BRUSH STROKES Careful manual cleaning should remove all visible debris.

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Breakdowns in endoscope reprocessing are making headlines seemingly every day. Take Baystate Noble Hospital, for example. The Westfield, Mass., hospital found itself in the news last January after it was forced to alert nearly 300 colonoscopy patients that they may have been exposed to HIV, hepatitis B and hepatitis C. Why? Because the hospital's reprocessing staff wasn't trained on proper high-level disinfection techniques for endoscopes. Many of those patients have filed lawsuits against the hospital.

Without a standardized practice, how many more patients will be put in harm's way before every facility offering GI services follows the same endoscope reprocessing protocols? That desire for uniformity drove me in helping to develop the national standard for endoscope reprocessing, ANSI/AAMI ST91:2015: Flexible and semi-rigid endoscope processing in health care facilities. This 58-page manual outlines standardized cleaning, disinfection and sterilization policies for endoscopes. Read on to see how many of the manual's key recommendations are in place at your facility.

1. Point-of-use cleaning
Don fresh gloves, a gown and eye protection before preparing a cleaning solution, as indicated by the solution's manufacturer. As soon as possible after the endoscope's use, place its controls in the unlocked position and wipe down the insertion tube with a lint-free cloth or sponge that's been soaked in the cleaning solution. Next, suction the solution through the endoscope's biopsy channel. Finally, flush the air, water, elevator and auxiliary channels with the solution. Visually inspect the scope for damage before placing it in a closed container or drawstring sack for transport to the reprocessing area.

2. Leak testing
This should occur as soon as possible after the scope arrives in the reprocessing area. When performing mechanical leak testing, remove all valve and port covers, attach the leak tester, turn on the air compressor to pressurize the scope and place it in a sink large enough for it to be loosely coiled and completely immersed. Manipulate the scope's knobs and elevator control for a minimum of 30 seconds while checking to see if changes in pressure occur. If the pressure remains constant, the scope is air tight, and cleaning and disinfecting can begin.

3. Manual cleaning
Prepare fresh cleaning solution in a sink for each endoscope according to the solution manufacturer's written instructions for required temperature, concentration and water quality. Place the endoscope in the solution while ensuring it remains completely submerged throughout the cleaning process. Use a lint-free cloth or sponge to clean the scope's exterior. Refer to the scope manufacturer's instructions for use to determine the size, length and width of the brush needed to clean the channels, cylinders, openings and forceps elevator housing. Flush the scope's channels with the cleaning solution and rinse the exterior surfaces with clean water until all trace of the cleaning solution is rinsed away. The manual cleaning of the scope should continue until all visible debris is removed. All removable parts must also be soaked, scrubbed and rinsed.

4. Assessing AERs
Strongly consider automatic endoscope reprocessors (AERs) with channel sensors that ensure recommended fluid and air pressures are achieved and maintained. It's also beneficial to invest in units that perform rinse cycles, automatic air purges after high-level disinfection cycles, self-disinfection cycles and alcohol flushes. They should also sound alarms when filters are clogged or dirty and provide verification of each cycle performed. Finally, make sure the AER's adaptors are verified for use with the endoscopes you use.

DEEP SOAK Sinks should be large enough to hold endoscopes placed in a loose coil.

5. Proper storage
How long can disinfected scopes remain in storage before they have to be reprocessed again? The issue is unresolved due to a lack of scientific data. In ST91, we left this recommendation open to interpretation by individual facilities that perform their own risk analyses when setting polices and procedures. Consider the complexity of your scopes, whether the storage cabinets are air-filtered, temperature or humidity controlled, and in an area with restricted access. How often are the scopes handled during storage? What do the scope manufacturers' instructions for use recommend? How often and how well do you monitor your reprocessing protocols? Are scopes hung vertically, so that fluid does not remain in the channels? Do you track the use of each endoscope and the high-level disinfection cycle they undergo? Assess all these factors when deciding how long endoscopes can be stored safely in your facility.

6. Staff training
ST91 recommends that all staff members who reprocess endoscopes be certified to do so. They should receive training and undergo competency verification upon initial hire, at designated times annually and whenever new endoscopes, AERs and chemicals are brought in.

Last September, the CDC and FDA issued an urgent report that called on facility leaders to review their procedures for cleaning, disinfecting and sterilizing reusable medical devices. In the directive, the CDC states that you should regularly monitor and document the performance of reprocessing techs with respect to their endoscope cleaning and recording of AER performance.

Keep in mind that reprocessing techs must be trained on how to care for every make and model scope you have, the use of automated flushing devices, how to perform manual disinfection (including the chemical used) and how your AERs operate. In other words, a general GI service line competency is not acceptable. Endoscope and AER manufacturers will train your staff on the proper care of their devices, but will no longer conduct competency assessments.

So who in your facility can perform competencies? Certified managers of sterile processing departments can do so for a departmental supervisor, who can then conduct competencies for the frontline staff. Keep in mind that CMS and accreditation surveyors are now looking at who's performing the competencies, and will ask what qualifies them to do so.

7. Cleanliness testing
The FDA suggests facilities sterilize duodensocopes, but most facilities don't have access to ethylene oxide, which is needed for sterilization. Some experts suggest reprocessing scopes with liquid chemical sterilization or high-level disinfecting scopes twice to limit cross-contamination risks. There's a problem with all 3 suggestions: Endoscope reprocessing must be based on proper cleaning, which is needed to ensure proper disinfection. ST91 suggests testing the effectiveness of your staff's endoscope cleaning at least weekly, but why not check every scope? There are several options available to do so, including a lumen inspection system that lets you visually confirm that the inside of a scope has been properly cleaned. With another on-the-spot test, you pour sterile water though the endoscope's biopsy channel, swab the channel with the kit's probe and drop the swab into a vial of activating agent. If the swab changes color, blood or protein residue remain in the channel and the scope must be reprocessed again. The test costs about a dollar. Isn't being able to sleep at night worth that much? OSM