Susan Klacik is a clinical educator at the International Association of Healthcare Central Service Materiel Management (IAHCSMM). As might be expected from someone holding that title, she shared a lot of knowledge when HealthCare Business News spoke to her about equipment sterilization and how to avoid sterilization failures.

Klacik started by emphasizing how training and education are the most important tools. She says sterile processing (SP) technicians need to be thoroughly trained on how to operate all the SP equipment as well as all the manual processes in between. “That includes the correct selection of cleaning implements, use of automated equipment, inspection tools, packaging system, and sterilizer. The technicians need to be thoroughly aware of how to process each medical device according to the instructions for use for each item, standards and best practices from the Association for the Advancement of Medical Instrumentation, and guidelines from the Association of periOperative Registered Nurses and the Centers for Disease Control and Prevention,” she says.

When selecting a biocidal method to use on instrumentation, that should be based on the Spaulding Classification Scheme. But Klacik says there’s a push to transition semi-critical devices from high-level disinfection to sterilization.

“It’s interesting that when the Spaulding Classification scheme was first devised, back in the 1960s, all the devices from back then as well as what we had as far as low-temperature modalities obviously differ greatly from what we have today. When Dr. Spaulding developed the classification scheme we go by — non-critical, semi-critical and critical items — in his original definition, it does state that items used in semi-critical procedures should be sterilized,” she says. “If sterilization is not possible, those items should undergo high-level disinfection. So as far back at the 1960s, we said all semi-critical items should undergo sterilization if possible and if not possible, high-level disinfection. Over the years, depending on what books you look at, that sentence has been left out.”

Citing examples of devices that should be sterilized but might just be getting high-level disinfection, Klacik points to duodenoscopes, ureteroscopes, cystoscopes and bronchoscopes. She says it was fairly common to see those devices undergoing high-level disinfection, but now more hospitals are going to the higher standard of sterilization. Still, she cautions that regardless of which standard is being used, the wheels come off the process if the device isn’t cleaned properly. “If it’s not clean, we still won’t be able to sterilize it. It has to be thoroughly cleaned or all the processes after that will not do the job.”

Cleaning varies from device to device or even between same devices but from different manufacturers. Devices need to be disassembled (if designed for disassembly), instructions for use need to be reviewed and the person doing the processing should have demonstrated competency regarding the task at hand.

“What is meant by that is that the technician should have been thoroughly trained on processing the device. The trainer should have had the student do a return demonstration on how to thoroughly clean the device. The trainer should have the instructions for use in front of them. The student should be able to follow the steps.”

Additionally, Klacik says the person processing a device should have the basic level in certification, such as the Certified Registered Central Service Technician (CRCST) certification offered by IAHCSMM. “If flexible endoscopes are all they’re doing, there is a certification for that as well — a Certified Endoscope Reprocessor (CER).”

The technician must know how to disassemble, clean, reassemble and process a device. They also need to know the best standard of practice for processing the device. From there, it’s required to monitor the disinfection or sterilization process and thoroughly review the physical monitors – the printout in front of the sterilizer. “If biologicals are used, the SP technicians need to know how to monitor those, and they need to know how to perform the incubations to get the final results in the chemical indicators. Again, the most important thing is to make sure the device is thoroughly cleaned,” says Klacik.

Failures often happen when employees are rushed and skip steps. That comes back to education, Klacik says. “If the technician processing the item doesn’t realize the item needs disassembling or brushing or even a certain size brush, that’s a problem. They also need to know about the detergent and the importance of changing the water after processing each surgical set. They need to have instrument air to help dry it, and the proper water quality. When I talk about following instructions for use, I’m talking about instructions for the medical device itself, the processing equipment and also the detergent manufacturer. If the detergent manufacturer states it is one ounce per gallon at a specific temperature range that needs to be followed precisely. Like in any profession, you often don’t know what you don’t know. Certification and continuing education help teach technicians about the essentials, so they know enough to ask or seek out more information when a question or concern arises.”