Corrective action for end-users on SBI International Medical Devices AutoFIX™ 3.0/4.0 non sterile range

Gen-Y (S) Pte Ltd would like to inform healthcare professionals of a potential compromise to the sterility of AutoFIX™ 3.0/4.0 due to the instructions given in the Instructions-for-Use (IFU). Small Bone Innovations Inc. has informed that gravity steam sterilization cycle stated in the IFU is not adequate to sterilize the products. Use of an inadequately sterilized product will lead to a patient risk of infection requiring post-operative follow-up care. The IFU has been revised and a IFU replacement will be made for any affected units supplied. Healthcare professionals are informed to change the sterilization practice for the product, if applicable. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.