Beyond cleaning
Reprocessing flexible GI endoscopes successfully
by Bradley Catalone, Ph.D. and George Koos

Today, it is hard to imagine that anyone remotely associated with the gastrointestinal (GI) department has not heard of the risks and problems associated with improper or inadequate reprocessing of flexible endoscopy equipment.

Although flexible scope sales representatives are knowledgeable about the entire process of using the scope in the procedure through successful reprocessing, they are unable to answer questions regarding other manufacturer’s automated endoscope reprocessors (AERs). Each AER manufacturer is required to validate its equipment and connections for use with each compatible endoscope. These AER manufacturers will have specific instructions for use, which may vary with each endoscope model. Not all flexible endoscopes may be compatible or validated for use in all AERs. Ask the manufacturer of your AER for an in-service to understand your equipment.

Secondly, only use validated connectors supplied by the AER manufacturer for each model of endoscope. Connections are vital to the disinfection or sterilization process in AERs. Each AER works with different pressures and designs, which in turn require specific connectors for specific scopes. Flexible endoscopes are complex devices comprising long, narrow lumens and bifurcations. The slightest difference in these channels may require different connections as determined and validated by the AER manufacturer. Endoscopes in the same series from the same manufacturer may have different channels and options that also require different connectors. When purchasing a new scope always contact your AER manufacturer for the right connectors and training. Once you have the right connectors, they must be maintained and cannot be modified. Do not allow staff to repair or replace parts of these connectors without specific authorization and instructions from the AER manufacturer. Contact your AER manufacturer with a list of your scopes to ensure you are using the proper connectors.

Next, have your equipment serviced regularly. If the endoscope has been thoroughly cleaned and properly connected with the AER manufacturer’s validated connector, but the AER itself is not working according to specification, there again is a risk to the process. Flexible endoscopy equipment and AERs should be serviced and maintained according to the manufacturer’s specifications. Many facilities maintain equipment with internal personnel, and these resources should be trained and have the proper instructions for the preventive maintenance and service of the equipment. Equipment may appear to be in working order, but only the proper upkeep can ensure the systems are working as intended. The repair and service of associated equipment is vital to ensuring the proper functionality of the scope. Proper maintenance also helps ensure patient safety by identifying physical damage that may reduce the effectiveness of reprocessing. Make sure your equipment and scopes are in good working order and contact the manufacturer for information as needed.

Here are some suggestions on how to maintain acceptable water quality:

• Check with the AER manufacturer to determine the specific requirements for the quality of the incoming feed water. Oftentimes, prefiltration systems are required to reduce the bioburden of the incoming feed water. Prefiltration will improve the quality of the water used to reprocess the endoscope, and also reduce contaminates that enter the AER internal tubing and reservoirs.

• Understand that the quality of the incoming feed water, especially for those facilities that do not centrally treat their incoming water, may change seasonally. As a result, the useful life of water filters may vary throughout the year.

• Maintain acceptable water quality by using the AER manufacturer’s recommended filters and replacement frequency. Not all filters are manufactured to the same specification nor are they appropriate for use with an AER water treatment system.

A primary reason for the lack of a consensus recommendation regarding endoscope storage is that the ability to maintain an endoscope in a patient-ready state during storage is highly dependent upon environmental factors that are unique to each facility. For example, the ambient air temperature and humidity, the number of air room changes per hour, and the general cleanliness of the endoscope storage area and cabinet are important variables that are related to the risk of endoscope contamination during storage.

Everyone understands the importance of thorough cleaning, and hopefully the need to understand all the factors that contribute to safe and effective reprocessing. Healthcare facilities make great investments in areas like the GI department to create medical miracles every day utilizing advanced technologies and innovative procedures…don’t risk patient safety by not having all the information. Utilize your equipment manufacturer’s resources to train staff and optimize the performance and safety of your equipment. HPN

1. Alvarado CJ, and Reichelderfer M. APIC guideline for infection prevention and control in flexible endoscopy. Am J Infect Control 2000, 28: 138-55.
2. Mehta, AC, Prakash, UBS, Garland R, Haponik E, Moses L, Schaffner W, and G Silvestri. American College of Chest Physicians and American Association for Bronchoscopy consensus statement: prevention of flexible bronchoscopy-associated infections. Chest 2005; 128: 1742-1755.
3. Glionna, JM. Unsterile devices prompt warnings: use of dirty endoscopes in colon and throat exams can pass along infections activists say. The Los Angeles Times, Los Angeles, CA, Feb 13, 2003, p B1.
4. Fahy, J, and Spice B. Monroeville hospital urges 200 colonoscopy patients to get checked for hepatitis, HIV. The Pittsburgh Post-Gazette, Pittsburgh, PA, March 31, 2005.
5. Muscarella, LF. Application of environmental sampling to flexible endoscope reprocessing: the importance of monitoring the rinse water. Infect Control Hosp Epidemiol. 2002; 23(5): 285-289.
6. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. Gastrointest Endosc 2003; 58(1): 1-8.
7. Recommended practices for cleaning and processing endoscopes and endoscope accessories. 2005. Standards, Recommended Practices, and Guidelines. Denver: Association of periOperative Registered Nurses, 2005: 341-346.

With minimally invasive techniques being more the rule than the exception in contemporary surgical practices it’s important for the tools surgeons use to be thoroughly cleaned and sterilized prior to each use. While that may seem like a no-brainer (and it is), mishaps and mistakes all too frequently occur. Even one incident that potentially could lead to patient complications, including infection, should be considered unacceptable, particularly as quality measures grow in importance among consumer evaluation programs.

As a result, Healthcare Purchasing News asked experts at one of the leading endoscope manufacturers to share some insights and tips for proper cleaning, care and maintenance of rigid and flexible endoscopes. Meridith Goldstein, product manager, Olympus Surgical America, Orangeburg, NY, addresses her specialty, which are rigid scopes.

Healthcare administrators are challenged to provide the latest technology and highest quality products to their surgeons while at the same time controlling costs. Repair and replacement of expensive instruments erode the capital available for use on new equipment. Reducing the frequency of damage is the key to gaining control of your repair budget.

Operating room managers have an advantage over the supply processing and distribution (SPD) department in this regard, owing to the ability to have nurses and technicians focus their activities on the various surgical specialties, which enables the members of these services to become totally familiar with the equipment and its uses. Conversely, SPD technicians are usually generalists who must be familiar with all of the instruments used in their department services. Responding to pressure to process instruments quickly, proper inspection often is not performed, resulting in sets with missing or broken instruments. Because the SPD staff is required to disassemble, clean, reassemble, inspect, package and sterilize the instruments, they need to know the instruments as well as or better than the O.R. staff. This lack of specialization challenges even the most tenured SPD technicians and places SPD at a real disadvantage in detecting and preventing damage, compared with the O.R. staff.

While the SPD department is blamed for much of this damage we have found that damage most often occurs during a period beginning with O.R. turnover and continuing through the decontamination process. If the O.R. staff and cleaning staff do not take the time to properly repackage the instruments in a safe and secure manner, the instruments will have a greater incidence of damage. Most of the damage in the O.R. occurs after the case has concluded and in many cases the staff is unaware that they are responsible for the damage. For example, we often see items not properly placed into their containers, heavy devices piled on top of delicate ones, cables and cords exposed to sharp objects, rough handling of instrument trays as they are placed on a cart for transportation, instruments and sets falling to the floor as the staff tries to prepare quickly for the next case, use of inappropriate tables for transport, and instrument sets stacked in an unsteady position with the camera and scope on the top of the pile.

The cost of replacing or repairing damaged equipment is staggering. At some large hospitals, the costs for repairing and replacing hand instruments, cameras, scopes and video equipment can approach $1 million per year. While some of the damage is unavoidable and/or attributable to normal use, the vast majority of damage is due to lapses in good care and handling practices caused by pressure to perform tasks quickly, inadequate knowledge of the device, failure to follow the manufacturer’s guidelines or apathy. The primary challenges of preventing instrument damage are to first detect it, then determine where it happened, how and by whom. Detection is often a challenge because the SPD staff has not been properly trained on the proper care and handling of the device or on how to inspect it for damage. Compounding the problem is the fact that many instruments and devices have special requirements for disassembly, washing and sterilization. Sometimes the SPD department creates rules for care and handling in response to problems they have experienced in the past.

We have visited many hospitals where cameras or scopes, both rigid and flexible, are not submerged during decontamination. When we questioned this practice, we found either that someone instructed them in error not to do this or that the O.R. complained of foggy cameras or scopes. The SPD staff related this problem of fogging to submerging the device, when in reality the poor image quality was most likely caused by a broken lens that distorted the image enough to make it look foggy. While general rules can be helpful, it is always best to follow the manufacturer’s suggested guidelines for care and handling of each specific device. Before a new product is placed in service at the hospital, the SPD manager should insist on thorough in-service training for all staff to avoid improper handling or damage.

To gain an appreciation for the challenges in controlling damage, one must look first at the areas instruments are cycled through on a daily basis, and then determine what potential for damage exists in those areas. On a daily basis, instruments travel through sterile storage, transportation to the O.R., use in the O.R., transportation to decontamination, reprocessing and sterilization. Damage can occur at any point during each cycle.

Here are some examples of mishandling and improper storage we have seen in hospitals:

• Endoscopes stacked high on a shelf so that when the nurse pulled one out, several fell to the floor

• O.R. where rigid endoscopes are dropped into a scope warmer

• O.R. where delicate items are not secured in their container prior to returning to the SPD

• Stacking instrument trays on ring stands for transport

• SPD technicians placing heavy or sharp instruments on top of delicate ones during cleaning

• Processing rigid endoscopes in an ultrasonic cleaner

• Sterilizing non-autoclavable instruments in an autoclave

Unfortunately the above examples are all too common in hospitals. The pressure for rapid O.R. turnover compounds the problem because staff tends to take shortcuts on proper care and handling to get the job done. Managers should anticipate that the faster the room turnover is performed, the greater the potential becomes for damage to occur.