FDA Urges Caution With Neurosurgical Head Holders Due to Slippage
Posted 26 February 2016 | By
The US Food and Drug Administration (FDA) issued a safety notice Thursday on the use of neurosurgical head holder (skull clamp) systems, which secure the patient’s head during surgical procedures.
From January 2009 to January 2016, the agency said it received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries, though the review did not find any specific deficiencies with particular manufacturers.
“These reports describe unintended patient movement during surgical procedures that resulted in injuries including skull fractures, facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots (hematoma),” FDA said. “Additionally, unintended patient movement has compromised procedures dependent upon head immobilization causing inaccurate stereotaxic navigation and delayed, prolonged, or halted surgical procedures.”
The causes of skull clamps slipping before and/or during surgical procedures are multifactorial, FDA added, noting that they “may include device performance (e.g., mechanical failure of the skull clamp), device application (e.g., issues with placement of the skull clamp and/or accessories), patient specific characteristics (e.g., thickness and bone quality of the patient’s skull) and lack of maintenance. Some of these risks can be mitigated through device placement considerations, proper use and proper device maintenance.”
Despite the MDRs, FDA said it still believes the overall benefits of the skull clamps continue to outweigh the risks, and there isn’t any specific manufacturer or brand of devices that’s higher risk. The agency, which also outline recommendations for health providers and hospital and health facility staff, said it will continue to monitor this issue and keep the public informed if significant new information becomes available.
Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication