SELF-STUDY SERIES Nonimplant load release


Routine load release guidance is split into two buckets: nonimplants and implants. Loads that do not contain an implant should be monitored using physical moni- tors (i.e., the print-out), chemical indicators, and may be monitored with a Process Challenge Device (PCD) containing: a BI; a BI and a Type 5 CI; a Type 5 CI; or a Type 6 CI. The use of the verb may, rather than the verb should, indicates the use of a PCD is optional for nonimplant loads. The decision about whether to release a load is made after evaluating the available data.


Implant load release


As biological indicators are the only moni- toring tool that demonstrate the lethality of the sterilization process, AAMI ST79:2017 continues to recommend that implant loads be monitored with a PCD containing a bio- logical indicator and a Type 5 integrating indicator. The implant should be quaran- tined until the BI result is available. (Sections 13.5.3.2 and 13.6.3) In defined emergency situations, the implant can be released on the basis of the Type 5 integrator contained with the PCD but the BI should still be incubated and the result documented. (Section 13.6.3) An example Exception Form for emergency load release documentation is provided in Annex K. This form continues to be a good tool to collect the reasons for emergency release. The collected data can be reviewed during quality improvement meetings so that mitigation measures can be identified and implemented.


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Routine efficacy monitoring The recommended frequency of monitor- ing steam sterilizers with a BI PCD did not change. AAMI ST79:2017 states: “A BI PCD should be used at least weekly and preferably daily.”(Section 13.6.1). Also unchanged is the recommendation that each type of cycle used be routinely monitored.(Section 13.7.1) While smaller clinics and dental offices elect to monitor daily or weekly, many larger facilities have adopted the best practice of every load monitoring to: ensure all implant loads are monitored; ensure each cycle type is monitored; simplify staff training; and minimize the impact of a recall. A small change to the guidance on routine biological monitoring of sterilizers larger than 2 cubic feet is that this section now recommends the use of commercially available PCDs with the rationale state- ment explaining that, “Commercially available disposable PCDs (BI challenge test packs) provide standardization and reduce variability and potential for error.”(Section 13.7.2.1)


Monitoring IUSS Cycles


Does your CSSD test the IUSS sterilizers located in the OR? AAMI ST79:2017 removed the separate section on routine biological monitoring of IUSS cycles. Other than dry time, for pre-vac cycles these sterilizers typically have the same sterilization parameters as those pro- grammed on sterilizers located in the CSSD. For guidance on routine monitor-


Table 1—Sterilization process monitoring recommendations Routine load release (see 13.5 and 13.6)


Nonimplants Physical monitoring of cycle


External and internal CI monitoring of packages


Optional monitoring of the load with a PCD containing one of the following:


• a BI


• a BI and a Type 5 integrat- ing indicator


• a Type 5 integrating indicator


• a Type 6 emulating indicator


Implants Physical monitoring of cycle


External and internal CI monitoring of packages


Monitoring of every load with a PCD containing a BI and a Type 5 integrating indicator


Physical monitoring of cycle


External and internal CI moni- toring of packages


Weekly, preferably daily (each day the sterilizer is used), moni- toring with a PCD containing a BI. (The PCD may also contain a CI.)


For sterilizers larger than 2 cubic feet and for table-top sterilizers, monitoring is done in a fully loaded chamber.


in IUSS cycles, monitoring may be done in an empty chamber.


For dynamic-air- removal sanitizers, daily Bowie-Dick testing in an empty chamber, if applicable (see 13.7.6).


Physical monitoring of cycle


External and internal CI monitoring of packages


For sterilizers larger than 2 cubic feet and for IUSS cycles, monitoring of three consecutive cycles in an empty chamber with a PCD containing a BI. (The PCD may also contain a CI.)


For table-top sterilizers, monitoring of three consecutive cycles in a fully loaded chamber with a PCD contain- ing a BI. (The PCD may also contain a CI.)


For dynamic-air- removal sanitizers, monitoring of three consecutive cycles in an empty chamber with a Bowie-Dick test pack, if applicable (see 13.7.6).


Note: See Section 15 for general guidelines on how to assess the specific label claims of new products that become commercially available. Reprinted with permission from AAMI. Copyright 2017.


46 October 2017 • HEALTHCARE PURCHASING NEWS • hpnonline.com Physical monitoring of cycle


Placement of Bls and Cls within product test samples


Routine sterilizer efficacy monitoring (see 13.7)


MONITORING IUSS STERILIZERS Previous editions of ST79 recommended end-user assembly of a representative BI PCD (typically a BI and a CI placed in an IUSS container) to monitor IUSS cycles. This new edition recommends use of a commercially available BI PCD for steril- izers larger than 2 cubic feet, which includes IUSS sterilizers. Bottom line: Routine efficacy monitoring of


dynamic-air-removal IUSS sterilizers should be done with a commercially available disposable BI PCD. Testing a loaded chamber is recommended,


however, as described in Table 1, for IUSS cycles, monitoring may be done in an empty chamber. Routine efficacy monitoring of gravity IUSS


sterilizers is done using a representative BI PCD assembled using the same type of tray that is routinely processed. (Section 13.7.4.1)


INTERNAL CHEMICAL INDICATORS The guidance on the use of internal chemical indicators is slightly modified and now reads, “One or more internal chemical indicators should be placed within each package, tray, or rigid container. These indicators can be any type (Type 3, 4, 5, or 6) but preferably a Type 5 or Type 6 indicator as these types of CIs provide the user with more information on the critical steam sterilization parameters.” (Section 13.5.2.2.2) This section goes on to state: “Internal CIs should be placed so that: a. one CI is visible to the person opening the package; b. CIs are in the area or areas considered least acces- sible to steam penetration; and c. all applicable written IFU are followed.”


Sterilizer qualification testing (after installation, relocation, mal- functions, major repairs, steriliza- tion process failures) (see 13.8)


Periodic product quality assurance testing (see 13.9)


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