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Single-Use (Disposable) Devices

What is a single-use device?

According to the Food and Drug Administration a single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized) and used on trays. The labeling may not identify the device as single-use or disposable. If a device does not have reprocessing instructions, regardless of labeling, it should be considered single-use and disposed of appropriately (i.e., according to federal, state, and local regulations) after one use.

Using disposable items improves patient safety by eliminating the risk of patient-to-patient contamination because the item is discarded and not used on another patient. Any single-use device or item for use during oral surgical procedures, such as gauze, irrigating syringes, syringe needles, and scalpel blades, should be sterile at the time of use.

Some disposable items have heat-tolerant alternatives; is one better than the other?

Sometimes disposable patient-care items have reusable heat-tolerant alternatives. This is often true for prophylaxis angles, high-volume evacuator tips, impression trays, dental burs, and air and water syringe tips. In many instances, the reusable version of these items is hard to clean adequately, and it may be safer, easier, and more cost-effective to use the disposable version. When determining the cost-effectiveness of disposable and reusable items, dental health care personnel should consider not only the cost of the disposable item, but also the cost, time, and materials involved with cleaning and reprocessing the reusable item.

Do single-use items have special disposal requirements?

Most single-use (disposable) items used in dental settings can be discarded with the regular trash. Some single-use items meet the definition of regulated medical waste and require special handling and disposal according to federal, state, and local rules and regulations. For example, solid waste soaked or saturated with blood or saliva (e.g., gauze saturated with blood after surgery that would release blood when squeezed or compressed; gauze caked with dried blood that may be released during handling) and contaminated sharp items such as needles and scalpel blades would be considered regulated waste.

A single leak-resistant biohazard bag is usually adequate for containment of non-sharp regulated medical waste, provided the bag is sturdy and the waste can be discarded without contaminating the bag’s exterior and can be securely closed for disposal. Puncture-resistant containers with a biohazard label, located at the point of use (i.e., sharps containers), are used to dispose of sharp items.

Are burs and endodontic files single-use items?

Some devices―such as burs, endodontic files, and broaches―may be practical to consider single-use because the way they are constructed makes them hard to clean. In addition, cleaning and heat sterilization can lead to deterioration on the cutting surfaces and raise the potential for breakage during patient treatment. The Food and Drug Administration (FDA) considers all diamond-coated burs and scaler tips single-use unless their manufacturers have submitted a 510(k) for reprocessing. FDA maintains a searchable database for 510(k) premarket notifications.

Dental health care personnel (DHCP) should always refer to manufacturer instructions to determine if a device is single-use. If a device does not have validated reprocessing (i.e., cleaning and disinfection or sterilization) instructions, it is considered single-use (i.e., disposable). If DHCP have a question about product labeling, manufacturer instructions, or whether manufacturer instructions should have been included with a product, they should contact the manufacturer directly.

References

CDC. Guidelines for infection control in dental health-care settings – 2003. MMWR 2003; 52(No. RR-17):1–66. Available at: https://www.cdc.gov/mmwr/PDF/rr/rr5217.pdf.

Food and Drug Administration. Labeling recommendations for single-use devices reprocessed by third parties and hospitals; final guidance for industry and FDA. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2001. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071069.pdf [PDF – 45KB].  Accessed March 14, 2016.

Miller CH, Palenik CJ. Aseptic Techniques. In: Miller CH, Palenik DJ, eds. Infection Control and Management of Hazardous Materials for the Dental Team, 4th ed St. Louis: Mosby: 2009:201–206.

Harte JA, Molinari JA. Role for Single-Use Disposable Items. In: Molinari JA, Harte JA eds. Cottone’s Practical Infection Control in Dentistry, 3rd ed. Baltimore: Lippincott Williams & Wilkins, 2009:232–236.

Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities, 2008:1–158. https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf [PDF – 1.26 MB].  Accessed March 14, 2016.

Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee. 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings 2007:1–219. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf [PDF – 1.4MB].  Accessed March 14, 2016.

US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens: Needlestick and Other Sharps Injuries: Final Rule. Federal Register 2001;66:5317–5325. Updated from and including 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56:64003–64182. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.  Accessed March 14, 2016.

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