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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period AGENCY: Food and Drug... Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in... highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application...

  5. Medical Device Safety

    MedlinePlus

    ... Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing options ... 17 More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and ...

  6. Optomechanical medical devices (instruments)

    NASA Astrophysics Data System (ADS)

    Reiss, Roger S.

    2004-03-01

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

  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 ... may 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. Advances in microbial biofilm prevention on indwelling medical devices with emphasis on usage of acoustic energy.

    PubMed

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

    2009-01-01

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

  10. [New Medical Device Evaluation].

    PubMed

    Ikeda, Koji

    2016-01-01

    In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates.

  11. 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.

  12. [International progress of unique device identification for medical devices].

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2014-09-01

    Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.

  13. 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.

  14. 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

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

    PubMed

    Tomasovic, Sanja; Predojevic, Maja

    2011-12-01

    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.

  16. 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

  17. 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.

  18. Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

    PubMed

    Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

    2016-12-06

    The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.

  19. [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.

  20. Metrology and Standards Needs for Some Categories of Medical Devices

    PubMed Central

    Chiao, J. C.; Goldman, Julian M.; Heck, David A.; Kazanzides, Peter; Peine, William J.; Stiehl, James B.; Yen, Dwight; Dagalakis, Nicholas G.

    2008-01-01

    With rapid advances in meso-, micro- and nano-scale technology devices and electronics, a new generation of advanced medical devices is emerging, which promises medical treatment that is less invasive and more accurate, automated, and effective. We examined the technological and economic status of five categories of medical devices. A set of metrology needs is identified for each of these categories and suggestions are made to address them. PMID:27096115

  1. Assurance Cases for Medical Devices

    DTIC Science & Technology

    2011-04-28

    SEI’s  Research,  Technology,  and  System   Solu2ons  program.  With  his  colleague  John   Goodenough ,  Weinstock...contact The SEI and Medical Devices *Charles B. Weinstock and John B. Goodenough , Towards an Assurance Case Practice for Medical Devices, CMU/SEI-2009-TN

  2. 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.

  3. Reducing Risks Associated with Medical Device Misconnections

    MedlinePlus

    ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  4. 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.

  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.

  6. Price transparency for medical devices.

    PubMed

    Pauly, Mark V; Burns, Lawton R

    2008-01-01

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

  7. 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

  8. Recent medical devices for tonsillectomy.

    PubMed

    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.

  9. [Consideration of Mobile Medical Device Regulation].

    PubMed

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

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

  10. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping..., 876, 878, 880, 882, 884, 886, 888, 890, and 892 Medical Devices; Technical Amendment AGENCY: Food and... Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code...

  11. 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.

  12. 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

  13. Power Approaches for Implantable Medical Devices.

    PubMed

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

    2015-11-13

    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.

  14. 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.

  15. Multiregional medical device development: regulatory perspective.

    PubMed

    Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    There are difficulties in conducting worldwide medical device development simultaneously because each country and/or region has their own medical device regulations. However, to aid globalization of the medical device market, and to quickly provide innovative medical devices to patients, attempts have been made to encourage harmonization and convergence of medical device regulations. 'Harmonization by doing' is a bilateral effort from the United States and Japan to develop global clinical trials and address regulatory barriers that may be impediments to timely device approval. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. Since 2012, the GHTF has been replaced by the International Medical Device Regulators Forum.

  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. The Universal Medical Device Nomenclature System.

    PubMed

    Gaev, J A

    1996-01-01

    To facilitate access to medical information, ECRI has developed and promulgated a hierarchical medical device nomenclature system containing over 4,800 valid terms and 3,100 cross-references. The Universal Medical Device Nomenclature System (UMDNS) is appropriate for a wide range of applications. It is used world-wide and is available in 5 languages (7 additional translations are in progress).

  18. Advanced Accelerators for Medical Applications

    NASA Astrophysics Data System (ADS)

    Uesaka, Mitsuru; Koyama, Kazuyoshi

    We review advanced accelerators for medical applications with respect to the following key technologies: (i) higher RF electron linear accelerator (hereafter “linac”); (ii) optimization of alignment for the proton linac, cyclotron and synchrotron; (iii) superconducting magnet; (iv) laser technology. Advanced accelerators for medical applications are categorized into two groups. The first group consists of compact medical linacs with high RF, cyclotrons and synchrotrons downsized by optimization of alignment and superconducting magnets. The second group comprises laser-based acceleration systems aimed of medical applications in the future. Laser plasma electron/ion accelerating systems for cancer therapy and laser dielectric accelerating systems for radiation biology are mentioned. Since the second group has important potential for a compact system, the current status of the established energy and intensity and of the required stability are given.

  19. [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.

  20. Medical device labeling and advertising: an overview.

    PubMed

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

    1999-01-01

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

  1. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY: Internal... certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in..., under the paragraph heading ``A. Proposed Regulations'', line 6, the language ``of taxable...

  2. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or...) whether the device generally must be implanted, inserted, operated, or otherwise administered by a medical... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI....

  3. Recent advances in medical physics.

    PubMed

    Kalender, Willi A; Quick, Harald H

    2011-03-01

    Some of the major interests in medical physics over the last few years have concerned the technical advances in Computed Tomography and high field Magnetic Resonance Imaging. This review discusses the introduction of Dual Source CT and explains how it can not only offer faster data acquisition but also operate with lower radiation doses. This provides enormous benefits for all patients, but for cardiac and pediatric examinations in particular. The advances in MRI at 7 T esla are also impressive, with better signal to noise; cardiac and musculoskeletal applications are discussed; technical improvements are work-in-progress for other applications.

  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.

  6. [Comments and suggestions on the medical device standardization system from the view point of medical devices test].

    PubMed

    Yang, Xiaofang; Wang, Chunren; Yang, Zhaopeng; Li, Deyu

    2013-06-01

    Medical device test is a very important step of medical device registration processes and is also a procedure to confirm whether the medical devices comply with applicable standards. The standardization system is imperfect yet in China due to the complexity of medical devices and the specialty of medical device industry. In this circumstance, the medical device standard is not only the important criteria for the medical devices registration, but also an important practical procedure of the medical device registration. This paper reviews the existing questions and also gives some comments and suggestions on the medical device standardization system from the view point of medical device test.

  7. 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.

  8. 77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ... other functions to paralyzed limbs and organs. These medical devices hold enormous promise to advance... promise to advance the state of medical care, lower health costs, and improve the quality of life for... significant advances in wireless medical technologies that are revolutionizing treatment for a wide variety...

  9. [Regulation of medical devices in the Region of the Americas].

    PubMed

    Enríquez, Nilda; Álvarez, Yadira; Martínez, Dulce María; Pérez, Ana; Lemgruber, Alexandre

    2016-05-01

    Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

  10. [Advancement of the medical doctorate].

    PubMed

    Baum, C; Förster, R; Schmidt, R E

    2009-08-01

    The medical doctorate and the subsequent advanced research qualification in medicine have an exceptional position within the natural sciences. While, in the German system, graduation to the degree of a medical doctor is often an initiation into scientific practice, the in-depth scientific education of medical doctors may be achieved in various configurations. In recent years, structured programs for doctorates in medicine and natural sciences have found increasing acceptance, following recommendations of national scientific councils ("Deutsche Forschungsgemeinschaft" and "Hochschulrat"). Hannover Medical School has been offering such programs for a number of years. The StrucMed program increases the quality of medical doctorate studies, typically performed in the third and fourth years of university studies. The Hannover Biomedical Research School (HBRS) combines several programs for a doctorate in natural sciences, creating a platform for an internationally oriented education of post-graduates in various disciplines of life sciences. Evaluating the achievements and career paths of the trainees will contribute to the successful integration of research work in an efficiency-oriented clinical environment.

  11. [Microbiological diagnosis of medical device-associated infections].

    PubMed

    de Cueto-López, Marina; Del Pozo-León, Jose Luis; Franco-Álvarez de Luna, Francisco; Marin-Arriaza, Mercedes

    2016-12-01

    The use of surgically implanted medical devices has increased greatly over the last few years. Despite surgical advances and improvements in the materials and design of devices, infection continues to be a major complication of their use. Device-associated infections are produced mainly during their implantation and, are caused by microorganisms that are part of the skin flora. Biofilm development on device surfaces is the most important factor to explain the pathophysiological aspects of infection. Microbiological diagnosis is difficult and can often only be achieved after removal of the device. Sonication of the removed device may be a useful tool, since this procedure dislodges and disaggregates biofilm bacteria from the device. Molecular techniques, especially PCR, applied to the tissues and material obtained after sonication have shown to have a high sensitivity and specificity for the diagnosis of cardiovascular device infections.

  12. Anti-thrombotic technologies for medical devices.

    PubMed

    Lavery, Karen S; Rhodes, Candace; Mcgraw, Adam; Eppihimer, Michael J

    2016-08-03

    Thrombosis associated with medical devices may lead to dramatic increases in morbidity, mortality and increased health care costs. Innovative strategies are being developed to reduce this complication and provide a safe biocompatible interface between device and blood. This article aims to describe the biological phenomena underlying device-associated thrombosis, and surveys the literature describing current and developing technologies designed to overcome this challenge. To reduce thrombosis, biomaterials with varying topographical properties and incorporating anti-thrombogenic substances on their surface have demonstrated potential. Overall, there is extensive literature describing technical solutions to reduce thrombosis associated with medical devices, but clinical results are required to demonstrate significant long-term benefits.

  13. 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...

  14. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  16. 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...

  17. Mobile medical device connectivity: real world solutions.

    PubMed

    Pettus, Dan

    2004-01-01

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

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

    PubMed

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

    2010-01-01

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

  19. Using Zigbee to integrate medical devices.

    PubMed

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

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

  20. 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...

  1. Home Healthcare Medical Devices: A Checklist

    MedlinePlus

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

  2. Proposed amendments to the medical devices Directives.

    PubMed

    Donawa, Maria

    2006-01-01

    As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.

  3. [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.

  4. 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

  5. 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.

  6. 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

  7. Use of mobile devices for medical imaging.

    PubMed

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

    2014-12-01

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

  8. Quantum functional devices for advanced electronics

    NASA Astrophysics Data System (ADS)

    Yokoyama, N.; Muto, S.; Imamura, K.; Takatsu, M.; Mori, T.; Sugiyama, Y.; Sakuma, Y.; Nakao, H.; Adachihara, T.

    Recent research in semiconductor device technology seems to be focused on reducing the cost and power dissipation of traditional Si CMOS integrated circuits, rather than developing new and advanced semiconductor devices. We believe however, that devices enter the nanometer-scale regime in the next century, where quantum mechanical effects play an important role in the device's function; therefore, it is important to continue basic research into the physics and technology of nanometer scale structures and device applications in order to cultivate "nanoelectronics". This paper reviews our research activities on quantum functional devices and discusses our future research direction.

  9. 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.

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

    PubMed

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

    2009-03-01

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

  11. Inhibition of bacterial adhesion on medical devices.

    PubMed

    Rodrigues, Lígia R

    2011-01-01

    Microbial infections resulting from bacterial adhesion to biomaterial surfaces have been observed on almost all medical devices. Biofilm infections pose a number of clinical challenges due to their resistance to immune defence mechanisms and antimicrobials, and, regardless of the sophistication of the implant, all medical devices are susceptible to microbial colonisation and infection. Research efforts are currently directed towards eliminating or reducing infection of medical devices. Strategies to prevent biofilm formation include physiochemical modification of the biomaterial surface to create anti-adhesive surfaces, incorporation of antimicrobial agents into medical device polymers, mechanical design alternatives, and release of antibiotics. Nevertheless, the success of these alternatives has been modest, mainly due to the various environments into which devices are placed and the diversity of ways in which organisms can colonise surfaces. Biosurfactants have been reported as a promising strategy as they effectively inhibit bacterial adhesion and retard biofilm formation, and are thus potentially useful as a new generation of anti-adhesive and antimicrobial coatings for medical devices.

  12. 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

  13. Medical ice slurry production device

    DOEpatents

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

    2008-06-24

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

  14. Center for advanced microstructures and devices (CAMD)

    NASA Astrophysics Data System (ADS)

    Craft, B. C.; Feldman, M.; Morikawa, E.; Poliakoff, E. D.; Saile, V.; Scott, J. D.; Stockbauer, R. L.

    1992-01-01

    The new synchrotron-radiation facility, Center for Advanced Microstructures and Devices, at Louisiana State University is described with regard to the status of installation of the storage ring, implementation of the various programs, and construction of the first beamlines.

  15. Medical Device Recalls: Examination of Selected Cases

    DTIC Science & Technology

    1989-10-01

    accelerator Device class: 2 Medical specialty: Radiology Brand: Therac - 25 Linear Accelerator Use: Used in clinical (cancer) radiotherapy Premarketing...design recalls.- As wouldl Ne exp~ected, becaulse all (lass 8 (high-risk) dev.ices require prenmarket ap)1O1lmtSt PNMA-dCSigfl r-ecalls ( 25 , or 89...Table 11.4 PMA-Design Recalls by Device Class, Fiscal Years 1983-88 No. oi Device class recalls Percent 2 (medium risk) 3 1 100 3 (high risk) 25 89

  16. Insertion devices at the advanced photon source

    SciTech Connect

    Moog, E.R.

    1996-07-01

    The insertion devices being installed at the Advanced Photon Source cause the stored particle beam to wiggle, emitting x-rays with each wiggle. These x-rays combine to make an intense beam of radiation. Both wiggler and undulator types of insertion devices are being installed; the characteristics of the radiation produced by these two types of insertion devices are discussed, along with the reasons for those characteristics.

  17. 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.

  18. Intravascular foreign bodies: danger of unretrieved fragmented medical devices.

    PubMed

    Tateishi, Minori; Tomizawa, Yasuko

    2009-01-01

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

  19. 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... (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...

  20. 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... (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...

  1. 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...

  2. 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... (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...

  3. 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 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  4. 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 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  5. 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....

  6. 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 892.2010 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....

  7. 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 892.2010 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....

  8. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892.2010 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....

  9. 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 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  10. 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 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  11. 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 892.2010 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....

  12. 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 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

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

    PubMed Central

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

    2010-01-01

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

  14. 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.

  15. [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.

  16. 75 FR 16351 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ..., and 1050 Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final... parts 1000 to 1050, subchapter J, to mean the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C... amending its authority citations in parts 1003, 1004, 1005, 1010, 1020, 1030, 1040, and 1050 to...

  17. [Membrane separation technology in medical devices].

    PubMed

    Hu, Xianghua; Dang, Xiyun; Wu, Minyu

    2014-01-01

    Membrane separation technology is a major branch in modern separation technology, which is widely applied in chemical, pharmaceutical and other industries. The purpose of this paper is to introduce principle and the application example of the membrane separation technology in medical devices, to analyse the problems existing in the current application, and to discuss the future development direction.

  18. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ..., pursuant to a written binding contract for the lease, installment sale, or sale on credit of a taxable... tax from sale price. Installment Sales, Leases, and Long-Term Contracts Several commenters requested transition relief for installment sales and leases of taxable medical devices where the contract is...

  19. [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.

  20. 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

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

    PubMed

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

    2010-01-01

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

  2. 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.

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

    PubMed

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

    2015-01-01

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

  4. 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.

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  11. 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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  12. 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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  13. 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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  14. 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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  15. [The Requirements of Medical Device Market Access in India].

    PubMed

    Qin, Shaoyan; Cui, Tao; Yin, Haisong

    2016-01-01

    This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of February 7, 2011... meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on...

  17. Mandibular Advancing Positive Pressure Apnea Remediation Device (MAPPARD)

    DTIC Science & Technology

    2014-06-01

    wiki/Starling_resistor Lankford, D. A., Proctor, C. D., & Richard, R. (2005). Continuous positive airway pressure (CPAP) changes in bariatric surgery ...Mandibular Advancing Device (after Schlaflabor-Saletu, n.d.). ............ 8  Figure 4.  Uvulopalatopharyngoplasty (before and after surgery ) (from...Lastly, when behavioral and medical techniques have been exhausted the last OSA reduction technique is surgery . Within the last 25 years, the

  18. 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

  19. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of...

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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...

  5. Medical Device Guidebook: A browser information resource for medical device users.

    PubMed

    Clarkson, Douglas M

    2017-03-01

    A web based information resource - the 'Medical Device Guidebook' - for the enabling of safe use of medical devices is described. Medical devices are described within a 'catalogue' of specific models and information on a specific model is provided within a consistent set of information 'keys'. These include 'user manuals', 'points of caution', 'clinical use framework', 'training/assessment material', 'frequently asked questions', 'authorised user comments' and 'consumables'. The system allows identification of known risk/hazards associated with specific devices, triggered, for example, by national alerts or locally raised safety observations. This provides a mechanism for more effective briefing of equipment users on the associated hazards of equipment. A feature of the system is the inclusion of a specific 'Operational Procedure' for each device, where the lack of this focus is shown in the literature to often be a key factor in equipment misuse and associated patient injury. The 'Guidebook' provides a mechanism for the development of an information resource developed within local clinical networks and encourages a consistent approach to medical device use.

  6. Teaching medical device design using design control.

    PubMed

    May-Newman, Karen; Cornwall, G Bryan

    2012-01-01

    The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.

  7. 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.

  8. 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;...

  9. 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.

  10. 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...

  11. Tracking medical devices to ensure patient safety.

    PubMed

    Beyea, Suzanne C

    2003-01-01

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

  12. 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.

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

    PubMed

    Kampfrath, Thomas; Cotten, Steven W

    2013-10-01

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

  14. 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...

  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. Software as a medical device: regulatory critical issues.

    PubMed

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

    2013-01-01

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

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

    PubMed Central

    Demiris, George; Marek, Karen D.

    2014-01-01

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

  18. 75 FR 48356 - Advancing the Development of Medical Products Used In the Prevention, Diagnosis, and Treatment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ... HUMAN SERVICES Food and Drug Administration Advancing the Development of Medical Products Used In the... ``Advancing the Development of Medical Products Used in the Prevention, Diagnosis, and Treatment of Neglected... the development of medical products (drugs, biological products, and medical devices) used in...

  19. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric... the regulations on premarket approval of medical devices to include requirements relating to the... submit certain medical device applications to include readily available information providing...

  20. 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

    ... during our review, see Guidance for Industry and FDA Staff: Interactive Review for Medical Device... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric... Administration (FDA) is amending the regulations on premarket approval of medical devices to include...

  1. 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...

  2. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Microbiology Devices Panel of the Medical Devices Advisory...

  3. 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...

  4. 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...

  5. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). 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...

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  7. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April...

  8. 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

    ... 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... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  9. 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...

  10. 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

    ... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced... July 14, 2011, FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of...

  11. Emerging medical devices for minimally invasive cell therapy.

    PubMed

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

    2014-02-01

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

  12. Medical devices and pharmaceuticals: differences in public acceptance.

    PubMed

    Holmes, David R; Wood, Douglas L

    2006-01-01

    In the past 15 years, rapid technologic advances have introduced medical devices for clinical use that have transformed the care of patients with chronic diseases, especially heart disease. These devices have become truly lifesaving, and their effectiveness has been demonstrated in randomized clinical trials and cost-effectiveness studies. At the same time, a remarkable number of pharmaceutical agents with new actions and capabilities have also been introduced into clinical use. These new compounds have altered the practice of oncology and the care of patients with hematologic malignancies, sometimes with significant improvement in survival. There have been other drugs introduced to manage chronic diseases that alter quality of life but do not usually threaten survival. Recent problems related to the COX-2 anti-inflammatory drugs and ongoing controversies associated with them have raised public awareness; however, there is even more concern about device failures and recalls that have occurred during the same time frame. There is limited information as to why there is such an apparent difference in public opinion toward adverse drug events compared with device problems that lead to advisories or recalls. Among possible reasons are that an implantable device that requires a catheter-based surgical procedure, with its need for hospitalization and detailed explanation about all the potential risks, may be emotionally and intellectually processed differently by a patient/family compared with having a change in prescription from one drug to another.

  13. 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.

  14. Medical device integration: CIOs must bridge the digital divide between devices and electronic medical records.

    PubMed

    Raths, David

    2009-02-01

    To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.

  15. 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.

  16. 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.

  17. Plasma etching for advanced polymer optical devices

    NASA Astrophysics Data System (ADS)

    Bitting, Donald S.

    Plasma etching is a common microfabrication technique which can be applied to polymers as well as glasses, metals, and semiconductors. The fabrication of low loss and reliable polymer optical devices commonly makes use of advanced microfabrication processing techniques similar in nature to those utilized in standard semiconductor fabrication technology. Among these techniques, plasma/reactive ion etching is commonly used in the formation of waveguiding core structures. Plasma etching is a powerful processing technique with many potential applications in the emerging field of polymer optical device fabrication. One such promising application explored in this study is in the area of thin film-substrate adhesion enhancement. Two approaches involving plasma processing were evaluated to improve substrate-thin film adhesion in the production of polymer waveguide optical devices. Plasma treatment of polymer substrates such as polycarbonate has been studied to promote the adhesion of fluoropolymer thin film coatings for waveguide device fabrication. The effects of blanket oxygen plasma etchback on substrate, microstructural substrate feature formation, and the long term performance and reliability of these methods were investigated. Use of a blanket oxygen plasma to alter the polycarbonate surface prior to fluoropolymer casting was found to have positive but limited capability to improve the adhesive strength between these polymers. Experiments show a strong correlation between surface roughness and adhesion strength. The formation of small scale surface features using microlithography and plasma etching on the polycarbonate surface proved to provide outstanding adhesion strength when compared to any other known treatment methods. Long term environmental performance testing of these surface treatment methods provided validating data. Test results showed these process approaches to be effective solutions to the problem of adhesion between hydrocarbon based polymer

  18. 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.

  19. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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. (a... medicine, medical devices, and medical services to the Palestinian Authority Ministry of Health,...

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

    MedlinePlus

    ... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...

  1. 75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer... available pediatric medical device information as a part of premarket approval applications, requests...

  2. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... 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... committee hot line/ phone line to learn about possible modifications before coming to the meeting....

  3. Micro- and Macrointegration Profiles for Medical Devices and Medical IT Systems.

    PubMed

    Pahontu, Raluca; Merzweiler, Angela; Schneider, Gerd; Bergh, Björn

    2015-01-01

    Collecting, saving, and providing patient data are essential processes of documentation in a hospital. Many IT systems have evolved to provide solutions in this area. The automatic transfer of medical device data to these information systems is a new challenge for hospital IT systems. Some vendors are focused on the integration of medical IT systems and medical devices. They provide great solutions with magnificent features. Nevertheless, those integration solutions are proprietary and isolated, limiting the operator's selection of his medical devices and medical IT systems. Standardizing communication processes within the operating room and between medical devices and medical IT systems brings benefits for both patient and hospital staff. This work identifies and proposes micro- and macrointegration profiles as a basis for new IHE Integration Profiles for both medical IT systems and medical devices of the operating room.

  4. 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

  5. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Food, medicine, and medical devices... REGULATIONS General Definitions § 561.327 Food, medicine, and medical devices. (a) The term food means items...-grade gelatin powder, and peptones and their derivatives. (b) The term medicine has the same...

  6. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

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

  7. 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.

  8. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... 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 Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug...

  9. 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...

  10. 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...

  11. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... 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... remaining pre-Amendment Class III devices. These systems typically consist of a treatment table,...

  12. 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

  13. 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

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

    PubMed

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

    2013-12-01

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

  15. Model-based engineering for medical-device software.

    PubMed

    Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

    2010-01-01

    This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

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

    PubMed

    Kirisits, Andreas; Redekop, W Ken

    2013-02-01

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

  17. Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.

    PubMed

    1998-12-04

    The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medical devices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens.

  18. 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).

  19. Microbial colonization of medical devices and novel preventive strategies.

    PubMed

    Shunmugaperumal, Tamilvanan

    2010-06-01

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

  20. 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

  1. 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.

  2. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  3. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  6. [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.

  7. [The current situation and consideration on the quality of medical device standards in China].

    PubMed

    Yang, Xiaofang; Mu, Rui hong; Li, Jingli

    2014-09-01

    Through the analysis of the present problems of the quality of medical device standards in China, combined with the development trend of the last ten years of medical devices, the paper made proposals on the medical device standards quality evaluation system, so as to improve the medical device standards management level and the quality of medical device standard in our country.

  8. 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

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would...

  9. 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.

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

    PubMed

    Großkopf, Volker; Jäkel, Christian

    2008-09-03

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

  11. Making Medical Devices Safer at Home

    MedlinePlus

    ... influence the caregiver's ability to use complex, high-maintenance devices. Usability is a critical factor in the ... with the start/stop button on an infusion pump or the inability to hear different types of ...

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

    PubMed

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

    2012-08-07

    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.

  13. Quality management for the processing of medical devices.

    PubMed

    Klosz, Kerstin

    2008-09-03

    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".

  14. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  15. 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

    ... 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.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices...

  16. 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...

  17. 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...

  18. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... soluble salts or other drugs into the body for purposes other than those specified in part (a). Devices... 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:...

  19. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... for the filing and review of a petition for reclassification of such class III devices. In order to... effectiveness of the device for its intended use. After review of the information submitted in the petition,...

  20. 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

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of... Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  1. 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...

  2. 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...

  3. 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...

  4. 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)...

  5. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... 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... outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... 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,...

  7. 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...

  8. 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... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter...

  9. 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...

  10. 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...

  11. 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...

  12. 4D Printing of Shape Memory-Based Personalized Endoluminal Medical Devices.

    PubMed

    Zarek, Matt; Mansour, Nicola; Shapira, Shir; Cohn, Daniel

    2017-01-01

    The convergence of additive manufacturing and shape-morphing materials is promising for the advancement of personalized medical devices. The capability to transform 3D objects from one shape to another, right off the print bed, is known as 4D printing. Shape memory thermosets can be tailored to have a range of thermomechanical properties favorable to medical devices, but processing them is a challenge because they are insoluble and do not flow at any temperature. This study presents here a strategy to capitalize on a series of medical imaging modalities to construct a printable shape memory endoluminal device, exemplified by a tracheal stent. A methacrylated polycaprolactone precursor with a molecular weight of 10 000 g mol(-1) is printed with a UV-LED stereolithography printer based on anatomical data. This approach converges with the zeitgeist of personalized medicine and it is anticipated that it will broadly expand the application of shape memory-exhibiting biomedical devices to myriad clinical indications.

  13. 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.

  14. Statistics in the world of medical devices: the contrast with pharmaceuticals.

    PubMed

    Campbell, Gregory

    2008-01-01

    Medical devices play a vital role in people's lives as these products are revolutionizing medicine with breathtaking advances in both the treatment and the detection of many diseases. While a similar, primarily therapeutic, revolution is ongoing in the pharmaceutical world; the focus here is the effect this device revolution is having on the statistical world. The similarities and differences between medical devices and pharmaceutical drugs are explored in terms of their natures, industries, and how they are regulated in the U.S. and globally. Statistical issues concerning the evaluation of devices versus those of drugs are compared and contrasted. These trends are creating new challenges for the statistical world in the development and evaluation of these new medical products.

  15. 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

  16. U.S. medical device reporting: who is responsible?

    PubMed

    Donawa, Maria

    2005-04-01

    When various companies are involved in the manufacture and export of medical devices to the United States (U.S.), it is not always easy to understand the reporting responsibilities under the U.S. Medical Device Reporting regulation. A new rule has been published to help companies better understand the requirements. This article discusses the new rule, ways to determine responsibilities and suggestions for compliance.

  17. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

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

  19. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... Medical Devices Workshop.'' The purpose of the workshop is to discuss factors affecting the reprocessing... devices with the overall goal to reduce the risk of infection. The topics to be discussed are: Factors... reprocessing may have been a contributing factor in microbial transmission and subsequent infection....

  20. 26 CFR 48.4191-2 - Taxable medical device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... Example 6. X manufactures pregnancy test kits. X sells the kits to distributors Y and Z, which, in turn, sell the pregnancy test kits to medical institutions and offices, medical professionals, and retail businesses. The FDA requires manufacturers of pregnancy test kits to list the kits as a device with the...

  1. Human factors: should your medical devices require intensive care?

    PubMed

    Hyman, William A

    2010-06-01

    The design of a medical device should include active consideration of the way in which real users will actually use the device in the real environment of use. This consideration must include making the way in which the user interfaces with the device, for example, the buttons, the displays, the connections, such that the user can complete their tasks without error and without undue burden. This consideration of realistic user needs is addressed by the discipline of human factors.

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

    PubMed

    Larose, Emily

    2013-01-01

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

  3. 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.

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

    PubMed

    Cui, Hongen; Yao, Shaowei

    2015-03-01

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

  5. 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.

  6. Medical devices manufactured from latex: European regulatory initiatives.

    PubMed

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

    2002-05-01

    In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities.

  7. 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.

  8. 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...

  9. Design Engineering of Biomaterials for Medical Devices

    NASA Astrophysics Data System (ADS)

    Hill, David

    1998-10-01

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

  10. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  11. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  13. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  15. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  16. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  17. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  18. Effectively utilizing device maintenance data to optimize a medical device maintenance program.

    PubMed

    Brewin, D; Leung, J; Easty, T

    2001-01-01

    Methods developed by the clinical engineering community and the principles outlined by ISO regulations for the application of risk management to medical devices were integrated to provide a basis for the unique optimization system implemented into the University Health Network medical device maintenance program. Device maintenance history data stored in the database is used to conduct a risk analysis and to compute predefined benchmarks to highlight groups of equipment for which the current maintenance regime is not optimal. Using a software data research tool we are able to investigate device history data and support alterations in maintenance intervals, user training, maintenance procedures, and/or device purchasing. These alterations are justified, documented, and monitored for risk in a continuous management cycle. The predicted benefits are an overall improvement in the reliability of the devices maintained, coupled with a drop in repetitive device checks that result in no measurable benefits.

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

    PubMed

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

    2013-01-01

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

  20. 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.

  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. 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.

  3. Medical Device Regulation: A Comparison of the United States and the European Union.

    PubMed

    Maak, Travis G; Wylie, James D

    2016-08-01

    Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.

  4. Guidewire-Controlled Advancement of the Amplatz Thrombectomy Device

    SciTech Connect

    Mueller-Huelsbeck, Stefan; Schwarzenberg, Helmut; Heller, Martin

    1998-01-15

    The Amplatz Thrombectomy Device (ATD) is a percutaneous rotational catheter proven to homogenize thrombus. The catheter design allows neither application over a coaxial running guidewire nor the use of the device as a monorail system. We report a technical modification that provides guided advancement of the catheter over a wire in order to prevent failure of application and to facilitate the interventional procedure.

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

    PubMed

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

    2010-01-01

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

  6. Femtosecond Optics: Advanced Devices and Ultrafast Phenomena

    DTIC Science & Technology

    2007-05-31

    periodically poled lithium niobate (PPLN), which already represents a significant advance . Gain is given by G=0.25(1+ exp(gl)), where for 7 t2 PPLN, g...H. Sotobayashi, J.T. Gopinath, and E.P. Ippen, ൟ cm long Bi20 3-based EDFA for picosecond pulse amplification with 80 nm gain bandwidth," IEEE...will be minimized by keeping the data in the optical domain. Such all- optical networks require advanced photonic technologies for a variety of

  7. Safety evaluation of a Medical Device Data System.

    PubMed

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

    2012-01-01

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

  8. [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.

  9. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

    PubMed

    1998-11-12

    The Food and Drug Administration (FDA) is proposing to amend 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 proposing to designate 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 Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

  10. Advanced silicon device technologies for optical interconnects

    NASA Astrophysics Data System (ADS)

    Wosinski, Lech; Wang, Zhechao; Lou, Fei; Dai, Daoxin; Lourdudoss, Sebastian; Thylen, Lars

    2012-01-01

    Silicon photonics is an emerging technology offering novel solutions in different areas requiring highly integrated communication systems for optical networking, sensing, bio-applications and computer interconnects. Silicon photonicsbased communication has many advantages over electric wires for multiprocessor and multicore macro-chip architectures including high bandwidth data transmission, high speed and low power consumption. Following the INTEL's concept to "siliconize" photonics, silicon device technologies should be able to solve the fabrication problems for six main building blocks for realization of optical interconnects: light generation, guiding of light including wavelength selectivity, light modulation for signal encoding, detection, low cost assembly including optical connecting of the devices to the real world and finally the electronic control systems.

  11. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... 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 Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food...

  12. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... 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 Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food...

  13. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

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

  14. 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

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

  15. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and...

  16. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 Medical Devices; Radiology Devices... the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY...

  17. 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

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

    PubMed

    Li, Weijia; Zhou, Jing; Xu, Yuyin

    2015-09-01

    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.

  19. 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

  20. 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.

  1. [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").

  2. Advanced Interconnect and Device-Field Modeling

    DTIC Science & Technology

    2007-01-15

    Essaaidi NATO Advanced Research Workshop : Bianisotropics 2002, 99th Conference on Electromagnetics of Complex Media 8-11May, 2002, Marrakech , Morocco...Bianisotropics 2002, 99th Conference on Electromagnetics of Complex Media 8-11May, 2002, Marrakech , Morocco. Study of Substrates Bi-anisotropy Effects on...Conference on Electromagnetics of Complex Media 8-11May, 2002, Marrakech , Morocco. Dielectric Substrates Anisotropic Effects on The Characteristics of

  3. [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.

  4. Low power signal processing electronics for wearable medical devices.

    PubMed

    Casson, Alexander J; Rodriguez-Villegas, Esther

    2010-01-01

    Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

  5. [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.

  6. 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.

  7. 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.

  8. [Regulatory Science in the Review of Drugs and Medical Devices].

    PubMed

    Koide, Akihiro

    2016-01-01

    The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

  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. 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.

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

    PubMed

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

    2009-01-01

    Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution.

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  15. Advanced colour processing for mobile devices

    NASA Astrophysics Data System (ADS)

    Gillich, Eugen; Dörksen, Helene; Lohweg, Volker

    2015-02-01

    Mobile devices such as smartphones are going to play an important role in professionally image processing tasks. However, mobile systems were not designed for such applications, especially in terms of image processing requirements like stability and robustness. One major drawback is the automatic white balance, which comes with the devices. It is necessary for many applications, but of no use when applied to shiny surfaces. Such an issue appears when image acquisition takes place in differently coloured illuminations caused by different environments. This results in inhomogeneous appearances of the same subject. In our paper we show a new approach for handling the complex task of generating a low-noise and sharp image without spatial filtering. Our method is based on the fact that we analyze the spectral and saturation distribution of the channels. Furthermore, the RGB space is transformed into a more convenient space, a particular HSI space. We generate the greyscale image by a control procedure that takes into account the colour channels. This leads in an adaptive colour mixing model with reduced noise. The results of the optimized images are used to show how, e. g., image classification benefits from our colour adaptation approach.

  16. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Collection; Comment Request; Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration... of information technology. Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control... to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness...

  17. 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.

  18. [Implanted medical device-related infections: pathophysiology and prevention].

    PubMed

    Lebeaux, David; Ghigo, Jean-Marc; Lucet, Jean-Christophe

    2014-05-01

    Medical progress led to an increase in the number of indications for indwelling devices. However, colonization of implanted devices by pathogenic microorganisms also increases risks of formation of microbial communities surrounded by an extracellular matrix called biofilms. Biofilms are able to survive in the presence of high concentrations of antimicrobials, therefore leading to treatment difficulties and exposing patients to the risk of infection recurrence. Because of these features, preventive measures reducing the risk of microbial contamination are cornerstone for the management of any patient carrying an indwelling device.

  19. 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.

  20. 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

  1. 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.

  2. Microscopy imaging device with advanced imaging properties

    DOEpatents

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

    2016-11-22

    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.

  3. Microscopy imaging device with advanced imaging properties

    DOEpatents

    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.

  4. 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...

  5. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  7. Lessons learned: mobile device encryption in the academic medical center.

    PubMed

    Kusche, Kristopher P

    2009-01-01

    The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.

  8. 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.…

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

    PubMed

    Kermit, Eben L

    2004-01-01

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

  10. The dilemma over reprocessing single-use medical devices.

    PubMed

    Parsons, M S

    1998-01-01

    Making informed decisions about the reuse of single-use medical devices requires considerable analysis, study and management buy-in. This article addresses such issues as the prevalence of the practice, the changing standards and guidelines, institutional responsibilities, risk and insurance concerns and the ethical issues posed by the concept of reuse.

  11. 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

  12. 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

  13. Missing data in the regulation of medical devices.

    PubMed

    Campbell, Gregory; Pennello, Gene; Yue, Lilly

    2011-03-01

    Handling missing data is an important consideration in the analysis of data from all kinds of medical device studies. Missing data in medical device studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point analysis can be used to examine nonparametrically the sensitivity of conclusions to missing data. In general, sensitivity analysis is an important tool to study deviations from simple assumptions about missing data, such as the data being missing at random. Approaches to missing data in Bayesian trials are discussed, including sensitivity analysis. Many types of missing data that can occur with diagnostic test evaluations are surveyed. Careful planning and conduct are recommended to minimize missing data. Although difficult, the prespecification of all missing data analysis strategies is encouraged before any data are collected.

  14. 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.

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

    NASA Astrophysics Data System (ADS)

    Lambert, Byron J.; Tang, Fuh-Wei

    2000-03-01

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

  16. 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,…

  17. Tracking and surveillance of patients with medical devices and implants.

    PubMed

    Morgan, R W

    1993-01-01

    The United States Congress and FDA recently proposed modifications to the regulation for the tracking of certain medical devices and implants that will place significant demands on the manufacturers and importers of those products. The regulation, which comes into effect in August this year, will require the industry to carry out not only tracking of those devices or implants to the end user, but also continued observation of the device user or implant recipient throughout the life of the patient or the device. In this article, the author outlines FDA requirements and advises how best to meet those demands. The important elements for setting up a patient-tracking programme are discussed; these include the use of a Patient Registry as a basis for tracking and the importance of confidentiality throughout the tracking process.

  18. 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.

  19. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices

    PubMed Central

    Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. Methods MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Results Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Conclusions Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization. PMID:28261526

  20. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 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...

  1. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  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 801.5 - 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  7. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Transitional pass-through payments: Medical devices... devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  8. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  9. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  10. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  11. 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...

  12. 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... 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...

  13. 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... (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...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  15. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices...

  17. Maintaining medical independence in advanced age.

    PubMed

    Barber, Ann

    2009-01-01

    Juneteenth Day celebrates June 19, 1865, when Major General Granger landed in Texas with news that the Civil War had ended and that slaves were now free (History of Juneteenth, n.d.). Similarly, this article brings you news that patients are free to make their own medical decisions. American law now guarantees the right of all patients to make their own such decisions. Thus, this article introduces the concept of medical policy statements, a new way for patients to give instructions to medical professionals.

  18. 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.

  19. Tunable Ultrasonic Energy Harvesting for Implantable Biosensors and Medical Devices

    NASA Astrophysics Data System (ADS)

    Pellegrino, M.; Eovino, B. E.; Beker, L.; Bourouina, T.; Lin, L.

    2016-11-01

    This work reports a tunable ultrasonic energy harvesting (UEH) device capable of high power output and/or large bandwidth based on concentric piezoelectric ring-shaped structures. Two different designs are presented: (1) the single ring-shaped UEH (r-UEH), and (2) concentric r-UEHs. Concentric r-UEHs can save space and therefore can provide benefits in powering low-power implantable biosensors and medical devices. This paper presents results of simulation studies and initial experiments of a single r-UEH.

  20. Career development of biomedical engineers in medical device industry.

    PubMed

    Ni, Quan; Pu, Yachuan

    2009-01-01

    With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper also provides personal perspectives of some of the differences between established device companies and start-ups in the product development process and career paths for biomedical engineers.

  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. Advances in scintillators for medical imaging applications

    NASA Astrophysics Data System (ADS)

    van Loef, Edgar V.; Shah, Kanai S.

    2014-09-01

    A review is presented of some recent work in the field of inorganic scintillator research for medical imaging applications, in particular scintillation detectors for Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET).

  3. Image analysis in medical imaging: recent advances in selected examples.

    PubMed

    Dougherty, G

    2010-01-01

    Medical imaging has developed into one of the most important fields within scientific imaging due to the rapid and continuing progress in computerised medical image visualisation and advances in analysis methods and computer-aided diagnosis. Several research applications are selected to illustrate the advances in image analysis algorithms and visualisation. Recent results, including previously unpublished data, are presented to illustrate the challenges and ongoing developments.

  4. Advances in medical therapies for Cushing's syndrome.

    PubMed

    Tritos, Nicholas A; Biller, Beverly M K

    2012-02-01

    Cushing's syndrome (CS) is a heterogeneous disorder of diverse etiologies, leading to cortisol excess. Endogenous CS is caused by tumors secreting adrenocorticotropin (ACTH) (either eutopically or ectopically), cortisol, or very rarely corticotropin-releasing hormone (CRH). Definitive therapy of endogenous CS optimally involves tumor resection. Indications for medical therapy include acutely ill patients in preparation for surgery, those for whom surgery is not indicated (such as patients with unknown tumor location or unresectable lesions, and patients unfit for surgery for medical reasons), or patients who remain hypercortisolemic postoperatively. In the current article, the published literature has been reviewed to summarize data on medical therapies used in CS. Several agents are either used "off label" or being studied as potential therapies for CS. Medications suppressing adrenal steroidogenesis currently in use include ketoconazole, metyrapone, mitotane, or etomidate. In addition, the investigational agent LCI699 is under study. Centrally acting agents, which suppress ACTH secretion, include cabergoline, octreotide, as well as the investigational agents pasireotide, bexarotene, and lapatinib, which are being studied in patients with pituitary tumors. Mifepristone, a type 2 glucocorticoid receptor antagonist, was recently approved by the FDA as a new therapy for CS. Although not definitive at present, medical therapies have an important role in the management of CS patients. It is anticipated that understanding the pathogenesis of these tumors at a molecular level may spawn the development of rationally designed, highly efficacious medical therapies for CS in the future.

  5. 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.

  6. Heparin coatings for improving blood compatibility of medical devices.

    PubMed

    Biran, Roy; Pond, Daniel

    2016-12-29

    Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause serious adverse clinical events. This includes thrombosis and thromboembolic complications due to activation of platelets and the coagulation cascade, activation of the complement system, and inflammation. Numerous surface coatings have been developed to improve blood compatibility of biomaterials. For more than thirty years, the anticoagulant drug heparin has been employed as a covalently immobilized surface coating on a variety of medical devices. This review describes the fundamental principles of non-eluting heparin coatings, mechanisms of action, and clinical applications with focus on those technologies which have been commercialized. Because of its extensive publication history, there is emphasis on the CARMEDA(®) BioActive Surface (CBAS(®) Heparin Surface), a widely used commercialized technology for the covalent bonding of heparin.

  7. 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%.

  8. 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.

  9. Lightweight Portable Plasma Medical Device - Plasma Engineering Research Laboratory

    DTIC Science & Technology

    2012-10-01

    oxides (NOx) are produced through N2 and O2 reactions [62, 63]. The production of NOx species is mainly dependent on the oxygen (O2) concentration...Federal, $812,594.00. Thiyagarajan, Magesh (Principal), "Plasma Assisted Microbial Decontamination for Food Product Processing Industries...processes and products including processing and preservation of food items such as 86 vegetables, fruits and packaged foods , medical devices and

  10. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1436, Silver...

  11. 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

    ... 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... and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December...

  12. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was...: In the Federal Register of August 16, 2010, FDA announced that a meeting of the General and...

  13. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... 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... the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This...

  14. 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.

  15. 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.

  16. Antimicrobial selenium nanoparticle coatings on polymeric medical devices.

    PubMed

    Tran, Phong A; Webster, Thomas J

    2013-04-19

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

  17. Devices in the management of advanced, chronic heart failure

    PubMed Central

    Abraham, William T.; Smith, Sakima A.

    2013-01-01

    Heart failure (HF) is a global phenomenon, and the overall incidence and prevalence of the condition are steadily increasing. Medical therapies have proven efficacious, but only a small number of pharmacological options are in development. When patients cease to respond adequately to optimal medical therapy, cardiac resynchronization therapy has been shown to improve symptoms, reduce hospitalizations, promote reverse remodelling, and decrease mortality. However, challenges remain in identifying the ideal recipients for this therapy. The field of mechanical circulatory support has seen immense growth since the early 2000s, and left ventricular assist devices (LVADs) have transitioned over the past decade from large, pulsatile devices to smaller, more-compact, continuous-flow devices. Infections and haematological issues are still important areas that need to be addressed. Whereas LVADs were once approved only for ‘bridge to transplantation’, these devices are now used as destination therapy for critically ill patients with HF, allowing these individuals to return to the community. A host of novel strategies, including cardiac contractility modulation, implantable haemodynamic-monitoring devices, and phrenic and vagus nerve stimulation, are under investigation and might have an impact on the future care of patients with chronic HF. PMID:23229137

  18. Infections associated with medical devices: pathogenesis, management and prophylaxis.

    PubMed

    von Eiff, Christof; Jansen, Bernd; Kohnen, Wolfgang; Becker, Karsten

    2005-01-01

    The insertion or implantation of foreign bodies has become an indispensable part in almost all fields of medicine. However, medical devices are associated with a definitive risk of bacterial and fungal infections. Foreign body-related infections (FBRIs), particularly catheter-related infections, significantly contribute to the increasing problem of nosocomial infections. While a variety of micro-organisms may be involved as pathogens, staphylococci account for the majority of FBRIs. Their ability to adhere to materials and to promote formation of a biofilm is the most important feature of their pathogenicity. This biofilm on the surface of colonised foreign bodies is regarded as the biological correlative for the clinical experience with FBRI, that is, that the host defence mechanisms often seem to be unable to handle the infection and, in particular, to eliminate the micro-organisms from the infected device. Since antibacterial chemotherapy is also frequently not able to cure these infections despite the use of antibacterials with proven in vitro activity, removal of implanted devices is often inevitable and has been standard clinical practice. However, in specific circumstances, such as infections of implanted medical devices with coagulase-negative staphylococci, a trial of salvage of the device may be justified. All FBRIs should be treated with antibacterials to which the pathogens have been shown to be susceptible. In addition to systemic antibacterial therapy, an intraluminal application of antibacterial agents, referred to as the 'antibiotic-lock' technique, should be considered to circumvent the need for removal, especially in patients with implanted long-term catheters. To reduce the incidence of intravascular catheter-related bloodstream infections, specific guidelines comprising both technological and nontechnological strategies for prevention have been established. Quality assurance, continuing education, choice of the catheter insertion site, hand

  19. 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.

  20. 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.

  1. 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.

  2. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing... public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and... statement that describes your experience or expertise with nanotechnology. There will be a limited number...

  3. 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.

  4. Recent advances in medical imaging: anatomical and clinical applications.

    PubMed

    Grignon, Bruno; Mainard, Laurence; Delion, Matthieu; Hodez, Claude; Oldrini, Guillaume

    2012-10-01

    The aim of this paper was to present an overview of the most important recent advances in medical imaging and their potential clinical and anatomical applications. Dramatic changes have been particularly observed in the field of computed tomography (CT) and magnetic resonance imaging (MRI). Computed tomography (CT) has been completely overturned by the successive development of helical acquisition, multidetector and large area-detector acquisition. Visualising brain function has become a new challenge for MRI, which is called functional MRI, currently based principally on blood oxygenation level-dependent sequences, which could be completed or replaced by other techniques such as diffusion MRI (DWI). Based on molecular diffusion due to the thermal energy of free water, DWI offers a spectrum of anatomical and clinical applications, ranging from brain ischemia to visualisation of large fibrous structures of the human body such as the anatomical bundles of white matter with diffusion tensor imaging and tractography. In the field of X-ray projection imaging, a new low-dose device called EOS has been developed through new highly sensitive detectors of X-rays, allowing for acquiring frontal and lateral images simultaneously. Other improvements have been briefly mentioned. Technical principles have been considered in order to understand what is most useful in clinical practice as well as in the field of anatomical applications. Nuclear medicine has not been included.

  5. An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.

    PubMed

    Peña, Carlos; Li, Khan; Felten, Richard; Ogden, Neil; Melkerson, Mark

    2007-06-01

    The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

  6. [Audit: medical record documentation among advanced cancer patients].

    PubMed

    Perceau, Elise; Chirac, Anne; Rhondali, Wadih; Ruer, Murielle; Chabloz, Claire; Filbet, Marilène

    2014-02-01

    Medical record documentation of cancer inpatients is a core component of continuity of care. The main goal of the study was an assessment of medical record documentation in a palliative care unit (PCU) using a targeted clinical audit based on deceased inpatients' charts. Stage 1 (2010): a clinical audit of medical record documentation assessed by a list of items (diagnosis, prognosis, treatment, power of attorney directive, advance directives). Stage 2 (2011): corrective measures. Stage 3 (2012): re-assessment with the same items' list after six month. Forty cases were investigated during stage 1 and 3. After the corrective measures, inpatient's medical record documentation was significantly improved, including for diagnosis (P = 0.01), diseases extension and treatment (P < 0.001). Our results highlighted the persistence of a weak rate of medical record documentation for advanced directives (P = 0.145).

  7. [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.

  8. Advanced fiber lasers and related all-fiber devices

    NASA Astrophysics Data System (ADS)

    Srinivasan, Balaji

    2000-11-01

    Fiber lasers based on rare-earth ions now play an important role in several applications ranging from communications and surgery to spectroscopic sensing because of their efficiency and compactness, and their intrinsic compatibility with single mode communication fibers. As such, there is a strong need to investigate key issues related to the design and fabrication of ``rugged'' state-of-the-art fiber lasers, and in particular to fabricate versatile high-performance fiber lasers based on ``all-fiber'' devices, i.e. using only in-fiber devices. This dissertation addresses some of these needs. One such issue is the polarization property of lasers and amplifiers based on polarization preserving fibers. A dedicated study of the polarization properties of amplifiers and lasers based on rare-earth doped elliptical core fibers has been performed. The results indicate a polarization dependent gain, with a larger gain at the polarization parallel to the major axis of the ellipse. This gain anisotropy is attributed to the differences in the confinement of the two orthogonally polarized fundamental modes of the fiber. Another issue that has been driven by several medical, sensing, and data storage applications is that of efficient laser transitions in the mid-infrared and visible spectral regions. Such lasers are difficult to achieve in conventional fibers based on silica glass hosts due to their relatively large phonon energies. A fluoride based glass host (ZBLAN) with low phonon energy was chosen to enable green and blue laser transitions using upconversion schemes in erbium and thulium respectively, and realize an efficient mid-infrared transition in erbium. Specifically, the following results have been demonstrated: (1)Green (544 nm) fiber laser with the highest combination of power (50 mW) and efficiency (37%) in Er:ZBLAN; (2)Novel Raman fiber laser-pumped 22 mW blue (490 nm) laser in Tm:ZBLAN; (3)Diode-pumped mid-infrared (2.7 μm) laser with 660 mW output in Er

  9. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

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

  13. 76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... HUMAN SERVICES Food and Drug Administration Medical Device Epidemiology Network 2011: Second Annual... and Drug Administration (FDA) is announcing a public workshop entitled ``Medical Device Epidemiology... for studying medical device performance. Date and Time: The public workshop will be held on April...

  14. [The Feasibility Study on the Application of Global Medical Device Nomenclature(GMDN)].

    PubMed

    Yang, Wanjuan; Zheng, Jian; Li, Jun; Huang, Ying; Zhang, Chunqing; Li, Jingli

    2015-09-01

    The article has analyzed the policy co-ordination, Industry coverage and technical experience of the global medical device nomenclature (GMDN) to our country, argued the feasibility on the application of GMDN in our medical device administration system, provided some reference on building the naming system of medical device in our country.

  15. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  16. 75 FR 58414 - Dental Products Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of June 11, 2010... announced that a meeting of the Dental Products Panel of the Medical Devices Advisory Committee would...

  17. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  18. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2015-07-01

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

  20. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or...

  1. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or...

  2. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  3. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  4. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices... DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets...

  5. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... No. FDA-2013-N-0580] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public... entitled ``Battery-Powered Medical Devices Workshop: Challenges and Opportunities''. The purpose of this workshop is to create awareness of the challenges related to battery-powered medical devices...

  6. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published... meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, and...

  7. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 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.

  9. 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.

  10. 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.

  11. Alzheimer's disease: research advances and medical reality.

    PubMed

    Seiguer, Erica

    2005-07-01

    Alzheimer's disease was the eighth-leading cause of death in 2001. There is no cure and no effective treatment. Alzheimer's disease presents policy-makers with several challenges, including the level of funding and direction of federally funded research, as well as the cost pressures on Medicare and Medicaid of long-term care. These challenges will increase in intensity as demographic changes, particularly the aging of baby boomers, take hold. Better prevention of Alzheimer's, advances in therapy, and appropriate care modalities will likely require significant investment.

  12. Medical regulation of cognitive enhancement devices: some concerns

    PubMed Central

    King, Mike; Gavaghan, Colin; McMillan, John

    2014-01-01

    The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration. PMID:27774173

  13. 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.

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

    PubMed

    Devillier, P; Salvator, H; Roche, N

    2015-06-01

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

  15. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  17. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

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

    PubMed

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

    2015-01-01

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

  1. 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.

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

    PubMed

    Fouretier, Alice; Bertram, Delphine

    2014-07-01

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

  3. Bayesian statistics in medical devices: innovation sparked by the FDA.

    PubMed

    Campbell, Gregory

    2011-09-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.

  4. Safety and cleaning of medical materials and devices.

    PubMed

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

    2000-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Lisk, Kenneth G.

    1984-08-01

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

  6. Integration of isothermal amplification methods in microfluidic devices: Recent advances.

    PubMed

    Giuffrida, Maria Chiara; Spoto, Giuseppe

    2017-04-15

    The integration of nucleic acids detection assays in microfluidic devices represents a highly promising approach for the development of convenient, cheap and efficient diagnostic tools for clinical, food safety and environmental monitoring applications. Such tools are expected to operate at the point-of-care and in resource-limited settings. The amplification of the target nucleic acid sequence represents a key step for the development of sensitive detection protocols. The integration in microfluidic devices of the most popular technology for nucleic acids amplifications, polymerase chain reaction (PCR), is significantly limited by the thermal cycling needed to obtain the target sequence amplification. This review provides an overview of recent advances in integration of isothermal amplification methods in microfluidic devices. Isothermal methods, that operate at constant temperature, have emerged as promising alternative to PCR and greatly simplify the implementation of amplification methods in point-of-care diagnostic devices and devices to be used in resource-limited settings. Possibilities offered by isothermal methods for digital droplet amplification are discussed.

  7. Recent advances in the medical treatment of breast cancer.

    PubMed

    Vorobiof, Daniel A

    2016-01-01

    Over the past few decades, the systemic therapy of breast cancer (early and advanced) has changed considerably. For the past 40-50 years, and since the discovery and further therapeutic use of tamoxifen, a selective estrogen receptor modulator, breast cancer treatment has become the model for the development and success of tailored medical treatment. Much still needs to be done in improving outcomes for all patients with breast cancer, and especially for those who have advanced breast cancer, a challenging area for medical oncologists. Ongoing international clinical trials are currently evaluating new therapeutic approaches and identifying specific biological subsets that could determine a patient's ability to respond to particular chemotherapeutic drugs.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office of the Secretary... rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device... demonstrations from medical literature, national organizations, or technology assessment bodies that the...

  9. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    NASA Astrophysics Data System (ADS)

    Coad, James E.

    2011-03-01

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

  10. Thermally Stable and Sterilizable Polymer Transistors for Reusable Medical Devices.

    PubMed

    Kyaw, Aung Ko Ko; Jamalullah, Feroz; Vaithieswari, Loga; Tan, Mein Jin; Zhang, Lian; Zhang, Jie

    2016-04-20

    We realize a thermally stable polymer thin film transistor (TFT) that is able to endure the standard autoclave sterilization for reusable medical devices. A thermally stable semiconducting polymer poly[4-(4,4-dihexadecyl-4Hcyclopenta[1,2-b:5,4-b]dithiophen-2-yl)-alt[1,2,5]thiadiazolo [3,4c] pyridine], which is stable up to 350 °C in N2 and 200 °C in air, is used as channel layer, whereas the biocompatible SU-8 polymer is used as a flexible dielectric layer, in addition to conventional SiO2 dielectric layer. Encapsulating with in-house designed composite film laminates as moisture barrier, both TFTs using either SiO2 or SU-8 dielectric layer exhibit good stability in sterilized conditions without significant change in mobility and threshold voltage. After sterilization for 30 min in autoclave, the mobility drops only 15%; from as-fabricated mobility of 1.4 and 1.3 cm(2) V(-1) s(-1) to 1.2 and 1.1 cm(2) V(-1) s(-1) for TFTs with SiO2 and SU-8 dielectric layer, respectively. Our TFT design along with experimental results reveal the opportunity on organic/polymer flexible TFTs in sterilizable/reusable medical device application.

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

    NASA Astrophysics Data System (ADS)

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

    2014-02-01

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

  12. Advances in medical treatment of hypertrophic cardiomyopathy.

    PubMed

    Hamada, Mareomi; Ikeda, Shuntaro; Shigematsu, Yuji

    2014-07-01

    We reviewed the natural history of patients with hypertrophic cardiomyopathy (HCM). The effect of medical treatments on natural history, left ventricular (LV) functions and LV remodeling was also evaluated. Sudden cardiac death and end-stage heart failure are the most serious complications of HCM. Age <30 years and a family history of sudden premature death are risk factors for sudden cardiac death in HCM patients. End-stage heart failure is not a specific additional phenomenon observed in patients with HCM, but is the natural course of the disease in most of those patients. After the occurrence of heart failure, the progression to cardiac death is very rapid. Young age at diagnosis, a family history of HCM, and greater wall thickness are associated with a greater likelihood of developing end-stage heart failure. Neither beta-blockers nor calcium antagonists can prevent this transition. The class Ia antiarrhythmic drugs, disopyramide and cibenzoline are useful for the reduction of LV pressure gradient. Unlike disopyramide, cibenzoline has little anticholinergic activity; therefore, this drug can be easily adapted to long-term use. In addition to the reduction in LV pressure gradient, cibenzoline can improve LV diastolic dysfunction, and induce regression of LV hypertrophy in patients with HCM. A decrease in intracellular Ca(2+) concentration through the activation of the Na(+)/Ca(2+) exchanger associated with cibenzoline therapy is likely to be closely related with the improvement in HCM-related disorders. It is possible that cibenzoline can prevent the progression from typical HCM to end-stage heart failure.

  13. Surgical hemostatic agents: assessment of drugs and medical devices.

    PubMed

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

    2011-12-01

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

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

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

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

  15. The 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. [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.

  17. [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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

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

    PubMed

    Simoens, Steven

    2009-01-01

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

  4. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  5. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  6. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  7. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  8. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  9. 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...

  10. Just a piece of equipment? The importance of medical device education.

    PubMed

    Brand, Darren

    2012-12-01

    The use of medical devices is an increasingly important element of a healthcare professional's role. It is crucial that users receive regular teaching and education to ensure that they are competent in the use of devices. This is particularly relevant in the increasingly litigious society in which we live. This article focuses upon the importance of a medical device education.

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... interstate commerce and the time of holding in such establishment, from compliance with the labeling and... or delivery into interstate commerce is the operator of the establishment where such device is to...

  12. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... interstate commerce and the time of holding in such establishment, from compliance with the labeling and... or delivery into interstate commerce is the operator of the establishment where such device is to...

  13. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient... ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... medical devices for the treatment of morbid obesity and other metabolic diseases and evolving...

  14. BioIntraface®: the next quantum in medical devices.

    PubMed

    Jarrell, John D

    2013-02-01

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

  15. Missing data handling methods in medical device clinical trials.

    PubMed

    Yan, Xu; Lee, Shiowjen; Li, Ning

    2009-11-01

    One of the major problems in the analysis of clinical trials is missing data caused by patients dropping out before study completion. The issue of missing data can result in biased treatment comparisons and can impact the interpretation of study results. Since the missing data mechanism is unknown and unverifiable in most situations, regulatory agencies often request various sensitivity analyses for handling missing data to evaluate the robustness of study results. This article discusses methods used to handle missing data in medical device clinical trials, focusing on tipping-point analysis as a general approach for the assessment of missing data impact. Tipping points are outcomes that result in a change of study conclusion. Such outcomes can be conveyed to clinical reviewers to determine if they are implausibly unfavorable. The analysis aids clinical reviewers in making judgment regarding treatment effect in the study. Three examples with a reasonably representative range of missing data rate are included to illustrate the methods referred.

  16. 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.

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

    PubMed

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

    2013-12-01

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

  18. Nanoscale Copper and Copper Compounds for Advanced Device Applications

    NASA Astrophysics Data System (ADS)

    Chen, Lih-Juann

    2016-12-01

    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. [Device-aided therapies in advanced Parkinson's disease].

    PubMed

    Timofeeva, A A

    2016-01-01

    Advanced stages of Parkinson's disease (PD) is a consequence of the severe neurodegenerative process and are characterized by the development of motor fluctuations and dyskinesia, aggravation of non-motor symptoms. Treatment with peroral and transdermal drugs can't provide an adequate control of PD symptoms and quality-of-life of the patients at this stage of disease. Currently, three device-aided therapies: deep brain stimulation (DBS), intrajejunal infusion of duodopa, subcutaneous infusion of apomorphine can be used in treatment of patients with advanced stages of PD. Timely administration of device-aided therapies and right choice of the method determine, to a large extent, the efficacy and safety of their use. Despite the high efficacy of all three methods with respect to the fluctuation of separate symptoms, each method has its own peculiarities. The authors reviewed the data on the expediency of using each method according to the severity of motor and non-motor symptoms, patient's age, PD duration, concomitant pathology and social support of the patients.

  20. 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

  1. Advanced Imaging and Robotics Technologies for Medical Applications

    NASA Astrophysics Data System (ADS)

    Masamune, Ken; Hong, Jaesung

    2011-10-01

    Due to the importance of surgery in the medical field, a large amount of research has been conducted in this area. Imaging and robotics technologies provide surgeons with the advanced eye and hand to perform their surgeries in a safer and more accurate manner. Recently medical images have been utilized in the operating room as well as in the diagnostic stage. If the image to patient registration is done with sufficient accuracy, medical images can be used as "a map" for guidance to the target lesion. However, the accuracy and reliability of the surgical navigation system should be sufficiently verified before applying it to the patient. Along with the development of medical imaging, various medical robots have also been developed. In particular, surgical robots have been researched in order to reach the goal of minimal invasiveness. The most important factors to consider are determining the demand, the strategy for their use in operating procedures, and how it aids patients. In addition to the above considerations, medical doctors and researchers should always think from the patient's point of view. In this article, the latest medical imaging and robotic technologies focusing on surgical applications are reviewed based upon the factors described in the above.

  2. [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.

  3. 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.

  4. Couching for cataract: advanced medical achievements of China in 1976?

    PubMed

    Fan, Ka-wai

    2011-01-01

    Cataracts have been a common disease in China for centuries. As early as the Tang dynasty, physicians of Chinese medicine had developed 'jin pi shu', a method of couching, to cure the disease. In 1976, a new method, invented by Tang Youzhi, was acknowledged as one of the most advanced medical achievements in communist China. This paper explores the significance of Tang's method for Mao Zedong's China. Tang's method achieved two goals set by Chairman Mao for medical and health policies: to serve rural China and to integrate Chinese and Western medicine.

  5. Insertion device operating experience at the Advanced Photon Source

    NASA Astrophysics Data System (ADS)

    Grimmer, John; Ramanathan, Mohan; Smith, Martin; Merritt, Michael

    2002-03-01

    The Advanced Photon Source has 29 insertion devices (IDs) installed in the 7 GeV electron storage ring; 28 of these devices, most of which are 3.3 cm period undulators, use two horizontal permanent magnet structures positioned over a straight vacuum chamber. A support and drive mechanism allows the vertical gap between the magnet structures to be varied, thus changing the x-ray energy produced by the ID [J. Viccaro, Proc. SPIE 1345, 28 (1990); E. Gluskin, J. Synchrotron Radiat. 5, 189 (1998)]. Most of these IDs use a drive scheme with two stepper motors, one driving each end through a mechanism synchronizing the upper and lower magnet structures. Our experience in almost 5 yr of operating this system will be discussed. All of the IDs are in continuous operation for approximately 10 weeks at a time. Reliability of operation is of paramount importance, as access to the storage ring for servicing of a single ID inhibits operation for all users. Our experience in achieving highly reliable ID operation is reviewed. Accuracy of operation and repeatability over time are also vital. To this end, these devices use absolute optical linear encoders with submicron resolution for primary position feedback. Absolute rotary encoders are used as a backup to the linear encoders. The benefits and limitations of each type of encoder, and our experience dealing with radiation and electrical noise are reviewed. The insertion devices operate down to gaps as small as 8.5 mm, with clearance over the vacuum chamber as small as 200 μm. The vacuum chamber has a minimum wall thickness of only 1 mm. A number of levels of safeguards are used to prevent contact between the magnet structure and the vacuum chamber. These safeguards and their evolution after gaining operational experience are presented.

  6. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  8. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... about my medical device report? 803.15 Section 803.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING; (Eff. Until 8... public health requires additional or clarifying information for medical device reports submitted to...

  10. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed

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

    2012-05-01

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

  12. 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.

  13. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

    DTIC Science & Technology

    2014-10-01

    procurement of medical devices and related equipment . We facilitated the endorsement of medical device interoperability for improving patient safety by...medical devices and test equipment to serve as a vendor-neutral environment to devaluate proposed standards through interoperability testing and...System, and the Partners HealthCare System community (MGH Anesthesia, Biomedical Engineering at MGH and Brigham & Women’s Hospital, and Partners

  14. [Development and application of a medical device maintenance information platform based on BS architecture].

    PubMed

    Liu, Shenglin; Zhang, Xutian; Wang, Guohong; Zhang, Qiang

    2012-03-01

    Based on specified demands on medical devices maintenance for clinical engineers and Browser/Server architecture technology, a medical device maintenance information platform was developed, which implemented the following modules such as repair, preventive maintenance, accessories management, training, document, system management and regional cooperation. The characteristics of this system were summarized and application in increase of repair efficiency, improvement of preventive maintenance and cost control was introduced. The application of this platform increases medical device maintenance service level.

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

    MedlinePlus

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

  16. 78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... international standards ``ISO 9001: Quality Systems Model for Quality Assurance in Design/Development... device CGMP requirements with QS specifications in the international standard ``ISO 9001: Quality Systems... Collection; Comment Request; Medical Devices Current Good Manufacturing Practice Quality System...

  17. 75 FR 36092 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... international standards ``ISO 9001: Quality Systems Model for Quality Assurance in Design/Development... harmonizes device CGMP requirements with QS specifications in the international standard ``ISO 9001: Quality... Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System...

  18. Recent advances in the medical treatment of breast cancer

    PubMed Central

    Vorobiof, Daniel A.

    2016-01-01

    Over the past few decades, the systemic therapy of breast cancer (early and advanced) has changed considerably. For the past 40–50 years, and since the discovery and further therapeutic use of tamoxifen, a selective estrogen receptor modulator, breast cancer treatment has become the model for the development and success of tailored medical treatment. Much still needs to be done in improving outcomes for all patients with breast cancer, and especially for those who have advanced breast cancer, a challenging area for medical oncologists. Ongoing international clinical trials are currently evaluating new therapeutic approaches and identifying specific biological subsets that could determine a patient’s ability to respond to particular chemotherapeutic drugs. PMID:27990275

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... December 23, 2010. SYSTEM. FDA-2011-M-0035 P100028 Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011...-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198] Medical Devices; Availability of...

  20. Instructions included? Make safety training part of medical device procurement process.

    PubMed

    Keller, James P

    2010-04-01

    Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

  1. 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.

    1997-09-01

    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. 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.

  2. [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.

  3. 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.

  4. 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

    ... Authorizations: Advanced Micro Devices China, Inc., Lam Research Corporation, SK hynix Semiconductor (China) Ltd... Advanced Micro Devices China Inc.'s (AMD China) current list of eligible destinations. BIS also amends the...-User Authorizations in the PRC Revisions to the List of Eligible Destinations for Advanced...

  5. Case studies in advanced monitoring with the Chronicle device.

    PubMed

    Bourge, Robert C

    2006-01-01

    Three case studies illustrate the utility of advanced implantable hemodynamic monitors (IHMs). The cases include a 70-year-old with ischemic cardiomyopathy, chronic kidney disease, and recurrent volume overload; a 53-year-old with ischemic heart disease, mild effort-related angina, and New York Heart Association class III chronic heart failure; and a 21-year-old with severe dilated cardiomyopathy, all 3 patients having an IHM. The outcomes in these cases illustrate the capability of the IHM system for monitoring and detecting early changes in hemodynamic data and the use of these data to adjust medical therapies and reduce morbidity and risk of hospitalization. When pathologic hemodynamic changes are observed, this alerts the cardiologist to search for underlying causes, even when a patient on initial questioning denies any change in compliance or symptoms.

  6. Advanced semiconductor quantum well devices for infrared applications

    NASA Astrophysics Data System (ADS)

    Kuznetsov, Vladimir V.

    High performance mid-wavelength infrared (MWIR) light emitting diodes (LEDs) are needed for chemical sensing, analysis and medical imaging. Efficient long wavelength infrared (LWIR) photodetectors are highly desirable for remote sensing and space exploration. The goal of this work is to investigate new mid-infrared LEDs and to optimize existing LWIR quantum well infrared photodetectors (QWIPs). Type-II "W" InAs/InGaSb/AlGaAsSb quantum wells were incorporated as optically active layers in MWIR LEDs. Influence of MBE crystal growth conditions on the density of Shockley-Read-Hall centers in the "W" quantum wells was studied and the optimal growth conditions were identified. A qualitative physical model was developed to describe relative importance of the radiative and non-radiative processes for various temperature ranges. MWIR LED structures lattice-matched to InAs and GaSb substrates were grown. Devices on InAs substrates were found to be at least twice as efficient as devices grown on GaSb. LEDs on InAs had 4.5 mum emission wavelength and 26.5 muW/A external efficiency. Possibility to operate GaAs/AIGaAs QWIP under normal-to-surface light incidence was studied. Metal nano-particle surface coating was developed and processes responsible for, light coupling into the QWIP were investigated. QWIP structure itself was optimized to eliminate Si-diffusion-assisted dark current enhancement by employing a new doping profile in the quantum wells. Devices with the new doping profile had an order of magnitude lower dark current and 20% higher photoresponse than commercially available QWIPs.

  7. Methodological choices for the clinical development of medical devices.

    PubMed

    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

  8. [Research progress on the treatment of obstructive sleep apnea and hypopnea syndrome with mandibular advancement device].

    PubMed

    Li, De-hong; Yang, Xiang-hong; Guo, Tian-wen

    2010-04-01

    Obstructive sleep apnea and hypopnea syndrome (OSAHS) is characterized by obstruction of upper airway and respiratory disturbance, excessive daytime sleepiness and tiredness.The possible causes are obesity, hypertension, and upper airway malformations,etc. The location and degree of upper airway structure narrowing in patients have been investigated in many ways, such as X-ray, multi-slices spiral computed tomography, etc. With multi-planar reconstruction technique,3-dimensional construction of upper airway can be established which shows the delicate changes of the upper airway structure. Mandibular advancement device is known as an effective treatment on mild and moderate OSAHS. By advancing the mandible forward, it can increase the space of upper airway, especially the oropharyngeal space. This paper reviewed the methods of investigating on OSAHS and the change of upper airway structure in OSAHS patients treated with mandibular advancement device. Supported by Combined Research Fund of Bureau of Health, Yunan Province and Kunming Medical College(Grant No.2009CD205).

  9. [Methodical reflections on epidemiological methods to measure adverse medical device events].

    PubMed

    Lessing, C

    2009-06-01

    Drugs and medical devices are common remedies in patient care. Concerning patient safety, much research has been undertaken to study medication-related events, such as adverse drug events or medication errors; however, only little is known about device-related events and patient safety. Until now, only one survey on the epidemiology of adverse medical device events has been published. Estimates amount to 8.4 adverse medical device events/100 hospitalizations. As this indicates, further research is needed on epidemiological methodology to investigate the frequency, distribution, causes and results of medical device-related events. Only profound knowledge will constitute a resilient base for the development of safety strategies which can be then implemented and evaluated. Also in the German health care system, the special challenges described for data collection have to be mastered.

  10. 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

  11. 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

    ... 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.... ACTION: Notice. SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND 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...

  13. 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.

  14. Introduction to patent strategies for medical device inventions.

    PubMed

    Gutman, Siegmond Y; Capraro, Joe; Chen, Tom

    2016-11-01

    Siegmund Gutman is the Chair of the Life Sciences Patent practice and a partner at the global law firm of Proskauer Rose LLP. Siegmund's practice focuses on developing and executing business-oriented patent strategies for medical device, biotechnology, and biopharmaceutical clients, including early-stage and mature companies, as well as academic and other research organizations. His background combines a graduate degree in biophysical chemistry and molecular and cell biology with more than 25 years of experience in the life sciences industry, including serving as senior counsel at Amgen. Joe Capraro is a partner and the Boston Office Head at the law firm of Proskauer Rose LLP. Joe has more than 25 years of experience advising start-ups and established companies on intellectual property issues. Joe has amassed broad intellectual property and transactional experience over the years and provides clients with practical, business-oriented advice. Tom Chen is a senior associate in the Los Angeles office of Proskauer Rose LLP, where his practice focuses on patent litigation and counseling in the life sciences sector. Tom holds an A.B. in chemistry and pharmacology from Duke University, and an M.S. in biotechnology from Johns Hopkins University. Prior to joining Proskauer, Tom previously served as a judicial law clerk for the Honorable Alvin A. Schall of the U.S. Court of Appeals for the Federal Circuit, and the Honorable Leonard P. Stark of the U.S. District Court for the District of Delaware.

  15. 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.

  16. 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.

  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. 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

  19. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury....526 Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a)...

  20. 31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Brokering commercial sales of agricultural commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury....533 Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a)...

  1. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury....526 Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a)...

  2. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury....526 Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a)...

  3. 75 FR 63845 - Medical Device User Fees; Public Meeting; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fees; Public Meeting; Extension of... requested input and comments from interested stakeholders on the Agency's medical user fee program and... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire...

  4. 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...

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

    NASA Astrophysics Data System (ADS)

    Bianco, Celestina

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

  6. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  7. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG...

  8. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG...

  9. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. [Licensing of Pharmaceuticals and Medical Devices in Germany: Weaknesses and Opportunities].

    PubMed

    Reinhardt, D; Wildner, M

    2016-12-01

    The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified. Methods: To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11. The results were critically assessed by comparing them with the current academic literature. Results: A central market authorization for medical devices was mentioned often, but seems politically not viable. However, quality, methodology and depth of the analyses necessary for the licensing of medical devices, especially for high-risk devices, can and should strive for higher standards, comparable to those of pharmaceuticals. With regard to post-market surveillance, the systems for both pharmaceuticals and medical devices should be improved. Innovativeness and competitiveness of European medical device manufacturers should not be promoted by reduced evidence standards and patient safety. Subsidies or easier licensing procedures for small product lines with particular importance for public health, similar to orphan drug regulations, are more desirable. Conclusion: This study helps to identify areas of improvement for licensing of pharmaceuticals and medical devices. Concrete recommendations were developed. Higher evidence standards should be mandatory especially for high-risk devices, comparable to those of pharmaceuticals. Post-marketing surveillance should be improved for pharmaceuticals and medical devices.

  12. Silicone surface with drug nanodepots for medical devices.

    PubMed

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

    2014-11-26

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

  13. Improving the Methods for the Economic Evaluation of Medical Devices.

    PubMed

    Tarricone, Rosanna; Callea, Giuditta; Ogorevc, Marko; Prevolnik Rupel, Valentina

    2017-02-01

    Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact. By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

  14. Near net shape forming of advanced structural ceramic devices

    NASA Astrophysics Data System (ADS)

    Liu, Hao-Chih

    This research applied a combination of rapid prototyping techniques and ceramic gelcasting processes in the design and manufacturing of advanced structural ceramic components that cannot be fabricated by other shape-forming processes. An Assembly Mold SDM process, a derivative process of Shape Deposition Manufacturing, was adopted along with modified gelcasting with great success. The fabricated gas turbine rotors, inlet nozzles, and mesoscale burner arrays have demonstrated superior shape accuracy, mechanical strength, and surface smoothness with a feature size of 200 mum. The design concepts and functionalities of the ceramic devices were verified with performance tests. The shape complexity and surface quality of ceramic parts have been further improved by the use of a mold assembly made of a low melting temperature metal alloy. The introduction of metal alloy required modifications in the mold design, machining procedure, and ceramic processing. A complete shape forming process (from slurry to final parts) was developed for the low melting temperature metal alloy. In addition, the choice of ceramic material now includes SiC, which is critical to the development of micro heat exchangers. Forty-channel, high-aspect-ratio structured SiC heat exchangers were fabricated, and the thermal conductivity value of SiC was found to be comparable to that of steel. The catalyst deposition and ceramic precursor impregnation processes were proposed to enable use of the SiC heat exchangers as micro reactors. Micro-electro-mechanical-systems (MEMS)-related techniques such as SU-8 deep photolithography and polydimethylsiloxane (PDMS) soft lithography were combined with gelcasting to make micro patterns on structural ceramics. A feature size of 125 mum and aspect ratio of 8 have been achieved in the preliminary experiments. Based on the fabricated ceramic devices, a graphical method to characterize the shape attributes of complex-shaped components was proposed and used to compare

  15. Medical and surgical therapy for advanced chronic venous insufficiency.

    PubMed

    Word, Ronnie

    2010-12-01

    Venous ulceration is the most serious consequence of chronic venous insufficiency. The disease has been known for more than 3.5 millennia with wound care centers established as early as 1500 bc. Unfortunately, still today it is a very poorly managed medical condition by most physicians despite that a great deal has been learned about the pathogenesis and treatment for venous ulcerations. We find that many wound care clinics treat the wound and not the cause of the problem. In this article, we review the basic pathophysiology of advanced chronic venous insufficiency and review the most up-to-date information with regard to medical therapy and different options of surgical therapy to address the underlying venous pathology responsible for chronic ulcers.

  16. Electronic security systems and active implantable medical devices.

    PubMed

    Irnich, Werner

    2002-08-01

    How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs

  17. 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. 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...

  18. 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. 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...

  19. 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. 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...

  20. 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. 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...

  1. 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...

  2. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Availability of Safety and Effectiveness..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... 18, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological...

  3. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ...-0063, FDA- 2010-M-0135, FDA-2010-M-0158] Medical Devices; Availability of Safety and Effectiveness..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... Regulations and Policy, Center for Devices and Radiological Health. BILLING CODE 4160-01-S...

  4. 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.

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

    PubMed

    Latini, G; Ferri, M; Chiellini, F

    2010-01-01

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

  6. Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

    PubMed

    Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

    2017-01-01

    A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.

  7. [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.

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

    PubMed

    Stephens, Anne; Assang, AnnMarie

    2010-12-01

    Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it

  9. Recent advances in the medical treatment of Cushing's disease.

    PubMed

    Fleseriu, Maria

    2014-01-01

    Cushing's disease is a condition of hypercortisolism caused by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma. While rare, it is associated with significant morbidity and mortality, which suggests that early and aggressive intervention is required. The primary, definitive therapy for patients with Cushing's disease in the majority of patients is pituitary surgery, generally performed via a transsphenoidal approach. However, many patients will not achieve remission or they will have recurrences. The consequences of persistent hypercortisolism are severe and, as such, early identification of those patients at risk of treatment failure is exigent. Medical management of Cushing's disease patients plays an important role in achieving long-term remission after failed transsphenoidal surgery, while awaiting effects of radiation or before surgery to decrease the hypercortisolemia and potentially reducing perioperative complications and improving outcome. Medical therapies include centrally acting agents, adrenal steroidogenesis inhibitors and glucocorticoid receptor blockers. Furthermore, several new agents are in clinical trials. To normalize the devastating disease effects of hypercortisolemia, it is paramount that successful patient disease management includes individualized, multidisciplinary care, with close collaboration between endocrinologists, neurosurgeons, radiation oncologists, and general surgeons. This commentary will focus on recent advances in the medical treatment of Cushing's, with a focus on newly approved ACTH modulators and glucocorticoid receptor blockers.

  10. Using advanced mobile devices in nursing practice--the views of nurses and nursing students.

    PubMed

    Johansson, Pauline; Petersson, Göran; Saveman, Britt-Inger; Nilsson, Gunilla

    2014-09-01

    Advanced mobile devices allow registered nurses and nursing students to keep up-to-date with expanding health-related knowledge but are rarely used in nursing in Sweden. This study aims at describing registered nurses' and nursing students' views regarding the use of advanced mobile devices in nursing practice. A cross-sectional study was completed in 2012; a total of 398 participants replied to a questionnaire, and descriptive statistics were applied. Results showed that the majority of the participants regarded an advanced mobile device to be useful, giving access to necessary information and also being useful in making notes, planning their work and saving time. Furthermore, the advanced mobile device was regarded to improve patient safety and the quality of care and to increase confidence. In order to continuously improve the safety and quality of health care, advanced mobile devices adjusted for nursing practice should be further developed, implemented and evaluated in research.

  11. Views of patients and professionals about electronic multicompartment medication devices: a qualitative study

    PubMed Central

    Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

    2016-01-01

    Objectives To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Design Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Participants and setting Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Results Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. Conclusions This study provides indicators of which patients might benefit from an electronic multicompartment

  12. 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

  13. An outline for public registration of clinical trials evaluating medical devices.

    PubMed

    Popp, Richard L; Lorell, Beverly H; Stone, Gregg W; Laskey, Warren; Smith, John J; Kaplan, Aaron V

    2006-04-18

    Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

  14. Advanced Energy Harvesting Control Schemes for Marine Renewable Energy Devices

    SciTech Connect

    McEntee, Jarlath; Polagye, Brian; Fabien, Brian; Thomson, Jim; Kilcher, Levi; Marnagh, Cian; Donegan, James

    2016-03-31

    The Advanced Energy Harvesting Control Schemes for Marine Renewable Energy Devices (Project) investigated, analyzed and modeled advanced turbine control schemes with the objective of increasing the energy harvested by hydrokinetic turbines in turbulent flow. Ocean Renewable Power Company (ORPC) implemented and validated a feedforward controller to increase power capture; and applied and tested the controls on ORPC’s RivGen® Power Systems in Igiugig, Alaska. Assessments of performance improvements were made for the RivGen® in the Igiugig environment and for ORPC’s TidGen® Power System in a reference tidal environment. Annualized Energy Production (AEP) and Levelized Cost of Energy (LCOE) improvements associated with implementation of the recommended control methodology were made for the TidGen® Power System in the DOE reference tidal environment. System Performance Advancement (SPA) goals were selected for the project. SPA targets were to improve Power to Weight Ratio (PWR) and system Availability, with the intention of reducing Levelized Cost of Electricity (LCOE). This project focused primarily reducing in PWR. Reductions in PWR of 25.5% were achieved. Reductions of 20.3% in LCOE were achieved. This project evaluated four types of controllers which were tested in simulation, emulation, a laboratory flume, and the field. The adaptive Kω2 controller performs similarly to the non-adaptive version of the same controller and may be useful in tidal channels where the mean velocity is continually evolving. Trends in simulation were largely verified through experiments, which also provided the opportunity to test assumptions about turbine responsiveness and control resilience to varying scales of turbulence. Laboratory experiments provided an essential stepping stone between simulation and implementation on a field-scale turbine. Experiments also demonstrated that using “energy loss” as a metric to differentiate between well-designed controllers operating at

  15. Point-of-Care (POC) Devices by Means of Advanced MEMS

    PubMed Central

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

    2015-01-01

    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

  16. Durable left ventricular assist device therapy in advanced heart failure: Patient selection and clinical outcomes

    PubMed Central

    Shah, Sachin P.; Mehra, Mandeep R.

    2016-01-01

    The increasing adoption of left ventricular assist devices (LVADs) into clinical practice is related to a combination of engineering advances in pump technology and improvements in understanding the appropriate clinical use of these devices in the management of patients with advanced heart failure. This review intends to assist the clinician in identifying candidates for LVAD implantation, to examine long-term outcomes and provide an overview of the common complications related to use of these devices. PMID:27056652

  17. 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

  18. [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.

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

    PubMed

    Mitchell, Ulrike H

    2015-01-01

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

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

    PubMed

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

    2012-01-01

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