A customer reported a positive result with a sterrad velocity¿ biological indicator (bi) after a completed sterrad® cycle.The customer stated they placed two bis into the sterrad sterilizer and one bi was negative and the other bi was positive after a completed cycle.The affected load included a davinci scope that 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 sterrad velocity¿ 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 device history record (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 from bi manufacture date to complaint open date and trending was not exceeded.Review of risk documentation shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the single sterrad® velocity¿ bi was returned for visual inspection.The bi was observed as activated with a compressed cap and broken/shattered media ampoule.The sample was observed as a processed bi with residual purple medium in the vial.The reason for return was not confirmed through visual analysis.Twenty two retains bis were subject to functional evaluation.All twenty 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.Additionally, the product was returned for visual analysis and the issue could not be confirmed.The customer was advised to follow their facility policies and procedures regarding the released load.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
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