A customer reported a positive result with a cyclesure¿ 24 biological indicator (bi) after a completed sterrad¿ 100s cycle.The bi was incubated for 24 hours.The chemical indicator (ci) changed color correctly.The subsequent bi results was negative.The affected load was partially released and used on a patients.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 wherein the affected loads have been released for use without reprocessing.
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The investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.Trending analysis by lot number was reviewed from (b)(6) 2017 to (b)(6) 2017 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 returned for visual inspection.The chemical indicator disc was yellow in color which indicates exposure to hydrogen peroxide.There was no media remaining in the vial.The complaint cannot be confirmed.Thirty-two retains bis were subject to functional evaluation.All thirty-two bis met specification.The assignable cause of the suspect positive bi could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.Also, no manufacturing anomalies were observed in the returned suspect bi that would contribute to a positive bi result.An issue with sterrad performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The issue will continue to be tracked and trended.(b)(4).
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