A customer reported a positive result with a cyclesure® 24 biological indicator (bi) after a completed sterrad® 100nx cycle.The bi was incubated for 24 hours.The two subsequent bi results were both negative.The affected load was released and used on a patient.There was no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of positive cyclesure® 24 biological indicators when the load has been released and used on patient(s) prior to reprocessing.
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H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.¿ the dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.¿ trending analysis by lot number was reviewed for the previous six months from open date and trending was not exceeded.¿ the sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." ¿ the single cyclesure® 24 bi was not returned for visual inspection, and therefore, visual analysis could not be performed.¿ thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause of the issue could not be verified.The dhr review found no anomalies that would contribute to the complaint issue and retains testing met specification.However, the product was not returned so no further analysis could be performed.A customer letter was sent addressing the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
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