By Nick Bromiley and Darren Dahlin

Infection prevention is arguably the unsung hero of a healthcare facility. Every hospital system has numerous protocols and standards in place to eliminate the risk of patients contracting a healthcare-associated infection (HAI) while seeking care at their facility.

Most infection reduction efforts include consistent compliance audits, special training to help implement new best practices and technologies, funding to support specific infection reduction initiatives, and support from hospital leadership. Yet, despite their best infection prevention efforts, one area of the hospital that requires more time and attention is flexible endoscope reprocessing.

Unfortunately, endoscopes are one of the biggest infection liabilities in hospitals today. More healthcare-associated outbreaks have been linked to contaminated endoscopes than any other medical device. According to a 2014 study published in the New England Journal of Medicine, gastrointestinal infections were the third most common HAI, behind pneumonia and surgical site infections, which tied for first. Additionally, endoscope reprocessing ranked No. 2 on ECRI Institute’s recent report, “Top 10 Health Technology Hazards for 2018.”

Several factors can contribute to endoscope-related infections, including inconsistent technician training, inadequate reprocessing space that complicates workflow, and human error. But perhaps the most prominent is the lack of standardization in flexible endoscope reprocessing procedures.

There are multiple governing bodies in our industry that offer flexible endoscope reprocessing guidelines that often conflict with one another. Some guidelines are confusing and outdated. This leads to reprocessing standards that simply maintain the minimum requirements for infection prevention and that create barriers for reprocessing staff in improving their processes.

However, there is good news: Based on recent advances in reprocessing technology and innovative processes, there is the opportunity, as an industry, to embrace globally recognized best practices and take endoscope reprocessing off the list of top HAI culprits. With a new approach, we can help healthcare professionals and their patients know that every endoscope is safe and ready for every procedure.

Reimagining Endoscope Reprocessing 

The lifecycle of endoscope reprocessing is circular: At a high level, the endoscope begins in the procedure room as a safe, patient-ready endoscope. After the procedure, the endoscope is transported to the decontamination area, where it is manually cleaned. It then is reprocessed and moved into clean storage to dry as it awaits use for the next patient. This journey provides multiple opportunities for an endoscope to be re-contaminated. It also means there are a lot of steps that need to be completed in each of these stages in order for an endoscope to be reprocessed correctly.

In many cases, process variances in this multistep procedure are normally the reason there is a breakdown in maintaining endoscope disinfection. Once the endoscope leaves the procedure room, nearly all of the reprocessing steps are completed in the same room, where it can be easy for technicians to miss a step or forget where they are in the process. We need to reimagine endoscope reprocessing to standardize procedures.

The best way to standardize endoscope reprocessing is to implement a unidirectional, or one-way, reprocessing workflow that follows this circular lifecycle and reduces the risk of human error and cross-contamination, to ensure safe, patient-ready endoscopes for every procedure.

A physical barrier should separate the dirty and clean reprocessing areas to reinforce the process of moving an endoscope through the circle in only one direction. This is best done with a pass-through automated endoscope reprocessor (AER). The design of a pass-through AER is becoming a globally recognized best practice in endoscope reprocessing, but is a new concept in the United States.

Pass-through endoscope reprocessing has been implemented in other parts of the world, including Europe, Canada and Australia, and the United States will welcome its first installation this spring. In fact, our company recently received 510(k) clearance from the U.S. FDA for the first pass-through AER, the ADVANTAGE PLUS® Pass-Thru AER, which offers high-level disinfection, like a traditional AER, although the machine is designed to be built directly into a wall.

With this product, dirty endoscopes are put into the machine in one side of the room, and clean endoscopes are taken out of the machine in a different room—physically separating dirty areas from clean ones. Once the AER process begins, the doors to the dirty side will not open until the endoscope completes its cycle and is taken out from the clean side.

Advanced Technology Is Still Not a Silver Bullet

While the one-way, pass-through approach can help improve endoscope reprocessing efficiency and quality, following the proper protocols is still critical to decreasing the risk for infection.

A great example of this happening is when we visited a hospital in the United Kingdom. The technician was singing the praises of the system and the ease of maintaining separate work areas. To demonstrate the ease of the process, he loaded a dirty scope into the machine, left the room to enter the room on the clean side of the machine, and took out a clean scope from the machine. However, we noticed he did not change his gloves when he went over to the clean side of the AER and most likely re-contaminated the clean scope he unloaded.

This was just a demonstration of the new processes, and that scope went through the full process again, but it goes to show that the best technology and processes are not the only requirements to achieving endoscope reprocessing success; people need to adopt process change in order for the technology to be effective. Each step in the circle, no matter how big or how small, supports the integrity of the entire process and the goal of maintaining a disinfected, patient-ready endoscope.

A few commonly missed steps include leak testing, covered transport, and improper storage. In addition, proper manual cleaning and reprocessing reusable valves pose the biggest challenges in the reprocessing cycle. If any steps are missed or incorrectly followed—such as a pair of gloves not being changed—the circle is not complete, and the scope could put patients at an increased risk of complication or infection.

Each reprocessing step needs to be executed at the highest level for the endoscope’s circular lifecycle to be complete. Adopting a pass-through approach to reprocessing is an excellent way to elevate the standard of care for endoscopy.

Raising the Bar of Endoscope Reprocessing

Healthcare professionals have the opportunity to elevate endoscope reprocessing standards and the level of confidence they have in their equipment if they advocate for and help implement similar procedures in endoscope reprocessing as we see in central sterilization today. We believe a pass-through approach can enable reprocessing procedures that are the same for every technician, which fosters more confidence for patients and physicians alike.

Aside from the prospect of significant, long-term financial cost savings afforded by infection reduction and improved efficiency, leadership should consider adopting a pass-through approach to improve patient outcomes, bolster patient confidence, and enhance technician workplace satisfaction. Senior leaders should consider the full range of these benefits when considering the structural changes needed for a pass-through AER—and adequate training to support change management—when budgeting for their next renovation.

Endoscopy needs to elevate endoscope reprocessing standards from the minimum requirements to best practices. The innovation the industry needs to do so is straightforward, and it’s here. Utilizing new technology and global best practices to standardize procedures will improve patient safety and clinical outcomes, while streamlining the disinfection process for technicians to deliver safe, patient-ready endoscopes for every procedure.

Nick Bromiley and Darren Dahlin are principal technical specialist and senior product manager, respectively, for Medivators Inc.—the endoscopy division of Cantel. Questions and comments can be directed to kst[email protected]

References:

  1. Rutala, W.A., Weber, D. J., and the Healthcare Infection Control Practices Advisory Committee (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities. (Last update: Feb. 15, 2017). Retrieved from CDC: https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf
  2. Magill, S. S., Edwards, J. R., Bamberg, W., Beldavs, Z. G., Dumyati, G., Kainer, M. A., . . . Fridkin, S. K. (2014). Multistate Point-Prevalence Survey of Health Care–Associated Infections. New England Journal of Medicine, 370(13), 1198-1208. doi:10.1056/nejmoa1306801. Retrieved from: http://www.nejm.org/doi/full/10.1056/NEJMoa1306801#t=articleResults
  3. ECRI Institute. (Nov. 6, 2017). Ransomware and Other Cybersecurity Threats Top ECRI Institute’s Annual Health Technology Hazards List [Press release}. Retrieved from: https://www.ecri.org/press/Pages/ECRI-Institute-Release-2018-Top-Hazards-List.aspx