FDA renews warnings of patient burns from handpieces

2009 07 28 13 33 39 581 Fda Logo 70

The U.S. FDA has issued a safety alert to dental practitioners and dental handpiece manufacturers following new reports of patients being burned by handpieces that overheat during treatment.

The agency first informed dental professionals of this problem in 2007. In that notice, the FDA reminded users of the importance of properly maintaining the handpieces.

Since that notice, however, the FDA said it has received numerous additional reports of patients being burned by electric handpieces. The burns range from first-degree burns to third-degree burns requiring reconstructive surgery.

“It is not limited to a specific manufacturer.”
— Karen Riley, FDA spokesperson

"Patients have been severely burned when these handpieces have overheated," said Karen Riley, a spokesperson with the FDA's Office of Public Affairs. "We've received a number of adverse event reports about this. And it is not limited to a specific manufacturer."

The overheating can occur during any dental procedure, she noted, and the 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 its ongoing investigation to address this problem, the FDA has also contacted the manufacturers of electric handpieces and oral bone-cutting handpieces. Last month the agency sent letters to these manufacturers requesting assistance with correcting problems associated with these devices and asking them to 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.
  • 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.

The FDA recommends that practitioners who suspect problems associated with the use of electric handpieces in their practices file a voluntary report through MedWatch, the agency's Safety Information and Adverse Event Reporting Program.

The FDA also recommends that dental practitioners:

  • Be vigilant about maintaining electric dental handpieces and electric oral bone-cutting handpieces according to the manufacturer's instructions.
  • Verify with the manufacturer the appropriate routine service interval for your dental practice, based on the actual use of your electric dental handpieces or electric intraoral bone-cutting handpieces.
  • Train personnel to properly clean and maintain the electric dental handpieces or electric intraoral bone-cutting handpieces.
  • Develop a method for tracking maintenance and routine service for each dental handpiece or electric intraoral bone-cutting handpiece.
  • Examine the electric dental handpiece attachments and electric intraoral bone-cutting handpiece attachments prior to use. Do not use worn drills or burs.
  • Do not use poorly maintained electric dental handpieces or electric intraoral bone-cutting handpieces.
  • Report overheating to the manufacturer.

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