Tackling the Tough Issues Related to Flexible Endoscopes: A Q&A with Sharon Van Wicklin

By Kelly M. Pyrek

The Association for periOperative Registered Nurses (AORN) is currently updating its guideline on flexible endoscope reprocessing. ICT spoke with Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E) CPSN-R, PLNC, a perioperative nursing specialist for AORN who is responsible for this undertaking. She shares her thoughts about the opportunities and challenges associated with revising a guideline of this magnitude.

ICT: Can you share with us where you are in the guideline update process?

Van Wicklin: Currently I am in the initial stages, just beginning the drafting of the guideline. Our goal is to have it posted for public comment in August or September. Drafting the guideline is very challenging because almost every day there is new information coming out and in addition to that, the many issues surrounding flexible endoscopes are exceedingly complex. There’s no simple answer. We must exercise great wisdom and critical thinking, and be astute in how we make the recommendations because we know the whole world is waiting for this guideline. I have read and appraised more than 1,200 articles covering a 20-year period, and I think now that is an under-estimate. As a result of all of that reading, there are some themes that have emerged, but I am just in the process of really synthesizing all of the evidence and beginning to develop those recommendations that will formulate the guidelines.

ICT: What is shaping your literature review and guideline writing?

Van Wicklin: I knew it would be an enormous task to conduct a 20-year literature search and review, so I was aware of what I was getting myself into - and I would do it again. There has been so much change in endoscopes, as they have become so much more complex and more clinically useful,  so I wanted to feel that when I started to write the guideline, that I had read everything that there was to read about them. I wanted to be certain that I had read about all of the different outbreaks, the various guidelines from different countries, etc. I feel comfortable that we haven’t missed anything and that we have the information we need to make really good, sound, evidence-based recommendations. My guiding principle going into this endeavor was saturating myself in the literature.

ICT: Is it challenging to block out the enormous expectations from myriad stakeholders?

Van Wicklin: There is a weight on my shoulders but I also feel that it is a huge privilege because when the guideline is finished and we release it for publication, it’s going to be right, as right as it can be - we won’t have been influenced by the things we shouldn’t be influenced by. We have looked at the evidence, weighed it and made the best possible recommendations that we can because we want to keep our patients safe.

ICT: Can you share any early observations stemming from your work so far?

Van Wicklin: The overarching message that we must understand and communicate is that you can’t have effective high-level disinfection (HLD) or sterilization without effective cleaning. We have to be able to clean the device - we know that if there is debris or bioburden remaining on the device it can prevent HLD or sterilization. We also know that when a device is only manually cleaned, there is a potential for human factors to interfere with that process. If you have ever spent a day in the sterile processing department, you know it’s a busy place and they work very hard; we give them our most complex devices with the most challenging instructions for reprocessing. It has been said that to clean the average flexible endoscope there are more than 100 steps, and we are asking these folks to do that while wearing heavy-duty gloves and other personal protective equipment (PPE) including face shields, masks, and gowns, and in an environment where there are multiple interruptions and distractions. So there is a huge potential for human factors to interfere with effective cleaning. The question needs to be asked, are we at the point where we should be recommending automated cleaning? Many countries already require automated cleaning so that’s a consideration.

ICT: How do we know that technology such as AERs are infallible?

Van Wicklin: Any medical device, and that would include the automated endoscope reprocessor, must be effectively maintained. End users must work with the manufacturers to ensure the device is being maintained properly, that the technicians know how to use it and connect it properly correctly, that the water being used in the device is of sufficient quality to prevent outbreaks, because there have been outbreaks associated with contaminated water. So there are many things to consider. AORN traditionally recommends education and competency verification in almost all of our guidelines. Relative to these complex, costly, high-maintenance devices, such as flexible endoscopes, it’s absolutely essential to educate and ensure competencies in order to prevent infection. It’s important that the folks reprocessing those devices get the necessary education and that they complete those competency verifications, not only when they are first hired but annually, at least, and whenever any kind of remediation is necessary or when you have new devices or products in use in the facility. We have to make sure to provide education on the need for strictly adhering to those manufacturers’ instructions for use, and thorough pre-cleaning at the point of use - this urgently needs to be done. I think we also need to emphasize the importance of meticulously cleaning all of the lumens, channels and sections of the endoscope, and particularly that elevator channel, plus the endoscope accessories. We will have to educate themprovide education on using the appropriate devices and products for cleaning, and that will include those automated endoscope reprocessors, as well as wearing the appropriate PPE, and not reprocessing the items such as caps and valves that are intended for single use. One thing that I discovered in all of my reading was that this preventive maintenance program is important; because the devices have different users in every facility, that preventive maintenance is going to need to be individualized to the facility. We can’t just say ‘You need to have your endoscopes checked every three or six months,’ because in some facilities it may be every month because the damage that occurs to the device is based on the type of scope that is used, for example cystoscopes are more prone to damage than colonoscopes. It is also related to the cleaning process - if it is maybe not as good as it should be there may be more debris in the internal lumens. So it may depend on how the cleaning is done at the facility and the type of water used, etc. In some cases those outbreaks of infections that were transmitted by the flexible endoscopes, the only thing that stopped them was when the scope was sent to the manufacturer and that manufacturer replaced the internal lumen in the scope. I think it will be a big change for everyone because it’s going to involve working closely with the device manufacturer and looking at the use that occurs in your facility, and then individualizing your program based on that. If you are doing several different types of scopes, one scope may need to be checked every month and another may be okay at every three months - it depends on the patterns of use that are unique to the facility.

ICT: How is industry in general playing a role in improving safety related to scope use?

Van Wicklin: AORN does not typically provide recommendations for manufacturers in our guidelines, but it is important to understand that the current manufacturers’ IFU for cleaning and processing of those devices need to designed so they can be followed and cleaning can be duplicated in the actual practice setting every time the device is cleaned. So many of the IFU are extremely lengthy and very complex, they require an inordinate amount of time and a number of steps to complete them, all in this environment where PPE is worn and there are distractions and interruptions - so the manufacturers have a responsibility, in their premarket validation, to provide assurance that if the user has followed reasonable IFU for reprocessing, then that device is going to be clean and safe to use on patients. I think the manufacturers are coming from the same place that we are - they want to produce the best device they can to allow clinicians to do more complex procedures to help patients but they also need to look at designing devices that can be disassembled for more effective cleaning, or even single-use devices - we are not likely to see that immediately, but I do think the manufacturers are committed to that.

ICT: What other issues being examined for this guideline?

Van Wicklin: We are looking at the use of rapid cleanliness indicators, such as ATP (adenosine triphosphate), and other tests for specific soil such as protein, carbohydrates and blood, as these may be helpful in determining the cleanliness of the device. ATP is a monitoring tool for assessing cleanliness, as it detects organic residuals but it is not a good indicator of microbial contamination, so it hasn’t been validated for that use. There’s also some evidence that indicates that some bacteria may be resistant to the aldehyde disinfectants we use for HLD, and that they can act as fixatives, making that biofilm more difficult to remove. There has been a lot of discussion about ethylene oxide sterilization rather than HLD, but again it goes back to cleaning - if there is debris or bioburden in the lumen you can put it in the reprocessor as many times as you want, it doesn’t mean it’s going to be sterile. And we know that ethylene oxide is not readily available in facilities; repeated exposure to ETO can be harmful to the device. So there are a lot of complex issues to investigate.

ICT: Have we made much progress in addressing device-related outbreaks since they were part of the discussion at the 2011 AAMI/FDA summit on reprocessing medical devices?

Van Wicklin: I can give you an example that speaks to this issue. Many years ago, the street around the corner from me was getting busier and busier and I thought, what we really need here is a stop sign because it’s not safe. I went to the city council and they flat out told me ‘You’re right, we know we need a stop sign but there haven’t been enough accidents, and when there are more accidents we can justify putting in the stop sign because the cost is $400.’ I thought, I’ll give you the $400 - that’s kind of what has happened here - we’re saying this street needs a stop sign but there haven’t been enough accidents yet. Now there have been serious outbreaks of infections caused by superbugs, and now we recognize that something needs to be done urgently. I think the manufacturers and the users, as well as the professional associations, are all working collaboratively to see that it gets done.