ISSUE: FDA is again alerting healthcare professionals and dental organizations of a safety issue described in a 2007 Public Health Notification, "Patient Burns from Electric Dental Handpieces". These devices are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. These burns range from first degree burns to third degree burns requiring reconstructive surgery. Since the notice, the FDA has received numerous additional reports of patients being burned by electric dental handpieces.
BACKGROUND: 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. In the 2007 notice, the FDA reminded users of the importance of properly maintaining the handpieces.
RECOMMENDATIONS: See the notice below for specific use, training, and recommendations for dental professionals and practices. As part of an ongoing investigation to address this continuing problem, FDA is communicating concerns to dental handpiece manufacturers. FDA sent letters to manufacturers, requesting assistance with correcting problems associated with these devices. The letters requested manufacturers take the following actions: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/23/2010 - Safety Investigation of Patient Burns - FDA]
Previous MedWatch Alert:
[12/13/2007 - Electric Dental Handpieces]