

409

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

Code of Federal Regulations, 2013 CFR

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

2013-10-01

410

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...Specific requirements for wireless medical telemetry devices operating in the...

2010-10-01

411

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

Code of Federal Regulations, 2011 CFR

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

2011-10-01

412

Safety-Ensured Coordination of Networked Medical Devices in MDPnP  

E-print Network

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

Hu, Fei

413

Development of Website for the Operating Procedure of Software Contained in Medical Devices  

Microsoft Academic Search

Fault or failure of software contained in medical devices will seriously endanger users and should be considered to reduce\\u000a risk. In software development process, the risk analysis and risk control are very important for software contained in medical\\u000a devices. In order to promote the quality of software contained in medical devices, a website is designed to provide the operating\\u000a procedure

Yeou-Jiunn Chen; A. T. Liu; P. J. Chen; Y. T. Chen; U. Z. Hsieh; K. S. Cheng

414

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

415

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

416

Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.  

PubMed

The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology. PMID:22702260

Mattei, Eugenio; Censi, Federica; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

2012-05-01

417

Older Adults’ Satisfaction with a Medication Dispensing Device in Home Care  

PubMed Central

Introduction Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults’ perceptions of a telehealth medication dispensing device as part of a clinical trial involving home health care clients, nurse coordination and use of the medication dispensing device. Methods Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Results Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. Conclusion The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research. Trial Registration clinicaltrials.gov identifier: NCT01321853 PMID:23323721

Demiris, George; Marek, Karen D.

2014-01-01

418

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

ERIC Educational Resources Information Center

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

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

2008-01-01

419

An Effective Design Process for the Successful Development of Medical Devices  

Microsoft Academic Search

\\u000a The most important point in the successful development of a medical device is the proper overall design. The quality, safety,\\u000a and effectiveness of a device are established during the design phase. The design process is the foundation of the medical\\u000a device and will be the basis for the device from its inception till the end of its lifetime. There are

Mike Colvin

2010-01-01

420

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

421

Stanford University Significant Risk and Nonsignificant Risk GUI-7m Research Compliance Office Medical Device Studies  

E-print Network

Medical Device Studies File:GUI01007 rev2 09/10 1 of 2 (FDA Information Sheets October 1, 1995) The Investigational Device Exemption (IDE) regulations [21 CFR part 812] describe two types of device studies; "significant risk" (SR) and "nonsignificant risk" (NSR). Significant risk device [21 CFR 812.3(m)] means

Puglisi, Joseph

422

An interstitial fluid transdermal extraction, collection and measurement system  

Microsoft Academic Search

We present a new microfluidic system for transdermal interstitial fluid (ISF) extraction, collection, and volumetric measurement towards the application of noninvasive, continuous, and real-time glucose monitoring. This device consists of a Venturi Tube for vacuum generation, chambers for the introduction of ISF and normal saline solution, pneumatic valves for fluid control, and flow sensors for ISF and normal saline solution

Haixia Yu; Dachao Li; Kexin Xu; Robert C. Roberts; Norman C. Tien

2011-01-01

423

An integrated microfluidic system for interstitial fluid transdermal extraction  

Microsoft Academic Search

We present a new microfluidic system for transdermal interstitial fluid (ISF) extraction, collection, and volumetric measurement towards the application of continuous glucose monitoring. This device consists of a venturi tube, a volume sensor, pneumatic valves, and microchannels. Under the management of pneumatic valves, demonstration of the defined volume normal saline injection, ISF extraction, collection and volumetric measurement functions of the

H. X. Yu; D. C. Li; R. C. Roberts; W. S. Liang; K. X. Xu; N. C. Tien

2011-01-01

424

Methodological choices for the clinical development of medical devices  

PubMed Central

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

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

2014-01-01

425

Devices for medical diagnosis with GaN lasers  

NASA Astrophysics Data System (ADS)

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

Kwasny, Miroslaw; Mierczyk, Zygmunt

2003-10-01

426

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

PubMed Central

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

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

2014-01-01

427

Thermal Energy Harvesting with Thermoelectrics for Self-powered Sensors: With Applications to Implantable Medical Devices, Body Sensor Networks and Aging in Place  

E-print Network

medical devices, thermoelectric and heat transfer designMedical Devices Bioheat Transfer Modeling Wearable Applications Thermoelectric Device Design &device design is proposed as an effective and scalable method for implantable medical

Chen, Alic

2011-01-01

428

PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION A SOCIOLEGAL STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL  

E-print Network

#12;PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION A SOCIOLEGAL STUDY OF MEDICAL DEVICE STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL REGULATION IN EUROPE DISSERTATION to obtain the degree;7 Summary One of the primary functions of law is to ensure that the legal structure governing all social

Vellekoop, Michel

429

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. PMID:19662153

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

2009-01-01

430

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

431

UK registered nurse medical device education: a comparison of hospital and bank nurses  

Microsoft Academic Search

During the last decade, health care delivery has seen the introduction of ever more sophisticated and complex equipment. This means that the medical devices first used in critical and high dependency care units are now integral requirements in the delive ry of direct patient care in acute ward areas. Registered nurses are the primary users of such medical devices (McConnell

Mary R. Douglas; Jacqueline A. Leigh; Calbert H. Douglas

2001-01-01

432

Contrasting the medical-device and aerospace-industries approach to reliability  

Microsoft Academic Search

A comparison is made between the defense driven aerospace industry and the medical device industry with respect to their approach to achieving reliability. The Department of Defense establishment has driven the aerospace industry to consider and analyze reliability through imposing a complex set of standards and specifications that control all aspects of design and analysis. The medical device industry, driven

Daniel D. Bell

1995-01-01

433

Assessment of Web-based information needs for medical device design  

Microsoft Academic Search

Medical device development involves interdisciplinary knowledge of engineering and the life sciences. In order to maintain a competitive advantage in the medical device industry, design engineers require extensive and detailed knowledge of engineering and biomedical technology. This underscores the need for continual self-education with the most current technical information. Inadequate access to biomedical information during the design process may have

Christopher T. Shen; Mark C. Tsai; Paul Yock; Kenneth L. Melmon

1999-01-01

434

A concept for a medical device plug-and-play architecture based on web services  

Microsoft Academic Search

Medical device interoperability is still an issue. Standards exist only for specific areas like HL7 and DICOM, or have not been widely adopted like ISO\\/IEEE 11073 except for the domain information model at the semantic level. An approach that covers interoperability below the semantics is proposed. It is based on Web services which are widely accepted outside the medical device

Stephan Pöhlsen; Stefan Schlichting; Markus Strähle; Frank Franz; Christian Werner

2009-01-01

435

Successful Collaborative Software Projects for Medical Devices in an FDA Regulated Environment: Myth or Reality?  

Microsoft Academic Search

The significance of executing a successful collaborative distributed software project in a regulated medical device industry is often recognized but such projects are never perfectly achieved. There expectations of standard software being delivered 'bug-free, on time and on budget'. In addition, FDA regulations impose a high standard on such medical device software by mandating the adherence to strict processes on

Subita Sudershana; Abel Villca-Roque; Jonathan Baldanza

2007-01-01

436

The square peg and the round hole: Murphy's Law and medical device connections  

Microsoft Academic Search

Engineers have long been aware of Murphy's Law: If anything can go wrong, it will. When applied to medical device design, Murphy's Law indicates that if there is a way that a medical device can be set up incorrectly then someday, somewhere it will be set up incorrectly. In the clinical environment the result may be patient injury or death.

M. F. Baretich

2004-01-01

437

Production planning for medical devices with an uncertain regulatory approval date  

Microsoft Academic Search

The demand for medical devices such as pacemakers, defibrillators, catheters and heart valves is growing rapidly throughout the world. This demand is driven by both the “technology push” of new medical device technologies and the “demand pull” of an aging population in North America, Western Europe, and Japan. Production planning for these products is increasing in importance as demand increases,

ARTHUR V. HILL; WILLIAM J. SAWAYA III

2004-01-01

438

Thermal effects of radiofrequency fields in magnetic resonance imaging on implanted medical devices  

Microsoft Academic Search

Magnetic resonance imaging (MRI) is a well established diagnostic technique, one which all patients should be able to benefit from, including those with implanted medical devices. This study focuses on determining the heating effects of the radiofrequency (RF) fields generated in MRI on a typical geometry that is representative of leads associated with implanted medical devices, such as cardiac pacemakers,

Christopher Don Smith

2000-01-01

439

Monitoring and improving the effectiveness of cleaning medical and surgical devices.  

PubMed

The overall risk of infection from medical devices is very low, but high infection transmission rates have been related to inadequate reprocessing of arthroscopic shavers and flexible duodenoscopes. Monitoring of manual and automated cleaning is needed to ensure that inadequately cleaned medical devices are recleaned prior to disinfection or sterilization. PMID:23622750

Alfa, Michelle J

2013-05-01

440

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

Technology Transfer Automated Retrieval System (TEKTRAN)

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

441

Optimize Use of Space Research and Technology for Medical Devices  

NASA Technical Reports Server (NTRS)

systems, and cutting-edge component technologies to conduct a wide range of scientific observations and measurements. These technologies are also considered for practical applications that benefit society in remarkable ways. At NASA Goddard, the technology transfer initiative promotes matching technologies from Earth and space science needs to targeted industry sectors. This requires clear knowledge of industry needs and priorities and social demands. The process entails matching mature technologies where there are known innovation challenges and good opportunities for matching technology needs. This requires creative thinking and takes commitment of time and resources. Additionally, we also look at applications for known hot industry or societal needs. Doing so has given us occasion to host discussions with representatives from industry, academia, government organizations, and societal special interest groups about the application of NASA Goddard technologies for devices used in medical monitoring and detection tools. As a result, partnerships have been established. Innovation transpired when new products were enabled because of NASA Goddard research and technology programs.

Minnifield, Nona K.

2012-01-01

442

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

PubMed

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. PMID:25255810

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

2014-11-01

443

Abstract--Medical device software is sometimes initially developed by using a PC simulation environment that executes  

E-print Network

Abstract--Medical device software is sometimes initially developed by using a PC simulation the actual medical device to a physical mockup of the physiological system. An alternative is to connect the medical device to a digital mockup of the physiological system, such that the device believes

Vahid, Frank

444

Technology Advances and Challenges in Hermetic Packaging for Implantable Medical Devices  

Microsoft Academic Search

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

Guangqiang Jiang; David D. Zhou

2010-01-01

445

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

Microsoft Academic Search

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

William H. Muto; Edmond W. Israelski

2007-01-01

446

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

447

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

448

Silicone surface with drug nanodepots for medical devices.  

PubMed

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

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

2014-11-26

449

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

E-print Network

data into electronic health records, integrate information from multiple devices into single health records (EHRs), integration of information from multiple devices in a clinical context (, hospital that has been proposed by the Medical Device Plug and Play Interoperability Project The implementa- tion

Huth, Michael

450

Department of Mechanical Engineering Spring 2013 3D Printed Medical Device  

E-print Network

PENNSTATE Department of Mechanical Engineering Spring 2013 3D Printed Medical Device Overview the movement of the device. This lack of control is due to the fact that the surgeon has to maneuver the scope from outside of the body and can only remotely control the leading 3"-4" of the device. Objectives

Demirel, Melik C.

451

In vitro and computational studies of transdermal perfusion of nanoformulations containing a large molecular weight protein.  

PubMed

Transdermal perfusion of a large protein is reported for the first time, using a nanoemulsion of bovine serum albumin (66kDa) of 160nm prepared by a solid-in-oil (S/O) process. Molecular dynamics simulations confirmed skin permeation by these formulations, with integration of the protein into the lipid bilayers. These results demonstrate the real possibility of delivering large proteins transdermally for a range of medical and cosmetic applications. PMID:23563294

Martins, Madalena; Azoia, Nuno G; Ribeiro, Artur; Shimanovich, Ulyana; Silva, Carla; Cavaco-Paulo, Artur

2013-08-01

452

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

PubMed

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

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

2013-12-01

453

Electronic security systems and active implantable medical devices.  

PubMed

How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs must be 1.7 stronger than that of the most sensitive unipolar pacemaker. The lowest interference thresholds measured over the last 10 years in the low frequency range (16 2/3 Hz-24 kHz) together with thresholds > 24 kHz that were supplied by the CETECOM study are listed. Both sets of data together with the coupling model, allow for judging which fields of ESSs could influence AIMDs. From measurements at gate antennas, it is possible to derive a "maximum allowed field" curve over the whole frequency range, below which no interference will occur. Comparison of data from literature with these maximum allowed fields confirm the correctness of the calculations. Thus, it is possible to predict interference situations in gates if the magnetic field is known. If all future pacemakers were to have the immunity against interference of the better 50% of today's pacemakers, the magnetic field ceiling values could be at least four times higher. The same is true if the ventricular sensitivity is routinely set at 7 mV. Pacemaker manufacturers should consider filter improvement with modern technology, but gate manufacturers should not claim the privilege of being out of bounds. PMID:12358176

Irnich, Werner

2002-08-01

454

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

PubMed Central

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

Skaer, Tracy L

2014-01-01

455

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

Code of Federal Regulations, 2013 CFR

...byproduct material for medical use. 32.74 ...distribution of sources or devices containing byproduct material for medical use. (a) An...distribute sources and devices containing byproduct... (ii) Details of design and construction...

2013-01-01

456

75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...  

Federal Register 2010, 2011, 2012, 2013, 2014

...s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, Etc.; Withdrawal of Guidance...s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG Sec....

2010-12-07

457

Use-related risk analysis for medical devices based on improved FMEA.  

PubMed

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described. PMID:22317712

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

458

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

Code of Federal Regulations, 2014 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; (Eff. Until 8-14-15)...

2014-04-01

459

Take Two Software Updates and See Me in the Morning: The Case for Software Security Evaluations of Medical Devices  

E-print Network

of Medical Devices Steven Hanna, Rolf Rolles, Andr´es Molina-Markham, Pongsin Poosankam§, Kevin Fu, Dawn Song is understood about the security vulnerabilities facing medical devices and their software. To investigate software security analysis of a medical device. We identify several software security vulnerabilities

Song, Dawn

460

Taxonomy of current medical devices for POCT applications and the potential acceptance of Bluetooth technology for secure interoperable applications  

Microsoft Academic Search

This paper presents a taxonomy for medical devices that includes the review of over 260 companies. The taxonomy classifies medical device products with respect to their output interface. Each medical device in the study is portable, designed for the point of care environment, non-implantable, and includes at least one output interface. The main motivation for this study is the possible

Dalimar Velez; Michael Shanblatt

2011-01-01

461

AC 2012-3822: GENERATING INTEREST IN TECHNOLOGY AND MED-ICAL DEVICES THROUGH AN INTERACTIVE EDUCATIONAL GAME  

E-print Network

their product design and research projects in the area of medical device engi- neering. His research interests EDUCATIONAL GAME Mr. Devin R. Berg, Medical Devices Center, University of Minnesota - Twin Cities Devin R. Through his work at the Medical Devices Center, he has been involved with a number of engineering outreach

Wu, Mingshen

462

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

PubMed Central

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

Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

2014-01-01

463

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

Federal Register 2010, 2011, 2012, 2013, 2014

...RV lead used with a CRT-D device also has the capability to...discretion of the clinician for both devices. The requested expansion in...parallel-controlled investigational device exemption (IDE) study. The primary objective of the trial...

2013-09-09

464

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2012-11-07

465

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

Federal Register 2010, 2011, 2012, 2013, 2014

...classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices...Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under...

2013-02-27

466

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

Federal Register 2010, 2011, 2012, 2013, 2014

...classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre-Amendment devices...Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under...

2013-04-02

467

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

Federal Register 2010, 2011, 2012, 2013, 2014

...Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug...apparatus device intended for negative pressure wound therapy (NPWT) into class II...Apparatus Device Intended for Negative Pressure Wound Therapy.'' The agency is...

2010-11-17

468

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

PubMed

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

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

2015-02-01

469

Using off-the-Shelf Medical Devices for Biomedical Signal Monitoring in a Telemedicine System for Emergency Medical Services.  

PubMed

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

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

2015-01-01

470

Transdermal Opioids for Cancer Pain Management  

Microsoft Academic Search

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

Rohan Hasmukh Vithlani; Ganesan Baranidharan

2010-01-01

471

Hollow Microneedle-based Sensor for Multiplexed Transdermal Electrochemical Sensing  

PubMed Central

The development of a minimally invasive multiplexed monitoring system for rapid analysis of biologically-relevant molecules could offer individuals suffering from chronic medical conditions facile assessment of their immediate physiological state. Furthermore, it could serve as a research tool for analysis of complex, multifactorial medical conditions. In order for such a multianalyte sensor to be realized, it must be minimally invasive, sampling of interstitial fluid must occur without pain or harm to the user, and analysis must be rapid as well as selective. Initially developed for pain-free drug delivery, microneedles have been used to deliver vaccines and pharmacologic agents (e.g., insulin) through the skin.1-2 Since these devices access the interstitial space, microneedles that are integrated with microelectrodes can be used as transdermal electrochemical sensors. Selective detection of glucose, glutamate, lactate, hydrogen peroxide, and ascorbic acid has been demonstrated using integrated microneedle-electrode devices with carbon fibers, modified carbon pastes, and platinum-coated polymer microneedles serving as transducing elements.3-7,8 This microneedle sensor technology has enabled a novel and sophisticated analytical approach for in situ and simultaneous detection of multiple analytes. Multiplexing offers the possibility of monitoring complex microenvironments, which are otherwise difficult to characterize in a rapid and minimally invasive manner. For example, this technology could be utilized for simultaneous monitoring of extracellular levels of, glucose, lactate and pH,9 which are important metabolic indicators of disease states7,10-14 (e.g., cancer proliferation) and exercise-induced acidosis.15 PMID:22688693

Miller, Philip R.; Skoog, Shelby A.; Edwards, Thayne L.; Wheeler, David R.; Xiao, Xiaoyin; Brozik, Susan M.; Polsky, Ronen; Narayan, Roger J.

2012-01-01

472

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

473

Development and Implementation of a Medical Device Course.  

ERIC Educational Resources Information Center

A course for fifth-year baccalaureate students provides a structured introduction to many of the devices with which pharmacists are involved (contraceptives, convalescent aids, surgical appliances, etc.), and includes assigned readings, lectures, and hands-on experience with industry representatives. Lists of the lecture material, devices, reading…

Mendel, Philip A.

1982-01-01

474

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

E-print Network

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

Mohd Fauzi, Mohammed Faizal B

2009-01-01

475

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

E-print Network

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

Li, Tieyu

2013-01-01

476

Model for a web based communication system between clinical engineers and medical device companies  

E-print Network

The Internet and its use is proliferating. Many medical device manufacturers have their own web sites where they provide useful, but not standardized information about their products and services. Similarly hospitals and clinics also have Web sites...

Misri, Sandeep

1999-01-01

477

They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices  

E-print Network

Wireless communication has become an intrinsic part of modern implantable medical devices (IMDs). Recent work, however, has demonstrated that wireless connectivity can be exploited to compromise the confidentiality of IMDs' ...

Gollakota, Shyamnath

478

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

Code of Federal Regulations, 2012 CFR

... 2012-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2012-07-01

479

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

Code of Federal Regulations, 2011 CFR

... 2011-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2011-07-01

480

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

Code of Federal Regulations, 2014 CFR

... 2014-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2014-07-01

481

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

Code of Federal Regulations, 2013 CFR

... 2013-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2013-07-01

482

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

Code of Federal Regulations, 2010 CFR

... 2010-07-01 false Calculation of patent term extension for a medical device. 1.777 Section...PATENT CASES Adjustment and Extension of Patent Term Extension of Patent Term Due to Regulatory Review § 1.777...

2010-07-01

483

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

Federal Register 2010, 2011, 2012, 2013, 2014

...approvals for medical devices; and methods to overcome the pitfalls and data gaps, including statistical approaches and modeling...scientific research data, and C. The methods to overcome the pitfalls and data gaps, including statistical approaches and...

2011-11-01

484

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

Federal Register 2010, 2011, 2012, 2013, 2014

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

2010-02-09

485

Inventory management strategy for the supply chain of a medical device company  

E-print Network

In the medical device industry, many companies rely on a high inventory strategy in order to meet their customers' urgent requirements, sometimes leading to excessive inventory. This problem is compounded when it involves ...

Tjhin, Poi Chung

2012-01-01

486

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

E-print Network

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

Buckley, Patrick Regan, 1981-

2004-01-01

487

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

Federal Register 2010, 2011, 2012, 2013, 2014

...The Food and Drug Administration's (FDA) Office of Orphan Products Development is announcing the following workshop...Pediatric Medical Devices Workshop is supported by FDA's Office of Orphan Product Development and will include participants from the...

2012-07-26

488

Granisetron Transdermal Patch  

MedlinePLUS

... time to remove it, you may apply medical adhesive tape or surgical bandages around the edges of ... other medications, any other skin patches, or medical adhesive tape or dressings.you should know that granisetron ...

489

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

NASA Astrophysics Data System (ADS)

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 these issues; such as electrolysis of water, safety concerns, material characterization and in vitro testing. Work on IPMC development has raised the threshold of the electrolysis of water during actuation from 2.35 V to 2.46 V in Tyrode's solution. The problem of back relaxation under DC excitation has been reduced. To ensure accurate measurements of IPMC performance, for medical applications, it is imperative that the appropriate in vitro testing conditions are chosen, such details are discussed. Material characterization techniques developed and used by Pavad Medical, which are based on medical device needs, are also highlighted.

Yung, Charisse; Kim, Doyeon; Bhat, Nikhil

2007-04-01

490

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

NASA Astrophysics Data System (ADS)

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

Taheri Andani, Masood; Elahinia, Mohammad

2014-07-01

491

Network of wireless medical devices to assess activity using non-traditional sensors  

Microsoft Academic Search

In this paper, we present the design of two smart sensors that were developed for deployment within a body worn wireless network of medical devices. Ambulatory and remote monitoring of biomedical signals have gained importance in the last decade as medical institutions try to reduce costs by discharging patients earlier while still requiring various levels of monitoring. Most of the

Alain Beaulieu; Henk Venter; Doug Priestley; Dion Marson; Collin Stockwell

2012-01-01

492

[The establishment of three methods to improve the management of implantable medical device].  

PubMed

Based on the managerial deficiencies of Implantable medical device, using the RFID technology, the automatically comparison of data, Intelligent logistics, this article has established three conceptional methods of the original system of increment and iterative development. And details are included in aspect of principle, framework and etc. Meanwhile, advices have been given in the scientific and effective management of the medical instrument. PMID:21553544

Zhong, Jianping; Ge, Yi

2011-01-01

493

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2012 CFR

...include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in...

2012-04-01

494

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2011 CFR

...include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in...

2011-04-01

495

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2014 CFR

...include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in...

2014-04-01

496

21 CFR 880.6310 - Medical device data system.  

Code of Federal Regulations, 2013 CFR

...include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in...

2013-04-01

497

Current challenges for clinical trials of cardiovascular medical devices.  

PubMed

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. PMID:24861254

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

498

Microneedle-mediated transdermal bacteriophage delivery  

PubMed Central

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

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

2012-01-01

499

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

2012-09-29

500

Electromagnetic compatibility issues between vehicular mounted antennas and implantable medical devices  

Microsoft Academic Search

Numerical investigations are performed to investigate the interactions between vehicular mounted antennas and an implantable medical device in the vicinity of the vehicular. From the studies, it is shown that higher electromagnetic energy deposition was found in the vicinity of the devices. In addition, it is observed that for higher frequency, emission from vehicular antenna will have stronger interference on

Minshen Wang; Jianxiang Shen; Ji Chen; Wolfgang Kainz; Gonzalo Mendoza; Giorgi Bit-Babik

2010-01-01