Cook—OptiLite Multi-Use Holmium Laser Fibers: Reprocessing Instructions May Be Inadequate
May 17, 2017 | Strategic Insights for Health System
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In a May 3, 2017, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Cook states that the reprocessing instructions for the above laser fibers may not provide sufficiently detailed information for cleaning, disinfection, and sterilization. Cook's preliminary investigation indicates that validation data related to the reprocessing of these devices does not meet the current guidance. Cook also states that it has received no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization of these devices; however, if the devices are not adequately reprocessed, adverse events such as urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure may occur. The manufacturer has not confirmed the...