RESUMO
OBJECTIVES: Sterilized reusable medical devices have a use-by date, after which sterility is no longer guaranteed. There is currently no consensus on how this should be determined. The aim is to re-evaluate the expiry date of reusable medical devices, by means of a risk analysis and an assessment of the maintenance of the sterile state of reusable medical devices over time. METHODS: The risk analysis focused on the stages whose malfunction could compromise the sterility of reusable medical devices over time: packaging, transport and storage. Risk mapping was carried out in accordance with the methodology recommended by the French Health Authority. Based on standard NF EN ISO 11737, the assessment of the maintenance of the sterile state was checked on reusable medical devices after two, four and six months storage and on reusable medical devices that had expired more than a year previously. RESULTS: The risk analysis identified four failures and sixty-eight potential causes. The most sensitive stage was storage, which accounted for most of the critical and major causes. Improvement actions were proposed, such as the definition of a container maintenance plan. At the same time, 256 reusable medical devices were tested. The cultures remained sterile for all the containers, for folded products tested at 6 months and more and for the sachets tested at 2 and 4 months and at more than one year of storage. CONCLUSIONS: The DLU has been extended to 4 months for sachets, 6 months for folded products and maintained at six months for containers.