SELF-STUDY SERIES Sponsored by


December 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 online at educationhub. hpnonline.com. You must have a passing score of 80% or higher to receive a certifi cate of completion.


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 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 November 1, 2026.


For further information, direct any ques- tions to Healthcare Purchasing News at editor@hpnonline.com.


LEARNING OBJECTIVES


1. Review the fundamental principles of medical device sterilization.


2. Discuss the most common sterilization methods used in hospitals.


3. Examine the quality control tools used for hospital sterilization processes.


Sponsored by:


Sterilization Choices for the SPD


by Craig Wallace P


roper sterilization of surgical instru- ments is critical to infection pre- vention and patient safety. The


sterilization process breaks the chain of infection by preventing transmission of pathogens between patients. Hospitals today can choose between different sterilization processes to accommodate the broad array of medical device designs and materials. Rigorous sterilization quality control pro- grams help ensure that the devices are safe and ready for patient use.


Sterilization Fundamentals The term “sterile” means”free from viable organisms.”1


It is impossible to conduct


microbiological laboratory tests on the medical devices themselves to determine if they are sterile, as these tests would render the devices unfi t for use on patients. So, the determination of sterility will be based on the original validation of the sterilization process supported by rigorous testing of each individual sterilization cycle (more on this testing later in this article). In the United States, sterilizer manufacturers are required to demonstrate that each programmed sterilizer cycle is validated under laboratory conditions and demonstrate to the U.S. Food and Drug Administration that the sterilizer achieves the required level of effectiveness and safety.2 In addition to the sterilizer itself, the effec-


tiveness of the cleaning process is critical to the overall success of the sterilization process. The CDC Guidance for Disinfection and Sterilization states: “Cleaning reduces the bioburden and removes foreign material (i.e., organic residue and inorganic salts) that interferes with the sterilization process by acting as a barrier to the sterilization agent.”3 Careful adherence to cleaning instructions provided by the sterilizer manufacturer or the medical device manufacturer will help ensure that the sterilization process will per- form as intended and the processed devices will meet the required level of safety. Packaging is also an important factor in


the sterilization process. The packaging sys- tem is intended to protect the sterile medical device from any environmental contamina- tion until the instrument is presented for use on the patient. The healthcare facilities’ packaging procedures should be based on


24 December 2023 • HEALTHCARE PURCHASING NEWS • hpnonline.com Steam sterilization


Steam sterilization is considered a physical sterilization process. It relies on saturated steam, that is, water vapor that is in a state of equilibrium between the gas and liquid phases. The steam condenses on surfaces and releases energy that will kill the microorganisms present on the surface. Steam will transfer heat energy to a medical device and can kill the microorganisms on the device even if it does not contact the microorganisms directly.


The critical variables of a sterilization process are the physical aspects of the pro- cess that have the greatest impact on the effectiveness of that process. The critical variables for a steam sterilization process are temperature, exposure time, and steam quality (level of saturation). Steam quality is critical to the process and can be very diffi cult to measure. Poor quality steam can be caused by residual air in the sterilization chamber, air leaks in the steam supply sys- tem, or poor boiler water quality. Sterilizer or loading issues can cause wet steam or superheated steam in the chamber. These steam quality issues can reduce the level of saturation and therefore the amount of energy transferred on condensation, thus reducing the effectiveness of the steriliza- tion process.


Typical steam sterilization processes in healthcare today operate at 132°C or 134°C and remove air from the chamber with a series of vacuum or steam pulses at the start of the cycle. Cycles that operate at 121°C and use gravity to remove the air are also used but are less common.


instructions for use from the sterilizer manu- facturer, medical device manufacturer, and packaging system manufacturer.


Today’s Sterilization Processes There are two general types of sterilization processes available to the hospital. The fi rst is high temperature sterilization, which is accomplished by steam sterilization. The sec- ond is called low temperature sterilization. Low temperature sterilization processes rely on chemical action rather than physical effects. The most common low temperature sterilization process used in healthcare is vaporized hydrogen peroxide (VH2O2).


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