Single-Use (Disposable) Devices
According to the Food and Drug Administration’s (FDA’s) guidance entitled Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitalsexternal icon, “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 (cleaned, disinfected/sterilized) and used on another patient. The labeling may or may not identify the device as single-use or disposable and does not include instructions for reprocessing.”
If a device does not have reprocessing instructions, it should be considered single-use and disposed of after one use, in accordance with local waste management system regulations.
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.
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.
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. If such devices do not have reprocessing instructions, they should be considered single-use.
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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 icon[PDF – 45KB]external icon. 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 icon[PDF – 1.26 MB]. Accessed March 14, 2016.
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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=10051external icon. Accessed March 14, 2016.