The US Food and Drug Administration (FDA) has issued a safety communication warning reminding neurosurgeons about the safe use of cranial perforators with automatic clutch mechanisms to reduce the risk they will fail to stop drilling once through the skull.

Cranial perforators are used to create burr holes in the skull during certain neurosurgical procedures. The devices often include a clutch mechanism designed to automatically disengage once the tip has penetrated the skull, a statement from FDA issued today notes.

"However, this clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer's instructions for use," the statement said. "The clinical consequences of cranial perforators failing to disengage can be serious."

The new safety communication aims "to remind neurosurgeons about the techniques for the safe use of cranial perforators with an automatic clutch mechanism to reduce the risk that these devices will fail to disengage or stop drilling," the statement said.

Between January 2005 and August 2015, the FDA received more than 300 medical device reports (MDRs) of automatic clutch mechanisms failing to disengage, resulting in more than 200 injuries, the statement notes. Injuries included perforation of the dura mater, hemorrhage, brain contusion, cerebral tissue damage, and neurologic deficit, the agency said. Outcomes of these injuries included seizures, aphasia, delayed or prolonged hospital stays, and the need for additional procedures.

The FDA analysis to date suggests that the failure to disengage is not specific to any manufacturer or brand of devices.

"The risk of these devices failing to disengage can be mitigated through proper use, patient considerations, and device selection in accordance with the device's instructions for use," the FDA says. "Failing to follow the manufacturer's instructions for use can lead to the device not performing as expected, potentially placing patients at risk."

The FDA's recommendations for neurosurgeons include the following:

"Review and follow the device labeling instructions for use for cranial perforators with an automatic clutch mechanism.

Utilize correct techniques for cranial perforators with an automatic clutch mechanism including: Select the appropriate cutting accessories based on the patient's skull thickness. Hold the perforator perpendicular to the inner table of the skull at the point of penetration throughout the entire drilling procedure. Do not rock, rotate, or change the angle of the device during drilling. Avoid using excessive pressure when nearing the point of perforation to prevent penetration into the brain.

Be cautious when using a cranial perforator with an automatic clutch mechanism if you: Perforate areas of the skull that have variations in bone contours and thickness such as the posterior fossa. Perforate the skull of infants, children, or elderly patients because of varying skull consistency and thickness of bone. Perforate a patient's skull if there is diseased or fragile bone or the possibility of adherent underlying dura mater.

Report any adverse events associated with the use of cranial perforators with an automatic clutch mechanism to the FDA and the manufacturer."

"The FDA will continue to monitor this issue and keep the public informed if significant new information becomes available," the statement concludes.