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Flexible Endoscopes: High-Level Disinfection or Sterilization?

By Brandon Huffman, BS, CRCST, CIS

Brandon Huffman, BS, CRCST, CISI have been asked quite a few times over my career whether I believe flexible endoscopes should be high-level disinfected or sterilized. This is a great question and I will tell you why. Not because there is a right or wrong answer, but because it opens the door of discovery into practices and processes currently going on with flexible endoscope reprocessing.

High-level disinfection is currently validated as an option for flexible endoscope reprocessing. But with the emergence of superbugs and even more recently SARS-CoV-2, it is unclear whether high-level disinfection will remain adequate as the world of organisms continue to evolve. Superbugs such as vancomycin-resistant enterococci (VRE) and carbapenem-resistant enterobacteriaceae (CRE) are very concerning and give insight into the capabilities and adaptation of organisms resisting treatment. What works now may not work tomorrow.

Generally, the question of whether to sterilize or high-level disinfect comes from a concern in the efficacy of the process in use. If you ask any sterile processing technician, they will say sterilization is greater than disinfection. So, since we believe sterilization is king why wouldn’t we seek to sterilize? If the answer was that easy, I wouldn’t need to write this column.

Before we assess sterilization, let’s talk about the most important factor in flexible endoscope reprocessing; manual cleaning. A switch from disinfection to sterilization does nothing for patient safety if the cleaning process is flawed to begin with. For disinfectants or sterilants to properly perform their function, it must be able to contact all surfaces of the medical device. This includes inside the working channels. Improper cleaning increases the risk of leftover tissue and/or organic material which can protect microorganisms during disinfection or sterilization. If the manual cleaning isn’t nailed down with proper education, supplies, cleaning efficacy tests and audits verifying the process is standardized and sustained by all staff members, then the entire effort is undermined. Though we have come a long way since the bombshell news articles of flexible endoscope-related outbreaks from several years back, cleaning remains inconsistent and challenging in real time across most organizations. This doesn’t apply only to flexible endoscope reprocessing; this applies to the cleaning of any medical device. I have had the privilege of entering a large number of sterile processing departments and working with thousands of sterile techs over my career, and cleaning efficacy is always the number one challenge. The number of medical devices that are returned to the decontamination area due to improper cleaning on the first go around is haunting.

A move to sterilization is dependent on several factors such as number of procedures performed, number of flexible endoscopes available whether owned or loaned, length of time to sterilize flexible endoscopes, and availability of proper sterilant within the facility such as an ethylene oxide (EO), hydrogen peroxide or ozone sterilizers depending on flexible endoscope manufacturer instructions for use. When it comes to sterilizing flexible endoscopes, EO remains one of the main options available and approved by flexible endoscope manufacturers. Besides the issues of inherent risk to health care workers and the limited capacity of each load, the EO cycle time with aeration presents a significant barrier to efficient workflows and daily procedure volume capabilities. A single EO cycle can take up to 16 hours. That is of course if your facility owns and operates an EO sterilizer of which most facilities do not. The fact of the matter is that sterilization isn’t impossible, it just brings a long list of logistical challenges that must be addressed.

I hope I haven’t scared you away just yet, we are safe for now if we follow current guidelines, manufacturer instructions for use and ensure our cleaning practices are in order. As the FDA continues to look at flexible endoscopes and their complex designs, there has been significant push for disposable options. Many device manufacturers have risen to the challenge with designing and providing flexible endoscopes containing disposable tips, and even flexible endoscopes that are completely disposable. These are incredible advancements in short periods of time working towards patient safety while maintaining high standards for surgical devices.

Whether you choose to high-level disinfect or sterilize your flexible endoscopes, remain vigilant on your pursuit of clean. The adage of “If it’s not clean, it cannot be sterilized” is very true. But I would take it a step further to be all inclusive and say, “If it’s not clean, it cannot be disinfected or sterilized.”

Brandon Huffman, BS, CRCST, CIS, is an infection preventionist and quality and improvement professional for the PeaceHealth Oregon Network.



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