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U.S. Department of Health and Human Services

Medical Devices

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Safety Investigation of Patient Burns Associated with Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces

Date issued:
Sept 23, 2010

Audiences:
Dentists, Dental Hygienists, Dental Assistants

Devices:
Electric dental handpieces and electric oral bone-cutting handpieces are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. For the purposes of this communication, is the term “handpiece” includes the motor, contrangle, and burr.

SUMMARY OF PROBLEM AND SCOPE
The FDA is 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.

The FDA first informed dental professionals of this problem in 2007 (see Public Health Notification: Patient Burns from Electric Dental Handpieces). In that notice, the FDA reminded users of the importance of properly maintaining the handpieces. Since the notice, the FDA has received numerous additional reports of patients being burned by electric dental handpieces.

RECOMMENDATIONS
The FDA is recommending that dental professionals:

  • 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 handpiece or electric intraoral bone cutting handpieces.
  • Train personnel to properly clean and maintain the electric dental handpiece 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.
  • 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.

FDA ACTIVITIES
As 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 handpieces, requesting assistance with correcting problems associated with these devices [Notice of Safety Concern for Electric Dental Handpieces and Accessories and Notice of Safety Concern for Electric Oral Bone Cutting Handpieces and Accessories].

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.

HOW TO REPORT PROBLEMS TO THE FDA
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical products. If you suspect problems with associated with the use of electric dental handpieces, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA):

Email: DSMICA@CDRH.FDA.GOV
Phone: 800-638-2041 (toll free) or 301-796-7100