Medivators clinical education specialist was at the facility performing an in service when he noticed the facility was using rapicide glutaraldehyde high level disinfectant with their ssd-102 automated endoscope reprocessor.The facility usually reprocesses endoscopes using rapicide opa high level disinfectant.Rapicide glutaraldehyde and rapicide opa require different test strips and settings.The facility continued to use rapicide opa test strips and settings while reprocessing with rapicide glutaraldehyde hld for a day and a half.In accordance with the ssd-102 aer instructions for use, the efficacy of the disinfectant must be monitored daily using the correct test strips.If the potency is below the minimum recommended concentration, the chemistry should be discarded and replaced with fresh solution.Using the incorrect test strips would not have indicated the correct mrc per the chemistry used.Additionally, the ifu states the user should verify the settings are appropriate for the disinfectant used.Thus, the facility was not reprocessing endoscopes in accordance with the aer's ifu and there is potential high level disinfection of the endoscopes was not reached.Medivators clinical education specialist informed the facility that the chemistry used was incorrect while using the rapicide opa test strips and settings.The facility will begin to order rapicide opa hld again.This complaint will continue to be monitored in the medivators complaint handling system.
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