Addressing the Largest Infection Prevention Gaps in Endoscope Reprocessing

By Darren Dahlin, Nick Bromiley
March 28, 2019


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory

In recent years, endoscope reprocessing has fallen under the spotlight as a growing infection prevention threat. From high profile infection outbreak news stories to being named on top healthcare hazards lists, endoscopes aren’t known for cleanliness.^1,2,3 Regardless of their reputation, endoscopes are necessary for performing a number of diagnostic and therapeutic procedures. Over the years we have heard a desire from customers and other facilities for better guidance on how to improve reprocessing processes. This article covers the main challenges facing facilities in effective endoscope reprocessing and offers actionable insights on how to improve infection prevention efforts, using a case study to illustrate.

It’s no secret that endoscope cleanliness has gotten a bad rap over the last few years. Several outbreaks have nabbed headlines and created an unflattering view of endoscope reprocessing. And it’s not just a catchy news headline.^1,2 Contaminated endoscopes can be linked to more healthcare-associated outbreaks than any other medical device.³ They were even rated at number two on ECRI’s “Top 10 health technology hazards for 2018” list.⁴

All this begs the question, “Why aren’t endoscopes being cleaned effectively?”

While a seemingly simple question, the answer is multi-faceted. Beyond endoscopes being innately complex and difficult to clean, inadequate workspace can complicate workflow and lead to human error, while a lack of standardization in flexible endoscope guidelines can further complicate an already complicated cleaning process.

Among these challenges, the lack of standardization in flexible endoscope reprocessing procedures is one that most consistently affects the broader industry because while multiple industry associations offer reprocessing guidelines, the guidelines can sometimes be conflicting, outdated and even confusing. Oftentimes they only go so far as to set minimum requirements. What results is a process, critical to the fight against healthcare acquired infections (HAIs), that does not give reprocessing technicians a clear path towards providing patients with safe, reliable and consistent care.

Additionally, some industry associations, such as the Association for the Advancement of Medical Instrumentation (AAMI), acknowledge workflow as an important factor in infection prevention efforts.⁵ A recently published resource from the American Hospital Association and the CDC entitled, “Using the Health Care Physical Environment to Prevent and Control Infection: A Best Practice Guide to Help Health Care Organizations Create Safe, Healing Environments,” recommends that facilities take the reprocessing area’s physical environment into consideration when looking to improve infection prevention efforts.⁶

The physical space in which critical medical instruments such as endoscopes are being disinfected needs to be the safest environment possible to help ensure safe, effective reprocessing. In the United States specifically, endoscope reprocessing needs a new approach to its workflow that brings standardization and raises the bar of industry best practices.

Reprocessing Area’s Impact on Infection Prevention Efforts and Workflow

Through our observation over the years, facilities typically have a linear reprocessing workflow. From a simplified view, a typical linear endoscope reprocessing might look like the following.

The process begins with a safe, patient-ready endoscope in the procedure room. After the endoscope is used and the procedure is completed, the endoscope undergoes in-room precleaning and is then transported to the decontamination area. Almost all remaining reprocessing steps are completed in this room, from manual cleaning to reprocessing to drying and storage until the endoscope needs to be used again.

Each of the aforementioned steps include other, smaller steps that must be completed for an endoscope to be successfully reprocessed. The sheer number of these smaller steps can make it difficult for technicians to remember all required reprocessing actions for each type of endoscope. Combine that with the majority of the steps all happening in one room and it can produce a situation in which it’s easy to miss a step or for a technician to forget where they are in the process.
Instead of this linear flow that can produce inconsistent results, reprocessing needs to be thought of as a unidirectional, circular process that begins and ends with a safe, patient-ready endoscope for every procedure. To get there, consider a three-pronged approach: Alter the decontamination area’s physical space to separate dirty from clean, incorporate the latest technology where possible and maintain best practice protocols.

Alter Decontamination Area’s Physical Space and Incorporate Latest Technology

To help achieve a circular process, a physical barrier should separate the dirty reprocessing area from the clean to not only be a physical marker of different parts of the process, but to also help reduce the risk of human error and subsequent cross-contamination. The backbone to a successful setup such as this is a pass-through automated endoscope reprocessor (AER). Pass-through AERs are recognized as best practice in other parts of the world, including the UK and Singapore, but they are a relatively new concept in the United States. The machines are built directly into a wall to physically separate the dirty and clean areas into two distinct rooms, indicating to technicians in a tangible manner what stage of the process the endoscope is in and helping eliminate confusion over what step needs to be completed next. Because of the divided setup, pass-through AERs can support a consistent and repeatable reprocessing procedure, helping to ensure safe, patient-ready endoscopes.

To support the pass-through process and a higher standard of reprocessing, consider incorporating other state-of-the-art technologies, such as:

• Endoscope flushing aid: Rather than requiring technicians to repeatedly clean channels—and risk repetitive motion injury—use a flushing aid. Some aids can provide continuous, hands-free channel flushing with a visual alert signal that a cycle is complete.
• Storage and drying systems: Ideal storage and drying systems force Instrument Grade HEPA-filtered air through internal channels and across external surfaces to completely dry an endoscope. Some of the latest were developed to be used in conjunction with pass-through AERs for a fully integrated reprocessing configuration.
• Electronic workflow and tracking system: Using such a system, when used right, can help improve efficiency and consistency between technicians, as well as eliminate the need for paper logs. Find one that monitors and verifies each step of the reprocessing cycle.

Maintain Best Practice Protocols

Although they can help improve efficiency and quality of the reprocessing process, incorporating the latest technology and a unidirectional workflow won’t innately guarantee improved outcomes. There is no silver bullet when it comes to patient safety. Proper protocols must still be followed to make the biggest impact towards decreasing the risk for infection. For example, it’s critical to change gloves between putting in a dirty endoscope in an AER and taking out a clean one. We’ve witnessed this error firsthand at a facility in the UK. Although the technician realized the mistake before the endoscope was used again, it still had to be sent back through the process, impacting department workflow and delaying the endoscope’s release time.

Changing gloves isn’t the only potential missed step, unfortunately. Other commonly missed steps are covered transport, leak testing and proper storage. Some of the more challenging issues our customers have reported include manual cleaning and reprocessing reusable valves. Each step in the circular workflow, no matter how big or small, supports the integrity of the process. If any step is missed or executed improperly, the circle isn’t complete and the endoscope might be unsafe to use. It is critical to ensure each technician is fulfilling every step of the process to provide the highest quality care possible and keep patients safe from endoscope-related infection risk.

Circular Approach in Action

Minneapolis-based Hennepin Healthcare was the first in the United States to fully execute this unidirectional, circular workflow using a pass-through AER.⁷ It began when the facility was preparing to build its new Clinic and Specialty Center.

“We reimagined our reprocessing area to further provide the best possible care to our patients,” said Uggen Jigmey, sterile processing department manager at Hennepin Healthcare. “Current standards aren’t enough to ensure patient safety and positive outcomes. We knew incorporating a pass-through AER, along with other updated technologies, would benefit our workflow and increase confidence in the cleanliness of our endoscopes in both our patients and our staff.”⁸

Training staff on the new process was easy, according to Jigmey. Beyond requiring sterile processing certification and a firm understanding of AAMI standards, Jigmey said training with the new pass-through AER only took an hour because the machine is easy to use.

The new workflow was put into action in the spring of 2018.

“Thanks to the new workflow and the latest technology, we’ve increased our efficiency and enhanced our infection prevention to the highest level available to-date. We’re excited about and proud of the work we do because we’re no longer meeting the industry’s minimum standards, but achieving best practices.”⁸

Endoscopes don’t have to be on ECRI’s top health technology hazards list or always be accompanied by the words “dirty” and “infection risk” in news stories.^1,2,4 The structure and technology to change the way endoscopes are thought of and reprocessed exist. We need to embrace new technology and examine how we reprocess, continue maintaining best practice protocols, elevate the standard of care and bring confidence to surgical staff and the public about reprocessed endoscopes.

References

1. Los Angeles Times. Timeline of scope-related outbreaks. (December 9, 2015). Retrieved from: https://www.latimes.com/business/la-fi-olympus-timeline-20151220-story.html
2. Los Angeles Times. Hospitals and device makers still struggle to rid medical scopes of infectious bacteria. (April 23, 2018). Retrieved from: https://www.latimes.com/business/la-fi-medical-scope-infections-20180423-story.html
3. 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: February 15, 2017). Retrieved from CDC: https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf
4. ECRI Institute. (November 6, 2017). Ransomware and Other Cybersecurity Threats Top ECRI Institute’s Annual Health Technology Hazards List. Press release. Retrieved from: https://www.ecri.org/Resources/Whitepapers_and_reports/Haz_18.pdf
5. Association for the Advancement of Medical Instrumentation. (April 8, 2015). ANSI/AAMI ST90: 2015 Flexible and semi-rigid endoscope processing in health care facilities. Section 3.2.2.
6. American Hospital Association and Center for Disease Control and Prevention. Using the Health Care Physical Environment to Prevent and Control Infection: A Best Practice Guide to Help Health Care Organizations Create Safe, Healing Environments. (2018).
7. Hennepin Healthcare. (June 11, 2018). Hennepin Healthcare Clinic & Specialty Center installs United States’ first pass-through endoscope reprocessor to enhance patient safety. Retrieved from: https://hcmcnews.org/2018/06/11/hennepin-healthcare-clinic-specialty-center-installs-united-states-first-pass-through-endoscope-reprocessor-to-enhance-patient-safety/
8.  U. Jigmey. Personal communication/interview. (April 2018)