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| DORO multipurpose skull clamp--Courtesy of pro med instruments |
The FDA warned healthcare providers of the risk of skull clamp slippage before or during surgical procedures, saying it has received more than 1,000 reports of the problem since 2009.
Unintended movement during surgery has resulted in more than 700 injuries over the time period, including skull fractures, facial injuries like bruises and cuts, deep cuts or lacerations, and blood clots (hematoma), the FDA says.
The FDA says the problem is not specific to a particular brand, and that the benefits of the devices continue to outweigh the risks.
The notice contains a number of recommendations, including proper cleaning, maintenance and inspection prior to use. "Prior to each use and before fixation, consider applying a force that is comparable to what is anticipated to be used during the surgical procedure to the neurosurgical head holder system. If the system appears unstable, consider obtaining another device," it says.
The agency also recommended proper technique, such as placement of the pins at a perpendicular angle to the skull, and not over uneven or fragile bone. Caution should be employed when placing pins in pediatric patients.
Skull clamps are placed at the end of the bed on which the patient lies during surgery. Used to hold the head in place, the devices "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 safety communication.
Manufacturers of skull clamps include Integra LifeSciences and pro med instruments.
- read the safety communication | more