FDA releases safety communication for neurosurgical head holders

According to Arthroplasty Watch, the FDA recently announced a safety communication for neurosurgical head holders — skull clamps — due to reports of the devices slipping during surgical procedures.

The FDA reports that between Jan. 2009 to Jan. 2016, more than 1,000 medical device reports were issued due to slippage or movement of a skull clamp before and/or during a surgical procedure, which resulted in more than 700 injuries. The injuries ranged from deep cuts, skull fractures, facial injuries and blood clots.

Head holders are used to secure a patient’s position during surgical procedures and may include a head holder frame that attaches to the operating table, skull clamp, neurosurgical head hold stabilization components, skull pins and other accessories, according to the FDA notification.

The FDA noted the overall benefits of the devices outweigh the risks, but health care providers should be aware of patient-specific characteristics and techniques for safe use to prevent slippage during a procedure.

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