By Gary Evans, Medical Writer

Infection preventionists and central sterile supply technicians must work together to protect patients from duodenoscopes that could remain contaminated after reprocessing. That is the take-home message from a comprehensive program that shows it can be done.

The intricate scopes are used to assess the pancreas and other organs in endoscopic retrograde cholangiopancreatography (ERCP). ERCPs using duodenoscopes are performed on some 500,000 patients annually in the United States. In a recent meeting with infection control advisors at the CDC, the FDA concluded that the standard protocol at many hospitals of reprocessing these scopes with high-level disinfection (HLD) leaves patients at risk of infections.

The failure to adequately disinfect the devices has been linked to outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and other pathogens. In response, some facilities have gone to more stringent reprocessing measures such as ethylene oxide (EtO) sterilization or use of liquid chemical sterilant reprocessing systems. However, some at the CDC meeting said the downside to these approaches includes prolonged reprocessing times and damage that shortens the “use life” of the scopes. Regardless of the reprocessing method, the scopes also can be damaged during ERCP procedures by, for example, sharp instruments. Currently. there are no disposable duodenoscopes on the market.

Patient safety advocates say the use of even a small percentage of potentially contaminated duodenoscopes is not an acceptable alternative, citing healthcare teams in hospitals that have committed to solving this problem. One such team includes infection preventionists and central sterile department experts at the Altru Health System in Grand Forks, ND.

Q&A

HIC asked Jenni Gibbs, BS, manager of the Central Sterile Department (CSD) at Altru, to describe her program in the following interview, which has been edited for length and clarity. As part of revamping and renovating the CSD several years ago, Gibbs and colleagues decided to transition away from EtO but continue their commitment to rigorously clean and sterilize duodenoscopes.

HIC: What method did you choose to sterilize duodenoscopes?

Gibbs: We went to a new product: a low-temp chemical sterilizer that uses hydrogen peroxide and ozone. We replaced an outdated hydrogen peroxide sterilizer and EtO with this new sterilizer. We knew that EtO wasn’t going to be a viable long-term solution for sterilizing scopes because of the turnaround time and the needed volume of scopes we would have to have in inventory. It wasn’t cost-effective.

The new hydrogen peroxide and ozone sterilizer has a 55- to 65-minute sterilization cycle, so it takes the same time to sterilize them as it does to high-level disinfect them in an automated endoscope reprocessor, but the scopes are terminally sterilized. We use event-related sterility, which means there isn’t an expiration date on sterility. It is event-related — meaning, for example, if the wrapper or package integrity is compromised. This negates the hang-time expiration reprocessing guideline. This also has the benefit of reducing the amount of reprocessing cycles on less-often-used scopes and the associated costs.

HIC: While patient safety is the prime objective, you solved logistical problems related to the supply of scopes and shortening sterilization times. What about the problem of damage to scopes that has been cited as a downside to using EtO?

Gibbs: I will say, from the damage standpoint, hydrogen peroxide — just like EtO — causes wear and tear on the scopes. Most endoscopes that can be sterilized in hydrogen peroxide plasma have a cycle count, [indicating when] you need to send them to the manufacturer [for inspection and repair]. There is a level of wear and tear from high-level disinfectants and sterilants on the soft materials and adhesives that all endoscopes are made of, so there is a certain point where you are going to have to send them in. We have been sterilizing our duodenoscopes for a year with hydrogen peroxide and ozone technology.

For two years now, we have been inspecting every scope, every time, internally, in addition to an external inspection. We inspect the scope internally to look for damage in the channel. We are also doing ATP [adenosine triphosphate] testing, a residual protein test that we use for verification of the manual cleaning. We do that on every scope, every time.

The internal channel inspection and verification of the manual clean has had the biggest impact on the quality of our scopes and reducing our risk of contamination. If the scopes cannot pass that verification of the manual clean testing, it is cleaned again. If, after the second clean, it comes back [contaminated], we send it in for repair. Same with the damage inside the channels. There is damage and residual contamination identified routinely within the channels, so we are sending our scopes in more frequently for these repairs than for damage associated with sterilization. When we started looking at them we had an initial big uptick in our repairs.

HIC: The FDA estimated that 3-5% of duodenoscopes remain contaminated after reprocessing. Your program shows these scopes can be sterilized, but it certainly does not sound easy.

Gibbs: Giving what I am seeing in our daily work here, I think that [FDA estimate] is low. I think that is an underinflated number. There is a cost to doing it right, but no matter what, the patient deserves a sterile scope. In healthcare, we say we do no harm to patients. High-level disinfection is only a certain percentage of kill. It is not terminal sterilization. One patient harmed should be one too many. I believe the industry someday will go to all sterile or disposable scopes. We use disposable scopes when we can; for example, bronchoscopes. At the end of the day, if [a disposable] scope can provide the services and do what it needs it to do for that surgeon, that is your safest model for the patient. You eliminate all the manual reprocessing variables for failures. There is a significant cost to reprocess a scope correctly. But we need to eliminate high-level disinfection. Whatever percentage [of contamination] that is left, why is that risk acceptable for that patient?

Stopping the Line

HIC: Issues of informed consent were raised at the CDC meeting, with some saying it would be unacceptable to tell a surgical patient the scalpel used on them may not be completely sterilized.

Gibbs: Patients assume that these scopes are sterile, and I think some physicians assume that they are sterile. I don’t think the physicians understand the time and skill [it takes] to clean these, and the risk of contamination that remains after high-level disinfection. I feel we are taking the steps to do it the absolute best we can.

We have centralized our reprocessing to a core team in the CSD. Only five CSD techs are validated to clean duodenoscopes. They have an extremely high level of competency. There is a lot of variation in levels of competency across the industry. There also is intense pressure to turn scopes around, and technicians do not always have the ability to stop the line.

Our technicians have the authority to say, “This has failed the test. This does not look right, this is not clean. I am pulling it out of service.” They are the experts on that scope, and it is pulled if anything is in question. That is a luxury that a large portion of the reprocessing technicians in the U.S. do not have. There often is not an investment in them with the time, education, tools, technology, or authority to make sure that scope is clean.

HIC: So, the manual cleaning, testing, and inspection processes are just as important as the actual sterilization?

Gibbs: To me, that has been the biggest bang for our buck in making sure we have clean, safe scopes for our patients. We are inspecting them and making sure they are manually clean before we [reprocess].

You can’t high-level disinfect or sterilize contaminates. If it is not clean, it is not going to be disinfected or sterile. We have to, as an industry, demand that technicians be given better resources for the current scope technology we have. Give them the tools, invest in inspection and sterilization technology, and then the leeway to do what they need to do to make sure that our patients are safe.

One sentinel event from a contaminated endoscope — I don’t even know how you can justify that. I can’t wrap my head around not doing it right.

I am blessed to be at an organization where I have the partnership with our infection prevention team and they are asking these questions. They introduced us to AAMI ST911 when I was new to my role. We have a partnership; we are together all the time. I know in some organizations IPs shy away from CSD. In others, they are the Big Brother watching over; it’s an adversarial relationship. It has to be an interdisciplinary approach. It needs to be a partnership so IPs can help us advocate, along with quality, risk management, and compliance. Everything we are trying to do in the CSD is about risk mitigation. Lift us up to be experts, and partner to mitigate the risks. Help us so that the practitioners, nurses, and doctors have the tools they need in perfect working order that are safe to use for their patients.

REFERENCE

  1. American National Standards Institute. Advancing Safety in Medical Technology. ANSI/AAMI ST91:2015: Flexible and semi-rigid endoscope processing in health care facilities. 2015. Available at: https://bit.ly/2XwKlyQ.