Juggling law, ethics, and intuition: practical answers to awkward questions.
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The eclectic problem solving methodology used by the British Medical Association (BMA) is described in this paper. It has grown from the daily need to respond to doctors' practical queries and incorporates reference to law, traditional professional codes, and established BMA policies-all of which must be regularly assessed against the benchmark of contemporary societal expectations. The two Jehovah's Witness scenarios are analysed, using this methodology and in both cases the four principles solution is found to concur with that of the BMA's approach. The author's overall conclusion is that although the BMA resorts to a lengthier list of things to consider, the solutions that emerge are often likely to coincide with the four principles approach. (+info)
Medical devices: cardiovascular devices: reclassification of the arrhythmia detector and alarm. Final rule.
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The Food and Drug Administration (FDA) is reclassifying arrhythmia detector and alarm devices from class III to class II (special controls). This device is used to monitor an electrocardiogram (ECG) and to produce a visible or audible signal or alarm when an atrial or ventricular arrhythmia occurs. An atrial or ventricular arrhythmia occurs during a premature contraction or ventricular fibrillation. FDA is reclassifying this device based on new information contained in reclassification petitions regarding the device submitted by the Health Industry Manufacturers Association (HIMA) (now known as Advamed), Quinton Instrument Co., and Zymed Medical Instrumentation. 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 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 (the FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). (+info)
Protecting competition and consumers: a conversation with Timothy J. Muris. Interview by William Sage.
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In this interview with William Sage of Columbia University, Federal Trade Commission (FTC) chair Timothy Muris discusses his commission's role in the health care arena. He details the FTC's antitrust and consumer protection activities in a variety of sectors, including hospitals, physicians, and pharmaceuticals. Muris affirms the commission's belief that markets benefit consumers and that markets need basic rules to operate. The FTC's role is to enforce those rules, based on empirical evidence, in as much of the economy as possible, including health care. (+info)
Medical devices: classification of the dental sonography device and jaw tracking device. Final rule.
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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). (+info)
Neurological devices; classification of human dura mater. Final rule.
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The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device. (+info)
Intellectual property conundrum for the biological sciences.
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Policy regarding academically generated biomedical intellectual property (IP) has been shaped by two important events: the Vannevar Bush report to then President Roosevelt in 1945 and the Bayh-Dole Act of 1980. This policy, which vests the intellectual property produced from federally funded biomedical research from the government to the academic institution, was designed to promote technology transfer and thus promote the health of the U.S. economy. However, the policy has led to significant challenges, particularly in implementation. Here it is argued that the difficulties are due to differences in the structure of motivations between biomedical scientists, institutional officials, and private sector entrepreneurs. Understanding these differences may lead to a review of policy with the goal of enhancing technology transfer for the future. (+info)
Facing requests for euthanasia: a clinical practice guideline.
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On 23 September 2002, the Belgian law on euthanasia came into force. This makes Belgium the second country in the world (after the Netherlands) to have an Act on euthanasia. Even though there is currently legal regulation of euthanasia in Belgium, very little is known about how this legal regulation could be translated into care for patients who request euthanasia. (+info)
Regulating preimplantation genetic diagnosis--how to control PGD.
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PURPOSE: To assess the regulations for Preimplantation Genetic Diagnosis (PGD). How to regulate and control PGD. Is any special licensing procedure necessary? METHODS: A review of the statements of the organization and the Japan Society of Obstetrics and Gynecology (JSOG). Also, we assess the JSOG guidelines for PGD and the statements on diagnosis of genetic diseases of the Japan Society of Human Genetics. We discuss extra licenses and qualifications for laboratories, staff, and directors. RESULTS: At present, there are no regulations governing PGD for laboratories, scientists, directors, and staff. Regulations are set by committees and organizations of the countries involved. We don't have any worldwide system of controls. In Japan, we are considering regulations in the fields of reproduction and genetics. CONCLUSIONS: PGD requires high-level techniques in taking samples, and high-level knowledge about genetic diseases. In diagnosis, we have to be as close to 100% accurate as possible. However, samples for PGD are so small that there is always a risk of failure. Also, we are required to have highly specialized knowledge about reproduction and genetics. In Japan, JSOG has a plan to join with the Society for Investigating Infertility and Society for Genetics. (+info)