Keeping patients and health-care workers safe by regulating the reuse of single use medical devices

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The reuse of single use devices (SUDs) is a practice that is common in Ontario hospitals. However, the practice is not safe for patients or health-care workers. It poses serious risks by potentially exposing patients and health-care workers to infectious diseases and malfunctioning devices. The reuse of SUDs should be banned until such time that the reused device can be validated with regard to safety, quality and performance to the same degree as the original product.

An SUD is a medical device that has been developed, designed and manufactured to be used only once and then disposed of after use. These devices evolved to reduce cross contamination from one patient to the next and to reduce the costs associated with reprocessing reusable devices. The designation of single use is employed by manufacturers in response to risk management associated with safety and effectiveness or reuse.

The medical device industry is regulated by the Health Protection and Food Branch at Health Canada. While the original medical device is regulated, reused SUDs are not. The reuse of SUDs should fall under the mandate of Health Canada.

“Single use medical devices are designed as a result of extensive research by the manufacturer intended to meet the needs of the patient and the health-care provider using the device,” said Stephen Dibert, President and CEO of MEDEC, the national association representing Canada’s medical device industry. “By reusing SUDs, the physical properties of a product and its functionality and sterile nature are seriously compromised, posing a health concern for patients and health-care providers.”

The practice of reuse of SUDs became common as Ontario hospitals and other hospitals in Canada faced financial constraints and looked to reusing SUDs as a means to help control costs. Interestingly, a thorough cost analysis of the reuse of SUDs has not been published after many, many years of reusing SUDs.

Hospital associations (e.g., OHA) discourage reprocessing of SUDs in hospitals. If a hospital wants to reuse SUDs, they propose using third party reprocessors that are regulated by the Federal Drug Administration in the United States. The reprocessors are not regulated in Canada.

Complete banning or reuse regulation is starting to occur outside of Canada. The United States introduced the Medical Device User Fee and Modernization Act (MDUFMA) in 2002, which regulates reprocessing of SUDs. In Australia, the Therapeutic Goods Administration (TGA), the national regulator for medical devices, does not permit the reuse of SUDs. In Europe, France has banned SUD reuse and Germany requires proof that the reprocessing procedure is safe. The United Kingdom issued a strong statement cautioning against reuse. Within Canada, British Columbia, Manitoba, Quebec and the Northwest Territories all recently banned the reuse of certain high-risk SUDs, such as angioplasty catheters.

In the US, the FDA regulates third party reprocessors and Canada still lags on preventative regulation. “Federal and provincial governments should address the disparity in regulatory requirements between reprocessors and original equipment manufacturers,” says Dibert. “Health Canada should regulate reprocessing in Canada, and third party reprocessors should have their practices be subject to the Medical Devices Regulations and the Food and Drugs Act.”

The lack of regulation may change. Health Canada is now more involved in a solution to the problem of unregulated reuse of SUDs. On June 9th, Health Canada held a public stakeholders conference on the Reprocessing of Single Use Medical Devices. There were approximately 70 participants at the meeting from hospitals, associations and industry. The goal for the day was to determine ‘whether there is a need for regulation in order to mitigate health risks and liability associated with the reuse of SUDs, and if so, what role Health Canada should play in the regulation.’

The government’s Scientific Advisory Panel on the Reprocessing of Medical Devices was looking to stakeholders for their views on the reuse of SUDs. At the conclusion of the conference, the participants were unanimous that Health Canada should regulate the reuse of single use medical devices. Health Canada has released their report on the views of stakeholders and will begin the process of regulating the reuse SUDs.

While this is good news for patients and health-care workers, it could take many months for any regulation to come into effect. Until such time that the reused device can be validated with regard to safety, quality and performance to the same degree as the original medical device, reuse of SUDs in Canada should be banned.