Endoscopic Water Bottles May Hide Dangerous Pathogens

With studies showing medical errors, including nosocomial infections, are responsible for 44,000 to 98,000 deaths in the United States annually, infection control practitioners are intensifying their efforts to identify problem areas within facilities.

Endoscopy suites are at the top of the list. With recent brochoscopy outbreaks getting hyped media attention, more eyes have fallen upon endoscopy departments, searching for potential pathogenic harbors. Infection control practitioners are finding staffs scrambling to balance the needs of their increased patient load and exhausted employees. During this dizzying dance, detailed manufacturer guidelines concerning infection control can be lost in the tarantella.

Official Stance

Water bottle systems that are attached to endoscopes and used during every procedure are under increased scrutiny. The current design of such systems includes an inner and outer tube - one for the actual water and one for air. The air tube functions as a conduit, compressing the water and pushing it outward to the endoscope.

While some argue this system has a critical design flaw, leaving patients at risk for infections and chemical exposure, officials at Olympus America, based in Melville, N.Y., say their No. 1 priority is to protect the health and safety of endoscopy patients.

Company officials updated their policy on reprocessing endoscopic water bottles several years ago. Their guidelines on how to efficiently disinfect the water bottle system were considerably increased -- from two pages of instructions to 10.

"All reusable water bottles purchased from Olympus are accompanied by user manuals, which contain reprocessing instructions that are consistent with those of the Society of Gastroenterology Nurses and Associates (SGNA) (May 2002) and the Association of Professionals in Infection Control and Epidemiology (APIC) (April 2000) in recommending that the water containers be cleaned, high-level disinfected or sterilized at least once a day," says Lorraine Botti, a public relations and brand marketing manager at Olympus. "For the past 15 years, Olympus water containers have been designed to be sterilized by either steam or ethylene oxide. However, some reprocessing details had been changed with the introduction of the 40/140 series of GI endoscopes. These changes were part of a general review, updating and reformatting of reprocessing instructions, and also reflected modifications dictated by changes in the water container design."

The changes to the water bottle design, Botti says, were incorporated to make the system easier to operate.

"We instituted the following design changes to enhance ease of use: wide-mouth bottle for easier cleaning, elimination of one-way valve to allow easy cleaning of water pick-up tube and to change some of the components from an opaque color to clear plastic to better visualize the water level," Botti says.

The newest guidelines include the following information about reprocessing the water bottle system.

"The water container has been designed to be compatible with U.S. guidelines on high-level disinfection processes. Olympus recommends that the water container is subjected to a high-level disinfection or sterilization process.¹"

In charts following this information, the guidelines show 2 to 3.2 percent glutaraldehyde is a compatible method of high-level disinfection for the water bottle; autoclaving is listed as a compatible method of sterilization.

The following equipment is recommended for either high-level disinfection or sterilization reprocessing of the water bottles: personal protective equipment, immersion tanks for disinfectant solution, disinfectant solution for immersion, 30 ml syringe, sterile packaging, sealing device for sterile packaging and an autoclave.¹

Even using this equipment, Olympus officials include the following warning: "The water container must be meticulously cleaned prior to disinfection or sterilization. Failure to clean compromises the effectiveness of disinfection and sterilization and will present an infection control risk. Maintain the water container daily. The water container should be emptied, cleaned and disinfected or sterilized at least once per day. Water containers that are not maintained properly may present an infection control risk. Even if the water container is reprocessed immediately after use, if it is not stored in a clean environment, it should be cleaned, disinfected or sterilized before use..."¹

The guidelines also include detailed step-by-step instructions for manual cleaning and disinfection and sterilization of the water bottles.

Botti says although changes have been made to the design and reprocessing of the system, the alterations were made voluntarily.

"Olympus America has not received complaints about microbial contamination of its water containers," she says. "When Olympus America learns of health and safety concerns involving its endoscopes, it begins an immediate inquiry."

She says the company has not received any complaints about infection control or contamination of water with reprocessing chemicals involving the water bottle system either.

Pentax Medical, based in Orangeburg, N.Y., also has guidelines concerning the appropriate reprocessing steps necessary for water bottle systems used with their endoscopes. Their manufacturing guidelines include three options for reprocessing: autoclave, ETO sterilization and cold sterilization.

For cold sterilization reprocessing, the guideline states: "Tests have shown solutions to be compatible with Pentax water bottles, providing the manufacturer's directions are followed." Solutions listed in a following table include: Endozime (Ruhof), Klenzyme (Calgon), Metrizyme (Metrex), Enzol (Johnson & Johnson), Enzy-Clean (Burnishine Products) and Cidex (Johnson & Johnson).

Similar recommendations about the necessity of daily reprocessing are included by Pentax. "Each water bottle assembly should be cleaned and sterilized at least on a daily basis. As with all endoscopic accessories, prior to sterilization, water bottle assemblies must be thoroughly cleaned. Failure to do so could result in incomplete or ineffective sterilization."²

Outsider's Point of View

Brent Carter, a territory manager for Byrne Medical in Conroe, Texas, says that while manufacturer's guidelines are written to ensure that water bottles are not pathogenic harbors, the steps necessary to follow such recommendations are pain staking and rarely followed.

"I can go into an endoscopy suite and sit down with a staff member and say, 'I don't even want to know what your protocol is,'" he says. "'I just want to tell you what Olympus says you are supposed to do with this bottle. You tell me if that is what you do.' Quickly, they say to me, 'You can stop there. We don't do any of that. All we do is wipe down the outside with alcohol, or we throw it into the Steris.'"

Other endoscopy team members, Carter says, think sterile materials are not necessary for procedures involving the colon.

"What is a typical thing we hear from nurses? 'It's not going into a sterile environment. It is going into the colon, for heaven's sake.' We hear that so many times, it is ridiculous," he says.

In the meantime, Carter says the design of the current water bottle systems is leaving patients at risk.

"The black tube on the outside acts like an air conduit, shoving air down into the water bottle, compressing the water and working basically like a reverse straw," he describes. "It shoves the water back up the tube, which travels back through the inside of the big tube and into the scope. In theory, all that goes in there is air, but when endoscopy team members take the cap off the water bottle at the end of the day, they can look in and see where the little tube comes out; it is not tight because air has to flow around it. The air has to flow around the inner tube, leaving a gap between the little tube and the top of the cap. The glutaraldehyde can soak and remain in this area. It will then be blown into the water and can mix and go into the new patient."

Byrne Medical president Don Byrne says several aspects make the current water bottle design prone to creating an environment for bacteria and other pathogens.

"It is a combination of things," he says. "It is a porous, damp, dark area. If just sterile water were to get inside of the tubing and it was left there for a long weekend and it wasn't dried or blown out, then just like any of the automatic endoscope reprocessors (AERs), you have the possibility of bacteria growing. The AER units are constantly having the risk of growing pseudomonas. It is the same thing with this tubing. If you don't dry it out at the end of the day, or do some sort of alcohol flush, you leave the moisture in there and it has the possibility of growing bacteria."

APIC, SGNA Chime In

Carla Alvarado, PhD, research scientist at the Center for Quality and Productivity Improvement at the University of Wiconsin-Madison, wrote the Association of Professionals in Infection Control's (APIC) Guidelines for Infection Prevention and Control in Flexible Endoscopy. Within the guideline, she writes: "Throughout the years, there has been progress in our understanding of microbial reservoirs and mechanisms of transmission. The ability of bacteria to form biofilms is an important factor in the pathogenesis of endoscopy-related infections, particularly as biofilms interfere with disinfection. Biofilms consist of colonies of organisms forming structures to maximize growth potential. Development of a biofilm begins when free-swimming bacteria attach to a surface. Cell-to-cell communication then signals formation of a biofilm with pillar- and mushroom-like structures around which water can circulate. This allows both maximal exposure of the bacteria to circulating nutrients and a decrease in the accumulation of waste products. Strategies aimed at decreasing biofilm formation and viability will have an important role in endoscope disinfection because biofilms have been found to adhere to the internal channels of endoscopes.³"

Using Alvarado's report as a reference, the SGNA issued an official "Statement on Reprocessing of Water Bottles Used During Endoscopy." It reads: "The SGNA, Inc., supports the following position: Water bottles should be manually cleaned and high-level disinfected or sterilized (according to manufacturer's recommendations) on a daily basis. Prior to storage, there should be no residual fluid or moisture remaining in the water bottle assembly. Thoroughly dry all water bottle surfaces to reduce the potential for bacterial colonization. Sterile water should be used in the water bottle for all endoscopic procedures. Pending further research, it is recommended that the water bottle be reprocessed prior to each ERCP."⁴

Disposable vs. Traditional

Byrne says the solution to the current water bottle design flaw, from an infection control perspective, is simple. Use a disposable system, eliminating the need to follow extensive reprocessing guidelines.

"If you don't follow the manufacturer's guidelines verbatim, you run a serious infection control risk," he says. "This is not necessarily a noted problem, but if you cannot get that inner tube clean and you are just tossing it in (to an AER) to be cleaned, you are not following the manufacturer's guidelines. You do open yourself up to infection control problems. You do open yourself up to the Olympus, Pentax or Fujinon people, who are going to say, 'If you didn't do this, that is your problem.'"

Alvarado, however, says adopting a disposable system, similar to the disposable trend with biopsy forceps, may not be necessary.

"Biopsy forceps enter sterile tissue, " she says. "They break the integument of the tissue, just as a needle or a surgical instrument does, and therefore should be sterile. Water bottles are an extension of the instrument itself. They are not an accessory like needles, biopsy forceps, etc., that enter the tissue. But the water bottles, of course, should receive a thorough cleaning."

Byrne argues turning toward a disposable water bottle system may reduce nosocomial infections as has been shown by the change to disposable biopsy forceps.

"Reusable water bottles are nonsterile," he says. "They are a possible infection control risk, just like the biopsy forceps of the past were. Disposable biopsy forceps are expensive -- $15. But we are talking about the average of $1.50 per patient to have a sterile product vs. a reusable product. They are willing to make a biopsy forcep disposable for $15; why not reusable water bottles? It is a controlled risk -- $1.50 for a sterile product with sterile water and elimination of all of the inconveniences and the hassles endoscopy team members face."

Byrne Medical's SmartCap was approved by the Food and Drug Administration (FDA) in 1997. The cap fits any size sterile water bottle and is made of medical-grade plastics and rubbers, excluding latex.

"It eliminates the reusable water bottle," Byrne says. "You don't reprocess anything. It is sterile and is approved for 24-hour use. You directly hook it to a one-liter bottle of sterile water and you don't clean, don't reprocess, don't come into contact with any chemicals. Because the system is sterile, you don't have any problem with infection control, pseudomonas, bacteria or anything growing. The entire system is disposable."

Byrne says the potential risks of not cleaning the water bottle tubing effectively have been shown by hospital infection control practitioners.

"We've had hospitals actually go back and culture the inside of the tubing, and it has grown bacteria," he says. "I've had hospitals culture it and it has grown pseudomonas and Staph. These are a possibility if endoscopy team members are not cleaning and reprocessing effectively."

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