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FAQ - Instrument Processing - 2016
 FAQ - Instrument Processing - 2016



I am working with several orthodontic offices on compliance with the March 2016 update.  One of the areas we are struggling with implementation is the sterilization and disinfection recommendation: Label sterilized items with the sterilizer used, the cycle or load number, the date of sterilization, and (if applicable) the expiration date

Does this apply to all instruments?  Or critical instruments?  And what if the office is not packaging prior to sterilization as is acceptable in some states?

A copy of the 2003 CDC guidelines for infection control in dentistry can be accessed at this link:    1

 These infection control guidelines state in part:

Patient-care items (dental instruments, devices, and equipment) are categorized as critical, semicritical, or noncritical, depending on the potential risk for infection associated with their intended use (Table 4) (242). Critical items used to penetrate soft tissue or bone have the greatest risk of transmitting infection and should be sterilized by heat. Semicritical items touch mucous membranes or nonintact skin and have a lower risk of transmission; because the majority of semicritical items in dentistry are heat-tolerant, they also should be sterilized by using heat. If a semicritical item is heat-sensitive, it should, at a minimum, be processed with high-level disinfection (2).

Noncritical patient-care items pose the least risk of transmission of infection, contacting only intact skin, which can serve as an effective barrier to microorganisms. In the majority of cases, cleaning, or if visibly soiled, cleaning followed by disinfection with an EPA-registered hospital disinfectant is adequate. When the item is visibly contaminated with blood or OPIM, an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant) should be used (2,243,244). Cleaning or disinfection of certain noncritical patient-care items can be difficult or damage the surfaces; therefore, use of disposable barrier protection of these surfaces might be a preferred alternative.

FDA-cleared sterilant/high-level disinfectants and EPA registered disinfectants must have clear label claims for intended use, and manufacturer instructions for use must be followed (245). A more complete description of the regulatory framework in the United States by which liquid chemical germicides are evaluated and regulated is included (Appendix A).

Three levels of disinfection, high, intermediate, and low, are used for patient-care devices that do not require sterility and two levels, intermediate and low, for environmental surfaces (242). The intended use of the patient-care item should determine the recommended level of disinfection. Dental practices should follow the product manufacturer’s directions regarding concentrations and exposure time for disinfectant activity relative to the surface to be disinfected (245). A summary of sterilizationand disinfection methods is included (Appendix C). 1


Sterilization of Unwrapped Instruments. An unwrapped cycle (sometimes called flash sterilization) is a method for sterilizing unwrapped patient-care items for immediate use. The time required for unwrapped sterilization cycles depends on the type of sterilizer and the type of item (i.e., porous or nonporous) to be sterilized (243). The unwrapped cycle in tabletop sterilizers is preprogrammed by the manufacturer to a specific time and temperature setting and can include a drying phase at the end to produce a dry instrument with much of the heat dissipated. If the drying phase requirements are unclear, the operation manual or manufacturer of the sterilizer should be consulted. If the unwrapped sterilization cycle in a steam sterilizer does not include a drying phase, or has only a minimal drying phase, items retrieved from the sterilizer will be hot and wet, making aseptic transport to the point of use more difficult. For dry-heat and chemical-vapor sterilizers, a drying phase is not required.

Unwrapped sterilization should be used only under certain conditions: 1) thorough cleaning and drying of instruments precedes the unwrapped sterilization cycle; 2) mechanical monitors are checked and chemical indicators used for each cycle; 3) care is taken to avoid thermal injury to DHCP or patients; and 4) items are transported aseptically to the point of use to maintain sterility (134,258,262). Because all implantable devices should be quarantined after sterilization until the results of biological monitoring are known, unwrapped or flash sterilization of implantable items is not recommended (134).

Critical instruments sterilized unwrapped should be transferred immediately by using aseptic technique, from the sterilizer to the actual point of use. Critical instruments should not be stored unwrapped (260). Semicritical instruments that are sterilized unwrapped on a tray or in a container system should be used immediately or within a short time. When sterile items are open to the air, they will eventually become contaminated. Storage, even temporary, of unwrapped semicritical instruments is discouraged because it permits exposure to dust, airborne organisms, and other unnecessary contamination before use on a patient (260). A carefully written protocol for minimizing the risk of contaminating unwrapped instruments should be prepared and followed (260) 1

Summary of Infection Prevention Practices in Dental Settings Basic Expectations for Safe Care can be accessed at:    2

This document states:

After cleaning, dried instruments should be inspected, wrapped, packaged, or placed into container systems before heat sterilization. Packages should be labeled to show the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date. This information can help in retrieving processed items in the event of an instrument processing / sterilization failure. 2

In summary, the classes of patient care items that require heat sterilization have been described. When patient care items that require heat sterilization have been packaged, items that should appear on the package label have been described. The sterilization of unwrapped dental instruments has also been referenced. Any further questions on this topic should be directed to your state dental board/dental licensing agency and/or your state public health agency (i.e., state health department). It should be noted that there may also be state specific requirements.


1)     Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM, Centers for Disease Control and Prevention (CDC). Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep 2003;52(RR-17):1-61.    Accessed on September 16, 2016.

2)     US 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.   Accessed on September 19, 2016.





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