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PubMed1996

The medical device directives and their impact on the development and manufacturing of medical implants.

The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. All implants must meet certain essential requirements to ensure that they do not harm the patient, clinician or any third party. For most implants this will be indicated on the product or its packaging by CE; marking involving an independent organization called a Notified Body; the latter are appointed by the Competent Authority of the Member State. Devices are classified in proportion to the risk associated with them. The steps needed to be taken by manufacturers are outlined and the verification options discussed. The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.

Equipment Design↗
PubMed1985

Research with animals: requirement, responsibility, welfare.

Recognition of unacceptable cruelty to animals in pasttimes such as bull-baiting, dates in Britain from the early 19th century. The Society for the Prevention of Cruelty to Animals was founded in 1824. Several bills to curb cruelty were discussed in Parliament, and the Cruel and Improper Treatment of Cattle Act was passed in 1822. Other Acts have followed over the years. Cruelty in the form of painful scientific experiments, including dissection of living, conscious animals, vivisection, was proscribed by the Cruelty to Animals Act 1876. That Act required anyone wishing to experiment with animals to obtain a licence from the Secretary of State. Conditions for issue of licences were strict and remain so to this day. The Act is still valid, and is enforced by the Home Office, with its medical and veterinary Inspectors. The Cruelty to Animals Act 1876 allows experiments on animals under strictly controlled conditions. Experiments must have the clear objective of improving the welfare of man and/or animals. Benefits from experiments carried out under the Act have been enormous, covering every aspect of diagnosis, treatment, and prophylaxis in human and veterinary medicine. Coincidentally, the welfare of laboratory animals has also been greatly improved. There has always been some opposition to the use of animals in biomedical research. The subject is emotive but, by and large, discussion has been rational and within the law. In recent years, however, the morality of using experimental animals has been examined more closely. The possibility of replacing them by alternative methods has been investigated. Where these alternatives are applicable, they are used and further research on them continues. The questioning of animal experiments has emphasized the need to look constantly at animal welfare to ensure humane treatment of all animals, especially those restricted in a laboratory or on a farm. Attention has been drawn in this work to our existing laws protecting animals, but new legislation is being demanded, not only by some lay welfare groups but also by scientists. Hence, it has become very important to discuss various ways of ensuring animal welfare, including by legislation, especially with those knowledgeable in laboratory animal science and animal experiments.(ABSTRACT TRUNCATED AT 400 WORDS)

Advisory Committees↗
PubMedDate not supplied

State syringe and drug possession laws potentially influencing safe syringe disposal by injection drug users.

OBJECTIVE: To review state laws and judicial decisions for potential barriers to proper syringe disposal by injection drug users (IDUs). DESIGN: Using standard legal research methods, this study reviewed drug paraphernalia, syringe prescription, drug possession, and syringe exchange laws and relevant case decisions in 59 jurisdictions. MAIN OUTCOME MEASURES: Drug paraphernalia, syringe prescription, and drug possession laws. RESULTS: Drug paraphernalia laws prohibit all possession of syringes by IDUs in 31 jurisdictions. Syringe prescription laws prohibit possession in 7 jurisdictions. In 53 jurisdictions, IDUs may be subject to prosecution for the possession of drug residue in used syringes. Only two states (HI, RI) have no legal barriers to safe syringe disposal by IDUs. Sixteen jurisdictions that have tried to expand syringe access for IDUs by authorizing SEPs or by deregulating pharmacy sale of syringes continue to have criminal law provisions that could pose barriers to proper disposal. CONCLUSION: IDUs are a significant source of syringes disposed of outside the health care system. Involving IDUs in safe community sharps disposal programs is an important public health goal, but may be frustrated by legal barriers. Although this study looked only at law on the books, and not law as actually applied, ethnographic and survey research indicates that criminal laws do influence the syringe possession behavior of IDUs. The findings of this study suggest that syringe and drug possession laws could deter IDUs from participating in safe syringe disposal programs.

Humans↗
PubMed1983

The impact of random breath testing in New South Wales, December, 1982 to February, 1983.

A survey to investigate the impact of random breath testing (RBT) was carried out in late February, 1983. The survey sample comprised 400 Sydney residents. In the first 10 weeks of operation, nearly half the Sydney population were directly exposed to RBT, either by being tested themselves or by driving past other people being tested. Despite this high penetration rate, many licence holders regarded their chances of being tested as lower than they were when RBT was first introduced, in December, 1982. Men, younger respondents, and heavy drinkers had higher rates of exposure to RBT, rated their chances of being tested more highly than did other groups and more often reported changes in behaviour due to RBT. However, respondents in these groups also more often reported drinking and driving since the advent of RBT. The implications of these findings for police law enforcement strategies and for the current debate on mandatory zero blood alcohol levels among provisionally licensed (P-plate) drivers are considered.

Adolescent↗