FDA issues Safety Communication on neurosurgical head holders

Editor's Note

The Food and Drug Administration (FDA) on February 25 issued a Safety Communication on neurosurgical head holders (skull clamps) and device slippage.

From January 2009 to January 2016, the FDA received more than 1,000 reports of slippage or movement of skull clamps before and/or during surgical procedures. The slippage, which resulted in more than 700 injuries, was caused by unintended patient movement.

Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of patient-specific characteristics, techniques for safe use, and maintenance of head holder systems to prevent skull clamps from slipping.

Date Issued: February 25, 2016 Audiences: Health care providers who use neurosurgical head holders, including: Ear, Nose and Throat Specialists, Neurological Surgeons, Orthopaedic Surgeons and Operating Room Staff Hospital staff responsible for maintenance of medical devices Medical Specialties: Neurosurgery, Otolaryngology, Orthopaedics Device: A neurosurgical head holder (skull clamp) system is a device used to secure the patient's head position during surgical procedures.