FDA Warns of Skull Clamp Slippage

When was the last time you inspected your skull clamp before surgery?

The FDA is advising all health care providers who use neurosurgical head clamps to readily inspect these devices for mechanical failure and normal wear and tear, as this can contribute to device slippage and cause harm to the patient.

From January 2009 to January 2016, over 1000 medical device reports associated with skull clamp slippage or movement before or during surgical procedures were submitted to the FDA. The unintended patient movement resulted in some 700 injuries, including skull fractures, facial injuries, lacerations, and hematomas. In some cases, the incidents compromised the procedure.

These incidents are not associated with any one manufacturer or brand of device; instead, device slippage is often caused by faults in device performance, device application, patient-specific characteristics, and lack of maintenance.

The FDA is urging health care providers to follow manufacturer instructions for the clamp systems, as well as:

• Inspect clamp systems and accessories before and after each use for damage or poor function
• Apply comparable force to the clamp system prior to each use and before fixation in order to test device stability
• Improve awareness of correct positioning techniques

Overall, the benefits of using these devices continue to outweigh the risks, however the FDA will continue to monitor the situation.

For more information about proper clamp placement and reporting procedures, go here.