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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 notenough time to get everything done.
Since the scopes have to be sterilized or high-level disinfected for aspecific period of time, the cleaning time will have to be shortened. What elsecan one do? While most healthcare professionals understand the need for thoroughand complete processing of endoscopes, the reality is that this may not alwaysbe done. Let's examine the risks associated with this practice.
The literature, including statistics from the infamous 1999 Institute ofMedicine study, is replete with reports of medical errors and increasedinfection rates. Some of these have been directly attributed to impropercleaning of flexible endoscopes.
The soils seen in healthcare facilities are protein in nature. Sterilizationor high-level disinfection (HLD) requires direct contact with all surfaces ofthe device for the parameters of the process selected. Sterilization or HLD willnot compensate for poor or inadequate cleaning.
There are ethical issues associated with inadequate processing. Patients cometo 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 properlycleaned/processed device and subsequent patients may not? Don't patients havethe right to the same standard of care regardless of the time of the day theirprocedure 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. Thestandard is dictated by accepted practices as established by the profession.There are several organizations that develop practices or standards. TheAssociation for the Advancement of Medical Instrumentation (AAMI) has a vastarray 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 Associationof periOperative Registered Nurses (AORN) has its Recommended Practices, to namea few.
In a court of law these practices are accepted as the minimum standard ofcare patients should receive, therefore it is essential that all policies andprocedures for reprocessing first be developed upon accepted standards ofpractice.
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 willcomply with the practices.
The device manufacturer's written instructions for processing must befollowed. The manufacturer of the device knows the design of the device and hasestablished the best procedures to ensure proper cleaning and processing. Whenwe arbitrarily do not follow these guidelines or decide we cannot afford topurchase the special brushes or equipment to ensure proper decontamination, webear full responsibility for the safety and efficacy of the device. Facilityadministrators also need to know the amount of time needed between patients toensure thorough processing of devices.
SGNA guidelines indicate that the cleaning process alone takes an average of20 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 isessential that a variety of brushes with the correct diameter and length, areneeded to effectively clean the channels. Of special concern is the elevatorchannel of certain scopes. The device manufacturer's specific instructions forcleaning and disinfection/sterilization must be strictly followed by allpersonnel every time. A sink of adequate size and depth is needed to permitcomplete immersion of the scope. Reusable brushes need to be cleaned after eachuse and at the end of each day. Bacteria can reproduce in as little as 20minutes, so the bioburden on the brushes can be significant if not cleanedthroughout the day. Manual pre-cleaning is required before placing the scope inan automated scope cleaner/disinfector (see photo). The pre-cleaning is acritical step of the process. Disposable brushes should be used for cleaning ofone scope then discarded. Brushes should be of the correct diameter and lengthto ensure that the bristles will make contact (provide friction) along thelumens of the channels. Bristle length is critical to cleaning effectiveness. Ifthe bristles are too short, there will not be sufficient friction created toremove soils; if the bristles are too long, they will bend back against thelumen walls thereby negating the friction needed for cleaning. Selection of theproper cleaning brush is critical. Use only as directed by the brushmanufacturer. If reusable, follow instructions for cleaning after use.
The use of enzymatic detergents is recommended for flexible scopes becausethey are specifically designed to loosen protein soils and make cleaning easier;however, correct dilution of the detergent and the temperature of the water canaffect the efficacy of these detergents. For example:
Selection and Use of Detergents
There are many detergents on the market today that can be used in theprocessing of surgical devices. Realistically, there is no single detergent thatwill meet all the cleaning needs for all surgical instruments. Decisionsregarding selection of detergents should be based upon the recommendations ofthe instrument and detergent manufacturers. It is important to read the label onthe detergent container to know how to use it, the contents, and how much to usebased upon the cleaning process selected (i.e., manual vs. mechanical).
Enzymatic cleaners are one of the most popular categories of detergents inuse. These products were initially developed for cleaning flexible endoscopes.The ability of these detergents to efficiently penetrate the protein soils foundin blood and body fluids have resulted in their wide use. These products aredivided 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 surethe water temperature does not exceed the recommended limit. The enzymaticdetergents 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 liquidform, however, is most desirable as it mixes easily and eliminates the potentialfor powder residues that are difficult to rinse off. As with all detergents,they must be measured accurately and combined with the correct quantity ofwater. This means measuring the water as well as the detergent. In order tofacilitate the process, when manually cleaning or soaking instruments, it ishelpful to mark the sink or container at 1-gallon intervals. This may be donewith a magic marker and repeated when the marks fade.
When utilizing mechanical washers, the appropriate amount of detergent usedper cycle is also critical. Because the process is automated the tendency is toassume the correct amount is being dispensed with each cycle. Periodic checksshould be made of the detergent utilization per cycle. Check with themanufacturer of your equipment to determine how this is done. If it appears thatyour utilization of detergents is higher or lower than normal you should alsocheck the washer.
When procedures are developed, healthcare workers should follow theOccupational Health and Safety Administration (OSHA)'s standards for blood andbloodborne pathogens. Decontamination attire consisting of head cover,impervious gown, fluid resistant facemask, goggles, cuffed gloves and shoecovers should be worn whenever processing scopes.
Decontamination activities should not be performed at the same time assterilization or high-level disinfection activities when both processes arelocated 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 arein essence stating that the device is safe for use. If it is not safe, why wasit released? It is also important to understand that in a court of law, the juryis not impressed with excuses. Correct processing of devices is not a luxury, itis what every patient deserves every time -- not just when we have the time.
Nancy Chobin, RN, CSPDM, is the central service/sterile processingdepartment 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.