Late last month, the U.S. Food and Drug Administration issued an alert to healthcare professionals and dental organizations concerning patient burns from dental handpieces. These devices are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. The patient burns from dental handpieces reported ranged from first degree burns to third degree burns requiring reconstructive surgery.
Serious patient burns can occur when electric dental handpieces overheat during dental procedures. Burns may not be apparent to the operator or the patient until after the tissue damage has occurred, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment.
The FDA has sent letters to manufacturers of the devices asking them to: identify the root causes of the overheating hazard; determine if the handpiece labeling is understood by users and if required maintenance is feasible; and consider risk mitigation steps such as design modification, the addition of an overheating alarm, warning labels, operator training to avoid overheating, or modified use of the handpieces.
Read the full text of the alert here.
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