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Eight Steps to Better Scope Reprocessing
Ready to brush up on your reprocessing technique? Our infection control experts identify the areas you're most likely to neglect.
Stephanie Wasek
Publish Date: October 10, 2007   |  Tags:   Infection Prevention

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."

Tracking Your Response Data

It makes sense, from an administrative standpoint, to document your endoscopes' reprocessing, say the infection control experts at Olympus. That way, if a scope or automatic reprocessor breaks, you can prevent problems.

The staff at the Berks Center for Digestive Health in Wyomissing, Pa., where up to 40 endoscopy procedures are performed in a day, have created such a quality-assurance system. Here are the four logs they keep to track each scope and each component of each cycle, according to endoscope reprocessor Janell Sonon, CMA:

  • Each scope is numbered, as are their three automatic reprocessors. When the cycle starts, the staffer documents on a paper attached to the machine which scopes are in, and the day and time the cycle was run, then initials it.
  • On a separate log, staff record daily checks of the automatic reprocessors' HLD-concentration levels and of the each machine's daily test run, including checking that the air and water work properly on each.
  • Each machine's HLD container is marked with a label specifying the date the HLD was last changed. Staff log HLD changes and check the HLD temperature to ensure it's in the manufacturer's recommended range.
  • The wall-mounted pre- and post-filters each sport a label clearly marking the date they were last changed. Filter changes are logged.

Sample logs are available at www.sgna.org/resources/Infection.html.

- Stephanie Wasek

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.

Seek help
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."

Where"s Your Endosuite?
Why More Surgeons Prefer Office-Based Endoscopy

More and more endoscopies are migrating out of hospitals and non-physician owned ambulatory surgery centers (ASCs) and into office-based suites. Patients prefer this setting. Insurers do, too. Irving Pike, MD, FACG, a physician-owner of Gastrointestinal Liver Specialists of Tidewater, Va., outlines the factors fueling the office-based endoscopy trend.

' You don't need a CON. A significant factor leading physicians to choose to open an office-based endoscopy (OBE) practice is that the cost of a certificate of need (CON) can be prohibitive. Between applying for and fighting for a CON, you can spend tens of thousands of dollars and many very valuable hours. Twenty-six states and the District of Columbia attempt to control surgery capacity, including the number and size of ASCs, with a CON. Presently, 13 states regulate office surgery practices, and four others are considering action. For now, at least, an office practice may be more attractive. To find out if your state has a CON law or regulates office surgery, visit www.cms.gov or call your state licensing agency.

Dr. Pike says it's important to keep in mind that while you probably won't need a CON, you may wish to be certified by one of the major accreditation bodies (JCAHO, AAAHC, AAAASF). Certain payers require it. You can assure your patients the safety they desire and distinguish yourself in the marketplace by going through this process. Building and practice specifications, policies and procedures for patient and staff safety, and quality improvement, are among the requirements you'll be surveyed on.

' It's more time efficient. You won't have to drive to the hospital or the ASC - everything will be right there in your office - significantly cutting travel time. You won't have to wait for patients to be registered or prepped, and you won't wait for other physicians to complete cases.

"One of the first major differences I found after opening an OBE practice in 1986 was that I could schedule procedures at 30-minute intervals instead of the one hour allotted at the hospital," says Dr. Pike. "The result can be a more productive day and less time at work."

Chances are, you don't have room in your current office space to accommodate OBE. The cost of renovating your office may be significant, warns Dr. Pike. "You're going to need at least two recovery rooms per endoscopy room, and three is preferable - and adding this space if you don't already have it can be very expensive," he says.

You'll also need extra space to accommodate increased patient and family flow. Other building considerations: moving walls or plumbing, installing additional electrical lines, and having adequate air conditioning and ventilation equipment for cleaning and disinfecting fluids. "Be sure to incorporate all these factors in your cost analysis," says Dr. Pike.

' It's more profitable. Once you're up and running, says Dr. Pike, the overhead may be less than if you were to perform endoscopy in the ASC. The office is smaller, so you're looking at less spent on rent, utilities and employees. These low costs can translate into higher case volume. "Insurance companies may be willing to designate you a preferred provider of endoscopy services because you can offer supply fee/tray fee costs at a lower rate," says Dr. Pike.

Dr. Pike sounds a note of caution about treating Medicare patients. Some of the most financially successful OBE practices he knows of perform endoscopy for commercial insurers and not Medicare. Based on the 1998 Health Care Financing Administration site-of-service policy, it would seem that Medicare pays a higher professional fee as an incentive to do endoscopy in the office setting. The higher office payment is deceptive, however - it is really only a global payment. Instead of supply or facility charges to cover the cost of the case, the physician receives only one, higher professional fee. And the difference between the global office fee and the facility fee may be less than enough to break even on overhead.

- Stephanie Wasek

References
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.

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