CS CONNECTION take days for results. She comments on
how facilities have increasingly turned to new technologies that can quickly provide objective and reliable measure- ments of cleanliness. “A rapid, reliable, easy-to-use solution is adenosine triphosphate monitoring (ATP testing),” explained Hilbert. “ATP is an indicator of biological residue, including bacteria, yeast and mold, so it is an excellent measure of cleanliness. In addition, ATP testing provides results in seconds and is sensitive, quantitative, effective and straightforward. General protein tests (i.e., Pro-Clean) can also be usefully in making sure residual proteins have been removed.”
Sterilization best practices The world of CS/SPD is not static, rather as instruments and IFUs change, and industry associations and regula- tory bodies change their stance on practices, sterile processing teams must adapt to remain effective, safe and compliant. And as practices evolve, CS/SPD departments can benefit from validity testing at each step of their process.
“First and foremost, the device manufactur- er’s IFU should be rigor- ously followed, and secondly, healthcare facilities should carefully follow current evidence- based practices dictated by organizations such as
container, and choosing the correct sterilization cycle,” explained Tull.
Sterilizer operation
There are numerous factors that can impact whether instruments are properly sterilized. Seth Hendee, CRCST, CIS, CHL, CER, CSPDT, CFER, IAHCSMM Approved Instructor, Clinical Education Coordinator, SPD, Healthmark Industries, points to proper loading as one practice that greatly affects sterilizer efficacy. “An overfull sterilizer cart reduces steam pen- etration and circulation,” he commented. “When sets are not appropriately orientated on the cart, it can impede steam but may also trap water and
Seth Hendee
create wet loads. Guidance on properly loading of sterilizers can be found in the sterilizer and packaging IFUs and in guidance documents like ANSI/AAMI ST79.”
Hudson Garrett Jr.
AAMI, CDC, and AORN,” said Dr. Hudson Garrett Jr, Adjunct Assistant Professor of Medicine, Division of Infectious Diseases, University of Louisville School of Medicine. “Additionally, the use of a variety of verification practices is the most prudent in ensuring the safety of surgical instruments.”
Janet Tull, VP, Clinical Operations, Moab Healthcare, a Sterile Processing Staffing, Interim Management & Consulting firm, rec- ommends that CS/SPD teams conduct random quality assurance audits to drive sterilization effi- cacy and safety.
“These audits should include proper place- ment of chemical indicators, tray weight evenly distributed, using correct wrap- per size and strength or correct rigid
Janet Tull
rays should be loaded at on the sterilizer cart and not placed on their sides unless they are non-perforated (e.g., basins and mayo trays),” Malinda Elammari, ST, CSPM, CSPDT, CFER, CSIS, CRCST, CIS, CHL, CER, CLSSGB, Clinical Education Specialist, Healthmark Industries added. “Keeping trays flat ensures the metal mass stays evenly distributed. Additionally, rigid trays should never be stacked unless validated by the container IFU. Heavier trays are always positioned below lighter trays and wrapped trays above rigid containers in mixed loads. Peel pouches are placed on the top shelf, standing on their edge, facing in the same direction.”
Sterilizer cleaning
One of the 2021 amendments to ANSI/ AAMI ST79 has a direct impact on steril- izer cleaning practices. Amendments 3 eliminates previously stated recommen- dations on daily cleaning of sterilizers, instead urging CS/SPD teams to follow the sterilizer manufacturer’s IFU when cleaning this equipment.
Hendee commended on these amend-
ments during an episode of the com- pany’s Ask the Educator podcast, stating: “Instead of AAMI taking a stance that might have been contradictory to an IFU, they said we are going to pull that back and say your IFU should tell you what to look for and if abnormalities are found
32 December 2021 • HEALTHCARE PURCHASING NEWS •
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(e.g., staining, debris), also follow your IFU. That will most likely prescribe clean- ing but again; that is up to the sterilizer manufacturer. It is their product and they should give us the guidance.”
Testing and monitoring
There are a variety of tests that CS/SPD team can employ to assess sterility assur- ance. Biological indicators (BI) contain microorganisms to test the effective- ness of steam, hydrogen peroxide gas, ethylene oxide and other sterilization methods.
Common chemical indicators employed include Type 1 chemical indicators to help differentiate between processed and unprocessed loads, Type 2 chemical indicators, such as Bowie-Dick tests, to monitor steam sterilizers for air removal efficiency and steam penetration, and Type 5 chemical indicators to test the parameters of time, temperature and steam.
Amendment 4 of the ANSI/AAMI ST79 guidelines is around the recording of BI lot numbers. As Hendee explained in the recent podcast episode, CS/SPD teams must now not only record the BI that was run, but also the BI control lot number as well.
“For those CS/SPD departments with
electronic systems that already attach their control results and lot number to each load, it should be very easy to comply,” said Hendee. “But those with manual systems where things are writ- ten down, they will have to figure out a system to make it work.”
With regards to Bowie-Dick tests used for routine monitoring of sterilizer air leaks and inadequate air removal, and Type 5 chemical indicators to test time, temperature and pressure, it is important to follow instructions to ensure the tests are correctly performed, explains John Sullivan, Director, Crosstex International, part of the Hu-Friedy Group a Steris Company. “There have been more than a few times that a facility will call us and say our Bowie Dick or Type 5 tests are not working. After further research and investigation at the facility we find that our products are working and doing exactly what they are designed to do and that is identify issues. Facilities want to make sure that the product they are using are performing, they also want to be able to see a Type 5 in the container when they open it and that they are priced fairly.”
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