Neurourgeons Beware: Cranial Perforators

Neurourgeons Beware: Cranial Perforators May Fail to Automatically Disengage, FDA Says:

Although certain cranial exercises are designed to automatically shut off after entering the skull (to avoid accidentally drill into the brain), the automatic clutch mechanism may fail to generate a wide range of devices, the Food and Drug Administration US . (FDA) warned Monday.

The FDA said its analysis of currently available data suggest that this "failure to withdraw" is not specific to a manufacturer or the brand of devices, but can be mitigated by proper use, patient considerations, and selection device as instructed. If the manufacturer's instructions are not followed may cause the unit does not work as expected, which could put patients at risk, the FDA says.

From January 2005 to August 2015, the FDA has received more than 300 reports of medical devices (MDR) associated with the use of blows to the head with an automatic clutch mechanism failing to disconnect, resulting in more than 200 injured .

Injury reports describe the drilling of the protective covering of the brain, just below the skull, bleeding, concussion, brain function and brain tissue damage decreased. Results injuries include convulsions, damage to part of the brain responsible for language, prolonged hospitalization delayed / and the need for additional procedures.

FDA asks neurosurgeons:

•     Review and follow the instructions on the device's instructions for use to pierce the skull with an automatic clutch mechanism
•     Use appropriate techniques to drill the skull with automatic clutch mechanism
•     Be careful with a punch head with automatic clutch mechanism if the surgeon
•         Perforated areas of the skull that have variations in the thickness and the bone contours as the posterior fossa.
•         Drill the skull of babies, children or the elderly, due to the change in the consistency and thickness of the skull bone.
•         Drilling the skull of a patient if weak or diseased bones or the possibility of adhesive underlying dura.

Neurosurgeons have also learned to report adverse reactions associated with the use of blows to the head with a system of automatic clutch FDA and the manufacturer.