Medical device manufacturer, Brainlab, has issued a medical device safety alert concerning its Offset Cup Impactor Universal [Product Reference: Article number 52856/52856A].
The manufacturer identified that when the affected product (blue handle) is reprocessed in a Sterilization Tray as described in the current Brainlab Cleaning, Disinfection and Sterilization Guide (Revision 5.2 and previous) the device may not be determined as sterile. The required sterility assurance level (SAL) of 10-6 can only be achieved if the device is individually wrapped for sterilization.
According to the manufacturer, if a non-sterile affected product is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient's body, potentially leading to infection.
The manufacturer advises users are to follow the updated sterilization instructions (BL-IL-60960-69ML Rev. 1) to achieve the required sterility assurance level (SAL) of 10-6.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 February 2017