No procedural delays or cancellations were reported.The user facility followed their hospital protocol in notifying the patients that were involved in the procedures.No adverse effects have been reported.A steris service technician inspected the v-pro sterilizer in which the positive bi subject of the reported event was run and found it to be operating properly.Additionally, the technician reviewed the cycle tapes which evidenced passing results.The dhr of the lot number subject of the reported event was reviewed; no issues were noted.Additionally, retains of the lot were tested, and no issues were noted.A steris account manager visited the facility and noted that the bis were being stored on top of the v-pro unit.Additionally, the relative humidity in the room was between 2-7%.The v24 self-contained biological indicator instructions for use state bi storage conditions requirements to be 21-25 degrees celsius and relative humidity of 40-60%.Steris provided in-service to the user facility on the proper storage of bis.The user facility is now storing bis in a separate room with conditions that meet the bi instructions for use.No additional positive bis have been obtained since the move.
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