Article originally published in EURALex in October 2008
The reprocessing of medical devices has been an increasing industrial practice since the late 1970s. While reprocessing of some medical devices has taken place within hospitals for many years, the market for professional third-party reprocessing service providers has developed during the last decade due to financial pressures as well as scientific and technological advances. Anne Ware and Brian Kelly discuss the risks of reprocessing single-use medical devices and the associated product liability issues that may arise.
Before the widespread availability and use of single use devices (SUDs) in the 1980s, the reuse of some medical devices was facilitated by their shape, their size and the fact that they were usually made of glass, metal or rubber. The reprocessing of these devices was relatively straightforward and more akin to “recycling”. With technological developments, including the use of novel plastics, instruments with smaller lumens and more intricate, delicate working mechanisms, devices are not as easy to clean or sterilize. Because of this, manufacturers label some products as “single-use”, i.e. they should be used for a single procedure on a single patient and then discarded.
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