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More Patient Burns from Dental Handpieces

Tue, 02/15/2011 - 9:31am
USFoodandDrugAdmin

FDA is again alerting dental professionals about the possibility of serious patient burns from electric dental handpieces that overheat. Some patients have experienced third-degree burns that required reconstructive surgery. Although FDA issued a warning about this problem in 2007, the agency continues to receive reports of patients being burned. Burns can occur if the electric handpiece is worn or clogged. If that happens, the motor sends increased power to the handpiece head to maintain performance, which generates heat at the head or the attachment. All of this can happen very quickly. And it can happen without warning, because the patient is anesthetized and may not be able to feel the heat, and the operator is protected from the heat by the handpiece housing. Here are some of the steps FDA recommends to prevent burns from electric handpieces: • Maintain the handpiece according to the manufacturer's instructions. Verify how often the device should be serviced, and then stick to that schedule. • Be sure that personnel are trained to clean and maintain the device, and that they track and record this. • Examine the handpiece before use, and be sure a worn drill or burr is not being used. • Do not use a handpiece that has not been properly maintained. • And finally, report overheating to the manufacturer. FDA is also asking the manufacturers of electric dental handpieces to help identify the root causes of overheating, determine whether their required maintenance procedures are feasible and whether users understand them, and consider steps to reduce the risk of overheating. FDA Patient Safety News: December 2010 For more information, please see our website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=105#5

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