viernes, 26 de febrero de 2016

Medical Device Safety and Recalls: Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication

A safety communication has been posted regarding
Neurosurgical Head Holders (Skull Clamps) and Device Slippage
From January 2009 to January 2016, the FDA 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. 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). Additionally, unintended patient movement has compromised
procedures dependent upon head immobilization causing inaccurate
stereotaxic navigation and delayed, prolonged, or halted surgical procedures.

The FDA’s review of medical literature and analysis of currently available
data suggests that device slippage is not specific to any manufacturer or 
brand of devices. The causes of skull clamps slipping before and/or during
surgical procedures are multifactorial, and 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.

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