UK Medical Devices Agency (MDA) issues first Bulletin on device re-use:
This article was originally published in Clinica
Executive Summary
Advice on the re-use of single use medical devices is contained in the first Device Bulletin from the UK Medical Devices Agency published on February 15th. Alan Kent, chief executive of the MDA, says the guidance document has been issued in response "to the growing volume of questions on re-use". "Manufacturers of single-use devices have also expressed concern about the extent of their liability when users are known to disregard the instruction to use a product once only," he notes. The Bulletin advises that single use devices should not be reprocessed and re-used unless the reprocessor can ensure the integrity and safety of each item.