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BI has been inactivated strongly implies that other potential patho- gens in the load have been killed.”2


So, sterilization processes are


intended to kill microorganisms, and BIs are the only monitoring device that directly measures the success of the process. While the large numbers of highly resistant spores do present a significant challenge to the sterilization process, it is important to remember that the sterilization cycles validated by the sterilizer manufacturers and cleared by the Food and Drug Administration (FD) are required to be very robust with a significant amount of overkill, or safety factor, built into the cycle. Sterilization processes that are operating correctly have enough overkill to easily inactivate all BIs. If a BI is positive, it means something went wrong in the process resulting in the sterilization process failure.


So, how do you know if the BI is creating the correct challenge to the process? BI per- formance requirements for most steriliza- tion processes are defined in international standards.3


SELF-STUDY SERIES


sterilization loads that contain implants than for loads that do not contain implants.


Steam sterilization - practices for using BIs for load release Best practices for sterilization quality control recommend using physical monitoring, chemical indicators, and BIs and consolidat- ing the information from all three to help decide if the sterilization process was successful and the instruments are safe for patient use. Table 1 reviews the recommended testing plan for load release for steam sterilization:


Table 1 – Load release testing – steam sterilization Loads containing implants Loads without implants Every cycle


Physical monitoring Every cycle


External (process) CI On the outside of every package On the outside of every package Internal (pack) CI PCD Testing


Inside every package


Compliance with these stan- dards should be noted on the BI’s instruc- tions for use (IF) or quality certificates. In addition, regulators like the FD will require BI manufacturers to define and control the challenge presented by their BIs, especially for processes not covered by the international standards [e.g., vaporized hydrogen peroxide (VH2


O2 )].


common sterilization processes used in healthcare facilities today. The Association for the Advancement of Medical Instrumentation (AAMI) publishes standards that specify best practices for all aspects of medical device reprocessing using these sterilization methods. These practice standards are AAMI ST794 and AAMI ST585


Recommended practices for use of BIs Steam and vaporized hydrogen peroxide (VH2


O2 for steam


monitoring recommendations from these standards in a moment. But first, we’ll take a minute to review a couple of terms used in the recommendations.


for VH2 O2


Process challenge devices (PCDs) In an ideal world, BIs would be placed inside of packs next to the instruments, so they could measure the lethality of the process precisely where the instruments are located. This, of course, is impossible from both a logistics and a cost standpoint. Instead, BIs are placed inside of PCDs. The intent of the PCD is to create a physical barrier that will slow down access of the sterilant to the BI, as if the BI were inside


Implant loads


Improperly sterilized implantable devices can present a greater risk of infection than other devices that are only in contact with the patient for short periods of time during the surgical pro- cedure. For this reason, recommended practices specify more frequent use of BIs (for a higher level of quality control) for


sterilization. We will review the BI


VH2 VH2


O2


ization processes, but the quality control testing recommendations are similar. Table 2 reviews the recommended testing plan for load release for VH2


O2 O2 sterilization:


Table 2 – Load release testing – vaporized hydrogen peroxide sterilization Loads containing implants Loads without implants Every cycle


Physical monitoring Every cycle


External (process) CI On the outside of every package On the outside of every package Internal (pack) CI


Inside every package PCD (load challenge) BI/PCD in every load


a pack. PCDs are easily retrieved by the sterile processing team and the BI testing can be started immediately.


Inside every package BI/PCD daily, preferably every load


Reference: ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in healthcare facilities. 2013. The recommendations for VH2


between implant and non-implant loads. However, there is no Type 5 chemical integrator requirement for VH2


O2


integrators are not defined for 2 healthcare facilities test every VH2


O2 O2


sterilization. Again, many load with a BI.


testing also differentiate O2


, as Type 5


Positive BIs – sterile processing mysteries A positive BI means there has been a sterilization process failure. Facility policies and procedures should specify all of the actions


Page 34 hpnonline.com • HEALTHCARE PURCHASING NEWS • April 2021 33


sterilization - practices for using BIs for load release sterilization processes are more complex than steam steril-


) are the most


PCD with BI and Type 5 CI: In every load


Inside every package


Optional use: PCD with BI, BI + Type 5 CI, Type 5 CI, or Type 6 CI


Reference: ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.2017. The BI testing recommendation for loads containing implants


is to test every cycle with a PCD containing a BI and a Type 5 chemical integrator. This is considered the highest level of quality control as every cycle is tested with a BI, and the Type 5 chemical integrator is present as an option for immediate release of the instruments if there is an emergency (the BI result must still be obtained, however). Testing recommendations for loads without implants are not as rigorous as those for implant loads, with optional use of a PCD that may or may not contain a BI. Many healthcare facilities have chosen to monitor all steam loads (with and without implants) with a BI PCD to achieve a uniform standard of care, to reduce the costs of a recall, and to reduce monitoring errors.


Self-Study Test Answers: 1. B, 2. A, 3. A, 4. B, 5. A, 6. A, 7. B, 8. A, 9. B, 10. A


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