The US Food and Drug Administration (FDA) is again alertingorthodontic professionals of the risk of patient burns from electricdental handpieces. The AC-powered handheld devices have beenresponsible for first-degree to third-degree burns to patients thatrequired 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 overheatduring procedures. Burns may not be apparent to the operator or thepatient until after the tissue damage has occurred, because theanesthetized patient cannot feel the tissue burning and the handpiecehousing 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. TheFDA has sent letters to manufacturers requesting assistance withcorrecting problems associated with these devices. The letters requestthat 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 trainingto avoid overheating, or modified use of the handpieces.
The FDA asks orthodontic professionals and patients to report adverseevents or side effects related to the use of these products.
