No device-related deaths or serious injuries were informed and there is no objective evidence of product malfuction.However, as no further information was provided, we consider the positive readout may have been caused by an ineffective sterilization process or an auto-reader malfunction, which may cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness.This could contribute to delay patient treatment and, hence, to a serious injury if it were to recur.
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