FDA Guidelines for Reprocessing Handpieces

FDA Guidelines for Reprocessing Handpieces

Although the principles of infection control remain unchanged; new technologies, materials, equipment, and data require continuous evaluation of current infection control practices. The unique nature of many dental practices, client care, and instruments may also require specific strategies directed to preventing pathogen transmission among dental health care personnel and their patients.

Last year the FDA released an updated statement to their 2015 guideline on Reprocessing Medical Devices in Health Care Settings. Although the guidelines were published with manufacturers in mind, the consumer needs to be aware of them for the safety of themselves and their patients. The guideline states the proper techniques for reprocessing your instruments, along with the validation methods and labeling procedures.  It also reports that each handpiece or instrument that can be removed from the water or air lines can become contaminated and must be cleaned and sterilized. If it cannot be heat sterilized the manufacturer should provide you with instructions on the proper techniques to use in between patient care.

The guidelines set forth by the FDA may constitute a problem for any reusable device manufactured before 2015. Although the FDA does recommend following the manufacturer’s instructions on cleaning and sterilizing if the instructions were published before 2015 there is no guarantee that they meet the new FDA Guidelines, unless specifically stated.

If you do have a dental handpiece that cannot be heat sterilized and does not have current FDA clearance with validated instructions for reprocessing, that device should not be used.  All manufacturers should have the proper documentation needed, and available if you have any questions on whether or not your device is cleared by the FDA.

Appendix E (starts on page 38) published in June 2017 includes a list of devices that require updated validation data as per the new regulations.  It was deemed that the devices listed pose a greater likelihood of microbial transmission. 

The Discount Disposables team stays on top of industry standards and recommendations and can help you with all of your infection control needs. 

https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf

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