Danger to public health: Medical devices,toxicity, virus and fraud |
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| Authors: | Sylvia Kierkegaard Patrick Kierkegaard |
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| Institution: | 1. Southampton Law School, University of Southampton, UK;2. International Association of IT Lawyers, Denmark;3. Department of Computer Science, University of Copenhagen, Denmark;1. Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea;2. Department of Orthopaedic Surgery, Orthopaedic Biomechanics Research Center, Rady Children''s Hospital, San Diego, California, U.S.A.;3. Department of Orthopaedic Surgery, University of California, San Diego Medical Center, San Diego, California, U.S.A.;2. Cardiology, St. Paul’s Hospital;3. Faculty of Pharmaceutical Sciences and Centre for Health Evaluation and Outcome Sciences, University of British Columbia, Vancouver, British Columbia, Canada;1. Department of Biotechnology, Madhav Institute of Technology and Science, Race Course Road, Gola Ka Mandir, Gwalior (M.P.) India;2. Department of Biotechnology, L.N. Mithila University, Darbhanga, Bihar-846004, India;1. Division of Cardiovascular-Thoracic Surgery, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois;3. Division of Cardiology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois;2. Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois;4. Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois |
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| Abstract: | The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient's safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure. |
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