[Reevaluating the shelf life of sterilized packaged items via a risk-analysis study]. / Réévaluation de la durée de péremption des dispositifs médicaux restérilisables via une analyse de risques.

ABSTRACT

In the hospital, all the reprocessed reusable medical devices (RMD) are conditioned with a sterile barrier system and a protection package and they expire after three months. The objective of this study is to reevaluate this shelf life via a risk-analysis study focusing on the steps whose malfunction can fail RMD sterility. The first step is analysing current conditions of packaging, transportation and storage of RMD. The risk-analysis study has been built on French National Authority for Health template. Risks are prioritized in three categories non critical risks, risks that need to be kept track of and risks to manage as a priority. Storage conditions have been evaluated in 52 wards in ten different structures. All of the wards respect the paper side of the pouches. They were stored in a dedicated storage unit in 85 % of the units. They were closed at the moment of the observation in 58 % of the cases. RMD were stacked in 81 % of the units and 36 % of them had at leat one expired RMD in their storage unit. The risk-analysis study identified two risks to manage as a priority. Some RMD were damaged during transportation to a subcontractor hospital. This step is barely manageable due to the human factor but the transport rules have been reminded in order to lower the risks on the materials. The operating rooms common storage include shelves that alter pouches and wraps, but a replacement of equipments is under discussion. Thanks to a better understanding of RMD circuit current conditions, allowing a better control of sensitive steps, their shelf life is reevaluated up to 6 months for containers and 4 months for other pouches.