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Discussing new device sterilization standards

by Lisa Chamoff, Contributing Reporter | June 03, 2022
Endoscopy Risk Management
From the May 2022 issue of HealthCare Business News magazine


Sterilization just really improves the quality of the scope. When you high-level disinfect, you do not have a sterility assurance level. When you sterilize a scope, you have a sterility assurance level of up to the negative 10. We have better quality monitoring systems for sterility. We do biological monitors for the load. We have chemical indicators for each item. The items are packaged, which prevents contamination. Also the packaging gives a visual that, “Yes, this item is patient ready.”

HCB News: When sterilization failures occur, are there usual suspects or common causes that may be attributed to that failure?
SK: Sometimes it’s the utilities, that could be cause of it. It could also be the sterilizer. It can also be operator error, and there are a lot of operator errors that can occur. The item may not have been thoroughly cleaned, which would definitely cause a sterilization failure. Maybe (it was) packaged improperly, or it could have been loaded improperly in the sterilizer. The incorrect cycle could have been selected.
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For the most part, it's operator error and that all comes down to training. Staff need to be thoroughly trained in the AAMI standards, both for the flexible and scope standard and the steam sterilization standard. It's recommended that technicians working with these processes are certified within two years of employment, because education is that important.

HCB News: Has COVID-⁠⁠19 impacted device sterilization in any way?
SK: Not really. In sterile processing everything is treated as though it's contaminated, and so we've always handled items as though, they have been contaminated.

I think COVID-19 has brought a more heightened awareness throughout healthcare facilities about the importance of sterile processing. That’s our world.

HCB News: Has sterile processing been affected by staffing issues like other parts of the hospital and healthcare system?
SK: Sadly, it has, but we're back to regular staffing now.

HCB News: What resources would you recommend for readers who want to learn more about sterilization training and education?
SK: There’s the HSPA, which is the Healthcare Sterile Processing Association. There are some publications. There's a technical manual, which is an introduction to sterile processing, and it provides the basic information. There's an instrument resource manual and also an endoscope manual. We've seen a lot of outbreaks with flexible endoscopes and people who are processing endoscopes really should have that manual. AAMI has some great documents, and AORN which is the Association of periOperative Registered Nurses, also has some good guidelines for instrument processing.


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