By Dr. Katherine Schrubbe, RDH, BS, MEd, PhD.
Compliance with CDC guidelines for reprocessing is vital to the safety of the dental staff and patients.
There seems to be a lot of buzz about dental handpieces these days. For whatever reason, the question of reprocessing these devices for patient use is once again a popular conversation in dental practices. Dental handpieces are medical devices accompanied by instructions for use (IFU). As discussed in a previous article, IFU are provided for medical devices and products in accordance with federal Food and Drug Administration (FDA) standards and provide information on cleaning, disinfection and 1 In any dental setting, IFUs must be strictly followed to ensure patient safety, as well as peak performance of the devices. Whether the organization is a DSO, a large group practice or a solo practice, there must be a sufficient number of instruments to serve the patient schedules in order to avoid shortcuts in reprocessing.
sterilization of patient care items.
Categories of patient care items
The Centers for Disease Control and Prevention sorts patient care items into three categories (referred to as the Spaulding classification), based on the potential risk for infection associated with their intended use: critical, semicritical or noncritical.2,3
Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings – 2003. MMWR 2003;52(No. RR-17); 20.
At the ends of the spectrum are the critical and noncritical patient care items. According to the CDC, all critical items should be heat sterilized between patient use, as they have the greatest risk of transmitting infection. Noncritical items, which pose the least risk of disease transmission, should be cleaned and disinfected with an EPA-registered hospital disinfectant.2,4
In the middle of the spectrum are semicritical items. These items come in contact with mucous – or non-intact – membranes, but they do not penetrate soft tissue, contact bone, the bloodstream or other normally sterile tissues.2
Dental handpieces are considered semicritical items. The CDC states, “dental handpieces and associated attachments, including low-speed motors and reusable prophylaxis angles, should always be heat sterilized between patients and not high-level or surface disinfected. Although these devices are considered semicritical, studies have shown that their internal surfaces can become contaminated with patient materials during use. If these devices are not properly cleaned and heat sterilized, the next patient may be exposed to potentially infectious materials.”4,5,6
In other words, there are no shortcuts to patient safety around handpieces, including low-speed motors use primarily for hygiene appointments. Eleven states require heat sterilization of dental handpieces: California, Florida, Indiana, Kansas, Missouri, New Mexico, Ohio, Oregon, South Carolina, Virginia, and Washington.7 And, the CDC guidelines fully apply in the remaining 39 states. Additional guidance from the CDC states, “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.”8
The updated guidance from the CDC provides a 3-point summary:
- Clean and heat sterilize handpieces and other intraoral instruments that can be removed from the air lines and waterlines of dental units.
- For handpieces that do not attach to air lines and waterlines, use FDA-cleared devices and follow the validated manufacturer’s instructions for reprocessing 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.9
|Dr. Katherine Schrubbe, RDH, BS, M.Ed, PhD|
- Schrubbe K. Instructions for use. Efficiency in Group Practice. Available at http://www.dentalgrouppractice.com/instructions-for-use.html. Accessed April 24, 2018.
- Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings — 2003. MMWR 2003;52(No. RR-17); 20.
- Miller CH, Palenik CJ. Infection Control and Management of Hazardous Materials for the Dental Team. 5th ed. St. Louis: Mosby Elsevier; 2013; 122.
- Centers for Disease Control and Prevention. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Oral Health, March 2016.
- Chin J.R., Miller C.H., Palenik, C.J. (2006). Internal contamination of air-driven low-speed handpieces and attached prophy angles. J Am Dent Assoc. 137(9):1275-80. Available at http://www.ncbi.nlm.nih.gov/pubmed/16946433. Accessed May 10, 2018.
- American Dental Association. Oral health topics; infection control. Available at https://www.ada.org/en/member-center/oral-health-topics/infection-control-resources. Accessed May 10, 2018.
- The Dental Student Network list of state licensing agencies. Available at http://www.studentdoctor.net/dental/state_boards.html. Accessed April 24, 2018.
- Centers for Disease Control and Prevention. Dental Handpieces and Other Devices Attached to Air and Waterlines. Available at https://www.cdc.gov/oralhealth/infectioncontrol/questions/dental-handpieces.html. Accessed May 10, 2018.
- Centers for Disease Control and Prevention. Statement on Reprocessing Dental Handpieces, April 11, 2018. Available at https://www.cdc.gov/oralhealth/infectioncontrol/statement-on-reprocessing-dental-handpieces.htm. Accessed May 10, 2018.
- US Department of Health and Human Services. Public Health Service Food and Drug
Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. March 17, 2015. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf. Accessed May 10, 2018.
- Vavrosky K. 5 infection control mistakes you may be making and not even realize. Dental Products Report, July 11, 2016. Available at http://www.dentalproductsreport.com/hygiene/article/5-infection-control-mistakes-you-may-be-making-and-not-even-realize?page=0,1. Accessed May 10, 2018.