SELF-STUDY SERIES Sponsored by


June 2023 The self-study lesson on this central service topic was developed by 3M Health Care. The lessons are administered by Endeavor Healthcare Media.


Earn CEUs After careful study of the lesson, complete the examination at the end of this section. Mail the completed test and scoring fee to Healthcare Purchasing News for grading. We will notify you if you have a passing score of 70% or higher, and you will receive a certifi - cate of completion within 30 days. Previous lessons are available at www.hpnonline.com.


Certifi cation The CBSPD (Certifi cation Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of fi ve (5) years from the date of original publication. Successful


completion of the lesson and post-test must be documented by facility management and those records maintained by the individual until recertifi cation is required. DO NOT SEND LES- SON OR TEST TO CBSPD. For additional infor- mation regarding certifi cation, contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.cbspd.net.


HSPA (Healthcare Sterile Processing Associa- tion, https://myhspa.org) ) has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years, until May 13, 2026. The approval number for this lesson is 3M-HPN 231305.


For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.


LEARNING OBJECTIVES


1. Identify the performance characteristics of a biological indicator.


2. Explain how Rapid Readout biological indicators detect sterilization process failures.


3. Discuss what a marginal sterilization process is.


4. Develop policy and procedures for the appropriate use of biological indicators.


Sponsored by: Figure 1. Brealout of biological indicator 40 June 2023 • HEALTHCARE PURCHASING NEWS • hpnonline.com


Positive biological indicators


by Nikki Kluck, Gale Havrilla, Martha Young P


ositive biological indicators (BI) set in motion the recall of all medical devices processed since the last


negative BI, an analysis of what caused the failure, correction of those causes, and retesting of the sterilizer before it is put back into routine use.1


The purpose of the


BI is to identify when microorganisms are not killed, which is a sterilization process failure. So, when you get a positive BI the appropriate question to ask is: what changed or was different about this ster- ilization process that the microorganisms were not killed?


Defi nition and performance characteristics of biological indicators


The Association for the Advancement of Medical Instrumentation (AAMI) defi nes a biological indicator as a “device intended for use by a health care provider to accom- pany products being sterilized through a sterilization procedure and to monitor ade- quacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of steriliza- tion, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.”1


A BI consists of a calibrated population of bacterial spores of a high resistance to the mode of sterilization being monitored. For example, Geobacillus stearothermophilus is the most resistant spore for steam steriliza- tion, hydrogen peroxide gas plasma and ozone sterilization. Bacillus atrophaeus is


the most resistant spore for ethylene oxide (EO) sterilization. In some BI confi gura- tions, spores are coated on a carrier, which is enclosed in a plastic vial containing a crushable glass media ampoule and cap that allows the sterilant to penetrate into the plastic vial, killing the spores and dem- onstrating whether sterilization conditions were met. This is called a self-contained biological indicator; Figure 1, below, shows the components of an exemplary BI. The performance characteristics of a


BI are defi ned in the Association for the Advancement of Medical instrumentation (AAMI) standards.2,3


BI performance is


based on spore population, D-value and survival/kill values. See Table 1 (next page) for an example of BI performance data for steam sterilization and Table 2 (next page) for BI performance data for EO sterilization. This data is included in a Quality Assurance Certifi cation that is found in each box of product. The labeling of a BI will state which sterilization cycle the BI can be used for, which spore is contained on the carrier, and what the population of the spores is. The population is expressed as the mean number of spores per strip and the term colony forming unit (CFU) is used. If the population is listed as 3.7x106 CFU, there are 3,700,000 spores on the carrier. In order to be an appropriate challenge for the ster- ilization process, the population of spores must not be less than 1x106 CFU for EO sterilization processes and 1x105 CFU for steam sterilization processes.2,3


A BI with


a spore count less than these would not be considered an appropriate challenge.


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