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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Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability…

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Mr. Kelly as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Mr. Kelly’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Mr. Kelly has also been advising on UK and European “Brexit” related issues including tariffs.

Mr. Kelly has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Mr. Kelly is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Mr. Kelly is an honorary lecturer at University College London.