Over the past eight years, the federal regulatory approach toward the commercial reprocessing of SUMDs has evolved as the business model of reprocessing has evolved. Under the Food and Drugs Act and Medical Devices Regulations, Health Canada has the authority to govern the safety and effectiveness of medical devices, including the manufacturing and sales of SUMDs. This report is based on information current as of February 2015. Information on the reprocessing of SUMDs is based on a limited literature search and communication with key informants. It is not intended that the findings of this Environmental Scan will provide a comprehensive review of the topic. What are SUMD reprocessing regulations, policies, and practices outside of Canada?.What are the current policies and practices across Canada on the reprocessing of critical, semi-critical, and non-critical SUMDs in hospitals? If a policy has changed since 2011, what was the rationale for the change?.What are Health Canada's regulations regarding the reprocessing of SUMDs?.7 The following questions will be addressed:
#Critical updates december 2015 update#
It is an update to a previous Environmental Scan that was published in September 2011. The objective of this report is to provide a summary of the policies and practices across Canada and internationally on the reprocessing of critical, semi-critical, and non-critical SUMDs. 5 As part of its advocacy efforts, MEDEC suggested amendments to Bill C-17 ( An Act to Amend the Food and Drugs Act) to address the issue of Health Canada not having the authority to regulate the reuse and reprocessing of SUMDs by health care facilities or third-party reprocessors. MEDEC's position is that Health Canada should regulate third-party reprocessing companies as manufacturers, in the context of Canada's Medical Devices Regulations. MEDEC, the Canadian association for the medical technology industry, has advocated for federal regulatory oversight for reprocessed SUMDs.
4 Canadian hospitals using commercial reprocessors have adopted either a closed-loop procurement model (the hospital receives only its own devices back from the third-party reprocessor) or an open-loop model (the hospital does not get its own devices back but rather buys them from a pool of reprocessed devices). Given that there are no commercial single-use device reprocessors in Canada, many Canadian hospital facilities outsource their reprocessing to FDA-licensed, third-party reprocessors in the US.
4Īs a result of recent provincial policies banning the in-house reprocessing of SUMDs, health care facilities are increasingly using services offered by commercial third-party reprocessors. Most of the health care facilities (85%) reprocessed SUMDs in-house within a central reprocessing department. 4 The reprocessed SUMDs most commonly used by hospitals in Canada include breast pump kits, ventilator circuits, and burrs (drill bits used to cut teeth or bone). Among the facilities that did not report reprocessing SUMDs in that year, the majority (81%) had done so in the past. 3 According to the responses to a 2007 national survey of Canadian hospitals, a little more than a quarter of health care facilities across Canada reprocessed SUMDs on economic and environmental grounds. Reprocessing a medical device encompasses cleaning, reconditioning, function testing, and disinfection or sterilization to ensure that a medical device can safely be reused.
Semi-critical – Devices that come in contact with mucous membranes, such as endoscopes.Critical – Devices that come in contact with blood or normally sterile tissue, such as surgical forceps.The internationally accepted classification scheme described by Spaulding, which groups devices according to the risk of infection associated with the device, categorizes medical devices, as follows: 2 Provincial and territorial policies regarding the reprocessing of medical devices are typically based on the device category. In contrast to reusable devices, manufacturers of SUMDs are not obliged to provide instructions for proper cleaning and sterilization. Single-use medical devices (SUMDs) that are licensed by Health Canada are intended by their manufacturers to be used once during a single procedure and not to be disassembled, cleaned, reassembled, and reused, where doing so can jeopardize their performance, safety, and effectiveness.
#Critical updates december 2015 how to#
Therefore, it is up to each manufacturer to decide how to design and label each medical device. Health Canada encourages medical device manufacturers to design and seek authorization to sell their products according to their intended use.
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