JLE

Journal de Pharmacie Clinique

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Management of non compliance in a cleaning area in a sterilization unit Volume 23, issue 1, janvier-février-mars 2004

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Authors
Service de pharmacie‐stérilisation, groupe hospitalier Pitié‐Salpêtrière, Paris

In France a quality system must be carried out about the sterilization of medical devices. We had previously performed a retrospective study on the management of non conform product during the batch validation step in the Babinski sterilization unit at Pitié‐Salpêtrière Hospital, Paris, France and this work had resulted in a significant quality improvement. The aim of this study was thus to extend the management of non compliance to the cleaning area. A prospective study was performed over ten weeks within the cleaning area in the Babinski sterilization unit. Non compliance was classified in three levels, according to its gravity (minor, major, or critical). In order to identify the appropriate actions, an assessment scale including severity and recurrence was defined. Ninety‐nine non compliance events were reported: 22% of minor level, 45% of major level and 32% of critic level. In 98% of the cases, curative actions were adapted. The assessment scale quickly identified non compliance events that were to be treated in priority. This process improved the quality of medical devices and improved security for patient. Furthers studies are required to extend the analysis of non compliance in the whole process of sterilization.