Medical devices have increased in complexity over the years, which has led to new guidance for sterilization, particularly of flexible endoscopes. HealthCare Business News recently talked with Susan Klacik, a clinical educator at the International Association of Healthcare Central Service Materiel Management (IAHCSMM), about new sterilization standards, including an amendment to ANSI/AAMI ST79, as well as the impact of COVID-19 on sterile processing.

HCB News: Can you tell us about your background and how you became an expert on medical device sterilization?
Susan Klacik: I worked my way through college (in the sterile processing field), got my bachelor's degree in-state. I liked it so much, I stayed.

I worked at a hospital in sterile processing and was very involved in my local sterile processing association. Any time they would ask me to do something, I always said yes. There was an opening for an alternate member for the AAMI committees. Then I became a voting member.

I read [the documents] cover to cover. We make comments on them, so I do the research on the comments. We get lot of input from members. I make the comments and then we've discussed them at the meetings.

I had the passion for it, and a lot of research went into it.

I enjoy helping patients and preventing infections. We’re behind-the-scenes people, and so we need to do the best that we can so that the surgeons can have what they need. That's our job, and it just makes you feel good when you know that by doing the best job you can, the surgeons can do the best job that they can do.

It’s really interesting because you're always seeing new technology, new processes, new designs of medical devices, all the regulations, how they've changed over the years.

HCB News: An amendment to ANSI/AAMI ST79 was recently added in response to the increasing complexity of devices. In what ways are newer devices more complex, and how does that complexity create sterilization vulnerabilities?
SK: With that amendment, we’re really talking a lot about insulation testing and how vitally important that is. What happens with that is when we prepare electrosurgical instrumentation, the laparoscopic instruments have insulation on them, and that prevents burns to the patients. If there is a breach in that insulation, it can have a negative impact on patient care — it could actually burn a patient. So, in the amendment, it is recommended that insulation testing is performed each and every time that we prepare those instruments. It’s very important.

It's interesting to note some of the feedback that I've been getting since this has come out. What it says in the document is that we inspect the instrument shaft for cuts, cracks and abrasions. There's a device that's called an insulation tester, and that's what we need to use. You have some older instruments that do not have the IFU (instructions for use). Some questions I’ve gotten are, “Why do I have to test these instruments?” Well, we can certainly go beyond the IFU. This is a quality improvement process. Many years ago, these devices weren't as readily available and so some older IFUs may not specify to use [insulation testers]. But it doesn't mean we shouldn't use them. When we do have an IFU for those devices, we should look and see exactly how to perform the insulation testing, if they have any recommendations in there. And if it's not in the IFU, the first thing I would do is contact the manufacturer for guidance.

HCB News: How does the amendment change sterilization protocols?
SK: This is in the preparation of the instruments. [They require] the same cycle [for sterilization] and we still recommend preparing them in a certain manner, so that we don't have cuts and nicks in the insulation itself.

There are different types of testers available. There are tabletops, handheld and wand testers, and they're each designed to detect a small current of leaks that could pose a threat to the patient, and of course we would remove it from service.

That was the whole purpose of the amendment, to say every time you processes these instruments, you must test them.

There was also an amendment added for sterilizer cleaning. And it basically refers the sterilizer operators to the manufacturer’s instructions for use to see how often that sterilizer should be cleaned. And by having a sterilizer cleaned, it works more efficient and effectively.

HCB News: Last time we spoke, you talked about high-level disinfection in contrast to sterilization, and cautioned that some hospitals were falling short of sterilization for certain scopes. Can you tell us a bit about the difference between those two terms?
SK: AAMI has just released the scope sterilization standard, and that is the ST91 flexible endoscope reprocessing standard. In that standard it talks about inspection and also sterilization versus disinfection for these scopes. It's recommended that high-risk endoscopes should undergo sterilization. It's not mandated. It is recommended that we do that.

The Spaulding Classification came out in the 1960s so it’s kind of old. It actually classifies medical devices as to the level of disinfection and sterilization that they should receive. For example, surgical instruments that are used directly with blood or in a sterile area, those must be sterile. And then the next level is semi-critical items. They don't necessarily touch the bloodstream, but they can contact mucous membranes, so that's most of our flexible endoscopes. Those are classified as semi-critical items, and in the Spaulding Classification it states that these items should be sterilized, and if sterilization is not possible that high-level disinfection is acceptable.

So for years and years, these flexible endoscopes have undergone high-level disinfection. What we’re seeing now there are a lot of multidrug-resistant organisms out there. And from the 1960s until now, the sterilization modalities have changed. Previously, we really didn't have the technology available to sterilize these scopes. Well, the sterilization technology is available now, and the scopes are made differently also. So it is possible to sterilize the scopes. By following the Spaulding Classification, we're saying if it's a high-risk scope — these would be the duodenoscopes, the linear ultrasound endoscopes, bronchoscopes, ureter scopes — we should look at sterilizing those, and also work with your facility because we can sterilize them now.

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.

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.