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Sample records for advanced medical devices

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public...

  2. 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.

  3. 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.

  4. 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

  5. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  6. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and... Application of Highly Multiplexed Microbiology Devices: Their clinical application and public health/clinical... clinical performance of highly multiplexed microbiology devices; approaches to device validation...

  7. Medical Device Safety

    MedlinePlus

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

  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.

  9. Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

    2016-03-01

    Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

  10. Combating medical device fouling.

    PubMed

    Harding, Jacqueline L; Reynolds, Melissa M

    2014-03-01

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

  11. New regulations for medical devices: Rationale, advances and impact on research and patient care.

    PubMed

    Labek, Gerold; Schöffl, Harald; Stoica, Christian Ioan

    2016-03-18

    A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients' risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

  12. [Medical device use errors].

    PubMed

    Friesdorf, Wolfgang; Marsolek, Ingo

    2008-01-01

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

  13. 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.

  14. [Medical Devices Law for anesthesiologists].

    PubMed

    Regner, M

    2015-09-01

    The Medical Devices Law is a relatively new legal system, which has replaced the still well-known medical devices regulations in Germany. The Medical Devices Law in Germany is based on European directives, which have been translated into national law with the Medical Devices Act. The Medical Devices Act is a framework of regulations and incorporates a number of decrees that address specific topics within the medical devices directives and in turn individual regulations refer to guidelines and recommendations from other sources which provide detailed technical information on specific topics. Overall, the Medical Devices Act represents a very complex legal system, which needs to be permanently observed with respect to continuous updating and adjustment. In this article the design and the structure are described but most of all the article filters significant problem areas that need to be considered when using and operating medical devices, especially for anesthesiologists.

  15. 4D Ultrasound - Medical Devices for Recent Advances on the Etiology of Cerebral Palsy

    PubMed Central

    Tomasovic, Sanja; Predojevic, Maja

    2011-01-01

    Children cerebral palsy (CCP) encompasses a group of nonprogessive and noninfectious conditions, which cause light, moderate, and severe deviations in neurological development. Diagnosis of CCP is set mostly by the age of 3 years. The fact that a large number of cerebral damage occurs prenatally and the fact that early intervention in cases of neurological damage is successful, prompted some researchers to explore the possibility of detecting neurologically damaged fetus in the uterus. This research was made possible thanks to the development of two-dimensional ultrasound technology in a real time, which enabled the display of the mobility of the fetus. Advancement of the ultrasound technology has enabled the development of 4D ultrasound where a spontaneous fetal movement can be observed almost in a real time. Estimate of the number and quality of spontaneous fetal movements and stitches on the head, the neurology thumb and a high palate were included in the prenatal neurological screening of the fetus. This raises the question, as to does the fetal behavior reflect, (which was revealed in 2D or 4D ultrasound), fetal neurological development in a manner that will allow the detection of the brain damage. PMID:23407920

  16. Medical devices for the anesthetist: current perspectives.

    PubMed

    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

  17. Medical devices for the anesthetist: current perspectives

    PubMed Central

    Ingrande, Jerry; Lemmens, Hendrikus JM

    2014-01-01

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

  18. Barriers to medical device innovation

    PubMed Central

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

    2014-01-01

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

  19. Advanced Resistive Exercise Device

    NASA Technical Reports Server (NTRS)

    Raboin, Jasen; Niebuhr, Jason; Cruz, Santana; Lamoreaux, chris

    2007-01-01

    The advanced resistive exercise device (ARED), now at the prototype stage of development, is a versatile machine that can be used to perform different customized exercises for which, heretofore, it has been necessary to use different machines. Conceived as a means of helping astronauts and others to maintain muscle and bone strength and endurance in low-gravity environments, the ARED could also prove advantageous in terrestrial settings (e.g., health clubs and military training facilities) in which many users are exercising simultaneously and there is heavy demand for use of exercise machines.

  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. 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

  2. [Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo].

    PubMed

    Niimi, Shingo; Umezu, Mitsuo; Iseki, Hiroshi; Harada, Hiroshi Kasanuki Noboru; Mitsuishi, Mamoru; Kitamori, Takehiko; Tei, Yuichi; Nakaoka, Ryusuke; Haishima, Yuji

    2014-01-01

    Division of Medical Devices has been conducting the projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo. The TWIns has been studying to aim at establishment of preclinical evaluation methods by "Engineering Based Medicine", and established Regulatory Science Institute for Medical Devices. School of Engineering, The University of Tokyo has been studying to aim at establishment of assessment methodology for innovative minimally invasive therapeutic devices, materials, and nanobio diagnostic devices. This report reviews the exchanges of personnel, the implement systems and the research progress of these projects.

  3. Advanced resistive exercise device

    NASA Technical Reports Server (NTRS)

    Raboin, Jasen L. (Inventor); Niebuhr, Jason (Inventor); Cruz, Santana F. (Inventor); Lamoreaux, Christopher D. (Inventor)

    2008-01-01

    The present invention relates to an exercise device, which includes a vacuum cylinder and a flywheel. The flywheel provides an inertial component to the load, which is particularly well suited for use in space as it simulates exercising under normal gravity conditions. Also, the present invention relates to an exercise device, which has a vacuum cylinder and a load adjusting armbase assembly.

  4. 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.

  5. 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

  6. Advanced underwater lift device

    NASA Technical Reports Server (NTRS)

    Flanagan, David T.; Hopkins, Robert C.

    1993-01-01

    Flexible underwater lift devices ('lift bags') are used in underwater operations to provide buoyancy to submerged objects. Commercially available designs are heavy, bulky, and awkward to handle, and thus are limited in size and useful lifting capacity. An underwater lift device having less than 20 percent of the bulk and less than 10 percent of the weight of commercially available models was developed. The design features a dual membrane envelope, a nearly homogeneous envelope membrane stress distribution, and a minimum surface-to-volume ratio. A proof-of-concept model of 50 kg capacity was built and tested. Originally designed to provide buoyancy to mock-ups submerged in NASA's weightlessness simulators, the device may have application to water-landed spacecraft which must deploy flotation upon impact, and where launch weight and volume penalties are significant. The device may also be useful for the automated recovery of ocean floor probes or in marine salvage applications.

  7. 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

  8. Ethics of medical device safety.

    PubMed

    Kriewall, Timothy J

    2008-01-01

    How safe is safe? The design intent of a medical device is to off er maximum flexibility, and low-cost and fail-safe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety and keep the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. As microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, the same techniques are germane to implantable devices such as cochlear implants. All engineering product development requires trade-off decisions considering how much is too much and how much is too little. Biomedical engineering faculty need to present this ethical dilemma to their students and give them the tools to help decide. However, in the final analysis, the operator of any medical product or installer of any medical device holds the primary responsibility for understanding how to use the system or install the implant in normal use as well as emergent or special situations; the technology is his or her backup in performing the medical professionals primary job.

  9. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Medical devices. 21 CFR Part 864 Blood, Medical devices, Packaging and containers. 21 CFR Part 866...) Identification. * * * This device, which is used outside the body, is used as a temporary substitute for...

  10. Advanced Semiconductor Devices

    NASA Astrophysics Data System (ADS)

    Shur, Michael S.; Maki, Paul A.; Kolodzey, James

    2007-06-01

    I. Wide band gap devices. Wide-Bandgap Semiconductor devices for automotive applications / M. Sugimoto ... [et al.]. A GaN on SiC HFET device technology for wireless infrastructure applications / B. Green ... [et al.]. Drift velocity limitation in GaN HEMT channels / A. Matulionis. Simulations of field-plated and recessed gate gallium nitride-based heterojunction field-effect transistors / V. O. Turin, M. S. Shur and D. B. Veksler. Low temperature electroluminescence of green and deep green GaInN/GaN light emitting diodes / Y. Li ... [et al.]. Spatial spectral analysis in high brightness GaInN/GaN light emitting diodes / T. Detchprohm ... [et al.]. Self-induced surface texturing of Al2O3 by means of inductively coupled plasma reactive ion etching in Cl2 chemistry / P. Batoni ... [et al.]. Field and termionic field transport in aluminium gallium arsenide heterojunction barriers / D. V. Morgan and A. Porch. Electrical characteristics and carrier lifetime measurements in high voltage 4H-SiC PiN diodes / P. A. Losee ... [et al.]. Geometry and short channel effects on enhancement-mode n-Channel GaN MOSFETs on p and n- GaN/sapphire substrates / W. Huang, T. Khan and T. P. Chow. 4H-SiC Vertical RESURF Schottky Rectifiers and MOSFETs / Y. Wang, P. A. Losee and T. P. Chow. Present status and future Directions of SiGe HBT technology / M. H. Khater ... [et al.]Optical properties of GaInN/GaN multi-quantum Wells structure and light emitting diode grown by metalorganic chemical vapor phase epitaxy / J. Senawiratne ... [et al.]. Electrical comparison of Ta/Ti/Al/Mo/Au and Ti/Al/Mo/Au Ohmic contacts on undoped GaN HEMTs structure with AlN interlayer / Y. Sun and L. F. Eastman. Above 2 A/mm drain current density of GaN HEMTs grown on sapphire / F. Medjdoub ... [et al.]. Focused thermal beam direct patterning on InGaN during molecular beam epitaxy / X. Chen, W. J. Schaff and L. F. Eastman -- II. Terahertz and millimeter wave devices. Temperature-dependent microwave performance of

  11. Regulatory science based approach in development of novel medical devices.

    PubMed

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development. PMID:26736611

  12. Regulatory science based approach in development of novel medical devices.

    PubMed

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

  13. Advanced Modeling of Micromirror Devices

    NASA Technical Reports Server (NTRS)

    Michalicek, M. Adrian; Sene, Darren E.; Bright, Victor M.

    1995-01-01

    The flexure-beam micromirror device (FBMD) is a phase only piston style spatial light modulator demonstrating properties which can be used for phase adaptive corrective optics. This paper presents a complete study of a square FBMD, from advanced model development through final device testing and model verification. The model relates the electrical and mechanical properties of the device by equating the electrostatic force of a parallel-plate capacitor with the counter-acting spring force of the device's support flexures. The capacitor solution is derived via the Schwartz-Christoffel transformation such that the final solution accounts for non-ideal electric fields. The complete model describes the behavior of any piston-style device, given its design geometry and material properties. It includes operational parameters such as drive frequency and temperature, as well as fringing effects, mirror surface deformations, and cross-talk from neighboring devices. The steps taken to develop this model can be applied to other micromirrors, such as the cantilever and torsion-beam designs, to produce an advanced model for any given device. The micromirror devices studied in this paper were commercially fabricated in a surface micromachining process. A microscope-based laser interferometer is used to test the device in which a beam reflected from the device modulates a fixed reference beam. The mirror displacement is determined from the relative phase which generates a continuous set of data for each selected position on the mirror surface. Plots of this data describe the localized deflection as a function of drive voltage.

  14. 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

  15. 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

  16. 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.

  17. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.

  18. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. PMID:25128009

  19. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... ``taxable medical device'' does not include eyeglasses, contact lenses, hearing aids, and any other medical... that the term ``taxable medical device'' does not include eyeglasses, contact lenses, hearing aids, and..., DC. FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations, Natalie Payne or...

  20. 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.

  1. The economic evaluation of medical devices: challenges.

    PubMed

    Kingkaew, Pritaporn; Teerawattananon, Yot

    2014-05-01

    While many of the principles that guide the economic evaluation of medical devices are somewhat similar to those that guide the evaluation of other health technologies, most outline a methodology that focuses on pharmaceutical products rather providing specific guidance for medical devices. Given that medical devices use a wide range of technologies and can be used for many purposes, conducting an economic analysis for medical devices is not straightforward. The cost and effectiveness of a given technology may depend on a number of factors. The objective of this paper is to provide a summary of issues that need to be addressed before undertaking an economic evaluation of medical devices and to outline a number of suggested approaches for undertaking an economic evaluation of medical devices.

  2. Laboratory partnership with the Medical Devices Agency.

    PubMed

    Lee, S

    2001-09-01

    To improve the quality of the information and advice provided to the Health Service, the Medical Devices Agency (MDA) is actively seeking to increase the number of reports from hospital laboratories. The Medical Devices Agency relies heavily on laboratory reports of problems with in vitro diagnostic medical devices to investigate and take action where necessary. Laboratories are encouraged to report all suspected adverse incidents to the MDA.

  3. [Software version and medical device software supervision].

    PubMed

    Peng, Liang; Liu, Xiaoyan

    2015-01-01

    The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.

  4. Medical devices and patient safety.

    PubMed

    Mattox, Elizabeth

    2012-08-01

    Errors related to health care devices are not well understood. Nurses in intensive care and progressive care environments can benefit from understanding manufacturer-related error and device-use error, the principles of human factors engineering, and the steps that can be taken to reduce risk of errors related to health care devices.

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

    PubMed

    Liu, Jiong

    2014-07-01

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

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  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, 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...

  13. 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...

  14. 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.

  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. 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.

  17. Using medical imaging for the detection of adverse events ("incidents") during the utilization of left ventricular assist devices in adult patients with advanced heart failure.

    PubMed

    Kaufmann, Friedrich; Krabatsch, Thomas

    2016-05-01

    Ventricular assist devices (VAD) are used for mechanical support of the terminally failing heart. Failure of these life supporting systems can be fatal. Early and reliable detection of any upcoming problems is mandatory and is crucial for the outcome. Medical imaging methods are described within this review, which are not only essential for diagnosis of typically VAD-related complications but also for the detection or verification of technical issues. Within this review the utilization of medical imaging equipment for the diagnosis of technical malfunctions or damages of implanted system components is discussed. A newly developed specialized acoustic imaging method for pump thrombosis detection will also be described along with the most common VAD-related medical complications and their respective imaging methods and the limitations induced by the use of the VAD-system.

  18. 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...

  19. 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...

  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, 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...

  2. 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...

  3. 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...

  4. 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...

  5. Irish medical device industry update.

    PubMed

    Higgins, Sharon

    2005-12-01

    The continued growth of the Irish medical technology industry has not been accidental. The sector is proactive in its drive for excellence in all aspects of the business, from concept to commercialisation. This reports on some recent initiatives.

  6. 75 FR 16351 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... protection. 21 CFR Part 1040 Electronic products, Labeling, Lasers, Medical devices, Radiation protection... MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS 0 12. The authority citation for 21 CFR part 1030 is...

  7. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... Device Single Audit Program International Coalition Pilot Program; Availability AGENCY: Food and Drug... 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...

  8. [Maintenance and obsolescence of medical devices].

    PubMed

    Ancellin, J

    1999-02-01

    Maintenance of medical devices is either curative, in case of a failure of the device, or preventive. Preventive maintenance (PM) is undertaken either at constant time intervals or when a given parameter crosses a specified limit. The aim of PM is to amend wear from intensive use as well as from ageing. Normally, the modalities of PM are defined by the manufacturer who must anticipate the possible deficiencies of the device. Some manufacturers tend to recommend exaggerated maintenance procedures. Obsolescence of a medical device is defined by one of the following criteria: a) loss of its initial performances; b) development of medical techniques requiring a wider spectrum of performances; c) presence of new devices with improved securities. PMID:10207602

  9. 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

  10. 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.

  11. 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.

  12. Future Opportunities for Advancing Glucose Test Device Electronics

    PubMed Central

    Young, Brian R; Young, Teresa L; Joyce, Margaret K; Kennedy, Spencer I; Atashbar, Massood Z

    2011-01-01

    Advancements in the field of printed electronics can be applied to the field of diabetes testing. A brief history and some new developments in printed electronics components applicable to personal test devices, including circuitry, batteries, transmission devices, displays, and sensors, are presented. Low-cost, thin, and lightweight materials containing printed circuits with energy storage or harvest capability and reactive/display centers, made using new printing/imaging technologies, are ideal for incorporation into personal-use medical devices such as glucose test meters. Semicontinuous rotogravure printing, which utilizes flexible substrates and polymeric, metallic, and/or nano “ink” composite materials to effect rapidly produced, lower-cost printed electronics, is showing promise. Continuing research advancing substrate, “ink,” and continuous processing development presents the opportunity for research collaboration with medical device designers. PMID:22027300

  13. Future opportunities for advancing glucose test device electronics.

    PubMed

    Young, Brian R; Young, Teresa L; Joyce, Margaret K; Kennedy, Spencer I; Atashbar, Massood Z

    2011-09-01

    Advancements in the field of printed electronics can be applied to the field of diabetes testing. A brief history and some new developments in printed electronics components applicable to personal test devices, including circuitry, batteries, transmission devices, displays, and sensors, are presented. Low-cost, thin, and lightweight materials containing printed circuits with energy storage or harvest capability and reactive/display centers, made using new printing/imaging technologies, are ideal for incorporation into personal-use medical devices such as glucose test meters. Semicontinuous rotogravure printing, which utilizes flexible substrates and polymeric, metallic, and/or nano "ink" composite materials to effect rapidly produced, lower-cost printed electronics, is showing promise. Continuing research advancing substrate, "ink," and continuous processing development presents the opportunity for research collaboration with medical device designers.

  14. Advances in device and formulation technologies for pulmonary drug delivery.

    PubMed

    Chan, John Gar Yan; Wong, Jennifer; Zhou, Qi Tony; Leung, Sharon Shui Yee; Chan, Hak-Kim

    2014-08-01

    Inhaled pharmaceuticals are formulated and delivered differently according to the therapeutic indication. However, specific device-formulation coupling is often fickle, and new medications or indications also demand new strategies. The discontinuation of chlorofluorocarbon propellants has seen replacement of older metered dose inhalers with dry powder inhaler formulations. High-dose dry powder inhalers are increasingly seen as an alternative dosage form for nebulised medications. In other cases, new medications have completely bypassed conventional inhalers and been formulated for use with unique inhalers such as the Staccato® device. Among these different devices, integration of software and electronic assistance has become a shared trend. This review covers recent device and formulation advances that are forming the current landscape of inhaled therapeutics. PMID:24728868

  15. Thermoelectric Devices Advance Thermal Management

    NASA Technical Reports Server (NTRS)

    2007-01-01

    Thermoelectric (TE) devices heat, cool, and generate electricity when a temperature differential is provided between the two module faces. In cooperation with NASA, Chico, California-based United States Thermoelectric Consortium Inc. (USTC) built a gas emissions analyzer (GEA) for combustion research. The GEA precipitated hydrocarbon particles, preventing contamination that would hinder precise rocket fuel analysis. The USTC research and design team uses patent-pending dimple, pin-fin, microchannel and microjet structures to develop and design heat dissipation devices on the mini-scale level, which not only guarantee high performance of products, but also scale device size from 1 centimeter to 10 centimeters. USTC continues to integrate the benefits of TE devices in its current line of thermal management solutions and has found the accessibility of NASA technical research to be a valuable, sustainable resource that has continued to positively influence its product design and manufacturing

  16. Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

    PubMed

    Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C

    2016-06-01

    Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements.

  17. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  18. 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 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  19. [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

  20. [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.

  1. [Batteries Used in Active Implantable Medical Devices].

    PubMed

    Ma, Bozhi; Hao, Hongwei; Li, Luming

    2015-03-01

    In recent years active implantable medical devices(AIMD) are being developed rapidly. Many battery systems have been developed for different AIMD applications. These batteries have the same requirements which include high safety, reliability, energy density and long service life, discharge indication. History, present and future of batteries used in AIMD are introduced in the article. PMID:26524787

  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.... Purchase at Retail Several commenters suggested that Internet sales should be included in the factor... consumers who are not medical professionals can purchase a device over the Internet should be a factor...

  3. 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:...

  4. 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

  5. Bluetooth Communication for Battery Powered Medical Devices

    NASA Astrophysics Data System (ADS)

    Babušiak, Branko; Borik, Štefan

    2016-01-01

    wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

  6. Improved Thermoelectric Devices: Advanced Semiconductor Materials for Thermoelectric Devices

    SciTech Connect

    2009-12-11

    Broad Funding Opportunity Announcement Project: Phononic Devices is working to recapture waste heat and convert it into usable electric power. To do this, the company is using thermoelectric devices, which are made from advanced semiconductor materials that convert heat into electricity or actively remove heat for refrigeration and cooling purposes. Thermoelectric devices resemble computer chips, and they manage heat by manipulating the direction of electrons at the nanoscale. These devices aren’t new, but they are currently too inefficient and expensive for widespread use. Phononic Devices is using a high-performance, cost-effective thermoelectric design that will improve the device’s efficiency and enable electronics manufacturers to more easily integrate them into their products.

  7. 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.

  8. Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.

  9. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  12. 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; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  14. Open-source hardware for medical devices

    PubMed Central

    2016-01-01

    Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device. PMID:27158528

  15. 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.

  16. Desktop supercomputers. Advance medical imaging.

    PubMed

    Frisiello, R S

    1991-02-01

    Medical imaging tools that radiologists as well as a wide range of clinicians and healthcare professionals have come to depend upon are emerging into the next phase of functionality. The strides being made in supercomputing technologies--including reduction of size and price--are pushing medical imaging to a new level of accuracy and functionality.

  17. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting...

  18. 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

  19. 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.

  20. 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...

  1. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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;...

  2. 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;...

  3. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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;...

  4. 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;...

  5. Medical technology advances from space research

    NASA Technical Reports Server (NTRS)

    Pool, S. L.

    1972-01-01

    Details of medical research and development programs, particularly an integrated medical laboratory, as derived from space technology are given. The program covers digital biotelemetry systems, automatic visual field mapping equipment, sponge electrode caps for clinical electroencephalograms, and advanced respiratory analysis equipment. The possibility of using the medical laboratory in ground based remote areas and regional health care facilities, as well as long duration space missions is discussed.

  6. Medical technology advances from space research.

    NASA Technical Reports Server (NTRS)

    Pool, S. L.

    1971-01-01

    NASA-sponsored medical R & D programs for space applications are reviewed with particular attention to the benefits of these programs to earthbound medical services and to the general public. Notable among the results of these NASA programs is an integrated medical laboratory equipped with numerous advanced systems such as digital biotelemetry and automatic visual field mapping systems, sponge electrode caps for electroencephalograms, and sophisticated respiratory analysis equipment.

  7. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A medical image storage device is a device that provides electronic storage and retrieval..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from...

  8. Advanced medical video services through context-aware medical networks.

    PubMed

    Doukas, Charalampos N; Maglogiannis, Ilias; Pliakas, Thomas

    2007-01-01

    The aim of this paper is to present a framework for advanced medical video delivery services, through network and patient-state awareness. Under this scope a context-aware medical networking platform is described. The developed platform enables proper medical video data coding and transmission according to both a) network availability and/or quality and b) patient status, optimizing thus network performance and telediagnosis. An evaluation platform has been developed based on scalable H.264 coding of medical videos. Corresponding results of video transmission over a WiMax network have proved the effectiveness and efficiency of the platform providing proper video content delivery. PMID:18002643

  9. Advanced medical video services through context-aware medical networks.

    PubMed

    Doukas, Charalampos N; Maglogiannis, Ilias; Pliakas, Thomas

    2007-01-01

    The aim of this paper is to present a framework for advanced medical video delivery services, through network and patient-state awareness. Under this scope a context-aware medical networking platform is described. The developed platform enables proper medical video data coding and transmission according to both a) network availability and/or quality and b) patient status, optimizing thus network performance and telediagnosis. An evaluation platform has been developed based on scalable H.264 coding of medical videos. Corresponding results of video transmission over a WiMax network have proved the effectiveness and efficiency of the platform providing proper video content delivery.

  10. 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

  11. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ... 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... multilumen device with two balloons mounted near the distal tip. The proximal end has a multiport...

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

    PubMed

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

    2012-05-01

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

  14. Advanced Electro-Optic Surety Devices

    SciTech Connect

    Watterson, C.E.

    1997-05-01

    The Advanced Electro-Optic Surety Devices project was initiated in march 1991 to support design laboratory guidance on electro-optic device packaging and evaluation. Sandia National Laboratory requested AlliedSignal Inc., Kansas City Division (KCD), to prepare for future packaging efforts in electro-optic integrated circuits. Los Alamos National Laboratory requested the evaluation of electro-optic waveguide devices for nuclear surety applications. New packaging techniques involving multiple fiber optic alignment and attachment, binary lens array development, silicon V-groove etching, and flip chip bonding were requested. Hermetic sealing of the electro-optic hybrid and submicron alignment of optical components present new challenges to be resolved. A 10-channel electro-optic modulator and laser amplifier were evaluated for potential surety applications.

  15. 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.

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Medical Device Epidemiology Network: Developing Partnership... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership Between... to facilitate discussion among FDA and academic researchers with expertise in epidemiology and...

  17. 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

    ... regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate...

  18. 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

    ... 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... onset. The CoAxia NeuroFlo Catheter is a 7F multi-lumen device with two balloons mounted near the...

  19. 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...

  20. 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 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...

  1. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

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

  2. 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...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  3. 21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; warning statements for devices... Section 801.63 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.63...

  4. Medical devices regulatory aspects: a special focus on polymeric material based devices.

    PubMed

    Sridhar, Radhakrishnan; Pliszka, Damian; Luo, He-Kuan; Chin Lim, Keith Hsiu; Ramakrishna, Seeram

    2015-01-01

    Medical devices form a broad range of appliances from a basic nanoparticle coating or surgical gloves to a complicated laser therapy device. These devices are designed to support patients, surgeons and healthcare personnel in meeting patients' healthcare needs. Regulatory authorities of each country regulate the process of approval, manufacturing and sales of these medical devices so as to ensure safety and quality to patients or users. Recent recalls of medical devices has increased importance of safety, awareness and regulation of the devices. Singapore and India have strong presence and national priorities in medical devices development and use. Herein we capture the rationale of each of these national regulatory bodies and compare them with the medical devices regulatory practices of USA and European nations. Apart from the comparison of various regulatory aspects, this review will specifically throw light on the polymer material based medical devices and their safety.

  5. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Request for Comments... Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and... global leader in medical device innovation and CDRH is committed to assuring that American patients...

  6. [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

  7. Education and training in regulatory science for medical device development.

    PubMed

    Sakuma, Ichiro

    2013-01-01

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

  8. Education and training in regulatory science for medical device development.

    PubMed

    Sakuma, Ichiro

    2013-01-01

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

  9. 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.

  10. An update on mobile phones interference with medical devices.

    PubMed

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

    2013-10-01

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

  11. Rapid medical advances challenge the tooling industry.

    PubMed

    Conley, B

    2008-01-01

    The requirement for greater performance in smaller spaces has increased demands for product and process innovation in tubing and other medical products. In turn, these developments have placed greater demands on the producers of the advanced tooling for these products. Tooling manufacturers must now continuously design equipment with much tighter tolerances for more sophisticated coextrusions and for newer generations of multilumen and multilayer tubing.

  12. 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.

  13. 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...); the Medical Device Manufacturers Association (MDMA); the Medical Imaging and Technology Alliance...

  14. Home Healthcare Medical Devices: A Checklist

    MedlinePlus

    ... your device and follow them for: - cleaning - replacing batteries, filters - protecting your device (e.g. keep food ... after-hour phone numbers. * If appropriate, keep extra batteries for your device. - Know how to replace them. ...

  15. Image stabilization for SWIR advanced optoelectronic device

    NASA Astrophysics Data System (ADS)

    Schiopu, Paul; Manea, Adrian; Cristea, Ionica; Grosu, Neculai; Craciun, Anca-Ileana; Craciun, Alexandru; Granciu, Dana

    2015-02-01

    At long ranges and under low visibility conditions, Advanced Optoelectronic Device provides the signal-to-noise ratio and image quality in the Short-wave Infra-red - SWIR (wavelengths between 1,1 ÷2,5 μm), significantly better than in the near wave infrared - NWIR and visible spectral bands [1,2]. The quality of image is nearly independent of the polarization in the incoming light, but it is influenced by the relative movement between the optical system and the observer (the operators' handshake), and the movement towards the support system (land and air vehicles). All these make it difficult to detect objectives observation in real time. This paper presents some systems enhance which the ability of observation and sighting through the optical systems without the use of the stands, tripods or other means. We have to eliminate the effect of "tremors of the hands" and the vibration in order to allow the use of optical devices by operators on the moving vehicles on land, on aircraft, or on boats, and to provide additional comfort for the user to track the moving object through the optical system, without losing the control in the process of detection and tracking. The practical applications of stabilization image process, in SWIR, are the most advanced part of the optical observation systems available worldwide [3,4,5]. This application has a didactic nature, because it ensures understanding by the students about image stabilization and their participation in research.

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to...

  18. 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....

  19. Regulatory approval of new medical devices: cross sectional study

    PubMed Central

    Payne, Christopher J; Hughes-Hallett, Archie; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

    2016-01-01

    Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. PMID:27207165

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

    PubMed

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

    2014-03-01

    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

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory... should have normal gonioscopic anatomy and a visually significant cataract eligible...

  7. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  8. 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

  9. Medical Devices in the Treatment of Obesity.

    PubMed

    Chang, Julietta; Brethauer, Stacy

    2016-09-01

    Obesity continues to be a growing epidemic worldwide. Although bariatric surgery remains the most effective and durable treatment of obesity and its comorbidities, there is a need for less invasive yet efficacious weight loss therapies. Currently the Food and Drug Administration has approved two endoscopically placed intragastric balloon devices and a surgically placed vagal blockade device. Another device that holds promise, particularly for the treatment of type 2 diabetes, is the endoscopically placed duodenojejunal bypass sleeve. This article reviews the indications and current data regarding results for these devices. PMID:27519137

  10. Product-based Safety Certification for Medical Devices Embedded Software.

    PubMed

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  11. [Data transparency regarding medical devices - the position of the medical device industry].

    PubMed

    Soskuty, Gabriela

    2011-01-01

    The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany.

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. Medical advances during the Civil War.

    PubMed

    Blaisdell, F W

    1988-09-01

    The contributions to medical care that developed during the Civil War have not been fully appreciated, probably because the quality of care administered was compared against modern standards rather than the standards of the time. The specific accomplishments that constituted major advances were as follows. 1. Accumulation of adequate records and detailed reports for the first time permitted a complete military medical history. This led to the publication of the Medical and Surgical History of the War of the Rebellion, which was identified in Europe as the first major academic accomplishment by US medicine. 2. Development of a system of managing mass casualties, including aid stations, field hospitals, and general hospitals, set the pattern for management of the wounded in World War I, World War II, and the Korean War. 3. The pavilion-style general hospitals, which were well ventilated and clean, were copied in the design of large civilian hospitals over the next 75 years. 4. The importance of immediate, definitive treatment of wounds and fractures was demonstrated and it was shown that major operative procedures, such as amputation, were optimally carried out in the first 24 hours after wounding. 5. The importance of sanitation and hygiene in preventing infection, disease, and death among the troops in the field was demonstrated. 6. Female nurses were introduced to hospital care and Catholic orders entered the hospital business. 7. The experience and training of thousands of physicians were upgraded and they were introduced to new ideas and standards of care. These included familiarity with prevention and treatment of infectious disease, with anesthetic agents, and with surgical principles that rapidly advanced the overall quality of American medical practice. 8. The Sanitary Commission was formed, a civilian-organized soldier's relief society that set the pattern for the development of the American Red Cross. PMID:3046560

  17. Standalone medical device software: The evolving regulatory framework.

    PubMed

    McCarthy, Avril D; Lawford, Patricia V

    2014-01-01

    The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice. PMID:26415828

  18. Standalone medical device software: The evolving regulatory framework.

    PubMed

    McCarthy, Avril D; Lawford, Patricia V

    2014-01-01

    The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.

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

    PubMed

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

    2012-08-01

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

  20. Bacterial resistance to silver in wound care and medical devices.

    PubMed

    Landsdown, A B G; Williams, A

    2007-01-01

    This review discusses the molecular and genetic evidence for silver resistance in bacteria isolated from skin wounds and medical devices with reference to a case study of resistant Enterobacter cloacae from the leg ulcers of an elderly woman.

  1. 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

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

  2. 76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... (76 FR 6625). The amendment is being ] made to reflect a change in the Agenda portion of the document... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Administration (FDA) is announcing an amendment to the notice of meeting of the Neurological Devices Panel of...

  3. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

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

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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

    ... 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... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS)...

  12. 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... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  13. 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,...

  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

    ... 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... recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI...

  15. 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

    ... 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...: ``Medtronic cardiac resynchronization therapy defibrillator (CRT-D) systems are indicated for heart...

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

    PubMed

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

    2014-01-01

    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.

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

    PubMed

    Gittard, Shaun D; Narayan, Roger J

    2010-05-01

    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.

  19. 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...

  20. The medical information bus: overview of the medical device data language.

    PubMed

    Gottschalk, H W

    1991-01-01

    The Medical Information Bus (MIB) reference model defines a new, object-oriented Medical Device Data Language (MDDL), under development by the Institute of Electrical and Electronic Engineers Society (IEEE) P1073 MIB Standard Committee. The MDDL treats medical devices, host computers, humans and device parameters as objects, and provides a flexible and extensible language for describing and passing messages between objects. This paper describes the MDDL semantic reference model and presents an overview of the MDDL structure, within the framework of the International Standards Organization (ISO) System Management Overview (SMO) model. A simple example of how the MDDL can be used to construct a device event report is also described.

  1. 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.

  2. Diversionary device history and revolutionary advancements.

    SciTech Connect

    Cooper, Paul W.; Grubelich, Mark Charles

    2005-04-01

    Diversionary devices also known as flash bangs or stun grenades were first employed about three decades ago. These devices produce a loud bang accompanied by a brilliant flash of light and are employed to temporarily distract or disorient an adversary by overwhelming their visual and auditory senses in order to gain a tactical advantage. Early devices that where employed had numerous shortcomings. Over time, many of these deficiencies were identified and corrected. This evolutionary process led to today's modern diversionary devices. These present-day conventional diversionary devices have undergone evolutionary changes but operate in the same manner as their predecessors. In order to produce the loud bang and brilliant flash of light, a flash powder mixture, usually a combination of potassium perchlorate and aluminum powder is ignited to produce an explosion. In essence these diversionary devices are small pyrotechnic bombs that produce a high point-source pressure in order to achieve the desired far-field effect. This high point-source pressure can make these devices a hazard to the operator, adversaries and hostages even though they are intended for 'less than lethal' roles. A revolutionary diversionary device has been developed that eliminates this high point-source pressure problem and eliminates the need for the hazardous pyrotechnic flash powder composition. This new diversionary device employs a fuel charge that is expelled and ignited in the atmosphere. This process is similar to a fuel air or thermobaric explosion, except that it is a deflagration, not a detonation, thereby reducing the overpressure hazard. This technology reduces the hazard associated with diversionary devices to all involved with their manufacture, transport and use. An overview of the history of diversionary device development and developments at Sandia National Laboratories will be presented.

  3. 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.

  4. 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

  5. Quality management for the processing of medical devices

    PubMed Central

    Klosz, Kerstin

    2008-01-01

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

  6. 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,...

  7. 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...

  8. 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...

  9. 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,...

  10. 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,...

  11. 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,...

  12. 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,...

  13. 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,...

  14. 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,...

  15. 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...

  16. 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...

  17. 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,...

  18. 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... established by this final rule create ``requirements'' for specific medical devices under 21 U.S.C. 360k, even..., 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to...

  19. The Downsides of a Major Medical Advance

    PubMed Central

    Fraenkel, Liana

    2010-01-01

    When positive, the results of randomized controlled trials designed to evaluate the effectiveness of new options are released with great fanfare. This is especially true for difficult to treat conditions for which there are few treatment alternatives. This scenario recently played out at the 2009 American College of Rheumatology National meeting when the long anticipated RAVE (Rituximab versus Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitis) trial results were announced. Since then the results of the RAVE and RITUXVAS trials have demonstrated that rituximab is as effective at inducing remission in patients with ANCA positive vasculitis as cyclophosphamide. Prior to these trials, cyclophosphamide was the option of choice for this potentially life threatening disease, and physicians have long hoped for a viable alternative given the significant toxicity associated with this medication, particularly infection, infertility, and cancer. While the results of the trial were justifiably received with great enthusiasm, practical clinical experience has revealed some noteworthy downsides to this important medical advance. PMID:20665748

  20. 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 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.

  1. 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.

  2. ARED (Advanced-Resistive Exercise Device) Update

    NASA Technical Reports Server (NTRS)

    Ploutz-Snyder, Lori

    2009-01-01

    This viewgraph presentation describes ARED which is a new hardware exercise device for use on the International Space Station. Astronaut physiological adaptations, muscle parameters, and cardiovascular parameters are also reviewed.

  3. Microfluidic Devices in Advanced Caenorhabditis elegans Research.

    PubMed

    Muthaiyan Shanmugam, Muniesh; Subhra Santra, Tuhin

    2016-01-01

    The study of model organisms is very important in view of their potential for application to human therapeutic uses. One such model organism is the nematode worm, Caenorhabditis elegans. As a nematode, C. elegans have ~65% similarity with human disease genes and, therefore, studies on C. elegans can be translated to human, as well as, C. elegans can be used in the study of different types of parasitic worms that infect other living organisms. In the past decade, many efforts have been undertaken to establish interdisciplinary research collaborations between biologists, physicists and engineers in order to develop microfluidic devices to study the biology of C. elegans. Microfluidic devices with the power to manipulate and detect bio-samples, regents or biomolecules in micro-scale environments can well fulfill the requirement to handle worms under proper laboratory conditions, thereby significantly increasing research productivity and knowledge. The recent development of different kinds of microfluidic devices with ultra-high throughput platforms has enabled researchers to carry out worm population studies. Microfluidic devices primarily comprises of chambers, channels and valves, wherein worms can be cultured, immobilized, imaged, etc. Microfluidic devices have been adapted to study various worm behaviors, including that deepen our understanding of neuromuscular connectivity and functions. This review will provide a clear account of the vital involvement of microfluidic devices in worm biology. PMID:27490525

  4. 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

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

    PubMed

    Röhm-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

  6. 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

  7. Developing medical device software in compliance with regulations.

    PubMed

    Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

    2015-08-01

    In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation. PMID:26736514

  8. 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

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

    PubMed

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

    2011-07-01

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

  10. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 Medical Devices; General Hospital and... CFR part 880 is amended as follows: PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES 0 1....

  11. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR)...

  12. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... 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...

  13. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... classification for human dura mater. This action is being taken to improve the accuracy of the regulations. DATES... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 (formerly Docket No. 1997N-0484P) Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical...

  14. 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

    ... 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...

  15. 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

    ... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave... 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:...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the endovascular suturing system into...

  17. 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

    ... 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. The... wounds from surgical incisions, including punctures from minimally invasive surgery, and...

  18. 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...

  19. Advances in nonlinear optical materials and devices

    NASA Technical Reports Server (NTRS)

    Byer, Robert L.

    1991-01-01

    The recent progress in the application of nonlinear techniques to extend the frequency of laser sources has come from the joint progress in laser sources and in nonlinear materials. A brief summary of the progress in diode pumped solid state lasers is followed by an overview of progress in nonlinear frequency extension by harmonic generation and parametric processes. Improved nonlinear materials including bulk crystals, quasiphasematched interactions, guided wave devices, and quantum well intersubband studies are discussed with the idea of identifying areas of future progress in nonlinear materials and devices.

  20. 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

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

    PubMed

    Hölscher, U M

    2014-12-01

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

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

    PubMed

    Hölscher, U M

    2014-12-01

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

  3. 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.

  4. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

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

  5. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

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

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

    PubMed

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

    2013-12-01

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

  7. Bulk Metallic Glasses for Implantable Medical Devices and Surgical Tools.

    PubMed

    Meagher, Philip; O'Cearbhaill, Eoin D; Byrne, James H; Browne, David J

    2016-07-01

    With increasing knowledge of the materials science of bulk metallic glasses (BMGs) and improvements in their properties and processing, they have started to become candidate materials for biomedical devices. A dichotomy in the types of medical applications has also emerged, in which some families of BMGs are being developed for permanent devices whilst another family - of Mg-based alloys - is showing promise in bioabsorbable implants. The current status of these metallurgical and technological developments is summarized.

  8. 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

  9. 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.

  10. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2013-10-01 2013-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  11. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2014-10-01 2014-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  12. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2012-10-01 2012-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  13. [The Preliminary Study on the Construction of Medical Device Naming System in China].

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2015-11-01

    The article has summarized the situation related to medical device naming, analyzed the problems of medical device naming in our country, put forward some new thinking in building the naming system of medical device in our country provided some reference on technical study of medical device naming. PMID:27066687

  14. Medical Devices Assess, Treat Balance Disorders

    NASA Technical Reports Server (NTRS)

    2009-01-01

    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.

  15. 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.

  16. Polymer Coats Leads on Implantable Medical Device

    NASA Technical Reports Server (NTRS)

    2008-01-01

    Langley Research Center s Soluble Imide (LaRC-SI) was discovered by accident. While researching resins and adhesives for advanced composites for high-speed aircraft, Robert Bryant, a Langley engineer, noticed that one of the polymers he was working with did not behave as predicted. After putting the compound through a two-stage controlled chemical reaction, expecting it to precipitate as a powder after the second stage, he was surprised to see that the compound remained soluble. This novel characteristic ended up making this polymer a very significant finding, eventually leading Bryant and his team to win several NASA technology awards, and an "R&D 100" award. The unique feature of this compound is the way that it lends itself to easy processing. Most polyimides (members of a group of remarkably strong and incredibly heat- and chemical-resistant polymers) require complex curing cycles before they are usable. LaRC-SI remains soluble in its final form, so no further chemical processing is required to produce final materials, like thin films and varnishes. Since producing LaRC-SI does not require complex manufacturing techniques, it has been processed into useful forms for a variety of applications, including mechanical parts, magnetic components, ceramics, adhesives, composites, flexible circuits, multilayer printed circuits, and coatings on fiber optics, wires, and metals. Bryant s team was, at the time, heavily involved with the aircraft polymer project and could not afford to further develop the polymer resin. Believing it was worth further exploration, though, he developed a plan for funding development and submitted it to Langley s chief scientist, who endorsed the experimentation. Bryant then left the high-speed civil transport project to develop LaRC-SI. The result is an extremely tough, lightweight thermoplastic that is not only solvent-resistant, but also has the ability to withstand temperature ranges from cryogenic levels to above 200 C. The thermoplastic

  17. MRI compatibility and visibility assessment of implantable medical devices.

    PubMed

    Schueler, B A; Parrish, T B; Lin, J C; Hammer, B E; Pangrle, B J; Ritenour, E R; Kucharczyk, J; Truwit, C L

    1999-04-01

    We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medical devices. The testing protocol consists of the evaluation of magnetic field-induced movement, electric current, heating, image distortion, and device operation. In addition, current induction is evaluated with a finite element analysis simulation technique that models the effect of radiofrequency fields on each device. The protocol has been applied to several implantable infusion pumps and neurostimulators with associated attachments. Experiments were performed using a 1.5-T whole-body MR system with parameters selected to approximate the intended clinical and worst case configuration. The devices exhibited moderate magnetic field-induced deflection and torque but had significant image artifacts. No heating was detected for any of the devices. Pump operation was halted in the magnetic field, but resumed after removed. Exposure to the magnetic field activated some of the neurostimulators. PMID:10232520

  18. 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,...

  19. 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....

  20. 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,...

  1. 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

    ... 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 of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice...

  2. Perinatal Staff Nurse Medical Device Use and Education.

    ERIC Educational Resources Information Center

    McConnell, Edwina A.

    1998-01-01

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

  3. Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device. Final order.

    PubMed

    2016-09-22

    The Food and Drug Administration (FDA) is classifying the strabismus detection 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 strabismus detection device'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:27658316

  4. Regulation of medicines and medical devices: contrasts and similarities.

    PubMed

    Parvizi, Nassim; Woods, Kent

    2014-02-01

    In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medical devices. This is in light of the topical, rather dissimilar, incidents involving poly-implant-prothèse (PIP) breast and metal-on-metal hip implants. Although medicines and devices are regulated under European Union (EU) law, the regulatory regimes are very different and some have argued that features of the pharmaceutical regime should be applied to medical devices in the current review of the medical devices directives. Both medicines and certain devices need to have an assessment of their risks and benefits before being used in patients, and undergo subsequent monitoring for adverse events. However, there are significant differences between these two groups in terms of the number of products, the pattern of innovation and development, and the types of adverse events that arise from their use. This review will summarise the key issues through a comparison of how both are regulated and monitored. PMID:24532735

  5. Balancing adoption and affordability of medical devices in Europe.

    PubMed

    Schreyögg, Jonas; Bäumler, Michael; Busse, Reinhard

    2009-10-01

    Dramatic increases in health expenditures have led to a substantial number of regulatory interventions in the markets for devices over the last years. However, little attention has been paid thus far to the regulation of medical devices and its effects. This article explores the policies pursued by European countries to find the right balance between improving access to new medical devices and restricting market forces to contain costs and ensure affordability. We outline the medical device policies of the four European countries with the largest expenditures on devices: Germany, France, Italy, and the UK. Subsequently, we discuss how these policies attempt to balance technological adoption and affordability by illustrating two case studies from Italy and Germany. We find that reference prices, if defined as maximum reimbursement levels, can help to achieve balance, because they are supposed to contain costs effectively, but do not necessarily act as a hurdle for the adoption of innovations. We also find that policy tools that encourage technological adoption should be used carefully since the benefits of a new technology are often difficult to predict. Finally, we draw a number of policy implications based on our observations.

  6. Clinical research challenges in the era of cardiovascular medical devices

    PubMed Central

    2016-01-01

    New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area. PMID:27785138

  7. 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.

  8. Astronomy helps advance medical diagnosis techniques

    NASA Astrophysics Data System (ADS)

    2001-11-01

    Effective treatment of cancer relies on the early detection and removal of cancerous cells. Unfortunately, this is when they are hardest to spot. In the case of breast cancer, now the most prevalent form of cancer in the United Kingdom, cancer cells tend to congregate in the lymph nodes, from where they can rapidly spread throughout the rest of the body. Current medical equipment can give doctors only limited information on tissue health. A surgeon must then perform an exploratory operation to try to identify the diseased tissue. If that is possible, the diseased tissue will be removed. If identification is not possible, the doctor may be forced to take away the whole of the lymphatic system. Such drastic treatment can then cause side effects, such as excessive weight gain, because it throws the patient's hormones out of balance. Now, members of the Science Payloads Technology Division of the Research and Science Support Department, at ESA's science, technology and engineering research centre (ESTEC) in the Netherlands, have developed a new X-ray camera that could make on-the-spot diagnoses and pinpoint cancerous areas to guide surgeons. Importantly, it would be a small device that could be used continuously during operations. "There is no photography involved in the camera we envisage. It will be completely digital, so the surgeon will study the whole lymphatic system and the potentially cancerous parts on his monitor. He then decides which parts he removes," says Dr. Tone Peacock, Head of the Science Payloads Technology Division. The ESA team were trying to find a way to make images using high-energy X-rays because some celestial objects give out large quantities of X-rays but little visible light. To see these, astronomers need to use X-ray cameras. Traditionally, this has been a bit of a blind spot for astronomers. ESA's current X-ray telescope, XMM-Newton, is in orbit now, observing low energy, so-called 'soft' X-rays. European scientists have always wanted to

  9. Microscopy imaging device with advanced imaging properties

    SciTech Connect

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2015-11-24

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  10. Microscopy imaging device with advanced imaging properties

    DOEpatents

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2016-10-25

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  11. Image quality characteristics of handheld display devices for medical imaging.

    PubMed

    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 1.2 × 10(-5) mm(2) at 1 mm(-1), while handheld displays have values lower than 3.7 × 10(-6) mm(2). Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

  12. 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 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

  13. Issues associated with off label use of medical devices.

    PubMed

    David, Yadin; Hyman, William A

    2007-01-01

    Off label use as applied to medical devices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses. Beyond a use not being indicated, some off label uses may be expressly contraindicated as well as explicitly warned against. One example here is the currently controversial topic of the reuse of devices labeled single use only, although off label use is a far more widespread issue than reuse. The justification for off label use can range from reasoned and studied applications beyond those for which the manufacturer has sought clearance or approval, to misapplication based on faulty analysis or ignorance. This paper will review the critical need to incorporate a risk assessment process for potential off label use. PMID:18002765

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

    PubMed

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

    2014-01-01

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

  15. Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device. Final order.

    PubMed

    2016-06-10

    The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:27295735

  16. Astronomy helps advance medical diagnosis techniques

    NASA Astrophysics Data System (ADS)

    2001-11-01

    Effective treatment of cancer relies on the early detection and removal of cancerous cells. Unfortunately, this is when they are hardest to spot. In the case of breast cancer, now the most prevalent form of cancer in the United Kingdom, cancer cells tend to congregate in the lymph nodes, from where they can rapidly spread throughout the rest of the body. Current medical equipment can give doctors only limited information on tissue health. A surgeon must then perform an exploratory operation to try to identify the diseased tissue. If that is possible, the diseased tissue will be removed. If identification is not possible, the doctor may be forced to take away the whole of the lymphatic system. Such drastic treatment can then cause side effects, such as excessive weight gain, because it throws the patient's hormones out of balance. Now, members of the Science Payloads Technology Division of the Research and Science Support Department, at ESA's science, technology and engineering research centre (ESTEC) in the Netherlands, have developed a new X-ray camera that could make on-the-spot diagnoses and pinpoint cancerous areas to guide surgeons. Importantly, it would be a small device that could be used continuously during operations. "There is no photography involved in the camera we envisage. It will be completely digital, so the surgeon will study the whole lymphatic system and the potentially cancerous parts on his monitor. He then decides which parts he removes," says Dr. Tone Peacock, Head of the Science Payloads Technology Division. The ESA team were trying to find a way to make images using high-energy X-rays because some celestial objects give out large quantities of X-rays but little visible light. To see these, astronomers need to use X-ray cameras. Traditionally, this has been a bit of a blind spot for astronomers. ESA's current X-ray telescope, XMM-Newton, is in orbit now, observing low energy, so-called 'soft' X-rays. European scientists have always wanted to

  17. Advanced devices and systems for radiation measurements

    SciTech Connect

    Knoll, G.F.; Wehe, D.K.; He, Z.; Barrett, C.; Miyamoto, J.

    1996-06-01

    The authors` most recent work continues their long-standing efforts to develop semiconductor detectors based on the collection of only a single type of charge carrier. Their best results are an extension of the principle of coplanar electrodes first described by Paul Luke of Lawrence Berkeley Laboratory 18 months ago. This technique, described in past progress reports, has the effect of deriving an output signal from detectors that depends only on the motion of carriers close to one surface. Since nearly all of these carriers are of one type (electrons) that are attracted to that electrode, the net effect is to nearly eliminate the influence of hole motion on the properties of the output signal. The result is that the much better mobility of electrons in compound semiconductors materials such as CZT can now be exploited without the concurrent penalty of poor hole collection. They have also developed new techniques in conjunction with the coplanar electrode principle that extends the technique into a new dimension. By proper processing of signals from the opposite electrode (the cathode) from the coplanar surface, they are able to derive a signal that is a good indication of the depth of interaction at which the charge carriers were initially formed. They have been the first group to demonstrate this technique, and examples of separate pulse height spectra recorded at a variety of different depths of interaction are shown in several of the figures that follow. Obtaining depth information is one step in the direction of obtaining volumetric point-of-interaction information from the detector. If one could known the coordinates of each specific interaction, then corrections could be applied to account for the inhomogeneities that currently plague many room-temperature devices.

  18. Medical Advances in Child Sexual Abuse

    ERIC Educational Resources Information Center

    Alexander, Randell A.

    2011-01-01

    This volume is the first of a two-part special issue detailing state of the art practice in medical issues around child sexual abuse. The six articles in this issue explore methods for medical history evaluation, the rationale for when sexual examinations should take place, specific hymenal findings that suggest a child has been sexually abused,…

  19. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  2. 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... OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language version of certain required statements. If devices restricted...

  3. 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... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  4. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  5. 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...

  6. 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... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  7. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  8. 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.

  9. 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

  10. [Design of medical devices management system supporting full life-cycle process management].

    PubMed

    Su, Peng; Zhong, Jianping

    2014-03-01

    Based on the analysis of the present status of medical devices management, this paper optimized management process, developed a medical devices management system with Web technologies. With information technology to dynamic master the use of state of the entire life-cycle of medical devices. Through the closed-loop management with pre-event budget, mid-event control and after-event analysis, improved the delicacy management level of medical devices, optimized asset allocation, promoted positive operation of devices.

  11. 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

  12. 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.

  13. Sustained prevention of biofilm formation on a novel silicone matrix suitable for medical devices.

    PubMed

    Steffensen, Søren Langer; Vestergaard, Merete Hedemark; Groenning, Minna; Alm, Martin; Franzyk, Henrik; Nielsen, Hanne Mørck

    2015-08-01

    Bacterial colonization and biofilm formation on medical devices constitute major challenges in clinical long-term use of e.g. catheters due to the risk of (re)infection of patients, which would result in additional use of antibiotics risking bacterial resistance development. The aim of the present project was to introduce a novel antibacterial approach involving an advanced composite material applicable for medical devices. The polymeric composites investigated consisted of a hydrogel network of cross-linked poly(2-hydroxyethyl methacrylate) (PHEMA) embedded in a poly(dimethylsiloxane) (PDMS) silicone elastomer produced using supercritical carbon dioxide (scCO2). In these materials, the hydrogel may contain an active pharmaceutical ingredient while the silicone elastomer provides the sufficient mechanical stability of the material. In these conceptual studies, the antimicrobial agent ciprofloxacin was loaded into the polymer matrix by a post-polymerization loading procedure. Sustained release of ciprofloxacin was demonstrated, and the release could be controlled by varying the hydrogel content in the range 13-38% (w/w) and by changing the concentration of ciprofloxacin during loading in the range of 1-20mg/mL. Devices containing 25% (w/w) hydrogel and loaded with ciprofloxacin displayed a strong antibacterial effect against Staphylococcus aureus bacterial colonization and subsequent biofilm formation on the device material was inhibited for 29days. In conclusion, the hydrogel/silicone composite represents a promising candidate material for medical devices that prevent bacterial colonization during long-term use. PMID:26028273

  14. Sustained prevention of biofilm formation on a novel silicone matrix suitable for medical devices.

    PubMed

    Steffensen, Søren Langer; Vestergaard, Merete Hedemark; Groenning, Minna; Alm, Martin; Franzyk, Henrik; Nielsen, Hanne Mørck

    2015-08-01

    Bacterial colonization and biofilm formation on medical devices constitute major challenges in clinical long-term use of e.g. catheters due to the risk of (re)infection of patients, which would result in additional use of antibiotics risking bacterial resistance development. The aim of the present project was to introduce a novel antibacterial approach involving an advanced composite material applicable for medical devices. The polymeric composites investigated consisted of a hydrogel network of cross-linked poly(2-hydroxyethyl methacrylate) (PHEMA) embedded in a poly(dimethylsiloxane) (PDMS) silicone elastomer produced using supercritical carbon dioxide (scCO2). In these materials, the hydrogel may contain an active pharmaceutical ingredient while the silicone elastomer provides the sufficient mechanical stability of the material. In these conceptual studies, the antimicrobial agent ciprofloxacin was loaded into the polymer matrix by a post-polymerization loading procedure. Sustained release of ciprofloxacin was demonstrated, and the release could be controlled by varying the hydrogel content in the range 13-38% (w/w) and by changing the concentration of ciprofloxacin during loading in the range of 1-20mg/mL. Devices containing 25% (w/w) hydrogel and loaded with ciprofloxacin displayed a strong antibacterial effect against Staphylococcus aureus bacterial colonization and subsequent biofilm formation on the device material was inhibited for 29days. In conclusion, the hydrogel/silicone composite represents a promising candidate material for medical devices that prevent bacterial colonization during long-term use.

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

    PubMed

    Luo, Qingfeng

    2014-05-01

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

  16. Developing an equivalent to the National Medicines Policy for medical devices.

    PubMed

    Smith, Matthew W; Faunce, Thomas A

    2009-12-01

    While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no equivalent national policy for medical devices. This is despite an established medical device legal framework that spans multiple departments across the Australian Government. The existing NMP offers an effective and proven benchmark for the development of a national medical devices policy. The four NMP principles of industry, standards, access and use are applicable to all phases of the medical device life-cycle and align with existing medical devices policy. This article proposes that Australia's approach to medical devices stands to benefit from an equivalent whole-of-government policy.

  17. Developing an equivalent to the National Medicines Policy for medical devices.

    PubMed

    Smith, Matthew W; Faunce, Thomas A

    2009-12-01

    While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no equivalent national policy for medical devices. This is despite an established medical device legal framework that spans multiple departments across the Australian Government. The existing NMP offers an effective and proven benchmark for the development of a national medical devices policy. The four NMP principles of industry, standards, access and use are applicable to all phases of the medical device life-cycle and align with existing medical devices policy. This article proposes that Australia's approach to medical devices stands to benefit from an equivalent whole-of-government policy. PMID:20169801

  18. Towards automated assistance for operating home medical devices.

    PubMed

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

    2010-01-01

    To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

  19. Ethics considerations for medical device R&D.

    PubMed

    Citron, Paul

    2012-01-01

    Medical devices have emerged as an important clinical option to treat certain serious diseases for which there are no equivalently effective surgical or pharmaceutical alternatives. Although all clinical activities impose high ethical standards of comportment to protect patients, medical device R&D and product application have a number of relatively unique aspects that distinguish them from other technologies such as pharmaceuticals. These include the following: R&D project selection; regulatory requirements, and their intended and unintended effects; when is a new product design sufficiently safe and effective for routine use in patients; and, physician-industry relationships in the innovation process in the context of real or perceived conflict of interest (COI). Each of these factors has implications for the delivery of care, health care leadership, and patient well-being. PMID:23217435

  20. Medical device-induced thrombosis: what causes it and how can we prevent it?

    PubMed

    Jaffer, I H; Fredenburgh, J C; Hirsh, J; Weitz, J I

    2015-06-01

    Blood-contacting medical devices, such as vascular grafts, stents, heart valves, and catheters, are often used to treat cardiovascular diseases. Thrombus formation is a common cause of failure of these devices. This study (i) examines the interface between devices and blood, (ii) reviews the pathogenesis of clotting on blood-contacting medical devices, (iii) describes contemporary methods to prevent thrombosis on blood-contacting medical devices, (iv) explains why some anticoagulants are better than others for prevention of thrombosis on medical devices, and (v) identifies future directions in biomaterial research for prevention of thrombosis on blood-contacting medical devices.

  1. Medical advances in child sexual abuse.

    PubMed

    Alexander, Randell A

    2011-09-01

    This volume is the first of a two-part special issue detailing state of the art practice in medical issues around child sexual abuse. The six articles in this issue explore methods for medical history evaluation, the rationale for when sexual examinations should take place, specific hymenal findings that suggest a child has been sexually abused, the healing of genital injuries, approaches to interpretation of medical findings, and the neurological harm of sexual abuse. From the initial history to the process of the medical examination, the mechanics of what a genital examination might show, and the neurobiological consequences, it is demonstrated that the harm of sexual abuse is has more effect on the brain than the genital area.

  2. 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.

  3. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART...

  4. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART...

  5. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ..., 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 Federal... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and...

  6. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... (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. 2011-6620... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and...

  7. 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... Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and...

  8. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... 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... Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and...

  9. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... comprehensive tutorial on best clinical practices for investigational medical device studies. Concurrent with the publication of this guidance in draft, November 10, 2011 (76 FR 70150), FDA initiated a pilot program for early feasibility study IDE applications (November 10, 2011, 76 FR 70152) to...

  10. 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.

  11. 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.

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

    PubMed

    Bachmor, T; Schöchlin, 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

  13. Advances in GaAs bistable optical devices

    NASA Astrophysics Data System (ADS)

    Jewell, J. L.; Tarng, S. S.; Gibbs, H. M.; Tai, K.; Weinberger, D. A.; Gossard, A. C.; McCall, S. L.; Passner, A.; Venkatesan, T. N. C.; Weigmann, W.

    1984-01-01

    Bistable optical devices (BOD's) using GaAs as the nonlinear medium are viable candidators for the achievement of fast ( ns), room temperature, low-power (mw), externally controllable optical switches which are easily fabricated and operated. Advances were made in all of these areas and efforts are in progress to improve performances in ways that are simultaneously compatible.

  14. Using an Advance Organizer to Improve Knowledge Application by Medical Students in Computer-Based Clinical Simulations.

    ERIC Educational Resources Information Center

    Krahn, Corrie G.; Blanchaer, Marcel C.

    1986-01-01

    This study investigated the efficacy of using the advance organizer as a device to improve medical students' understanding of a clinical case simulation on the microcomputer and to enhance performance on a posttest. Advance organizers were found to be effective and most consistent with Mayer's assimilation theory. (MBR)

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

    PubMed

    Wang, Qi; Webster, Thomas J

    2012-12-01

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

  16. 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...) is announcing a public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing... brief statement that describes your experience or expertise with nanotechnology. There will be a...

  17. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... HUMAN SERVICES Food and Drug Administration Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and... entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This...

  18. 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.

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

    PubMed

    Zhou, Li; Xu, Liang

    2011-11-01

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

  20. Organisational impact: Definition and assessment methods for medical devices.

    PubMed

    Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine

    2016-02-01

    Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle. PMID:27080633

  1. Organisational impact: Definition and assessment methods for medical devices.

    PubMed

    Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine

    2016-02-01

    Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.

  2. Medical abortion options may advance in 1998.

    PubMed

    1997-12-01

    The US debut of mifepristone (RU-486) was delayed in 1997 by legal and manufacturer problems. However, the Population Council is searching worldwide for companies to produce mifepristone for the US market. In the meantime, women in a number of US cities can obtain mifepristone through clinical trials coordinated by the New York City-based Abortion Rights Mobilization. The trials are evaluating the effectiveness of a 200 mg dosage of the drug and will continue until there is a commercial product. New developments in medical abortion will be announced in 1998. Currently, 29 Planned Parenthood Federation of America (PPFA) affiliates are recruiting women for its study of methotrexate and misoprostol. By midsummer 1998, the organization expects to have data from what is the largest multicenter trial to date of a methotrexate and misoprostol medical abortion regimen. PMID:12348221

  3. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Public Meeting... ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to...) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of...

  4. Additional peculiarities of medical devices that should be considered in their development process.

    PubMed

    Santos, Isa C T; Tavares, João Manuel R S

    2013-05-01

    Medical devices are peculiar products: their definition varies from country to country, they are used to treat diseases and they are different from pharmaceuticals. In 2012, the authors began to describe the complex and demanding environment of the medical device industry. In this article, the authors' previous research is extended with additional peculiarities of medical devices such as recall, pricing and adoption factors.

  5. 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...

  6. 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. 801.5 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...

  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. 801.5 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...

  8. 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. 801.5 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...

  9. 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... patent for a medical device will be extended by the length of the regulatory review period for...

  10. 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...

  11. 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...

  12. Designing medical devices for conformance with harmonized standards. The European Community's Medical Devices Directives and their effect on the product development process.

    PubMed

    Fries, R C; Graber, M D

    1995-01-01

    The European Community's Medical Devices Directives represent an ambitious effort to streamline the regulation of medical devices within the European Economic Area, and area comprising more than 380 million people. In this, the first of two special reports, Richard C. Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product development process. In the second report, appearing on page 294 Jean A. Goggins uses a case study format to demonstrate the process that would be used to gain European approval for a hypothetical medical device. PMID:7550495

  13. Are bioresorbable polylactate devices comparable to titanium devices for stabilizing Le Fort I advancement?

    PubMed

    Blakey, G H; Rossouw, E; Turvey, T A; Phillips, C; Proffit, W R; White, R P

    2014-04-01

    The purpose of this study was to evaluate whether skeletal and dental outcomes following Le Fort I surgery differed when stabilization was performed with polylactate bioresorbable devices or titanium devices. Fifty-seven patients with preoperative records and at least 1 year postoperative records were identified and grouped according to the stabilization method. All cephalometric X-rays were traced and digitized by a single operator. Analysis of covariance was used to compare the postsurgical change between the two stabilization methods. Twenty-seven patients received bioresorbable devices (group R), while 30 received titanium devices (group M). There were no statistically significant differences between the two groups with respect to gender, race/ethnicity, age, or dental and skeletal movements during surgery. Subtle postsurgical differences were noted, but were not statistically significant. Stabilization of Le Fort I advancement with polylactate bioresorbable and titanium devices produced similar clinical outcomes at 1 year following surgery.

  14. Advanced photon source experience with vacuum chambers for insertion devices

    SciTech Connect

    Hartog, P.D.; Grimmer, J.; Xu, S.; Trakhtenberg, E.; Wiemerslage, G.

    1997-08-01

    During the last five years, a new approach to the design and fabrication of extruded aluminum vacuum chambers for insertion devices was developed at the Advanced Photon Source (APS). With this approach, three different versions of the vacuum chamber, with vertical apertures of 12 mm, 8 mm, and 5 mm, were manufactured and tested. Twenty chambers were installed into the APS vacuum system. All have operated with beam, and 16 have been coupled with insertion devices. Two different vacuum chambers with vertical apertures of 16 mm and 11 mm were developed for the BESSY-II storage ring and 3 of 16 mm chambers were manufactured.

  15. Advanced Sensor Fish Device for ImprovedTurbine Design

    SciTech Connect

    Carlson, Thomas J.

    2009-09-14

    Juvenile salmon (smolts) passing through hydroelectric turbines are subjected to environmental conditions that can potentially kill or injure them. Many turbines are reaching the end of their operational life expectancies and will be replaced with new turbines that incorporate advanced “fish friendly” designs devised to prevent injury and death to fish. To design a fish friendly turbine, it is first necessary to define the current conditions fish encounter. One such device used by biologists at Pacific Northwest National Laboratory was the sensor fish device to collect data that measures the forces fish experience during passage through hydroelectric projects.

  16. The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician.

    PubMed

    Almond, Christopher S

    2012-05-01

    Pediatric medical devices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medical devices used in children today are used off-label where the risk-benefit of devices has not been well characterized. Pediatric medical devices face a variety of challenges to FDA approval related in large part to the small target population, heterogeneity of the patient population and ethical considerations of device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully is growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases making it suitable for devices treating congenital heart disease. This review summarizes the FDA review process for pediatric medical devices as it continues to evolve in response to the unique challenges of understanding device performance in the pediatric population. PMID:22661882

  17. 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.

  18. 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.

  19. Empowering patients: total product life cycle for medical devices.

    PubMed

    Ciarkowski, Arthur A

    2003-01-01

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

  20. Advanced ultrasound probes for medical imaging

    NASA Astrophysics Data System (ADS)

    Wildes, Douglas G.; Smith, L. Scott

    2012-05-01

    New medical ultrasound probe architectures and materials build upon established 1D phased array technology and provide improved imaging performance and clinical value. Technologies reviewed include 1.25D and 1.5D arrays for elevation slice thickness control; electro-mechanical and 2D array probes for real-time 3D imaging; catheter probes for imaging during minimally-invasive procedures; single-crystal piezoelectric materials for greater frequency bandwidth; and cMUT arrays using silicon MEMS in place of piezo materials.

  1. 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

  2. Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices

    NASA Astrophysics Data System (ADS)

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

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

  3. 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.

  4. A medical device regulatory framework - case study: South Africa.

    PubMed

    Poluta, Mladen A

    2006-01-01

    The regulation of medical devices is well-established in industrialized countries, with increasing global standardization and harmonization. In developing and resource-poor countries, however, there is a much greater degree of variability and implementation. For such countries, this paper suggests a comprehensive and integrated regulatory framework approach using the South African health technology policy framework as a basis for comparison and benchmarking. It is hoped that this compact model, which covers a wide range of HTM-related aspects, will be useful to governments and their partners, amongst other role-players.

  5. 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

  6. Establishing advanced practice for medical imaging in New Zealand

    SciTech Connect

    Yielder, Jill; Young, Adrienne; Park, Shelley; Coleman, Karen

    2014-02-15

    Introduction: This article presents the outcome and recommendations following the second stage of a role development project conducted on behalf of the New Zealand Institute of Medical Radiation Technology (NZIMRT). The study sought to support the development of profiles and criteria that may be used to formulate Advanced Scopes of Practice for the profession. It commenced in 2011, following on from initial research that occurred between 2005 and 2008 investigating role development and a possible career structure for medical radiation technologists (MRTs) in New Zealand (NZ). Methods: The study sought to support the development of profiles and criteria that could be used to develop Advanced Scopes of Practice for the profession through inviting 12 specialist medical imaging groups in NZ to participate in a survey. Results: Findings showed strong agreement on potential profiles and on generic criteria within them; however, there was less agreement on specific skills criteria within specialist areas. Conclusions: The authors recommend that one Advanced Scope of Practice be developed for Medical Imaging, with the establishment of generic and specialist criteria. Systems for approval of the overall criteria package for any individual Advanced Practitioner (AP) profile, audit and continuing professional development requirements need to be established by the Medical Radiation Technologists Board (MRTB) to meet the local needs of clinical departments. It is further recommended that the NZIMRT and MRTB promote and support the need for an AP pathway for medical imaging in NZ.

  7. Establishing advanced practice for medical imaging in New Zealand

    PubMed Central

    Yielder, Jill; Young, Adrienne; Park, Shelley; Coleman, Karen

    2014-01-01

    IntroductionThis article presents the outcome and recommendations following the second stage of a role development project conducted on behalf of the New Zealand Institute of Medical Radiation Technology (NZIMRT). The study sought to support the development of profiles and criteria that may be used to formulate Advanced Scopes of Practice for the profession. It commenced in 2011, following on from initial research that occurred between 2005 and 2008 investigating role development and a possible career structure for medical radiation technologists (MRTs) in New Zealand (NZ). MethodsThe study sought to support the development of profiles and criteria that could be used to develop Advanced Scopes of Practice for the profession through inviting 12 specialist medical imaging groups in NZ to participate in a survey. ResultsFindings showed strong agreement on potential profiles and on generic criteria within them; however, there was less agreement on specific skills criteria within specialist areas. ConclusionsThe authors recommend that one Advanced Scope of Practice be developed for Medical Imaging, with the establishment of generic and specialist criteria. Systems for approval of the overall criteria package for any individual Advanced Practitioner (AP) profile, audit and continuing professional development requirements need to be established by the Medical Radiation Technologists Board (MRTB) to meet the local needs of clinical departments. It is further recommended that the NZIMRT and MRTB promote and support the need for an AP pathway for medical imaging in NZ. PMID:26229631

  8. Advancing Resident Assessment in Graduate Medical Education

    PubMed Central

    Swing, Susan R.; Clyman, Stephen G.; Holmboe, Eric S.; Williams, Reed G.

    2009-01-01

    Background The Outcome Project requires high-quality assessment approaches to provide reliable and valid judgments of the attainment of competencies deemed important for physician practice. Intervention The Accreditation Council for Graduate Medical Education (ACGME) convened the Advisory Committee on Educational Outcome Assessment in 2007–2008 to identify high-quality assessment methods. The assessments selected by this body would form a core set that could be used by all programs in a specialty to assess resident performance and enable initial steps toward establishing national specialty databases of program performance. The committee identified a small set of methods for provisional use and further evaluation. It also developed frameworks and processes to support the ongoing evaluation of methods and the longer-term enhancement of assessment in graduate medical education. Outcome The committee constructed a set of standards, a methodology for applying the standards, and grading rules for their review of assessment method quality. It developed a simple report card for displaying grades on each standard and an overall grade for each method reviewed. It also described an assessment system of factors that influence assessment quality. The committee proposed a coordinated, national-level infrastructure to support enhancements to assessment, including method development and assessor training. It recommended the establishment of a new assessment review group to continue its work of evaluating assessment methods. The committee delivered a report summarizing its activities and 5 related recommendations for implementation to the ACGME Board in September 2008. PMID:21975993

  9. Insertion devices for the Advanced Light Source at LBL

    SciTech Connect

    Hassenzahl, W.; Chin, J.; Halbach, K.; Hoyer, E.; Humphries, D.; Kincaid, B.; Savoy, R.

    1989-03-01

    The Advanced Light Source (ALS) at the Lawrence Berkeley Laboratory will be the first of the new generation of dedicated synchrotron light sources to be put into operation. Specially designed insertion devices will be required to realize the high brightness photon beams made possible by the low emittance of the electron beam. The complement of insertion devices on the ALS will include undulators with periods as short as 3.9 cm and one or more high field wigglers. The first device to be designed is a 5 m long, 5 cm period, hybrid undulator. The goal of very high brightness and high harmonic output imposes unusually tight tolerances on the magnetic field quality and thus on the mechanical structure. The design process, using a generic structure for all undulators, is described. 5 refs., 4 figs., 1 tab.

  10. 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.

  11. Recent Advances in Flexible and Stretchable Bio-Electronic Devices Integrated with Nanomaterials.

    PubMed

    Choi, Suji; Lee, Hyunjae; Ghaffari, Roozbeh; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2016-06-01

    Flexible and stretchable electronics and optoelectronics configured in soft, water resistant formats uniquely address seminal challenges in biomedicine. Over the past decade, there has been enormous progress in the materials, designs, and manufacturing processes for flexible/stretchable system subcomponents, including transistors, amplifiers, bio-sensors, actuators, light emitting diodes, photodetector arrays, photovoltaics, energy storage elements, and bare die integrated circuits. Nanomaterials prepared using top-down processing approaches and synthesis-based bottom-up methods have helped resolve the intrinsic mechanical mismatch between rigid/planar devices and soft/curvilinear biological structures, thereby enabling a broad range of non-invasive, minimally invasive, and implantable systems to address challenges in biomedicine. Integration of therapeutic functional nanomaterials with soft bioelectronics demonstrates therapeutics in combination with unconventional diagnostics capabilities. Recent advances in soft materials, devices, and integrated systems are reviewes, with representative examples that highlight the utility of soft bioelectronics for advanced medical diagnostics and therapies.

  12. Recent Advances in Flexible and Stretchable Bio-Electronic Devices Integrated with Nanomaterials.

    PubMed

    Choi, Suji; Lee, Hyunjae; Ghaffari, Roozbeh; Hyeon, Taeghwan; Kim, Dae-Hyeong

    2016-06-01

    Flexible and stretchable electronics and optoelectronics configured in soft, water resistant formats uniquely address seminal challenges in biomedicine. Over the past decade, there has been enormous progress in the materials, designs, and manufacturing processes for flexible/stretchable system subcomponents, including transistors, amplifiers, bio-sensors, actuators, light emitting diodes, photodetector arrays, photovoltaics, energy storage elements, and bare die integrated circuits. Nanomaterials prepared using top-down processing approaches and synthesis-based bottom-up methods have helped resolve the intrinsic mechanical mismatch between rigid/planar devices and soft/curvilinear biological structures, thereby enabling a broad range of non-invasive, minimally invasive, and implantable systems to address challenges in biomedicine. Integration of therapeutic functional nanomaterials with soft bioelectronics demonstrates therapeutics in combination with unconventional diagnostics capabilities. Recent advances in soft materials, devices, and integrated systems are reviewes, with representative examples that highlight the utility of soft bioelectronics for advanced medical diagnostics and therapies. PMID:26779680

  13. 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.

  14. [Assessment of benefit and efficiency of innovative medical devices].

    PubMed

    Perleth, M; Lühmann, D

    2010-08-01

    Medical devices cover a wide spectrum of products with very different diagnostic and therapeutic applications. However, for market licensing, uniform rules apply. Uniform rules are also valid for coverage decisions in German health care. In this article, the criteria for the assessment of benefit and efficiency of innovative biomedical technologies are described from the perspective of the statutory health insurance system. The key concepts relevant in the mandatory health insurance' "innovation"' "benefit", and "economic efficiency" are characterized. Only measurable effects of an intervention which lead to a more than marginal improvement in prognosis, symptoms, or quality of life as compared to a standard treatment are considered as beneficial. An innovative device is, therefore, subject to a benefit assessment if it is not yet reimbursed (or not yet part of the benefit package), when it is relevant to the health care system and a high public interest exists. In addition, it is important to consider a positive benefit assessment as a part of the value added chain to avoid conflicts of interest. Within the scope of early technology assessment, some conclusions can already be drawn in the early developmental stage of a device.

  15. The Tablet Device in Hospital Neurology and in Neurology Graduate Medical Education

    PubMed Central

    Newey, Christopher R.; Bhimraj, Adarsh

    2015-01-01

    Background and Purpose: There is limited literature on tablet devices for neurohospitalists and in neurological graduate medical education. This study evaluated utilization, benefits, and limitations of customized tablets on inpatient neurology practice and resident education. The hypothesis was the perception of the tablet would be positive, given their portability, convenience to accessing point-of-care reference, and accessibility to the electronic medical record. Methods: Second-generation iPads with neurology-specific applications and literature were provided to our in-hospital general, stroke, and consult neurology teams. After 1 year, residents on these teams were surveyed on demographic data, familiarity, and utilization of the iPad and their perceptions of the device. Results: All 27 residents responded to the survey. Most participants (23 of 27) used a tablet while on inpatient service. Twelve regularly utilized the neurology-specific apps and/or accessed scientific articles. Technologically savvy residents felt significantly more comfortable using tablets and were more quickly acquainted with the features. Thirteen respondents wanted a formal orientation on the advanced features of the tablet independent of their familiarity with the device or level of technological comfort. Conclusion: Overall, the perception was that the tablet was beneficial for inpatient clinical care and as an educational reference. Participants became easily familiarized with the device features quickly, regardless of whether they owned one previously or not. Most physicians indicated interest in advanced features of tablets; however, a formal orientation may be beneficial for optimal utilization. A reliable network connection is essential to in-hospital use of tablet devices. Additional research pertaining to patient outcomes, objective educational benefit, and cost-effectiveness is necessary. PMID:25553224

  16. VME insertion device control at the Advanced Photon Source

    NASA Astrophysics Data System (ADS)

    Smith, M.; Ramanathan, M.; Grimmer, J.; Merritt, M.

    2002-03-01

    The Advanced Photon Source (APS) currently has 29 insertion devices (IDs) installed and operating. The need to remotely diagnose and correct problems has become increasingly important. This has been accomplished through the development of a new control system with greatly enhanced input/output (I/O) capabilities specifically targeted to this control task. The system features a custom VME control card and three rack-mounted interface chassis for ID control, encoder interface, and motor drive shutdown. The card provides device interlocks, limit switch logic, motor axis selection, digital I/O, and status feedback. This VME insertion device control was designed to operate with an eight-axis intelligent motor controller and a stepper-motor drive that accepts step and direction inputs. The front panel of the card has two connectors for all of the control signals for the stepper-motor drives. There is a third connector for the ID limit switch inputs and the emergency stop circuit, and a fourth connector provides 23 bits of digital outputs and 16 bits of digital inputs. Light-emitting diodes indicate which motions are inhibited by the limit switch logic. An experimental physics industrial control system (EPICS) (http://www.APS.ANL-GOV/EPICS) device driver was developed to access all the registers on the VME control card. Using standard EPICS records, the insertion device status can be viewed remotely. This minimizes downtime for APS ID beamline users by allowing faster resolution of any problems preventing a user from operating the insertion device. This new insertion device control has been in use at the APS since July of 1999. The design features of the control system and rationale for them will be presented, along with our experience in building, testing, installing, and operating the control system.

  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. 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...

  19. 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...

  20. 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.

  1. [Psychiatric advance directives--medical models into psychiatric medicine].

    PubMed

    Mautner, Sigal; Lachman, Max; Kaplan, Zeev; Shalev, Anat

    2014-01-01

    Since the year 2005, in the field of general medicine, the legislature in Israel determined ways to implement medically advanced directives according to the power of the law. Different states in the world had implemented parallel legislation for patients who suffer from mental illness. Psychiatric Advance Directives is a legitimate document which is valid in Australia, New Zealand, Scotland, England and in 25 countries in the U.S.A. Psychiatric advance directives (PAD's) allow competent persons, through advance instructions, to state their preferences for future mental health treatment in the event of an incapacitating psychiatric crisis. Self Determination Theory, Self Care and Autonomy are dominant supportive approaches in the creation of Psychiatric Advance Directives. Research conducted on psychiatric advance directives shows positive potential benefits for mental health clients, therapists and psychiatrists. More research in that area must be conducted. Psychiatric advance directives are currently developed and implemented with the cooperation of the Tauber Foundation and the Beer Sheva Mental Health Center. This is the first step in learning of effective ways to use this intervention in Israel and change perceptions toward a positive connection between medical efficiency and client preferences.

  2. Pediatric medical devices: a look at significant US legislation to address unmet needs.

    PubMed

    Samuels-Reid, Joy H; Blake, Erica D

    2014-03-01

    There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.

  3. 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

  4. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Pediatric Medical Devices... 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...

  5. 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 prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico...

  6. Evaluation of ExPress glaucoma filtration device in Indian patients with advanced glaucoma.

    PubMed

    Angmo, Dewang; Sharma, Reetika; Temkar, Shreyas; Dada, Tanuj

    2015-05-01

    ExPress glaucoma filtration device (GFD) has recently become available in India as a surgical option for glaucoma patients. We retrospectively evaluated the outcome of ExPress GFD in 12 eyes with advanced glaucoma with intraocular pressures (IOPs) not controlled on maximal tolerable medical therapy. The mean preoperative IOP of 29.58 ± 7.13 mmHg decreased to 17.0 ± 2.67 and 17.40 ± 0.89 mmHg at 6 and 12 months after surgery. Absolute success (IOP ≤ 18 mmHg, with no additional glaucoma medications) was achieved in eight cases (66.7%) and qualified success (IOP ≤ 18 mmHg, with additional glaucoma medications) in two cases (16.7%) at 1-year after surgery. Early intervention was needed in 4 patients; two underwent anterior chamber reformation while the other two required needling. Two patients required resurgery. There was no significant change in the best corrected visual acuity postoperatively (P = 0.37). ExPress GFD does not seem to offer a benefit over standard trabeculectomy in patients with advanced glaucomatous disease in terms of IOP control or complication rate. However, due to the small sample size with a heterogeneous mixture of primary and secondary glaucoma's, we await further studies with a larger sample size and long-term follow-up, to see how the device performs.

  7. Evaluation of ExPress glaucoma filtration device in Indian patients with advanced glaucoma

    PubMed Central

    Angmo, Dewang; Sharma, Reetika; Temkar, Shreyas; Dada, Tanuj

    2015-01-01

    ExPress glaucoma filtration device (GFD) has recently become available in India as a surgical option for glaucoma patients. We retrospectively evaluated the outcome of ExPress GFD in 12 eyes with advanced glaucoma with intraocular pressures (IOPs) not controlled on maximal tolerable medical therapy. The mean preoperative IOP of 29.58 ± 7.13 mmHg decreased to 17.0 ± 2.67 and 17.40 ± 0.89 mmHg at 6 and 12 months after surgery. Absolute success (IOP ≤ 18 mmHg, with no additional glaucoma medications) was achieved in eight cases (66.7%) and qualified success (IOP ≤ 18 mmHg, with additional glaucoma medications) in two cases (16.7%) at 1-year after surgery. Early intervention was needed in 4 patients; two underwent anterior chamber reformation while the other two required needling. Two patients required resurgery. There was no significant change in the best corrected visual acuity postoperatively (P = 0.37). ExPress GFD does not seem to offer a benefit over standard trabeculectomy in patients with advanced glaucomatous disease in terms of IOP control or complication rate. However, due to the small sample size with a heterogeneous mixture of primary and secondary glaucoma's, we await further studies with a larger sample size and long-term follow-up, to see how the device performs. PMID:26139813

  8. Advanced Measurement Devices for the Microgravity Electromagnetic Levitation Facility EML

    NASA Technical Reports Server (NTRS)

    Brillo, Jurgen; Fritze, Holger; Lohofer, Georg; Schulz, Michal; Stenzel, Christian

    2012-01-01

    This paper reports on two advanced measurement devices for the microgravity electromagnetic levitation facility (EML), which is currently under construction for the use onboard the "International Space Station (ISS)": the "Sample Coupling Electronics (SCE)" and the "Oxygen Sensing and Control Unit (OSC)". The SCE measures by a contactless, inductive method the electrical resistivity and the diameter of a spherical levitated metallic droplet by evaluating the voltage and electrical current applied to the levitation coil. The necessity of the OSC comes from the insight that properties like surface tension or, eventually, viscosity cannot seriously be determined by the oscillating drop method in the EML facility without knowing the conditions of the surrounding atmosphere. In the following both measurement devices are explained and laboratory test results are presented.

  9. TID Simulation of Advanced CMOS Devices for Space Applications

    NASA Astrophysics Data System (ADS)

    Sajid, Muhammad

    2016-07-01

    This paper focuses on Total Ionizing Dose (TID) effects caused by accumulation of charges at silicon dioxide, substrate/silicon dioxide interface, Shallow Trench Isolation (STI) for scaled CMOS bulk devices as well as at Buried Oxide (BOX) layer in devices based on Silicon-On-Insulator (SOI) technology to be operated in space radiation environment. The radiation induced leakage current and corresponding density/concentration electrons in leakage current path was presented/depicted for 180nm, 130nm and 65nm NMOS, PMOS transistors based on CMOS bulk as well as SOI process technologies on-board LEO and GEO satellites. On the basis of simulation results, the TID robustness analysis for advanced deep sub-micron technologies was accomplished up to 500 Krad. The correlation between the impact of technology scaling and magnitude of leakage current with corresponding total dose was established utilizing Visual TCAD Genius program.

  10. 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 SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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 801.15 - 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 SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical...

  13. Novel device-based interventional strategies for advanced heart failure

    PubMed Central

    Vanderheyden, Marc; Bartunek, Jozef

    2016-01-01

    While heart failure is one of the leading causes of mortality and morbidity, our tools to provide ultimate treatment solutions are still limited. Recent developments in new devices are designed to fill this therapeutic gap. The scope of this review is to focus on two particular targets, namely (1) left ventricular geometric restoration and (2) atrial depressurization. (1) Reduction of the wall stress by shrinking the ventricular cavity has been traditionally attempted surgically. Recently, the Parachute device (CardioKinetix Inc., Menlo Park, CA, USA) has been introduced to restore ventricular geometry and cardiac mechanics. The intervention aims to partition distal dysfunctional segments that are non-contributory to the ventricular mechanics and forward cardiac output. (2) Diastolic heart failure is characterized by abnormal relaxation and chamber stiffness. The main therapeutic goal achieved should be the reduction of afterload and diastolic pressure load. Recently, new catheter-based approaches were proposed to reduce left atrial pressure and ventricular decompression: the InterAtrial Shunt Device (IASD™) (Corvia Medical Inc., Tewksbury, MA, USA) and the V-Wave Shunt (V-Wave Ltd, Or Akiva, Israel). Both are designed to create a controlled atrial septal defect in symptomatic patients with heart failure. While the assist devices are aimed at end-stage heart failure, emerging device-based percutaneous or minimal invasive techniques comprise a wide spectrum of innovative concepts that target ventricular remodeling, cardiac contractility or neuro-humoral modulation. The clinical adoption is in the early stages of the initial feasibility and safety studies, and clinical evidence needs to be gathered in appropriately designed clinical trials. PMID:26966444

  14. Novel device-based interventional strategies for advanced heart failure.

    PubMed

    Toth, Gabor G; Vanderheyden, Marc; Bartunek, Jozef

    2016-01-01

    While heart failure is one of the leading causes of mortality and morbidity, our tools to provide ultimate treatment solutions are still limited. Recent developments in new devices are designed to fill this therapeutic gap. The scope of this review is to focus on two particular targets, namely (1) left ventricular geometric restoration and (2) atrial depressurization. (1) Reduction of the wall stress by shrinking the ventricular cavity has been traditionally attempted surgically. Recently, the Parachute device (CardioKinetix Inc., Menlo Park, CA, USA) has been introduced to restore ventricular geometry and cardiac mechanics. The intervention aims to partition distal dysfunctional segments that are non-contributory to the ventricular mechanics and forward cardiac output. (2) Diastolic heart failure is characterized by abnormal relaxation and chamber stiffness. The main therapeutic goal achieved should be the reduction of afterload and diastolic pressure load. Recently, new catheter-based approaches were proposed to reduce left atrial pressure and ventricular decompression: the InterAtrial Shunt Device (IASD™) (Corvia Medical Inc., Tewksbury, MA, USA) and the V-Wave Shunt (V-Wave Ltd, Or Akiva, Israel). Both are designed to create a controlled atrial septal defect in symptomatic patients with heart failure. While the assist devices are aimed at end-stage heart failure, emerging device-based percutaneous or minimal invasive techniques comprise a wide spectrum of innovative concepts that target ventricular remodeling, cardiac contractility or neuro-humoral modulation. The clinical adoption is in the early stages of the initial feasibility and safety studies, and clinical evidence needs to be gathered in appropriately designed clinical trials. PMID:26966444

  15. [Utility of medical devices: approaches to planning and conducting clinical trials].

    PubMed

    Ziegler, Andreas; Heimerl, Albert; Krockenberger, Katja; Hemmelmann, Claudia

    2012-01-01

    Medicines and medical devices do not only differ in the approval process, but also in the aim and conduct of clinical trials. We first discuss important differences between medicinal products and medical devices. Emphasis is put on the differences in the framework for clinical trials. We point out that a different analysis set should be used in clinical trials of medical devices when compared with medicinal products and medical devices in the USA. Specifically, regulators generally ask for the full analysis set based on the intention-to-treat principle as proof of efficacy of medicines. A central aspect of clinical trials of medical devices is that they have to be tested under normal conditions of use according to the performance data. As a result, all data acquired while the medical device was not during normal conditions of use should be excluded from statistical analyses. We discuss statistical methodological particularities of medical devices, such as blinding and the control of placebo effects. Using the conservative treatment of anal incontinence as an example, we show that comprehensive technical and physical knowledge is required for assessing the utility of medical devices. Finally, we consider reporting of severe adverse events and of severe adverse device effects of medical devices.

  16. Highly sensitive pyrogen detection on medical devices by the monocyte activation test.

    PubMed

    Stang, Katharina; Fennrich, Stefan; Krajewski, Stefanie; Stoppelkamp, Sandra; Burgener, Iwan Anton; Wendel, Hans-Peter; Post, Marcell

    2014-04-01

    Pyrogens are components of microorganisms, like bacteria, viruses or fungi, which can induce a complex inflammatory response in the human body. Pyrogen contamination on medical devices prior operation is still critical and associated with severe complications for the patients. The aim of our study was to develop a reliable test, which allows detection of pyrogen contamination on the surface of medical devices. After in vitro pyrogen contamination of different medical devices and incubation in a rotation model, the human whole blood monocyte activation test (MAT), which is based on an IL-1β-specific ELISA, was employed. Our results show that when combining a modified MAT protocol and a dynamic incubation system, even smallest amounts of pyrogens can be directly detected on the surface of medical devices. Therefore, screening of medical devices prior clinical application using our novel assay, has the potential to significantly reduce complications associated with pyrogen-contaminated medical devices.

  17. [Study on situations of review and pre-evaluation for medical device product specification in China].

    PubMed

    Li, Baolin

    2013-07-01

    This paper researched on course of registration and administrative licensing for medical device product specification, analyzed the existing demands of review and pre-evaluation, discussed about how to improve and manage pre-evaluation results for testing laboratory and manufacturer in China, based on "Provision of Medical Device Product Specification Standardization", "Provision on Medical Device Registration" and relative documents of States Food & Drug Administration. It suggested that set up and maintain a professional team of review and approval staff, further strengthen standardization of medical device specification, arming at current situations of non-compatibility between documents and inconformity of performance in different provinces. It paid attention to control the quality of medical device to ensure the core of safety and effectiveness for using medical device.

  18. Nanoscale Copper and Copper Compounds for Advanced Device Applications

    NASA Astrophysics Data System (ADS)

    Chen, Lih-Juann

    2016-04-01

    Copper has been in use for at least 10,000 years. Copper alloys, such as bronze and brass, have played important roles in advancing civilization in human history. Bronze artifacts date at least 6500 years. On the other hand, discovery of intriguing properties and new applications in contemporary technology for copper and its compounds, particularly on nanoscale, have continued. In this paper, examples for the applications of Cu and Cu alloys for advanced device applications will be given on Cu metallization in microelectronics devices, Cu nanobats as field emitters, Cu2S nanowire array as high-rate capability and high-capacity cathodes for lithium-ion batteries, Cu-Te nanostructures for field-effect transistor, Cu3Si nanowires as high-performance field emitters and efficient anti-reflective layers, single-crystal Cu(In,Ga)Se2 nanotip arrays for high-efficiency solar cell, multilevel Cu2S resistive memory, superlattice Cu2S-Ag2S heterojunction diodes, and facet-dependent Cu2O diode.

  19. Team-Based Development of Medical Devices: An Engineering-Business Collaborative.

    PubMed

    Eberhardt, Alan W; Johnson, Ophelia L; Kirkland, William B; Dobbs, Joel H; Moradi, Lee G

    2016-07-01

    There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a "virtual company," with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement. PMID:26902869

  20. Team-Based Development of Medical Devices: An Engineering-Business Collaborative.

    PubMed

    Eberhardt, Alan W; Johnson, Ophelia L; Kirkland, William B; Dobbs, Joel H; Moradi, Lee G

    2016-07-01

    There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a "virtual company," with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement.

  1. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-01-14

    The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. PMID:11010655

  2. Recent advances in conjugated polymers for light emitting devices.

    PubMed

    Alsalhi, Mohamad Saleh; Alam, Javed; Dass, Lawrence Arockiasamy; Raja, Mohan

    2011-01-01

    A recent advance in the field of light emitting polymers has been the discovery of electroluminescent conjugated polymers, that is, kind of fluorescent polymers that emit light when excited by the flow of an electric current. These new generation fluorescent materials may now challenge the domination by inorganic semiconductor materials of the commercial market in light-emitting devices such as light-emitting diodes (LED) and polymer laser devices. This review provides information on unique properties of conjugated polymers and how they have been optimized to generate these properties. The review is organized in three sections focusing on the major advances in light emitting materials, recent literature survey and understanding the desirable properties as well as modern solid state lighting and displays. Recently, developed conjugated polymers are also functioning as roll-up displays for computers and mobile phones, flexible solar panels for power portable equipment as well as organic light emitting diodes in displays, in which television screens, luminous traffic, information signs, and light-emitting wallpaper in homes are also expected to broaden the use of conjugated polymers as light emitting polymers. The purpose of this review paper is to examine conjugated polymers in light emitting diodes (LEDs) in addition to organic solid state laser. Furthermore, since conjugated polymers have been approved as light-emitting organic materials similar to inorganic semiconductors, it is clear to motivate these organic light-emitting devices (OLEDs) and organic lasers for modern lighting in terms of energy saving ability. In addition, future aspects of conjugated polymers in LEDs were also highlighted in this review.

  3. Recent Advances in Conjugated Polymers for Light Emitting Devices

    PubMed Central

    AlSalhi, Mohamad Saleh; Alam, Javed; Dass, Lawrence Arockiasamy; Raja, Mohan

    2011-01-01

    A recent advance in the field of light emitting polymers has been the discovery of electroluminescent conjugated polymers, that is, kind of fluorescent polymers that emit light when excited by the flow of an electric current. These new generation fluorescent materials may now challenge the domination by inorganic semiconductor materials of the commercial market in light-emitting devices such as light-emitting diodes (LED) and polymer laser devices. This review provides information on unique properties of conjugated polymers and how they have been optimized to generate these properties. The review is organized in three sections focusing on the major advances in light emitting materials, recent literature survey and understanding the desirable properties as well as modern solid state lighting and displays. Recently, developed conjugated polymers are also functioning as roll-up displays for computers and mobile phones, flexible solar panels for power portable equipment as well as organic light emitting diodes in displays, in which television screens, luminous traffic, information signs, and light-emitting wallpaper in homes are also expected to broaden the use of conjugated polymers as light emitting polymers. The purpose of this review paper is to examine conjugated polymers in light emitting diodes (LEDs) in addition to organic solid state laser. Furthermore, since conjugated polymers have been approved as light-emitting organic materials similar to inorganic semiconductors, it is clear to motivate these organic light-emitting devices (OLEDs) and organic lasers for modern lighting in terms of energy saving ability. In addition, future aspects of conjugated polymers in LEDs were also highlighted in this review. PMID:21673938

  4. Recent advances in conjugated polymers for light emitting devices.

    PubMed

    Alsalhi, Mohamad Saleh; Alam, Javed; Dass, Lawrence Arockiasamy; Raja, Mohan

    2011-01-01

    A recent advance in the field of light emitting polymers has been the discovery of electroluminescent conjugated polymers, that is, kind of fluorescent polymers that emit light when excited by the flow of an electric current. These new generation fluorescent materials may now challenge the domination by inorganic semiconductor materials of the commercial market in light-emitting devices such as light-emitting diodes (LED) and polymer laser devices. This review provides information on unique properties of conjugated polymers and how they have been optimized to generate these properties. The review is organized in three sections focusing on the major advances in light emitting materials, recent literature survey and understanding the desirable properties as well as modern solid state lighting and displays. Recently, developed conjugated polymers are also functioning as roll-up displays for computers and mobile phones, flexible solar panels for power portable equipment as well as organic light emitting diodes in displays, in which television screens, luminous traffic, information signs, and light-emitting wallpaper in homes are also expected to broaden the use of conjugated polymers as light emitting polymers. The purpose of this review paper is to examine conjugated polymers in light emitting diodes (LEDs) in addition to organic solid state laser. Furthermore, since conjugated polymers have been approved as light-emitting organic materials similar to inorganic semiconductors, it is clear to motivate these organic light-emitting devices (OLEDs) and organic lasers for modern lighting in terms of energy saving ability. In addition, future aspects of conjugated polymers in LEDs were also highlighted in this review. PMID:21673938

  5. Advanced Silicon Solar Cell Device Physics and Design

    NASA Astrophysics Data System (ADS)

    Deceglie, Michael Gardner

    A fundamental challenge in the development and deployment of solar photovoltaic technology is a reduction in cost enabling direct competition with fossil-fuel-based energy sources. A key driver in this cost reduction is optimized device efficiency, because increased energy output leverages all photovoltaic system costs, from raw materials and module manufacturing to installation and maintenance. To continue progress toward higher conversion efficiencies, solar cells are being fabricated with increasingly complex designs, including engineered nanostructures, heterojunctions, and novel contacting and passivation schemes. Such advanced designs require a comprehensive and unified understanding of the optical and electrical device physics at the microscopic scale. This thesis focuses on a microscopic understanding of solar cell optoelectronic performance and its impact on cell optimization. We consider this in three solar cell platforms: thin-film crystalline silicon, amorphous/crystalline silicon heterojunctions, and thin-film cells with nanophotonic light trapping. The work described in this thesis represents a powerful design paradigm, based on a detailed physical understanding of the mechanisms governing solar cell performance. Furthermore, we demonstrate the importance of understanding not just the individual mechanisms, but also their interactions. Such an approach to device optimization is critical for the efficiency and competitiveness of future generations of solar cells.

  6. Designing medical devices for conformance with harmonized standards: a case study of non-active implants.

    PubMed

    Gogins, J A

    1995-01-01

    The European Community's Medical Devices Directives represent an ambitious effort to streamline the regulation of medical devices within the European Economic Area, an area comprising more than 380 million people. In this, the second of two special reports, Jean A. Goggins uses a case study format to demonstrate the process that would be used to gain European approval for a hypothetical medical device. In the first report, appearing on page 284, Richard C. Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product-development process. PMID:7550496

  7. Devices for medical diagnosis with GaN lasers

    NASA Astrophysics Data System (ADS)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

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

  8. Methodological choices for the clinical development of medical devices

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    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.

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

    PubMed

    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

  12. 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

  13. Nanoscience and Nanotechnology: From Energy Applications to Advanced Medical Therapies

    ScienceCinema

    Tijana Rajh

    2016-07-12

    Dr. Rajh will present a general talk on nanotechnology – an overview of why nanotechnology is important and how it is useful in various fields. The specific focus will be on Solar energy conversion, environmental applications and advanced medical therapies. She has broad expertise in synthesis and characterization of nanomaterials that are used in nanotechnology including novel hybrid systems connecting semiconductors to biological molecules like DNA and antibodies. This technology could lead to new gene therapy procedures, cancer treatments and other medical applications. She will also discuss technologies made possible by organizing small semiconductor particles called quantum dots, materials that exhibit a rich variety of phenomena that are size and shape dependent. Development of these new materials that harnesses the unique properties of materials at the 1-100 nanometer scale resulted in the new field of nanotechnology that currently affects many applications in technological and medical fields.

  14. [Recent advances in medical and surgical treatment of ulcerative colitis].

    PubMed

    Sugita, Akira; Koganei, Kazutaka; Tatsumi, Kenji; Futatsuki, Ryo; Kuroki, Hirosuke; Yamada, Kyoko; Arai, Katsuhiko; Fukushima, Tsuneo

    2015-03-01

    Recent advances in both medical and surgical treatment of ulcerative colitis have been remarkable. Changes in medical treatment are mainly good results of therapy with the anti-TNF-α antibody, tacrolimus, and those in surgical treatment are an expansion of the surgical indications to include patients with intractable disease, such as treatment refractoriness and chronic corticosteroid dependence, by a better postoperative clinical course after pouch surgery, improred selection of surgical procedures and the timing of surgery in elderly patients. To offer the optimal treatment for patients with ulcerative colitis, new medical therapies should be analyzed from the standpoint of the efficacy and limitations of effect. Long postoperative clinical course of surgical patients including colitic cancer, prevention of postoperative complications should be also analyzed.

  15. 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.

  16. 75 FR 1396 - The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration The General Hospital and Personal Use 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...

  17. 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...

  18. 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...

  19. 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.

  20. Accelerated aging for testing polymeric biomaterials and medical devices.

    PubMed

    Hukins, D W L; Mahomed, A; Kukureka, S N

    2008-12-01

    Elevated temperature is frequently used to accelerate the aging process in polymers that are associated with medical devices and other applications. A common approach is to assume that the rate of aging is increased by a factor of 2(DeltaT/10), where DeltaT is the temperature increase. This result is a mathematical expression of the empirical observation that increasing the temperature by about 10 degrees C roughly doubles the rate of many polymer reactions. It is equivalent to assuming that the aging process is a first order chemical reaction with an activation energy of 10R/log(e)2, where R is the universal gas constant. A better approach would be to determine the activation energy for the process being considered but this is not always practicable. The simple approach does not depend on the temperature increase, provided that it is not so great that it initiates any physical or chemical process that is unlikely to be involved in normal aging. If a temperature increment theta were to increase a given polymer reaction rate n times, then an elevated temperature would increase the rate of aging by a factor of n(DeltaT/theta).

  1. Online Medical Device Use Prediction: Assessment of Accuracy.

    PubMed

    Maktabi, Marianne; Neumuth, Thomas

    2016-01-01

    Cost-intensive units in the hospital such as the operating room require effective resource management to improve surgical workflow and patient care. To maximize efficiency, online management systems should accurately forecast the use of technical resources (medical instruments and devices). We compare several surgical activities like using the coagulator based on spectral analysis and application of a linear time variant system to obtain future technical resource usage. In our study we examine the influence of the duration of usage and total usage rate of the technical equipment to the prediction performance in several time intervals. A cross validation was conducted with sixty-two neck dissections to evaluate the prediction performance. The performance of a use-state-forecast does not change whether duration is considered or not, but decreases with lower total usage rates of the observed instruments. A minimum number of surgical workflow recordings (here: 62) and >5 minute time intervals for use-state forecast are required for applying our described method to surgical practice. The work presented here might support the reduction of resource conflicts when resources are shared among different operating rooms. PMID:27577445

  2. The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

    PubMed

    Kellmeyer, Philipp; Cochrane, Thomas; Müller, Oliver; Mitchell, Christine; Ball, Tonio; Fins, Joseph J; Biller-Andorno, Nikola

    2016-10-01

    Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public. PMID:27634714

  3. The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

    PubMed

    Kellmeyer, Philipp; Cochrane, Thomas; Müller, Oliver; Mitchell, Christine; Ball, Tonio; Fins, Joseph J; Biller-Andorno, Nikola

    2016-10-01

    Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

  4. Factors Associated With Electronic Cigarette Users’ Device Preferences and Transition From First Generation to Advanced Generation Devices

    PubMed Central

    Veldheer, Susan; Hrabovsky, Shari; Nichols, Travis T.; Wilson, Stephen J.; Foulds, Jonathan

    2015-01-01

    Introduction: Electronic cigarettes (e-cigs) are becoming increasingly popular but little is known about how e-cig users’ transition between the different device types and what device characteristics and preferences may influence the transition. Methods: Four thousand four hundred twenty-one experienced e-cig users completed an online survey about their e-cig use, devices, and preferences. Participants included in analysis were ever cigarette smokers who used an e-cig at least 30 days in their lifetime and who reported the type of their first and current e-cig device and the nicotine concentration of their liquid. Analyses focused on transitions between “first generation” devices (same size as a cigarette with no button) and “advanced generation” devices (larger than a cigarette with a manual button) and differences between current users of each device type. Results: Most e-cig users (n = 2603, 58.9%) began use with a first generation device, and of these users, 63.7% subsequently transitioned to current use of an advanced generation device. Among users who began use with an advanced generation device (n = 1818, 41.1%), only 5.7% transitioned to a first generation device. Seventy-seven percent of current advanced generation e-cig users switched to their current device in order to obtain a “more satisfying hit.” Battery capabilities and liquid flavor choices also influenced device choice. Conclusion: E-cig users commonly begin use with a device shaped like a cigarette and transition to a larger device with a more powerful battery, a button for manual activation and a wider choice of liquid flavors. PMID:25744966

  5. Towards manufacturing of advanced logic devices by double-patterning

    NASA Astrophysics Data System (ADS)

    Koay, Chiew-seng; Halle, Scott; Holmes, Steven; Petrillo, Karen; Colburn, Matthew; van Dommelen, Youri; Jiang, Aiqin; Crouse, Michael; Dunn, Shannon; Hetzer, David; Kawakami, Shinichiro; Cantone, Jason; Huli, Lior; Rodgers, Martin; Martinick, Brian

    2011-04-01

    As reported previously, the IBM Alliance has established a DETO (Double-Expose-Track-Optimized) baseline, in collaboration with ASML, TEL, and CNSE, to evaluate commercially available DETO photoresist system for the manufacturing of advanced logic devices. Although EUV lithography is the baseline strategy for <2x nm logic nodes, alternative techniques are still being pursued. The DETO technique produces pitch-split patterns capable of supporting 16 nm and 11 nm node semiconductor devices. We present the long-term monitoring performances of CD uniformity (CDU), overlay, and defectivity of our DETO process. CDU and overlay performances for controlled experiments are also presented. Two alignment schemes in DETO are compared experimentally for their effects on inter-level & intralevel overlays, and space CDU. We also experimented with methods for improving CDU, in which the CD-OptimizerTMand DoseMapperTM were evaluated separately and in tandem. Overlay improvements using the Correction Per Exposure (CPE) and the intra-field High-Order Process Correction (i-HOPC) were compared against the usual linear correction method. The effects of the exposure field size are also compared between a small field and the full field. Included in all the above, we also compare the performances derived from stack-integrated wafers and bare-Si wafers.

  6. Evaluation of Advanced COTS Passive Devices for Extreme Temperature Operation

    NASA Technical Reports Server (NTRS)

    Patterson, Richard; Hammoud, Ahmad; Dones, Keishla R.

    2009-01-01

    Electronic sensors and circuits are often exposed to extreme temperatures in many of NASA deep space and planetary surface exploration missions. Electronics capable of operation in harsh environments would be beneficial as they simplify overall system design, relax thermal management constraints, and meet operational requirements. For example, cryogenic operation of electronic parts will improve reliability, increase energy density, and extend the operational lifetimes of space-based electronic systems. Similarly, electronic parts that are able to withstand and operate efficiently in high temperature environments will negate the need for thermal control elements and their associated structures, thereby reducing system size and weight, enhancing its reliability, improving its efficiency, and reducing cost. Passive devices play a critical role in the design of almost all electronic circuitry. To address the needs of systems for extreme temperature operation, some of the advanced and most recently introduced commercial-off-the-shelf (COTS) passive devices, which included resistors and capacitors, were examined for operation under a wide temperature regime. The types of resistors investigated included high temperature precision film, general purpose metal oxide, and wirewound.

  7. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...The Food and Drug Administration (FDA) is announcing the following public meeting entitled ``Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance system in the United...

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

    PubMed

    Shao, Anliang; Xu, Liming

    2015-01-01

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

  9. 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...

  10. [Exploring Current Problems and Corresponding Strategies for Evaluation of Innovative Medical Devices in China].

    PubMed

    Du, Ranran; Ouyang, Zhaolian; Li, Yang; Yang, Yuan; Yang, Guozhong; Chi, Hui

    2015-03-01

    Through the analysis of the current status and problems of innovative medical devices evaluation, tnis paper discussed the strategies of evaluation, and ultimately raises the frame of evaluation, so as to provide reference for scientific evaluation of medical devices in China.

  11. 77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-20

    ... Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance... ``ASTM International-FDA Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of... interested in attending this public workshop must register online by November 13, 2012. Early registration...

  12. [Problems and Solutions on the Management of Medical Devices in Different Places].

    PubMed

    Jiang, Haihong; Li, Xiao

    2015-11-01

    The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements. PMID:27066688

  13. 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 SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.18 Format of dates...

  14. 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 certain required statements. 801.16 Section 801.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions §...

  15. 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 certain required statements. 801.16 Section 801.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions §...

  16. 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 certain required statements. 801.16 Section 801.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions §...

  17. 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.

  18. 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

    ... on Risk Management Through the Product Life Cycle; Public Workshop AGENCY: Food and Drug... ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide information about FDA's Medical Device...

  19. 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...

  20. [Problems and Solutions on the Management of Medical Devices in Different Places].

    PubMed

    Jiang, Haihong; Li, Xiao

    2015-11-01

    The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.

  1. 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

  2. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... HUMAN SERVICES Food and Drug Administration Battery-Powered Medical Devices Workshop: Challenges and... following public workshop entitled ``Battery-Powered Medical Devices Workshop: Challenges and Opportunities''. The purpose of this workshop is to create awareness of the challenges related to...

  3. 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.

  4. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... HUMAN SERVICES Food and Drug Administration MDEpiNet 2012 Annual Meeting: The Medical Device... ``MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building... Medical Device Epidemiology Network (MDEpiNet) as a partnership for building global medical...

  6. Advanced materials and concepts for energy storage devices

    NASA Astrophysics Data System (ADS)

    Teng, Shiang Jen

    Over the last decade, technological progress and advances in the miniaturization of electronic devices have increased demands for light-weight, high-efficiency, and carbon-free energy storage devices. These energy storage devices are expected to play important roles in automobiles, the military, power plants, and consumer electronics. Two main types of electrical energy storage systems studied in this research are Li ion batteries and supercapacitors. Several promising solid state electrolytes and supercapacitor electrode materials are investigated in this research. The first section of this dissertation is focused on the novel results on pulsed laser annealing of Li7La3Zr2O12 (LLZO). LLZO powders with a tetragonal structure were prepared by a sol-gel technique, then a pulsed laser annealing process was employed to convert the tetragonal powders to cubic LLZO without any loss of lithium. The second section of the dissertation reports on how Li5La 3Nb2O12 (LLNO) was successfully synthesized via a novel molten salt synthesis (MSS) method at the relatively low temperature of 900°C. The low sintering temperature prevented the loss of lithium that commonly occurs during synthesis using conventional solid state or wet chemical reactions. The second type of energy storage device studied is supercapacitors. Currently, research on supercapacitors is focused on increasing their energy densities and lowering their overall production costs by finding suitable electrode materials. The third section of this dissertation details how carbonized woods electrodes were used as supercapacitor electrode materials. A high energy density of 45.6 Wh/kg and a high power density of 2000 W/kg were obtained from the supercapacitor made from carbonized wood electrodes. The high performance of the supercapacitor was discovered to originate from the hierarchical porous structures of the carbonized wood. Finally, the fourth section of this dissertation is on the electrochemical effects of

  7. 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

    ... structure and organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure as well. These Panels were established with the 1976 Medical Device Amendments, and... unclassified devices and devices not yet classified. In the Federal Register of January 3, 2012 (77 FR...

  8. 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

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was...

  9. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices having commonly known directions. 801.116 Section 801.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  10. 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...

  11. Effect of ionizing radiation on advanced life support medications

    SciTech Connect

    Sullivan, D.J.; Hubbard, L.B.; Broadbent, M.V.; Stewart, P.; Jaeger, M.

    1987-06-01

    Advanced life support medications stored in emergency department stretcher areas, diagnostic radiology rooms, and radiotherapy suites are exposed to ionizing radiation. We hypothesized that radiation may decrease the potency and thus the shelf life of medications stored in these areas. Atropine, dopamine, epinephrine, and isoproterenol were exposed to a wide range of ionizing radiation. The potency of the four drugs was unaffected by levels of radiation found in ED stretcher areas and high-volume diagnostic radiograph rooms (eg, chest radiograph, computed tomography, fluoroscopy). The potency of atropine may be reduced by gamma radiation in high-use radiotherapy suites. However, dopamine, epinephrine, and isoproterenol were unaffected by high doses of gamma radiation. Atropine, dopamine, epinephrine, and isoproterenol may be safely kept in ED stretcher areas and diagnostic radiology rooms without loss of potency over the shelf life of the drugs.

  12. Ethics of the allocation of highly advanced medical technologies.

    PubMed

    Sass, H M

    1998-03-01

    The disproportionate distribution of financial, educational, social, and medical resources between some rich countries of the northern hemisphere and less fortunate societies creates a moral challenge of global dimension. The development of new forms of highly advanced medical technologies, including neoorgans and xenografts, as well as the promotion of health literacy and predictive and preventive medical services might reduce some problems in allocational justice. Most governments and the World Health Organization (WHO) reject financial and other rewards for living organ donors thus indirectly contributing to the development of black markets. A societal gratuity model supporting and safeguarding a highly regulated market between providers and recipients of organs might provide for better protection of those who provide organs not solely based on altruistic reasons. The moral assessment of global issues in allocation and justice in the distribution of medical technologies must be increased and will have to be based on the principles of self determination and responsibility, solidarity and subsidiarity, and respect for individual values and cultural traditions. PMID:9527289

  13. [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.

  14. 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

    ... promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft. These devices are not intended for use in motion-sparing, non-fusion procedures. Spinal sphere devices... classification of spinal sphere devices. These devices are spheres manufactured from metallic (e.g.,...

  15. [Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?].

    PubMed

    Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J

    2014-01-01

    Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.

  16. Radiation doses to insertion devices at the advanced photon source

    SciTech Connect

    Moog, E. R.; Den Hartog, P. K.; Semones, E. J.; Job, P. K.

    1997-07-01

    Dose measurements made on and around the insertion devices (IDs) at the Advanced Photon Source are reported. Attempts are made to compare these dose rates to dose rates that have been reported to cause radiation-induced demagnetization, but comparisons are complicated by such factors as the particular magnet material and the techniques used in its manufacture, the spectrum and type of radiation, and the demagnetizing field seen by the magnet. The spectrum of radiation at the IDs has been measured and found to include a large high-energy (7 GeV) component, at least during some runs. Lead shielding installed immediately upstream of the IDs has been found to decrease the dose to the upstream ends of the IDs. It has almost no effect on the dose to the downstream ends of the IDs, however, since much of the radiation travels through the ID vacuum chamber and cannot be readily shielded. Opening the gaps of the IDs during injection and at other times also helps decrease the radiation exposure.

  17. Radiation doses to insertion devices at the advanced photon source

    SciTech Connect

    Moog, E.R.; Den Hartog, P.K.; Semones, E.J.; Job, P.K.

    1997-07-01

    Dose measurements made on and around the insertion devices (IDs) at the Advanced Photon Source are reported. Attempts are made to compare these dose rates to dose rates that have been reported to cause radiation-induced demagnetization, but comparisons are complicated by such factors as the particular magnet material and the techniques used in its manufacture, the spectrum and type of radiation, and the demagnetizing field seen by the magnet. The spectrum of radiation at the IDs has been measured and found to include a large high-energy (7 GeV) component, at least during some runs. Lead shielding installed immediately upstream of the IDs has been found to decrease the dose to the upstream ends of the IDs. It has almost no effect on the dose to the downstream ends of the IDs, however, since much of the radiation travels through the ID vacuum chamber and cannot be readily shielded. Opening the gaps of the IDs during injection and at other times also helps decrease the radiation exposure. {copyright} {ital 1997 American Institute of Physics.}

  18. Design of advanced ultrasonic transducers for welding devices.

    PubMed

    Parrini, L

    2001-11-01

    A new high frequency ultrasonic transducer has been conceived, designed, prototyped, and tested. In the design phase, an advanced approach was used and established. The method is based on an initial design estimate obtained with finite element method (FEM) simulations. The simulated ultrasonic transducers and resonators are then built and characterized experimentally through laser interferometry and electrical resonance spectra. The comparison of simulation results with experimental data allows the parameters of FEM models to be adjusted and optimized. The achieved FEM simulations exhibit a remarkably high predictive potential and allow full control of the vibration behavior of the transducer. The new transducer is mounted on a wire bonder with a flange whose special geometry was calculated by means of FEM simulations. This flange allows the transducer to be attached on the wire bonder, not only in longitudinal nodes, but also in radial nodes of the ultrasonic field excited in the horn. This leads to a total decoupling of the transducer to the wire bonder, which has not been achieved so far. The new approach to mount ultrasonic transducers on a welding device is of major importance, not only for wire bonding, but also for all high power ultrasound applications and has been patented.

  19. Advanced, High Power, Next Scale, Wave Energy Conversion Device

    SciTech Connect

    Mekhiche, Mike; Dufera, Hiz; Montagna, Deb

    2012-10-29

    The project conducted under DOE contract DE‐EE0002649 is defined as the Advanced, High Power, Next Scale, Wave Energy Converter. The overall project is split into a seven‐stage, gated development program. The work conducted under the DOE contract is OPT Stage Gate III work and a portion of Stage Gate IV work of the seven stage product development process. The project effort includes Full Concept Design & Prototype Assembly Testing building on our existing PowerBuoy technology to deliver a device with much increased power delivery. Scaling‐up from 150kW to 500kW power generating capacity required changes in the PowerBuoy design that addressed cost reduction and mass manufacturing by implementing a Design for Manufacturing (DFM) approach. The design changes also focused on reducing PowerBuoy Installation, Operation and Maintenance (IO&M) costs which are essential to reducing the overall cost of energy. In this design, changes to the core PowerBuoy technology were implemented to increase capability and reduce both CAPEX and OPEX costs. OPT conceptually envisaged moving from a floating structure to a seabed structure. The design change from a floating structure to seabed structure would provide the implementation of stroke‐ unlimited Power Take‐Off (PTO) which has a potential to provide significant power delivery improvement and transform the wave energy industry if proven feasible.

  20. Concordance of adherence measurement using self-reported adherence questionnaires and medication monitoring devices.

    PubMed

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

    2010-01-01

    The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the following search terms: 'patient compliance', 'medication adherence', 'treatment compliance', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'drugs', 'pharmaceutical preparations', 'compliance' and 'medications'. We identified studies that included SRQs and electronic monitoring devices to measure adherence and focused on the SRQs that were found to be moderately to highly correlated with the monitoring devices. Of the 1679 citations found via the primary search, 41 full-text articles were reviewed for correlation between monitoring devices and SRQs. A majority (68%) of articles reported high (27%), moderate (29%) or significant (12%) correlation between monitoring devices (37 using Medication Event Monitoring System [MEMS®] and four using other devices) and SRQs (11 identified and numerous other unnamed SRQs). The most commonly used SRQs were the Adult/Pediatric AIDS Clinical Trial Group (AACTG/PACTG; 24.4%, 10/41) followed by the 4-item Morisky (9.8%, 4/41), Brief Medication Questionnaire (9.8%, 4/41) and visual analogue scale (VAS; 7.3%, 3/41). Although study designs differed across the articles, SRQs appeared to report a higher rate of medication adherence (+14.9%) than monitoring devices. In conclusion, several medication adherence SRQs were validated using electronic monitoring devices. A majority of them showed high or moderate correlation with medication adherence measured using monitoring devices, and could be considered for measuring patient

  1. 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…

  2. Remembrance of conversations past: oral advance statements about medical treatment.

    PubMed Central

    Sommerville, A.

    1995-01-01

    Polls show increasing public interest in advance statements or directives about medical treatment ("living wills") but that few people, apart from Jehovah's Witnesses, carry such documents. Patients' firm, witnessed oral decisions are often sufficient to aid clinical decision making but should still be recorded in medical notes. Without documentation, dilemmas arise when others claim to know patients' views on the basis of past unrecorded conversations and demand withdrawal of treatment when patients are not terminally ill and cannot speak for themselves. Legal and ethical considerations oblige doctors to act in the best interests of an incapacitated patient; these considerations are now formally defined in draft legislation as including consideration of the patient's past wishes. The practicalities of ascertaining the strength and validity of such wishes from conversations reported second hand are complex. The paucity of legal and ethical guidance on reported oral advance statements makes debate imperative and renders the alternative of having designated surrogate decision makers increasingly attractive. Images p1664-a PMID:7795460

  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. 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...

  5. [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.

  6. 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

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

    NASA Astrophysics Data System (ADS)

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

    2012-03-01

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

  8. 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.

  9. 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

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

    PubMed

    Pak, JuGeon; Park, KeeHyun

    2012-01-01

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

  11. Synergistic advances in diagnostic and therapeutic medical ultrasound

    NASA Astrophysics Data System (ADS)

    Lizzi, Frederic L.

    2003-04-01

    Significant advances are more fully exploiting ultrasound's potential for noninvasive diagnosis and treatment. Therapeutic systems employ intense focused beams to thermally kill cancer cells in, e.g., prostate; to stop bleeding; and to treat specific diseases (e.g., glaucoma). Diagnostic ultrasound techniques can quantitatively image an increasingly broad spectrum of physical tissue attributes. An exciting aspect of this progress is the emerging synergy between these modalities. Advanced diagnostic techniques may contribute at several stages in therapy. For example, treatment planning for small ocular tumors uses 50-MHz, 3-D ultrasonic images with 0.05-mm resolution. Thermal simulations employ these images to evaluate desired and undesired effects using exposure stategies with specially designed treatment beams. Therapy beam positioning can use diagnostic elastography to sense tissue motion induced by radiation pressure from high-intensity treatment beams. Therapy monitoring can sense lesion formation using elastography motion sensing (to detect the increased stiffness in lesions); harmonic imaging (to sense altered nonlinear properties); and spectrum analysis images (depicting changes in the sizes, concentration, and configuration of sub-resolution structures.) Experience from these applications will greatly expand the knowledge of acoustic phenomena in living tissues and should lead to further advances in medical ultrasound.

  12. 78 FR 3319 - Amendments to Existing Validated End User Authorizations: Advanced Micro Devices China, Inc., Lam...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... Micro 3D002, 3D003, AMD Technologies 75 FR 25763, 5/10/ Devices China, 3E001 (limited to (China) Co., 10... Suzhou, China 78 FR [INSERT FR 3C002 and 3C004 215021. PAGE NUMBER] 1/16/ and Advanced Micro 13... Authorizations: Advanced Micro Devices China, Inc., Lam Research Corporation, SK hynix Semiconductor (China)...

  13. 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.

  14. Assessment of risks of EMI for personal medical electronic devices (PMEDs) from emissions of millimeter-wave security screening systems

    NASA Astrophysics Data System (ADS)

    Witters, Donald; Bassen, Howard; Guag, Joshua; Addissie, Bisrat; LaSorte, Nickolas; Rafai, Hazem

    2013-06-01

    This paper describes research and testing of a representative group of high priority body worn and implantable personal medical electronic devices (PMEDs) for exposure to millimeter wave (MMW) advanced imaging technology (AIT) security systems used at airports. The sample PMEDs included in this study were implantable cardiac pacemakers, ICDs, neurostimulators and insulin pumps. These PMEDs are designed and tested for susceptibility to electromagnetic interference (EMI) under the present standards for medical device electromagnetic compatibility (EMC). However, the present standards for medical equipment do not address exposure to the much higher frequency fields that are emitted by MMW security systems. Initial AIT emissions measurements were performed to assess the PMED and passenger exposures. Testing protocols were developed and testing methods were tailored to the type of PMED. In addition, a novel exposure simulation system was developed to allow controlled EMC testing without the need of the MMW AIT system. Methodology, test results, and analysis are presented, along with an assessment of the human exposure and risks for PMED users. The results on this study reveal no effects on the medical devices from the exposure to the MMW security system. Furthermore, the human exposure measurements and analysis showed levels well below applicable standard, and the risks for PMED users and others we assessed to be very low. These findings apply to the types of PMEDs used in the study though these findings might suggest that the risks for other, similar PMEDs would likely be similar.

  15. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Direct Final Rule... condition that a device is intended to treat, diagnose, or cure. Elsewhere in this issue of the Federal... that suffer from the disease or condition that the device is intended to treat, diagnose, or cure,...

  16. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  17. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  18. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  19. 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...

  20. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  2. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a)...

  3. 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 115-341 nm). 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 1 × 10(-1) to 1 × 10(6) ng/cm(2) (conditions ranged from 37 to 50 °C, 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.

  4. Assessment and approval of medical devices used in diagnostic imaging in the United States.

    PubMed

    Johnson, G C

    1986-01-01

    Development of new and improved medical imaging technology has been increasing rapidly over the past two decades. While media attention has focused on the revolutionary advances, such as computed tomography, magnetic resonance imaging and metabolic assessment by positron emission tomography, important progress has also been made in the more conventional modalities, including contrast radiography, ultrasound, scintigraphy and mammography. These evolutionary developments have produced fundamental changes in the character of imaging information and in the methods of its acquisition, storage, manipulation, analysis and display. The assessment process-vis-à-vis safety, effectiveness, efficacy or cost-has moved from a previously well-defined physical and engineering evaluation to one of assessing quality, relevance and appropriateness of the "information." A regulatory scheme has evolved in the U.S., whereby the Food and Drug Administration (FDA) is responsible for assuring that new medical devices be approved for commercial distribution only if their safety and effectiveness can be assured. Clear distinctions should be drawn between the FDA "approval" process, assessment of clinical efficacy, and planning for health care delivery. PMID:3536797

  5. 78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug...

  6. 76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Pressure... (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...

  7. 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...

  8. 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...

  9. 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...

  10. Point-of-care (POC) devices by means of advanced MEMS.

    PubMed

    Karsten, Stanislav L; Tarhan, Mehmet C; Kudo, Lili C; Collard, Dominique; Fujita, Hiroyuki

    2015-12-01

    Microelectromechanical systems (MEMS) have become an invaluable technology to advance the development of point-of-care (POC) devices for diagnostics and sample analyses. MEMS can transform sophisticated methods into compact and cost-effective microdevices that offer numerous advantages at many levels. Such devices include microchannels, microsensors, etc., that have been applied to various miniaturized POC products. Here we discuss some of the recent advances made in the use of MEMS devices for POC applications.

  11. Point-of-care (POC) devices by means of advanced MEMS.

    PubMed

    Karsten, Stanislav L; Tarhan, Mehmet C; Kudo, Lili C; Collard, Dominique; Fujita, Hiroyuki

    2015-12-01

    Microelectromechanical systems (MEMS) have become an invaluable technology to advance the development of point-of-care (POC) devices for diagnostics and sample analyses. MEMS can transform sophisticated methods into compact and cost-effective microdevices that offer numerous advantages at many levels. Such devices include microchannels, microsensors, etc., that have been applied to various miniaturized POC products. Here we discuss some of the recent advances made in the use of MEMS devices for POC applications. PMID:26459443

  12. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... 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 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... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  14. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... 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. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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.

  2. 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

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

    NASA Astrophysics Data System (ADS)

    Colvin, Mike

    The most important point in the successful development of a medical device is the proper overall design. The quality, safety, and effectiveness of a device are established during the design phase. The design process is the foundation of the medical device and will be the basis for the device from its inception till the end of its lifetime. There are domestic and international guidelines on the proper steps to develop a medical device. However, these are guides; they do not specify when and how to implement each phase of design control. The guides also do not specify to what depth an organization must go as it progresses in the overall developmental process. The challenge that faces development organizations is to create a design process plan that is simple, straightforward, and not overburdening.

  4. 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.

  5. 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

  6. [Contemplation and suggestion on the medical device adverse event reporting program].

    PubMed

    Yu, Baodong; Guan, Yingjie; Mo, Xiaomei

    2014-01-01

    The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.

  7. Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives

    PubMed Central

    O’Connor, Bonnie; Pollner, Fran; Fugh-Berman, Adriane

    2016-01-01

    Background Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. Study Design We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. Results While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). Conclusions Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel. PMID:27486992

  8. 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

  9. [Web-based support system for medical device maintenance].

    PubMed

    Zhao, Jinhai; Hou, Wensheng; Chen, Haiyan; Tang, Wei; Wang, Yihui

    2015-01-01

    A Web-based technology system was put forward aiming at the actual problems of the long maintenance cycle and the difficulties of the maintenance and repairing of medical equipments. Based on analysis of platform system structure and function, using the key technologies such as search engine, BBS, knowledge base and etc, a platform for medical equipment service technician to use by online or offline was designed. The platform provides users with knowledge services and interactive services, enabling users to get a more ideal solution.

  10. 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.

  11. Advances in Medications and Tailoring Treatment for Alcohol Use Disorder

    PubMed Central

    Seneviratne, Chamindi; Johnson, Bankole A.

    2015-01-01

    Alcohol use disorder (AUD) is a chronic heritable brain disorder with a variable clinical presentation. This variability, or heterogeneity, in clinical presentation suggests complex interactions between environmental and biological factors, resulting in several underlying pathophysiological mechanisms in the development and progression of AUD. Classifying AUD into subgroups of common clinical or pathological characteristics would ease the complexity of teasing apart underlying molecular mechanisms. Genetic association analyses have revealed several polymorphisms—small differences in DNA—that increase a person’s vulnerability to develop AUD and other alcohol-related intermediate characteristics, such as severity of drinking, age of AUD onset, or measures of craving. They also have identified polymorphisms associated with reduced drinking. Researchers have begun utilizing these genetic polymorphisms to identify alcoholics who might respond best to various treatments, thereby enhancing the effectiveness of currently tested medications for treating AUD. This review compares the efficacy of medications tested for treatment of AUD with and without incorporating genetics. It then discusses advances in pre-clinical genetic and genomic studies that potentially could be adapted to clinical trials to improve treatment efficacy. Although a pharmacogenetic approach is promising, it is relatively new and will need to overcome many challenges, including inadequate scientific knowledge and social and logistic constraints, to be utilized in clinical practice. PMID:26259086

  12. 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

  13. 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

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

  14. 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

    ... equipment, and other logistics associated with this event. If you need special accommodations due to a... HUMAN SERVICES Food and Drug Administration Educational Forum on Medical Device Reporting, Complaint... Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum...

  15. 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,...

  16. 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.

  17. 77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... 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 the... document establishes FY 2013 fee rates for other types of submissions, and for periodic reporting,...

  18. 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”....

  19. 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”....

  20. 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”....

  1. 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”....

  2. 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”....

  3. 76 FR 22805 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ....7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (DC Cir. 1985); Contact Lens Assoc. v... this device. DATES: This rule is effective May 25, 2011. FOR FURTHER INFORMATION CONTACT: Charles N... rule classifying this device into class III (53 FR 23856, June 24, 1988). In August 1997, in...

  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

    ... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health 510(k... Drug Administration (FDA) is announcing a public meeting entitled ``510(k) Implementation: Discussion... cleared medical devices. The CDRH Preliminary Internal Evaluations 510(k) Working Group Report of...

  5. BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

    PubMed

    Bruzzi, M S; Linehan, J H

    2013-09-01

    In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners. PMID:23494126

  6. BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

    PubMed

    Bruzzi, M S; Linehan, J H

    2013-09-01

    In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

  7. Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.

    PubMed

    2016-09-21

    The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument 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 magnetic surgical instrument 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:27658314

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

    PubMed

    2014-07-01

    The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25016622

  9. 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

  10. 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

  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; 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.

  13. Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.

    PubMed

    2016-09-21

    The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument 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 magnetic surgical instrument 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.

  14. 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.

  15. Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia. Final order.

    PubMed

    2016-07-11

    The Food and Drug Administration (FDA) is classifying the thermal system for insomnia 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 thermal system for insomnia'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:27400464

  16. Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System. Final order.

    PubMed

    2016-05-31

    The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder 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 diurnal pattern recorder 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:27236873

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

    PubMed

    2014-02-24

    : The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:25735053

  18. 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.

  19. 26 CFR 48.4191-2 - Taxable medical device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Subpart C of 42 CFR part 414 (Parenteral and Enteral Nutrition) and Subpart D of 42 CFR part 414 (Durable... and enteral nutrients, equipment, and supplies” as defined in 42 CFR 411.351 and described in 42 CFR...) of the FFDCA and 21 CFR part 807, pursuant to FDA requirements. (2) Devices that should have...

  20. 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.