The CDC has finally come out with guidance about handpieces and sterilization. We have been waiting for this for a long time. Our company has always advocated sterilization of handpieces between patients and for good reason. Basically, the CDC recommends (which most if not all State Dental Boards interpret as law) that you should be heat sterilizing your handpieces and other intraoral instruments that can be removed from air and water lines between each patient use. (see the article below)
If you have any questions about this or need help teaching proper sterilization techniques to your staff, please give us a call. 817-755-0035. The only shame is asking for help- is in asking for help after it is too late. Patient safety first.
CDC recognizes that the dental community requires clear, consistent guidelines on the best way to reprocess dental handpiece devices between patient encounters. CDC guidelines for infection prevention and control state that, between patients, dental health care personnel (DHCP) should clean and heat-sterilize handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units.1 This recommendation is based on studies that have shown that the internal components of air-driven dental handpieces (both low-speed and high-speed devices) can become contaminated with patient material during use, and this material can then be expelled into the mouth of other patients during subsequent uses.2–5 For handpieces and other intraoral instruments that can be removed from the air and waterlines of dental units, CDC continues to recommend that DHCP follow CDC guidelines to clean and heat sterilize.
Dental handpieces are medical devices regulated by the US Food and Drug Administration (FDA). Some handpieces are independent of air and waterlines (e.g., cordless devices). For these devices, CDC recommends that DHCP follow current FDA regulations. DHCP should use FDA-cleared devices6 and follow the validated manufacturer’s instructions for use for reprocessing (cleaning, lubricating, and/or sterilizing) these devices.7
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.” It is incumbent upon the device manufacturer to provide sufficient instructions on how to prepare devices for use on the next patient.
If a dental handpiece cannot be heat sterilized and does not have FDA clearance with validated instructions for reprocessing, DHCP should not use that device.7 If DHCP are concerned about the validity of the manufacturer’s instructions for reprocessing or believe that the instructions are not consistent with basic infection prevention and control principles, they should contact the manufacturer to request documentation of FDA clearance. If the manufacturer is not able to provide sufficient information, DHCP can contact FDA’s Office of Compliance at OCMedicalDeviceCo@fda.hhs.gov or (240) 402-7675 for assistance.
Dental Compliance Specialists, LLC is the Premier Dental Health Compliance and Quality Assurance provider in the country. We help Dentists develop and maintain compliance programs with the goal of keeping them out of the regulatory limelight. We have in-office and virtual programs all catered to the Provider’s specific needs. Dental Healthcare Compliance includes: DEA, ICE/Homeland Security, OIG, OSHA, HIPAA, Infection Control, Auditing and Monitoring, Record Auditing, employee training, Radiology Compliance, Medicaid Compliance and more…It’s not just about OSHA anymore! Give us a call 817-755-0035.