Last month, the FDA announced it was investigating post-procedure infections and contamination issues involving urological endoscopes that were cited in 450 Medical Device Reports (MDRs) from January 2017 to February 2021. The FDA emphasized that MDRs aren’t evidence that the devices involved were faulty or defective, and said the agency hadn’t concluded whether any particular brand of endoscope was riskier to patients than others.
“While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling,” says Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Although we believe that the risk of infection is low based on available data, we’re reminding healthcare providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.”
The reports have reignited concerns about reliable endoscope reprocessing. To healthcare facilities, these challenges are old news. We’ve been performing risk assessments, educating teams and investing in enhanced reprocessing equipment for years to meet the many challenges involved in cleaning and high-level disinfecting these devices. With this new round of attention, it will be helpful for you to refocus on basic reprocessing steps and identify potential gaps in the process.
• Assess the risks. Shadow your facility’s reprocessing steps from start to finish, and solicit feedback from the frontline team members about the process. Observe bedside cleaning, manual cleaning and disinfection/sterilization practices, and compare them to your standard operating procedures and competencies.
Those of you who work in a hospital setting might even discover that endoscopes are being handled in areas without procedures, policies or competencies in place. For example, scopes are frequently used in inpatient care areas, often by nurses who are unfamiliar with the proper way to care for and handle the devices. This can lead to mishandling of the scopes, a lack of pre-cleaning or point-of-use care, and inappropriate transport through hospital hallways. These factors can cause scope damage, and increase risks of cross-contamination and patient infection. Even staff who work in various departments within a freestanding surgery center might not always follow proper endoscope care protocols.
This is why it’s imperative to create a robust, multidisciplinary team to perform the risk assessment. A formal process, education plan, visual guides, checklists, points of contact and monitoring plan should be implemented to ensure all steps of pre-treatment and reprocessing are properly performed.
• Look for leaks. One of the MDRs the FDA is investigating involved a cystoscope that did not pass a leak test. Leak testing has an important role in infection prevention because it can detect damage to the scope that may lead to fluid invasion, which increases the risk of cross-contamination. Unfortunately, it is one of the most misunderstood and frequently missed steps in endoscope reprocessing.
There are two leak-testing methods: dry and wet. Both tests require attention to detail and human interpretation. Catching damage early will help lower the risk of cross-contamination and hopefully reduce repair costs.
During a dry manual leak test, the scope is pressurized and manipulated. The technician observes a pressure gauge looking for drops in pressure. During a wet manual leak test, the scope is pressurized and submerged in clean water. The technician looks for bubbles while manipulating different components of the scope. Automated leak testers can help detect minor damage that may be missed during a manual leak test. The leak-sensing technology utilized by this equipment is more sensitive and consistent than using an unaided eye to watch a pressure gauge during a dry test or searching for bubbles during a wet test.
The reports have reignited concerns about reliable endoscope reprocessing.
• Confirm cleanings. Adenosine triphosphate protein (ATP) testing helps to verify the effectiveness of the endoscope cleaning process. ATP is an organic chemical that provides energy for cellular processes. The presence of ATP in a “clean” endoscope is an indicator that potentially pathogenic material is still present.
ATP testing usually involves flushing sterile water through an endoscope’s channel or swabbing its surface, and then using a test strip to determine if organic material is present. To develop and implement a testing program, determine which endoscopes you’ll monitor, the testing frequency, the pass-fail threshold and a standardized way to track results for process-improvement purposes.
Incorporating a verification program into your current practices can help identify trends and gaps in your cleaning and disinfecting processes. Whenever you implement an enhanced testing or verification program, it’s a good idea to have a backup inventory of scopes available in the event still-dirty scopes need to be removed from service.