Sample records for transdermal medical devices

  1. Development of Thin-Film Battery Powered Transdermal Medical Devices

    SciTech Connect

    Bates, J.B.; Sein, T.

    1999-07-06

    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.

  2. Medical Device Safety

    MedlinePLUS

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

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

    PubMed

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

    2014-05-01

    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

  4. Implantable Medical Devices

    MedlinePLUS

    Implantable Medical Devices Updated:Oct 23,2014 Implantable Medical Devices - 2 types 1. Rhythm control ICD -- Implantable cardioverter-defibrillator ( ... medical treatment. 2. Support of the Circulation Implantable Medical Devices Left Ventricular Assist Device (Also known as ...

  5. Recent Medical Device Recalls

    MedlinePLUS

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

  6. Micro-scale devices for transdermal drug delivery.

    PubMed

    Arora, Anubhav; Prausnitz, Mark R; Mitragotri, Samir

    2008-12-01

    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

  7. Medical Device Safety

    MedlinePLUS

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

  8. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation. PMID:25458071

  9. Medical device development

    Microsoft Academic Search

    Dorin Panescu

    2009-01-01

    The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

  10. Immunotoxicity of Medical Devices

    Microsoft Academic Search

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

    1997-01-01

    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

  11. Microwave medical devices

    Microsoft Academic Search

    F. Sterzer

    2002-01-01

    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

  12. Medical Device Interoperability The lack of interoperability between medical devices

    E-print Network

    Medical Device Interoperability The lack of interoperability between medical devices can lead to preventable medical errors and potentially serious inefficiencies that could otherwise be avoided. Overview an accurate diagnostic and treatment discipline, medical devices are playing an ever-increasing role

  13. Medical Device Wafer Singulation

    Microsoft Academic Search

    A. Teng; F. Wilhelmsen

    2007-01-01

    Singulation can be the most damaging step in electronic manufacturing where individual dice are freed from a brittle silicon wafer. So much torque and force is applied to the silicon during this process that if precautionary steps are not taken, the freed die may exhibit low strength due to chipping damage. For medical devices, this is particularly a problem because

  14. Registration of Medical Devices

    PubMed Central

    George, Bobby

    2010-01-01

    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

  15. Biofilms on medical devices.

    PubMed

    Talsma, Silke S

    2007-10-01

    Biofilm consists of microorganisms with altered phenotypes living in a self-organized, cooperative community attached to surfaces and each other and embedded in a self-produced matrix of exopolymer saccharides. Biofilms are relevant for home care and hospice clinicians because they are related to the majority of infectious diseases. Colonization of medical devices plays a key role in the problem of healthcare-associated infections. This article aims to provide an overview of the science of biofilms. Understanding biofilms and the risks associated with them is the first step toward prevention of biofilm formation and the potentially serious outcomes of infections. PMID:18049256

  16. Advances in Medical Devices and Medical Electronics

    Microsoft Academic Search

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

    2012-01-01

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

  17. Barriers to medical device innovation.

    PubMed

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

    2014-01-01

    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

  18. Barriers to medical device innovation

    PubMed Central

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

    2014-01-01

    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

  19. Micro- and nanofabrication methods in nanotechnological medical and pharmaceutical devices

    PubMed Central

    Betancourt, Tania; Brannon-Peppas, Lisa

    2006-01-01

    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

  20. Human Factors and Medical Devices

    Microsoft Academic Search

    Dick Sawyer

    1998-01-01

    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

  1. Estradiol Transdermal Patch

    MedlinePLUS

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

  2. Human Factors and Medical Devices

    SciTech Connect

    Dick Sawyer

    1998-12-31

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

  3. MEDIC: Medical embedded device for individualized care

    Microsoft Academic Search

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

    2008-01-01

    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

  4. Transdermal Delivery by Iontophoresis

    PubMed Central

    Rawat, Swati; Vengurlekar, Sudha; Rakesh, B.; Jain, S.; Srikarti, G.

    2008-01-01

    Recently there has been an increased interest in using iontophoretic technique for the transdermal delivery of medications, both ionic and nonionic. This article is an overview of the history of iontophoresis and factors affecting iontophoretic drug transfer for the systemic effects and laws for development of Transdermal delivery system are discussed. PMID:20390073

  5. Candida Infections of Medical Devices

    PubMed Central

    Kojic, Erna M.; Darouiche, Rabih O.

    2004-01-01

    The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the infected device is generally needed to establish cure of Candida infections of medical devices. However, since the pathogenesis of Candida bloodstream infection is complicated, more studies are necessary to determine the role of catheter exchange in patients with both gastrointestinal tract mucositis and indwelling catheters. The medical and economic impact of these infections is enormous. PMID:15084500

  6. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ...1545-BJ44 Taxable Medical Devices; Correction...to final regulations...The final regulations provide guidance...of certain medical devices, enacted...Proposed Regulations'', line...of taxable medical device to the...

  7. Medical Device Reliability BIOMATERIALS

    E-print Network

    (hypothermic to febritic) - mechanical (breathing, bending) - chemical (corrosive fluids) - electrical (current, and neural stimulators, have unacceptably high failure rates. For current devices, we are establishing new-generation devices, we are developing test structures to evaluate alternative packaging materials, which have

  8. Medical Device Alarms – The Clinician

    Microsoft Academic Search

    M. Imhoff

    \\u000a The alarms of medical devices are a matter of concern in critical and perioperative care. The high rate of false alarms is\\u000a not only a nuisance for patients and caregivers, but can also compromise patient safety and effectiveness of care. The development\\u000a of alarm systems has lagged behind the technological advances of medical devices over the last 20 years. From

  9. Nitinol medical devices and implants

    Microsoft Academic Search

    D. Stoeckel

    2000-01-01

    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

  10. Reliable Design of Medical Devices

    Microsoft Academic Search

    S J Meldrum

    1998-01-01

    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

  11. Microneedles permit transdermal delivery of a skin-impermeant medication to humans

    PubMed Central

    Wermeling, Daniel P.; Banks, Stan L.; Hudson, David A.; Gill, Harvinder S.; Gupta, Jyoti; Prausnitz, Mark R.; Stinchcomb, Audra L.

    2008-01-01

    Drugs with poor oral bioavailability usually are administered by hypodermic injection, which causes pain, poor patient compliance, the need for trained personnel, and risk of infectious disease transmission. Transdermal (TD) delivery provides an excellent alternative, but the barrier of skin's outer stratum corneum (SC) prevents delivery of most drugs. Micrometer-scale microneedles (MNs) have been used to pierce animal and human cadaver skin and thereby enable TD delivery of small molecules, proteins, DNA, and vaccines for systemic action. Here, we present a clinical study of MN-enhanced delivery of a medication to humans. Naltrexone (NTX) is a potent mu-opioid receptor antagonist used to treat opiate and alcohol dependence. This hydrophilic and skin-impermeant molecule was delivered from a TD patch to healthy human subjects with and without pretreatment of the skin with MNs. Whereas delivery from a standard NTX TD patch over a 72-h period yielded undetectable drug plasma levels, pretreatment of skin with MNs achieved steady-state plasma concentrations within 2 h of patch application and were maintained for at least 48 h. The MNs and NTX patch were well tolerated with mild systemic and application site side effects. The MN arrays were painless upon administration and not damaged during skin insertion, and no MNs were broken off into the skin. This human proof-of-concept study demonstrates systemic administration of a hydrophilic medication by MN-enhanced TD delivery. These findings set the stage for future human studies of skin-impermeant medications and biopharmaceuticals for clinical applications. PMID:18250310

  12. Body Implanted Medical Device Communications

    NASA Astrophysics Data System (ADS)

    Yazdandoost, Kamya Yekeh; Kohno, Ryuji

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

  13. Medical device market in china.

    PubMed

    Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

    2015-06-01

    With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. PMID:25735659

  14. Recent medical devices for tonsillectomy

    PubMed Central

    Sayin, I; Cingi, C

    2012-01-01

    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

  15. Billing Medicare for Medical Devices

    E-print Network

    Nguyen, Danh

    Billing Medicare for Medical Devices Daniel Redline, BA, CCRP, CCRC, Director, Clinical Affairs for Medicare & Medicaid Services (CMS) policies and procedures · Describe the basics of research billing? · Centers for Medicare and Medicaid Services is a federal agency within the United States Department

  16. Medical Device Alarms - The Statistician

    Microsoft Academic Search

    R. Fried

    \\u000a The high rate of false alarms triggered by medical devices raises concerns over the reliability of current clinical alarm\\u000a systems. In close cooperation between physicians, statisticians and engineers within the Collaborative Research Centre SFB\\u000a 475, we have worked on improved alarm algorithms for online monitoring in intensive care. In current clinical practice there\\u000a are procedures based on simple fixed thresholds,

  17. DELIVERABLE 5 Report on Medical Device Product

    E-print Network

    Oakley, Jeremy

    DELIVERABLE 5 Report on Medical Device Product Development Processes: Some Illustrative Examples P2 within the medical device industry are generally more complex than those encountered within most this additional burden, the medical device sector must still bring products to market that meet commercial

  18. Medical Devices and Systems PRECISE Center

    E-print Network

    Rajkumar, Ragunathan "Raj"

    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

  19. Overview of Medical Devices:Overview of Medical Devices: The Important StuffThe Important Stuff

    E-print Network

    Carmichael, Owen

    Overview of Medical Devices:Overview of Medical Devices: The Important StuffThe Important Stuff Dan Affairs Volcano CorporationVolcano Corporation June 24, 2011June 24, 2011 #12;What is a Medical Device?What is a Medical Device? An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent

  20. Metrological Reliability of Medical Devices

    NASA Astrophysics Data System (ADS)

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

    2015-02-01

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

  1. Medical Device Industry Educatinon Cosortium

    NSDL National Science Digital Library

    Sullivan, Michael

    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.

  2. Lithium ion batteries for medical devices

    Microsoft Academic Search

    David M. Spillman; Esther S. Takeuchi

    1999-01-01

    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

  3. Standalone Software as an Active Medical Device

    Microsoft Academic Search

    Martin McHugh; Fergal McCaffery; Valentine Casey

    \\u000a With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active\\u000a medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the\\u000a current software development lifecycle framework followed by medical device software developers but important processes are\\u000a beyond the scope of IEC

  4. Design for reliability in medical devices

    Microsoft Academic Search

    V. Hegde; D. Raheja

    2010-01-01

    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,

  5. A novel network module for medical devices

    Microsoft Academic Search

    Ping-Yu Chen

    2008-01-01

    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,

  6. Engineering high confidence medical device software

    Microsoft Academic Search

    Arnab Ray; Raoul Jetley; Paul Jones

    2009-01-01

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

  7. Security and Privacy for Implantable Medical Devices

    Microsoft Academic Search

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

    2008-01-01

    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

  8. Overview of quality assurance for medical devices

    Microsoft Academic Search

    H. Troy Nagle

    1992-01-01

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

  9. 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.

  10. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  11. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section...HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL...Miscellaneous Devices § 880.6310 Medical device data system. (a)...

  12. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section...HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL...Miscellaneous Devices § 880.6310 Medical device data system. (a)...

  13. 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 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...

  14. 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 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...

  15. 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 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...

  16. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...CFR Part 890 (Physical Medicine Devices). The proposed...other medical and health care providers and institutions...ongoing, resource-intensive effort to collect industry-wide...devices used in veterinary medicine. However, the definition...of a medical or health care professional or the...

  17. Precision assembly systems for medical devices

    Microsoft Academic Search

    Christine Connolly

    2009-01-01

    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

  18. Computerized Medical Devices: Trends, Problems, and Safety

    Microsoft Academic Search

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

    1986-01-01

    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

  19. E3 TEST PROTOCOL MEDICAL DEVICES

    E-print Network

    Bennett, Gisele

    E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY AND LOGISTICAL SYSTEMS Ver 5.1 August 2007 Ralph M.1 August 2007 GTRI MDTC TEST PROTOCOL Page 2 E3 TEST PROTOCOL FOR MEDICAL DEVICES TO SECURITY emanating from current representative EAS Systems and Tag #12;Ver 5.1 August 2007 GTRI MDTC TEST PROTOCOL

  20. Residuals on medical devices following reprocessing

    Microsoft Academic Search

    H. Martiny; H. Floss

    2001-01-01

    Micro-organisms may be transmitted by medical devices. A large variety of infectious agents may be involved in infections transmitted by endoscopic procedures. We review a series of examples that demonstrate to what extent micro-organisms can be detected on medical devices and how transmission on to subsequently examined persons due to inadequate reprocessing can occur. Hardly any data are available regarding

  1. [Information safety test of digital medical device].

    PubMed

    Liu, Jiong

    2014-07-01

    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

  2. Efficacy of silver-coated medical devices

    Microsoft Academic Search

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

    1998-01-01

    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

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

    PubMed

    Ventura, M; Chambrin, P-Y

    2005-08-01

    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

  4. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J [ORNL] [ORNL

    2010-01-01

    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.

  5. GESTATION OF A MEDICAL DEVICE COMPANY

    E-print Network

    Barrett, Jeffrey A.

    GESTATION OF A MEDICAL DEVICE COMPANY from an intellectual property perspective February 22, 2012;Document It* Legible Description/Drawings Photographs or Prototypes Witnessed and Dated "Continuous;Seek Many Overlapping Forms of Claims The Device Subassemblies within the Device Combinations

  6. Anti-malware software and medical devices.

    PubMed

    2010-10-01

    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

  7. Mobile medical device connectivity: real world solutions.

    PubMed

    Pettus, Dan

    2004-01-01

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

  8. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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....

  9. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...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....

  10. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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...

  11. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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...

  12. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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....

  13. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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...

  14. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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....

  15. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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....

  16. Medical ice slurry production device

    Microsoft Academic Search

    Kenneth E. Kasza; John Oras; HyunJin Son

    2008-01-01

    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

  17. Medical devices for the anesthetist: current perspectives

    PubMed Central

    Ingrande, Jerry; Lemmens, Hendrikus JM

    2014-01-01

    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

  18. Buying Medical Devices and Diagnostic Tests Online

    MedlinePLUS

    ... can be misused by unscrupulous dealers. While the Internet offers many quality medical devices from legitimate sites, ... sale. Below are some examples of problems with Internet purchases. Contact lenses are being sold without a ...

  19. To compound or not to compound: a veterinary transdermal discussion.

    PubMed

    Eichstadt, Lauren R; Davidson, Gigi S

    2014-01-01

    Administering chronic medications to feline patients without the daily battle of oral and injectable medications is the holy grail of veterinary pharmacotherapy. For some medications, the transdermal route may be the solution. However, there are many considerations for determining if a medication will be safe for the patient and caregiver as well as effective when administered transdermally. A comprehensive checklist to assess the appropriateness of transdermal therapy is provided. PMID:25577884

  20. Inhibition of Bacterial Adhesion on Medical Devices

    Microsoft Academic Search

    Lígia R. Rodrigues

    \\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

  1. Regulation of Medical Devices involving Software in Australia - an Overview

    Microsoft Academic Search

    John Jamieson

    2001-01-01

    The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia - including medical devices. Many medical devices are not programmable, electronic, or even electrical. However more devices are becoming programmable, and existing medical device software is becoming more complex. Currently in Australia, certain types of medical devices are subjected to extensive pre-market documentary evaluation by the TGA.

  2. 75 FR 55803 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ...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...

  3. Handheld Diagnostic Device Delivers Quick Medical Readings

    NASA Technical Reports Server (NTRS)

    2014-01-01

    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.

  4. Agile Development in a Medical Device Company

    Microsoft Academic Search

    Pieter Adriaan Rottier; Victor Rodrigues

    2008-01-01

    This article discuss the experience of the software development group working in Cochleartrade with introducing Scrum as an agile methodology. We introduce the unique challenges we faced due to the nature of our product and the medical device industry.These are long validation cycles, strict regulatory standards and a high level of dependence on physical devices among others. We then show

  5. Medical device development: The challenge for ergonomics

    Microsoft Academic Search

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

    2008-01-01

    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

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

    E-print Network

    Oakley, Jeremy

    the effects of different imaging and diagnostic medical devices that patients may encounter in clinical pathways, and · the role of information provision when such devices are encountered and the effects

  7. A platform for implantable medical device validation

    Microsoft Academic Search

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

    2010-01-01

    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

  8. Immune Responses to Indwelling Medical Devices

    Microsoft Academic Search

    M. Nymer; E. Cope; R. Brady; M. E. Shirtliff; J. G. Leid

    Implanted medical devices have offered clinical hope to patients who either have critical illnesses or have more chronic problems\\u000a such as joint destruction. No doubt, these devices have saved many lives and improved the quality of life of hundreds of thousands\\u000a of people. Indeed, the use of indwelling devices has reached epic proportions in human medicine over the last three

  9. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ...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...

  10. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ...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...

  11. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

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

  12. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

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

  13. 78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-02

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

  14. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

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

  15. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ...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...

  16. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ...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...

  17. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ...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...

  18. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...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...

  19. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...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...

  20. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ...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...

  1. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ...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...

  2. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ...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...

  3. 78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ...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...

  4. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ...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...

  5. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...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...

  6. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ...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...

  7. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ...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...

  8. Economic Content in Medical Journal Advertisements for Medical Devices and Prescription Drugs

    Microsoft Academic Search

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

    2010-01-01

    Background: 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. Objective: To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Methods: Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through

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

    PubMed Central

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

    2010-01-01

    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

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

    PubMed

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

    2010-10-01

    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

  11. Medical Device Databases: A Scoping Study

    Microsoft Academic Search

    S. Price; R. Summers; D. J. Williams

    2005-01-01

    Databases of medical devices were identified via complex search strategies to discover breadth and depth of coverage. The databases could be categorised into three types: product, business and regulation. Evaluation of the databases uncovered several issues including: lack of continuity relating to the level of information provided; and little or no evidence that evaluation criteria has been applied to the

  12. Overview of Agreement Statistics for Medical Devices

    Microsoft Academic Search

    Lawrence Lin

    2007-01-01

    This paper is an overview that summarizes recently developed tools in assessing agreement for methods comparison and instrument\\/assay validation in medical devices. This paper emphasizes concept, sample sizes, and examples more than analytical formulas. We have considered a unified approach of evaluating agreement among multiple instruments (k), each with multiple replicates (m) for both continuous and categorical data. We start

  13. Technology needs of the medical device industry

    Microsoft Academic Search

    D. T. Achord

    1996-01-01

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

  14. Lessons from 342 Medical Device Failures

    Microsoft Academic Search

    Dolores R. Wallace; D. Richard Kuhn

    1999-01-01

    Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This paper presents an analysis of software- related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults, and

  15. Quality assurance in production of medical devices

    Microsoft Academic Search

    J. Kuba

    2003-01-01

    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

  16. Using Medical Devices to Teach Formal Modeling

    Microsoft Academic Search

    Orieta Celiku; David Garlan

    2007-01-01

    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

  17. Literature Review of Testing Techniques for Medical Device Software

    E-print Network

    Xie, Tao

    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

  18. Process-based derivation of requirements for medical devices

    Microsoft Academic Search

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

    2010-01-01

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

  19. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ...requirements of medical devices quality management systems and other specific regulatory...comments to the Division of Dockets Management (HFA-305), Food and Drug...final documents for the IMDRF Management Committee meeting in...

  20. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  1. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  2. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...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...

  3. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  4. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...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...

  5. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...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...

  6. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  7. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  8. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...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...

  9. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  10. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...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...

  11. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...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...

  12. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  13. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  14. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  15. MEDEMAS Medical Device Management and Maintenance System Architecture

    Microsoft Academic Search

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

    2010-01-01

    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

  16. An open test bed for medical device integration and coordination

    Microsoft Academic Search

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

    2009-01-01

    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

  17. 75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ...Rules and Regulations] [Page 41986...RIN 0910-AG29 Medical Devices; Pediatric Uses...Condition That a Device Is Intended to...amendments to existing regulations which would require...available pediatric medical device information...

  18. Reuse of single use medical devices.

    PubMed

    Tapp, Ann

    2003-03-01

    During the ten years that I have worked at the Canadian Nurses Protective Society, we have had numerous calls from Operating Room nurses questioning the practice of re-using single use medical devices in their facilities and voicing their concerns about possible harm to patients, themselves and potential liability exposure. Interest in this topic has been rekindled by the recent Saskatchewan case involving the death of a patient from variant Creutzfeld-Jakob Disease (vCJD) and possible transmission of vCJD to 71 patients who may have been exposed to the same endoscope as the deceased while in hospital. In this article, I propose to address some of the concerns related to the reuse of single use medical devices by focusing on the prevalence of this practice, the legal risks involved, regulation of this practice, and risk management. PMID:12703234

  19. Model-Based Development of Medical Devices

    Microsoft Academic Search

    Uwe Becker

    2009-01-01

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

  20. 63 FR 9571 - Medical Devices; Postmarket Surveillance; Guidance Documents; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    1998-02-25

    ...98D-0108] Medical Devices; Postmarket Surveillance; Guidance Documents; Availability...three guidance documents on postmarket surveillance of medical devices. These guidance...the implementation of the postmarket surveillance provisions of the Federal Food,...

  1. Strategic inventory management of externally sourced medical devices

    E-print Network

    Hillstrom, Nichole L. (Nichole Leigh)

    2013-01-01

    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 ...

  2. Characterization of Therapeutic Coatings on Medical Devices

    NASA Astrophysics Data System (ADS)

    Wormuth, Klaus

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

  3. A platform for implantable medical device validation: demo abstract

    Microsoft Academic Search

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

    2010-01-01

    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

  4. MATCH Guide towards User Involvement in Medical Device Technology

    E-print Network

    Oakley, Jeremy

    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

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

    E-print Network

    Bishop, Matt

    Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer to receive health care through the use of pervasive medical devices, sensors, and applications, even outside, and following policies set by the patient's doctors. Because many medical devices are highly specialized

  6. 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

  7. Improving acute care through use of medical device data

    Microsoft Academic Search

    Robert J Kennelly

    1998-01-01

    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

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

    E-print Network

    Bishop, Matt

    Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer to receive health care through the use of pervasive medical devices, sensors, and applications, even outside and the patient, and following policies set by the patient's doctors. Because many medical devices are highly

  9. Medical devices manufactured from latex: European regulatory initiatives

    Microsoft Academic Search

    W. H. De Jong; R. E. Geertsma; J. J. B. Tinkler

    2002-01-01

    In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be

  10. Medical Device Integration Copyright 2010 The University of Vermont

    E-print Network

    Hayden, Nancy J.

    . Connect medical devices to the electronic health record. Develop a system of quality assurance SolutionCase 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

  11. Determination of Compounds Inhibiting Bacterial Growth in Sterilized Medical Devices

    Microsoft Academic Search

    H. Shintani; E. Suzuki; M. Sakurai

    2003-01-01

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

  12. Medical device development practices: empirical survey and legal implications

    Microsoft Academic Search

    L. K. Holley; C. F. Hughes

    1998-01-01

    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

  13. Enabling National Education Networking For Medical Device Industry

    Microsoft Academic Search

    Ming-Yih Lee; Chung-Hsien Kuo

    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

  14. 80 FR 10125 - National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2015-02-25

    ...National Medical Device Postmarket Surveillance System Planning Board Report...Effective National Medical Device Surveillance System,'' developed by the National Medical Device Postmarket Surveillance System Planning Board. In...

  15. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ...manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable...reports in full compliance with FDA's Medical Device Reporting regulation, pending future FDA notice...

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

    E-print Network

    De Micheli, Giovanni

    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 monitoring and lately even some basic treatment procedures. Medical guidelines (GLs) can be seen

  17. Health economics of medical devices: opportunities and challenges.

    PubMed

    Simoens, Steven

    2008-01-01

    Expenditure on medical devices is substantial and is expected to grow in the future. This Editorial draws attention to health economic issues surrounding medical devices. To this effect, opportunities and challenges involved in the economic analysis of the market structure of medical device sectors and in the economic evaluation of medical devices are identified. Markets for medical devices tend to be fragmented and suffer from a lack of transparency and competition. In response to this, there is extensive government intervention in many developed countries with a view to keeping down prices, restricting public reimbursement and promoting an efficient use of medical devices. Studies are called for that evaluate and compare country approaches towards regulating medical device markets with a view to informing medical-device policies. Whereas economic evaluation of medicines is well established, and is used to inform pricing and reimbursement decisions in many developed countries, this is less the case for medical devices. There is a need for economic evaluations of medical devices with a view to demonstrating their cost effectiveness. In addition, countries need to implement frameworks for the assessment of new and emerging medical devices with a view to taking pricing and reimbursement decisions. PMID:19450077

  18. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

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

  19. Onboard tagging for smart medical devices.

    PubMed

    Li, Kejia; Warren, Steve

    2011-01-01

    Most medical devices are 'dumb:' their role is to acquire, display, and forward data. They make few if any operational decisions based on those data. Onboard tagging is a means whereby a device can embed information about itself, its data, and the sensibility of those data into its data stream. This diagnostic add-on offers a move toward 'smart' devices that will have the ability to affect changes in operational modes based on onboard contextual decision making, such as decisions to avoid needless wireless transmission of corrupt data. This paper presents a description of three types of onboard tags that relate to device hardware (type I tag), signal statistics (type II tag), and signal viability for the intended application (type III tag). A custom wireless pulse oximeter is presented as a use case to show how type II and III tags that convey photoplethysmogram (PPG) statistics and usability specifiers can be calculated and embedded into the data stream without degrading performance. PMID:22254768

  20. A DPWS-Based Architecture for Medical Device Interoperability

    Microsoft Academic Search

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

    \\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

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

    PubMed Central

    Jefferys, D B

    2001-01-01

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

  2. MEDEMAS Medical Device Management and Maintenance System Architecture

    Microsoft Academic Search

    Yekta Ülgen; Mehmed Özkan

    \\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

  3. Vibration analysis of medical devices with a calibrated FEA model

    Microsoft Academic Search

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

    2002-01-01

    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

  4. MEDICAL DEVICE DIAGNOSTIC ENGR. COURSE PLAN (EFFECTIVE FALL 2008)

    E-print Network

    Valero-Cuevas, Francisco

    515 Quality Systems and Standards OR AVAILABLE YEAR-ROUND ISE 527 Quality Management for Engineers 3MS MDDE MEDICAL DEVICE DIAGNOSTIC ENGR. COURSE PLAN (EFFECTIVE FALL 2008) Name of Medical Devices and Diagnostics 3 AVAILABLE SUMMER & FALL RSCI 527 Medical Product Safety 3 ASK PROGRAM

  5. Medical Device Communication: A Standards based Conformance Testing Approach

    Microsoft Academic Search

    John J. Garguilo; Sandra Martinez; Maria Cherkaoui

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

  6. Missing Data in the Regulation of Medical Devices

    Microsoft Academic Search

    Gregory Campbell; Gene Pennello; Lilly Yue

    2011-01-01

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

  7. The radiation resistance of the bioburden from medical devices

    Microsoft Academic Search

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

    1998-01-01

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

  8. Medical Devices Competitiveness and Impact on Public Health Expenditure

    Microsoft Academic Search

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

    2005-01-01

    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

  9. Implementation of Risk Management in the Medical Device Industry

    Microsoft Academic Search

    Rachelo Dumbrique

    2010-01-01

    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

  10. Using usability heuristics to evaluate patient safety of medical devices

    Microsoft Academic Search

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

    2003-01-01

    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

  11. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

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

  12. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

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

  13. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents...part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part...

  14. Production of Medical Device Using MIM Technique

    NASA Astrophysics Data System (ADS)

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

    2010-03-01

    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.

  15. Assessment of technical documentation of Annex II medical devices

    Microsoft Academic Search

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

    2007-01-01

    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

  16. How Can Software SMEs Become Medical Device Software SMEs

    Microsoft Academic Search

    Fergal McCaffery; Valentine Casey; Martin McHugh

    \\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

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

    Microsoft Academic Search

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

    2011-01-01

    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'

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

    Microsoft Academic Search

    W J ODowd

    2002-01-01

    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

  19. Transdermal patches: history, development and pharmacology.

    PubMed

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

    2015-05-01

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

  20. Defining the role of software quality assurance in a medical device company

    Microsoft Academic Search

    Kurt R. Linberg

    1993-01-01

    The use of software by medical device companies is growing exponentially. In addition to software providing major functionality of medical functionality of medical devices, software is being used to manufacture medical devices, and to validate the efficacy of medical devices prior to use. Many medical device companies have implemented software quality assurance programs to ensure software products and software development

  1. 76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

  2. Supporting medical device development: a standard product design process model

    Microsoft Academic Search

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

    2012-01-01

    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

  3. Software Development Practice for FDA-Compliant Medical Devices

    Microsoft Academic Search

    Weiguo Lin; Xiaomin Fan

    2009-01-01

    Software development in medical devices by implementing lightweight processes in formal regulatory environments is an issue. This paper describes software development practice with the project of Digital Subtraction Angiography (DSA) medical device, and introduces experiences to ensure FDA regulatory compliance In addition, we introduce a hybrid methodology adopted in our software development process which is to use agile method to

  4. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...2012-07-01 2012-07-01 false Food, medicine, and medical devices. 561.327...General Definitions § 561.327 Food, medicine, and medical devices. (a) The term...their derivatives. (b) The term medicine has the same meaning given the...

  5. Medical devices for developing countries: Design constraints and approaches

    Microsoft Academic Search

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

    2009-01-01

    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

  6. Towards sustainable design for single-use medical devices

    Microsoft Academic Search

    Jacob J. Hanson; Robert W. Hitchcock

    2009-01-01

    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

  7. Using Storytelling to Elicit Design Guidance for Medical Devices

    Microsoft Academic Search

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

    2011-01-01

    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

  8. Development of wearable medical device for Bio-MEMS

    Microsoft Academic Search

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

    2006-01-01

    Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medical device used for blood sugar control. The new type compact medical device comprises (1) a micropump system to extract

  9. Evaluation of MEMS materials of construction for implantable medical devices

    Microsoft Academic Search

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

    2002-01-01

    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

  10. FMEA for rework reduction in software medical devices-experience

    Microsoft Academic Search

    Saraswathi Deora

    2012-01-01

    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

  11. Proving experience speeds medical device time to market

    Microsoft Academic Search

    Lori E Lucke; Anne Mickelson; David Anderson

    2009-01-01

    Experience is important for developing medical devices. This seems like a straightforward statement, yet it has been difficult to prove. In this paper, several medical device projects are compared to demonstrate how experience improves both overall development time and user interface design time. To prove that experience counts, actual data was assessed over a number of development projects. All projects

  12. The regulation of cognitive enhancement devices: extending the medical model

    PubMed Central

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

    2014-01-01

    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

  13. Human factors and the FDA's goals: improved medical device design.

    PubMed

    Burlington, D B

    1996-01-01

    The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here. PMID:8673158

  14. Towards sustainable design for single-use medical devices.

    PubMed

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

    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 provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

  15. Toward patient safety in closed-loop medical device systems

    Microsoft Academic Search

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

    2010-01-01

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

  16. Perspective Towards self-sterilizing medical devices: controlling infection

    Microsoft Academic Search

    Ahmad E Madkour; Gregory N Tew

    Medical devices are an important component of modern medicine. In many cases, medical devices are used to improve the 'quality of life' for the patient, and their use is increasing dramatically. At the same time, the emergence of multi-drug-resistant bacteria, or 'super-bugs', is a global crisis. At least in part, biomedical devices proliferate the growth of resistant bacteria. This has

  17. The economic evaluation of medical devices: challenges ahead.

    PubMed

    Kirisits, Andreas; Redekop, W Ken

    2013-02-01

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

  18. FDA regulatory requirements for medical devices with control algorithms

    Microsoft Academic Search

    A. Ciarkowski

    2000-01-01

    Discusses how the US Food and Drug Administration (FDA) regulates medical devices that include an automatic control system. First, the context of FDA regulation is given. It is indicated how the FDA regulates control systems, so that a device developer may develop an idea of when the device is subject to FDA regulation, what steps he can follow to comply

  19. Cyber–Physical Modeling of Implantable Cardiac Medical Devices

    Microsoft Academic Search

    Zhihao Jiang; Miroslav Pajic; Rahul Mangharam

    2012-01-01

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

  20. A Development of HL7 Middleware for Medical Device Communication

    Microsoft Academic Search

    Tung Tran; Hwa-Sun Kim; Hune Cho

    2007-01-01

    An efficient middleware has been developed to support medical device communication. HL7 is known to be best international standard to facilitate clinical device data transfer to information systems in hospital. In this study, we developed a middleware with capability of receiving data from mCare 300 Vital signs monitoring device and converting to HL7 data type format.

  1. Digital Watermarking of Medical Images for Mobile Devices

    Microsoft Academic Search

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

    2010-01-01

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

  2. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...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 Administration, HHS....

  3. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ...SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug...

  4. Home Healthcare Medical Devices: A Checklist

    MedlinePLUS

    ... how to replace them. Educate your family and caregivers about your devices. * Include them in hospital planning ... that may change the way you or your caregiver use the device. - Are there changes in vision, ...

  5. A concept ideation framework for medical device design.

    PubMed

    Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

    2015-06-01

    Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. PMID:25956618

  6. Current advances in the fabrication of microneedles for transdermal delivery.

    PubMed

    Indermun, Sunaina; Luttge, Regina; Choonara, Yahya E; Kumar, Pradeep; du Toit, Lisa C; Modi, Girish; Pillay, Viness

    2014-07-10

    The transdermal route is an excellent site for drug delivery due to the avoidance of gastric degradation and hepatic metabolism, in addition to easy accessibility. Although offering numerous attractive advantages, many available transdermal systems are not able to deliver drugs and other compounds as desired. The use of hypodermic needles, associated with phobia, pain and accidental needle-sticks has been used to overcome the delivery limitation of macromolecular compounds. The means to overcome the disadvantages of hypodermic needles has led to the development of microneedles for transdermal delivery. However, since the initial stages of microneedle fabrication, recent research has been conducted integrating various fabrication techniques for generating sophisticated microneedle devices for transdermal delivery including progress on their commercialization. A concerted effort has been made within this review to highlight the current advances of microneedles, and to provide an update of pharmaceutical research in the field of microneedle-assisted transdermal drug delivery systems. PMID:24806483

  7. Current Status of the Regulation for Medical Devices

    PubMed Central

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

    2008-01-01

    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

  8. Functional Alarms for Systems of Interoperable Medical Devices

    PubMed Central

    Venkatasubramanian, Krishna K.; Vasserman, Eugene Y.; Sokolsky, Oleg; Lee, Insup

    2014-01-01

    Alarms are essential for medical systems in order to ensure patient safety during deteriorating clinical situations and inevitable device malfunction. As medical devices are connected together to become interoperable, alarms become crucial part in making them high-assurance, in nature. Traditional alarm systems for interoperable medical devices have been patientcentric. In this paper, we introduce the need for an alarm system that focuses on the correct functionality of the interoperability architecture itself, along with several considerations and design challenges in enabling them. PMID:25404867

  9. Legal framework conditions for the reprocessing of medical devices.

    PubMed

    Großkopf, Volker; Jäkel, Christian

    2008-01-01

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

  10. 78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

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

  11. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...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...

  12. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...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...

  13. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...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...

  14. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...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...

  15. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...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...

  16. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...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,...

  17. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...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...

  18. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...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,...

  19. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...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,...

  20. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...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...

  1. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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...

  2. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  3. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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...

  4. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...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,...

  5. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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...

  6. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...2014-10-01 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)...

  7. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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...

  8. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...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...

  9. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...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)...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...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,...

  11. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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...

  12. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...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)...

  13. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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...

  14. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...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...

  15. 77 FR 27234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-09

    ...Comment Request; Medical Devices; Inspection by Accredited...Persons Program Under the Medical Device User Fee and Modernization...ways to enhance the quality, utility, and clarity...Persons Program Under the Medical Device User Fee and...

  16. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...

  17. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...

  18. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ...current FDA regulation that addresses...manufacturers of medical devices for certain...The first Medical Device Reporting (MDR) regulation became effective...www.regulations.gov. To receive ``Medical Device...

  19. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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,...

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

    E-print Network

    Hu, Fei

    for MCPS ­ [Event recording for medical devices] · MCPS validation and certification ­ Assurance casesAssuring the Safety, Security, and Reliability of Medical-Device Cyber- Physical Systems (MDCPS Finance Healthcare Transportation Energy Large-scale Infrastructure ... #12;Monitoring Medical Devices

  1. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...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...

  2. [Standardization and certification of medical devices].

    PubMed

    Mubarakshin, R G

    2001-01-01

    The paper deals with the problems associated with the absence of a well-defined standard basis of the standardization, licensing, etc. of medical engineering articles, which the public corporation "Izhevsk Motor Plant Axion-Holding", one of the largest manufacturers of medical equipment comes up against. PMID:11515263

  3. Factors influencing the time for FDA review of medical devices

    E-print Network

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

    2007-01-01

    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 ...

  4. Quality management for the processing of medical devices

    PubMed Central

    Klosz, Kerstin

    2008-01-01

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

  5. Green manufacturing in the medical device industry : a case study

    E-print Network

    Gautreau, Leigh (Leigh Ann)

    2009-01-01

    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 ...

  6. Quality management for the processing of medical devices.

    PubMed

    Klosz, Kerstin

    2008-01-01

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

  7. Mergers and acquisitions in the medical device industry

    E-print Network

    Ohashi, Kevin Lee

    2007-01-01

    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 ...

  8. Transdermal Photopolymerization for Minimally Invasive Implantation

    NASA Astrophysics Data System (ADS)

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

    1999-03-01

    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.

  9. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ...the Federal Food, Drug, and Cosmetic Act (FFDCA), that is intended...part 878 (General and Plastic Surgery Devices), 21 CFR part 882...drug stores, supermarkets, cosmetic supply stores or other similar...part 878 (General and Plastic Surgery Devices) and product...

  10. Power sources and electrical recharging strategies for implantable medical devices

    Microsoft Academic Search

    Xiaojuan Wei; Jing Liu

    2008-01-01

    Implantable medical devices (IMDs) are critically requested for the survival of patients subject to certain serious diseases\\u000a such as bradycardia, fibrillation, diabetes, and disability, etc. Appropriate working of an active implantable medical device\\u000a (IMD) heavily relies on the continuous supply of electricity. In this sense, long-term powering and recharging of an IMD via\\u000a a highly safe, efficient and convenient way

  11. Improving Verification & Validation in the Medical Device Domain

    Microsoft Academic Search

    M. S. Sivakumar; Valentine Casey; Fergal McCaffery; Gerry Coleman

    \\u000a The benefits of effective verification and validation activities in the medical device domain include increased usability\\u000a and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification\\u000a and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement,\\u000a as there is no consolidated information

  12. Databases for Studying the Epidemiology of Implanted Medical Devices

    Microsoft Academic Search

    Deborah Shatin; Roselie A. Bright; Brad Astor

    The worldwide market for implanted medical devices continues to accelerate from 41.7 billion in 1993 to41.7 billion in 1993 to 56.7 billion in\\u000a 1995 (1). Unlike epidemiological research for pharmaceuticals, which builds knowledge on clinical trials that are typically completed\\u000a in several months, clinical trials for implanted medical devices require longer follow-up to determine safety and efficacy.\\u000a Follow-up for the

  13. New obstacles in the path of marketing new medical devices.

    PubMed

    Bucci, V A; Reiss, J B; Hall, N C

    1985-01-01

    Approval of a new medical device's safety and effectiveness by the Food and Drug Administration (FDA) is only one step in the typical device's passage into the marketplace. A review of 10 new Class II and III devices found an average of 62 months elapsing between the beginning of FDA-approved clinical trials and the device's final approval for general marketing. However, FDA marketing approval does not mean a new device can be sold because, for many new devices, the Health Care Financing Administration (HCFA) requests a technology assessment from the Office of Health Technology Assessment (OHTA) in order to determine whether the device's use is "reasonable and necessary" and thus appropriate for Medicare payment. The Medicare decision often guides other third parties. OHTA assessments of 93 devices and procedures required an average of 26 months to complete; of 16 FDA-approved Class III devices, OHTA reported to HCFA that insufficient data existed to recommend coverage for 12 (75 percent). Under the Medicare prospective payment system (PPS) for hospital care, a third step has been added to the process, consideration by the Prospective Payment Assessment Commission (ProPAC) and HCFA of the new device's impact on PPS payment rates. Further, under recent legislation, OHTA is mandated also to consider a device's cost effectiveness. Duplicative reviews of new devices should be eliminated, and until they are, medical equipment developers must recognize that delays and conflicting payment rulings may have serious impacts on the ability to market a new device. PMID:10300491

  14. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...Distinguishing Medical Device Recalls From...Center for Devices and Radiological...of Dockets Management (HFA-305...Center for Devices and Radiological...of marketed medical devices can...an effective quality system, often...

  15. 75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

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

  16. Statistical and Regulatory Issues in Nonrandomized Medical Device Clinical Studies

    Microsoft Academic Search

    Heng Li; Lilly Q. Yue

    2007-01-01

    While randomized, well-controlled, clinical trials have been viewed as the gold standard in the evaluation of medical products, it is not uncommon for medical device clinical studies to depart from the paradigm of randomized trials, due to ethical or practical reasons. In nonrandomized studies, the advantages of well-designed and conducted randomized clinical trials are no longer available, and consequently the

  17. Collaborative architecture framework for the design & manufacturing of medical devices

    Microsoft Academic Search

    Celestine Aguwa; Leslie Monplaisir

    2009-01-01

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

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

    E-print Network

    Wolf, Daniel W. (Daniel William)

    2010-01-01

    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 ...

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

    E-print Network

    Oakley, Jeremy

    The Headroom Method of early economic evaluation of medical devices: A useful tool for device: What the NHS is Willing To Pay for extra health benefit, normally measured in QALYs [Quality Adjusted Life Year] Headroom Determines the maximum reimbursable price of the new device Can the manufacturer

  20. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ...List of Subjects in 21 CFR Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug, and...21 CFR part 890 is amended as follows: PART 890--PHYSICAL MEDICINE DEVICES 0 1. The authority citation for 21 CFR part...

  1. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ...List of Subjects in 21 CFR Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug, and...21 CFR part 890 is amended as follows: PART 890--PHYSICAL MEDICINE DEVICES 0 1. The authority citation for 21 CFR part...

  2. The How and Why of Medical Devices Standards

    Microsoft Academic Search

    Tofy Mussivand

    2008-01-01

    The utilization of medical devices includes prevention, diagnosis and treatment of disease. Despite the many benefits, devices also pose potential adverse effects. As a result, standards have been implemented as a precluding determinant to protect the public against adverse effects and support approval for clinical use. Standards are formulated based on the following: 1. Safety, efficacy and protection of society

  3. Use of standards in the review of medical devices

    Microsoft Academic Search

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

    2005-01-01

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

  4. Power and Information Transmission to Implanted Medical Device Using Ultrasonic

    Microsoft Academic Search

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

    2001-01-01

    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

  5. Low invasive propulsion of medical devices by traction using mucus

    Microsoft Academic Search

    Ken Ikeuchi; Kiyoshi Yoshinaka; Naohide Tomita

    1997-01-01

    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

  6. Portable, low-cost medical ultrasound device prototype

    Microsoft Academic Search

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

    2004-01-01

    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

  7. Fast and Collaborative Interference Avoidance for Wireless Medical Devices

    Microsoft Academic Search

    Mohammad Sajjad Hossain; Tanzima Zerin Islam; Saurabh Bagchi; Vijay Raghunathan

    Interference has long been a serious problem in wireless communication devices, causing packet losses and degra- dation in communication quality. The need to address this problem is exacerbated by the increasing use of wireless embedded devices in a range of medical applications. This paper presents an interference detection and avoidance technique based on fast and collaborative channel switchin g, that

  8. Design of interactive medical devices: Feedback and its improvement

    Microsoft Academic Search

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

    2011-01-01

    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,

  9. Recent Results in Computer Security for Medical Devices

    E-print Network

    Shenoy, Prashant

    of networked, and especially wireless, interfaces in IMDs. Paul Jones of the U.S. Food and Drug Administration, creating new challenges in medical device design." (personal communication, Aug. 2007) IMDs behave like any other networked computing devices in many ways, and, as such, many existing security and privacy risks

  10. Legal implications of single-use medical device reprocessing.

    PubMed

    Larose, Emily

    2013-01-01

    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

  11. Rate-controlling biopolymer membranes as transdermal delivery systems for nifedipine: Development and in vitro evaluations

    Microsoft Academic Search

    D. Thacharodi; K. Panduranga Rao

    1996-01-01

    Membrane permeation-controlled transdermal delivery devices for the controlled delivery of nifedipine were developed using collagen (which was extracted from calf fetus skin) and chitosan membranes as rate-controlling membrane. To increase the stability of nifedipine in the systems, alginate gel was used as drug reservoir. Transdermal devices were fabricated by adhesive sealing techniques. In vitro drug release studies were carried out

  12. Microelectronics to build smart medical devices

    Microsoft Academic Search

    M. Sawan

    2001-01-01

    Summary form only given. The bladder controller and the visual cortical stimulator are the main subjects of research activities of the PolySTIM team at the Ecole Polytechnique de Montreal. Such devices are dedicated to recuperate or enhance neuromuscular functions in patients by means of peripherals or central nervous systems. While the bladder controllor is dedicated to recuperate voiding and retention

  13. Semantic Alarms in Medical Device Networks

    Microsoft Academic Search

    Albert Goldfain; Atanu Roy Chowdhury; Min Xu; Jim DelloStritto; Jonathan Bona; Blue Highway

    We describe preliminary work on semantic alarms, a framework for context-sensitive clinical alerts. Semantic alarms are intended for deployment in a multi-parameter vital sign monitoring system. Requirements for device and data interoperability within this system are discussed. Extended examples are provided for sepsis and congestive heart failure disease state alarms.

  14. Do medical devices have enhanced placebo effects?

    Microsoft Academic Search

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

    2000-01-01

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

  15. [Ethic review on clinical experiments of medical devices in medical institutions].

    PubMed

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed. PMID:22097752

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

    E-print Network

    Duchowski, Andrew T.

    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

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

    E-print Network

    Huth, Michael

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

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

    Microsoft Academic Search

    Kejia Li; Steve Warren; John Hatcliff

    2012-01-01

    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

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

    Microsoft Academic Search

    Jan Wittenber; M. Michael Shabot

    1991-01-01

    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

  20. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM)...

  1. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ...Food and Drug Administration Pediatric Medical Devices Workshop; Notice...announcing the following workshop: FDA Pediatric Medical Devices Workshop. This...intended to focus on challenges in pediatric device...

  2. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ...or serious injury. Device importers report deaths...interaction with the medical device community, that all...part of their internal quality control system. There are an estimated 30,000 medical device distributors....

  3. Battery power comparison to charge medical devices in developing countries.

    PubMed

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

    2009-01-01

    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

  4. Assessment of technical documentation of medical devices for clinical investigation

    Microsoft Academic Search

    Roszek B; Bruijn ACP de; Drongelen AW van; Geertsma RE

    2007-01-01

    The technical documentation on non-market approved medical devices\\u000aintended for clinical investigation contains major shortcomings. This\\u000acould imply increased risks which could affect patient safety. The\\u000ainvestigation described here focused on the availability and quality of\\u000athe technical documentation which is required in the Medical Devices\\u000aDirective 93\\/42\\/EEC (MDD), complemented by items directly related to the\\u000ause and safety of

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

    PubMed

    Hölscher, U M

    2014-12-01

    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 systematic exchange of much safety-relevant information. 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 management in health-care facilities without risk policy is dangerously incomplete. PMID:24824355

  6. [Radiotherapy and implantable medical device: example of infusion pumps].

    PubMed

    Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

    2013-12-01

    Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. PMID:24268844

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

    Microsoft Academic Search

    Christian Mauro; Ali; Sunyaev; Helmut Krcmar

    2010-01-01

    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

  8. The Use of Medical Devices in Self Monitoring of Chronic Diseases

    Microsoft Academic Search

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

    \\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

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

    Microsoft Academic Search

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

    2001-01-01

    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

  10. Multi-camera recognition of people operating home medical devices

    Microsoft Academic Search

    Zan Gao; Marcin Detyniecki; Ming-yu Chen; Wen Wu; A. G. Hauptmann; H. D. Wactlar; A. Cai

    2010-01-01

    We perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed

  11. The IEEE 1073 Standard for Medical Device Communications

    Microsoft Academic Search

    R. J. Kennelly

    1998-01-01

    The IEEE 1073 Standard for Medical Device Communications provides a new tool to healthcare providers looking to excel in the new competitive environment. Standardized data communications in life critical acute care situations enables new levels of systems performance for hospital information systems. New IT uses will require systems level validation similar to that already performed for avionics

  12. Bayesian Statistics in Medical Devices: Innovation Sparked by the FDA

    Microsoft Academic Search

    Gregory Campbell

    2011-01-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials

  13. Perspectives on In Vitro Toxicity for Medical Devices

    Microsoft Academic Search

    Sharon J. Northup

    1988-01-01

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

  14. Thermal management of a medical device using thermoelectric coolers

    Microsoft Academic Search

    Kuang-yu Wang

    2004-01-01

    A thermal management system was developed and validated to meet the cooling need of a medical device generating a continuous 60 Watt of heat. Due to the operational and geometric constraints, thermoelectric modules combined with air-to-liquid heat exchanger became the viable solution. Measurements were conducted to validate the design. It was concluded that with proper arrangement, the system actually exceeded

  15. Medical Device Risk Assessment Paradigm: Use and Case History

    Microsoft Academic Search

    R. D. White; J. N. Cammack; R. J. Eyre; D. M. Wilson

    1999-01-01

    In the medical device industry, risk assessment is required for product development and support, regulatory compliance, and manufacturing support. The risk assessment process can be divided into four major steps. The first step, hazard identification, involves determining whether exposure to an agent can cause an increased incidence of an adverse health condition (e.g., acute toxicity, cancer, birth defects, etc.). The

  16. CASE STUDY: Safety assessment for new medical device

    Microsoft Academic Search

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

  17. A quantitative approach for medical device Health Hazard Analysis

    Microsoft Academic Search

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

    2011-01-01

    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

  18. Applied ergonomics: Determining user needs in medical device design

    Microsoft Academic Search

    Mary Beth Privitera; D. L. Murray

    2009-01-01

    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

  19. From concept to exit strategies - medical device innovation

    Microsoft Academic Search

    E. L. Kermit

    2004-01-01

    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

  20. Biofilms in infectious disease and on medical devices

    Microsoft Academic Search

    G Reid

    1999-01-01

    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

  1. MRI compatibility and visibility assessment of implantable medical devices

    Microsoft Academic Search

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

    1999-01-01

    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

  2. Perinatal Staff Nurse Medical Device Use and Education.

    ERIC Educational Resources Information Center

    McConnell, Edwina A.

    1998-01-01

    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.…

  3. Lost in menuspace: user interactions with complex medical devices

    Microsoft Academic Search

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

    2004-01-01

    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

  4. Career development of biomedical engineers in medical device industry

    Microsoft Academic Search

    Quan Ni; Yachuan Pu

    2009-01-01

    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

  5. Quality and continuous improvement in medical device manufacturing

    Microsoft Academic Search

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

    2008-01-01

    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

  6. A Formal Methods Approach to Medical Device Review

    Microsoft Academic Search

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

    2006-01-01

    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

  7. A Risk Driven Approach to testing Medical Device Software

    Microsoft Academic Search

    Albert Farré Benet

    2011-01-01

    Software for medical devices is strongly driven by regulatory requirements. Among those, safety assurance is critical. To achieve the required high levels of safety, it is essential to reliably reduce safety risks to a residual low level. This requirement is verified and validated mostly with software testing. An approach to software testing driven by safety risks is presented and complemented

  8. A model of user engagement in medical device development

    Microsoft Academic Search

    Patricia Grocott; Heather Weir; Mala Bridgelal Ram

    2007-01-01

    Purpose – The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a

  9. Auctions vs. Bargaining: An Empirical Analysis of Medical Device Procurement

    Microsoft Academic Search

    Andrea Bonaccorsi; Thomas Lyon; Fabio Pammolli; Giuseppe Turchetti

    1999-01-01

    We test recent theory on the benefits of auctions and bargaining as alternative procurement mechanisms using data on the procurement of medical devices by Italian hospitals. Theory suggests that auctions perform well when cost control is the key concern, but are less effective at producing the optimal mix of quality and price for complex products where quality is difficult to

  10. E-management of medical devices in Italy

    Microsoft Academic Search

    D. Bravar; G. Carlini; A. Cortese; T. dell'Aquila; N. Pangher

    2001-01-01

    The Italian Health sector has been experiencing, for several years, a re-organization process, to improve the efficiency of medical device management by the introduction of new instruments, included the Internet. In this setting, many companies offer innovative products via the web to the health administration, especially for e-procurement. Ital TBS is an Italian Clinical Engineering Services company, managing different biomedical

  11. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...is recommended because Web cast connections are limited...connection per location. Web cast participants will...please visit the following Web site: http://www...should be considered when designing reusable medical devices...Management (HFA-305), Food and Drug...

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

    E-print Network

    Lu?trek, Mitja

    2014-01-01

    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

  13. Product Recalls in the Medical Device Industry: An Empirical Exploration of the Sources and Financial Consequences

    Microsoft Academic Search

    Sriram Thirumalai; Kingshuk K. Sinha

    2011-01-01

    Medical devices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medical devices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in this regard. First, it empirically assesses the financial implications of medical device recalls to understand if these

  14. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ...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...

  15. Feasibility of energy harvesting techniques for wearable medical devices.

    PubMed

    Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

    2014-08-01

    Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us. PMID:25570037

  16. Management information system of medical equipment using mobile devices

    NASA Astrophysics Data System (ADS)

    Núñez, C.; Castro, D.

    2011-09-01

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

  17. Prototyping closed loop physiologic control with the medical device coordination framework

    Microsoft Academic Search

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

    2010-01-01

    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

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

    Microsoft Academic Search

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

    2009-01-01

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

  19. Smart alarms from medical devices in the OR and ICU.

    PubMed

    Imhoff, Michael; Kuhls, Silvia; Gather, Ursula; Fried, Roland

    2009-03-01

    Alarms in medical devices are a matter of concern in critical and perioperative care. The high rate of false alarms is not only a nuisance for patients and caregivers, but can also compromise patient safety and effectiveness of care. The development of alarm systems has lagged behind the technological advances of medical devices over the last 20 years. From a clinical perspective, major improvements in alarm algorithms are urgently needed. This review gives an overview of the current clinical situation and the underlying problems, and discusses different methods from statistics and computational science and their potential for clinical application. Some examples of the application of new alarm algorithms to clinical data are presented. PMID:19449615

  20. Design of medical devices--a home perspective.

    PubMed

    Bitterman, Noemi

    2011-02-01

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

  1. A Risk Driven Approach to testing Medical Device Software

    Microsoft Academic Search

    Albert Farré Benet

    \\u000a Software for medical devices is strongly driven by regulatory requirements. Among those, safety assurance is critical. To\\u000a achieve the required high levels of safety, it is essential to reliably reduce safety risks to a residual low level. This\\u000a requirement is verified and validated mostly with software testing. An approach to software testing driven by safety risks\\u000a is presented and complemented

  2. The liabilities and consequences of medical device development.

    PubMed

    Price, J M

    1987-04-01

    A large increase in medical products liability litigation during the past 40 years has resulted in a flood of litigation against drug and device manufacturers. The medical technology and chemical industries are prime targets for products liability litigation. Physicians and other health care providers are willing to accept a reasonable degree of risk associated with the use of a medical product when compared to the benefit to be achieved by that product but lay juries are less likely to tolerate the concept of an acceptable failure rate. Plaintiffs' lawyers believe that the medical products industry should be held to a standard of absolute liability and that anyone injured by a medical product is entitled to recover without regard for the circumstances. Large compensatory and punitive damage awards, the high cost of insurance, large defense costs, and low profit margins have forced some companies to remove their products from the market. The medical or biomaterials manufacturer can significantly reduce its exposure for products liability by adopting a successful product safety program. Manufacturers have significant control over the quality, safety, and reliability of their products through appropriate design, testing, manufacture, labeling, and sale of quality products. PMID:3571302

  3. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ...Administration [Docket No. FDA-2012-N-0677] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting...open to the public. Name of Committee: Dental Products Panel of the Medical Devices Advisory Committee. General...

  4. 75 FR 33315 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ...Administration [Docket No. FDA-2010-N-0268] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting...open to the public. Name of Committee: Dental Products Panel of the Medical Devices Advisory Committee. General...

  5. 31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  6. 31 CFR 561.327 - Agricultural commodities, food, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...false Agricultural commodities, food, medicine, and medical devices. 561.327...327 Agricultural commodities, food, medicine, and medical devices. (a) The term...their derivatives. (c) The term medicine has the same meaning given the...

  7. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  8. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  9. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    21 Food and Drugs 8 2012-04-01...false Medical devices; processing, labeling, or repacking... Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...150 Medical devices; processing, labeling, or...

  10. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  11. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    21 Food and Drugs 8 2014-04-01...false Medical devices; processing, labeling, or repacking... Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...150 Medical devices; processing, labeling, or...

  12. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  13. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  14. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    21 Food and Drugs 8 2011-04-01...false Medical devices; processing, labeling, or repacking... Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...150 Medical devices; processing, labeling, or...

  15. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    21 Food and Drugs 8 2013-04-01...false Medical devices; processing, labeling, or repacking... Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION...150 Medical devices; processing, labeling, or...

  16. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ...public workshop entitled ``Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections...workshop is to provide information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated...

  18. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  19. 31 CFR 561.327 - Agricultural commodities, food, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...false Agricultural commodities, food, medicine, and medical devices. 561.327...327 Agricultural commodities, food, medicine, and medical devices. (a) The term...their derivatives. (c) The term medicine has the same meaning given the...

  20. Printable thermoelectric devices and conductive patterns for medical applications

    NASA Astrophysics Data System (ADS)

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

    2012-10-01

    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.

  1. Antimicrobial selenium nanoparticle coatings on polymeric medical devices

    NASA Astrophysics Data System (ADS)

    Tran, Phong A.; Webster, Thomas J.

    2013-04-01

    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.

  2. Medical devices; physical medicine devices; classification of the powered lower extremity exoskeleton; republication. Final order; republication.

    PubMed

    2015-05-01

    The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25985478

  3. 75 FR 58414 - Dental Products Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ...FDA-2010-N-0268] Dental Products Panel of the Medical Devices Advisory Committee...notice of meeting of the Dental Products Panel of the Medical Devices Advisory Committee...that a meeting of the Dental Products Panel of the Medical Devices Advisory...

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

    Microsoft Academic Search

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

    2012-01-01

    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

  5. MATCH Guide on Product Development Processes in the Medical Device Industry

    E-print Network

    Oakley, Jeremy

    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

  6. Safety-Ensured Coordination of Networked Medical Devices in MDPnP

    E-print Network

    Hu, Fei

    Safety-Ensured Coordination of Networked Medical Devices in MDPnP Tao Li, and Jiannong Cao,csjcao}@comp.polyu.edu.hk Abstract--In recent years, research on medical device inte- gration has attracted a lot of attentions in this research is the Medical Device Plug-and-Play (MDPnP) Interoperability program. The continuous effort

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

    E-print Network

    Massachusetts at Amherst, University of

    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

  8. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...of patent term extension for a medical device. 1.777 Section 1.777...of patent term extension for a medical device. (a) If a determination is...1.750 that a patent for a medical device is eligible for...

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

    E-print Network

    Jawitz, James W.

    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

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

    E-print Network

    Hu, Fei

    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

  11. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...of patent term extension for a medical device. 1.777 Section 1.777...of patent term extension for a medical device. (a) If a determination is...1.750 that a patent for a medical device is eligible for...

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

    E-print Network

    Young, R. Michael

    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

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

    Microsoft Academic Search

    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

    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

  14. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...of patent term extension for a medical device. 1.777 Section 1.777...of patent term extension for a medical device. (a) If a determination is...1.750 that a patent for a medical device is eligible for...

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

    E-print Network

    Oakley, Jeremy

    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

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

    Microsoft Academic Search

    Ralph M. Herkert

    2008-01-01

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

  17. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ...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...

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

    E-print Network

    Huth, Michael

    the software engineering re- searchers/practitioners, industrial medical device developers, and governmentDemonstration 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

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

    E-print Network

    Huth, Michael

    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

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

    E-print Network

    Hu, Fei

    , medical devices have been designed to operate in a stand- alone manner. However, recent years have seen device interoperability. Such interoperable medical de- vices (IMDs) can afford many advantages decision. This eavesdropping is possible in many medical devices that use wirelesscommunication

  1. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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...

  2. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...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...

  3. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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...

  4. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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...

  5. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...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...

  6. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...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...

  7. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...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...

  8. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...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...

  9. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...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...

  10. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...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...

  11. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...

  12. 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 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...

  13. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...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...

  14. Nanostructured selenium for preventing biofilm formation on polycarbonate medical devices.

    PubMed

    Wang, Qi; Webster, Thomas J

    2012-12-01

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

  15. Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule.

    PubMed

    1991-11-26

    The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance. PMID:10115705

  16. The Safe Medical Devices Act of 1990: new directions for FDA software regulation

    Microsoft Academic Search

    Vincent M. Brannigan

    1991-01-01

    An analysis of the effect of the `safe medical devices act' (1990) on nonembedded software which interacts directly with medical devices is presented. Such devices include laboratory analyzers, image generators, therapeutic machinery, and patient monitors. Nonembedded software might interact with such devices across a computer network. Typical nonembedded software includes clinical laboratory systems, radiology systems, and intensive car systems. These

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

    Microsoft Academic Search

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

    2006-01-01

    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

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

    Microsoft Academic Search

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

    2006-01-01

    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

  19. A systems approach to improving patient safety through medical device purchasing

    E-print Network

    Hinrichs, Saba

    2010-10-12

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

  20. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ...360c), FDA must classify devices into one of three regulatory...FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable...effectiveness. Under the Medical Device Amendments of 1976...

  1. Make Sure the Medical Device You Choose Is Designed for You

    MedlinePLUS

    ... from Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management FDA/CDRH/OHIP/DDUPSA (PGS) ... device? 2. Is the device right for the environment where you plan to use it? q Does ...

  2. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...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...

  3. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ...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...

  4. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations. (2) Prosthetic devices, other than...

  5. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations. (2) Prosthetic devices, other than...

  6. Transdermal Diagnosis of Malaria Using Vapor Nanobubbles.

    PubMed

    Lukianova-Hleb, Ekaterina; Bezek, Sarah; Szigeti, Reka; Khodarev, Alexander; Kelley, Thomas; Hurrell, Andrew; Berba, Michail; Kumar, Nirbhay; D'Alessandro, Umberto; Lapotko, Dmitri

    2015-07-01

    A fast, precise, noninvasive, high-throughput, and simple approach for detecting malaria in humans and mosquitoes is not possible with current techniques that depend on blood sampling, reagents, facilities, tedious procedures, and trained personnel. We designed a device for rapid (20-second) noninvasive diagnosis of Plasmodium falciparum infection in a malaria patient without drawing blood or using any reagent. This method uses transdermal optical excitation and acoustic detection of vapor nanobubbles around intraparasite hemozoin. The same device also identified individual malaria parasite-infected Anopheles mosquitoes in a few seconds and can be realized as a low-cost universal tool for clinical and field diagnoses. PMID:26079141

  7. Transdermal Diagnosis of Malaria Using Vapor Nanobubbles

    PubMed Central

    Lukianova-Hleb, Ekaterina; Bezek, Sarah; Szigeti, Reka; Khodarev, Alexander; Kelley, Thomas; Hurrell, Andrew; Berba, Michail; Kumar, Nirbhay; D’Alessandro, Umberto

    2015-01-01

    A fast, precise, noninvasive, high-throughput, and simple approach for detecting malaria in humans and mosquitoes is not possible with current techniques that depend on blood sampling, reagents, facilities, tedious procedures, and trained personnel. We designed a device for rapid (20-second) noninvasive diagnosis of Plasmodium falciparum infection in a malaria patient without drawing blood or using any reagent. This method uses transdermal optical excitation and acoustic detection of vapor nanobubbles around intraparasite hemozoin. The same device also identified individual malaria parasite–infected Anopheles mosquitoes in a few seconds and can be realized as a low-cost universal tool for clinical and field diagnoses. PMID:26079141

  8. Assessment and non-clinical impact of medical devices.

    PubMed

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

    2015-01-01

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

  9. Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices

    NASA Astrophysics Data System (ADS)

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

    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.

  10. A Risk Driven Approach to testing Medical Device Software

    NASA Astrophysics Data System (ADS)

    Benet, Albert Farré

    Software for medical devices is strongly driven by regulatory requirements. Among those, safety assurance is critical. To achieve the required high levels of safety, it is essential to reliably reduce safety risks to a residual low level. This requirement is verified and validated mostly with software testing. An approach to software testing driven by safety risks is presented and complemented with comments from a real project where it has been applied. Specific comments to improve test design so as to detect more safety risks and issues are also provided based on experiences from the same project.

  11. [The choice of inhalation device: A medical act.

    PubMed

    Devillier, P; Salvator, H; Roche, N

    2014-11-01

    Inhaled treatments are essential for respiratory diseases management, including COPD and asthma. Optimal control of the disease largely depends on patient's compliance and proper use of these treatments. Different types of ready-to-use inhaler devices are available: metered dose inhaler, dry powder inhaler or soft mist inhaler. Each of these devices presents specific characteristics and constraints that have to be evaluated and taken into account before prescription. In order to optimize adherence and treatment efficacy, the choice of inhaler device should depend on the specific needs, abilities and preferences of each patient and a specific education to treatment should be provided. Inhaled treatments, even containing the same drug, have different technical constraints and are thus not easily interchangeable. Their substitution without prior medical consent and without proper training can lead to errors in taking treatment, treatment failures and increased health care consumption. In France, substitution by the pharmacist is not authorized. While patient education must be carried out in collaboration with all health professionals, it is preferable that the choice of inhaler device remains the responsibility of the physician. PMID:25433462

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

    PubMed

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices"). PMID:23243983

  13. Transdermal Delivery of Drugs with Microneedles-Potential and Challenges.

    PubMed

    Ita, Kevin

    2015-01-01

    Transdermal drug delivery offers a number of advantages including improved patient compliance, sustained release, avoidance of gastric irritation, as well as elimination of pre-systemic first-pass effect. However, only few medications can be delivered through the transdermal route in therapeutic amounts. Microneedles can be used to enhance transdermal drug delivery. In this review, different types of microneedles are described and their methods of fabrication highlighted. Microneedles can be fabricated in different forms: hollow, solid, and dissolving. There are also hydrogel-forming microneedles. A special attention is paid to hydrogel-forming microneedles. These are innovative microneedles which do not contain drugs but imbibe interstitial fluid to form continuous conduits between dermal microcirculation and an attached patch-type reservoir. Several microneedles approved by regulatory authorities for clinical use are also examined. The last part of this review discusses concerns and challenges regarding microneedle use. PMID:26131647

  14. Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging

    NASA Astrophysics Data System (ADS)

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

    2014-02-01

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

  15. Effective use of transdermal drug delivery in children.

    PubMed

    Delgado-Charro, M Begoña; Guy, Richard H

    2014-06-01

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

  16. Which barriers prevent the efficient use of resources in medical device sectors?

    PubMed

    Simoens, Steven

    2009-01-01

    This article aims to examine barriers to the efficient use of resources relating to medical devices, by focusing specifically on an economic analysis of the market structure of medical devices and on the assessment procedures for medical devices. A desktop analysis was conducted of the health economic literature relating to both of these aspects. This information was structured and analysed with a view to identifying and discussing the major issues that may threaten the efficient use of medical devices. Medical device sectors do not tend to operate as perfectly competitive markets because of the presence of heterogeneous products, information asymmetry and a restricted number of manufacturers. There is a need for government intervention to keep prices down, restrict public reimbursement and promote an efficient use of medical devices. Assessment procedures governing pricing and reimbursement of medical devices are lacking, are in development, or have only recently been established in the majority of developed countries. There is limited transparency and less formal attention of decision makers to assessment of the efficient use of resources in medical device sectors as compared with medicines. In conclusion, there is a need for more studies exploring the safety, effectiveness, cost effectiveness and budget impact of medical devices, so that decision makers can make informed pricing and reimbursement decisions based on objective analyses. Additionally, there is a need for more formal assessment systems for medical devices. PMID:19905034

  17. Department of Bioengineering Spring 2011 ISO 80369-Compliant Design of Medical Device Connectors/Standards

    E-print Network

    Demirel, Melik C.

    PENNSTATE Department of Bioengineering Spring 2011 ISO 80369- Compliant Design of Medical Device rise to medical device misconnections. B Braun has been contracted to generate several new concepts for medical connectors that are incompatible with each other and with the current Luer standard to prevent

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

    E-print Network

    Rajkumar, Ragunathan "Raj"

    1 Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare highlights C I M I T Julian M. Goldman, MD Harvard Medical School Massachusetts General Hospital Depts. of Anesthesia and Biomedical Engineering Director, CIMIT Program on Interoperability and the Medical Device Plug

  19. Influence of Mobile Phones on the Quality of ECG Signal Acquired by Medical Devices

    Microsoft Academic Search

    T. Buczkowski; D. Janusek; H. Zavala-Fernandez; M. Skrok; M. Kania; A. Liebert

    2013-01-01

    Health aspects of the use of radiating devices, like mobile phones, are still a public concern. Stand-alone electrocardiographic systems and those built-in, more sophisticated, medical devices have become a standard tool used in everyday medical practice. GSM mobile phones might be a potential source of electromagnetic interference (EMI) which may affect reliability of medical appliances. Risk of such event is

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

    E-print Network

    Potkonjak, Miodrag

    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: (i) an increase in medical information quality by sampling aggressively over semantically important

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

    Microsoft Academic Search

    Celestine C. Aguwa; Leslie Monplaisir; Prasanth Achuthamenon Sylajakumari

    2012-01-01

    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

  2. OpenECG: Medical device interoperability as a quality label for ehealth services

    Microsoft Academic Search

    C. E. Chronaki; F. Chiarugi; R. Fischer

    2006-01-01

    Personal medical devices proliferate as emerging eHealth consumers -chronic patients and health conscious citizens- use them regularly to monitor their health. In the quest for quality and performance, plug- interoperability of medical devices is a quality label for electronic health records (EHRs) and eHealth systems that effectively collect, process, and analyze medical data. However implementing standards typically involves additional costs,

  3. Swarm Intelligent Selection and Optimization of Machining System Parameters for Microchannel Fabrication in Medical Devices

    Microsoft Academic Search

    Elisa Vázquez; Joaquim Ciurana; Ciro A. Rodríguez; Thanongsak Thepsonthi; Tugrul Özel

    2011-01-01

    Current technology trends in medical device industry calls for fabrication of massive arrays of microfeatures such as microchannels on to nonsilicon material substrates with high accuracy, superior precision, and high throughput. Microchannels are typical features used in medical devices for medication dosing into the human body, analyzing DNA arrays or cell cultures. In this study, the capabilities of machining systems

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

    Microsoft Academic Search

    HUMMEL JM

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

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

    Microsoft Academic Search

    Sidsel Sundvor

    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

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

    Microsoft Academic Search

    James Saviola

    2005-01-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual

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

    Microsoft Academic Search

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

    2007-01-01

    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

  8. Prototyping Closed Loop Physiologic Control with the Medical Device Coordination Framework

    E-print Network

    Hu, Fei

    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 connectivity mechanisms that enable device data to be streamed to electronic health records and displays

  9. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...2011-10-01 false Specific requirements for wireless medical telemetry devices operating...SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) ...95.1121 Specific requirements for wireless medical telemetry devices...

  10. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...2012-10-01 false Specific requirements for wireless medical telemetry devices operating...SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) ...95.1121 Specific requirements for wireless medical telemetry devices...

  11. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...2014-10-01 false Specific requirements for wireless medical telemetry devices operating...SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) ...95.1121 Specific requirements for wireless medical telemetry devices...

  12. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...2013-10-01 false Specific requirements for wireless medical telemetry devices operating...SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) ...95.1121 Specific requirements for wireless medical telemetry devices...

  13. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...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...

  14. Large Eddy Simulation of FDA's Idealized Medical Device.

    PubMed

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

    2013-12-01

    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

  15. Large Eddy Simulation of FDA’s Idealized Medical Device

    PubMed Central

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

    2013-01-01

    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

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

    E-print Network

    Dhavale, Todd V

    2011-01-01

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

  17. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...and FDA-2011-M-0917] Medical Devices; Availability of Safety...COBALT October 26, 2011. iliac balloon- expandable stent system...delivery system, RETROFLEX balloon catheter and crimper. P090016...FDA-2011-M-0848.......... BSD Medical Corp..... BSD-2000...

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

    Microsoft Academic Search

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

    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

  19. JAMA Patient Page: FDA Authorization of Medical Devices

    MedlinePLUS

    ... well as a local institutional review board. Device review: The investigational device either undergoes a review process ... Class II devices usually undergo a 510(k) review , which focuses on determining whether the new device ...

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

    MedlinePLUS

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

  1. Nanobionics: the impact of nanotechnology on implantable medical bionic devices

    NASA Astrophysics Data System (ADS)

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

    2012-07-01

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

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

    PubMed

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

    2013-08-01

    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

  3. An Effective Design Process for the Successful Development of Medical Devices

    Microsoft Academic Search

    Mike Colvin

    2010-01-01

    \\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

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

    PubMed Central

    Skaer, Tracy L

    2014-01-01

    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

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

    PubMed Central

    Herkert, Ralph M.

    2008-01-01

    Background Electromagnetic emissions from technologies that surround us can produce interference with implanted and externally worn medical devices. Electromagnetic environmental effects (E3) testing of medical devices at the Georgia Tech Research Institute (GTRI) began almost four decades ago and continues to incorporate new devices and new sources of electromagnetic emissions as they are developed and become available. The GTRI Medical Device Test Center provides real-world exposure fields to identify interactions and help manufacturers prevent disruptions from the environments in which their devices must function. Methods Typically, the medical device is mounted in or on a torso simulator containing a saline solution that simulates the electrical characteristics of the body. The torso simulator and the device under test are then moved through the fields generated by production security and logistical system technologies using a computer-controlled positioning system. These tests are conducted with different orientations of the medical device to the electromagnetic source, simulating the way in which device wearers interact with these systems in representative situations. Results Particular E3 test results measured on specific devices in the GTRI Medical Device Test Center are proprietary; however, the results of tests to date with current medical devices used for the treatment of diabetes have been encouraging. These devices have included implantable and externally worn insulin infusion pumps and continuous glucose monitoring systems from different manufacturers. Conclusion Since E3 tests of diabetes treatment devices to date in the test center have centered on devices from only a few of the many current manufacturers, further testing is warranted. In addition, increased functionality, which is being added to existing devices, will create new possibilities for interference in the future. PMID:19885264

  6. 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

    Chen, Alic

    2011-01-01

    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

  7. Devices for medical diagnosis with GaN lasers

    NASA Astrophysics Data System (ADS)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

    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.

  8. Polymeric microdevices for transdermal and subcutaneous drug delivery.

    PubMed

    Ochoa, Manuel; Mousoulis, Charilaos; Ziaie, Babak

    2012-11-01

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

  9. ISO 13485:2003 : Implementation reference model from the Malaysian SMEs medical device industry

    Microsoft Academic Search

    Izatul Hamimi Abdul Razak; Shahrul Kamaruddin; Ishak Abdul Azid; Indra Putra Almanar

    2009-01-01

    Purpose – The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000

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

    Microsoft Academic Search

    Subita Sudershana; Abel Villca-Roque; Jonathan Baldanza

    2007-01-01

    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

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

    NASA Astrophysics Data System (ADS)

    Bianco, Celestina

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

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

    E-print Network

    de Weck, Olivier L.

    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 and electronic copies of this thesis document in whole or in part in any medium now known or hereafter created

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

    Microsoft Academic Search

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

    2001-01-01

    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

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

    Microsoft Academic Search

    Daniel D. Bell

    1995-01-01

    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

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

    Microsoft Academic Search

    M. F. Baretich

    2004-01-01

    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.

  16. Assessment of Web-based information needs for medical device design

    Microsoft Academic Search

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

    1999-01-01

    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

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

    Microsoft Academic Search

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

    2009-01-01

    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

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

    Microsoft Academic Search

    Harriet Chan-Myers; David McAlister; Patricia Antonoplos

    1997-01-01

    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

  19. A Software Process Improvement Lifecycle Framework for the Medical Device Industry

    Microsoft Academic Search

    Fergal Mccaffery; Donald Mcfall; Pat Donnelly; F. George Wilkie; Roy Sterritt

    2005-01-01

    This paper describes a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI - medical devices software process improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes.

  20. EUNOMIA: A Fast and Collaborative Interference Avoidance Technique for Wireless Medical Devices

    Microsoft Academic Search

    Mohammad S. Hossain; Tanzima Zerin Islam; Jinliang Wei; Vijay Raghunathan; Saurabh Bagchi

    2011-01-01

    Interference has long been a serious problem in wireless communication systems, causing packet loss and degradation in communication quality. The problem becomes life-threatening when it happens with medical devices. The need to address this problem is exacerbated by the increasing use of wireless embedded devices in a range of medical applications. This paper presents an interference avoidance protocol, called Eunomia,

  1. Surgical Robotics | Jacob Rosen Medical Devices: Surgical and Image Guided Technologies, First Edition

    E-print Network

    Rosen, Jacob

    Surgical Robotics | Jacob Rosen Medical Devices: Surgical and Image Guided Technologies, First- and CE-approved surgical robotic systems. The #12;Surgical Robotics | Jacob Rosen Medical Devices and clinical breakthroughs in developing new robotic systems and surgical techniques to improve the quality

  2. [Overview on the market, supervision and standardization of nanomaterial-contained medical devices].

    PubMed

    Shao, Anliang; Xu, Liming

    2015-01-01

    In this paper, industry development and market tendency, supervision and standardization of nanomaterial-contained medical devices are overviewed comprehensively based on a large number of reference data including national and international information. Furthermore, the consideration about standardization of biological evaluation for nanomaterial-contained medical devices is discussed by combined some works performed in our laboratory. PMID:26027296

  3. A Review of the Design Process for Implantable Orthopedic Medical Devices

    PubMed Central

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

    2009-01-01

    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

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

    E-print Network

    Vahid, Frank

    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

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

    PubMed

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

    2014-11-01

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

  6. Athrombogenic hydrogel coatings for medical devices - Examination of biological properties.

    PubMed

    Butruk-Raszeja, Beata A; ?ojszczyk, Ilona; Ciach, Tomasz; Ko?cielniak-Ziemniak, Magdalena; Janiczak, Karolina; Kustosz, Roman; Gonsior, Ma?gorzata

    2015-06-01

    In the article the authors present hydrogel coatings prepared from polyvinylpyrrolidone (PVP) macromolecules, which are chemically bonded to polyurethane (PU) substrate. The coating is designed to improve the surface hemocompatibility of blood-contacting medical devices. The coating was characterized in terms of physical properties (swelling ratio, hydrogel density, surface morphology, coating thickness, coating durability). In order to examine surface hemocompatibility, the materials were contacted with whole human blood under arterial flow simulated conditions followed by calculation of platelet consumption and the number of platelet aggregates. Samples were also contacted with platelet-poor plasma; the number of surface-adsorbed fibrinogen molecules was measured using ELISA assay. Finally, the inflammatory reaction after implantation was assessed, using New Zealand rabbits. The designed coating is characterized by high water content and excellent durability in aqueous environment - over a 35-day period, no significant changes in coating thickness were observed. Experiments with blood proved twice the reduction in adsorption of serum-derived fibrinogen together with a moderate reduction in the number of platelet aggregates formed during the contact of the material with blood. The analysis of an inflammatory reaction after the implantation confirmed high biocompatibility of the fabricated materials - studies have shown no toxic effects of the implanted material on the surrounding animal tissues. PMID:25912028

  7. Medication reminder device for the elderly patients with mild cognitive impairment.

    PubMed

    Kamimura, Tomoko; Ishiwata, Rina; Inoue, Takenobu

    2012-06-01

    Reminder devices reportedly improve medication adherence in the elderly patients with mild dementia; however, the efficacy of such devices remains unexplored. Therefore, a 3-month before and after study with convenience sampling was conducted to determine the efficacy of a medication reminder device used by 18 participants (aged 81.2 ± 6.2 years) with Clinical Dementia Rating scores of 0.5 or 1. At the onset of device use, examiners visited the users' homes to ensure that they and their caregivers understood how to use the device. Caregivers monitored its use during the first week. Values of the self-administration medication rate during 1 week for 13 (72.2%) users showed improvement at 3 months. This result revealed that reminder devices can improve medication adherence in the elderly patients with mild cognitive impairment. Further study is needed to assess the magnitude of this improvement and to enhance its support for users with mild cognitive impairment. PMID:22739031

  8. Technology Advances and Challenges in Hermetic Packaging for Implantable Medical Devices

    Microsoft Academic Search

    Guangqiang Jiang; David D. Zhou

    2010-01-01

    \\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

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

    Microsoft Academic Search

    William H. Muto; Edmond W. Israelski

    2007-01-01

    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,

  10. Implantable CMOS imaging devices for bio-medical applications

    Microsoft Academic Search

    Jun Ohta

    2011-01-01

    This paper reviews recent results for implantable CMOS imaging devices applied to biomedical applications. The topics include retinal prosthesis devices and deep-brain implantation devices for small animals. Device structures and their characteristics are described, and the results of in vivo experiments are demonstrated.

  11. Sumatriptan iontophoretic transdermal system for the acute treatment of migraine.

    PubMed

    Vikelis, Michail; Mitsikostas, Dimos D; Rapoport, Alan M

    2014-03-01

    SUMMARY We will describe the pharmacokinetic profile, clinical efficacy and safety data of the sumatriptan iontophoretic transdermal system (Zecuity®, NuPathe Inc., PA, USA), recently approved for the acute treatment of migraine with or without aura in adults, by the US FDA. This transdermal system utilizes a low-level electrical current to deliver sumatriptan transdermally and circumvents the GI tract. Pharmacokinetic studies have shown that iontophoretic delivery of sumatriptan achieves detectable plasma concentrations 15 min after activation with a maximum mean serum concentration of 22 ng/ml. A randomized, double-blind, controlled clinical trial demonstrated minimal triptan-related side effects and superior efficacy versus placebo. The pain-free rate at 2 h postdose was 18% of patients applying the sumatriptan patch versus 9% using the placebo (p = 0.0092). This sumatriptan transdermal system may be a good choice for migraineurs with severe nausea or vomiting, those with intolerable triptan-related adverse events and/or those not responding optimally to oral medications. PMID:24641436

  12. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...and FDA-2012-M-1013] Medical Devices; Availability of Safety...FDA-2012-M-0893....... Torax Medical, Inc LINX \\TM\\ Reflux March...FDA-2012-M-0734....... Abbott Medical Healon[supreg] July 2...Elite July 31, 2012. Vascular Balloon- Expandable Stent...

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

    Microsoft Academic Search

    Oisín Cawley; Ita Richardson; Xiaofeng Wang

    \\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

  14. Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

    PubMed

    Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

    2015-06-01

    In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events. Lansdowne K , Scully CG , Galeotti L , Schwartz S , Marcozzi D , Strauss DG . Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events. Prehosp Disaster Med. 2015;30(3):1-4. PMID:25868677

  15. FDA Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Base Section (FY-92). Manual

    SciTech Connect

    Not Available

    1992-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

  16. FDA Compliance Program Guidance Manual. Section 4. Medical and radiological devices. Base section (FY91). Manual

    SciTech Connect

    Not Available

    1990-01-24

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices.

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

    PubMed

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

    2013-12-01

    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

  18. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ...technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information...around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might...

  19. Proniosomes in transdermal drug delivery.

    PubMed

    Rahimpour, Yahya; Kouhsoltani, Maryam; Hamishehkar, Hamed

    2015-01-01

    Proniosomes are liquid crystalline-compact niosomal hybrid that can be hydrated to form niosomal dispersion instantly before use. It is a promising drug carrier with better physical and chemical stability than niosomes. Proniosomes have the potential to be scaled up for industrial purposes. They have been remarkably considered for transdermal drug delivery because of their competences, including the penetration enhancing ability of surfactants and their non-toxic characteristics. This review offers current approaches in the research and development of proniosomal formulations for the transdermal delivery of drugs with a focus on therapeutic applications. PMID:25925111

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

    Microsoft Academic Search

    Dalimar Velez; Michael Shanblatt

    2011-01-01

    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

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

    E-print Network

    Song, Dawn

    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

  2. Wellcome Trust CONSULTATION RESPONSE Wellcome Trust response to MHRA consultation on the revision of European legislation on medical devices

    E-print Network

    Rambaut, Andrew

    of European legislation on medical devices January 2013 1 Medicines and Healthcare products Regulatory Agency: The revision of European legislation on medical devices Response by the Wellcome Trust January 2013 Key Points on medical devices. We consider the proposals to be largely balanced and proportionate, providing a greater

  3. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...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)...

  4. U.S. industry leads the world in medical device innovation and production. From imaging instrumentation, monitoring

    E-print Network

    Fainman, Yeshaiahu

    objectives. The Medical Device Engineering program is designed to provide a high-quality and focusedU.S. industry leads the world in medical device innovation and production. From imaging generation of medical devices will build on recent advances in bioengineering, biomaterials, genomics

  5. 77 FR 52741 - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...Network as a Partnership for Building Global Medical Device Epidemiology...Network as a Partnership for Building Global Medical Device Epidemiology...implementing an action plan for sustainable partnership toward improving...MDEpiNet) as a partnership for building global medical device...

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

    PubMed

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

    2015-02-01

    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

  7. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES...FDA-2010-N-0001] Radiological Devices Panel of the...Name of Committee: Radiological Devices Panel of the...Center for Devices and Radiological Health, 10903 New...

  8. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ...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...

  9. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed

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

    2015-01-01

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

  11. Oxybutynin Transdermal Patch

    MedlinePLUS

    ... can use baby oil or a medical adhesive removal pad to remove residue that will not come ... room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication ...

  12. 65 FR 45991 - Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2000-07-26

    ...Medical Devices; Draft Guidance for Surveillance and Detention Without Physical Examination...guidance entitled ``Guidance for Surveillance and Detention Without Physical Examination...guidance entitled ``Draft Guidance for Surveillance and Detention Without Physical...

  13. [Recommendation for validation and routine monitoring of sterilization processes with ethylene oxide for medical devices].

    PubMed

    Jakimiak, B; Röhm-Rodowald, E

    1999-01-01

    The European Medical Device Directives specifically address sterilization issues in a number of instances. The European Standards for sterilization of medical devices, especially EN 550, EN 554, EN 556 regulate the manufacture, installation and operation of sterilizers as well as the validation of sterilization processes, on using ethylene oxide (EN 550) or moist heat (EN 554) for sterilization. This recommendation is intended as a source of information for conducting validation according to EN 550 and concomitantly for ensuring that the medical devices reprocessed (cleaned, disinfected, packed, sterilized, stored) in the hospital setting or in other healthcare establishments are endowed with the same level of safety with respect to sterility as that of industrially produced and marketed sterile medical devices. PMID:10474298

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

    PubMed

    Yu, Dong; Li, Genchi

    2012-01-01

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

  15. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ...provide the potential for nanomaterials to be used in a variety of medical device applications. However, some of these nanomaterial properties may also present safety concerns that are not found in their larger counterparts. The use of nanotechnology...

  16. 77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ...of Dockets Management (HFA- 305...Information Management, Food and...the Office of Management and Budget...enhance the quality, utility...technology. Medical Device User Fee Cover...tracking system. The...

  17. 78 FR 58316 - Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ...pediatric rare diseases. C. Specialty Practice Areas 1. For specialty practices areas (e.g. cardiology, orthopedics, and neurology) what existing medical devices appear to have the best potential for modification for rare diseases that affect the...

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

    E-print Network

    Robins, Jason S

    2008-01-01

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

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

    E-print Network

    Misri, Sandeep

    1999-01-01

    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...

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

    E-print Network

    AlEisa, Abdulaziz A. (Abdulaziz Asaad)

    2012-01-01

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

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

    E-print Network

    Dev, Nishanth K. (Nishanth Krishna)

    2013-01-01

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

  2. Development and Implementation of a Medical Device Course.

    ERIC Educational Resources Information Center

    Mendel, Philip A.

    1982-01-01

    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…

  3. Retrofitting Software Safety in an Implantable Medical Device

    Microsoft Academic Search

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

    1994-01-01

    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

  4. FDA Offers Tips about Medical Devices and Hurricane Disasters

    MedlinePLUS

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

  5. Interconnections of basic science research and product development in medical device design.

    PubMed

    Privitera, Mary Beth; Design, M; Johnson, Jeffrey

    2009-01-01

    The relationship between basic science research and product design/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition of a medical device is broad and varied. This paper is aimed towards those devices which interact with tissue and are rooted in the tenets of science. Both the scientific method and the design process are compared with similarities and opposites identified. The paper concludes identifying fundamental principles of medical device development and highlights the importance of both entities. PMID:19964135

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

    Microsoft Academic Search

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

    2012-01-01

    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

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

    Microsoft Academic Search

    Byron J Lambert; Fuh-Wei Tang

    2000-01-01

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

  8. Software quality in medical devices-a top-down approach

    Microsoft Academic Search

    D. A. Leggingwell; B. Norman

    1993-01-01

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

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

    Microsoft Academic Search

    V. P. Bulygin; A. G. Chepaikin

    2003-01-01

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

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

    Microsoft Academic Search

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

    2000-01-01

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

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

    Microsoft Academic Search

    Gregory Campbell

    2007-01-01

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

  12. Modeling of the Cuffless Blood Pressure Measurement Errors for the Evaluation of a Wearable Medical Device

    Microsoft Academic Search

    X. Y. Xiang; C. C. Y. Poon; Yuan-ting Zhang

    2006-01-01

    The two widely used standards for validating the conventional cuff-based BP devices are those set up by the American Association for the Advancement of Medical Instrumentation (AAMI) and the British Hypertension Society (BHS) respectively. It was reported that although both standards work well for most BP devices, they do not agree with each other in all circumstances. Previous attempts to

  13. Interconnections of basic science research and product development in medical device design

    Microsoft Academic Search

    Mary Beth Privitera; Jeffrey Johnson

    2009-01-01

    The relationship between basic science research and product design\\/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition

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

    Microsoft Academic Search

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

    1988-01-01

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

  15. New trends in medical devices-consequences for the curriculum at Stavanger College

    Microsoft Academic Search

    Arne Rettedal

    1996-01-01

    The development of new medical devices has many impacts on a clinical engineering department. The need for advanced repair decreases due to more sophisticated devices with self-diagnostic capabilities, while the demand for instruction, guidance and application support increases. Knowledge about quality assurance, organisation, equipment management, education and instruction is therefore strengthened in the curriculum to the Bachelor of Science degree

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

    Microsoft Academic Search

    S. V. Mikheev

    2011-01-01

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

  17. Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

    Microsoft Academic Search

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

    1995-01-01

    This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory

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

    Microsoft Academic Search

    Yamu Hu; Mohamad Sawan

    2005-01-01

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

  19. Development of a guideline for protein chip evaluation as medical devices

    Microsoft Academic Search

    H. W. Roh; N. R. Lee; Y. H. Cho; J. B. Jung; H. N. Chung; W. S. Yang; W. K. Lee; H. K. Lee; G. H. Ryu

    2006-01-01

    Protein chip technology can be applied to diagnosis of disease, prognosis, drug discovery, tailored drug therapy, screening of drug candidates and so on. A protein chip should be evaluated and approved as a medical device to be used as a diagnostic device before marketing. In this study, we prepared a cancer protein chip and evaluated it. From the results of

  20. Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices.

    PubMed

    Black, Joyce; Alves, Paulo; Brindle, Christopher Tod; Dealey, Carol; Santamaria, Nick; Call, Evan; Clark, Michael

    2015-06-01

    Medical device related pressure ulcers (MDR PUs) are defined as pressure injuries associated with the use of devices applied for diagnostic or therapeutic purposes wherein the PU that develops has the same configuration as the device. Many institutions have reduced the incidence of traditional PUs (sacral, buttock and heel) and therefore the significance of MDR PU has become more apparent. The highest risk of MDR PU has been reported to be patients with impaired sensory perception, such as neuropathy, and an impaired ability for the patient to communicate discomfort, for example, oral intubation, language barriers, unconsciousness or non-verbal state. Patients in critical care units typify the high-risk patient and they often require more devices for monitoring and therapeutic purposes. An expert panel met to review the evidence on the prevention of MDR PUs and arrived at these conclusions: (i) consider applying dressings that demonstrate pressure redistribution and absorb moisture from body areas in contact with medical devices, tubing and fixators, (ii) in addition to dressings applied beneath medical devices, continue to lift and/or move the medical device to examine the skin beneath it and reposition for pressure relief and (iii) when simple repositioning does not relieve pressure, it is important not to create more pressure by placing dressings beneath tight devices. PMID:23809279