Endoscopy and Infection Control
By Nancy Chobin, RN, CSPDM and Sue Ellen Erickson, RN, MSN, CNOR
Has this ever happened to you: today's schedule reflects 20 GI scopings. There are only 20 minutes scheduled between patients and there simply is not enough time to get everything done.
Since the scopes have to be sterilized or high-level disinfected for a specific period of time, the cleaning time will have to be shortened. What else can one do? While most healthcare professionals understand the need for thorough and complete processing of endoscopes, the reality is that this may not always be done. Let's examine the risks associated with this practice.
The literature, including statistics from the infamous 1999 Institute of Medicine study, is replete with reports of medical errors and increased infection rates. Some of these have been directly attributed to improper cleaning of flexible endoscopes.
The soils seen in healthcare facilities are protein in nature. Sterilization or high-level disinfection (HLD) requires direct contact with all surfaces of the device for the parameters of the process selected. Sterilization or HLD will not compensate for poor or inadequate cleaning.
There are ethical issues associated with inadequate processing. Patients come to us for medical care. Ethically, we are obligated to do the right thing; however, is it fair or ethical that the first patient receives a properly cleaned/processed device and subsequent patients may not? Don't patients have the right to the same standard of care regardless of the time of the day their procedure is scheduled? When you are finished processing a scope, ask yourself, "Would I want this scope used on me or a member of my family?" If not, why are you using it?
Standard of Care and Legal Implications
All patients have the right to receive the same standard of care. The standard is dictated by accepted practices as established by the profession. There are several organizations that develop practices or standards. The Association for the Advancement of Medical Instrumentation (AAMI) has a vast array of Technical Information Reports (TIR) and standards including ST-46 (Steam Sterilization and Sterility Assurance in Health Care Facilities and ST-35 (Decontamination); the Society for Gastroenterology Nurses Associates (SGNA) has "Guidelines for Infection Control in Endoscopy"; and the Association of periOperative Registered Nurses (AORN) has its Recommended Practices, to name a few.
In a court of law these practices are accepted as the minimum standard of care patients should receive, therefore it is essential that all policies and procedures for reprocessing first be developed upon accepted standards of practice.
What Should You Do?
Review your policies and procedures to ensure they reflect best practices. Revise as needed. Then inservice personnel to ensure they understand and will comply with the practices.
The device manufacturer's written instructions for processing must be followed. The manufacturer of the device knows the design of the device and has established the best procedures to ensure proper cleaning and processing. When we arbitrarily do not follow these guidelines or decide we cannot afford to purchase the special brushes or equipment to ensure proper decontamination, we bear full responsibility for the safety and efficacy of the device. Facility administrators also need to know the amount of time needed between patients to ensure thorough processing of devices.
SGNA guidelines indicate that the cleaning process alone takes an average of 20 minutes. This includes pre-cleaning of the scope in the procedure room, transfer to the workroom, leak testing and cleaning.
Flexible scopes have multiple channels with different diameters, so it is essential that a variety of brushes with the correct diameter and length, are needed to effectively clean the channels. Of special concern is the elevator channel of certain scopes. The device manufacturer's specific instructions for cleaning and disinfection/sterilization must be strictly followed by all personnel every time. A sink of adequate size and depth is needed to permit complete immersion of the scope. Reusable brushes need to be cleaned after each use and at the end of each day. Bacteria can reproduce in as little as 20 minutes, so the bioburden on the brushes can be significant if not cleaned throughout the day. Manual pre-cleaning is required before placing the scope in an automated scope cleaner/disinfector (see photo). The pre-cleaning is a critical step of the process. Disposable brushes should be used for cleaning of one scope then discarded. Brushes should be of the correct diameter and length to ensure that the bristles will make contact (provide friction) along the lumens of the channels. Bristle length is critical to cleaning effectiveness. If the bristles are too short, there will not be sufficient friction created to remove soils; if the bristles are too long, they will bend back against the lumen walls thereby negating the friction needed for cleaning. Selection of the proper cleaning brush is critical. Use only as directed by the brush manufacturer. If reusable, follow instructions for cleaning after use.
The use of enzymatic detergents is recommended for flexible scopes because they are specifically designed to loosen protein soils and make cleaning easier; however, correct dilution of the detergent and the temperature of the water can affect the efficacy of these detergents. For example:
- Is the detergent measured or just poured out?
- Is the volume of water measured (how many gallons of water are in your clean-up sink)?
- Do you know the temperature of your water?
- Do you know your water quality?
- Always follow the detergent manufacturer's instructions for dilution and use.
Selection and Use of Detergents
There are many detergents on the market today that can be used in the processing of surgical devices. Realistically, there is no single detergent that will meet all the cleaning needs for all surgical instruments. Decisions regarding selection of detergents should be based upon the recommendations of the instrument and detergent manufacturers. It is important to read the label on the detergent container to know how to use it, the contents, and how much to use based upon the cleaning process selected (i.e., manual vs. mechanical).
Enzymatic cleaners are one of the most popular categories of detergents in use. These products were initially developed for cleaning flexible endoscopes. The ability of these detergents to efficiently penetrate the protein soils found in blood and body fluids have resulted in their wide use. These products are divided into two categories: proteolytic (protein dissolving) and lipolytic (fat/marrow dissolving). These enzymatic detergents can be heat sensitive (negatively affected by heat), therefore, you must read the label to make sure the water temperature does not exceed the recommended limit. The enzymatic detergents are ideal for devices with lumens (cannulated) such as suctions, flexible GI scopes, reamers, etc.
Enzyme detergents are available in both powder and liquid form. The liquid form, however, is most desirable as it mixes easily and eliminates the potential for powder residues that are difficult to rinse off. As with all detergents, they must be measured accurately and combined with the correct quantity of water. This means measuring the water as well as the detergent. In order to facilitate the process, when manually cleaning or soaking instruments, it is helpful to mark the sink or container at 1-gallon intervals. This may be done with a magic marker and repeated when the marks fade.
When utilizing mechanical washers, the appropriate amount of detergent used per cycle is also critical. Because the process is automated the tendency is to assume the correct amount is being dispensed with each cycle. Periodic checks should be made of the detergent utilization per cycle. Check with the manufacturer of your equipment to determine how this is done. If it appears that your utilization of detergents is higher or lower than normal you should also check the washer.
When procedures are developed, healthcare workers should follow the Occupational Health and Safety Administration (OSHA)'s standards for blood and bloodborne pathogens. Decontamination attire consisting of head cover, impervious gown, fluid resistant facemask, goggles, cuffed gloves and shoe covers should be worn whenever processing scopes.
Decontamination activities should not be performed at the same time as sterilization or high-level disinfection activities when both processes are located in the same room. This can prevent cross contamination of the scope.
It is important to remember that when a device is released for use, you are in essence stating that the device is safe for use. If it is not safe, why was it released? It is also important to understand that in a court of law, the jury is not impressed with excuses. Correct processing of devices is not a luxury, it is what every patient deserves every time -- not just when we have the time.
Nancy Chobin, RN, CSPDM, is the central service/sterile processing department educator for the Saint Barnabas Health Care System in Livingston, N.J. She is a member of AAMI, AORN, ASHCSP and IACHSMM. Sue Ellen Erickson, RN, MSN, CNOR is a perioperative consultant in New Jersey.