Q: Premier has recently introduced the AeroPro™ Cordless Prophy handpiece system and states that it is “CDC-Compliant.” Can you tell me more about what that means?
A: Important question, thank you for asking. In 2018, the Centers for Disease Control and Prevention issued a statement on “Reprocessing Dental Handpieces.”* It stated that, “CDC recognizes that the dental community requires clear, consistent guidelines on the best way to reprocess dental handpiece devices between patient encounters.” For dental handpieces that are connected to air and waterlines, these instruments should be cleaned and heat sterilized after each patient use. However, with the introduction of cordless prophy handpieces, the CDC recommends that dental healthcare providers follow FDA-cleared manufacturer instructions for use and reprocessing (cleaning, disinfection, and sterilization).
It is important to note that some prophy handpiece systems received clearance prior to the 2015 FDA document on reprocessing medical devices in healthcare settings. Dental healthcare providers who have older handpieces must be aware that the FDA states, “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.” In these cases, the manufacturer is responsible for providing appropriate instructions for preparing the device for next patient use.
In April 2019, Premier Dental Products launched the AeroPro™ Cordlesss Prophy Handpeice System with FDA-cleared and CDC-compliant instructions for reprocessing. According to the AeroPro Directions for Use “Infection Prevention Procedures,” the parts of the AeroPro™ system should be reprocessed as follows:
|Autoclavable Outer Sheath||Autoclave|
|Disposable Barriers||N/A Disposable|
|2pro™ Disposable Prophy Angles||N/A Disposable|
|O-rings||Follow instructions per component after replacement|
|O-ring Replacement Tool||Autoclave|
|NOTE: Sterilize the other sheath and the stand prior to each use. Additional outer sheaths and stands are available to purchase to accommodate uninterrupted patient procedures.|