Standardization in the Outpatient GI Center

Consistent endoscope care by following IFUs is crucial to keep patients free from harm when using these challenging-to-disinfect devices.

There’s nothing easy about cleaning flexible endoscopes. They’re fragile and expensive and one can argue the margin for reprocessing them safely is as narrow as the channels and lumens in the devices themselves.

Updated best practices

The difficulty in cleaning the reusable devices to make sure they’re safe enough for the next patient means the infection rates that accompany them are high — and so are the stakes to make sure they’re properly sterilized. Last year, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN) updated their guidelines because of how urgent the need is to ensure facilities are using the best practices to keep their patients safe.

With these complex instruments, “standardization” is key, and has two meanings. A fleet of scopes from the same manufacturer can arguably be invaluable to a busy sterile processing department that feels the fewer sets of manufacturers’ Instructions for Use (IFUs), the better. It also means to heed the latest guidelines from groups such as AORN and AAMI.

AAMI’s standards, revised in 2021, recommend using a storage cabinet with an active-drying function that uses filtered air to dry the devices’ deep internal channels after processing. A big question is always how long the scopes can hang after they’ve undergone high-level disinfection, because any remaining water in the devices is a hazard for bacterial growth. Luci Perri, RN, BSN, MSN, MPH, CIC, FAPIC, CSPDT, owner and president of Infection Control Results, a Charlotte, N.C.-based consulting company, says there’s no broad consensus on the perfect amount of time a device can hang before it should be reprocessed, but notes there is agreement on the importance of revising storage times to keep them to a minimum.

Key revisions

Other key AAMI revisions include issues surrounding decontamination sinks, how to monitor air and water quality at facilities, leak testing and staff training.

New items in the updated AORN guideline, meanwhile, include recommendations of drying flexible scopes for at least 10 minutes or until no moisture is visible with HEPA-filtered or pressure-regulated air; using tests to verify the effectiveness of manual cleaning before beginning high-level disinfection and/or sterilization; inspecting internal channels of endoscopes with a borescope before high-level disinfection or sterilization; and improving communication and documentation between those who transport the devices after they’ve undergone point-of-use care and the staff in the decontamination area.

“AORN also recommends facilities form an interdisciplinary team to develop a process for performing pre-purchase evaluations of these devices,” says Ms. Perri. “The guideline provides a list of what to evaluate during product reviews and specific criteria are identified to review flexible endoscopes, automated endoscope reprocessors, storage cabinets, borescopes, cleaning solutions and detergents.”

FDA urges more proactive processes

The FDA has issued warning letters to multiple scope manufacturers in recent years, telling them to do a better job at being more proactive in general and, specifically, more responsive when Medical Device Reports — which are on the rise — come in about their products.

Ultimately, all stakeholders must change for improvements to be made, says Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, a research and consulting firm that offers evidence-based solutions to challenging issues such as how to improve scope reprocessing.

Ms. Ofstead’s team has researched cases to better understand the issues that led to the FDA’s issuance of warning letters. “The problems involve all types of flexible endoscopes — not just GI scopes — and they indicate that damaged, dirty scopes are commonly used for procedures, placing patients at risk of injury or infection,” says Ms. Ofstead. “Addressing these issues will require active collaboration by the device manufacturers, guideline-issuing bodies and leadership of healthcare institutions — who need to develop more effective methods for processing and inspecting endoscopes that are practical and achievable by the personnel working on the front lines in sterile processing and endoscopy departments.”

The FDA has also recommended that endoscopy centers, over time, transition to devices with disposable end caps, or even to fully disposable duodenoscopes to decrease the risks of infection, says Ms. Perri. To the extent that single-use scopes could one day be an affordable solution, they could also likely bring their own challenges, as evidenced by the caution to manufacturers of single-use items delivered recently by ECRI, an independent nonprofit patient safety organization. Faulty single-use medical devices of any kind made the group’s 2023 list of top health technology hazards, noting that non-pristine items present in the supply chain could cause healthcare-acquired infections and other patient harm. “ECRI challenges manufacturers of single-use medical devices to revisit and improve their quality control processes to prevent defective products from reaching the market,” states the group’s recent report on the issue.

Skills needed

A recent study featured in the American Journal of Infection Control about a pilot study conducted by Ms. Ofstead and others offered encouraging news, saying that a training program developed in conjunction with the Healthcare Sterile Processing Association produced promising results for teaching reprocessing technicians how to properly process complex borescopes. The trainers sought to improve the mastery and retention of the skills needed because inadequate processing and inspection are believed to be factors in cases that resulted in infections and other injuries.

The pilot group of sterile processing professionals were given time for firsthand practice to cement what they learned in a series of lectures and were tested before and after the curriculum. Knowledge and skills regarding visual inspection of these complex devices among the group improved after the training. Test scores of 41% pre-study improved to 84% afterward, and tests given two months later produced an average score of 90%, with the trainees reporting higher levels of confidence and satisfaction with their technical knowledge.

“After the workshop, all trainees identified actionable visible defects on patient-ready endoscopes in their facilities,” notes the study. “This study demonstrated effectiveness and clinical relevance of a new, evidence-based model for training sterile processing professionals that incorporated pre-testing, lectures, hands-on practice, a training booster and post-testing to enhance learning.” OSM

Note: This three-part article series is supported by Karl Storz.