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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. Cosmetic devices based on active transdermal technologies.

    PubMed

    Scott, Jessica A; Banga, Ajay K

    2015-09-01

    Active transdermal technology, commonly associated with drug delivery, has been used in recent years by the cosmetic industry for the aesthetic restoration of skin and delivery of cosmetic agents. In this article, we provide an overview of the skin's structure, various skin types, skin's self-repair mechanisms that are stimulated from the usage of cosmetic devices and discuss cosmetic applications. Summaries of the most common active transdermal technologies such as microneedles, iontophoresis, sonophoresis, lasers and microdermabrasion will be provided, in relation to the marketed cosmetic devices available that incorporate these technologies. Lastly, we cover combinations of active technologies that allow for more enhanced cosmetic results, and the current limitations of cosmetic devices. PMID:26389853

  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. 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

  5. Micro-scale Devices for Transdermal Drug Delivery

    PubMed Central

    Arora, Anubhav; Prausnitz, Mark; Mitragotri, Samir

    2009-01-01

    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

  6. 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 ...

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

    PubMed Central

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

    2013-01-01

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

  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 Safety

    MedlinePLUS

    ... 02/25/16 Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may ... MDR) MedWatcher Mobile App MedSun: Medical Product Safety Network Educational Webinar Materials Recognize and Report Device Problems ...

  10. Estradiol Transdermal Patch

    MedlinePLUS

    ... more from a different medication that does not contain estrogen. Most brands of estradiol transdermal patches are ... normally produced by the body.Menostar® brand patches contain less estrogen than other brands of estradiol transdermal ...

  11. Optomechanical medical devices (instruments)

    NASA Astrophysics Data System (ADS)

    Reiss, Roger S.

    2004-03-01

    Optomechanical Medical Devices (Instruments) use lightwaves (UV, Visible, IR) for one or more of the following functions; to observe, to measure, to record, to test (align) and or to cut/repair. The evolution of Optomechanical Medical Devices probably started when the first torch or candle or petrochemical lamp used a polished reflector (possibly with a concave configuration) to examine a part of a patient's body (possibly a wound).Once the glass lens was invented, light sources of any type could be forcussed to increase illuminating power on a selected area. Medical Devices have come a great distance since these early items. Skipping across time to three rather significant inventions and advancements, we are well into the era of Laser and Fiber Optics and Advanced Photodetectors, all being integrated into Medical Devices. The most notable fields have been Ophthalmology, Dermatology, and Surgery. All three fields have been able to incorporate both the use of the Laser and the use of Fiber Optics (and at times the use of Photodetectors), into a single device (instrument). Historical: Philipp Bozzini (a Doctor, maybe) in the early 1800's used a hollow tube (tube material not identified) to project the light of a candle through the tube to view a patient's 'what ever'. Only Philipp, the patient and G-d knows what was being viewed. This ws the first recorded information on what could be considered the very first 'Endoscope examination'

  12. Ex vivo evaluation of a microneedle array device for transdermal application.

    PubMed

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

    2015-12-30

    A new approach of transdermal drug delivery is the use of microneedles. This promising technique offers the potential to be broadly used for drug administration as it enables the dramatic increase in permeation of medicaments across the stratum corneum. The potential of microneedles has evolved to spawn a plethora of potential transdermal applications. In order to advance the microneedle capabilities and possibly revolutionize advanced drug delivery, this study introduces a novel transdermal electro-modulated hydrogel-microneedle array (EMH-MNA) device composed of a nano-porous, embeddable ceramic microneedle array as well as an optimized EMH for the electro-responsive delivery of indomethacin through the skin. The ex vivo permeation as well as drug release experiments were performed on porcine skin tissue to ascertain the electro-responsive capabilities of the device. In addition, the microbial permeation ability of the microneedles across the viable epidermis in both microneedle-punctured skin as well as hypodermic needle-punctured skin was determined. Ex vivo evaluation of the EMH-MNA device across porcine skin demonstrated that without electro-stimulation, significantly less drug release was obtained (0.4540mg) as compared to electro-stimulation (2.93mg). PMID:26453791

  13. 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

  14. Medical device regulation for manufacturers.

    PubMed

    McAllister, P; Jeswiet, J

    2003-01-01

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

  15. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-15

    ...The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions......

  16. 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 its 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

  17. 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

  18. 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.

  19. Transdermal power transfer for recharging implanted drug delivery devices via the refill port.

    PubMed

    Evans, Allan T; Chiravuri, Srinivas; Gianchandani, Yogesh B

    2010-04-01

    This paper describes a system for transferring power across a transdermal needle into a smart refill port for recharging implantable drug delivery systems. The device uses a modified 26 gauge (0.46 mm outer diameter) Huber needle with multiple conductive elements designed to couple with mechanical springs in the septum of the refill port of a drug delivery device to form an electrical connection that can sustain the current required to recharge a battery during a reservoir refill session. The needle is fabricated from stainless steel coated with Parylene, and the refill port septum is made from micromachined stainless steel contact springs and polydimethylsiloxane. The device properties were characterized with dry and wet ambient conditions. The needle and port pair had an average contact resistance of less than 2 Omega when mated in either environment. Electrical isolation between the system, the liquid in the needle lumen, and surrounding material has been demonstrated. The device was used to recharge a NiMH battery with currents up to 500 mA with less than 15 degrees C of resistive heating. The system was punctured 100 times to provide preliminary information with regard to device longevity, and exhibited about 1 Omega variation in contact resistance. The results suggest that this needle and refill port system can be used in an implant to enable battery recharging. This allows for smaller batteries to be used and ultimately increases the volume efficiency of an implantable drug delivery device. PMID:19936931

  20. [Benefit assessment of medical devices].

    PubMed

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

    2015-03-01

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

  1. Implantable medical devices MRI safe.

    PubMed

    Dal Molin, Renzo; Hecker, Bertrand

    2013-01-01

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

  2. 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

  3. 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

  4. Nanocoatings on implantable medical devices.

    PubMed

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

    2013-07-01

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

  5. Legislation to regulate medical devices.

    PubMed

    Harris, M

    1975-01-01

    The history of medical device regulation began with the need to rid the marketplace of bogus inventions which were either harmful in themselves or harmful because they delayed meaningful treatment of illness. Since World War II, sophistication in medical technology and development of electronic and other types of medical devices has created a new need for regulation of safety and performance of devices used to cure and mitigate disease in man. The 1938 amendments to the Food, Drug, and Cosmetic Act gave FDA authority over labeling and advertising of devices, enforceable only after devices were marketed. In 1969 a study by an HEW commission documented the need for further legislation. The commission recommended three categories of medical devices: those requiring premarket clearance or scientific review, those for which standards could be established to protect the public, and those which are generally recognized as safe and for which nor standards would be necessary. In 1974 the Senate unanimously approved Senator Kennedy's "Medical Device Amendments of 1973" legislation which fulfills the recommendations of the HEW commission report. The House of Representatives failed to pass their version of the legislation in the 93rd Congress. Senator Kennedy re-introduced the bill in the 94th Congress and it passed the Senate in April 1975. Representative Rogers re-introduced an amended bill. The bill is expected to become law in 1975. PMID:1212490

  6. 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.

  7. 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

  8. Price transparency for medical devices.

    PubMed

    Pauly, Mark V; Burns, Lawton R

    2008-01-01

    Hospital buyers of medical devices contract with manufacturers with market power that sell differentiated products. The medical staff strongly influences hospitals' choice of devices. Sellers have sought to limit disclosure of transaction prices. Policy-makers have proposed legislation mandating disclosure, in the interest of greater transparency. We discuss why a manufacturer might charge different prices to different hospitals, the role that secrecy plays, and the consequences of secrecy versus disclosure. We argue that hospital-physician relationships are key to understanding what manufacturers gain from price discrimination. Price disclosure can catalyze a restructuring of those relationships, which, in turn, can improve hospital bargaining. PMID:18997210

  9. 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

  10. 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

  11. [Consideration of Mobile Medical Device Regulation].

    PubMed

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

    The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method. PMID:26665948

  12. Marketing medical devices in Japan.

    PubMed

    Ohashi, J

    1998-01-01

    The control of medical devices in Japan has recently undergone significant changes as the country brings its systems into line with those of the United States and Europe. This article discusses pre-market approval, quality system requirements and post-market surveillance. Many technical issues have been harmonized but language is likely to continue to be a barrier to trade. Details of information services that are available to foreign manufacturers and importers are supplied. PMID:10176143

  13. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ..., 876, 878, 880, 882, 884, 886, 888, 890, and 892 Medical Devices; Technical Amendment AGENCY: Food and... Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of... outdated Web site addresses affecting certain regulations regarding medical devices. Publication of...

  14. 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.

  15. Magnetically driven medical devices: a review.

    PubMed

    Sliker, Levin; Ciuti, Gastone; Rentschler, Mark; Menciassi, Arianna

    2015-11-01

    A widely accepted definition of a medical device is an instrument or apparatus that is used to diagnose, prevent or treat disease. Medical devices take a broad range of forms and utilize various methods to operate, such as physical, mechanical or thermal. Of particular interest in this paper are the medical devices that utilize magnetic field sources to operate. The exploitation of magnetic fields to operate or drive medical devices has become increasingly popular due to interesting characteristics of magnetic fields that are not offered by other phenomena, such as mechanical contact, hydrodynamics and thermodynamics. Today, there is a wide range of magnetically driven medical devices purposed for different anatomical regions of the body. A review of these devices is presented and organized into two groups: permanent magnetically driven devices and electromagnetically driven devices. Within each category, the discussion will be further segregated into anatomical regions (e.g., gastrointestinal, ocular, abdominal, thoracic, etc.). PMID:26295303

  16. 3D medical thermography device

    NASA Astrophysics Data System (ADS)

    Moghadam, Peyman

    2015-05-01

    In this paper, a novel handheld 3D medical thermography system is introduced. The proposed system consists of a thermal-infrared camera, a color camera and a depth camera rigidly attached in close proximity and mounted on an ergonomic handle. As a practitioner holding the device smoothly moves it around the human body parts, the proposed system generates and builds up a precise 3D thermogram model by incorporating information from each new measurement in real-time. The data is acquired in motion, thus it provides multiple points of view. When processed, these multiple points of view are adaptively combined by taking into account the reliability of each individual measurement which can vary due to a variety of factors such as angle of incidence, distance between the device and the subject and environmental sensor data or other factors influencing a confidence of the thermal-infrared data when captured. Finally, several case studies are presented to support the usability and performance of the proposed system.

  17. [Buprenorphine transdermal patch (Norspan tape)].

    PubMed

    Hamaguchi, Shinsuke; Ikeda, Tomohito

    2013-07-01

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

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

    PubMed Central

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

    2011-01-01

    Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests. PMID:22125761

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

    NASA Astrophysics Data System (ADS)

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

    2011-09-01

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

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

    PubMed

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

    2011-09-01

    Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests. PMID:22125761

  1. Medical device labeling and advertising: an overview.

    PubMed

    Basile, E M; Armentrout, E; Reeves, K N

    1999-01-01

    The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims. PMID:11824451

  2. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... rulemaking (REG-113770-10) (the proposed regulations) in the Federal Register (77 FR 6028). The IRS and the... provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health... provide guidance on the excise tax imposed on the sale of certain medical devices under section 4191...

  3. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ...The Food and Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the diverse international regulatory requirements of medical devices quality management systems and......

  4. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J

    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. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  6. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  7. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  8. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  9. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  11. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  12. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  13. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  14. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  15. 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

  16. Transdermal drug delivery

    PubMed Central

    Prausnitz, Mark R.; Langer, Robert

    2009-01-01

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

  17. Transdermal drug delivery.

    PubMed

    Prausnitz, Mark R; Langer, Robert

    2008-11-01

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

  18. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  19. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  20. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  1. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  2. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  3. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  4. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  5. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  6. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  7. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices; Custom Devices; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and...

  8. Home Healthcare Medical Devices: A Checklist

    MedlinePLUS

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

  9. 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

  10. Using Zigbee to integrate medical devices.

    PubMed

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

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

  11. 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.

  12. Use of mobile devices for medical imaging.

    PubMed

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

    2014-12-01

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

  13. Medical ice slurry production device

    DOEpatents

    Kasza, Kenneth E.; Oras, John; Son, HyunJin

    2008-06-24

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

  14. The physician, the manufacturer, and medical devices.

    PubMed

    Bruner, J D; Drinker, P A

    1975-12-01

    Better communication between physicians and manufacturers of medical devices is becoming increasingly important due to wider usage of these devices, as well as more intense scrutiny by consumer interest groups. Physicians should therefore have more complete knowledge of techniques of new product development. A new product typically passes through at least six stages, as follows: (1) idea conception; (2) merit and feasibility study; (3) design and testing; (4) production preparation; (5) market preparation; and (6) marketing. These steps are completed over a period of several years at an ever increasing cost. We propose that interaction procedures be undertaken so as to enhance direct physician-manufacturer communications in the medical device arena. Some possible techniques of improving these communications include the direct training of physicians and manufacturers in each other's problems, the establishment of hospital engineering groups, the placement of medical consultants in industry, and the active participation in device standards-generating groups and other groups of mutual interest. PMID:1200835

  15. Residual ethylene oxide in medical devices and device material.

    PubMed

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

    2003-08-15

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

  16. Positive ID. Medical device standard looming.

    PubMed

    DeJohn, Paula

    2009-11-01

    After much work and research, the Food and Drug Administration is preparing to publish a proposed rule for unique device identifier (UDI) standards for medical devices. The UDI would be used to identify a vast array of medical products and would streamline the hospital supply chain while improving patient safety. For instance, having a UDI in place would assist product recall efforts. But getting hospital supply chain leaders, manufacturers, group purchasing organizations and others to embrace UDI standards won't be easy. Here's a look at what's ahead. PMID:20034178

  17. Advertising and promotion of medical devices.

    PubMed

    Portnoy, Stuart

    2006-01-01

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

  18. [Design and application of implantable medical device information management system].

    PubMed

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

    Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk. PMID:23777076

  19. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...This document contains proposed regulations that provide guidance on the excise tax imposed on the sale of certain medical devices under section 4191 of the Internal Revenue Code, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act. The proposed regulations affect manufacturers, importers, and producers of......

  20. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of... Accordingly, the final regulations (TD 9604), that are the subject of FR Doc. 2012-29628, are corrected as... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY:...

  1. The grays of medical device color additives.

    PubMed

    Seidman, Brenda

    2014-01-01

    The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its ability, better understand its past medical device color additive practices (as well as the variations that have developed within the last twenty or so years), and engage in a dialogue with stakeholders on how it and the medical device industry should consider unlisted color additives currently used in marketed devices in the United States. PMID:25654940

  2. 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

  3. Power Approaches for Implantable Medical Devices.

    PubMed

    Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  4. Power Approaches for Implantable Medical Devices

    PubMed Central

    Ben Amar, Achraf; Kouki, Ammar B.; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  5. Electronic medication packaging devices and medication adherence: A systematic review

    PubMed Central

    Checchi, Kyle D.; Huybrechts, Krista F.; Avorn, Jerry; Kesselheim, Aaron S.

    2014-01-01

    Importance Medication non-adherence, which has been estimated to affect 28-31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices. Objective To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Evidence Acquisition We systematically reviewed peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, and International Pharmaceutical Abstracts databases from searches conducted to June 13, 2014. We extracted the associations between the interventions and adherence, as well as other key findings. We assessed each study for bias using the Cochrane Handbook for Systematic Reviews of Interventions. We qualitatively assessed features of EMP devices and interventions. Results 37 studies (32 randomized and 5 non-randomized) including 4,326 patients met review criteria: 10 patient-interface-only simple interventions and 29 complex interventions integrated into the health care system (2 qualified for both categories). Overall, the effect estimates for mean adherence ranged from -2.9 to 34.0% and the effect estimates for the proportion of patients defined as adherent ranged from -8.0 to 49.5%. We identified 5 common EMP characteristics: recording dosing events and storing a record of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and providing patients with adherence performance feedback. Conclusion and Relevance Many varieties of EMP exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices and evidence of reporting bias. Devices that are integrated into the care delivery system and that are designed to record dosing events are most frequently associated with improved adherence. Higher quality evidence is needed to determine the effect, if any, of these low cost interventions on medication nonadherence and to identify their most useful components. PMID:25247520

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

    PubMed

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

    2014-10-01

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

  7. Transdermal opioids for cancer pain

    PubMed Central

    Skaer, Tracy L

    2006-01-01

    Patients with moderate to severe malignancy-related pain frequently require the use of opioid pharmacotherapy. Unfortunately, many cancer patients continue to be prescribed subtherapeutic doses of pain medications resulting in undo suffering and diminished quality of life. The choice of analgesic pharmacotherapy should be individualized and based on the intensity and etiology of pain reported by the patient. Health care providers must be able to readily quantify the relative analgesic potency when converting from one opioid to another or from one route of administration to another. Transdermal fentanyl is effective and well tolerated pharmacotherapy for the cancer pain patients. However, clinicians need to be cognizant that the U.S./U.K. manufacturer's recommendations for equilalagesic dosing of transdermal fentanyl may result in initial doses that produce subtherapeutic levels and unrelieved pain in some patients. A more aggressive dosing algorithm for transdermal fentanyl using a 2:1 (mg/day of oral morphine: mcg/hr of transdermal fentanyl) conversion ratio that considers both a review of the literature and clinical experience should help clinicians individualize cancer pain pharmacotherapy. Transdermal buprenorphine is now being prescribed in Europe and Australia for chronic and cancer pain management. Buprenorphine's mixed agonist/antagonist activity, dosage ceiling, and high affinity to the opiate receptor limits its use to those patients who do not already require large daily doses of opioids. Thus, buprenorphine may not be an appropriate medication for some patients with advanced unremitting cancer pain. PMID:16573839

  8. 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

  9. 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.

  10. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting...

  11. Overview of the US FDA medical device approval process.

    PubMed

    Sastry, Ashwani

    2014-01-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices;...

  13. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices;...

  14. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use 801.127 Medical devices... under the regulations in this section is made to a person in whose possession the article is not...

  15. 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

    ... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... related to medical devices intended for obese patients. The committee will provide...

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function... intervention for patients who have failed maximal medical management. Of note, the CoAxia NeuroFlo Catheter...

  17. 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

  18. Hacking medical devices a review - biomed 2013.

    PubMed

    Frenger, Paul

    2013-01-01

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

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

    PubMed

    Kampfrath, Thomas; Cotten, Steven W

    2013-10-01

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

  20. Integrated Microbatteries for Implantable Medical Devices

    NASA Technical Reports Server (NTRS)

    Whitacre, Jay; West, William

    2008-01-01

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

  1. 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.

  2. [USA approval of high-risk medical device].

    PubMed

    Chang, Yongheng

    2013-03-01

    During the practice of supervision and management of medical device in different countries, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device. PMID:23777072

  3. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  4. Legislative aspects of the development of medical devices.

    PubMed

    Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

    2015-09-01

    European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices. PMID:26459127

  5. MEDEMAS -Medical Device Management and Maintenance System Architecture

    NASA Astrophysics Data System (ADS)

    Dogan, Ülkü Balcı; Dogan, Mehmet Ugur; Ülgen, Yekta; Özkan, Mehmed

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

  6. Medical devices, the FDA, and the home healthcare clinician.

    PubMed

    Simone, Lisa K; Brumbaugh, JoAnn; Ricketts, Catherine

    2014-01-01

    This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments. PMID:24978574

  7. Medical device reporting: electronic submission requirements. Final rule.

    PubMed

    2014-02-14

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

  8. 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

  9. 77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical... Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis....

  10. Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices.

    PubMed

    Vinck, Imgard; Hulstaert, Frank; Van Brabandt, Hans; Neyt, Mattias; Stordeur, Sabine

    2011-12-01

    The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA. PMID:22128518

  11. 77 FR 16239 - Medical Device User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... MDUFA reauthorization process with a public meeting held on September 14, 2010 (75 FR 49502, August 13... 26, 2012. To register for the meeting, please visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to the FDA Medical Devices News & Events--Workshops &...

  12. Medical device regulations and testing for toxicologic pathologists.

    PubMed

    Schuh, Joann C L

    2008-01-01

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

  13. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical...

  14. Sterilization equipment and services: a medical device technology survey.

    PubMed

    Pearson, L S

    1992-01-01

    Most medical device manufacturers use sterilization procedures at some point in their production processes. Many factors affect the choice of sterilization method and whether manufacturers sterilize products in-house or subcontract their sterilization requirements. Underlying trends are apparent, and this article summarizes these trends from the results of a survey recently conducted among European medical device, diagnostic, and pharmaceutical manufacturers. PMID:10171587

  15. 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

  16. Medical Device Integration Model Based on the Internet of Things.

    PubMed

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner. PMID:26628938

  17. Medical Device Integration Model Based on the Internet of Things

    PubMed Central

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner. PMID:26628938

  18. 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

  19. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan?

    PubMed Central

    Handa, Nobuhiro; Ishii, Kensuke; Matsui, Yutaka; Ando, Yuki

    2015-01-01

    Background Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15days (some cases 30days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC>15days (DOC15) and delayed reports (DCR>15 or 30days) were also calculated. Results AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30. Comments Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential. PMID:26501120

  20. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying norovirus...

  1. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... the brain. The device is intended to be used as a monotherapy, after surgical and radiation options... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  2. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Collection; Comment Request; Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration... solicits comments on information collection requirements for humanitarian use devices (HUDs). DATES: Submit... of information technology. Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB...

  3. 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

  4. NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

    PubMed Central

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

    2010-01-01

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

  5. Current status of the regulation for medical devices.

    PubMed

    Shah, Anuja R; Goyal, R K

    2008-11-01

    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

  6. Experiences of new product development in the medical device industry.

    PubMed

    Dixon, D; Brown, A; Meenan, B J; Eatock, J

    2006-04-01

    A survey of medical device professionals has revealed the factors that influence the development time and market success of new products. The vital elements that deliver commercial success are reported here. PMID:16736659

  7. Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA. PMID:10128335

  8. PVC and phthalates in medical devices: a never ending story.

    PubMed

    Hansen, O Grndahl

    2006-04-01

    Phthalate-plasticised poly (vinyl chloride) (PVC) medical devices have been subject to critical attention for 15 years. This article reviews latest developments. It addresses whether hospitals have achieved their goal of phasing out PVC and phthalates and if it is a certainty that a medical device is better with regard to health and the environment just because it does not contain PVC and phthalates. European risk assessments are also reported. PMID:16736658

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

    PubMed

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

    2014-01-01

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

  10. Development of Implantable Medical Devices: From an Engineering Perspective

    PubMed Central

    2013-01-01

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

  11. 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

  12. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor... solicits comments on medical device reporting (MDR); manufacturer, importer, user facility, and distributor... appropriate, and other forms of information technology. Medical Device Reporting: Manufacturer, Importer,...

  13. 76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... Collection; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration, HHS... on the information collection requirements for medical device recall authority. DATES: Submit either... of information technology. Medical Device Recall Authority--21 CFR Part 810 (OMB Control Number...

  14. 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

    ... in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can... HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices...

  15. 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

    ..., the names and addresses of proposed participants, and an indication of the approximate time requested... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the...

  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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of...

  19. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system...

  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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... and are pre-loaded onto 6 or 7 Fr \\1\\ (diameter of 2 or 2.3 mm) delivery systems. Upon deployment,...

  2. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 14, 2011 (76 FR 41507). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the...

  3. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  4. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  6. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  8. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  9. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  10. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  11. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  12. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  14. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  15. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  16. 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

  17. Design Engineering of Biomaterials for Medical Devices

    NASA Astrophysics Data System (ADS)

    Hill, David

    1998-10-01

    Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.

  18. [Key Technology and Quantity Control of Wearable Medical Devices].

    PubMed

    Cui, Hongen; Yao, Shaowei

    2015-03-01

    In recent years, because the wearable medical devices can indicate the health monitoring index of blood sugar, blood pressure, heart rate, oxygen content, temperature, respiration of the human body anytime and anywhere, can also be used for the treatment of various diseases, accompanied by the development of large data, which will bring a subversive revolution for the medical device industry. This paper introduces the development of wearable devices, key technical index of main products, and to make a preliminary study on its quantity control. PMID:26204741

  19. Medical devices in dermatology using DLP technology from Texas Instruments

    NASA Astrophysics Data System (ADS)

    Kock, M.; Lüllau, F.

    2012-03-01

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

  20. Evaluation of Measuring Devices Packaged With Prescription Oral Liquid Medications

    PubMed Central

    Johnson, Anthony

    2016-01-01

    OBJECTIVES: The US Food and Drug Administration industry guidelines for manufacturers of oral, over-the-counter, liquid medications recommend that these products be packaged with dosage-delivery devices. This study describes the prevalence of these devices and instructions packaged with prescription, oral, liquid medications. METHODS: This was a descriptive study of prescription oral-liquid medications dispensed during a 6-month period at a community pharmacy. Product information was obtained from the National Library of Medicine's DailyMed database and from the products themselves. Endpoints included provision of a measuring device, the type of device, the maximum dose measurable and intervals on the provided device, and inclusion of instructions to the pharmacist. RESULTS: A total of 382 liquid prescription medications were included in the study. Forty-nine of the 382 products (12.8%) were packaged with a measuring device. The most commonly provided device was a calibrated dropper (n = 18; 36.7%), followed by an oral syringe with a bottle adaptor (n = 9, 18.4%). Specific instructions on proper use of the provided measuring device were included with 20 products (40.8%). Among the products that did not provide a measuring device, only 70 of the 333 package inserts (21%) included instructions to the pharmacist regarding counseling the patient on proper administration. CONCLUSIONS: Packaging of prescription oral-liquid medications is inconsistent and leaves room for vast variability in patient or parent administration practices. In the future, patterns of actual dispensing practices among pharmacies and pharmacists would help determine the true incidence of dispensing of measuring devices. PMID:26997931

  1. Standards for medical devices in MRI: present and future.

    PubMed

    Woods, Terry O

    2007-11-01

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

  2. Medical device integration using mobile telecommunications infrastructure.

    PubMed

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

    Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment. PMID:23692108

  3. 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.

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

    PubMed

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

    2007-04-01

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

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

    PubMed

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

    2010-01-01

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

  6. Design considerations for medical devices in the home environment.

    PubMed

    Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

    2010-01-01

    Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment. PMID:22049603

  7. Implantable photonic devices for improved medical treatments

    NASA Astrophysics Data System (ADS)

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

    2014-10-01

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

  8. Implantable photonic devices for improved medical treatments.

    PubMed

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

    2014-01-01

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

  9. Assessment of cardiovascular and noncardiovascular medical device recalls.

    PubMed

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

    2014-06-01

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

  10. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ...-angle glaucoma currently treated with ocular hypotensive medication. For this device, the patients... phacoemulsification. The patient's glaucoma should be considered mild to moderate Primary Open Angle Glaucoma, or the secondary open angle glaucomas, Pigmentary Glaucoma and Pseudoexfoliation Glaucoma. Patients with...

  11. Government health policy and the diffusion of new medical devices.

    PubMed Central

    Hillman, B J

    1986-01-01

    The combination of absent financial incentives, aspects of physicians' clinical training, and the uncertainty surrounding the appropriate application of expensive new medical devices have been the most significant factors in promoting their wasteful diffusion and use. This presentation summarizes the forces that have resulted in regulatory and reimbursement initiatives to make more efficient the acquisition and utilization of new medical devices. The case histories of computed tomography (CT) and magnetic resonance imaging (MRI) serve as a paradigm demonstrating why such initiatives have thus far proved ineffectual. More effective would be to abandon distinctions between inpatient and outpatient reimbursement for using new medical devices and to improve the relationship between reimbursement and technology assessment. PMID:3818311

  12. Study of the in vitro cytotoxicity testing of medical devices

    PubMed Central

    LI, WEIJIA; ZHOU, JING; XU, YUYIN

    2015-01-01

    The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices. PMID:26405534

  13. Facilitating Virtual Health Management Using Medical Device Integration.

    PubMed

    Zaleski, John R

    2015-01-01

    Data from connected medical devices (CMDS) provides an objective and rich source of information to augment patient care management and clinical decision making. A principal reason is measurements of patient properties made through bedside CMDs are not typically subject to errors associated with misinterpretation, incorrect recording, and incorrect time stamping. Furthermore, data from CMDs can be collected regularly, ensuring a dense and robust data record on a given patient. The ability to remotely manage and monitor patients is greatly facilitated by access to data, as measurements represent an objective source of information that facilitate clinical decision making. In my recent book, Connected Medical Devices: Integrating Patient Care Data in Healthcare System, I discuss the topic of medical device integration (MDI) in relation to implementing CMDs in healthcare settings as a guide to assist hospitals in this undertaking. The following discussion about MDI are the opening paragraphs from this text, followed by a discussion of MDI architectures. PMID:26571635

  14. Risk management in the design of medical device software systems.

    PubMed

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

    2002-01-01

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

  15. Rotigotine Transdermal Patch

    MedlinePLUS

    ... that causes difficulties with movement, muscle control, and balance) including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Rotigotine transdermal patches are also used to treat ...

  16. Transdermal delivery of testosterone.

    PubMed

    Hadgraft, Jonathan; Lane, Majella E

    2015-05-01

    Male hypogonadism has been treated with exogenous testosterone since the 1930s. The early transdermal patches of testosterone became available in the 1980s with gel and solution preparations following subsequent decades. This review focusses on the skin permeation characteristics of testosterone, pharmacokinetics following application of transdermal formulations and formulations currently available. At present, gels dominate the market for transdermal testosterone replacement therapy, presumably because of their greater patient acceptability and non-occlusive nature compared with patches. However, specific incidences of secondary transfer of gels to children with consequent unwanted effects such as precocious puberty have been reported. A regulatory review of all testosterone replacement therapies is currently underway which may have implications for future prescribing practices of transdermal testosterone products. PMID:25709060

  17. Medical devices transition to information systems: lessons learned.

    PubMed

    Charters, Kathleen G

    2012-01-01

    Medical devices designed to network can share data with a Clinical Information System (CIS), making that data available within clinician workflow. Some lessons learned by transitioning anesthesia reporting and monitoring devices (ARMDs) on a local area network (LAN) to integration of anesthesia documentation within a CIS include the following categories: access, contracting, deployment, implementation, planning, security, support, training and workflow integration. Areas identified for improvement include: Vendor requirements for access reconciled with the organizations' security policies and procedures. Include clauses supporting transition from stand-alone devices to information integrated into clinical workflow in the medical device procurement contract. Resolve deployment and implementation barriers that make the process less efficient and more costly. Include effective field communication and creative alternatives in planning. Build training on the baseline knowledge of trainees. Include effective help desk processes and metrics. Have a process for determining where problems originate when systems share information. PMID:24199054

  18. A Review of Simulators with Haptic Devices for Medical Training.

    PubMed

    Escobar-Castillejos, David; Noguez, Julieta; Neri, Luis; Magana, Alejandra; Benes, Bedrich

    2016-04-01

    Medical procedures often involve the use of the tactile sense to manipulate organs or tissues by using special tools. Doctors require extensive preparation in order to perform them successfully; for example, research shows that a minimum of 750 operations are needed to acquire sufficient experience to perform medical procedures correctly. Haptic devices have become an important training alternative and they have been considered to improve medical training because they let users interact with virtual environments by adding the sense of touch to the simulation. Previous articles in the field state that haptic devices enhance the learning of surgeons compared to current training environments used in medical schools (corpses, animals, or synthetic skin and organs). Consequently, virtual environments use haptic devices to improve realism. The goal of this paper is to provide a state of the art review of recent medical simulators that use haptic devices. In particular we focus on stitching, palpation, dental procedures, endoscopy, laparoscopy, and orthopaedics. These simulators are reviewed and compared from the viewpoint of used technology, the number of degrees of freedom, degrees of force feedback, perceived realism, immersion, and feedback provided to the user. In the conclusion, several observations per area and suggestions for future work are provided. PMID:26888655

  19. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery..., 21 CFR part 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1....

  20. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878 continues to read as...

  1. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878 continues to read as...

  2. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ..., 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration,...

  3. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  4. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a...

  5. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... to facilitate discussion among FDA and academic researchers with expertise in epidemiology and health... experience in epidemiology or health services research with an interest in medical device outcome and... Between the Center for Devices and Radiological Health and Academia; Public Workshop AGENCY: Food and......

  6. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... HUMAN SERVICES Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open...

  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

    ... HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  8. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying...

  9. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice. This notice announces a forthcoming meeting of...

  10. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  11. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  13. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  14. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  15. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  16. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  17. 78 FR 46977 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  18. 76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the eyelid thermal...

  19. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration...

  20. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  1. 77 FR 32125 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA)...

  2. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting...

  3. Medical Devices Assess, Treat Balance Disorders

    NASA Technical Reports Server (NTRS)

    2009-01-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  5. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  6. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services....

  7. Development of wearable medical device for Bio-MEMS

    NASA Astrophysics Data System (ADS)

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

    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 blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 μm in internal diameter, was measured. The wearable medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 μl/sec. If the wearable medical device extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15μl/sec.

  8. Risk evaluation of medical and industrial radiation devices

    SciTech Connect

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

    1994-03-01

    In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis.

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Educational Forum on Medical Device Reporting, Complaint... (ORA), Southwest Region (SWR), Dallas District Office (DALDO), in collaboration with the FDA Medical... Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals.'' The purpose of...

  10. From concept to exit strategies--medical device innovation.

    PubMed

    Kermit, Eben L

    2004-01-01

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

  11. 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.

  12. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. The Food and Drug Administration (FDA)...

  13. Applied ergonomics: determining user needs in medical device design.

    PubMed

    Privitera, Mary Beth; Design, M; Murray, Dale L

    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 defined. PMID:19964396

  14. Medical Device Safety - Multiple Languages: MedlinePlus

    MedlinePLUS

    ... of All Topics All Medical Device Safety - Multiple Languages To use the sharing features on this page, please enable JavaScript. Chinese - Traditional (繁體中文) French (français) Japanese (日本語) Korean (한국어) Russian (Русский) Somali ( ...

  15. Statistical and regulatory issues in nonrandomized medical device clinical studies.

    PubMed

    Li, Heng; Yue, Lilly Q

    2008-01-01

    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 statistical inference obtained from such studies may carry a lower level of scientific assurance, compared to randomized trials. This paper provides a brief overview of nonrandomized medical device clinical studies in terms of design and statistical analysis as well as regulatory issues, including some challenges that frequently arise in those endeavors. PMID:18161539

  16. Medical Device Risk Management For Performance Assurance Optimization and Prioritization.

    PubMed

    Gaamangwe, Tidimogo; Babbar, Vishvek; Krivoy, Agustina; Moore, Michael; Kresta, Petr

    2015-01-01

    Performance assurance (PA) is an integral component of clinical engineering medical device risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and improved PA program operational decision making. However, a common framework that relates the various processes of a quantitative risk system does not exist. This article provides a perspective that focuses on medical device quality and risk-based elements of the PA program, which include device inclusion/exclusion, schedule optimization, and inspection prioritization. A PA risk management framework is provided, and previous quantitative models that have contributed to the advancement of PA risk management are examined. A general model for quantitative risk systems is proposed, and further perspective on possible future directions in the area of PA technology is also provided. PMID:26618842

  17. French Sizing of Medical Devices is not Fit for Purpose

    SciTech Connect

    Kibriya, Nabil Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

    2013-08-01

    PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  18. Image Quality Characteristics of Handheld Display Devices for Medical Imaging

    PubMed Central

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

    2013-01-01

    Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.210?5 mm2 at 1 mm?1, while handheld displays have values lower than 3.710?6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

  19. Use of transdermal drug formulations in the elderly.

    PubMed

    Kaestli, Laure-Zoé; Wasilewski-Rasca, Anne-Florence; Bonnabry, Pascal; Vogt-Ferrier, Nicole

    2008-01-01

    Transdermal drug delivery systems are pharmaceutical forms designed to administer a drug through the skin to obtain a systemic effect. They ensure a constant rate of drug administration and a prolonged action. Several different types of transdermal delivery devices are available on the market. They are either matrix or reservoir systems and their main current uses are to treat neurological disorders, pain and coronary artery disease, and as hormone replacement therapy. Transdermal drug administration has a number of advantages compared with the oral route: it avoids gastrointestinal absorption and hepatic first-pass metabolism, minimizes adverse effects arising from peak plasma drug concentrations and improves patient compliance. Compared with the parenteral route, transdermal administration entails no risk of infection. For elderly people, who are often polymedicated, transdermal drug delivery can be a good alternative route of administration. Transdermal absorption depends on passive diffusion through the different layers of the skin. As skin undergoes many structural and functional changes with increasing age, it would be useful to know whether these alterations affect the transdermal diffusion of drugs. Studies have shown that age-related changes in hydration and lipidic structure result in an increased barrier function of the stratum corneum only for relatively hydrophilic compounds. In practice, no significant differences in absorption of drugs from transdermal delivery systems have been demonstrated between young and old individuals. The need for dose adaptation in elderly patients using transdermal drug delivery systems is therefore not related to differences in skin absorption but rather to age-related cardiovascular, cerebral, hepatic and/or renal compromise, and to ensuing geriatric pharmacokinetic and pharmacodynamic changes. PMID:18361538

  20. Perspectives on transdermal ultrasound mediated drug delivery

    PubMed Central

    Smith, Nadine Barrie

    2007-01-01

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

  1. Transdermal iontophoresis. Part I: Basic principles and considerations.

    PubMed

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

    1999-03-01

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

  2. Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair. Final order.

    PubMed

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. These devices are used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. This order exempts electric positioning chairs, class II devices, from premarket notification, subject to certain conditions for exemption. This exemption from premarket notification, subject to these conditions (and the limitations in the physical medicine devices limitations of exemptions from premarket notification section of the device regulations), is immediately in effect for electric positioning chairs. FDA is publishing this order in accordance with the exemption from class II premarket notification section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). PMID:26595944

  3. 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.

  4. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ...) Implementation: Online Repository of Medical Device Labeling, Including Photographs; Public Meeting AGENCY: Food... of an Online Repository of Medical Device Labeling and of Making Device Photographs Available in a... of a searchable medical device labeling repository that would be accessible by the public and...

  5. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... HUMAN SERVICES Food and Drug Administration Distinguishing Medical Device Recalls From Product... clarify for industry when a potential change to a device is a medical device recall, distinguish those... single copies of the draft guidance document entitled ``Distinguishing Medical Device Recalls...

  6. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  8. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  9. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

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

    PubMed Central

    2011-01-01

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

  11. Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

    PubMed

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

    Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. PMID:25710902

  12. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for... availability of the draft guidance entitled ``Medical Device Development Tools.'' This document provides... of medical device development tools (MDDT) for use in device development and evaluation...

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

    PubMed

    Wittenber, J; Shabot, M M

    1990-04-01

    A new object-oriented Medical Device Data Language (MDDL) has been developed by the P1073 Medical Information Bus (MIB) Standard Committee, under the auspices of the Engineering in Biology and Medicine Society (EMBS) of the Institute of Electronic and Electrical Engineers (IEEE). The MDDL treats devices, host computers, persons and parameters as objects, and provides methods for describing and passing messages between objects. An elegant method of specifying parameter attributes incorporates the inheritance and encapsulation qualities common to object-oriented languages. Existing standards for device, parameter and attribute nomenclatures are used to represent MDDL components whenever possible. The MDDL provides a rich and extensible method for standardized host-device communications. PMID:2373946

  14. Wireless energy transfer platform for medical sensors and implantable devices.

    PubMed

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

    2009-01-01

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

  15. Observations on medical device design, Part I: Current practice.

    PubMed

    Clarkson, J; Alexander, K; Bishop, D

    1999-09-01

    Medical devices must be designed and proven to be fit for the purpose that they were intended. Good design practice ensures this fitness for purpose and is reflected in the commercial success of products. This two-part article focuses on current industry design practice and proposes that there are significant benefits to be obtained by defining good design practice: better products and reduced development costs. PMID:10623354

  16. 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.

  17. 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.

  18. Antimicrobial selenium nanoparticle coatings on polymeric medical devices.

    PubMed

    Tran, Phong A; Webster, Thomas J

    2013-04-19

    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. PMID:23519147

  19. 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

  20. Materials Advances for Next-Generation Ingestible Electronic Medical Devices.

    PubMed

    Bettinger, Christopher J

    2015-10-01

    Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted. PMID:26403162

  1. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology..., HHS. ACTION: Final rule; correction. SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272..., 301- 796-6694. SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5675 appearing on page 14272 in the...

  2. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... (FDA) is correcting a final rule that appeared in the Federal Register of March 23, 2011 (76 FR 16292..., Rm. 3208, Silver Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc....

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

    PubMed

    Bachmor, T; Schchlin, J; Bolz, A

    2002-01-01

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

  4. Perspectives on Transdermal Electroporation.

    PubMed

    Ita, Kevin

    2016-01-01

    Transdermal drug delivery offers several advantages, including avoidance of erratic absorption, absence of gastric irritation, painlessness, noninvasiveness, as well as improvement in patient compliance. With this mode of drug administration, there is no pre-systemic metabolism and it is possible to increase drug bioavailability and half-life. However, only a few molecules can be delivered across the skin in therapeutic quantities. This is because of the hindrance provided by the stratum corneum. Several techniques have been developed and used over the last few decades for transdermal drug delivery enhancement. These include sonophoresis, iontophoresis, microneedles, and electroporation. Electroporation, which refers to the temporary perturbation of the skin following the application of high voltage electric pulses, has been used to increase transcutaneous flux values by several research groups. In this review, transdermal electroporation is discussed and the use of the technique for percutaneous transport of low and high molecular weight compounds described. This review also examines our current knowledge regarding the mechanisms of electroporation and safety concerns arising from the use of this transdermal drug delivery technique. Safety considerations are especially important because electroporation utilizes high voltage pulses which may have deleterious effects in some cases. PMID:26999191

  5. 77 FR 27234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-09

    ... based these estimates on conversations with industry, trade association representatives, and internal... Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY: Food and Drug... notice solicits comments on the Inspection by Accredited Persons Program Under the Medical Device...

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

    PubMed

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

    2009-12-01

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

  7. Transdermal delivery of therapeutic agent

    NASA Technical Reports Server (NTRS)

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

    2008-01-01

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

  8. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Format of dates provided on a medical device label. 801.18 Section 801.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... on a medical device label. (a) In general. Whenever the label of a medical device includes a...

  9. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for...

  10. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to 1.750 that a patent for a medical device is eligible for extension, the term shall be extended by the time as...

  11. 75 FR 53702 - Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... (75 FR 49502), FDA announced that a public meeting on the reauthorization of the medical device user... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Act; Public Meeting; Request for... reauthorization of the medical device user fee program. This meeting was announced in the Federal Register...

  12. [The Analysis on Application of Global Medical Device Nomenclature(GMDN)].

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2015-07-01

    The article has reviewed the administration technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country. PMID:26665949

  13. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Transitional pass-through payments: Medical devices... DEPARTMENT SERVICES Transitional Pass-through Payments 419.66 Transitional pass-through payments: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets...

  14. 75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2011 AGENCY... announcing the ] fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments...

  15. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2012 AGENCY... announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee...

  16. 78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2014 AGENCY... announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee...

  17. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... of agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  18. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  19. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Drug Administration 21 CFR Part 874 Medical Devices; Ear, Nose, and Throat Devices; Classification of... to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: PART 874--EAR,...

  20. 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

  1. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false Medical supplies, appliances, and devices: Scope... HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services 410.36 Medical supplies, appliances, and devices: Scope. (a) Medicare Part B pays for...

  2. Development of medical electronic devices in the APL space department

    NASA Technical Reports Server (NTRS)

    Newman, A. L.

    1985-01-01

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

  3. Navigating conflicts of interest for the medical device entrepreneur.

    PubMed

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. PMID:23217436

  4. Emerging medical devices for minimally invasive cell therapy.

    PubMed

    O'Cearbhaill, Eoin D; Ng, Kelvin S; Karp, Jeffrey M

    2014-02-01

    The past decade has seen the first wave of cell-based therapeutics undergo clinical trials with varying degrees of success. Although attention is increasingly focused on clinical trial design, owing to spiraling regulatory costs, tools used in delivering cells and sustaining the cells' viability and functions in vivo warrant careful scrutiny. While the clinical administration of cell-based therapeutics often requires additional safeguarding and targeted delivery compared with traditional therapeutics, there is significant opportunity for minimally invasive device-assisted cell therapy to provide the physician with new regenerative options at the point of care. Herein we detail exciting recent advances in medical devices that will aid in the safe and efficacious delivery of cell-based therapeutics. PMID:24485137

  5. What the Internet means for the medical device industry.

    PubMed

    Frank, T

    2000-12-01

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

  6. Polymeric biomaterials for load-bearing medical devices

    NASA Astrophysics Data System (ADS)

    Pruitt, Lisa; Furmanski, Jevan

    2009-09-01

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

  7. Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices

    NASA Astrophysics Data System (ADS)

    Weltmann, Klaus-Dieter; Winter, Jrn; Polak, Martin; Ehlbeck, Jrg; 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.

  8. Challenges to validation of a complex nonsterile medical device tray.

    PubMed

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

    2014-01-01

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

  9. [The choice of inhalation device: A medical act].

    PubMed

    Devillier, P; Salvator, H; Roche, N

    2015-06-01

    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

  10. Safety and cleaning of medical materials and devices.

    PubMed

    Merritt, K; Hitchins, V M; Brown, S A

    2000-01-01

    A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough cleaning procedure should precede sterilization or disinfection (with the exception of NaOCl bleach which also cleans). PMID:10713558

  11. 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.

  12. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    NASA Astrophysics Data System (ADS)

    Coad, James E.

    2011-03-01

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

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

    MedlinePLUS

    ... device and all device manuals. □ First aid kit □ Medical records □ Insurance cards □ Current home care doctor’s orders □ Plan of treatment □ What a family member, friend or hospital should do to help me in an emergency. □ My power of attorney (personal and medical) allowing someone to act on my behalf if ...

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

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

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

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

    PubMed

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices. PMID:15876645

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

    PubMed

    Mattamal, George J

    2008-01-01

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

  17. [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

  18. Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook.

    PubMed

    Walter, Jessica R; Xu, Shuai

    2015-11-01

    The US Food and Drug Administration (FDA) approved the first transdermal drug over 35 years ago. Today, transdermal products represent a growing, multibillion dollar market. From 2000 to 2014, an average of 2.6 new transdermal drug were approved each year. However, only two of these approvals represented new molecular entities (NMEs). Furthermore, none of these approvals were designated for priority review by the FDA. Currently, transdermal drugs are limited in scope to fewer than 20 clinical indications. The past decade has seen significant safety, performance, and cost issues surrounding multiple transdermal drug products. As the field moves towards more complex drug-device combinations to overcome the natural barrier function of the skin, there will likely be more regulatory challenges, but also the potential for broader clinical scope. PMID:26116094

  19. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December 1, 2011. The meeting was announced in the Federal Register of Friday, October 7, 2011 (76 FR 62419). The... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the...

  20. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of August 16, 2010 (75 FR 49940). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the...

  1. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 7, 2011 (76 FR 39882). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the...

  2. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Ear, Nose and Throat Devices Panel...

  3. 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

  4. EDI system definition for a European medical device vigilance system.

    PubMed

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

    1996-01-01

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

  5. An electronic post market surveillance system for medical devices.

    PubMed

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

    2003-06-01

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

  6. Large Eddy Simulation of FDAs 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 Administrations (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

  7. 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

  8. 75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-13

    ... register by August 31, 2010. Please register at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops... provided to help potential meeting participants better understand the history and evolution of the medical.../MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm approximately 10 days before the...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... required by such clause. (e) As it is a common industry practice to manufacture and/or assemble, package... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions 801.150 Medical...

  10. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... required by such clause. (e) As it is a common industry practice to manufacture and/or assemble, package... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions 801.150 Medical...

  11. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions 801.15 Medical...

  12. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  13. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under 801.15(c)....

  14. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under 801.15(c)....

  15. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under 801.15(c)....

  16. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  17. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ...The Food and Drug Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to solicit feedback on select actions outlined in the Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of identified......

  18. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under 801.15(c)....

  19. Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

    PubMed

    2006-09-25

    The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA. PMID:17017469

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  1. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges

    PubMed Central

    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

  2. Effective use of transdermal drug delivery in children.

    PubMed

    Delgado-Charro, M Begoa; 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

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

    MedlinePLUS

    ... Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out ... needed. What is the role of your home healthcare provider and supplier in your infusion therapy? Your ...

  4. The potential of medical device industry in technological and economical context

    PubMed Central

    Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

    2015-01-01

    The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow. PMID:26491337

  5. Optimize Use of Space Research and Technology for Medical Devices

    NASA Technical Reports Server (NTRS)

    Minnifield, Nona K.

    2012-01-01

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

  6. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    PubMed

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation. PMID:26292478

  7. 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

  8. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ...The Department of Defense is publishing this final rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device.'' This provision codifies the coverage of those medically necessary indications for which there are demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use is safe and effective......

  9. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Federal Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review and... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical.... ACTION: Notice. SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the...

  10. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  11. 75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting...

  12. 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

  13. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ...The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Region (SWR), Dallas District Office (DALDO), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to......

  14. Medical device registration, agreements on mutual recognition a step forward to global harmonization?

    NASA Astrophysics Data System (ADS)

    Eidenberger, Reiner

    2000-03-01

    The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal a safe product but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force.

  15. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on Medical Device Safety and Quality... Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on... extreme weather effects on medical device safety and quality. DATES: Submit either electronic or...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity... notice solicits comments on Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  18. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis....

  19. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis....

  20. 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

  1. 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

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

    PubMed

    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

  3. 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 patients 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 patients 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 75:1110:1 have been suggested. Cancer patients may require larger transdermal buprenorphine doses to control their pain and may respond better to a more aggressive 75100:1 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

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

    PubMed

    Hodgins, Diana

    2004-01-01

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

  5. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability of Safety and Effectiveness... Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc LINX \\TM\\ Reflux March 22, 2012...-M-0734....... Abbott Medical Healon July 2, 2012. Optics, Inc. EndoCoat OpViscosurgical...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Medical supplies, appliances, and devices: Scope. 410.36 Section 410.36 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other...

  7. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false Medical supplies, appliances, and devices: Scope. 410.36 Section 410.36 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other...

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

    PubMed

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

    2012-12-01

    Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA. PMID:23116531

  9. 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.

  10. 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.

  11. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... assistance to pediatric device innovators. This workshop will support FDA's efforts to define pathways for... scientific literature, to support and establish pediatric indications for medical devices. The topics to be... for approval of pediatric devices that uses certain literature. FDA can advance this goal...

  12. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... unclassified devices and devices not yet classified. In the Federal Register of January 3, 2012 (77 FR 125... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration,...

  13. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound... Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure... Apparatus Device Intended for Negative Pressure Wound Therapy.'' The agency is classifying the device...

  14. 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

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

    PubMed

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

    2014-12-01

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

  16. Implantable Medical Devices with Electric Current Retrieval Assist

    Cancer.gov

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

  17. Materials degradation in PVC medical devices, DEHP leaching and neonatal outcomes.

    PubMed

    Latini, G; Ferri, M; Chiellini, F

    2010-01-01

    Polymeric materials play a key role in the production of medical and clinical devices thanks to their special features such as flexibility, easy processing and good price/performance ratio. Among the different polymeric matrixes, one of the most used is Poly(vinyl chloride) (PVC). At room temperature PVC is hard and brittle, thus great amounts (40-50%) of phthalate esters that act as plasticizers are added to the polymer to make it flexible and appropriate for medical use. Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC medical devices. However, DEHP is not chemically bound to PVC and migrates from medical devices with time and use. The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community. In particular, newborns in the new environment have to be considered at particularly increased risk, because of their small body size and the multiple medical device-related to the DEHP exposure. The major factors determining the degree to which DEHP migrates from medical devices are temperature, amount of DEHP in the device, storage time, shaking of the device while in contact with the medical solutions and degree of PVC degradation. PMID:20858177

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

    PubMed

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

    2014-03-01

    SUMMARYWe 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

  19. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., 15 CFR part 774, supplement no. 1 (excluding items classified as EAR 99). (c) The term medical... Administration Regulations, 15 CFR part 774, supplement no. 1 (excluding items classified as EAR 99). ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Food, medicine, and medical...

  20. Transdermal delivery of human epidermal growth factor facilitated by a peptide chaperon.

    PubMed

    Ruan, Ren-Quan; Wang, Shan-Shan; Wang, Chang-Li; Zhang, Li; Zhang, Yun-Jiao; Zhou, Wei; Ding, Wei-Ping; Jin, Pei-Pei; Wei, Peng-Fei; Man, Na; Wen, Long-Ping

    2013-04-01

    Peptide chaperon TD1 was discovered to facilitate several proteins' transdermal delivery via topical co-administration. To design a practical, safe system for advanced transdermal peptide, a novel method was carried out. Human epidermal growth factor (hEGF) was selected as the model biological agent and a fusion protein: TD1-hEGF was designed. Study showed that TD1-hEGF not only had the similar bioactivity with native hEGF, but also possessed considerable higher transdermal ability than hEGF and a co-administration of TD1 and hEGF. These results provided convincing evidence for the advantages of TD1-hEGF in cosmetic and medical applications. Moreover, the fusion pattern between the cargoes and TD1 offered a new approach to facilitate other hydrophilic drugs' transdermal delivery for therapeutic application. PMID:23385091

  1. 26 CFR 48.4191-2 - Taxable medical device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... product code NBW. The FDA classifies the lancets under 21 CFR part 878 (General and Plastic Surgery...) of the FFDCA and 21 CFR part 807, pursuant to FDA requirements. (2) Devices that should have been... classified by the FDA under Subpart D of 21 CFR part 890 (Physical Medicine Devices). (ii) Primarily for...

  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. Design of tactile device for medical application using magnetorheological fluid

    NASA Astrophysics Data System (ADS)

    Oh, J. S.; Kim, J. K.; Lee, S. R.; Choi, S. B.; Song, B. K.

    2013-02-01

    For the tactile recognition of human organ in minimally invasive surgery (MIS), this paper presents a novel tactile device that incorporates with magnetorheological (MR fluid). The MR fluid is contained by diaphragm and several pins. The operator for MIS can feel different force (or stiffness) from the proposed tactile device by applying different magnetic field or current. In order to generate required force from the device, the repulsive force from the human body is measured as reference data and an appropriate size of tactile device is designed and manufactured. It has been demonstrated via experiment that the repulsive force corresponding to the human body can be achieved by applying proper control input current. In addition, it has been shown that we can control the repulsive force by dividing the tactile device by several sections.

  4. [Wearable Medical Devices' MCU Selection Analysis Based on the ARM Cortex-MO+ Architecture].

    PubMed

    Wu, Zaoquan; Liu, Mengxing; Qin, Liping; Ye, Shuming; Chen, Hang

    2015-03-01

    According to the characteristics of low cost, high performance, high integration and long battery life of wearable medical devices, the mainstream low-power microcontroller(MCU) series were compared, and came to the conclusion that the MCU series based on ARM Cortex-M0+ architecture were suitable for the development of wearable medical devices. In aspects of power consumption, operational performance, integrated peripherals and cost, the MCU series based on Cortex-M0+ architecture of primary semiconductor companies were compared, aimed at providing the guides of MCU selection for wearable medical devices. PMID:26524785

  5. Medical devices for restless legs syndrome – clinical utility of the Relaxis pad

    PubMed Central

    Mitchell, Ulrike H

    2015-01-01

    Restless Legs Syndrome or Willis–Ekbom Disease, a neurosensory disorder, can be treated with pharmaceuticals or conservatively. This review focuses on conservative treatments, more specifically on treatments with medical devices. Two modes of action, enhancement of circulation and counter stimulation, are introduced. Medical devices that use enhancement of circulation as their mechanism of action are whole body vibration, pneumatic compression, and near-infrared light. Medical devices that use counter stimulation include transcutaneous electrical nerve stimulation and the vibration Relaxis pad. The clinical utility of the Relaxis pad and its place in therapy is proposed. PMID:26664128

  6. Medical devices for restless legs syndrome - clinical utility of the Relaxis pad.

    PubMed

    Mitchell, Ulrike H

    2015-01-01

    Restless Legs Syndrome or Willis-Ekbom Disease, a neurosensory disorder, can be treated with pharmaceuticals or conservatively. This review focuses on conservative treatments, more specifically on treatments with medical devices. Two modes of action, enhancement of circulation and counter stimulation, are introduced. Medical devices that use enhancement of circulation as their mechanism of action are whole body vibration, pneumatic compression, and near-infrared light. Medical devices that use counter stimulation include transcutaneous electrical nerve stimulation and the vibration Relaxis pad. The clinical utility of the Relaxis pad and its place in therapy is proposed. PMID:26664128

  7. Microneedle-mediated transdermal bacteriophage delivery

    PubMed Central

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

    2012-01-01

    Interest in bacteriophages as therapeutic agents has recently been reawakened. Parenteral delivery is the most routinely-employed method of administration. However, injection of phages has numerous disadvantages, such as the requirement of a health professional for administration and the possibility of cross-contamination. Transdermal delivery offers one potential means of overcoming many of these problems. The present study utilized a novel poly (carbonate) (PC) hollow microneedle (MN) device for the transdermal delivery of Escherichia coli-specific T4 bacteriophages both in vitro and in vivo. MN successfully achieved bacteriophage delivery in vitro across dermatomed and full thickness skin. A concentration of 2.67נ106PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0נ103PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13נ103PFU/ml being detected in blood 30min following initial MN-mediated phage administration. Clearance occurred rapidly, with phages being completely cleared from the systemic circulation within 24h, which was expected in the absence of infection. We have shown here that MN-mediated delivery allows successful systemic phage absorption. Accordingly, bacteriophage-based therapeutics may now have an alternative route for systemic delivery. Once fully-investigated, this could lead to more widespread investigation of these interesting therapeutic viruses. PMID:22750416

  8. The transdermal delivery of fentanyl.

    PubMed

    Lane, Majella E

    2013-08-01

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

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

    PubMed Central

    Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

    2014-01-01

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

  10. 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

  11. On-line integration of computer controlled diagnostic devices and medical information systems in undergraduate medical physics education for physicians.

    PubMed

    Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir

    2013-01-01

    We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. PMID:22200603

  12. Applying the interaction design approach to medical devices.

    PubMed

    Smith, J; Leftwich, J

    1991-04-01

    The medical industry is undergoing a radical transformation as increasingly powerful personal computers become the predominant user interface for both clinical and laboratory equipment. Accompanying this change is the introduction of a design discipline known as interaction design, which has given rise to a new breed of specialists whose role is to champion the end user--that is, the physician, scientist, or medical technician--at every stage of the product-development cycle. PMID:10147994

  13. Transdermal innovations in diabetes management.

    PubMed

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

    2014-01-01

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

  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. PMID:25868677

  15. 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

  16. 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 Labeling; Availability AGENCY... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling... ``Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health...

  17. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content and... content and format for medical device labeling and the use of a repository containing medical device... session. Standard content and format of full labeling and a shortened version of labeling will...

  18. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with...

  19. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with...

  20. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. SUMMARY: The Food and Drug Administration...

  1. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing...

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

    PubMed

    Baretich, Matthew F

    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. Despite this received wisdom, clinical engineers continue to encounter examples of medical device design that invite users to do the wrong thing, with potentially harmful results. This paper focuses on electrical and other connectors incorporated into medical device designs. Examples of potential and actual misconnections, from the earliest days of clinical engineering to the present, are presented and discussed. PMID:17271042

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

    PubMed

    Jakimiak, B; Rhm-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

  4. 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

    ... Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric... Estimate and Reward True Patient-Centric Value in Innovation.'' FDA is cosponsoring the workshop with...

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

    PubMed

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26595943

  6. Assessment of total silver and silver nanoparticle extraction from medical devices.

    PubMed

    Sussman, Eric M; Jayanti, Priyanka; Dair, Benita J; Casey, Brendan J

    2015-11-01

    There is concern over the release of silver nanoparticles (AgNPs) from medical devices due to their potential toxicological consequences inside the body. Towards developing the exposure component of a risk assessment model, the purpose of this study was to determine the amount and physical form of silver released from medical devices. Scanning electron microscopy was used to confirm that three of five marketed medical devices contained nanosilver coatings (mean feature sizes 115-341nm). Aqueous device extracts (water, saline and human plasma) were analyzed with inductively coupled plasma mass spectrometry, ultraviolet-visible spectroscopy, dynamic light scattering, transmission electron microscopy, and nanoparticle tracking analysis. The amount of silver extracted from the devices ranged from 1נ10(-1) to 1נ10(6)ng/cm(2) (conditions ranged from 37 to 50C, over one hour to seven days). The results further indicated that one of the five devices (labeled MD1) released significantly more AgNPs than the other devices. This data suggests that some but not all devices that are formulated with nanosilver may release detectable levels of AgNPs upon extraction. Further work is underway to quantitate the proportion of silver released as AgNPs and to incorporate this data into a risk assessment for AgNP exposure from medical devices. PMID:26282371

  7. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient... stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of... treatment; Seizure; Scalp discomfort, scalp burn, or other adverse effects; Magnetic field effects...

  8. 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

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

    PubMed

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

    2004-01-01

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

  10. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  11. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  12. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  13. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  14. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  15. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: Obstetrics and...

  16. A Structured Approach for Investigating the Causes of Medical Device Adverse Events

    PubMed Central

    Amoore, John N.

    2014-01-01

    Aim. Medical device-related adverse events are often ascribed to “device” or “operator” failure although there are more complex causes. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes. Method. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was explored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework of causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each aspect having detailed subdivisions. The approach was applied to incidents from the literature and an anonymous incident database. Results. The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of “device,” “operator,” or “infrastructure” failures. Applied to incident databases it suggested that causes differ between device types and identified the causes of device unavailability. Discussion. The structured approach enables digging deeper to uncover the wider causes rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology for describing and sharing information on the causes of medical device adverse events.

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

    PubMed

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

    2010-07-01

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

  18. 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

    .../common/help/en/support/meeting_test.htm . To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview . (FDA has verified the Web site addresses in this document, but... established to promote the development of products (drugs, biologics, medical devices, or medical foods)...

  19. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    .... Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that amended... December 23, 2010. SYSTEM. FDA-2011-M-0035 P100028 Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011...-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198] Medical Devices; Availability of...

  20. 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 ...

  1. 77 FR 23484 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-19

    ... Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot Study AGENCY: Food and... Device Decision Analysis: A Risk-Tolerance Pilot Study.'' DATES: Submit either electronic or written... treatment decision. With the assistance of advisory panels, FDA determines the acceptable risk threshold...

  2. 75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... response to the 60-day notice of February 5, 2008 (73 FR 6729) (Docket No. FDA-2008-N-0050). FDA... the Federal Register of February 8, 2002 (67 FR 5943), FDA issued a final rule which conformed... Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration,...

  3. 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

  4. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... contains human blood or a blood component as a component of the final device, and the human blood or blood... that the product was manufactured from a donation found to be reactive by a screening test for evidence... reactivity of the human blood or blood component in the medical device presents no significant health...

  5. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... contains human blood or a blood component as a component of the final device, and the human blood or blood... that the product was manufactured from a donation found to be reactive by a screening test for evidence... reactivity of the human blood or blood component in the medical device presents no significant health...

  6. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... contains human blood or a blood component as a component of the final device, and the human blood or blood... that the product was manufactured from a donation found to be reactive by a screening test for evidence... reactivity of the human blood or blood component in the medical device presents no significant health...

  7. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... contains human blood or a blood component as a component of the final device, and the human blood or blood... that the product was manufactured from a donation found to be reactive by a screening test for evidence... reactivity of the human blood or blood component in the medical device presents no significant health...

  8. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

  9. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

  11. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

  13. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... Workshop; Notice of Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device...

  14. 77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... of 2012 (Title 2 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144... certain medical device submissions, and annual fees both for certain periodic reports and for... collectively as ``submissions'' or ``applications''); for periodic reporting on class III devices; and for...

  15. 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

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  16. 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

    ... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  17. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... visiting public workshop participants (non-FDA employees) must enter through Building 1 for routine..., Standardization, Emerging technology and innovation, and Mitigation of challenges. Goals 1. Create awareness of... medical devices. 5. Promote innovation in technology and processes to improve device performance...

  18. Dip molding to form intricately-shaped medical elastomer devices

    NASA Technical Reports Server (NTRS)

    Broyles, H. F.

    1975-01-01

    Preshaped mandrel mounted on rotating mechanism is partically immersed in tank filled with liquid elastomer. While mandrel rotates, elastomer film forms om mandrel surface due to surface tension and capillary behavior of liquid. Devices with well-defined flanges can be made using process.

  19. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 801.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is exempt... such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The...

  20. Trust and transparency in clinical trials of medical devices

    PubMed Central

    Kramer, Daniel B.; Cutlip, Donald E.

    2015-01-01

    Regulatory approval of high-risk cardiovascular devices is on the basis of clinical studies submitted with a premarket approval application. Failure to publish many of these studies in peer-reviewed literature, and major discrepancies between premarket approval submissions and those studies that are published, raise important questions for clinicians and other stakeholders. PMID:26194550

  1. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 801.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is exempt... such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The...

  2. Electromagnetic compatibility of WLAN adapters with life-supporting medical devices.

    PubMed

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

    2011-05-01

    This paper investigates the electromagnetic compatibility of 45 critical care medical devices (infusion pumps, defibrillators, monitors, lung ventilators, anesthesia machines and external pacemakers) with various types of wireless local area network (WLAN, IEEE 802.11 b/g, 2.45 GHz, 100 mW) adapters. Interference is evaluated by performing ad-hoc tests according to the ANSI C63.18 recommended practice. The behavior of the devices during the tests was monitored using patient simulators/device testers specific for each device class. Electromagnetic interference cases were observed in three of 45 devices at a maximum distance of 5 cm. In two cases the interference caused malfunctions that may have clinical consequences for the patient. The authors' findings show that the use of these wireless local area network adapters can be considered reasonably safe, although interference may occur if they are operated at very close distance (<10 cm) to the medical devices. PMID:21451319

  3. Fentanyl Transdermal Patch

    MedlinePLUS

    ... need pain medication around the clock for a long time and who cannot be treated with other medications. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

  4. Transdermal Nicotine for Smoking Cessation.

    ERIC Educational Resources Information Center

    Hughes, John R.; Glaser, Mitchell

    1993-01-01

    Discusses the use of transdermal nicotine (TN) in smoking cessation and its value as an effective procedure. The article reveals that, compared to a placebo, TN has double the quit rate percentages, and less than 5% of smokers quit TN due to side effects. (GLR)

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

    NASA Astrophysics Data System (ADS)

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

    2014-01-01

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

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

    PubMed Central

    SORENSON, CORINNA; DRUMMOND, MICHAEL

    2014-01-01

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

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

    PubMed Central

    Rome, Benjamin N.; Kramer, Daniel B.

    2014-01-01

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

  8. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    PubMed

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

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

  9. Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid. Final order.

    PubMed

    2015-09-22

    The Food and Drug Administration (FDA) is classifying the oral electronic vision aid 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 oral electronic vision aid'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:26394454

  10. Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System. Final order.

    PubMed

    2016-01-01

    The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26742184

  11. Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.

    PubMed

    2015-08-01

    The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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:26245004

  12. Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System. Final order.

    PubMed

    2015-09-30

    The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the steerable cardiac ablation catheter remote control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26422836

  13. Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System. Final order.

    PubMed

    2015-11-23

    The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26595945

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

    NASA Astrophysics Data System (ADS)

    Harrison, Ian

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

  15. Implantable Glucose BioFuel Cells for Medical Devices

    NASA Astrophysics Data System (ADS)

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

    2013-12-01

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

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

    PubMed

    Blake, Kathleen

    2013-03-01

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

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

    PubMed Central

    Gittard, Shaun D; Narayan, Roger J

    2010-01-01

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

  18. [Assessment of the sterilization of medical devices--an important challenge to health care in Poland].

    PubMed

    Rhm-Rodowald, Ewa; Jakimiak, Bozenna

    2004-01-01

    The aim of the study was the evaluation of sterilization of medical devices in Polish hospitals. The system that we use to establish which sterilization procedures should be employed to reduce the risk of hospital infections associated with medical devices. Based on inquiries, the conditions for the sterilization of medical devices in 21 Warsaw hospitals were assessed. The following issues were taken into consideration: preparation of medical supplies for sterilization, methods of sterilization and the monitoring system. In order to evaluate hygienic conditions due to sterilization points system was applied. 10% of the hospitals had Central Sterilization Service Department with 3 zones where automatic washing and disinfection, sorting, packaging, sterilization and storage of medical devices had been performed. The other 20% had CSSD without zones. In more than 65% there were common services for sterilization only. Instruments were delivered already prepared for sterilization. In remaining hospitals all steps, including sterilization were performed in words. According preparation of medical devices for sterilization it was established that mainly chemical disinfection just after use and than manual cleaning was used; the automatic cleaning in washer-disinfectors is used mainly in CSSD. Steam was the preferred method of sterilization, but also low temperature methods were used for heat sensitive devices. The monitoring of sterilization processes was satisfactory. There were first trials of the validation of the sterilization processes. There is still a need for improvement in the sterilization of medical devices, especially including: the organisation of CSSD in all Polish hospitals; replacement of manual cleaning processes by automatic cleaning; organisation of advanced training courses for the heads and staff of the CSSD. PMID:15730015

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

    PubMed Central

    2014-01-01

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

  20. 78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... stainless steel with or without a gold, silver, or titanium coating. II. Regulatory History of the Device In the Federal Register of January 25, 2013 (78 FR 5327), FDA proposed to classify scleral plug devices... coating in gold, silver, or titanium) from premarket notification (510(k)) and continuing to...

  1. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... FR 31040), FDA issued a proposed rule to reclassify the device, full-field digital mammography system... discussed in the preamble to the proposed rule (73 FR 31040) and comments on the proposed rule and draft... controls). The device type is intended to produce planar digital x-ray images of the entire breast;...

  2. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... device is intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a proposed order which, if... FR 19834). The committee's discussion will include recommendations regarding the regulatory... Class I devices that are subject to premarket notification (510(k)) requirements (48 FR 53041)....

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

    PubMed

    2013-03-01

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

  4. 76 FR 71045 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov , (301) 796-3805, or FDA... reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued...

  5. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast... Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating...

  6. Needle free parenteral drug delivery: leveraging active transdermal technologies for pediatric use.

    PubMed

    Subramony, J Anand

    2013-10-15

    Administration of medications via the parenteral route directly to the systemic circulation is an effective way of overcoming the first pass effect, obtaining quicker onset of action, and achieving higher bioavailability. However, needle phobia and the pain perceived during the injection process often make this a less preferred route than oral in terms of patient acceptance and compliance, particularly for pediatrics. Needleless injection technologies that deliver medications via the transdermal interface have been an active area of pharmaceutical research for many years. This review summarizes the various emerging technologies in the area of active transdermal delivery that can be potentially extended to pediatric applications. PMID:23916825

  7. SMPTE Test Pattern For Certification Of Medical Diagnostic Display Devices

    NASA Astrophysics Data System (ADS)

    Lisk, Kenneth G.

    1984-08-01

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

  8. Noninvasive and minimally invasive methods for transdermal glucose monitoring.

    PubMed

    Sieg, Anke; Guy, Richard H; Delgado-Charro, M Begoña

    2005-02-01

    Noninvasive and minimally invasive techniques for monitoring glucose via the skin are reviewed. These approaches rely either on the interaction of electromagnetic radiation with the tissue or on the extraction of fluid across the barrier. The structure and physiology of the skin make the technical realization of transdermal glucose monitoring a difficult challenge. The techniques involving transdermal fluid extraction circumvent and/or compromise the barrier function of skin's outermost and least permeable layer, the stratum corneum, by the application of physical energy. While sonophoresis and microporation methods, for example, are in relatively early-stage development, a device using reverse iontophoresis [the GlucoWatch Biographer (Cygnus, Inc., Redwood City, CA)] is already commercially available. Optical techniques to monitor glucose are truly noninvasive. The tissue is irradiated, the absorbed or scattered radiation is analyzed, and the information is processed, to provide a measure proportional to the concentration of glucose in the dermal tissue. These techniques include near-infrared and Raman spectroscopy, polarimetry, light scattering, and photoacoustic spectroscopy. By contrast, impedance spectroscopy measures changes in the dielectric properties of the tissue induced by blood glucose variation. Large-scale studies in support of efficacy of these methodologies are as yet unavailable. At present, therefore, transdermal fluid extraction technologies are offering greater promise in terms of practical and realizable devices for patient use. The truly noninvasive allure of the optical approach assures continued and intense research activity--for the moment, however, an affordable, efficient, and portable system is not on the immediate horizon. PMID:15738715

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

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

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

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

    PubMed

    Thacharodi, D; Rao, K P

    1996-07-01

    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 using modified Franz diffusion cells. Drug release was found to depend on the type of membrane used to control the drug delivery, suggesting that drug delivery is efficiently controlled by the rate-controlling membranes. PMID:8805978

  11. Modular reservoir concept for MEMS-based transdermal drug delivery systems

    NASA Astrophysics Data System (ADS)

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

    2014-11-01

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

  12. Needle phobia and stress-reducing medical devices in pediatric and adult chemotherapy patients.

    PubMed

    Kettwich, Sharon C; Sibbitt, Wilmer L; Brandt, John R; Johnson, Courtney R; Wong, Craig S; Bankhurst, Arthur D

    2007-01-01

    Needle phobia--fear of medical devices--is a significant problem in pediatric and adult chemotherapy patients. Stress-reducing medical devices is a new, effective cognitive therapy for needle phobia. Twenty-five pediatric and 25 adult chemotherapy patients were randomly exposed to conventional or stress-reducing decorated butterfly needles and syringes. Emotional stress responses were determined with the Visual Aversion Scale, Visual Analogue Fear Scale, Visual Analogue Anxiety Scale, and Visual Overall Stress Score for each needle and syringe design. Sixty-eight percent of the pediatric and 52% of the adult patients were overtly needle phobic, but children demonstrated significantly more aversion and stress (P < .001). Stress-reducing medical devices effectively and significantly reduced aversion, anxiety, fear, and overall stress, and were 76% effective in preventing overt needle phobia in children and 92% effective in adults (P < .001). One hundred percent of children and adults felt that stress-reducing medical devices should be available in chemotherapy clinics. Needle phobia and stress in pediatric and adult chemotherapy patients are significantly reduced by the use of stress-reducing medical devices. PMID:17185398

  13. Cerebrospinal fluid-compensated medication reservoir for an implantable infusion device: concept and preliminary evaluation.

    PubMed

    Nam, Kyoung Won; Choi, Seong Wook; Kim, In Young; Kim, Kwang Gi; Jo, Yung Ho; Kim, Dae Hyun

    2013-05-17

    Conventional gas-compensated medication reservoirs used for implantable infusion devices require perfect sealing of the gas chamber, because the gases used are generally toxic. In addition, the physical properties of selected gas critically affect the performance of infusion devices and hydraulic performance of the infusion device can be affected by the amount of medication discharged.?In this study, we suggest a new medication reservoir that adopts a cerebrospinal fluid (CSF)-compensating mechanism, such that when a medication is released from the reservoir by a mechanical actuator, native CSF enters into the reservoir to minimize the build-up of pressure drop. We evaluated in vitro performance and conducted in vivo feasibility tests by using an intrathecal infusion device developed at the Korean National Cancer Center. Experimental results showed that the proposed CSF-compensated infusion pump was essentially less affected by ambient temperature or pressure conditions compared to the gas-compensated infusion pump. Moreover, it showed moderate implant feasibility and operating stability during an animal experiment performed for 12 days. We believe that the proposed volume-compensating mechanism could be applied in various medical fields that use implantable devices. PMID:23504815

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

    PubMed

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

    2013-09-01

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

  15. Developing a Commercial Air Ultrasonic Ceramic Transducer to Transdermal Insulin Delivery

    PubMed Central

    Jabbari, Nasrollah; Asghari, Mohammad Hossein; Ahmadian, Hassan; Mikaili, Peyman

    2015-01-01

    The application of low-frequency ultrasound for transdermal delivery of insulin is of particular public interest due to the increasing problem of diabetes. The purpose of this research was to develop an air ultrasonic ceramic transducer for transdermal insulin delivery and evaluate the possibility of applying a new portable and low-cost device for transdermal insulin delivery. Twenty-four rats were divided into four groups with six rats in each group: one control group and three experimental groups. Control group (C) did not receive any ultrasound exposure or insulin (untreated group). The second group (T1) was treated with subcutaneous insulin (Humulin R, rDNA U-100, Eli Lilly and Co., Indianapolis, IN) injection (0.25 U/Kg). The third group (T2) topically received insulin, and the fourth group (T3) received insulin with ultrasound waves. All the rats were anesthetized by intraperitoneal injection of ketamin hydrochloride and xylazine hydrochloride. Blood samples were collected after anesthesia to obtain a baseline glucose level. Additional blood samples were taken every 15 min in the whole 90 min experiment. In order for comparison the changes in blood glucose levels to In order to compare the changes in blood glucose levels. The statistical multiple comparison (two-sided Tukey) test showed a significant difference between transdermal insulin delivery group (T2) and subcutaneous insulin injection group (T1) during 90 min experiment (P = 0.018). In addition, the difference between transdermal insulin delivery group (T2) and ultrasonic transdermal insulin delivery group (T3) was significant (P = 0.001). Results of this study demonstrated that the produced low-frequency ultrasound from this device enhanced the transdermal delivery of insulin across hairless rat skin. PMID:26120571

  16. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a... market this type of device must submit to FDA a premarket notification, prior to marketing the...

  17. 76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-29

    ... approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft...

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

    PubMed

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

    2009-03-01

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

  19. Patient safety and interactive medical devices: Realigning work as imagined and work as done

    PubMed Central

    Furniss, Dominic; Vincent, Chris

    2014-01-01

    Medical devices are essential tools for modern healthcare delivery. However, significant issues can arise if medical devices are designed for work as imagined when this is misaligned with work as done. This problem can be compounded as the details of device design, in terms of usability and the way a device supports or changes working practices, often receives limited attention. The ways devices are designed and used affect patient safety and quality of care: inappropriate design can provoke user error, create system vulnerabilities and divert attention from other aspects of patient care. Current regulation involves a series of pre-market checks relating to device usability, but this assumes that devices are always used under the conditions and for the purposes intended (i.e. work as imagined); there are many reasons for devices being used in ways other than those assumed at development time. Greater attention needs to be paid to learning points in actual use and user experience (i.e. work as done). This needs to inform manufacturers designs, management procurement decisions and local decisions about how devices are used in practice to achieve co-adaptation; without these, we foster risks and inefficiencies in healthcare. PMID:25866466

  20. 75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... HUMAN SERVICES Food and Drug Administration Medical Device Use in the Home Environment: Implications for... Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... technology in the home environment. FDA seeks input and comments on a number of identified topics related...

  1. Josephson junction devices: Model quantum mechanical systems and medical applications

    NASA Astrophysics Data System (ADS)

    Chen, Josephine

    In this dissertation, three experiments using Josephson junction devices are described. In Part I, the effect of dissipation on tunneling between charge states in a superconducting single-electron transistor (sSET) was studied. The sSET was fabricated on top of a semi-conductor heterostructure with a two-dimensional electron gas (2DEG) imbedded beneath the surface. The 2DEG acted as a dissipative ground plane. The sheet resistance of the 2DEG could be varied in situ by applying a large voltage to a gate on the back of the substrate. The zero-bias conductance of the sSET was observed to increase with increasing temperature and 2DEG resistance. Some qualitative but not quantitative agreement was found with theoretical calculations of the functional dependence of the conductance on temperature and 2DEG resistance. Part II describes a series of experiments performed on magnesium diboride point-contact junctions. The pressure between the MgB2 tip and base pieces could be adjusted to form junctions with different characteristics. With light pressure applied between the two pieces, quasiparticle tunneling in superconductor-insulator-superconductor junctions was measured. From these data, a superconducting gap of approximately 2 meV and a critical temperature of 29 K were estimated. Increasing the pressure between the MgB2 pieces formed junctions with superconductor-normal metal-superconductor characteristics. We used these junctions to form MgB2 superconducting quantum interference devices (SQUIDS). Noise levels as low as 35 fT/Hz1/2 and 4 muphi 0/Hz1/2 at 1 kHz were measured. In Part III, we used a SQUID-based instrument to acquire magnetocardiograms (MCG), the magnetic field signal measured from the human heart. We measured 51 healthy volunteers and 11 cardiac patients both at rest and after treadmill exercise. We found age and sex related differences in the MCG of the healthy volunteers that suggest that these factors should be considered when evaluating the MCG for disease. We also defined a spatio-temporal MCG parameter, the repolarization stabilization interval, which successfully discriminated our patients from our healthy controls.

  2. [Design of transdermal ultrasonophoresis equipment].

    PubMed

    Li, Liangcheng; Zhang, Yongshun; Li, Zhonghong

    2009-02-01

    The recent fast development in biotechnology has resulted in a large number of therapeutic biologicals coming in the foreground for clinical application. Transdermal drug delivery (TDD) is designed for patching the drug on the skin, and then the drug molecules permeate through the skin into the subcutaneous capillary vessels. However,very few drugs can be administered transdermally at the therapeutic levels to pass through the barrier of stratum corneum. Several physical and chemical methods are applied to improve the permeability of skin. Research result shows that the low-frequency ultrasonic technique can extraordinarily increase the rate of permeation. As a result, it is becoming one of the potential methods that serve as the substitutes for traditional methods. In this paper is presented a type of equipment based on MSP430. The principle of design, the structure of hardware, and the applied function in this area are described. PMID:19334582

  3. [Design of transdermal ultrasonophoresis equipment].

    TOXLINE Toxicology Bibliographic Information

    Li L; Zhang Y; Li Z

    2009-02-01

    The recent fast development in biotechnology has resulted in a large number of therapeutic biologicals coming in the foreground for clinical application. Transdermal drug delivery (TDD) is designed for patching the drug on the skin, and then the drug molecules permeate through the skin into the subcutaneous capillary vessels. However,very few drugs can be administered transdermally at the therapeutic levels to pass through the barrier of stratum corneum. Several physical and chemical methods are applied to improve the permeability of skin. Research result shows that the low-frequency ultrasonic technique can extraordinarily increase the rate of permeation. As a result, it is becoming one of the potential methods that serve as the substitutes for traditional methods. In this paper is presented a type of equipment based on MSP430. The principle of design, the structure of hardware, and the applied function in this area are described.

  4. Wearable medical devices for tele-home healthcare.

    PubMed

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

    2004-01-01

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

  5. Nicotine Transdermal Patch

    MedlinePLUS

    ... first 2 weeks on the medication. A gradual reduction to lower strength patches is recommended to reduce ... of reach of children. Store it at room temperature and away from excess heat and moisture (not ...

  6. Buprenorphine Transdermal Patch

    MedlinePLUS

    ... safely dispose of the used patch in the trash. Used patches may still contain some medication and ... safely dispose of the unwanted patch in the trash. Wash your hands well with water after throwing ...

  7. Application of a Temporal Reasoning Framework Tool in Analysis of Medical Device Adverse Events

    PubMed Central

    Clark, Kimberly K.; Sharma, Deepak K.; Chute, Christopher G.; Tao, Cui

    2011-01-01

    The Clinical Narrative Temporal Relation Ontology (CNTRO)1 project offers a semantic-web based reasoning framework, which represents temporal events and relationships within clinical narrative texts, and infer new knowledge over them. In this paper, the CNTRO reasoning framework is applied to temporal analysis of medical device adverse event files. One specific adverse event was used as a test case: late stent thrombosis. Adverse event narratives were obtained from the Food and Drug Administrations (FDA) Manufacturing and User Facility Device Experience (MAUDE) database2. 15 adverse event files in which late stent thrombosis was confirmed were randomly selected across multiple drug eluting stent devices. From these files, 81 events and 72 temporal relations were annotated. 73 temporal questions were generated, of which 65 were correctly answered by the CNTRO system. This results in an overall accuracy of 89%. This system should be pursued further to continue assessing its potential benefits in temporal analysis of medical device adverse events. PMID:22195199

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

    PubMed Central

    Ferguson, John E; Redish, A David

    2013-01-01

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

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

    PubMed

    Ferguson, John E; Redish, A David

    2011-07-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

    Howard, Jason J

    2014-01-01

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

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

    PubMed

    Howard, Jason J

    2014-01-01

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

  13. Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India

    PubMed Central

    Deorukhkar, Sachin C.; Saini, Santosh

    2016-01-01

    Health care associated infections (HCAIs) add incrementally to the morbidity, mortality, and cost expected of the patient's underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI), catheter-associated urinary tract infection (CA-UTI), intravascular catheter-related blood stream infections (CR-BSI), and ventilator-associated pneumonia (VAP), were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp. PMID:26904115

  14. Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India.

    PubMed

    Deorukhkar, Sachin C; Saini, Santosh

    2016-01-01

    Health care associated infections (HCAIs) add incrementally to the morbidity, mortality, and cost expected of the patient's underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI), catheter-associated urinary tract infection (CA-UTI), intravascular catheter-related blood stream infections (CR-BSI), and ventilator-associated pneumonia (VAP), were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp. PMID:26904115

  15. New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues.

    PubMed

    Martelli, Nicolas; van den Brink, Hélène; Borget, Isabelle

    2016-01-01

    We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers. PMID:26797231

  16. 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

    .... DATES: The direct final rule published at 75 FR 16347, April 1, 2010, is withdrawn on July 19, 2010. FOR... Food and Drugs, the direct final rule published on April 1, 2010, at 75 FR 16347 is withdrawn. Dated... From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal...

  17. 78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... Personal Use Monitoring Devices; Classification of the Ingestible Event Marker AGENCY: Food and Drug... May 7, 2012, classifying the Proteus Personal Monitor including ingestible event marker into class III... petition requesting classification of the Proteus Personal Monitor including ingestible event marker...

  18. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... depth of compressions for the duration of CPR. On January 8, 2013 (78 FR 1162), FDA issued a proposed... regulatory history of ECC devices has been discussed as part of the proposed rule (77 FR 36951, June 20, 2012... sensitivity, and other pacing variables. On October 17, 2011 (76 FR 64224), FDA issued a proposed rule...

  19. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... Devices; Classification of Contact Cooling System for Aesthetic Use AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the contact... Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' The Agency is classifying...

  20. 77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ...This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA) to discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific......

  1. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from....) In the Federal Register of June 1, 2012 (77 FR 32644), FDA published a notice announcing that this... criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees they weigh...

  2. 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

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from..., p. 3.) In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing that... against the criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees...

  3. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... published a proposed rule (44 FR 50520) for classification of iontophoresis devices for specialized uses... the proposed rule, FDA published a final rule (48 FR 53047) on November 23, 1983, classifying... rule 44 FR 50520), FDA disagreed with the comments and concluded that insufficient data exist...

  4. 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

    ... notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting... for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In FR doc. 2013-04543... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel...

  5. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    PubMed Central

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

  6. Trial Registration for Public Trust: Making the Case for Medical Devices

    PubMed Central

    2007-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration. PMID:18095047

  7. Trial registration for public trust: making the case for medical devices.

    PubMed

    Sim, Ida

    2008-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration. PMID:18095047

  8. A service protocol for post-processing of medical images on the mobile device

    NASA Astrophysics Data System (ADS)

    He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

    2014-03-01

    With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

  9. Linking Engineering and Medical Training: A USC program seeks to introduce medical and engineering students to medical device development.

    PubMed

    Tolomiczenko, George; Sanger, Terry

    2015-01-01

    Medical students are attracted by the prospect of a meaningful addition to their clinical work. Engineering students are excited by a unique opportunity to learn directly alongside their medical student peers. For both, as well as the scientific community at large, the boutique program at the University of Southern California (USC) linking engineering and medical training at the graduate level is instructive of a new way of approaching engineering education that can potentially provide benefits to both students and society. Students who have grown up in an era of ?mass customization? in the retail and service industries can enjoy that same degree of flexibility also in the realm of education. At the same time, society gains engineers who have developed an increased empathy and awareness of the clinical contexts in which their innovations will be implemented. PMID:26583889

  10. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A..., or medicine not involving clinical use, or engaged in law enforcement, or in research not...

  11. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A..., or medicine not involving clinical use, or engaged in law enforcement, or in research not...

  12. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A..., or medicine not involving clinical use, or engaged in law enforcement, or in research not...

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

    NASA Astrophysics Data System (ADS)

    Schmidt, Craig L.; Skarstad, Paul M.

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

  14. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...; prominence of required label statements. (a) A word, statement, or other information required by or...

  15. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...; prominence of required label statements. (a) A word, statement, or other information required by or...

  16. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...; prominence of required label statements. (a) A word, statement, or other information required by or...

  17. An average enumeration method of hyperspectral imaging data for quantitative evaluation of medical device surface contamination

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We propose a quantification method called Mapped Average Principal Component Analysis Score (MAPS) to enumerate the contamination coverage on common medical device surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions on a full frame hyperspe...

  18. 75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fees; Public Meeting; Extension of... the notice that appeared in the Federal Register of August 13, 2010 (75 FR 49502). In the notice, FDA... FR 49502), FDA published a notice announcing a public meeting on September 14, 2010, and the...

  19. 76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... HUMAN SERVICES Food and Drug Administration Medical Device Epidemiology Network 2011: Second Annual... Network (MDEpiNet) 2011: Second Annual Public Workshop.'' The purpose of the public workshop is to provide... establishment of a network that works with FDA experts to determine the evidence gaps and questions,...

  20. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices. 419.66 Section 419.66 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL...

  1. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Transitional pass-through payments: Medical devices. 419.66 Section 419.66 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) PROSPECTIVE PAYMENT SYSTEM FOR...

  2. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period AGENCY: Food and Drug... the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public...

  3. 76 FR 16350 - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend...

  4. 31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... classified EAR 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debits or... agricultural commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance:...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debits or... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury...

  6. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debit to... agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance:...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debit to... agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance:...

  8. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debits or... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury...

  9. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 99 under the Export Administration Regulations, 15 CFR parts 730 through 774, may in certain... CFR 736.2(b)(5), 744.2 through 744.4, 744.7, and 744.10; see also 22 CFR 123.9.) (c) No debit to... agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance:...

  10. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Testing Requirements for Communicable Disease Agents §...

  11. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21... HUMAN SERVICES Food and Drug Administration Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION:...

  12. 75 FR 61494 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... November 30, 2004 (69 FR 69606), FDA published a notice of availability of the guidance entitled ``Use of... Collection; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of... ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In...

  13. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Calculation of patent term extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Calculation of patent term extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment...

  15. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Calculation of patent term extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES Adjustment...

  16. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ...The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials, global regulators, and industry experts. The public conference has three separate tracks of interest for quality,......

  17. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... Fee by Attendee April 3, Fee by May 2011 3, 2011 Industry $995 $1,200 Small Business (...

  18. 75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... notice that appeared in the Federal Register of August 23, 2010 (75 FR 51829). The notice announced the... INFORMATION: In FR Doc. 2010-20837, appearing on page 51829 in the Federal Register of Monday, August 23, 2010... HUMAN SERVICES Food and Drug Administration Public Workshop on Medical Devices and...

  19. Impact of sanctions on procurement of medicine and medical devices in Iran; a technical response.

    PubMed

    Hosseini, Seyed Alireza

    2013-12-01

    Following recent sanctions on foreign trade, financial and banking services, Iran has faced major difficulties for importing medicines (both finished products and pharmaceutical raw materials) and medical devices. Problems with money transfer have made it extremely lengthy in time to import medicine and medical devices and these have negatively affected access to and affordability of medicines. Quality of pharmaceuticals and treatment of patients have also been affected due to changing the sources of imported medicines and raw materials for locally produced pharmaceuticals. Several interventions have been employed during the past few months in Iran to overcome the effects imposed by recent sanctions and drug shortages have been managed to some extent with attempts made by Iran Food and Drug Organization (IRI FDO). As recommended by the experts, a specific Society for Worldwide Interbank Financial Telecommunication line should be allocated for transferring money for medicines and medical devices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medical device companies together with their foreign counterparts would facilitate this process. It appears that, in a public health prospective, ordinary people and patients are hurt and paying the cost for current sanctions. It remains the responsibility of the public health and international communities to separate public health from politics and to ease the pain of public from sanctions. PMID:24329148

  20. 76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ...The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to......