This might have been the perfect opportunity for Health Canada to finally put a regulatory stake in the ground and define the rules for the safe reuse of (non-sharps) medical devices, with or without refurbishment and/or other reprocessing. After all, Health Canada’s Action Plan on Medical Devices defined its mandate as “continuously improving safety, effectiveness and quality” of medical devices, all of which are directly relevant to the burgeoning market for used medical devices.
Presumably cost is also included within the focus of every policy on medical devices from Health Canada and yet no mention is made in the Action Plan of a circular economy approach to achieve real savings for the healthcare sector. But why not?
Just What are the Rules on Used Medical Devices?
The problem starts at the point of use, in a hospital or other medical facility. Provincial and territorial law generally treats any device which, in its present state, can no longer be used and originating from a medical facility as necessarily a “waste” and, out of an abundance of safety, a “hazardous waste”. This designation creates substantial waste management processes and related financial burdens on medical facilities, ultimately increasing their cost of hosting the medical device.
Further, where the device is deployed outside of a medical facility, such as a patient home, it’s unclear how the provider of that device may easily re-obtain it without putting the patient into the waste management business.
Appropriate for Reuse v. Biomedical Waste
There is some guidance on what is “biomedical waste”, which comes from provincial sources and not the federal government. Most notably, the Ontario Hospital Association standard C-4: the Management of Biomedical Waste in Ontario includes definitions of biomedical waste which center around it being both a “waste” and coming from a medical or biomedical source. It merely begs the question: Is it a (bio)medical waste if it isn’t wasted?
Internationally, there is also a clear need for a commonly accepted standard as to when a properly refurbished used medical device can be used anew. Such a standard presumably will draw from accepted circular economy practices around resource recovery and move away from rigid applications of waste laws without consideration of the underlying intention of the parties.
Should Health Canada Define the Reverse Supply Chain?
For used devices which are perfectly suitable to be certified for re-usage, there are currently two solitudes: Health Canada has their certification process under the Medical Device Regulations and the provinces and territories have their waste designations and related laws, and never the two seem to meet. If the devices will ultimately be reused, then surely a resource recovery path (and not a waste process) could be invoked early in the second life of a device to streamline refurbishment and avoid unnecessary regulatory costs.
In short, it’s time for federal-provincial/territorial harmonization on a circular strategy for medical devices. Without such guidance, market inefficiencies will continue to be borne as costs to the healthcare system.
Federal Government Already Endorsed National Circular Economy Strategy
Finally, it is worth noting that, while waste is a provincial/territorial matter in Canada, the federal government recently received the Council of Ministers of the Environment’s commitment on circular economy laws on plastics (for more info, click HERE). The need for federal action on a circular economy on medical devices is arguably both financially more imperative and closer to home for Health Canada as the certification body.
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To remain silent on the reuse of medical devices isn’t an option for Health Canada as the societal and financial pressures to avoid the wastage of valuable medical devices will continue to spawn markets, with or without clarity on the law. Canada needs more action in its plan on medical devices.
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For further information, please contact Jonathan Cocker:
416-865-6908
