Any facility that does flexible endoscopy knows how tough it is to clean and maintain the scopes. While there's nothing terribly complicated about reprocessing an endoscope, there are plenty of opportunities along the way to fall short. The key, experts say, is to remain vigilant and to resist the temptation to take shortcuts. The experts we talked to pinpointed eight facets of endoscope reprocessing where errors are most likely to occur and what you can do to reduce the risk they will.
1. Train your reprocessing staff
First, dedicate - don't sporadically assign - a reprocessing staff formally trained on the process for all scopes in your inventory. Personnel should "receive device-specific reprocessing instructions," and be tested for competency at the beginning of employment and once annually thereafter, according to the "Multi-society guideline for reprocessing flexible gastrointestinal endoscopes."1 The guidelines, endorsed by 11 organizations including JCAHO, also discourage letting temporary personnel reprocess endoscopes.
"Cleaning seems so simple," says an Olympus representative. "But these are medical instruments, and a patient's health is at risk. Different models have different connectors, features and accessories that require specific steps."
In addition to annual, formalized competency testing, Susan Przybylinski, RN, CGRN, a staff nurse in the GI lab at St. Anthony/Memorial Health Center in Michigan City, Ind., suggests you should include in your guidelines a provision that all staff who reprocess scopes will clean scopes a minimum number of days per month to maintain competency.
John M. Poisson, chief operating officer at Physicians Endoscopy, suggests that you ask your endoscope manufacturer to send a field service rep to your facility to perform a comprehensive in-service. "Not only did the service rep train all the technicians very well," says Mr. Poisson, "but he even awarded an education certificate for reprocessor training for each staff member."
2. Don't skip pre-cleaning in the procedure room
"The most common thing I see people not doing is pre-cleaning," says Candy LeBlanc, RN, BSN, the manager of product consulting at Advanced Sterilization Products. "It's the lowest-tech part of the procedure, but it's the most important. I'd say 50 percent of the facilities I go to don't do it."
According to guidelines issued by the Society of Gastroenterology Nurses and Associates (SGNA), immediately after you remove the endoscope from the patient, wipe down the insertion tube and put the scope's distal tip in enzymatic detergent, then alternately suction detergent and air. "It should be done within 30 seconds of taking the scope out," says Jason Ylizarde, a product manager for Fujinon.
If you don't pre-clean, the bioburden will harden in the scope's lumens before it gets to the cleaning room, making the remaining cleaning and reprocessing far less likely to be efficacious, says Ms. LeBlanc.
"Immediate immersion in an enzymatic solution is key," says Outpatient Surgery columnist Dan Mayworm. "Simply throwing a wet towel over the used scopes is idiotic and ineffective."
"Many people are resistant to starting the pre-cleaning process in the procedure room," says Ms. Przybylinski. "Those who resist complain that it takes too much time. But it really only takes less than one minute."
3. Leak test every scope, every time
For preventive maintenance and infection control, say Olympus's experts, don't overlook this step. And, says Mr. Ylizarde, the scopes should always be leak-tested under-water, not just dry tested.
"We recommend two-stage (dry then wet) leak testing," says Keith Nelson, Pentax's director of technical services.
Not only that, but you should leak test the entire scope, reminds Ms. Przybylinski: "I've seen some people do just the tip. And you really must angulate the tip in several directions or you may miss a small leak."
"It's more than just preventing major scope damage," says Mr. Nelson. "If there's a leak, the scope is compromised and it could be a potential source for harboring microorganisms."
What's more, "some people damage the scope when they try to do leak testing improperly," says Mr. Mayworm. "Personnel must be well-trained in disassembly," the first step in the leak test, which can open the scope up to damage. According to Steris, damage will occur if fluid enters the scope through, for example, a hole in the outside or inside of the scope, through worn gaskets or through loose lenses at the distal tip.
4. Follow dilution instructions
"People use too much enzymatic detergent," says Ms. LeBlanc. "Sometimes, they just free-pour it into the sink. I made 17 calls to hospitals this year strictly as a result of their using too much detergent."
The reasoning may be "the more, the better," but you're only complicating reprocessing. "The surfactants in enzymatic cleaner help the solution penetrate where bioburden may reside," says Ms. LeBlanc. "But they're also what make it so difficult to rinse, and if you can't fully rinse the detergent, you have improper cleaning."
Ms. LeBlanc says some high-level disinfectants will stain the enzymes in the detergent, leaving the scope "dripping colored liquid" - and clearly not properly cleaned - after it's been through the disinfection cycle. To ensure you achieve proper dilution, Mr. Nelson recommends marking the sink or basin at one-gallon intervals so you have "a consistent volume of water to mix with the proper concentration of detergent."
5. Help the reprocessor do its job
Many assume that if they buy an endoscope reprocessor, it will take care of everything. "That's not the case," says an Olympus infection control expert. The FDA hasn't cleared any automatic reprocessors to clean scopes; such machines are meant only to decrease the potential for human error in disinfection/sterilization and save on labor.
Up to 99 percent of bioburden can be removed during cleaning, says Steris. So you still must soak, brush and, yes, rinse the endoscope manually.
6. Ensure the LCG is at the MEC
There are two parts to this equation: test the liquid chemical germicide (LCG) in your machines to ensure it is at the minimal effective concentration (MEC), and ensure that the test strips aren't giving you false positives. "You can't rely just on the use-life of the germicide, such as 14 days," says Mr. Nelson. "You must test more frequently, especially if you're in heavy-use situations. So there it should be done daily."
To perform a quality-control test of the test strips, says Ms. LeBlanc, dip three strips in fresh, full-strength solution. The strips' colors should change to indicate a pass. Dilute a second sample of solution with water to the ratio prescribed in the instructions for use. Dip three new strips in this sample; all should indicate a fail. She recommends doing this test each time you open a new bottle of test strips to ensure you achieve a true positive and a true negative. Record the results of each of these tests and what, if any, action was taken, says Janell Sonon, CMA, an endoscope reprocessor at the Berks Center for Digestive Health in Wyomissing, Pa.
7. To dry, rinse with alcohol
A 1999 public health alert issued by the CDC and FDA2, recommends that you "consider incorporating a final drying step." The passage doesn't differentiate between HLD or sterile reprocessors, but says flushing the channels with alcohol, then purging them with air "greatly reduces the possibility of recontamination of the endoscope by water-borne microorganisms." Some machines automatically do this, but you can do it manually.
The advantage of the alcohol flush, says Ms. LeBlanc, is that regardless of whether the scope will be hung overnight or will be on a tray to be used again, the scope's lumens will be dry.
Adding the drying step hastened turnover at her high-volume facility, says Ms. Sonon. "We were noticing fluid in the scopes when they were taken off the trays [to be used]," she says. "They get used so fast, there just isn't any time for them to dry if we don't do this."
However, Steris does not recommend performing an alcohol flush on endoscopes after they have been reprocessed in the company's machines.
8. Don't forget the filters
All the automatic reprocessing systems have filtration systems that include two filters. The 1.0-micron pre-filter removes large particulates (such as sand) from the water. The .2-micron post-filter is bacterio-static; it removes waterborne bacteria such as pseudomonas. These filters must be changed regularly.
"How often are these filters changed?" asks Ms. LeBlanc. "If you don't know, you're probably not doing it. I've seen a case where a customer did not change the post-filter, and bacteria multiplied in there and got on the scopes. You must change the filters according to instructions."
Ms. Przybylinski notes that not only do the filters need to be maintained, but "each reprocessor has maintenance that should be performed according to manufacturer's recommendations to ensure the machine is in proper working condition and isn't harboring harmful bacteria." She suggests including daily reprocessor maintenance in the competency assessments of the individuals operating it.
Often, a thorough reading of the manufacturer's guidelines or your instruction manuals can provide answers to your reprocessing practice questions - or prevent you from running into problems in the first place.
"When in doubt, contact the manufacturer," says Mr. Nelson. "Ask your automatic reprocessor manufacturer for instructions not just on a Pentax colonoscope or Olympus gastroscope, but on the model number. They should have studies that support their claims."
1. "Multi-society guideline for reprocessing flexible gastrointestinal endoscopes." Am J Infect Control 2003;31:309-15.
2. "Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System." FDA and CDC Public Health Advisory. www.fda.gov/cdrh/safety/endoreprocess.html. 10 Sept. 1999.