In 2016, The ECRI Institute placed endoscope reprocessing failure at the top of its list of health technology hazards. We spoke with Jahan Azizi, BS, CBET, to find out where institutions may be going wrong in their cleaning procedures and how they can assess and address cross-contamination risk.
Q: “So, why not just follow cleaning procedures?”
Mr. Azizi: “It’s a complicated issue. For example, small clinics often don’t have adequate space to clean scopes properly. Take the example of the sterilant glutaraldehyde. It is an effective cold sterilant, but can’t be used casually. To use it properly, you need negative pressure, at least 15 air exchanges per hour. A small clinic may have cleaning equipment tucked away in a little closet where they put the scopes in a bucket to soak. They are not really outfitted for 15 air exchanges.
“The posters may be up, but nothing in them says how often you need to change glutaraldehyde-treated water. And glutaraldehyde is not potent all the time. So cleaning procedures have the potential for the human factor to cause problems.”
Q: “Is training ever an issue?”
Mr. Azizi: “Always. Does the staff have the same level of competence and training? I don’t think that’s happening at all of the institutions, or all the small clinics.”
Q: “How would you assess the risk of biofilm?”
Mr. Azizi: “Microbial and bacterial contamination can live underneath biofilm and become activated once the instrument is soaked and put to use. We found that as you hydrate those layers of biofilm, you loosen some of the bacteria that was living under the crust. If it’s not visible to the naked eye, and you don’t have a test mechanism, it’s difficult for the clinician to even know it exists.
“It’s not uncommon for clinicians to use a scope in the morning and not clean it until the end of the day, eight hours later. This is especially true if the clinician is responsible for the cleaning.
“But if a scope is not cleaned within two hours, bioburden is stuck in it—in a cannulated item. Now it has become impossible to clean.”
Q: “How would you solve that?”
Mr. Azizi: “I believe what should happen is to create an automated system for cleaning all these instruments. But that doesn’t exist. Most manufacturer’s instructions rely on manual cleaning, within X number of hours. That’s what has been validated. But that validation was not based on real-life scenarios. At least not real-life, worst-case scenarios.”
Q: “What’s an example of a real-life scenario?”
Mr. Azizi: “You have two different scopes, sometimes similar, from two different manufacturers. You may have two different sets of instruction for processing. You have to have two posters, because the protocols may be different. All of this has the potential to create conflicts.
“A problem you see in large and small hospitals is varying approaches for cleaning the same instruments. This causes more headaches and complications. Or, alternately, you will see two or three different types of scope from different manufacturers being used in the same hospital. So then you have the requirement for two or three different types of cleaning. But once you’re under the mask and gloves, it’s really difficult to find the right procedure for each scope.
“This is a problem CMS should address; they should set guidelines for standardization.
“In a busy hospital, you can see that scope number one in the morning gets really clean, cleaner than scopes number four and five, which they need to turn around faster. You’re worried about volume and quantity throughput.”
Q: “Is there a solution?”
Mr. Azizi: “Automation, or going with a disposable product. If you’re a small place, you simply don’t have the means of cleaning your equipment properly. You don’t have the physical space, the 15 air exchanges, and you probably don’t have the manpower to do it properly in the appropriate time frame. So maybe you have to move away from that approach and go with something that you do not have to do the cleaning on.”
Q: “What is the most elusive problem?”
Mr. Azizi: “The areas that are not visible to the naked eye, the unaided eye. How can you really verify that you cleaned all the area of the lumens? If you have a scope, two, three, four, or eight feet of length, you cannot really see all the nooks and crannies, all the channels, all the angles. So what do you need to do? You should come up with a process at least to be able to visually see them. And then moreover, try to check biochemically.
“Unfortunately, there are not really a lot of indicators in the market that you can just pick. Take a swab, look for biofilms, or look for other stuff that you didn’t clean. Because if you really cannot clean it, you cannot high-level disinfect or sterilize it. Nobody out there said that if you put a dirty item in the autoclave it will get rid of all the bacteria.”
Jahan Azizi, BS, CBET, has over 28 years of experience in Biomedical Engineering. As the Clinical Engineer Consultant for the University of Michigan Health System Office of Clinical Safety until 2014, Jahan’s responsibilities included investigating and analyzing potential professional liability claims and incidents related to medical equipment; and advising and training medical staff in assessing, resolving and preventing incidents of risk to patient. He is currently the Director of Regulatory Affairs for Heart Sync Inc., a medical device manufacturer. Mr. Azizi has presented on patient safety and equipment issues to the Association for the Advancement of Medical Instrumentation (AAMI), the American Society for Testing of Materials (ASTM), and the FDA’s MedSun reporting group, and has published in AAMI Horizons and AORN Journal.
This article was originally published in An Intensivist’s Handbook, September 2016, by Ambu, Inc.