medical devices, single-use, healthcare, liability, tort, regulation, manufacturers, reprocessors, care providers, Canada
The reprocessing and subsequent reuse of medical devices labelled by the manufacturer as 'single-use only' is a cost cutting strategy employed by many healthcare centres. However, attempting to extend the life of a device labelled as 'single-use only' raises a number of unique concerns surrounding the issue of legal liability specifically who should bear responsibility if someone suffers harm as a result of a reprocessed single-use device. Following an overview of the current regulatory environment, the potential tortious liability attaching to those who may be implicated in the reprocessing chain is discussed. Specifically, this paper examines the duty and standard ofcare owed byregulatory bodies, original manufacturers, third-party reprocessors, healthcare facilities and care providers in the reuse of devices labelled as 'single-use only'. Finally, bydrawing on various international practices the paper concludes by advocating for regulatory reform to better provide proactive oversight in the area of reuse in Canada.
Brian Wilson, "Ifit's Reusable Why not Reuse it? The Reuse of Single Use Medical Devices" (2011) 34:1 Dal LJ 229.