HEALTHCARE SELF-STUDY SERIES N


PURCHASING EWS


February 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 (Certifi cation Board for Sterile Pro- cessing 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. 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 January 15, 2024. The approval number for this lesson is 3M-HPN 211501. For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.


LEARNING OBJECTIVES To explai n:


• the variety of sterilization processes used to sterilize medical devices and relevant standards.


• the approaches used to validate and routinely control sterilization processes.


• how CIs are categorized into different types.


• how CIs can be used in validating and routinely monitoring VH2


sterilization processes. O2 CIs. O2


• the results of some new studies examining the performance of VH2


Sponsored by:


Current evidence


Monitoring vaporized hydrogen peroxide sterilization processes using chemical indicators by Dr. Brian Kirk


S


terile single-use and reusable medi- cal devices must be sterilized by a validated sterilization process.1,2 There are many microbicidal agents and fi gure  shows some which have been used in sterilization processes using physical methods or chemical agents. Physical methods include hot and cold processes. Hot processes use high pres- sure steam in an autoclave or dry heat in an oven. Cold processes employ ionizing radiation and are used at an industrial scale for bulk sterilization of single-use devices.


Chemical sterilization methods include


those which use alylating chemicals such as ethylene oxide (EO), formaldehyde and glutaraldehyde. Chemical steriliza- tion also uses oxidizing agents such as hydrogen peroxide vapor, chlorine diox- ide, peracetic acid and ozone gas. Many of the chemical methods operate at low temperatures (ca<80o


C) and are used for


small scale sterilization in hospitals and some, e.g. EO, in industry. In hospitals >90 percent of theatre sets are processed using steam sterilization, however there is a need for low temperature processes for


instruments which cannot withstand high temperatures, e.g. fl eible endoscopes. The three most popular low temperature methods used in hospitals would be O, low temperature steam with formalde- hyde (in Europe) and vaporized hydrogen peroxide (VH2


O2 ).


Validation and routine control of sterilization processes All processes used to sterilize medical devices must be validated. Validation involves proving that what we want is what we get sterility being one such attribute. Validation involves three steps. The fi rst is installation ualifi cation (I), and this involves checking the physi- cal status of euipment installed in the hospital, including supplied services, to make sure they are correct. The second is operational ualifi cation (O) and this involves operating the sterilizer, often empty or using standardised test loads, to mae sure the euipment runs correctly. The fi nal step is performance ualifi cation () involving tests carried out to ensure the sterilizer can process loads that the hospital wishes to sterilize.


Table 1: International standards for the validation and routine control of various sterilization processes used in industry and hospitals and their ANSI/AAMI equivalents for hospital sterilization. N/A-I indicates a standard for industrial sterilization exists. aEN ISO 22441 is in development.


46 February 2021 • HEALTHCARE PURCHASING NEWS • hpnonline.com


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