HEALTHCARE SELF-STUDY SERIES N


PURCHASING EWS


December 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% 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 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 LESSON OR TEST TO CBSPD. For additional information regarding certifi cation, contact CBSPD - 148 Main Street, Suite C-1, Lebanon, NJ 08833 • www.cbspd.net.


IAHCSMM (International Association of Health- care Central Service Materiel Management)


has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years, until November 11, 2024. The approval number for this lesson is 3M-HPN 211111. For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.


LEARNING OBJECTIVES


1. To understand the International and National standards and guidance for chemical indicators


2. To understand how chemical indicators are tested


3. To understand how standards of practice prescribe the use of chemical indicators


Sponsored by: by Brian Kirk I


n this second article covering chemical indicators, we will examine the interna- tional standards for chemical indicators,


how they are categorized, how they are tested and how practice standards describe they should be used.


National and international standards and guidance International Standards, termed ISOs, are developed by expert committees working within the International Standards Organi- zation (ISO). The committees are made up of individuals who represent their country’s standards organization and are experts in the fi eld drawn from academia, industry, and professional organizations. National standards and guidance are created by country-based committees made up of experts coming from within the country. Once completed, international standards are often published as local country stan- dards possibly with minor modifi cation. Thus, some of the chemical indicator series ISO 11140 are published in the US and under such circumstances the standard will be labelled with an ANSI/AAMI ISO number e.g., ANSI/AAMI ISO 11140-1.1


This indi-


cates that the international standard has been adopted and published as a national standard by, in this case, the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI). Inter- national standards are sometimes devel- oped in cooperation with the European standards organization, CEN (Committee European de Normalization or European


Description Process Indicator


Committee for Standardization). Under such circumstances, a standard will then be published for use in Europe and have an EN ISO notation which, when published by a European country’s standards body, will appear as a local standard. For example, the United Kingdom will publish these jointly developed standards as British Standards with the notation BS EN ISO such as BS EN ISO 11140-1 and these will in principle be the same as those published in the US.1


Standards for chemical indicators


The requirements for chemical indicators are described in the series of international standards numbered 11140 and some of these are published in the US as AAMI/ ANSI standards as discussed above.1


There


are six parts in the series. The fi rst part cov- ers general requirements, as well as require- ments for the majority of indicators printed on a substrate or designed as a moving front indicator for use with sterile medical device packs, such as surgical instrument sets. Part 2 is unused. Parts 3, 4 and 5 cover special test chemical indicators used for the daily Bowie-Dick test. Part 6, which is in devel- opment, is an international replacement for European Standard EN 867-5, which specifically covers indicators for testing small steam sterilizers and covers the helix device often used by practitioners. Part 1 of the 11140-1 series describes six types of indicators.1


These are shown


in table 2. Each type has specifi c require- ments that are associated with it. Part 1 of the standard also describes the require-


Table 2: The six types of CI described in EN ISO 11140-1:2014 CI Type Title 1


2


3 4 5


6 Special Test Indicator


For use with every pack to distinguish processed from unprocessed load items


Intended for use in specifi c tests defi ned in relevant sterilizer/sterilization standards (e.g. Bowie- Dick Test 9


described in EN ISO 17665)


Single Variable Indicator Reacts to one of the process variables of the sterilization process Multi Variable Indicator Reacts to two or more of the process variables of the sterilization process Integrating Indicator


Emulating Indicator 24 December 2021 • HEALTHCARE PURCHASING NEWS • hpnonline.com


Reacts to all of the process variables of the sterilization process that mimic the response of a biological indicator


Reacts to all of the process variables of the sterilization process giving a result related to the standard exposure conditions specifi ed in a sterilization standard e.g., 132 for 4 minutes 4


Chemical Indicators for monitoring sterilization processes: Part two

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