On September 23, 2010 the US Food and Drug Administration issued a safety alert concerning patient burns associated with electric dental handpieces and electric oral bone-cutting hand-pieces. This was the second warning regarding these dental products.
The FDA first informed dental professionals of this problem in December 2007. Now they are again alerting dental professionals that 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. These burns range from first degree burns to third degree burns requiring reconstructive surgery.
In that December 12, 2007 notice, the FDA reminded users of the importance of properly maintaining the hand-pieces. The notice stated, “Dear Dental Health Professional: This is to inform you about serious patient injuries, including third degree burns associated with the use of poorly maintained electric dental hand-pieces, and to recommend specific actions to prevent or minimize the problem. While this notification is directed to dental health professionals, the following information may be useful to all users of electric handpieces.”
However, even since this notice, the FDA has received numerous additional reports of patients being burned by electric dental hand-pieces.
In this recent statement, the FDA states, “[a]s part of our ongoing investigation to address this continuing problem, the FDA is communicating our concerns to dental handpiece manufacturers.” On Aug. 20, 2010 the FDA sent letters to manufacturers of dental handpieces and electric oral bone cutting hand-pieces, 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 hand-piece 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 hand-pieces.
To prevent patient burns, the FDA is recommending that dental professionals do a number of specific things, including: increase vigilance about maintaining electric dental hand-pieces and electric oral bone cutting hand-pieces according to the manufacturer’s instructions; verify the proper routine service interval with the manufacturer based on the actual use of your electric dental hand-piece or electric intraoral bone cutting handpieces.
The FDA would like them to train personnel to properly clean and maintain the electric dental hand-piece or electric intraoral bone cutting handpiece, develop a method for tracking maintenance and routine service for each dental handpiece or electric intraoral bone cutting handpiece, and examine the electric dental hand-piece attachments and electric intraoral bone cutting handpiece attachments prior to use.
The FDA does not want dental profession to use worn drills, burs or poorly maintained electric dental handpieces or electric intraoral bone cutting hand-pieces when performing dental surgery on patients.