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Sample records for accessible medical device

  1. [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. PMID:27197502

  2. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

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

  3. Medical Device Safety

    MedlinePlus

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

  4. Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda

    PubMed Central

    2012-01-01

    Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher

  5. 78 FR 6825 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Administration (FDA) is correcting a document that appeared in the Federal Register of January 7, 2013 (78 FR 951... Federal Register of January 7, 2013, in FR Doc. 951-953, on page 952, the following correction is made... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content...

  6. Medical Device Safety

    MedlinePlus

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

  7. Medical Device Safety

    MedlinePlus

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

  8. Medical device error.

    PubMed

    Goodman, Gerald R

    2002-12-01

    This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical device failure tracking are presented, as are sources of information on medical device failures. The importance of near-accident reporting is discussed to alert users that reported medical device errors are typically limited to those that have caused an injury or death. This can represent only a fraction of the true number of device problems. This article concludes with a summary of the most frequently reported medical device failures by technology type, clinical application, and clinical setting. PMID:12400632

  9. 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. PMID:27040333

  10. [Implantable medical devices].

    PubMed

    Crickx, B; Arrault, X

    2008-01-01

    Medical devices have been individualized to include a category of implantable medical devices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medical device has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medical devices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years. PMID:18442666

  11. Handheld Diagnostic Device Delivers Quick Medical Readings

    NASA Technical Reports Server (NTRS)

    2014-01-01

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

  12. Access to Medical Records.

    ERIC Educational Resources Information Center

    Cooper, Nancy

    Although confidentiality with regard to medical records is supposedly protected by the American Medical Associaton's principles of Ethics and the physician-patient privilege, there are a number of laws that require a physician to release patient information to public authorities without the patient's consent. These exceptions include birth and…

  13. Barriers to medical device innovation

    PubMed Central

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

    2014-01-01

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

  14. Implantable medical devices MRI safe.

    PubMed

    Dal Molin, Renzo; Hecker, Bertrand

    2013-01-01

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

  15. Medical devices; device tracking. Final rule.

    PubMed

    2002-02-01

    The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. PMID:11838471

  16. Medical records and access thereto.

    PubMed

    McQuoid-Mason, D

    1996-01-01

    Medical records are essential tools in the practice of medicine. They are important in the planning and monitoring of patient care and for the protection of the legal interests of patients, hospitals and doctors. There is a legal duty on doctors to maintain confidentiality and failure to do so may result in an action for invasion of privacy, defamation or even breach of contract. There are, however, exceptions to this rule. There are procedural remedies available to obtain access to medical records where they are relevant to civil or criminal proceedings. There are also constitutional provisions under the Interim and Working Draft Constitutions which may allow such access. The former only applies to records held by the state while the latter applies to both state and privately held records. Ownership of medical records usually vests in the doctor or institution treating the patient, but such ownership is custodial rather than absolute. Patient records should be accurate, objective and contemporaneous. The international trend is to allow patients to inspect their records and to allow them to make copies thereof. It is submitted that given the provisions of the Interim and Working Draft Constitutions the same should apply in South Africa. PMID:9009602

  17. Medical device market in China.

    PubMed

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

    2015-06-01

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

  18. Price transparency for medical devices.

    PubMed

    Pauly, Mark V; Burns, Lawton R

    2008-01-01

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

  19. Investing in medical device companies.

    PubMed

    Benson, B; Mutsch, E

    1993-11-01

    For companies seeking investors, money is available, but it is not as easy to obtain as it has been in recent years. Although the medical device industry remains an attractive proposition, several factors have contributed to the downturn in public-offering investment. This article outlines these factors and discusses the types of medical technologies that are likely to attract investment in the immediate future. PMID:10146504

  20. Intraosseous access in trauma by air medical retrieval teams.

    PubMed

    Sheils, Mark; Ross, Mark; Eatough, Noel; Caputo, Nicholas D

    2014-01-01

    Trauma accounts for a significant portion of overall mortality globally. Hemorrhage is the second major cause of mortality in the prehospital environment. Air medical retrieval services throughout the world have been developed to help improve the outcomes of patients suffering from a broad range of medical conditions, including trauma. These services often utilize intraosseous (IO) devices as an alternative means for access of both medically ill and traumatically injured patients in austere environments. However, studies have suggested that IO access cannot reach acceptable rates for massive transfusion. We review the subject to find the answer of whether IO access should be performed by air medical teams in the prehospital setting, or would central venous (CVC) access be more appropriate? We decided to assess the literature for capacity of IO access to meet resuscitation requirements in the prehospital management of trauma. We also decided to compare the insertion and complication characteristics of IO and CVC access. PMID:25049187

  1. [Consideration of Mobile Medical Device Regulation].

    PubMed

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

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

  2. Assessing standards of vascular access device care.

    PubMed

    McGuire, Rose

    Vascular access devices (VADs) are essential in health care as they provide vital access for treatment including the infusion of medication, fluids, blood products and nutritional supplements. However, their invasive nature predisposes patients to potential complications, primarily bloodstream infections. This article examines the current standards of VAD care and assesses compliance with current guidelines (national and trust policy) in one hospital setting utilising a practice audit. The audit was conducted in a 500-bed district general hospital over 6 non-consecutive week days. The medical division where the audit took place had 13 wards with 288 beds. A total of 120 VADs were audited, averaging n=9.2 per ward (with a range of 4-18 on each ward). The results demonstrated a collective non-compliance rate of 48%. Although overall compliance was 52%, a poor standard of care was highlighted across the division for all components of the care elements. The post-insertion care of VADs is an essential component of a comprehensive strategy to prevent complications. Consequently, initiatives such as audit, education and feedback should be used in an effort to improve practice and maintain optimal care. PMID:25904534

  3. 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.

  4. 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.

  5. Hacking medical devices a review - biomed 2013.

    PubMed

    Frenger, Paul

    2013-01-01

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

  6. 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 rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending certain medical.... 360hh- 360ss). The Safe Medical Devices Act of 1990 (SMDA) (Public Law 101- 629), transferred...

  7. 3D medical thermography device

    NASA Astrophysics Data System (ADS)

    Moghadam, Peyman

    2015-05-01

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

  8. [Patients' access to their medical records].

    PubMed

    Laranjo, Liliana; Neves, Ana Luisa; Villanueva, Tiago; Cruz, Jorge; Brito de Sá, Armando; Sakellarides, Constantitno

    2013-01-01

    Until recently, the medical record was seen exclusively as being the property of health institutions and doctors. Its great technical and scientific components, as well as the personal characteristics attributed by each doctor, have been the reasons appointed for that control. However, nowadays throughout the world that paradigm has been changing. In Portugal, since 2007 patients are allowed full and direct access to their medical records. Nevertheless, the Deontological Code of the Portuguese Medical Association (2009) explicitly states that patients' access to their medical records should have a doctor as intermediary and that the records are each physician's intellectual property. Furthermore, several doctors and health institutions, receiving requests from patients to access their medical records, end up requesting the legal opinion of the Commission for access to administrative documents. Each and every time, that opinion goes in line with the notion of full and direct patient access. Sharing medical records with patients seems crucial and inevitable in the current patient-centred care model, having the potential to improve patient empowerment, health literacy, autonomy, self-efficacy and satisfaction with care. With the recent technological developments and the fast dissemination of Personal Health Records, it is foreseeable that a growing number of patients will want to access their medical records. Therefore, promoting awareness on this topic is essential, in order to allow an informed debate between all the stakeholders. PMID:23815842

  9. Access to children's medical records.

    PubMed

    Bird, Sara

    2008-06-01

    Case histories are based on actual medical negligence claims or medicolegal referrals; however certain facts have been omitted or changed by the author to ensure the anonymity of the parties involved. When the parents of a young child are separated or divorced, it is not uncommon for general practitioners to receive requests from one of the parents for information about the medical management of the child, including a request for a copy of the child's medical records. The role of the GP is to provide medical care to the child and act in the child's best interests. This article outlines some strategies for GPs to minimise the possibility of becoming 'piggy in the middle' of a dispute between the parents. PMID:18523700

  10. Child Health and Access to Medical Care

    ERIC Educational Resources Information Center

    Leininger, Lindsey; Levy, Helen

    2015-01-01

    It might seem strange to ask whether increasing access to medical care can improve children's health. Yet Lindsey Leininger and Helen Levy begin by pointing out that access to care plays a smaller role than we might think, and that many other factors, such as those discussed elsewhere in this issue, strongly influence children's health.…

  11. 75 FR 35439 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... TRANSPORTATION BARRIERS COMPLIANCE BOARD Medical Diagnostic Equipment Accessibility Standards AGENCY... consultation with the Food and Drug Administration, to issue accessibility standards for medical diagnostic... accessibility needs of individuals with disabilities with respect to medical diagnostic equipment and...

  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. Medical device labeling and advertising: an overview.

    PubMed

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

    1999-01-01

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

  15. A biometric access personal optical storage device

    NASA Astrophysics Data System (ADS)

    Davies, David H.; Ray, Steve; Gurkowski, Mark; Lee, Lane

    2007-01-01

    A portable USB2.0 personal storage device that uses built-in encryption and allows data access through biometric scanning of a finger print is described. Biometric image derived templates are stored on the removable 32 mm write once (WO) media. The encrypted templates travel with the disc and allow access to the data providing the biometric feature (e.g. the finger itself) is present. The device also allows for export and import of the templates under secure key exchange protocols. The storage system is built around the small form factor optical engine that uses a tilt arm rotary actuator and front surface media.

  16. Learning from adverse incidents involving medical devices.

    PubMed

    Amoore, John; Ingram, Paula

    While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms. PMID:12715578

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

    PubMed

    Smith, Matthew W; Faunce, Thomas A

    2009-12-01

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

  18. 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..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010...

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

    PubMed

    Liu, Jiong

    2014-07-01

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

  20. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  1. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  2. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  3. [Medical Devices Law for pain therapists].

    PubMed

    Regner, M; Sabatowski, R

    2016-08-01

    Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular. PMID:27333770

  4. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J

    2010-01-01

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

  5. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  6. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  7. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  8. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  9. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  11. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  12. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  13. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  14. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. Anti-malware software and medical devices.

    PubMed

    2010-10-01

    Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices. PMID:21306047

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

    PubMed

    Charters, Kathleen G

    2012-01-01

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

  17. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  18. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  19. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  1. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. 21 CFR 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...

  3. Facilitating Physician Access to Medical Reference Information

    PubMed Central

    Bellman, Philip; Havens, Carol; Bertolucci, Ysabel; Streeter, Beth

    2005-01-01

    Context: Computer-based medical reference information is augmenting—and in some cases, replacing—many traditional sources. For Kaiser Permanente (KP) physicians, this change presents both advantages and obstacles to finding medical reference information. Objective: To improve understanding of physician information-seeking behavior and the barriers that limit use of both print-based and computer-based medical reference resources. Design: During 2002 and 2003, two quality-improvement surveys were distributed to full-time KP physicians. Survey instruments sent by conventional mail and by e-mail were based on results of telephone interviews and focus groups, and were designed to be concise and easy to use. Participant response rates exceeded 83%. Outcomes Measures: The surveys examined physician use of online medical reference information, medical libraries and services, self-directed learning resources, and continuing medical education (CME). Results: Of the physicians who responded to the survey, 89% used online resources frequently to enhance care, to inform clinical decisions, to update knowledge, to educate patients, or for a combination of these purposes. Compared with responses from older physicians, responses from younger physicians showed a greater proclivity for using nearly all types of online information. Most physicians obtained CME credits primarily through in-person education programs; few physicians used self-directed electronic learning tools. Obstacles to effective access to information included lack of time, overly complex access methods, and lack of awareness about available resources. Conclusions: A considerable gap exists between physicians' need for information and the resources currently available for delivering this information. Although we observed a clear shift from using printed medical references to using computer-based resources, many barriers prevent their effective use. Clinicians need easy-to-use, seamless systems of medical

  4. [Remote monitoring of active implantable medical device].

    PubMed

    Zhang, Yujing

    2013-09-01

    Active implantable medical device develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper. PMID:24409793

  5. Medical devices for the anesthetist: current perspectives.

    PubMed

    Ingrande, Jerry; Lemmens, Hendrikus Jm

    2014-01-01

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

  6. 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

  7. Using Zigbee to integrate medical devices.

    PubMed

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

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

  8. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration International Medical Device Regulators Forum; Medical... Medical Device Regulators Forum (IMDRF) was conceived in 2011 as a forum to discuss future directions...

  9. Child Health and Access to Medical Care

    PubMed Central

    Leininger, Lindsey; Levy, Helen

    2016-01-01

    It might seem strange to ask whether increasing access to medical care can improve children’s health. Yet Lindsey Leininger and Helen Levy begin by pointing out that access to care plays a smaller role than we might think, and that many other factors, such as those discussed elsewhere in this issue, strongly influence children’s health. Nonetheless, they find that, on the whole, policies to improve access indeed improve children’s health, with the caveat that context plays a big role—medical care “matters more at some times, or for some children, than others.” Focusing on studies that can plausibly show a causal effect between policies to increase access and better health for children, and starting from an economic framework, they consider both the demand for and the supply of health care. On the demand side, they examine what happens when the government expands public insurance programs (such as Medicaid), or when parents are offered financial incentives to take their children to preventive appointments. On the supply side, they look at what happens when public insurance programs increase the payments that they offer to health-care providers, or when health-care providers are placed directly in schools where children spend their days. They also examine how the Affordable Care Act is likely to affect children’s access to medical care. Leininger and Levy reach three main conclusions. First, despite tremendous progress in recent decades, not all children have insurance coverage, and immigrant children are especially vulnerable. Second, insurance coverage alone doesn’t guarantee access to care, and insured children may still face barriers to getting the care they need. Finally, as this issue of Future of Children demonstrates, access to care is only one of the factors that policy makers should consider as they seek to make the nation’s children healthier. PMID:27516723

  10. Use of mobile devices for medical imaging.

    PubMed

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

    2014-12-01

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

  11. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    .../ MedicalDevices/ pma/. DeviceRegulationa ndGuidance/ HowtoMarketYourDe vice/ PremarketSubmissi ons/ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/...

  12. [Accessing medical records for research purposes].

    PubMed

    Alcalde Bezhold, Guillermo; Alfonso Farnós, Iciar

    2013-01-01

    The Organic Law 15/1999 of 13 December on the Protection of Personal Data and the Law 41/2002 of 14 November regulating patient autonomy and rights and obligations of information and clinical documentation are the basic rules which govern the medical history in Spain. However, the lack of development of these laws regarding data protection in clinical research, particularly in terms of access to the medical history, repeatedly causes doubts about its construction by the Research Ethics Committees. Therefore, the aim of this paper is to analyze the rules which govern the access to the medical history for research purposes, with particular emphasis on the common problems that arise in the Committees for the ethical evaluation of these projects and finally setting a series of recommendations. The use for research purpose of genetic personal data contained in the medical history is also addressed in this paper. In this sense, a key contribution of the Law on Biomedical Research is relating to the specific regulation of the genetic personal data, both with respect to their production and access to the data as a support and regarding to its use for research purpose. PMID:24868961

  13. 5 CFR 297.205 - Access to medical records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Access to medical records. 297.205... PROCEDURES FOR PERSONNEL RECORDS Request for Access § 297.205 Access to medical records. When a request for access involves medical or psychological records that the system manager believes requires...

  14. 5 CFR 297.205 - Access to medical records.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Access to medical records. 297.205... PROCEDURES FOR PERSONNEL RECORDS Request for Access § 297.205 Access to medical records. When a request for access involves medical or psychological records that the system manager believes requires...

  15. 5 CFR 297.205 - Access to medical records.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Access to medical records. 297.205 Section 297.205 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PRIVACY PROCEDURES FOR PERSONNEL RECORDS Request for Access § 297.205 Access to medical records. When a request for access involves medical or...

  16. 5 CFR 297.205 - Access to medical records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Access to medical records. 297.205... PROCEDURES FOR PERSONNEL RECORDS Request for Access § 297.205 Access to medical records. When a request for access involves medical or psychological records that the system manager believes requires...

  17. 5 CFR 297.205 - Access to medical records.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Access to medical records. 297.205... PROCEDURES FOR PERSONNEL RECORDS Request for Access § 297.205 Access to medical records. When a request for access involves medical or psychological records that the system manager believes requires...

  18. 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.

  19. 20 CFR 401.55 - Access to medical records.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... _____'s (Name of minor) medical records. Please be informed that if any medical record was found... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Access to medical records. 401.55 Section 401... INFORMATION The Privacy Act § 401.55 Access to medical records. (a) General. You have a right to access...

  20. 20 CFR 401.55 - Access to medical records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... _____'s (Name of minor) medical records. Please be informed that if any medical record was found... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Access to medical records. 401.55 Section 401... INFORMATION The Privacy Act § 401.55 Access to medical records. (a) General. You have a right to access...

  1. 20 CFR 401.55 - Access to medical records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... _____'s (Name of minor) medical records. Please be informed that if any medical record was found... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Access to medical records. 401.55 Section 401... INFORMATION The Privacy Act § 401.55 Access to medical records. (a) General. You have a right to access...

  2. 20 CFR 401.55 - Access to medical records.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Access to medical records. 401.55 Section 401... INFORMATION The Privacy Act § 401.55 Access to medical records. (a) General. You have a right to access your medical records, including any psychological information that we maintain. (b) Medical records...

  3. Facilitating Virtual Health Management Using Medical Device Integration.

    PubMed

    Zaleski, John R

    2015-01-01

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

  4. [Perspectives on the supervision of medical device software].

    PubMed

    Li, Jun; Yang, Guozhong

    2011-05-01

    Medical device software is a special kind of medical device, which is different from hardware and may introduce more risk. How to reduce the risk of software efficiently is the important thing for medical device regulation system. This article analyzes medical device software's properties, introduces the status of foreign supervision, and finally gives some advises to the related parties. PMID:21954581

  5. 77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Submit... INFORMATION: Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory... with or considering hip replacement (...

  6. 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... (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...

  7. 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...

  8. 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...

  9. 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...

  10. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

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

  11. Electron beam sterilisation of heterogeneous medical devices

    NASA Astrophysics Data System (ADS)

    Sadat, T.; Morisseau, MrD.; Ross, MissA.

    1993-07-01

    Electron beam radiation is used in the sterilisation of medical disposable devices. High energy, 10 MeV, electron beam linear accelerators are in use worldwide for this purpose. The dose distribution achieved in the products treated influences the efficiency of treatment. This paper looks at the dose distribution achieved with such machines and the methods used to define it in heterogeneous products.

  12. 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

  13. Adhesive bonding of medical and implantable devices.

    PubMed

    Tavakoli, S M

    2002-09-01

    Although there are many commercially available medical-grade adhesives, their use for new applications requires detailed investigation. It is also important that as well as the initial joint strength, durability of the bonded components during intended use, including exposure to low and high temperatures, stress, fluids and sterilisation, are investigated. Design of accelerated ageing tests, which can simulate the service environments, is critical in providing realistic durability data. Interpretation of ageing data and lifetime prediction of the joint is essential in assessing the performance of medical devices. Emergence of new types of adhesives as well as further development of precision dispensing and rapid-curing technologies offer many exciting and commercially attractive opportunities for joining medical devices. PMID:12397833

  14. 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.

  15. Medical devices; classification for medical washer and medical washer-disinfector. Final rule.

    PubMed

    2002-11-15

    The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA). PMID:12437015

  16. Data sources: use in the epidemiologic study of medical devices.

    PubMed

    Torrence, Mary E

    2002-05-01

    Medical device epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medical devices in a population. The identification of large data sources with medical device data provides a large population for epidemiologic studies. Two challenges in medical device epidemiology are the ability to find data on the specific device and the exposure of a patient to that device. This paper identifies data sources both from the govenment and from the private sector that can be used for epidemiologic studies of medical devices and, to a limited degree, studies of medical devices in women. Each source provides data for different types of devices and in differing specificity. The paper also discusses briefly the strengths and weaknesses of each data source. More data sources are needed to enhance the study of medical device epidemiology. Additional efforts and focus are needed to enhance the ability to study medical devices in women. PMID:12071476

  17. 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

  18. Power Approaches for Implantable Medical Devices.

    PubMed

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

    2015-01-01

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

  19. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

    PubMed

    Kelley, Peter

    2010-01-01

    It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. SLAC All Access: Vacuum Microwave Device Department

    SciTech Connect

    Haase, Andy

    2012-10-09

    The Vacuum Microwave Device Department (VMDD) builds the devices that make SLAC's particle accelerators go. These devices, called klystrons, generate intense waves of microwave energy that rocket subatomic particles up to nearly the speed of light.

  6. SLAC All Access: Vacuum Microwave Device Department

    ScienceCinema

    Haase, Andy

    2014-06-13

    The Vacuum Microwave Device Department (VMDD) builds the devices that make SLAC's particle accelerators go. These devices, called klystrons, generate intense waves of microwave energy that rocket subatomic particles up to nearly the speed of light.

  7. 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

  8. 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...

  9. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    .../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request... HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 Medical Devices; Exemption From Premarket... Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug,...

  10. 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.

  11. 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.

  12. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

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

  13. SW Architecture for Access to Medical Information for Knowledge Execution

    NASA Astrophysics Data System (ADS)

    Kim, Suntae; Shim, Bingu; Kim, Jeong Ah; Cho, Insook

    Recently, many approaches have been studied to author medical knowledge and verify doctor's diagnosis based on the specified knowledge. During the verification, intensive access to medical information is unavoidable. Also, the access approach should consider modifiability in order to cover diverse medical information from the variety of hospitals. This paper presents an approach to generating query language from medical knowledge, and shows software architecture for accessing medical information from hospitals by executing generated query languages. Implementation of this architecture has been deployed in a hospital of South Korea so that it shows the feasibility of the architecture.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    PubMed

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

    2014-01-01

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

  16. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

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

  17. 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...

  18. 77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... requirement for premarket approval for implanted blood access devices (52 FR 17732 at 17738, May 11, 1987). In 2009, FDA published an order for the submission of information on implanted blood access devices (74 FR... the Device In the preamble to the proposed rule (46 FR 7616, January 23, 1981), the...

  19. Widening Access by Changing the Criteria for Selecting Medical Students

    ERIC Educational Resources Information Center

    Powis, David; Hamilton, John; McManus, I. C.

    2007-01-01

    Objective: To review the principles underlying medical student selection from the perspective of the imperatives of widening access policies. Setting: A recent government initiative has increased the number of medical school places in Great Britain. A priority is to widen access to sections of the community hitherto inadequately represented in…

  20. 28 CFR 115.182 - Access to emergency medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Access to emergency medical services. 115.182 Section 115.182 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Lockups Medical and Mental Care § 115.182 Access to...

  1. 28 CFR 115.182 - Access to emergency medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Access to emergency medical services. 115.182 Section 115.182 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Lockups Medical and Mental Care § 115.182 Access to...

  2. 28 CFR 115.182 - Access to emergency medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Access to emergency medical services. 115.182 Section 115.182 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Lockups Medical and Mental Care § 115.182 Access to...

  3. 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.

  4. 77 FR 39656 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... Proposed Rulemaking (NPRM) on Medical Diagnostic Equipment Accessibility Standards. See 77 FR 14706 (March.... In February 2012, the Access Board published an NPRM proposing the accessibility standards. See 77 FR..., Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: Rex Pace, Office of Technical and Information...

  5. 77 FR 6915 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... accommodations are accessible to individuals with disabilities.\\7\\ See 75 FR 43452 (July 26, 2010). Among other... Rehabilitation Engineering Research Center on Accessible Medical Instrumentation conducted a national survey in.... Consultation With Food and Drug Administration G. ANSI/AAMI HE 75 H. Barriers Affecting Accessibility...

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

    PubMed

    Sakuma, Ichiro

    2015-08-01

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

  7. 78 FR 1166 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Medical Diagnostic Equipment Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM and... TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1195 RIN 3014-AA40 Medical Diagnostic Equipment.... ACTION: Notice of advisory committee meeting. SUMMARY: The Medical Diagnostic Equipment...

  8. Exploring dimensions of access to medical care.

    PubMed

    Andersen, R M; McCutcheon, A; Aday, L A; Chiu, G Y; Bell, R

    1983-01-01

    This paper examines the dimensions of the access concept with particular attention to the extent to which more parsimonious indicators of access can be developed. This process is especially useful to health policy makers, planners and researchers in need of cost-effective social indicators of access to monitor the need for and impact of innovative health care programs. Three stages of data reduction are used in the analysis, resulting in a reduced set of key indicators of the concept. Implication for subsequent data collection and measurement of access are discussed. PMID:6841113

  9. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 Medical Devices; Obstetrical and... these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility...., August 17, 2009. List of Subjects in 21 CFR Part 884 Medical devices. Therefore, under the Federal...

  10. Production of Medical Device Using MIM Technique

    NASA Astrophysics Data System (ADS)

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

    2010-03-01

    Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medical devices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 μm and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at 160° C using a sigma-blade mixer for one hour to prepare the feedstock of the fracture fixation plates. The fracture fixation plate component was injection molded using vertical injection moulding machine with the nozzle temperature of 200° C. Prior to sintering, the specimens were debound using a combination of solvent extraction and thermal pyrolysis method. The specimens were then sintered under vacuum. The properties of the fracture fixation plates such as physical and mechanical properties were presented and discussed. The in-vitro biocompatibility study on the fracture plates produced was examined.

  11. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

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

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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

    ... 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...

  17. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular...

  18. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... 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...

  19. 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

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

  20. 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...

  1. 78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... 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...

  2. 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. PMID:23559585

  3. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... medical devices and pediatric device approvals or clearance; the scientific and regulatory limitations and... to support pediatric effectiveness claims for medical devices and pediatric device approvals or... HUMAN SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Request...

  4. 75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS... device information is collected to facilitate identifying the current location of medical devices and... solicits comments on information collection requirements for the tracking of medical devices. DATES:...

  5. Medical devices: classification of the dental sonography device and jaw tracking device. Final rule.

    PubMed

    2003-12-01

    The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action 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 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). PMID:14651050

  6. 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

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

    PubMed

    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

  8. Home Healthcare Medical Devices: A Checklist

    MedlinePlus

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

  9. 77 FR 62479 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... Medical Diagnostic Equipment Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM and... refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see...

  10. 78 FR 10582 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... Medical Diagnostic Equipment Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM and... the meetings are requested to refrain from using perfume, cologne, and other fragrances for...

  11. 77 FR 53163 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-31

    ...) on Medical Diagnostic Equipment Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM... provided. Persons attending the meetings are requested to refrain from using perfume, cologne, and...

  12. 78 FR 16448 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-15

    ... previously published NPRM on Medical Diagnostic Equipment Accessibility Standards. See 77 FR 6916 (February 9... provided. Persons attending the meetings are requested to refrain from using perfume, cologne, and...

  13. Magnetic Random Access Memory (MRAM) Device Development

    SciTech Connect

    Cerjan, C; Law, B P

    2000-01-18

    The recent discovery of materials that have anomalous magneto-resistive properties has generated renewed commercial interest in metal-based fast memory storage as an alternative to the currently used semiconductor-based devices. One particularly promising ternary alloy, fabricated at LLNL, appeared to have exceptional field response. This proposal extended the investigation of this class of materials by examining the scaling properties of test structures made from this material that could definitively verify the preliminary observations of high field sensitivity. Although the expected scaling was observed, technical issues, such as excessive oxidation, prevented a definitive assessment of the effect. Despite the difficulties encountered, several test structures demonstrated superior performance in a ''spin-valve'' configuration that might have applications for very high density recording heads.

  14. Access to continued-use medication among older adults, Brazil

    PubMed Central

    Viana, Karynna Pimentel; Brito, Alexandre dos Santos; Rodrigues, Claudia Soares; Luiz, Ronir Raggio

    2015-01-01

    OBJECTIVE To determine the prevalence and associated access factors for all continued-use prescription drugs and the ways in which they can be obtained. METHODS Data was obtained from the 2008 Household National Survey. The sample comprised 27,333 individuals above 60 years who reported that they used continued-use prescription drugs. A descriptive analysis and binary and multiple multinomial logistic regressions were performed. RESULTS 86.0% of the older adults had access to all the medication they needed, and among them, 50.7% purchased said medication. Those who obtained medication from the public health system were younger (60-64 years), did not have health insurance plans, and belonged to the lower income groups. It is remarkable that 14.0% of the subjects still had no access to any continued-use medication, and for those with more than four chronic diseases, this amount reached 22.0%. Those with a greater number of chronic diseases ran a higher risk of not having access to all the medication they needed. CONCLUSIONS There are some groups of older adults with an increased risk of not obtaining all the medication they need and of purchasing it. The results of this study are expected to contribute to guide programs and plans for access to medication in Brazil. PMID:25741646

  15. 78 FR 32612 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM and information related to the proposed... translation (CART) web streaming link will be posted on the Access Board's Medical Diagnostic Equipment Web..., 1331 F Street NW., suite 1000, Washington, DC 20004- 1111. Telephone number (202) 272-0023...

  16. 77 FR 14706 - Medical Diagnostic Equipment Accessibility Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... the Federal Register, 77 FR 6916, on accessibility standards for medical diagnostic equipment and... published an NPRM in the February 9, 2012 edition of the Federal Register, 77 FR 6916, proposing the... TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1195 RIN 3014-AA40 Medical Diagnostic...

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

    PubMed Central

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

    2016-01-01

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

  18. Natural Language Access to Medical Text *

    PubMed Central

    Walker, Donald E.; Hobbs, Jerry R.

    1981-01-01

    This paper describes research on the development of a methodology for representing the information in texts and of procedures for relating the linguistic structure of a request to the corresponding representations. The work is being done in the context of a prototype system that will allow physicians and other health professionals to access information in a computerized textbook of hepatitis through natural language dialogues. The interpretation of natural language queries is derived from DIAMOND/DIAGRAM, a linguistically motivated, domain-independent natural language interface developed at SRI. A text access component is being developed that uses representations of the propositional content of text passages and of the hierarchical structure of the text as a whole to retrieve relevant information.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk......

  20. 75 FR 55803 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... 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... a disability, please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966...

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

    PubMed Central

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

    2014-01-01

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

  2. Managing the medical device directive. A practical case study.

    PubMed

    Nielsen, M

    1995-11-01

    Through a case study of a fictional company, this article provides a guide on how to implement CE-marking procedures, as detailed in the Medical Device Directive. The overlap in transitional periods between the Medical Device and Electromagnetic Compatibility Directives is discussed, together with issues such as selection of conformity assessment routes. PMID:10158130

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

    PubMed

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

    Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

  4. 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. PMID:21142522

  5. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and... Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment...). In the Federal Register of November 24, 2004 (69 FR 68612), FDA published a final rule...

  6. 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

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... published a proposed rule (44 FR 50520) for classification of iontophoresis devices for specialized...

  7. [Proceedings maintenance of the devices of venous access].

    PubMed

    Castro, Carmen Noya; Casamayor, Conchita Martínez; Trillo, Inmaculada Serrano

    2007-10-01

    An extended version of the winning Poster Prize 3M Tegaderm 2007. It shows the proceedings maintenance of the devices of venous access settle down, based on the best scientific evidence available and consensus with the professionals of infirmary of the work centre. PMID:18274391

  8. Medical Devices in the Treatment of Obesity.

    PubMed

    Chang, Julietta; Brethauer, Stacy

    2016-09-01

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

  9. Detection and response to unauthorized access to a communication device

    DOEpatents

    Smith, Rhett; Gordon, Colin

    2015-09-08

    A communication gateway consistent with the present disclosure may detect unauthorized physical or electronic access and implement security actions in response thereto. A communication gateway may provide a communication path to an intelligent electronic device (IED) using an IED communications port configured to communicate with the IED. The communication gateway may include a physical intrusion detection port and a network port. The communication gateway may further include control logic configured to evaluate physical intrusion detection signal. The control logic may be configured to determine that the physical intrusion detection signal is indicative of an attempt to obtain unauthorized access to one of the communication gateway, the IED, and a device in communication with the gateway; and take a security action based upon the determination that the indication is indicative of the attempt to gain unauthorized access.

  10. 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. PMID:20236065

  11. Overcoming barriers to health care access for medically underserved children.

    PubMed

    Redlener, I

    1993-01-01

    The NYCHP was designed to serve the special needs of medically underserved, extremely disadvantaged children in New York City. As a model, and as the flagship program of a national network, the NYCHP demonstrates that it is possible to provide a medical home for children in a variety of challenging situations where access to traditional providers is limited. It is clear, however, that mobile units or other creative ways to overcome barriers to access to care are an insufficient long-term answer. Ultimately, the public sector must take steps to ensure that all American children have regular access to a true medical home regardless of their social or economic situation. In the interim, special initiatives such as the NYCHP must continue to fill the gap. PMID:10123427

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

    PubMed

    Soskuty, Gabriela

    2011-01-01

    The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany. PMID:21530908

  13. A concept ideation framework for medical device design.

    PubMed

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

    2015-06-01

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

  14. 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

  15. Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

  16. Shared medical appointments: increasing patient access without increasing physician hours.

    PubMed

    Bronson, David L; Maxwell, Richard A

    2004-05-01

    Shared medical visits are a new concept in patient care. Doctors perform a series of one-on-one patient encounters in a group setting during a 90-minute visit and manage and advise each patient in front of the others. Patients benefit from improved access to their physician and significantly increased education, while providers can boost their access and productivity without increasing hours. Such group visits are voluntary and for established patients only. PMID:15195773

  17. Physicians’ Attitudes regarding Patient Access to Electronic Medical Records

    PubMed Central

    Dorr, David A.; Rowan, Belle; Weed, Matt; James, Brent; Clayton, Paul

    2003-01-01

    Prior to the implementation of Electronic Medical Record (EMR) web access for patients at a large integrated delivery systems, we surveyed physicians’ attitudes. Our web based questionnaire revealed largely positive attitudes about access. The exceptions included abnormal reports, progress notes, and e-care. A factor analysis identified the group of physicians who didn’t view patients as partners felt most negative about the process. PMID:14728337

  18. Equal access for all? Access to medical information for European psychiatric trainees.

    PubMed

    Marques, João Gama; Stefanovic, Maja Pantovic; Mitkovic-Voncina, Marija; Riese, Florian; Guloksuz, Sinan; Holmes, Kevin; Kilic, Ozge; Banjac, Visnja; Palumbo, Claudia; Nawka, Alexander; Jauhar, Sameer; Andlauer, Olivier; Krupchanka, Dzmitry; da Costa, Mariana Pinto

    2016-04-30

    Access to medical information is important as lifelong scientific learning is in close relation with a better career satisfaction in psychiatry. This survey aimed to investigate how medical information sources are being used among members of the European Federation of Psychiatric Trainees. Eighty-three psychiatric trainees completed our questionnaire. A significant variation was found, and information availability levels were associated with training duration and average income. The most available sources were books and websites, but the most preferred ones were scientific journals. Our findings suggest that further steps should be taken to provide an equal access to medical information across Europe. PMID:27086225

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

    PubMed

    McCarthy, Avril D; Lawford, Patricia V

    2014-01-01

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

  20. Access to medications and conducting clinical trials in LMICs.

    PubMed

    Okpechi, Ikechi G; Swanepoel, Charles R; Venter, Francois

    2015-03-01

    Access to essential medications is limited in many low-to-middle income countries (LMICs) and those that are available may be prohibitively expensive to the general population. Clinical trials have been suggested as an approach to improve drug access in LMICs but the number of trials conducted in these countries is small because of regulatory issues and a lack of infrastructure. In this article, Nature Reviews Nephrology asks three experts their opinions on how to improve drug access and increase the numbers of clinical trials conducted in LMICs. PMID:25668002

  1. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... rulemaking (REG-113770-10) (the proposed regulations) in the Federal Register (77 FR 6028). The IRS and the... ``Intended for Humans'' A number of commenters suggested that certain devices, such as sterilization...

  2. Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010624

  3. Medical Devices that Treat Obesity: What to Know

    MedlinePlus

    ... For Consumers Consumer Updates Medical Devices that Treat Obesity: What to Know Share Tweet Linkedin Pin it ... be less invasive.” back to top How is obesity measured? Obesity is typically measured by calculating body ...

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

    PubMed

    1993-09-01

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

  5. When medical devices fail: Lessons learned in a hemodialysis unit.

    PubMed

    Phillips, J Matthew; Mossop, Paula; Bartol, Carolyn; Hodgson, Barbara

    2015-01-01

    Technology and medical equipment devices have become integrated in the delivery of health care. These technologies and devices can introduce new risks, either through user error or malfunction. When these incidents occur, it is important they are reported so that learning and improvements are possible. A just culture encourages reporting of incidents by not blaming individuals, but rather by seeking to understand incidents in relation to how they occurred because of the systems in place. These concepts are explored through a case study in a dialysis unit where a malfunction of a medical equipment device (central venous catheter) was identified. The process for addressing the issue is defined and includes reviewing applicable data, reporting incidents, and evaluating devices that malfunctioned. Finally, the role of the frontline health care professional is identified as an important stakeholder in identifying issues with technology and medical devices, reporting these incidents, and participating in the process that resolves the issues. PMID:26901981

  6. 32 CFR 324.13 - Access to medical and psychological records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Program’ (see 32 CFR part 310). ... 32 National Defense 2 2011-07-01 2011-07-01 false Access to medical and psychological records. 324... to medical and psychological records. Individual access to medical and psychological records...

  7. 32 CFR 324.13 - Access to medical and psychological records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Program’ (see 32 CFR part 310). ... 32 National Defense 2 2013-07-01 2013-07-01 false Access to medical and psychological records. 324... to medical and psychological records. Individual access to medical and psychological records...

  8. 32 CFR 324.13 - Access to medical and psychological records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Program’ (see 32 CFR part 310). ... 32 National Defense 2 2014-07-01 2014-07-01 false Access to medical and psychological records. 324... to medical and psychological records. Individual access to medical and psychological records...

  9. 32 CFR 324.13 - Access to medical and psychological records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Program’ (see 32 CFR part 310). ... 32 National Defense 2 2012-07-01 2012-07-01 false Access to medical and psychological records. 324... to medical and psychological records. Individual access to medical and psychological records...

  10. 32 CFR 324.13 - Access to medical and psychological records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Program’ (see 32 CFR part 310). ... 32 National Defense 2 2010-07-01 2010-07-01 false Access to medical and psychological records. 324... to medical and psychological records. Individual access to medical and psychological records...

  11. 20 CFR 401.55 - Access to medical records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Access to medical records. 401.55 Section 401.55 Employees' Benefits SOCIAL SECURITY ADMINISTRATION PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND... physician, other health professional, or other responsible individual who will be willing to review...

  12. 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. PMID:25230354

  13. 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

  14. Development of implantable medical devices: from an engineering perspective.

    PubMed

    Joung, Yeun-Ho

    2013-09-01

    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

  15. 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...

  16. 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...

  17. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

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

  18. 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... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class...

  19. 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

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make...

  20. 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

    ... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting... Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration,...

  1. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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

  2. 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...

  3. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

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

  4. 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...

  5. 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...

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

    PubMed

    Gottschalk, H W

    1991-01-01

    The Medical Information Bus (MIB) reference model defines a new, object-oriented Medical Device Data Language (MDDL), under development by the Institute of Electrical and Electronic Engineers Society (IEEE) P1073 MIB Standard Committee. The MDDL treats medical devices, host computers, humans and device parameters as objects, and provides a flexible and extensible language for describing and passing messages between objects. This paper describes the MDDL semantic reference model and presents an overview of the MDDL structure, within the framework of the International Standards Organization (ISO) System Management Overview (SMO) model. A simple example of how the MDDL can be used to construct a device event report is also described. PMID:10114051

  7. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

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

  8. 76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

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

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  14. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  16. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  18. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  19. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  1. Safe patient care when using vascular access devices.

    PubMed

    Moureau, Nancy

    Any health professional providing care and treatment should first do no harm. With many serious infections affecting hospitals, patient scan be fearful. Education and competency processes specific to vascular access devices (VADs) ensure staff have knowledge of the pathophysiology of infection, basic aseptic techniques for cannulation,device management, methods of flushing, assessing device functions,and dressing and securement techniques (Coopersmith et al, 2002;Centers for Disease Control and Prevention (CDC), 2011; Infusion Nurses Society (INS), 2011; Pratt et al, 2007). However, knowledge in these areas is often taken for granted and it is assumed that health professionals are applying such knowledge in practice. Staff education is effective in reducing infection and complications (Coopersmith et al, 2002). Through teaching the Clean, Assess and Clear model, which applies to intravenous access, patient assessment and flushing catheters until clear, the basics of safe intravenous care can be consistently understood and applied, and competency assessed (Moureau, 2012).Education on the principles of aseptic technique. is a necessary for all nurses and doctors to establish a culture of safety in all healthcare settings. Establishing consistent, simple and clear health professional education on the care and maintenance of intravenous devices, in compliance with guidelines and recommendations, is necessary to achieve the best outcomes. PMID:23634458

  2. Medical device specificities: opportunities for a dedicated product development methodology.

    PubMed

    Santos, Isa C T; Gazelle, G Scott; Rocha, Luís A; Tavares, João Manuel R S

    2012-05-01

    The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression 'medical device', and before entering the market, manufacturers must demonstrate their product's safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, medical device specificities are identified, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology. PMID:22702261

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

    PubMed Central

    Johnson, Anthony

    2016-01-01

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

  4. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... HUMAN SERVICES Food and Drug Administration Distinguishing Medical Device Recalls From Product... Device Recalls From Product Enhancements; Reporting Requirements.'' This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish...

  6. Medical device integration using mobile telecommunications infrastructure.

    PubMed

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

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

  7. Quality management for the processing of medical devices

    PubMed Central

    Klosz, Kerstin

    2008-01-01

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

  8. Providing Context: Medical Device Litigation and Inferior Vena Cava Filters.

    PubMed

    Keller, Eric J; Vogelzang, Robert L

    2016-06-01

    Over the last few years, an increasing number of lawsuits have been filed involving inferior vena cava filters. This has prompted the U.S. Judicial Panel on Multidistrict Litigation to centralize these lawsuits into two multidistrict litigations: one for Cook's filters and one for Bard's. Both sets of cases share similar questions of facts, in particular whether these filters' design and manufacturing practices made them unreasonably prone to serious complications. The resolution of these cases will add to a larger legal debate concerning how much legal protection the 1976 Medical Device Amendments should offer firms from tort liability. As a specialty that often relies on medical devices, it is not only important for interventional radiologists to have a general understanding of medical device litigation but also to reflect upon the approaches to informed consent regarding these devices. PMID:27247482

  9. Medical devices; immunology and microbiology devices; classification of the endotoxin assay. Final rule.

    PubMed

    2003-10-31

    The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. PMID:14594019

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

    PubMed

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

    2007-04-01

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

  11. 36 CFR 1202.42 - How are requests for access to medical records handled?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... to medical records handled? 1202.42 Section 1202.42 Parks, Forests, and Public Property NATIONAL... Individual Access to Records § 1202.42 How are requests for access to medical records handled? When NARA receives a request for access to medical records, if NARA believes that disclosure of medical...

  12. 36 CFR 1202.42 - How are requests for access to medical records handled?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... to medical records handled? 1202.42 Section 1202.42 Parks, Forests, and Public Property NATIONAL... Individual Access to Records § 1202.42 How are requests for access to medical records handled? When NARA receives a request for access to medical records, if NARA believes that disclosure of medical...

  13. 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. PMID:25279540

  14. 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.

  15. 78 FR 38867 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... section 513(e) proposing the reclassification of implanted blood access devices for hemodialysis (77 FR... reclassification for June 27, 2013 (78 FR 25747; May 2, 2013). The three comments submitted in response to the... discussed in the preamble to the proposed rule (46 FR 7616; January 23, 1981), the...

  16. 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. PMID:23400187

  17. 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. PMID:11765697

  18. Auditing Medical Records Accesses via Healthcare Interaction Networks

    PubMed Central

    Chen, You; Nyemba, Steve; Malin, Bradley

    2012-01-01

    Healthcare organizations are deploying increasingly complex clinical information systems to support patient care. Traditional information security practices (e.g., role-based access control) are embedded in enterprise-level systems, but are insufficient to ensure patient privacy. This is due, in part, to the dynamic nature of healthcare, which makes it difficult to predict which care providers need access to what and when. In this paper, we show that modeling operations at a higher level of granularity (e.g., the departmental level) are stable in the context of a relational network, which may enable more effective auditing strategies. We study three months of access logs from a large academic medical center to illustrate that departmental interaction networks exhibit certain invariants, such as the number, strength, and reciprocity of relationships. We further show that the relations extracted from the network can be leveraged to assess the extent to which a patient’s care satisfies expected organizational behavior. PMID:23304277

  19. Auditing medical records accesses via healthcare interaction networks.

    PubMed

    Chen, You; Nyemba, Steve; Malin, Bradley

    2012-01-01

    Healthcare organizations are deploying increasingly complex clinical information systems to support patient care. Traditional information security practices (e.g., role-based access control) are embedded in enterprise-level systems, but are insufficient to ensure patient privacy. This is due, in part, to the dynamic nature of healthcare, which makes it difficult to predict which care providers need access to what and when. In this paper, we show that modeling operations at a higher level of granularity (e.g., the departmental level) are stable in the context of a relational network, which may enable more effective auditing strategies. We study three months of access logs from a large academic medical center to illustrate that departmental interaction networks exhibit certain invariants, such as the number, strength, and reciprocity of relationships. We further show that the relations extracted from the network can be leveraged to assess the extent to which a patient's care satisfies expected organizational behavior. PMID:23304277

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

    PubMed

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

    2002-01-01

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

  1. 76 FR 73676 - Certain Dynamic Random Access Memory Devices, and Products Containing Same; Receipt of Complaint...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... COMMISSION Certain Dynamic Random Access Memory Devices, and Products Containing Same; Receipt of Complaint... complaint entitled In Re Certain Dynamic Random Access Memory Devices, and Products Containing Same, DN 2859... within the United States after importation of certain dynamic random access memory devices, and...

  2. 76 FR 80964 - Certain Dynamic Random Access Memory Devices, and Products Containing Same; Institution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... COMMISSION Certain Dynamic Random Access Memory Devices, and Products Containing Same; Institution of... States after importation of certain dynamic random access memory devices, and products containing same by... dynamic random access memory devices, and products containing same that infringe one or more of claims...

  3. 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. PMID:26867696

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

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

  5. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

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

  6. 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...

  7. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

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

  8. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

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

  9. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

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

  10. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

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

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

    PubMed

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

    2016-04-01

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

  12. Medical devices; obstetrical and gynecological devices; classification of the breast lesion documentation system. Final rule.

    PubMed

    2003-07-28

    The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:12884877

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

    PubMed

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

    2009-01-01

    Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution. PMID:19964250

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

    PubMed

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

    2016-07-01

    With increasing knowledge of the materials science of bulk metallic glasses (BMGs) and improvements in their properties and processing, they have started to become candidate materials for biomedical devices. A dichotomy in the types of medical applications has also emerged, in which some families of BMGs are being developed for permanent devices whilst another family - of Mg-based alloys - is showing promise in bioabsorbable implants. The current status of these metallurgical and technological developments is summarized. PMID:27031058

  15. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

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

  16. 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.

  17. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  18. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  19. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  20. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.18 Format of dates provided on a medical device label. (a) In general. Whenever the label of a medical device includes a printed... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Format of dates provided on a medical device...

  1. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  3. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  4. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... data can be used to support pediatric effectiveness claims for medical devices and pediatric device... support pediatric effectiveness claims for medical devices and pediatric device approvals or clearance, 2... HUMAN SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Reopening...

  5. 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...

  6. Security mechanism based on Hospital Authentication Server for secure application of implantable medical devices.

    PubMed

    Park, Chang-Seop

    2014-01-01

    After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance. PMID:25276797

  7. Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices

    PubMed Central

    2014-01-01

    After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance. PMID:25276797

  8. 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.

  9. Mult-I/O - a middleware multi input and output for access devices: a case study applied the biomedical devices.

    PubMed

    Lacerda, João M T; Bezerra, Heitor U; Valentim, Ricardo A M; Guerreiro, Ana M G; Brandão, Glaucio B; Ribeiro, Anna G D; Soares, Heliana B; Araújo, Bruno G; Leite, Cicilia R M

    2010-01-01

    The great diversity in the architecture of hardware devices allied to many communication protocols, has been hindering the implementation of systems that need to access these devices. Given these differences, it appears the need of providing the access of these devices in a transparent way. In this sense, the present work proposes a middleware, mult input and output for access the devices, as a way of abstracting the writing and reading data mechanisms in hardware devices, contributing this way, for increasing systems productivity, as the developers are just focused in their functional requirements. PMID:21097073

  10. Risk evaluation of medical and industrial radiation devices

    SciTech Connect

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

    1994-03-01

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

  11. 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. PMID:19382736

  12. Percutaneous Endovascular Salvage Techniques for Implanted Venous Access Device Dysfunction

    SciTech Connect

    Breault, Stéphane; Glauser, Frédéric; Babaker, Malik Doenz, Francesco Qanadli, Salah Dine

    2015-06-15

    PurposeImplanted venous access devices (IVADs) are often used in patients who require long-term intravenous drug administration. The most common causes of device dysfunction include occlusion by fibrin sheath and/or catheter adherence to the vessel wall. We present percutaneous endovascular salvage techniques to restore function in occluded catheters. The aim of this study was to evaluate the feasibility, safety, and efficacy of these techniques.Methods and MaterialsThrough a femoral or brachial venous access, a snare is used to remove fibrin sheath around the IVAD catheter tip. If device dysfunction is caused by catheter adherences to the vessel wall, a new “mechanical adhesiolysis” maneuver was performed. IVAD salvage procedures performed between 2005 and 2013 were analyzed. Data included clinical background, catheter tip position, success rate, recurrence, and rate of complication.ResultsEighty-eight salvage procedures were performed in 80 patients, mostly women (52.5 %), with a mean age of 54 years. Only a minority (17.5 %) of evaluated catheters were located at an optimal position (i.e., cavoatrial junction ±1 cm). Mechanical adhesiolysis or other additional maneuvers were used in 21 cases (24 %). Overall technical success rate was 93.2 %. Malposition and/or vessel wall adherences were the main cause of technical failure. No complications were noted.ConclusionThese IVAD salvage techniques are safe and efficient. When a catheter is adherent to the vessel wall, mechanical adhesiolysis maneuvers allow catheter mobilization and a greater success rate with no additional risk. In patients who still require long-term use of their IVAD, these procedures can be performed safely to avoid catheter replacement.

  13. 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...

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

    PubMed

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

    1999-04-01

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

  15. 78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... Collection; Comment Request; Medical Devices Current Good Manufacturing Practice Quality System Regulation... devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation... appropriate, and other forms of information technology. Medical Devices Current Good Manufacturing...

  16. 75 FR 36092 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations... devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation... of information technology. Medical Devices: Current Good Manufacturing Practice Quality...

  17. Dangerous Close Call With Wintergreen Oil; Are 10 mL Syringes Needed When Giving Drugs Via Venous Access Devices?; Use of “NoAC” Abbreviation; Unsafe Frequency Notation; 2014-15 Targeted Medication Safety Best Practices for Hospitals

    PubMed Central

    Cohen, Michael R.; Smetzer, Judy L.

    2014-01-01

    These medication errors have occurred in health care facilities at least once. They will happen again—perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your news-letters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers’ names will be published if desired. ISMP may be contacted at the address shown below. Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at ismpinfo@ismp.org. ISMP guarantees the confidentiality and security of the information received and respects reporters’ wishes as to the level of detail included in publications. PMID:24958936

  18. Dangerous Close Call With Wintergreen Oil; Are 10 mL Syringes Needed When Giving Drugs Via Venous Access Devices?; Use of "NoAC" Abbreviation; Unsafe Frequency Notation; 2014-15 Targeted Medication Safety Best Practices for Hospitals.

    PubMed

    Cohen, Michael R; Smetzer, Judy L

    2014-04-01

    These medication errors have occurred in health care facilities at least once. They will happen again-perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your news-letters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program. Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below. Errors, close calls, or hazardous conditions may be reported directly to ISMP through the ISMP Web site (www.ismp.org), by calling 800-FAIL-SAFE, or via e-mail at ismpinfo@ismp.org. ISMP guarantees the confidentiality and security of the information received and respects reporters' wishes as to the level of detail included in publications. PMID:24958936

  19. 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.…

  20. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should... in the retention of blood, tissue, and other biological debris (soil) in reusable medical devices. This soil can allow microbes to survive the high level disinfection or sterilization...

  1. [Understanding and Thinking on America Clinical Evaluation of Medical Devices].

    PubMed

    Yuan, Fuqiang; Yuan, Peng; Deng, Gang

    2015-09-01

    This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions. PMID:26904887

  2. In vitro biocompatibility testing of biomaterials and medical devices.

    PubMed

    Müller, U

    2008-01-01

    Biomaterials used for medical devices must be thoroughly tested according to ISO 10993 before their introduction so that any negative effects on the body are known about and prevented. By using in vitro laboratory tests, dangers for patients and unnecessary animal experiments can be avoided. Here, in vitro tests for cell compatibility (cytotoxicity) and blood compatibility (haemocompatibility) are described. PMID:18605289

  3. 42 CFR 480.131 - Access to medical records for the monitoring of QIOs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Access to medical records for the monitoring of... Improvement Organizations (QIOs) Disclosure of Confidential Information § 480.131 Access to medical records... Federal statute to monitor a QIO will have access to medical records maintained by institutions or...

  4. 42 CFR 480.131 - Access to medical records for the monitoring of QIOs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Access to medical records for the monitoring of... Improvement Organizations (QIOs) Disclosure of Confidential Information § 480.131 Access to medical records... Federal statute to monitor a QIO will have access to medical records maintained by institutions or...

  5. 42 CFR 480.131 - Access to medical records for the monitoring of QIOs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Access to medical records for the monitoring of... Improvement Organizations (QIOs) Disclosure of Confidential Information § 480.131 Access to medical records... Federal statute to monitor a QIO will have access to medical records maintained by institutions or...

  6. 42 CFR 480.131 - Access to medical records for the monitoring of QIOs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Access to medical records for the monitoring of... Improvement Organizations (QIOs) Disclosure of Confidential Information § 480.131 Access to medical records... Federal statute to monitor a QIO will have access to medical records maintained by institutions or...

  7. Medical devices; immunology and microbiology devices; classification of the beta-glucan serological assay. Final rule.

    PubMed

    2004-09-23

    The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan." The agency is taking this action in response to a petition submitted 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, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:15386877

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

    PubMed

    Parvizi, Nassim; Woods, Kent

    2014-02-01

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

  9. Improving acute care through use of medical device data.

    PubMed

    Kennelly, R J

    1998-02-01

    The Medical Information Bus (MIB) is a data communications standard for bedside patient connected medical devices. It is formally titled IEEE 1073 Standard for Medical Device Communications. MIB defines a complete seven layer communications stack for devices in acute care settings. All of the design trade-offs in writing the standard were taken to optimize performance in acute care settings. The key clinician based constraints on network performance are: (1) the network must be able to withstand multiple daily reconfigurations due to patient movement and condition changes; (2) the network must be 'plug-and-play' to allow clinicians to set up the network by simply plugging in a connector, taking no other actions; (3) the network must allow for unambiguous associations of devices with specific patients. A network of this type will be used by clinicians, thus giving complete, accurate, real time data from patient connected devices. This capability leads to many possible improvements in patient care and hospital cost reduction. The possible uses for comprehensive automatic data capture are only limited by imagination and creativity of clinicians adapting to the new hospital business paradigm. PMID:9600414

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

    PubMed

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

    2015-01-01

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

  11. 76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

  12. Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information*

    PubMed Central

    Boruff, Jill T.; Storie, Dale

    2014-01-01

    Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes. PMID:24415916

  13. 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.

  14. 36 CFR 1202.42 - How are requests for access to medical records handled?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... medical records handled? 1202.42 Section 1202.42 Parks, Forests, and Public Property NATIONAL ARCHIVES AND... Records § 1202.42 How are requests for access to medical records handled? When NARA receives a request for access to medical records, if NARA believes that disclosure of medical and/or psychological...

  15. Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device. Final order.

    PubMed

    2015-10-21

    The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26495515

  16. Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

    PubMed

    2004-03-16

    The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted 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), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:15025053

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

    PubMed Central

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

    2013-01-01

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

  18. Impact of sanctions on procurement of medicine and medical devices in Iran; a technical response.

    PubMed

    Hosseini, Seyed Alireza

    2013-12-01

    Following recent sanctions on foreign trade, financial and banking services, Iran has faced major difficulties for importing medicines (both finished products and pharmaceutical raw materials) and medical devices. Problems with money transfer have made it extremely lengthy in time to import medicine and medical devices and these have negatively affected access to and affordability of medicines. Quality of pharmaceuticals and treatment of patients have also been affected due to changing the sources of imported medicines and raw materials for locally produced pharmaceuticals. Several interventions have been employed during the past few months in Iran to overcome the effects imposed by recent sanctions and drug shortages have been managed to some extent with attempts made by Iran Food and Drug Organization (IRI FDO). As recommended by the experts, a specific Society for Worldwide Interbank Financial Telecommunication line should be allocated for transferring money for medicines and medical devices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medical device companies together with their foreign counterparts would facilitate this process. It appears that, in a public health prospective, ordinary people and patients are hurt and paying the cost for current sanctions. It remains the responsibility of the public health and international communities to separate public health from politics and to ease the pain of public from sanctions. PMID:24329148

  19. Pyoderma gangrenosum after totally implanted central venous access device insertion

    PubMed Central

    Inan, Ihsan; Myers, Patrick O; Braun, Rolf; Hagen, Monica E; Morel, Philippe

    2008-01-01

    Background Pyoderma gangrenosum is an aseptic skin disease. The ulcerative form of pyoderma gangrenosum is characterized by a rapidly progressing painful irregular and undermined bordered necrotic ulcer. The aetiology of pyoderma gangrenosum remains unclear. In about 70% of cases, it is associated with a systemic disorder, most often inflammatory bowel disease, haematological disease or arthritis. In 25–50% of cases, a triggering factor such as recent surgery or trauma is identified. Treatment consists of local and systemic approaches. Systemic steroids are generally used first. If the lesions are refractory, steroids are combined with other immunosuppressive therapy or to antimicrobial agents. Case presentation A 90 years old patient with myelodysplastic syndrome, seeking regular transfusions required totally implanted central venous access device (Port-a-Cath®) insertion. Fever and inflammatory skin reaction at the site of insertion developed on the seventh post-operative day, requiring the device's explanation. A rapid progression of the skin lesions evolved into a circular skin necrosis. Intravenous steroid treatment stopped the necrosis' progression. Conclusion Early diagnosis remains the most important step to the successful treatment of pyoderma gangrenosum. PMID:18325095

  20. Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work.

    PubMed

    Al-Surimi, Khaled; Househ, Mowafa; Almohandis, Essam; Alshagathrh, Fahd

    2015-01-01

    Medical device evaluation presents several unique challenges due to the great diversity and complexity of medical devices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the Medical Device National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medical device registry and post-market surveillance system in Saudi Arabia. PMID:26152943

  1. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; prominence of required label... 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  3. 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...

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

  5. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  6. 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... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  8. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking,...

  11. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices for processing, repacking,...

  13. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; prominence of required label... 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...

  14. 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...

  15. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  17. 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...

  18. 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...

  19. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 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 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

  3. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; Spanish-language version of... OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language version of certain required statements. If devices restricted...

  5. 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...

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 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...

  9. 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...

  10. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    PubMed

    2016-06-10

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

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

    PubMed

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

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

  13. Validation of medical modeling & simulation training devices and systems.

    PubMed

    Magee, J Harvey

    2003-01-01

    For almost a decade, research has been conducted in many areas of science to develop medical simulation training devices and even comprehensive training systems. To propel the field, the Telemedicine and Advanced Technology Research Center (TATRC), an agency of the United States Army Medical Research Materiel Command (USAMRMC), has been managing a portfolio of research projects in the area of Medical Modeling and Simulation (MM&S) since 1999. Significant progress has made to identify and harness enabling technologies. Generally, these developments can be categorized in four areas: (1) PC-based interactive multimedia, (2) Digitally Enhanced Mannequins, (3) Virtual Workbench, or "part-task", simulators, and (4) Total Immersion Virtual Reality (TIVR). Many medical simulation-training systems have shown great potential to improve medical training, but the potential shown has been based largely on anecdotal feedback from informal user studies. Formal assessment is needed to determine the degree to which simulator(s) train medical skills and the degree to which skills learned on a simulator transfer to the practice of care. A robust methodology is required as a basis for these assessments. Several scientific workshops sponsored in 2001 focused on algorithm and metrics development in support of surgical simulation. Also in 2001, TATRC chartered a Simulation Working Group (SWG) to develop a robust methodology upon which to base an assessment of the effectiveness of simulation training devices and systems. After the terrorist attacks of September 11, 2001, attention was redirected for a period, and progress was delayed. In the summer of 2002, TATRC chartered a follow-on group called the Validation, Metrics and Simulation (VMAS) Committee. The poster will highlight and summarize the development of the methodology and identify validation studies to be conducted (supported by various funding sources and research programs). The interaction between TATRC and the National Capital

  14. Ethics considerations for medical device R&D.

    PubMed

    Citron, Paul

    2012-01-01

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

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

    PubMed

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

    2009-01-01

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

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

    PubMed

    Wittenber, J; Shabot, M M

    1990-04-01

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

  17. Medical devices; reclassification of three anesthesiology preamendments class III devices into class II. Final rule.

    PubMed

    2001-11-15

    The Food and Drug Administration (FDA) is reclassifying three anesthesiology preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997. PMID:11776278

  18. Case studies of innovative medical device companies from India: barriers and enablers to development

    PubMed Central

    2013-01-01

    Background Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered. Methods Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources. Results In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market. Conclusions Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products. PMID:23721110

  19. 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.

  20. Printable thermoelectric devices and conductive patterns for medical applications

    NASA Astrophysics Data System (ADS)

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

    2012-10-01

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

  1. Antimicrobial selenium nanoparticle coatings on polymeric medical devices.

    PubMed

    Tran, Phong A; Webster, Thomas J

    2013-04-19

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics. PMID:23519147

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

    PubMed

    2015-05-01

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

  3. Use of Mobile Devices to Access Resources Among Health Professions Students: A Systematic Review.

    PubMed

    Mi, Misa; Wu, Wendy; Qiu, Maylene; Zhang, Yingting; Wu, Lin; Li, Jie

    2016-01-01

    This systematic review examines types of mobile devices used by health professions students, kinds of resources and tools accessed via mobile devices, and reasons for using the devices to access the resources and tools. The review included 20 studies selected from articles published in English between January 2010 and April 2015, retrieved from PubMed and other sources. Data extracted included participants, study designs, mobile devices used, mobile resources/apps accessed, outcome measures, and advantages of and barriers to using mobile devices. The review indicates significant variability across the studies in terms of research methods, types of mobile programs implemented, resources accessed, and outcomes. There were beneficial effects of using mobile devices to access resources as well as conspicuous challenges or barriers in using mobile devices. PMID:26794197

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... (FDA) is correcting a final rule that appeared in the Federal Register of March 23, 2011 (76 FR 16292..., Rm. 3208, Silver Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-6620... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and...

  7. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

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

    PubMed

    Bettinger, Christopher J

    2015-10-01

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

  9. Orthopedic medical devices: ethical questions, implant recalls and responsibility.

    PubMed

    Racine, Jennifer

    2013-06-01

    The hip replacement is a surgical procedure to replace the femoral head and acetabulum with prosthetic implants to improve function, increase mobility, and relieve pain caused by damage from disorders such as osteoarthritis and fractures. In recent years, we have seen several recalls of poorly functioning implant systems, most recently, the Johnson and Johnson (J&J) Articular Surface Replacement device. Product recalls are often the results of premature failure of implants requiring additional surgery to exchange the failed device. This raises many questions - technical, medical, regulatory, ethical, and legal - that ultimately put patients at risk, compromise confidence in medicine and regulatory agencies, and important relationships including those between the physician-patient and physician-industry. Where do the responsibilities lie for the patients' suffering, morbidity, and costs of removing the failed device? This article discusses the current recall of the J&J implant, the responsibilities of the manufacturer, surgeons, and the regulatory agency. PMID:23741723

  10. 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

  11. New Specimen Access Device for the Large Space Simulator

    NASA Astrophysics Data System (ADS)

    Lazzarini, P.; Ratti, F.

    2004-08-01

    The Large Space Simulator (LSS) is used to simulate in- orbit environmental conditions for spacecraft (S/C) testing. The LSS is intended to be a flexible facility: it can accommodate test articles that can differ significantly in shape and weight and carry various instruments. To improve the accessibility to the S/C inside the LSS chamber a new Specimen Access Device (SAD) has been procured. The SAD provides immediate and easy access to the S/C, thus reducing the amount of time necessary for the installations of set-ups in the LSS. The SAD has been designed as bridge crane carrying a basket to move the operator into the LSS. Such a crane moves on parallel rails on the top floor of the LSS building. The SAD is composed by three subsystems: the main bridge, the trolley that moves along the main bridge and the telescopic mast. A trade off analysis has been carried out for what concerns the telescopic mast design. The choice between friction pads vs rollers, to couple the different sections of the mast, has been evaluated. The resulting design makes use of a four sections square mast, with rollers driven deployment. This design has been chosen for the higher stiffness of the mast, due to the limited number of sections, and because it reduces radically the risk of contamination related to a solution based on sliding bushings. Analyses have been performed to assess the mechanical behaviour both in static and in dynamic conditions. In particular the telescopic mast has been studied in detail to optimise its stiffness and to check the safety margins in the various operational conditions. To increase the safety of the operations an anticollision system has been implemented by positioning on the basket two kind of sensors, ultrasonic and contact ones. All the translations are regulated by inverters with acceleration and deceleration ramps controlled by a Programmable Logic Controller (PLC). An absolute encoder is installed on each motor to provide the actual position of the

  12. Medical education and information literacy in the era of open access.

    PubMed

    Brower, Stewart M

    2010-01-01

    The Open Access movement in scholarly communications poses new issues and concerns for medical education in general and information literacy education specifically. For medical educators, Open Access can affect the availability of new information, instructional materials, and scholarship in medical education. For students, Open Access materials continue to be available to them post-graduation, regardless of affiliation. Libraries and information literacy librarians are challenged in their responses to the Open Access publishing movement in how best to support Open Access endeavors within their own institutions, and how best to educate their user base about Open Access in general. PMID:20391168

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

    PubMed

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

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

  14. 45 CFR 5b.6 - Special procedures for notification of or access to medical records.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... to medical records. 5b.6 Section 5b.6 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PRIVACY ACT REGULATIONS § 5b.6 Special procedures for notification of or access to medical records. (a) General. An individual in general has a right to notification of or access to his medical...

  15. 45 CFR 5b.6 - Special procedures for notification of or access to medical records.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... to medical records. 5b.6 Section 5b.6 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PRIVACY ACT REGULATIONS § 5b.6 Special procedures for notification of or access to medical records. (a) General. An individual in general has a right to notification of or access to his medical...

  16. 45 CFR 5b.6 - Special procedures for notification of or access to medical records.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... to medical records. 5b.6 Section 5b.6 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PRIVACY ACT REGULATIONS § 5b.6 Special procedures for notification of or access to medical records. (a) General. An individual in general has a right to notification of or access to his medical...

  17. 45 CFR 5b.6 - Special procedures for notification of or access to medical records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... to medical records. 5b.6 Section 5b.6 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PRIVACY ACT REGULATIONS § 5b.6 Special procedures for notification of or access to medical records. (a) General. An individual in general has a right to notification of or access to his medical...

  18. 5 CFR 293.504 - Composition of, and access to, the Employee Medical File System.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Composition of, and access to, the Employee Medical File System. 293.504 Section 293.504 Administrative Personnel OFFICE OF PERSONNEL... Composition of, and access to, the Employee Medical File System. (a) All employee occupational medical...

  19. 5 CFR 293.504 - Composition of, and access to, the Employee Medical File System.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Composition of, and access to, the Employee Medical File System. 293.504 Section 293.504 Administrative Personnel OFFICE OF PERSONNEL... Composition of, and access to, the Employee Medical File System. (a) All employee occupational medical...

  20. 5 CFR 293.504 - Composition of, and access to, the Employee Medical File System.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Composition of, and access to, the Employee Medical File System. 293.504 Section 293.504 Administrative Personnel OFFICE OF PERSONNEL... Composition of, and access to, the Employee Medical File System. (a) All employee occupational medical...

  1. 5 CFR 293.504 - Composition of, and access to, the Employee Medical File System.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Composition of, and access to, the Employee Medical File System. 293.504 Section 293.504 Administrative Personnel OFFICE OF PERSONNEL... Composition of, and access to, the Employee Medical File System. (a) All employee occupational medical...

  2. 5 CFR 293.504 - Composition of, and access to, the Employee Medical File System.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Composition of, and access to, the Employee Medical File System. 293.504 Section 293.504 Administrative Personnel OFFICE OF PERSONNEL... Composition of, and access to, the Employee Medical File System. (a) All employee occupational medical...

  3. Insertion of Totally Implantable Central Venous Access Devices by Surgeons

    PubMed Central

    An, Hyeonjun; Ryu, Chun-Geun; Jung, Eun-Joo; Kang, Hyun Jong; Paik, Jin Hee; Yang, Jung-Hyun

    2015-01-01

    Purpose The aim of this study is to evaluate the results for the insertion of totally implantable central venous access devices (TICVADs) by surgeons. Methods Total 397 patients, in whom TICVADs had been inserted for intravenous chemotherapy between September 2008 and June 2014, were pooled. This procedure was performed under local anesthesia in an operation room. The insertion site for the TICVAD was mainly in the right-side subclavian vein. In the case of breast cancer patients, the subclavian vein opposite the surgical site was used for insertion. Results The 397 patients included 73 males and 324 females. Primary malignant tumors were mainly colorectal and breast cancer. The mean operation time was 54 minutes (18-276 minutes). Operation-related complications occurred in 33 cases (8.3%). Early complications developed in 15 cases with catheter malposition and puncture failure. Late complications, which developed after 24 hours, included inflammation in 6 cases, skin necrosis in 6 cases, hematoma in 3 cases, port malfunction in 1 case, port migration in 1 case, and intractable pain at the port site in 1 case. Conclusion Insertion of a TICVAD under local anesthesia by a surgeon is a relatively safe procedure. Meticulous undermining of the skin and carefully managing the TICVAD could minimize complications. PMID:25960974

  4. Regulation of medical devices in radiology: current standards and future opportunities.

    PubMed

    Smith, J J

    2001-02-01

    Today's radiology community depends heavily on cutting-edge diagnostic and therapeutic medical devices to serve patients. These products are regulated by the U.S. Food and Drug Administration (FDA) under a system that grants marketing approval for only those indications for which the safety and effectiveness have been established. Although this complex system is the result of a societal decision to ensure device safety and effectiveness, it has the potential to delay product marketing and impede innovation. Medical device regulation recently has undergone major changes with the enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA), legislation that is intended to increase system efficiency while retaining the requirement of safety and effectiveness. However, many of the envisioned improvements cannot occur without cooperative interaction between stakeholders in the device development process, including the FDA and the clinical medicine community. The radiology field must continue to build on its strong history of productive dialogue with the FDA to transform the legislative vision of FDAMA into regulatory reality. Such action will ensure timely access to the new device technologies that are necessary for the growth of our specialty and the effective care of our patients. PMID:11161144

  5. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Public Workshop on Medical Devices and Nanotechnology...) is announcing a public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing... brief statement that describes your experience or expertise with nanotechnology. There will be a...

  6. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Quality System Regulation Educational Forum... ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product...

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

    PubMed

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

    2009-12-01

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

  8. [Preselection procedure for medical devices suppliers at the essential medicines and generic drugs purchasing central in Togo (CAMEG-Togo)].

    PubMed

    Babaley, M

    2006-12-01

    One of the main objectives of pharmaceutical policies in developing countries is to ensure accessibility and affordability of good quality medicines for the population. The Essential Medicines and Generic Drugs Purchasing Central (French acronym, CAMEG-Togo) is a not-for-profit association established in 1998 to ensure procurement for public and not-for-profit private public health facilities within the framework of recovery of costs. Although attention has been focused mainly on medicines, medical devices account for a growing part of the pharmaceutical products purchased by central stores, hospitals and health programs. Recognizing this need in 2002, CAMEG-Togo in collaboration with the French cooperation agency decided to upgrade its competency in evaluating the quality of medical devices. For that purpose the information sheet used to preselect suppliers for international tenders and the technical specifications sheet for medical devices was revised and pharmacists responsible for processing these files were given specific training. European directive N 93/42/CEE of 14 June 1993 is currently used by CAMEG-Togo as the regulatory basis for preselection of medical device suppliers. Referencing based on American regulatory requirements is now under way to widen the scope of suppliers eligible for preselection. The purpose of this article is first to describe the main guidelines of the European directive used by medical device manufacturers to obtain EC certification and second to present the procedures used by the CAMEG-Togo to preselect medical device suppliers, with special focus on the technical specifications sheet. PMID:17286037

  9. [The current situation and suggestions on the institutes for medical devices test in China].

    PubMed

    Yang, Xiaofang; Li, Xiaoliang; Mu, Ruihong; Wang, Chunren; Li, Jingli

    2014-01-01

    This paper introduces the current status of Chinese medical device testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment. PMID:24839853

  10. [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. PMID:22379772

  11. Medical devices; reclassification of six cardiovascular preamendments class III devices into class II. Final rule.

    PubMed

    2001-04-10

    The Food and Drug Administration (FDA) is reclassifying six cardiovascular pre amendments devices from class III (pre market approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations. PMID:11721689

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

    PubMed

    Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine

    2016-02-01

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

  13. Harmonized Medical Device Regulation: Need, Challenges, and Risks of not Harmonizing the Regulation in Asia

    PubMed Central

    Kaushik, A; Saini, KS; Anil, B; Rambabu, S

    2010-01-01

    Medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. Despite the fact that Asia has 60% of the world population providing large market potential, Asian healthcare expenditure constitutes only 15% of the global healthcare expenditure. The accelerated ageing population and increasing prevalence of chronic disease are the key drivers that contribute toward the increase in the total healthcare expenditure on medical devices in the region. Several policies clearly showed the eagerness of the government to provide better healthcare infrastructure with better medical devices and facilities. The fundamental objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive. After the era of liberalization and globalization, the desires of developing economies is to ensure safety and performance of the product brought to their markets and for this harmonized regulation is an important tool for strengthening the same. If we talk about the industry need, then this approach will eliminate redundant requirements that do not contribute to safety and effectiveness. In addition, Asia is diverse in many respects and with it come the various challenges to harmonizing the regulation which includes diversity in culture, politics, economy, historical issues, etc. If, by any reason, the regulation of medical devices is not harmonized and consequently, the harmonized regulation is not adopted, then it leads to serious concerns like delayed or absent access to innovative technology, continued rise in the cost of medical therapies, etc. So this issue is written to attract all stakeholders to move toward the concept of harmonization, keeping in mind their need, challenges, and risks of not harmonizing the regulation as well. PMID:21331201

  14. A Framework for Context Sensitive Risk-Based Access Control in Medical Information Systems

    PubMed Central

    Choi, Donghee; Kim, Dohoon; Park, Seog

    2015-01-01

    Since the access control environment has changed and the threat of insider information leakage has come to the fore, studies on risk-based access control models that decide access permissions dynamically have been conducted vigorously. Medical information systems should protect sensitive data such as medical information from insider threat and enable dynamic access control depending on the context such as life-threatening emergencies. In this paper, we suggest an approach and framework for context sensitive risk-based access control suitable for medical information systems. This approach categorizes context information, estimating and applying risk through context- and treatment-based permission profiling and specifications by expanding the eXtensible Access Control Markup Language (XACML) to apply risk. The proposed framework supports quick responses to medical situations and prevents unnecessary insider data access through dynamic access authorization decisions in accordance with the severity of the context and treatment. PMID:26075013

  15. A Framework for Context Sensitive Risk-Based Access Control in Medical Information Systems.

    PubMed

    Choi, Donghee; Kim, Dohoon; Park, Seog

    2015-01-01

    Since the access control environment has changed and the threat of insider information leakage has come to the fore, studies on risk-based access control models that decide access permissions dynamically have been conducted vigorously. Medical information systems should protect sensitive data such as medical information from insider threat and enable dynamic access control depending on the context such as life-threatening emergencies. In this paper, we suggest an approach and framework for context sensitive risk-based access control suitable for medical information systems. This approach categorizes context information, estimating and applying risk through context- and treatment-based permission profiling and specifications by expanding the eXtensible Access Control Markup Language (XACML) to apply risk. The proposed framework supports quick responses to medical situations and prevents unnecessary insider data access through dynamic access authorization decisions in accordance with the severity of the context and treatment. PMID:26075013

  16. 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...

  17. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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. 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...

  20. 77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug... notice solicits comments on Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment...

  1. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

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

  2. 76 FR 36989 - Medical Devices; Exception From General Requirements for Informed Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 50 Medical Devices; Exception From General... interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed... medical devices under 21 U.S.C. 360k. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)....

  3. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis....

  4. 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...

  5. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices for use in teaching, law..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis....

  6. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to § 1.750 that a patent... patent for a medical device will be extended by the length of the regulatory review period for...

  7. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to § 1.750 that a patent... patent for a medical device will be extended by the length of the regulatory review period for...

  8. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on Medical Device Safety and Quality... medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality. DATES: Submit either electronic or...

  9. Nurses’ Use of Mobile Devices to Access Information in Health Care Environments in Australia: A Survey of Undergraduate Students

    PubMed Central

    2014-01-01

    Background The growth of digital technology has created challenges for safe and appropriate use of mobile or portable devices during work-integrated learning (WIL) in health care environments. Personal and professional use of technology has outpaced the development of policy or codes of practice for guiding its use at the workplace. There is a perceived risk that portable devices may distract from provision of patient or client care if used by health professionals or students during employment or WIL. Objective This study aimed to identify differences in behavior of undergraduate nurses in accessing information, using a portable or mobile device, when undertaking WIL compared to other non-work situations. Methods A validated online survey was administered to students while on placement in a range of health care settings in two Australian states. Results There were 84 respondents, with 56% (n=47) reporting access to a mobile or portable device. Differences in use of a mobile device away from, compared with during WIL, were observed for non-work related activities such as messaging (P<.001), social networking (P<.001), shopping on the Internet (P=.01), conducting personal business online (P=.01), and checking or sending non-work related texts or emails to co-workers (P=.04). Study-related activities were conducted more regularly away from the workplace and included accessing University sites for information (P=.03) and checking or sending study-related text messages or emails to friends or co-workers (P=.01). Students continued to access nursing, medical, professional development, and study-related information away from the workplace. Conclusions Undergraduate nurses limit their access to non-work or non-patient centered information while undertaking WIL. Work-related mobile learning is being undertaken, in situ, by the next generation of nurses who expect easy access to mobile or portable devices at the workplace, to ensure safe and competent care is delivered to

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

    PubMed

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

    2015-01-01

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

  11. 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.

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

    PubMed

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

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

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

    PubMed Central

    Betancourt, Tania; Brannon-Peppas, Lisa

    2006-01-01

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

  14. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the 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 regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research......

  15. Singaporean Parents' Views of Their Young Children's Access and Use of Technological Devices

    ERIC Educational Resources Information Center

    Ebbeck, Marjory; Yim, Hoi Yin Bonnie; Chan, Yvonne; Goh, Mandy

    2016-01-01

    Debates continue about the access young children have to technological devices, given the increasingly accessible and available technology in most developed countries. Concerns have been expressed by parents/caregivers and researchers, and questions have been raised about possible risks and benefits of these devices on young children who, in some…

  16. 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

  17. Flow-test device fits into restricted access passages

    NASA Technical Reports Server (NTRS)

    Fitzgerald, J. J.; Oberschmidt, M.; Rosenbaum, B. J.

    1967-01-01

    Test device using a mandrel with a collapsible linkage assembly enables a fluid flow sensor to be properly positioned in a restricted passage by external manipulation. This device is applicable to the combustion chamber of a rocket motor.

  18. Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule.

    PubMed

    2002-01-24

    The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11820252

  19. Arterial devices for regional hepatic chemotherapy: transaxillary versus laparotomic access.

    PubMed

    Arru, M; Aldrighetti, L; Gremmo, F; Ronzoni, M; Angeli, E; Caterini, R; Ferla, G

    2000-01-01

    Introduction. Intra-Arterial Hepatic Chemotherapy (IAHC) based on floxuridine (FUdR) infusion is an effective treatment for hepatic metastases from colorectal cancer. A percutaneously implanted intra-arterial device may overcome the surgical stress of the laparotomic placement allowing an increase in the number of patients treated by IAHC. The aim of the present study is the comparative analysis of surgical and percutaneous transaxillary approaches to implant the catheter into the hepatic artery (HA) for IAHC. Materials and Methods. Between September 1993 and February 1999, 56 patients received an implantable infu-sion system [SynchroMed(R) (Medtronic, USA) or Port-a-cath(R) (Deltec, USA) connected to an external infusion pump (CADD(R) , Deltec, USA)] for IAHC. Twenty-eight patients (LPT group) underwent laparotomy to implant the catheter into the HA, the other 28 patients (PCT group) received a percutaneous catheter into the HA through a transaxillary percutaneous access. Indications for the laparotomic placement were: 1) synchronous metastases not suitable [technically unresectable or large (>40% of liver parenchyma) or multiple (> 3) metas-tases] for hepatic resection during colorectal surgery; 2) metachronous metastases treated by radical hepatic resection and subsequent adjuvant IAHC. Indications for percutaneous placement were: 1) metachronous metastases not suitable [see above] for hepatic resection; 2) metachronous metastases suitable for hepatic resection after neoadjuvant IAHC for tumor downstaging. All patients received IAHC based on continuous infusion of FU-dR (dose escalation 0.15-0.30 mg/kg/day for 14 days every 28 days) plus dexamethasone 28 mg. For the purpose of the study, the LPT group and the PCT group were comparatively analyzed in terms of age, gender, primary diagnosis, vascular anatomy of HA, ligation/embolization of aberrant HA, previous intestinal or hepatic surgery, contextual systemic chemotherapy, concomitant diseases. Safety and

  20. Standardized access, display, and retrieval of medical video

    NASA Astrophysics Data System (ADS)

    Bellaire, Gunter; Steines, Daniel; Graschew, Georgi; Thiel, Andreas; Bernarding, Johannes; Tolxdorff, Thomas; Schlag, Peter M.

    1999-05-01

    The system presented here enhances documentation and data- secured, second-opinion facilities by integrating video sequences into DICOM 3.0. We present an implementation for a medical video server extended by a DICOM interface. Security mechanisms conforming with DICOM are integrated to enable secure internet access. Digital video documents of diagnostic and therapeutic procedures should be examined regarding the clip length and size necessary for second opinion and manageable with today's hardware. Image sources relevant for this paper include 3D laparoscope, 3D surgical microscope, 3D open surgery camera, synthetic video, and monoscopic endoscopes, etc. The global DICOM video concept and three special workplaces of distinct applications are described. Additionally, an approach is presented to analyze the motion of the endoscopic camera for future automatic video-cutting. Digital stereoscopic video sequences are especially in demand for surgery . Therefore DSVS are also integrated into the DICOM video concept. Results are presented describing the suitability of stereoscopic display techniques for the operating room.

  1. Method and device for maximizing memory system bandwidth by accessing data in a dynamically determined order

    NASA Technical Reports Server (NTRS)

    Wulf, William A. (Inventor); McKee, Sally A. (Inventor); Klenke, Robert (Inventor); Schwab, Andrew J. (Inventor); Moyer, Stephen A. (Inventor); Aylor, James (Inventor); Hitchcock, Charles Young (Inventor)

    2000-01-01

    A data processing system is disclosed which comprises a data processor and memory control device for controlling the access of information from the memory. The memory control device includes temporary storage and decision ability for determining what order to execute the memory accesses. The compiler detects the requirements of the data processor and selects the data to stream to the memory control device which determines a memory access order. The order in which to access said information is selected based on the location of information stored in the memory. The information is repeatedly accessed from memory and stored in the temporary storage until all streamed information is accessed. The information is stored until required by the data processor. The selection of the order in which to access information maximizes bandwidth and decreases the retrieval time.

  2. Effectiveness of adverse effects search filters: drugs versus medical devices

    PubMed Central

    Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

    2016-01-01

    Objective The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%–87%) than for drugs (88%–93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81%) than in MEDLINE (67%–87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs. PMID:27366123

  3. 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.

  4. 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. PMID:27039992

  5. 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.

  6. Evidence-based consensus on the insertion of central venous access devices: definition of minimal requirements for training.

    PubMed

    Moureau, N; Lamperti, M; Kelly, L J; Dawson, R; Elbarbary, M; van Boxtel, A J H; Pittiruti, M

    2013-03-01

    There is a lack of standard minimal requirements for the training of insertion techniques and maintenance of central venous access devices (CVADs). An international evidence-based consensus task force was established through the World Congress of Vascular Access (WoCoVA) to provide definitions and recommendations for training and insertion of CVADs. Medical literature published from February 1971 to April 2012 regarding 'central vascular access', 'training', 'competency', 'simulation', and 'ultrasound' was reviewed on Pubmed, BioMed Central, ScienceDirect, and Scopus databases. The GRADE and the GRADE-RAND methods were utilized to develop recommendations. Out of 156 papers initially identified, 83 papers described training for central vascular access placement. Sixteen recommendations are proposed by this task force, each with an evidence level, degree of consensus, and recommendation grade. These recommendations suggest central venous access education include didactic or web-based teaching with insertion procedure, infection prevention, complications, care, and maintenance of devices, along with laboratory models and tools for simulation practice incorporating ultrasound. Clinical competence should be determined by observation during clinical practice using a global rating scale rather than by the number of procedures performed. Ensuring safe insertion and management of central venous devices requires standardized education, simulation practice, and supervised insertions. PMID:23361124

  7. Access Scheme for Controlling Mobile Agents and its Application to Share Medical Information.

    PubMed

    Liao, Yu-Ting; Chen, Tzer-Shyong; Chen, Tzer-Long; Chung, Yu-Fang; Chen, Yu- Xin; Hwang, Jen-Hung; Wang, Huihui; Wei, Wei

    2016-05-01

    This study is showing the advantage of mobile agents to conquer heterogeneous system environments and contribute to a virtual integrated sharing system. Mobile agents will collect medical information from each medical institution as a method to achieve the medical purpose of data sharing. Besides, this research also provides an access control and key management mechanism by adopting Public key cryptography and Lagrange interpolation. The safety analysis of the system is based on a network attacker's perspective. The achievement of this study tries to improve the medical quality, prevent wasting medical resources and make medical resources access to appropriate configuration. PMID:27010391

  8. 29 CFR 1926.33 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 8 2010-07-01 2010-07-01 false Access to employee exposure and medical records. 1926.33 Section 1926.33 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Health Provisions § 1926.33 Access to employee exposure and medical records. Note: The...

  9. 29 CFR 1915.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 7 2013-07-01 2013-07-01 false Access to employee exposure and medical records. 1915.1020 Section 1915.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Toxic and Hazardous Substances § 1915.1020 Access to employee exposure and medical records. Note:...

  10. 29 CFR 1926.33 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 8 2012-07-01 2012-07-01 false Access to employee exposure and medical records. 1926.33 Section 1926.33 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Health Provisions § 1926.33 Access to employee exposure and medical records. Note: The...

  11. 29 CFR 1926.33 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 8 2013-07-01 2013-07-01 false Access to employee exposure and medical records. 1926.33 Section 1926.33 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Health Provisions § 1926.33 Access to employee exposure and medical records. Note: The...

  12. 29 CFR 1915.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 7 2011-07-01 2011-07-01 false Access to employee exposure and medical records. 1915.1020 Section 1915.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Toxic and Hazardous Substances § 1915.1020 Access to employee exposure and medical records. Note:...

  13. 29 CFR 1926.33 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Access to employee exposure and medical records. 1926.33 Section 1926.33 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Health Provisions § 1926.33 Access to employee exposure and medical records. Note: The...

  14. 29 CFR 1915.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 7 2012-07-01 2012-07-01 false Access to employee exposure and medical records. 1915.1020 Section 1915.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Toxic and Hazardous Substances § 1915.1020 Access to employee exposure and medical records. Note:...

  15. 29 CFR 1926.33 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 8 2014-07-01 2014-07-01 false Access to employee exposure and medical records. 1926.33 Section 1926.33 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... Health Provisions § 1926.33 Access to employee exposure and medical records. Note: The...

  16. 45 CFR 5b.6 - Special procedures for notification of or access to medical records.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Special procedures for notification of or access to medical records. 5b.6 Section 5b.6 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PRIVACY ACT REGULATIONS § 5b.6 Special procedures for notification of or access to medical records. (a) General. An individual...

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

    PubMed

    Matsuoka, Atsuko

    2012-01-01

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

  18. Consumers' Perceptions of Patient-Accessible Electronic Medical Records

    PubMed Central

    Vaughon, Wendy L; Czaja, Sara J; Levy, Joslyn; Rockoff, Maxine L

    2013-01-01

    Background Electronic health information (eHealth) tools for patients, including patient-accessible electronic medical records (patient portals), are proliferating in health care delivery systems nationally. However, there has been very limited study of the perceived utility and functionality of portals, as well as limited assessment of these systems by vulnerable (low education level, racial/ethnic minority) consumers. Objective The objective of the study was to identify vulnerable consumers’ response to patient portals, their perceived utility and value, as well as their reactions to specific portal functions. Methods This qualitative study used 4 focus groups with 28 low education level, English-speaking consumers in June and July 2010, in New York City. Results Participants included 10 males and 18 females, ranging in age from 21-63 years; 19 non-Hispanic black, 7 Hispanic, 1 non-Hispanic White and 1 Other. None of the participants had higher than a high school level education, and 13 had less than a high school education. All participants had experience with computers and 26 used the Internet. Major themes were enhanced consumer engagement/patient empowerment, extending the doctor’s visit/enhancing communication with health care providers, literacy and health literacy factors, improved prevention and health maintenance, and privacy and security concerns. Consumers were also asked to comment on a number of key portal features. Consumers were most positive about features that increased convenience, such as making appointments and refilling prescriptions. Consumers raised concerns about a number of potential barriers to usage, such as complex language, complex visual layouts, and poor usability features. Conclusions Most consumers were enthusiastic about patient portals and perceived that they had great utility and value. Study findings suggest that for patient portals to be effective for all consumers, portals must be designed to be easy to read, visually

  19. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

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

  1. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

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

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

    PubMed

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

    1996-01-01

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

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

    PubMed

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

    2013-12-01

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

  4. 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. PMID:24387679

  5. Critical factors in the translation of improved antimicrobial strategies for medical implants and devices.

    PubMed

    Grainger, David W; van der Mei, Henny C; Jutte, Paul C; van den Dungen, Jan J A M; Schultz, Marcus J; van der Laan, Bernard F A M; Zaat, Sebastian A J; Busscher, Henk J

    2013-12-01

    Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medical device technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medical device innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively

  6. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories...

  7. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories...

  8. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories...

  9. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories...

  10. 21 CFR 876.5540 - Blood access device and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories...

  11. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

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

  12. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...) Implementation: Online Repository of Medical Device Labeling, Including Photographs; Public Meeting AGENCY: Food... of an Online Repository of Medical Device Labeling and of Making Device Photographs Available in...

  13. 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)....

  14. 28 CFR 115.282 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Mental Care § 115.282 Access to emergency medical and mental health services. (a) Resident victims of... intervention services, the nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are...

  15. 28 CFR 115.282 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Mental Care § 115.282 Access to emergency medical and mental health services. (a) Resident victims of... intervention services, the nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are...

  16. 28 CFR 115.382 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....382 Access to emergency medical and mental health services. (a) Resident victims of sexual abuse shall... nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are on duty at the time...

  17. 28 CFR 115.382 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....382 Access to emergency medical and mental health services. (a) Resident victims of sexual abuse shall... nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are on duty at the time...

  18. 28 CFR 115.382 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ....382 Access to emergency medical and mental health services. (a) Resident victims of sexual abuse shall... nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are on duty at the time...

  19. 28 CFR 115.282 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Mental Care § 115.282 Access to emergency medical and mental health services. (a) Resident victims of... intervention services, the nature and scope of which are determined by medical and mental health practitioners according to their professional judgment. (b) If no qualified medical or mental health practitioners are...

  20. Hand geometry biometric device for secure access control

    SciTech Connect

    Colbert, C.; Moles, D.R. )

    1991-01-01

    This paper reports that the authors developed for the Air Force the Mark VI Personal Identity Verifier (PIV) for controlling access to a fixed or mobile ICBM site, a computer terminal, or mainframe. The Mark VI records the digitized silhouettes of four fingers of each hand on an AT and T smart card. Like fingerprints, finger shapes, lengths, and widths constitute an unguessable biometric password. A Security Officer enrolls an authorized person who places each hand, in turn, on a backlighted panel. An overhead scanning camera records the right and left hand reference templates on the smart card. The Security Officer adds to the card: name, personal identification number (PIN), and access restrictions such as permitted days of the week, times of day, and doors. To gain access, cardowner inserts card into a reader slot and places either hand on the panel. Resulting access template is matched to the reference template by three sameness algorithms. The final match score is an average of 12 scores (each of the four fingers, matched for shape, length, and width), expressing the degree of sameness. (A perfect match would score 100.00.) The final match score is compared to a predetermined score (threshold), generating an accept or reject decision.

  1. 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)...

  2. 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)...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  4. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.

    PubMed

    Alder, H C

    1993-10-01

    The Safe Medical Devices Act of 1990 (Public Law 101-629) was signed by President George Bush almost three years ago on November 28, 1990. The law expanded the Food and Drug Administration's (FDA) authority to regulate medical devices and grew out of congressional concerns about the FDA's ability to quickly learn when a medical device caused an adverse patient event, and to ensure that hazardous devices are removed from hospitals and other health care facilities in a timely manner. The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. It gives the FDA the legal authority to directly regulate the use of medical devices in health care facilities. Among the Safe Medical Devices Act's provisions are specific requirements for hospitals, health professionals, and other users of medical devices to report patient incidents involving medical devices to the manufacturer and to the FDA if a device caused or contributed to a serious injury, death, or other "adverse experience." Adverse experiences are defined by the FDA to include concussions, fractures, burns, temporary paralysis, and temporary loss of sight, hearing, or smell. Hospitals have been required to comply with this provision of the law, called user reporting, since 1991. Hospitals are also required to participate in tracking certain medical devices whose failure could result in a serious adverse health outcome. The law requires distributors and manufacturers of specific devices to adopt a method for device tracking. Hospitals are required to cooperate with and provide device manufacturers with information about patients with permanently implantable devices and life-sustaining and life-supporting devices used outside device user facilities. The law also gives the FDA the authority to designate other devices subject to tracking if the agency determines such tracking is warranted to preserve the

  5. 78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device......

  6. A Guide to Paperless Braille Devices. Random Access.

    ERIC Educational Resources Information Center

    Leventhal, J.; And Others

    1988-01-01

    This review examines electronic braille input-output devices which have a braille keyboard for data entry and/or a braille display. Four braille notetakers and two braille computer systems are evaluated, commenting on their keyboards, ease of use, documentation, and analysis of speech and/or the braille display. (JDD)

  7. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Educational Forum on Medical Device Reporting, Complaint... Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum...

  8. [The German Medical Devices Information System containing over 100,000 documents].

    PubMed

    Laby, R; Hummel, P

    2009-06-01

    The legal foundations, the aims, and the set up of the German Medical Devices Information System are presented. The functioning of the online registration system is demonstrated on hand of the electronic reports relating to certification with respect to section sign 18 Medical Devices Act (MPG). Using the email-based message system, the electronic routes for information are explained. The large amount of data in the medical devices database illustrates the high performance of the continuously developing information system. The future national and European perspectives of the German Medical Devices Information System are described. PMID:19458914

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

    PubMed

    Gogins, J A

    1995-01-01

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

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

    PubMed

    2000-01-14

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

  11. 78 FR 23872 - Medical Diagnostic Equipment Accessibility Standards Advisory Committee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... Accessibility Standards. See 77 FR 6916 (February 9, 2012). The NPRM and information related to the proposed... provided. Persons attending the meetings are requested to refrain from using perfume, cologne, and...

  12. Devices for medical diagnosis with GaN lasers

    NASA Astrophysics Data System (ADS)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

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

  13. Access to patient-centered medical home among Ohio's Children with Special Health Care Needs.

    PubMed

    Conrey, Elizabeth J; Seidu, Dazar; Ryan, Norma J; Chapman, Dj Sam

    2013-06-01

    Medical homes deliver primary care that is accessible, continuous, comprehensive, family centered, coordinated, compassionate and culturally effective. Children with special health care needs (CSHCN) require a wide range of support to maintain health, making medical home access particularly important. We sought to understand independent risk factors for lacking access. We analyzed Ohio, USA data from the National Survey of Children with Special Health Care Needs (2005-2006). Among CSHCN, 55.6% had medical home access. The proportion achieving each medical home component was highest for having a personal doctor/nurse and lowest for receiving coordinated care, family-centered care and referrals. Specific subsets of CSHCN were significantly and independently more likely to lack medical home access: Hispanic (AOR=3.08), moderate/high severity of difficulty (AOR=2.84), and any public insurance (AOR=1.60). Efforts to advance medical home access must give special attention to these CSHCN populations and improvements must be made to referral access, family-centered care, and care coordination. PMID:23242811

  14. 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

  15. An in vitro comparison of microbial ingress into 8 different needleless IV access devices.

    PubMed

    Casey, Anna; Karpanen, Tarja; Nightingale, Peter; Elliott, Tom

    2015-01-01

    There are conflicting reports of the effect needleless intravenous access devices have on rates of catheter-related bloodstream infection. The aim of this study was to identify any differences between the rates of microbial ingress into 8 different devices following contamination. Each type of device was subjected to a 7-day clinical simulation that involved repeated microbial contamination of the injection site and decontamination followed by saline flushes. Significant differences in the number of microorganisms associated with each device were detected in the saline eluates. Three positive-displacement mechanical valves were associated with the ingress of significantly fewer microorganisms compared with other devices. PMID:25545971

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

    PubMed

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

    2015-01-01

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

  17. 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

  18. Encryption Devices for Use in a Conditional Access System

    NASA Astrophysics Data System (ADS)

    Pinder, Howard G.; Palgon, Michael S.

    2002-07-01

    A cable television system provides conditional access to services. The cable television system includes a headend from which service 'instances', or programs, are broadcast and a plurality of set top units for receiving the instances and selectively decrypting the instances for display to system subscribers. The service instances are encrypted using public and/or private keys provided by service providers or central authorization agents. Keys used by the set tops for selective decryption may also be public or private in nature, and such keys may be reassigned at different times to provide a cable television system in which piracy concerns are minimized.

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

    PubMed

    Maktabi, Marianne; Neumuth, Thomas

    2016-01-01

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

  20. 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.

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

    PubMed Central

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

    2014-01-01

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

  2. Giving Patients Access to Their Medical Records via the Internet

    PubMed Central

    Masys, Daniel; Baker, Dixie; Butros, Amy; Cowles, Kevin E.

    2002-01-01

    Objective: The Patient-Centered Access to Secure Systems Online (pcasso) project is designed to apply state-of-the-art-security to the communication of clinical information over the Internet. Design: The authors report the legal and regulatory issues associated with deploying the system, and results of its use by providers and patients. Human subject protection concerns raised by the Institutional Review Board focused on three areas—unauthorized access to information by persons other than the patient; the effect of startling or poorly understood information; and the effect of patient access to records on the record-keeping behavior of providers. Measurements: Objective and subjective measures of security and usability were obtained. Results: During its initial deployment phase, the project enrolled 216 physicians and 41 patients; of these, 68 physicians and 26 patients used the system one or more times. The system performed as designed, with no unauthorized information access or intrusions detected. Providers rated the usability of the system low because of the complexity of the secure login and other security features and restrictions limiting their access to those patients with whom they had a professional relationship. In contrast, patients rated the usability and functionality of the system favorably. Conclusion: High-assurance systems that serve both patients and providers will need to address differing expectations regarding security and ease of use. PMID:11861633

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

    PubMed

    Smith, Colleen

    2015-01-01

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

  4. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

    PubMed

    Krucoff, Mitchell W; Brindis, Ralph G; Hodgson, Patricia K; Mack, Michael J; Holmes, David R

    2012-07-01

    Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innovation as an ecosystem. Desiloing experience and expertise encourages high-impact infrastructure efficiencies unique to pre-competitive constructs. Alignment of processes and objectives across the regulatory, reimbursement, clinical research, and clinical practice enterprises, with particular attention to the total product life cycle and continuous accrual of safety information, promotes more predictable equipoise for speed of access relative to residual safety concerns. Professional societies are well positioned to convene pre-competitive dialogue, facilitate alignment, and add perspective to equipoise within the innovation ecosystem. PMID:22814785

  5. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

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

  6. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

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

  7. Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule.

    PubMed

    2005-11-01

    The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device. PMID:16273747

  8. 29 CFR 1910.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... with 29 CFR 1910.1200(g). (C) Biological monitoring results designated as exposure records by specific... are contained in 29 CFR 1913.10. (ii) Whenever OSHA seeks access to personally identifiable employee medical information by presenting to the employer a written access order pursuant to 29 CFR...

  9. 29 CFR 1910.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 6 2011-07-01 2011-07-01 false Access to employee exposure and medical records. 1910.1020 Section 1910.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) Toxic and Hazardous Substances § 1910.1020 Access...

  10. 29 CFR 1910.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 6 2013-07-01 2013-07-01 false Access to employee exposure and medical records. 1910.1020 Section 1910.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) Toxic and Hazardous Substances § 1910.1020 Access...

  11. 29 CFR 1910.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... with 29 CFR 1910.1200(g). (C) Biological monitoring results designated as exposure records by specific... are contained in 29 CFR 1913.10. (ii) Whenever OSHA seeks access to personally identifiable employee medical information by presenting to the employer a written access order pursuant to 29 CFR...

  12. 29 CFR 1910.1020 - Access to employee exposure and medical records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 6 2014-07-01 2013-07-01 true Access to employee exposure and medical records. 1910.1020 Section 1910.1020 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED) Toxic and Hazardous Substances § 1910.1020 Access...

  13. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2012 AGENCY... announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The... 30, 2010 Fees Fiscal year appropriated Fees collected Difference 2008 Actual $48,431,000...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2011 AGENCY... announcing the ] fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The... Commissioner for Policy. BILLING CODE 4160-01-S...

  15. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification... (1976 amendments) (Pub. L. 94-295)), as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L....'' That guidance is available through the Internet at http://www.fda. ]...

  16. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

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

  17. 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

  18. 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...

  19. 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.

  20. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

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

  1. 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... sensation, mobility, and other functions to paralyzed limbs and organs. These medical devices hold enormous... other functions to nonfunctioning limbs and organs. 5. The work that AMF has done with the...

  2. Ethics and access to teaching materials in the medical library.

    PubMed

    Atlas, M C

    2000-01-01

    The American Library Association's Library Bill of Rights states that "Materials should not be excluded because of the origin, background, or views of those contributing to their creation." Medical ethicists question the use of data derived from experimentation that may have involved inhuman and degrading treatment of subjects or disrespect of a human corpse. Thus conflict between the upholding of ethical standards of research and freedom of information occurs. This conflict was brought to attention of the medical and library communities when journal articles purported that the source of the subjects for the illustrations in the classic anatomy atlas, Eduard Pernkopf's Topographische Anatomie des Menschen, were victims of the Nazi holocaust. While there has never been any dispute about the accuracy or educational value of the work, efforts were made to remove the book from medical libraries. Were these efforts a violation of the Library Bill of Rights or is it the responsibility of the library to discard those items that do not meet current standards of medical ethics? Librarians made different choices about what to do with the controversial Pernkopf title. PMID:11143883

  3. Access to Biomedical Information: The Unified Medical Language System.

    ERIC Educational Resources Information Center

    Squires, Steven J.

    1993-01-01

    Describes the development of a Unified Medical Language System (UMLS) by the National Library of Medicine that will retrieve and integrate information from a variety of information resources. Highlights include the metathesaurus; the UMLS semantic network; semantic locality; information sources map; evaluation of the metathesaurus; future…

  4. 28 CFR 115.82 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Access to emergency medical and mental health services. 115.82 Section 115.82 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Adult Prisons and Jails Medical and Mental...

  5. 28 CFR 115.82 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Access to emergency medical and mental health services. 115.82 Section 115.82 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Adult Prisons and Jails Medical and Mental...

  6. 28 CFR 115.82 - Access to emergency medical and mental health services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Access to emergency medical and mental health services. 115.82 Section 115.82 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PRISON RAPE ELIMINATION ACT NATIONAL STANDARDS Standards for Adult Prisons and Jails Medical and Mental...

  7. Expanded Access to Naloxone Among Firefighters, Police Officers, and Emergency Medical Technicians in Massachusetts

    PubMed Central

    Davis, Corey S.; Ruiz, Sarah; Glynn, Patrick; Picariello, Gerald; Walley, Alexander Y.

    2014-01-01

    Naloxone is a medication that reverses respiratory depression from opioid overdose if given in time. Paramedics routinely administer naloxone to opioid overdose victims in the prehospital setting, and many states are moving to increase access to the medication. Several jurisdictions have expanded naloxone administration authority to nonparamedic first responders, and others are considering that step. We report here on policy change in Massachusetts, where several communities have equipped emergency medical technicians, law enforcement officers, and firefighters with naloxone. PMID:24922133

  8. 'Pharmacy deserts' are prevalent in Chicago's predominantly minority communities, raising medication access concerns.

    PubMed

    Qato, Dima M; Daviglus, Martha L; Wilder, Jocelyn; Lee, Todd; Qato, Danya; Lambert, Bruce

    2014-11-01

    Attempts to explain and address disparities in the use of prescription medications have focused almost exclusively on their affordability. However, the segregation of residential neighborhoods by race or ethnicity also may influence access to the pharmacies that, in turn, provide access to prescription medications within a community. We examined whether trends in the availability of pharmacies varied across communities in Chicago with different racial or ethnic compositions. We also examined the geographic accessibility of pharmacies to determine whether "pharmacy deserts," or low-access neighborhoods, were more common in segregated black and Hispanic communities than elsewhere. We found that throughout the period 2000-2012 the number of pharmacies was lower in segregated minority communities than in segregated white communities and integrated communities. In 2012 there were disproportionately more pharmacy deserts in segregated black communities, as well as in low-income communities and federally designated Medically Underserved Areas. Our findings suggest that public policies aimed at improving access to prescription medications may need to address factors beyond insurance coverage and medication affordability. Such policies could include financial incentives to locate pharmacies in pharmacy deserts or the incorporation of pharmacies into community health centers in Medically Underserved Areas. PMID:25367990

  9. Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule.

    PubMed

    2003-10-30

    The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. PMID:14587527

  10. Medical devices; clinical chemistry and clinical toxicology devices; classification of the breath nitric oxide test system. Final rule.

    PubMed

    2003-07-01

    The Food and Drug Administration (FDA) is classifying the breath nitric oxide test system into class II (special controls). The agency is taking this action in response to a petition submitted 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. PMID:12858842

  11. Medical devices; ear, nose, and throat devices; classification of the transcutaneous air conduction hearing aid system. Final rule.

    PubMed

    2002-11-01

    The Food and Drug Administration (FDA) is classifying the transcutaneous air conduction hearing aid system (TACHAS) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:12422884

  12. Medical devices; immunology and microbiology devices; classification of the immunomagnetic circulating cancer cell selection and enumeration system. Final rule.

    PubMed

    2004-05-11

    The Food and Drug Administration (FDA) is classifying the Immunomagnetic Circulating Cancer Cell Selection and Enumeration System device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device. PMID:15137395

  13. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  14. 76 FR 55417 - In the Matter of Certain Dynamic Random Access Memory and Nand Flash Memory Devices and Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... COMMISSION In the Matter of Certain Dynamic Random Access Memory and Nand Flash Memory Devices and Products... States after importation of certain dynamic random access memory and NAND flash memory devices and... the sale within the United States after importation of certain dynamic random access memory and...

  15. Surgical approaches to vascular access for large-caliber devices in preclinical research models.

    PubMed

    Barka, Noah; Rakow, Nancy; Lentz, Linnea; Kopcak, Michael; Wika, Kent; Menk, Ana; Green, Mike

    2010-07-01

    Percutaneous vascular access options in preclinical models are often smaller than the relevant structures in humans or undersized for early-prototype research devices. Here we describe the surgical approaches and results for surgical vascular access sites in preclinical swine and sheep models. Fourteen adult miniature swine underwent successful 18-French vascular access by means of thoracotomy to the brachiocephalic artery. In addition, 11 swine and 10 sheep underwent successful 22-French vascular access by means of retroperitoneal laparotomy to the abdominal aorta. The relevancy of approach angles and vessel tortuosity should be considered when selecting appropriate preclinical models and techniques. The techniques described are effective for delivery of large-caliber devices in preclinical testing. PMID:20819395

  16. From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology--part 2: coverage.

    PubMed

    Raab, G Gregory; Parr, David H

    2006-10-01

    This paper, the second of 3 that discuss the reimbursement challenges facing new medical device technology in various issues of this journal, explains the key aspects of coverage that affect the adoption of medical devices. The process Medicare uses to make coverage determinations has become more timely and open over the past several years, but it still lacks the predictability that product innovators prefer. The continued uncertainty surrounding evidence requirements undermines the predictability needed for optimal product planning and innovation. Recent steps taken by the Centers for Medicare and Medicaid Services to provide coverage in return for evidence development should provide patients with access to promising new technologies and procedures while generating important evidence concerning their effectiveness. PMID:17412167

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

    PubMed

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

    2013-12-01

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

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

    PubMed

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

    2014-12-01

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

  19. Open access: implications for scholarly publishing and medical libraries

    PubMed Central

    Albert, Karen M.

    2006-01-01

    Purpose: The paper reviews and analyzes the evolution of the open access (OA) publishing movement and its impact on the traditional scholarly publishing model. Procedures: A literature survey and analysis of definitions of OA, problems with the current publishing model, historical developments, funding agency responses, stakeholder viewpoints, and implications for scientific libraries and publishing are performed. Findings: The Internet's transformation of information access has fueled interest in reshaping what many see as a dysfunctional, high-cost system of scholarly publishing. For years, librarians alone advocated for change, until relatively recently when interest in OA and related initiatives spread to the scientific community, governmental groups, funding agencies, publishers, and the general public. Conclusions: Most stakeholders acknowledge that change in the publishing landscape is inevitable, but heated debate continues over what form this transformation will take. The most frequently discussed remedies for the troubled current system are the “green” road (self-archiving articles published in non-OA journals) and the “gold” road (publishing in OA journals). Both movements will likely intensify, with a multiplicity of models and initiatives coexisting for some time. PMID:16888657

  20. Medical devices; immunology and microbiology devices; classification of reagents for detection of specific novel influenza A viruses. Final rule.

    PubMed

    2006-03-22

    The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, "Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses" and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device. PMID:16562353