HEALTHCARE SELF-STUDY SERIES N
PURCHASING EWS
April 2021 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 percent 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 (Certification 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 publica- tion. 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 LESSON OR TEST TO CBSPD. For additional information regarding certifi cation, contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.
sterileprocessing.org.
IAHCSMM (International Association of Health-
care Central Service Materiel Management) has pre-approved this in-service for 1.0 Continu-
ing Education Credits for a period of three years, until March 2, 2024. The approval number for this lesson is 3M-HPN 210303
.
For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.
LEARNING OBJECTIVES
1. Examine the science behind and the information provided by BIs.
2. Review current recommended practices for the use of BIs.
3. Discuss positive BI troubleshooting success stories. by Craig Wallace
Sterile processing mysteries: The story of the positive BI
as this happened in your sterile processing department? It’s a busy day, lots of surgeries scheduled, the department is humming and every- thing’s great until . . . you get a positive BI (BI) in one of your sterilizers. Why is it posi- tive? What does it mean? BIs are complex devices that measure the lethality (killing power) of the sterilization process. If the BI is positive, there was a problem in the cycle. Today, we’ll take a closer look at how BIs work, and how you should use them to make sure your sterilization processes are working correctly. We’ll fi nish with some stories about real-life BI positives and how the sterile processing team solved these sterile processing mysteries.
H
BI basics International standards defi ne a BI as a “test system containing viable microor- ganisms providing a defi ned resistance to a specifi ed sterilization process”1
The
key part of this defi nition are the words “viable microorganisms.” BIs contain a large number of viable (living) microorgan- isms. The microorganisms used in BIs are bacterial spores. A few kinds of bacteria can change themselves into spores as a sort of self-preservation tool, to allow the bacteria to survive when conditions are toxic or not favorable for growth. Spores are like hard, dry seeds that are biologically dormant, and they are very stable and hard to kill. BIscontain a large number of these highly resistant spores to create a signifi cant chal- lenge for the sterilization process. BIs used in healthcare today are called self-contained BIs (SCBIs). Self-contained means that all the components required for the BI test are held within the indicator so there is no need for a microbiology lab to read the results. The basic components of a typical SCBI are shown in Figure 1.
BIs require incubation, which means exposure to heat over a defi ned period of time. During incubation, any surviving spores turn back into regular bacterial cells, and then start to grow. You incubate a BI to fi nd out if the sterilization process operated correctly and all the spores are dead, or if there was a sterilization process failure and some of the spores survived. But how can you tell if any spores survived or not? You need a signal from the BI that tells you what is happening.
Manufacturers design their BIs to pro- duce a signal that you can easily recognize to indicate if the BI is positive or negative. The simplest design has a pH indicator in the growth medium that will change color if bacteria are growing (positive BI). Today’s rapid readout BIs leverage early biochemical activity from surviving spores coupled with specialized fl uorescent indi- cators in the growth medium to produce a fl uorescence. This fl uorescence is measured by an incubator/reader device that then indicates a positive or negative BI result on the reader.
A simple explanation of the value of BIs and the basic assumption for BI testing is clearly stated by the Centers for Disease Control and Prevention (CDC) in their Guideline for Disinfection and Steriliza- tion in Health Care Facilities: “BIsare recognized by most authorities as being closest to the ideal monitors of the steril- ization process because they measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacil- lus spores), and not by merely testing the physical and chemical conditions necessary for sterilization. Since the Bacillus spores used in BIs are more resistant and pres- ent in greater numbers than the common microbial contaminants found on patient- care equipment, the demonstration that the
Sponsored by: Figure 1 – Self-contained BI Photo courtesy: 3M 32 April 2021 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
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