[Reuse of disposable equipment. Medicolegal viewpoint].
The ethical foundation supporting legislation on medical devices deals with safeguard of both individual and collective rights in health care and protection; there is no ethical reason in protecting individuals from reuse of medical devices, if reuse can be proved safe and efficacious, and if it is a way to ensure provision of services otherwise unextendable to all patients, due to lack of funds. This paper explores legal feasibility of reuse, and provides an interpretation of relevant legislation, with special concern on European Directives on Medical Devices. Whereas it is commonly accepted that controls can be imposed to test whether devices meet legal standards on safety and adherence to label indications, clinical investigations and research may as well illuminate different and wider features of the same items, not considered by the manufacturer and not included in the actual labelling. The present wording of the directives does not provide for an autonomous role of member states in asking for modifications in the provisions of the manufacturer, except when devices do not meet specific requirements stated by the directive. Nevertheless, there is no legal ground to emphasize labelling when contrasting with clinical research findings, thus leading to the conclusion that widening a possible manufacturer's understatement in therapeutic uses of medical devices is legally feasible. In the present situation in which responsibility for casualties from reused medical devices is unduly vested on physicians, Health Authorities in member States bear a moral responsibility in promoting adequate research trials to support safety and efficacy of reuse practices, thereby prompting manufacturers to apply for label modification.
Fallani
M
M
Istituto di Medicina Legale e delle Assicurazioni, Università degli Studi, Bologna,
Milandri
M
M
D002170:Canada; D004203:Disinfection; D004209:Disposable Equipment; D017743:Equipment Reuse / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D006801:Humans; D007558:Italy; D007883:Legislation, Medical; D016365:Liability, Legal; D013525:Surgical Instruments; D014481:United States