The Centers for Medicare & Medicaid Services (CMS) suspended healthcare associated infection (HAI) reporting requirements through June of 2020, leaving less oversight and prevention of these infections. The focus was instead on activities related to the COVID-19 response and surges.
By December of 2020, a review of HAIs for the year showed an uptick related to the pandemic. A survey conducted that month by the Association for Professionals in Infection Control and Epidemiology (APIC) found HAI rates between 17 and 28 percent. These rates were most closely associated with central line-associated bloodstream infections, ventilator-associated pneumonia or ventilator-associated events and catheter-associated urinary tract infections.
Because most elective procedures and surgeries were put on hold, the rate of infections from flexible and semi-ridged endoscopes were less than in previous years.
Researchers anticipate that when more thorough numbers of HAIs are available, the rate of CLABSI, which COVID-19 patients are at higher risk of contracting, will have risen more than all other HAIs.
The pandemic changed this dynamic since pathogens remaining on endoscopes was the leading risk for these infections not long ago, and a combination of new protocols and fewer elective procedures, has displaced the endoscope from the top of the list.
That doesn’t mean that the cleaning, sterilization and safe storage of these instruments can be ignored now. For every patient who has to undergo a colonoscopy, ERCP biliary study, upper GI endoscopy, small bowel manometry, double balloon enteroscopy or other procedure, the safety of these instruments is critical.
Although HTM plays a peripheral role in endoscope reprocessing, it is good to be aware of updated procedures in this crucial area. Most of the responsibility for this task falls to the sterile processing department (SPD) in the hospital environment.
As of late December, AAMI ST91:2021 earned final approval from the American National Standards Institute (ANSI). According to AAMI, the updated ST91 is expected to be made available at the AAMI store (aami.org) sometime this February, 2022. Those with an electronic subscription will have immediate access to the revised standard at that time. The printed standard will be available to HSPA members (formerly IAHSCMM) at a reduced rate. The HSPA website is myhspa.org.
Outside of the hospital setting, the cleaning and sterilization of endoscopes is carried out in GI and pulmonary endoscopy units, respiratory therapy departments and ambulatory care clinics – especially urology and ENT, ambulatory surgery and/or endoscopy centers, according to John Whelan, BSN, RN, clinical education specialist at Healthmark Industries.
“More commonly – outside of SPD areas – clinical staff are processing reusable devices. Endo areas commonly have endo techs or RNs processing scopes. In ambulatory care clinic settings, it is commonly medical assistants who have been trained in processing,” Whelan says.
A review of the ECRI Institute’s lists of health care concerns in past years found that endoscope reprocessing was a critical issue that resulted in HAIs.
The organization publishes it’s “Top 10 Patient Safety Concerns for Healthcare Organizations” every year. In 2016, the number four entry on the list was “Inadequate Cleaning and Disinfection of Flexible Endoscopes.”
In its outline of the concern, ECRI stated that “A series of deaths due to carbapenem-resistant Enterobacteriaceae (CRE) infections has highlighted the importance of effectively cleaning and disinfecting flexible endoscopes – a problem that has been on ECRI Institute’s radar for years.”
ECRI pointed out that endoscopes had become more intricate and complex as technology had advanced and that this posed a greater challenge in making these instruments clean. Duodenoscopes were of particular concern that year.
Endoscopes also made the ECRI list the previous year. “Device Cleaning, Disinfection, and Sterilization” was also highlighted on the list in 2018, but endoscopes were not singled out.
Despite the focus on endoscopes, and measures to improve sterilization, there continues to be concern.
Mairead Smith, senior project engineer with ECRI, says that endoscope reprocessing continues to be a major challenge for health care facilities. She is part of the organization’s medical device evaluation team.
Smith says that, in particular, facilities struggle with workflow challenges. The pre-cleaning and manual cleaning processes that are required for flexible endoscopes are long and labor-intensive. Staff deal with physical strain and time constraints, as well as the challenge of remembering and following the very detailed instructions, which vary by model.
Other challenges include managing equipment, including the proper accessories as recommended by the manufacturer, expiration dates on test strips and cleaning agents, water quality used by installed reprocessing or sterilization devices, and cleanliness of storage cabinets.
“Endoscopes that are very difficult to clean. In some cases, even when facilities follow all of the validated reprocessing instructions, endoscopes can still be contaminated,” Smith says.
She says that there have been some major changes over the last few years that may help to reduce the risks. Some of the highest profile changes with great potential include:
Duodenoscopes. In August 2019, the FDA recommended that facilities consider using duodenoscopes with single-use components. They believe that, “Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps.”
Single-use endcaps are used with reusable duodenoscopes. They allow staff to better access the intricate geometry of the tip of the duodenoscope, where the forceps elevator is. Reusable duodenoscope reprocessing IFU now recommend detailed manual brushing on all sides of the tip, including the front and back of the forceps elevator. Single-use endcaps allow much easier access than with traditional fixed endcaps.
“Fully single-use models should be disposed of after each procedure. They arrive sterile and are not validated for reprocessing. Although relatively costly, they may offer particular benefit under selected circumstances, such as when a patient has a known or suspected infection, or if a patient is immunocompromised,” Smith says.
She says that there has also been recent FDA guidance as it pertains to bronchoscopes.
One more recent example of concerns with the cleanliness of endoscopes appeared in an FDA notice issued in April of 2021 titled; “Infections Associated with Reprocessed Urological Endoscopes – Letter to Health Care Providers.”
The FDA specified cystoscopes, cystourethroscopes and ureteroscopes and stated that since 2017, the agency had received 450 Medical Device Reports (MDRs) related to post-procedure infections in patients.
This FDA notice was cited in a presentation at the 2021 AAMI eXchange Rewired given by Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), AAMIF, FAPIC, director of clinical affairs for Healthmark Industries. Drosnock is also the co-chair of AAMI’s ST91 working group.
The title of the presentation was: “Updated AAMI ST91:2020 for Endoscope Reprocessing: An HTM Perspective.”
The presentation looked at the AAMI ST90 and the goal of the standard. She said that “This standard specifies the minimum requirements for a quality management system that can be used by health care organizations that process medical devices.”
“It was developed to help health care professionals more effectively, efficiently and consistently reprocess reusable medical devices in order to prevent infections, pyrogenic reactions or other adverse events,” she added.ANSI/AAMI ST91 sets a standard for health care facilities for the processing of flexible and semi-rigid endoscopes. According to Drosnock’s presentation, the standard includes best practices in any health care setting and covers all steps of processing from precleaning through reuse. It excludes TEE/ultrasound probes/dilators/manometry and rigid scopes.
Some of the changes in ST91 include point of use treatment re-termed, cleaning verification, inspection of borescopes and standards for drying, storage and handling. There are also recommendations against manual disinfection, the adding of FDA Maude database citations and appendix on inspection, simethicone and cleaning verification.
A portion of the ST91 presentation that has direct implications for HTM is the section that details quality assurance policies for logging endoscope inventory, accessories, processing equipment, serial numbers or other assigned numbers and unique identifiers.
“HTM has a huge role in inventory management of devices and lists of endoscope models with serial numbers. HTM would also be responsible for keeping an inventory of the various endoscopes in their health care setting and maybe having some type of notation when each instrument was last repaired but not when it was sterilized. That falls to SPD,” Drosnock says.
In addition to the inventory items, section 12.2 of policies for quality assurance states: “Development and implementation of procedures that address specification evaluation, acquisition management, scheduled maintenance and removal of equipment from use.”
Drosnock’s presentation also highlighted Section 6.4.1 of the standard, which deals with quality assurance of leakage testers. Some general considerations include: “automated leak testers should be placed on a calibration schedule to verify the leak tester is producing the correct pressure.”
“Historically, the only thing HTM (or anyone else) could do for leak testers was electrical safety testing. It’s been only the last two years since devices exist for testing pressure outputs from leak testers. This can and should be now incorporated as part of standard QC practices for this automated equipment,” Whelan says.
In HTM’s peripheral role, biomeds are responsible for maintaining the equipment and managing the devices that allows the cleaning process to work. Most of the direct hands-on work of cleaning these devices falls to the sterile processing department in a hospital setting while this function can be undertaken by others in other health care settings.
Examples of HTM’s involvement in the process may be to maintain the TEE probe reprocessors, leak detectors, drying cabinets and manage the contracts for the washers.
“HTM would be responsible for calibrating the leak tester units for PMs on a routine basis (like annually or biannually), but daily testing of the leak test units would be up to the sterile processing department to do,” Drosnock says.
She says that HTM may have a role in water management. Especially since there will be recommendations for testing water in the AERs. Sterile processing may need help setting that up initially or HTM may do that for them.
Drosnock says that HTM would also be responsible for checking the integrity of loaned endoscopes and tracking those loaned out.
“HTM should also have a team member who sits on any committees related to endoscopes, new purchases for SPD/endoscopy, and likely any cross-functional that makes risk-management type decisions for the sterile processing/endoscopy processing areas,” she adds.
“In my experience, this has not been the norm; but would certainly be an asset. This should include existing committee structures for: infection prevention, risk management, purchasing,” Whelan says.
Smith says that there is definitely a role for the HTM department in supporting the cleaning/disinfecting/sterilization process. In particular; equipment management and maintenance.
“As mentioned earlier, management of reprocessing, sterilization, drying and storage equipment is a challenge for sterile processing departments. The equipment should undergo appropriate inspection and preventive maintenance, and service as recommended by the manufacturer. In conjunction with the infection prevention team at a facility, HTM departments can also perform water quality tests and take appropriate preventive measures (e.g., changing filters at regular intervals) to meet the needs of sterile processing departments,” she says.
She adds that in addition, endoscopes must be properly maintained. As part of the reprocessing procedure, staff should perform leak tests to look for damage to the endoscope insertion portion or working channels.
“If damage is found, such as punctures, tears,or grooves, it should be repaired promptly by the device manufacturer or another qualified service organization. Endoscopes with damaged surfaces can trap water and contaminants, harboring pathogens and allowing for cross-contamination. HTM departments can help manage the process of gathering damaged scopes, returning them to the manufacturer for repair, requesting loaner devices to meet the facility’s workload, tracking the serial number of loaner devices, and finally, returning repaired endoscopes to service,” Smith says.
Depending on the health care environment, those tasked with endoscope processing may work in a variety of capacities.
“It is common that most of high-level disinfection (HLD) and endoscope processing occurs outside of the standard sterile processing domain. For example, endoscope processing often occurs locally for GI and pulmonary endoscopy units, respiratory therapy departments, and ambulatory care clinics – especially urology and ENT,” Whelan says.
He says that in recent years, a significant portion of clinical outpatient procedures have transitioned to ambulatory surgery and/or endoscopy centers. Depending on the organizational structure, HTM may or may not be actively supporting this “wider net” of reusable device processing.
Whether in a hospital or other health care setting, the integrity and cleanliness of endoscopes is a team effort. The safety and health of patients undergoing procedures that uses these devices are on the line.
*By entering your email address, you agree to receive emails regarding TechNation Magazine, Webinars, and Exclusive Promos.
© 2021, TechNation Magazine. Site designed by MD Publishing, Inc.