Brain Injury Reports Spark FDA Safety Advisory

The FDA is advising healthcare professionals to strictly follow the instructions for use for cranial perforators with automatic clutch mechanisms following reports of more than 200 injuries related to their use.

A cranial perforator is used to create a small hole in a patient’s skull to allow a neurosurgeon to access the brain. It is designed to stop drilling automatically after penetrating the skull to prevent the tip from plunging into the patient’s brain. However, failure to follow the manufacturer’s IFU can result in the clutch mechanism not engaging, leading to an adverse patient event.

Between January 2005 and August 2015, more than 300 medical device reports associated with use of the perforators were filed. Injuries include perforation of the brain’s protective covering just beneath the skull, bleeding, brain contusion, cerebral tissue damage and decreased function of the brain. Patients have experienced seizures, damage to the portion of the brain responsible for language, delayed or prolonged hospital stays and the need for additional procedures.

The communication doesn’t single out a specific manufacturer or brand of device; rather, it emphasizes the need to strictly follow the IFU to ensure proper use.

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