THIS WEEK'S ARTICLES
GI Centers Getting Back Up to Speed
Efficient endoscope care is key to maintaining case volumes in high-volume facilities.
Many GI centers were hit hard by last year's pause of elective procedures and had to adjust routine practices to build case volumes back to pre-pandemic levels. Now the facilities are working at full capacity and reemphasizing expert endoscope reprocessing to keep up with the demand for colonoscopy screenings.
"We had a horrible two-month dip — an 80% to 90% reduction in screening volumes — during the shutdown, so we knew our numbers were going to be low last year," says Frank Kim, MD, a gastroenterologist at the Center for Digestive Health & Nutrition in Moon Township, Pa. "It took some convincing to get patients to return to get the screenings they needed."
The center's return to relative normalcy involved implementing updated safety protocols and clear communication with patients to ensure they had confidence in the care they received. To keep the facility running at full speed when patients started to reschedule postponed procedures, Dr. Kim's staff allotted additional time for the thorough cleaning of procedure rooms and made sure endoscopes were cared for effectively and efficiently.
Multi-society guidelines for the proper handling and reprocessing of endoscopes during the pandemic provided some guidance for facilities in a similar situation as the Center for Digestive Health & Nutrition. The steps outlined in the guidance were largely the same as recommendations in place during non-pandemic times — immediate bedside cleaning, transport in a closed container, meticulous manual cleaning and vertical storage to ensure channels remain dry — but the societies suggested limiting the number of reprocessing techs who reprocessed scopes, and making sure the techs who handled the reprocessing were experienced and had documented competencies.
"Transmission of viral infections during endoscopy is exceedingly rare and when it does occur, it is the result of noncompliance or deviation from the required steps of reprocessing," note the guidelines. So, as the pandemic showed and routine times confirm, turning around endoscopes quickly and properly is essential to providing safe and speedy patient care.
Keeping Endoscopes Safe and Secure During Transit
Facilities must have a plan to protect the delicate devices while they're on the move.
Efforts to improve endoscope care typically focus on point-of-care treatments and best practices in high-level disinfection. Just as much attention should be paid to how scopes are handled during transport, according to Michael Gudejko, BS, manager of sterile processing and central processing at Baystate Medical Center in Springfield, Mass. He established protocols to ensure his facility's fleet of scopes are moved between procedure rooms and the reprocessing area safely and effectively.
Reprocessed scopes are placed in closed containers with green "clean" stickers affixed to the lids for their journey to procedure rooms. Reprocessing techs note on the outside of the containers the types of scopes that are inside. Individual containers also have unique identification barcodes that are scanned into the facility's instrument-tracking system. Endoscopes are tagged with radio-frequency identification tags to help staff track the location of each device.
Staff in procedure rooms confirm containers are locked with green clips, which signify the scopes within have been reprocessed. Additionally, reprocessing techs attach a white "clean" tag to the control heads of properly reprocessed scopes, so procedural staff know it's safe to proceed if the tags are on the scopes they remove from containers. One final safeguard ensures properly cared-for scopes are used during procedures: Before handing a scope to physicians, nurses or techs verbally confirm that the serial number matches what's noted in the reprocessing papers.
At the end of procedures, staff remove the green label from the transport container to reveal a red biohazard sticker and secure the container with red clips to identify the scope as "dirty" for the return trip to the reprocessing area.
"Examine the moving parts of the scope transport and delivery process to identify deficiencies, breakdowns or inconsistencies," says Mr. Gudejko. "Then develop a response plan and implement a process to improve the practices."
The Flexible Endoscope Processing Journey
The Center for Disease Control recommends seven critical processing steps to ensure endoscopes are safe for patient use.
Endoscopy is a procedure to visually examine the inside of the body using an endoscope. Duodenoscopes are an example of a flexible endoscope used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. In recent years, they have received attention due to the infections associated with the improper processing.1
Duodenoscope are complex instruments that contain intricate working parts. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain when it is used on a subsequent patient.1
The Center for Disease Control (CDC) recommends seven critical processing steps to ensure endoscopes are safe for patient use. The guidance includes bedside cleaning, leak testing, manual cleaning, visual inspection, disinfection and sterilization, storage and documentation.2
What's the difference between disinfection and sterilization? Disinfection and sterilization are essential for ensuring that medical and surgical instruments do not transmit infectious pathogens to patients.3 Sterilization is a process that destroys or eliminates all forms of microbial life. Disinfection is a process that eliminates many or all pathogenic microorganisms.
There are three levels of disinfection:4
High-level disinfection - The destruction of all mycobacterium, vegetative bacteria, fungi, viruses, and some, but not all, bacterial spores.
Intermediate-level disinfection - The destruction of all mycobacteria, vegetative bacteria, fungi, and some nonlipid viruses, but not bacterial spores.
Low-level disinfection - A process that can kill vegetative bacteria, some fungi and lipid viruses but not mycobacteria or bacterial spores.
How do you determine endoscope processing modality? Determining the appropriate processing modality requires an understanding of the Spaulding Classification of instrumentation. This classification defines the minimum levels of disinfection or sterilization that should be used according to the infection risk associated with a medical device.5
Advanced Sterilization Products (ASP) offers solutions for high-level disinfection with several options for high-level disinfection of flexible endoscopes with a biocide by manual or automated means. All AER systems automate high-level disinfection, but some systems have additional features such as automated cleaning and leak testing. In addition, biocide monitoring is an important aspect with high-level disinfection processing. ANSI AAMI ST91:2015 Flexible and semi-rigid endoscope processing in healthcare facilities recommends monitoring biocide Minimum Recommended Concentration (MRC) every cycle; MRC testing is typically performed with a manual test strip.6
The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) automates critical steps including the proper monitoring and documentation of MRC. ASP AEROFLEX™ AER is the only system with AUTOSURE™ MRC Monitor, an automatic, integrated system that eliminates the use of test strips. The exclusive AUTOSURE™ MRC monitor reduces the opportunity for human error and reduces patient risks associated with manual test strip.7
According to researcher W.A. Rutala, PhD, MPH, CIC, "Nearly all infections and patient exposures associated with reprocessing medical or surgical instruments involve high-level disinfection (HLD) of reusable semi-critical items", while "critical items are rarely, if ever, associated with disease transmission."8
STERRAD® System is a patented low-temperature hydrogen peroxide gas plasma sterilization system, a popular solution for institutions looking to sterilize flexible endoscopes. The technology in the STERRAD NX® System and STERRAD® 100NX System delivers hydrogen peroxide through long and narrow lumens to terminal sterilize flexible endoscopes. Check out the STERRAD® Sterility Guide for an up-to-date list of flexible endoscopes from leading manufacturers that have been validated in STERRAD® Systems.
Note: Roger Vu works in ASP Research & Development working on technical feasibility of technologies and new product development. He completed his Master's degree in Molecular Microbiology and Immunology at the University of Southern California, Keck School of Medicine and holds a Bachelors' degree in Biological Sciences from the University of California, Irvine. He contributed to this article (see: https://www.asp.com/media/roger-vu). For more information, visit www.asp.com.
1. U.S. Food & Drug Administration (FDA). Infections Associated with Reprocessed Duodenoscopes. Available: https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes Accessed August 4, 2020.
2. Centers for Disease Control and Prevention (CDC). Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee. Last updated: June 28, 2017.
3. Centers for Disease Control and Prevention (CDC). Introduction, Methods, Definition of Terms -Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) https://www.cdc.gov/infectioncontrol/guidelines/disinfection/introduction.html. Accessed August 4, 2020.
4. Lichtenstein D, Alfa MJ. Cleaning and Disinfecting Gastrointestinal Endoscopy Equipment. Clinical Gastrointestinal Endoscopy 2019: 32-50.e5.
5. Centers for Disease Control and Prevention (CDC). A Rational Approach to Disinfection and Sterilization - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/rational-approach.html. Accessed August 4, 2020.
6. Association for the Advancement of Medical Instrumentation (2015). ANSI/AAMI ST91:2015. Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA.
7. Ofstead CL, Hopkins KM, Buro BL, Eiland JE, Wetzler HP. Challenges in Achieving Effective High-Level Disinfection in Endoscope Reprocessing. Am J Infect Control 2019: 10.1016.
8. Rutala WA, Weber DJ. Reprocessing semicritical ítems: Current issues of new technologies. Am J Infect Control 2016: 44 e53-62.
How to Be Certain Scopes Are Clean
Reprocessing techs verify the devices are safe for patient use.
In April, the FDA issued a warning about patient infections potentially caused by improperly reprocessed urological endoscopes. The FDA's investigation into the reported incidents serves as a reminder to consistently follow high-level disinfection protocols.
Alison Sonstelie, BS, CRCST, CIS, CHL, sterile processing lead coordinator at Sanford Health in Fargo, N.D., touches on the tools and tests that endoscope reprocessing techs use to confirm that the difficult-to-clean instruments have been properly reprocessed:
- Borescopes. Techs use these small inspection cameras to examine the internal channels of endoscopes, checking for residual bacteria or water and minute damage that increase cross-contamination risks.
- Automated leak testers. Attaching scopes to these devices improves the likelihood that techs detect small defects in lumens that can allow fluid to invade interior channels and components, causing damage that can lead to costly repair bills or, worse, patient infection.
- Adenosine triphosphate (ATP) testing. Swabbing the inside of lumens and exterior of endoscopes for the presence of ATP helps techs determine if pathogenic material remains on the surfaces. The test is an effective way to ensure the high-level disinfection process was performed correctly and the scope is safe for use on patients.
"National organizations recommend visual inspection and cleaning verification of endoscopes after manual cleaning and before high-level disinfection," says Ms. Sonstelie. "The human factors of cleaning endoscopes get a boost by using these technologies during routine reprocessing."
How Long Can Endoscopes Hang in Storage?
The widely accepted week-long limit impacts the flow and finances of busy GI centers.
The number of days endoscopes can remain in storage before having to be reprocessed again is open to discussion, although guidance provided by the Society of Gastroenterology Nurses and Associates (SGNA) sets the cutoff at seven days.
Randall Rentschler, RN, perioperative director at Artesia (N.M.) General Hospital, says the seven-day limit is based on evidence that shows bacteria can grow in scopes with residual moisture in their channels after a week's time and it has become the industry standard. He also points out that following the SGNA's recommendation in real-world practice can be challenging.
"Scopes are delicate and expensive, and putting them through a reprocessor every seven days, especially if you're not using them, increases their exposure to high-level disinfectant, which can even decrease their lifespans," he says. "It also increases personnel costs and the costs associated with increased use of automated endoscope reprocessors."
Mr. Rentschler suggests GI centers conduct their own studies based on adenosine triphosphate (ATP) testing to determine how long their fleet of scopes can be stored before having to reprocessed. Swabbing the lumens of endoscopes in storage and testing the swabs for the presence residual blood and bioburden are steps that provide information for establishing safe storage protocols.
For example, the testing could show a facility's scopes remain free of microbial contamination for longer than a week, a finding that could lead to extending the safe storage duration. (CMS permits the storage of endoscopes for up to 30 days without reprocessing if the scopes are proven to be safe for patient use.)
"The key is to document your testing method and make sure it's strong enough to stand behind," says Mr. Rentschler.