CDA Practice Support often receives calls from members who have questions about reprocessing dental handpieces, which as medical devices are regulated by the Food and Drug Administration.
Recognizing the dental community’s need for clear and consistent guidance on this subject, the Centers for Disease Control recently issued a statement
pointing to its current recommendations.
“CDC guidelines for infection prevention and control state that, between patients, dental health care personnel should clean and heat-sterilize handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units,” the statement reads. The CDC explains that this recommendation is based on studies indicating that “retained patient material can be expelled intraorally during subsequent uses.”
Also, from the California Code of Regulations on minimum standards for infection control
: “All high-speed dental handpieces, low-speed handpieces, rotary components, and dental unit attachments such as reusable air/water syringe tips and ultrasonic scaler tips, shall be packaged, labeled and heat-sterilized in a manner consistent with the same sterilization practices as a semi-critical item.”
The detachable handpieces can be sterilized through autoclaving, dry heat or unsaturated chemical vapor according to the manufacturer’s specified sterilization time, pressure and temperature.
For cordless dental handpieces that function independently of airlines and waterlines, the CDC recommends that dental care providers follow current FDA regulations for cleaning these devices, which call for using only “FDA-cleared devices” and following the manufacturer’s directions on cleaning, lubricating and sterilizing them. Manufacturers are instructed to follow the FDA’s 2015 guidance on writing reprocessing instructions that have been scientifically validated. Providers who have concerns about the validity of these instructions can either contact the manufacturer or, if that fails, contact the FDA’s Office of Compliance.
Handpieces that cannot tolerate high temperatures and therefore cannot be heat-sterilized, as well as those that have not been cleared by the FDA, should not be used.
“These infection control guidelines should be followed in every dental office,” says CDA Regulatory Compliance Analyst Teresa Pichay, who recommends that offices as a best practice designate one team member to monitor infection prevention protocols and ensure that the personnel adhere to them.
Pichay also recommends the CDC’s DentalCheck app
to help offices stay on top of infection control best practices. The CDC used its “Infection Prevention Checklist for Dental Settings” to develop the app, which covers cleaning and sterilization of handpieces and includes easy “yes-no” checkboxes to indicate compliance.
Reference the CDC statement and infection control guidelines
for the dental office. For CDA Practice Support resources on infection control, visit cda.org/resourcelibrary