From the May 2022 issue of HealthCare Business News magazine


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.

May 2022 Magazine

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