FDA urges proper handpiece maintenance
Rockville, Md.—The U.S. Food and Drug Administration wants to remind dental professionals that serious injuries, including third-degree burns, may be associated with the use of poorly maintained electric dental handpieces during dental procedures.
Previously, the FDA urged health professionals to service and maintain the handpieces in accordance with the manufacturer’s recommendations and to strictly adhere to those instructions for use, maintenance, servicing and lubrication. In August, the agency sent letters to manufacturers of dental handpieces and electric oral bone cutting handpieces, requesting them to assist in identifying the causes of the overheating hazard; determine if the labeling is understood by users or if required maintenance is needed; and consider risk mitigation steps such as design modification, adding an overheating alarm, operator training or modified use of the handpieces.
The FDA first reported in 2007 that some patients have suffered burns that required plastic surgery and says that the injuries may not be immediately apparent to the operator or the patient until after the tissue damage has occurred, because anesthetized patients cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns occurred during the cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating can also occur during any dental procedure.
Electric handpieces are designed to maintain bur speed during cutting, but unlike air-turbine handpieces that can bog down or stall when something interferes with the rotation, the electric handpiece micromotor sends more power to the gears, and friction in the gears and/or the bearing assemblies transfers into heat.
Electric handpieces can become dangerously hot in a matter of seconds, without any warning to the user.
For dentists experiencing overheating of an electric handpiece, or who have any other adverse experience with any dental equipment or material, contact the FDA’s MedWatch program by phone at 1-800-332-1088 or visit the website at www.fda.gov/medwatch/how.
To see a copy of the latest FDA alert on the topic, visit www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm226995.htm.