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Dental Handpieces and Other Devices Attached to Air and Waterlines

Update: CDC has released a statement on reprocessing dental handpieces.

How should dental handpieces and other devices attached to air and waterlines be reprocessed between patients?

Handpieces and other intraoral devices that can be removed from the air and waterlines of dental units should be cleaned and heat-sterilized between patients. Follow the manufacturer’s instructions for cleaning, lubricating, and sterilizing these devices. These devices include high-speed, low-speed, electric, endodontic, and surgical handpieces, as well as all handpiece motors and attachments, such as reusable prophylaxis angles, nose cones, and contra-angles.

If a dental handpiece cannot be heat sterilized and does not have FDA clearance with validated instructions for reprocessing, do not use that device. For more information, see CDC’s Statement on Reprocessing Dental Handpieces.

How should dental handpieces that are independent of dental unit air and waterlines be reprocessed between patients?

Handpieces that are independent of dental unit air and waterlines, such as cordless devices, should follow current US Food and Drug Administration (FDA) regulations. Use only FDA-cleared devices and follow the validated manufacturer’s instructions for reprocessing (cleaning, lubricating, and/or sterilizing) these devices.

If a dental handpiece cannot be heat sterilized and does not have FDA clearance with validated instructions for reprocessing, do not use that device. For more information, see CDC’s Statement on Reprocessing Dental Handpieces.

How can I find out if my dental handpiece is FDA-cleared?

FDA maintains a searchable database of devices intended for human use that must follow certain FDA regulations to be cleared for commercial distribution in the United States. Dental health care personnel can visit this site and search by multiple characteristics, such as device or applicant name.

How do I know if my dental handpiece has validated manufacturer’s instructions for use?

In 2015, FDA released updated guidance for reprocessing medical devices in health care settings [PDF – 805KB]. This guidance gives manufacturers of reusable medical devices recommendations on how to write and scientifically validate reprocessing instructions. Reusable devices that received FDA clearance before 2015 might not have reprocessing instructions that meet the requirements of the 2015 guidance. According to FDA, “reprocessing instructions for some older, legally-marketed, reusable devices may not be consistent with state-of-the-art science and therefore may not ensure that device is clean, disinfected, or sterile.”

Manufacturers must provide sufficient instructions on how to prepare devices for use on the next patient. If dentists are concerned about the validity of the manufacturer’s reprocessing instructions or believe that the instructions are not consistent with basic infection prevention and control principles, CDC recommends that they contact the manufacturer to request documentation of FDA clearance of the device in question. If the manufacturer is not able to provide sufficient information, dental health care personnel can contact FDA’s Office of Compliance at OCMedicalDeviceCo@fda.hhs.gov or (240) 402-7675 for assistance.

References

Centers for Disease Control and Prevention. Guidelines for infection control in dental health-care settings – 2003 [PDF – 1.21 MB]. MMWR Recomm Rep. 2003;52(RR-17):1–66.

Chin JR, Miller CH, Palenik CJ. Internal contamination of air-driven low-speed handpieces and attached prophy angles. J Am Dent Assoc. 2006;137:1275–1280.

Chin JR, Westerman AE, Palenik CJ, Eckert SG. Contamination of handpieces during pulpotomy therapy on primary teeth. Pediatr Dent. 2009;31:71–75.

US Food and Drug Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff [PDF – 805 KB]. Silver Spring, MD: US Food and Drug Administration, US Dept of Health and Human Services; 2015.

Harte JA, Molinari JA. Sterilization procedures and monitoring. In: Molinari JA, Harte JA, eds. Cottone’s Practical Infection Control in Dentistry. 3rd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2009:148–170.

Herd S, Chin J, Palenik CJ, Ofner S. The in vivo contamination of air-driven low-speed handpieces with prophylaxis angles. J Am Dent Assoc. 2007;138:1360–1365.

Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2008.

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