HEALTHCAREPURCHASING EWS


February 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 Dis- tribution) 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 January 12, 2025. The approval number for this lesson is 3M-HPN 231201.


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


LEARNING OBJECTIVES


1. Review the importance of cleaning a reusable medical device before sterilization


2. Identify critical mechanical components in an automated washing phase


3. Discuss automated washer performance verifi cation


Sponsored by:


N Washer disinfector release for use after maintenance


SELF-STUDY SERIES Sponsored by by Paulo R. Laranjeira, PhD


Surgical instruments and other reusable devices can be washed and disin- fected prior to sterilization in an automated washer disinfector. The use of automated equipment helps standardize the cleaning process, providing optimal cleaning and improving patient safety. These types of equipment are subject to maintenance and repairs, and this article aims to present critical operational assessments to be performed by the end-user after maintenance, before release for use.


R


eusable medical devices that are processed in a hospital sterile processing department (SPD) are


cleaned, inspected, packaged, and steril- ized according to manufacturer’s instruc- tions for use (IFU). A medical device is considered sterilized only if the sterility assurance level (SAL) of 10-6


at the end of the sterilization cycle1


was obtained .


The SAL requirement is normally seen as a goal of the sterilization process, but in fact it depends on the correct execu- tion of the cleaning and packaging steps that precede the sterilization step. In this article, it will be discussed the cleaning step of sterile processing.


Sterilizer manufacturers validate their sterilization cycle based on a bioburden load (viable spores present on the medi- cal device) of one million spores, 1 x 106


,


and confi gure the sterilization cycle with process parameters to deliver a medi- cal device with a SAL of at least 10-6


at


the end of the cycle. The inactivation of viable spores follows a logarithmic expression and the SAL of 10-6


is achieved


after a 12-log reduction (Figure 1). Medi- cal device manufacturers validate their IFU using the same criteria of a 12-log reduction2


.


Since sterilizers can’t measure the bioburden load on each medical device before the sterilization cycle begins, they will always deliver a sterilization cycle that achieves a 12-log reduction. There- fore, if the bioburden load on a medical


32 February 2023 • HEALTHCARE PURCHASING NEWS • hpnonline.com


and the medical device cannot be considered sterilized and safe to use on a medical procedure.


Therefore, cleaning before sterilization is extremely important to reduce the bio- burden load to the level that the medical device can effectively be sterilized. A dirty instrument will have a higher bio- burden load, and the SAL on that device will never achieve 10-6


.


device is higher than predicated, the sterilization cycle will not achieve the SAL of 10-6


Figure 1: Graphical representation of a logarithmical spore reduction


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