Updates in Instructions For Use (IFU) for Impella heart pumps on potential risk of inlet perforation due to operator handling and risk of fiber ingestion

A Dear Healthcare Professional Letter has been issued by DCH Auriga Singapore Pte Ltd to alert healthcare professionals of important updates in the Instructions For Use (IFU) for Impella heart pumps on the potential risk of inlet perforation through the myocardial wall of the left ventricle due to operator handling and the potential risk of fibers being drawn into the device.  Information on the safe use of Impella heart pumps to avoid these potential risks was found to be absent in the product(s) package inserts. Healthcare professionals are advised to refer to the letter for additional precautions to take to prevent ventricular perforation and fiber ingestion for Impella heart pumps. 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.