Medical device manufacturer, Brainlab, has issued a field safety notice concerning Brainlab Offset Cup Impactor Universal [Reference number: 52856/52856A].
The manufacturer identified that when the device is reprocessed according to the instructions in the current Brainlab Cleaning, Disinfection and Sterilization Guide (Revision 4.9 and previous), the device may not be determined as sterile. The required sterility assurance level (SAL) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times. If a non-sterile Offset Cup Impactor Universal is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could enter the patient's body, potentially leading to infection and serious injury or even death of the patient.
The manufacturer advises users to follow newly validated sterilization cycles to achieve the required sterility assurance level (SAL) of 10-6.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 January 2015