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Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices., (Copyright © 2013 Longwoods Publishing.)

Efforts to reduce both costs and medical waste have led many health systems to start reusing single-use medical devices (SUDs) after cleaning and sterilizing (i.e. reprocessing). There is a currently a wide range of SUD types being reused in many health systems. The objective of this paper is to provide a brief summary of risk issues associated with critical SUDs, based on a rapid review of the available literature. The specific focus is on risk issues, but includes discussion of economic and legal/ethical issues as well. The evidence in the literature regarding the safety of reuse of SUDs indicates that for certain devices (e.g. heart catheters) reuse can be safe (in terms of patient infection) and cost-effective as long as stringent reprocessing protocols are followed. However, potential risks associated with reusing SUDs are not just limited to infection of patients. There are staff and environmental risks, plus important legal, ethical, and financial issues to consider in a reuse policy. There are currently no Canadian guidelines on reuse or reprocessing SUDs, although a national Scientific Advisory Panel on Reprocessing of Medical Devices has made recommendations. Additionally, reuse of SUDs is interwoven with the issue of infection control and reprocessing procedures in general and as applied to multiple-use devices. With limited healthcare resources, there will always be a trade-off between the human resources and costs required to clean and sterilize reused devices with costs associated with purchasing and disposing of non-reused SUDs. Evaluation of complete operational pathways, especially for more expensive and commonly used SUDs, will be useful to properly determine the balance of benefits, risks, and costs under a reuse policy.

During the ten years that I have worked at the Canadian Nurses Protective Society, we have had numerous calls from Operating Room nurses questioning the practice of re-using single use medical devices in their facilities and voicing their concerns about possible harm to patients, themselves and potential liability exposure. Interest in this topic has been rekindled by the recent Saskatchewan case involving the death of a patient from variant Creutzfeld-Jakob Disease (vCJD) and possible transmission of vCJD to 71 patients who may have been exposed to the same endoscope as the deceased while in hospital. In this article, I propose to address some of the concerns related to the reuse of single use medical devices by focusing on the prevalence of this practice, the legal risks involved, regulation of this practice, and risk management.

Two recent judgments by the Supreme Court of Canada limit the liability of doctors and hospitals. One decision confirmed that the contract between a physician and patient is primarily for provision of a service, not the sale of goods. The other held that the manufacturer of a highly technical product is responsible for informing the ultimate consumer of its product's risks. It is a risk physicians may not be able to assume on the manufacturer's behalf.

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.