The US Food and Drug Administration (FDA) is again alerting orthodontic professionals of the risk of patient burns from electric dental handpieces. The AC-powered hand-held devices have been responsible for first-degree to third degree-burns to patients that required reconstructive surgery. Since the FDA’s initial 2007 Public Health Notification, the agency has received additional reports of patients being burned by the devices.
Serious patient burns can occur when electric dental handpieces overheat during 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.
As part of an ongoing investigation to address this continuing problem, the FDA is communicating concerns to dental handpiece manufacturers. The FDA has sent letters to manufacturers requesting assistance with correcting problems associated with these devices. The letters request that manufacturers take the following actions:
- identifying the root causes of the overheating hazard;
- determining if the handpiece labeling is understood by users and if required maintenance is feasible; and
- considering 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.
The FDA asks orthodontic professionals and patients to report adverse events or side effects related to the use of these products.