The minimal standard of care for flexible endoscopes is high-level disinfection (HLD) based on their Spaulding classification within the semi-critical category (Society of Gastroenterology Nurses and Associates [SGNA], 2005). An effective cleaning must be achieved before hand (SGNA, 2000). Successful disinfection is dependent upon the compatibility of the scope, chemical(s), and automated or manual reprocessor capabilities.
Chemicals selected for HLD should be approved for flexible endoscopes (Nelson et al., 2003). Some chemicals used in the reprocessing of other medically and surgically used devices may cause damage to the components of flexible endoscopes. As chemicals are considered for use, the user information accompanying them and material safety data sheets (MSDS) should be reviewed first. Each time a new chemical is introduced, all persons involved should be educated as to its specifics.
There are a few environmental considerations that need to be addressed when using chemicals. Dispose the container in which the chemical was stored according to the label directions-some may indicate to rinse the empty container prior to disposal. Some areas of the country require the chemicals commonly used to reprocess flexible endoscopes be neutralized prior to the primary disposal of the chemicals. A spill kit always needs to be available in the area of use (SGNA, 2000). Appropriate personal protective equipment should be made available and used conscientiously. An eye wash station should be located in the area of use and be accessed only by cold water, as warm water may activate a chemical causing greater harm to the eye.
There are also recommendations as to the type of protective glove materials and safe period of use for certain glove materials (Nelson et al., 2003). Each chemical used will describe the safety recommendations within its user information.
Regardless of the approved chemical selected to achieve HLD, a consistent application of all parameters must be adhered to. These include concentration, temperature, exposure period, and rinse instructions. Should there be variables to the selected parameters of the chemicals, become aware of how one modification may alter another parameter, that is, when selections for exposure periods decrease, the temperature to achieve HLD usually goes up.
The outcome of HLD will be achieved only if all internal channels are flowed and all external surfaces are exposed to the disinfectant according to label parameters. Proper adapters must be connected appropriately to deliver the chemical and the scope must be within a basin that allows for complete submersion (Nelson et al., 2003; SGNA, 2000). In situations where multiple scopes are in one bath, the height of the scopes may be above the surface level of the chemical and may not receive complete chemical exposure.
The minimal effective concentration of each disinfectant bath should be tested according to the instructions regarding the chemical (SGNA, 2000, 2005). There are multiple brands and concentration-test reagent pads that can lead to confusion. When a chemical-concentration indicator has been selected, the user should assure it is appropriate to the disinfectant by brand and concentration that is being used. For example, there are multiple brand-name and generic glutaraldehydes with pH values from 3 to 6.3; however, 2.0 to 2.5% concentrations are commonly used in endoscopy practices. Should the chemical indicator not be advised for the concentration of the solution in use, there may be false-positive concentration checks. Attention should be paid to the storage of the chemical indicators as related to the expiration date, exposure to temperature and humidity, as well as other retardants that may be identified by label instructions.
Whether manually or electronically logged, a method of tracking the devices that are reprocessed a particular bath or automated unit in relation to a particular patient should be maintained (SGNA, 2005). If a need to determine retrospective data should the potential of contamination arise, easy tracking needs to be in a system other than, or additional to, the patient's record. In addition to the routine maintenance of an automated endoscope reprocessor, including flushing of the lines, diagnostic cycles, and filter changes, a routine heating and air-conditioning vent maintenance in the reprocessing area should also be maintained. Keep a log of these activities on hand as well (Nelson et al., 2003).
Following disinfection, removal of the chemical should be in accordance to the chemical-label instructions. Failure to remove all chemicals externally and internally may result in a chemical insult to the next patient using the equipment. Those items that are reprocessed in a bath without directed flow, that is, medication atomizers or water bottles, also may result in chemical-related patient injuries.
The final disinfection step is to dry the scope prior to its next use or storage. This occurs by flowing the air through the scope, instilling alcohol, and then air-drying the second time (Nelson et al., 2003; SGNA, 2000). Any moisture residual to the scope may become a medium for bacterial growth within a short period of time. In this period of antibiotic-resistant organisms and undiagnosed comorbidities, absolute dehydration of all moisture should be an imperative step.
The air that is delivered to the scope, if not canned, should be metered by a gauge that is set below a detrimental capacity of the scope. Sending substantial, unregulated air pressure through the scope can cause tornado-like damage to the "O" ring seals or glue joints. This damage is enhanced when internal and undetectable contact damage has already occurred to the scope. The processor used to insufflate the patient during the procedure will offer levels of air tolerance safe for the scopes in your inventory. The range of tolerance will be given in pounds per square inch (PSI).
Isopropyl alcohol is an adjunct that facilitates internal lumen dehydration. The alcohol used should be stored in airtight containers. Should the solution be kept in an open container, its evaporative properties will disperse in the room's atmosphere and it will not be effective in dehydrating the scope.
Focusing on your area of practice, critically review your practices involving HLD of endoscopes as it relates to the following list of considerations:
* Are the manufacturers' recommendations for the chemicals used followed in relation to concentration, time, temperature, exposure, and rinses?
* Is there a log that tracks all disinfection processes?
* Are the manufacturers' recommendations for the automated reprocessor followed?
* Are chemical indicators appropriate for the disinfectant used?
* Is the chemical selected compatible with the endoscope?
* Is the endoscope compatible with the reprocessor?
* Are there stains on the floor of the storage area?
* Are there wet or puckered linens on the floor of the storage area?
* Was the automated endoscopic reprocessor or soak allowed to be completed without interruption?
Repair History Process Improvement Plan
After critically evaluating people, environments, and processes relative to flexible endoscopy, goals for process improvement should be established. There are multiple factors to determine a baseline from which to establish goals. There are other factors that impact the wear and tear of endoscopes not addressed in this evaluation process. Negative influence on the endoscopes may increase also when the number of staff who use and process the scope increases. Another negative influence can be on an inadequate inventory of scopes to perform the case load. Inventory in this case should be measured by the scopes in active (or preferred for) use.
First, review 12 months of endoscope repair invoices. Be sure to look at those invoices provided by all service vendors. From these, take the total amount of money spent on scope repairs and divide it by the number of endoscopic exams performed during the same period. This will give you the average cost of repairs per case. Next, look at the top three recurring repairs and the three most expensive repair types. From this information, one can determine where to focus initial efforts to reduce the cost of repairs per case. Typical goals can be the following:
* to reduce the repair expenses by a designated percentage;
* to eliminate/reduce the two most frequently repeated repair needs; and
* to eliminate/reduce the two most expensive repeated repair needs.
The ownership of the process improvement by all staff will result in a decreased recidivism of the scopes to the repair facility and an increased overall life span of the scopes in inventory. Without process improvement initiatives, expensive equipment will need more frequent and more extensive repairs and will have a shorter life span.
Compliance of scope care and handling can be correlated to effective drug therapy. Medications must be taken according to the label directions in regard to dosage, times, and meals. Without compliance, medical therapy is not effectively achieved. Without compliance, with regard to safe handling and environments, endoscope health is not maintained.
Two factors are fundamental to the buy-in of any established process-improvement initiative. First, all persons making decisions regarding the design for environment, purchasing of supplies or equipment, and providing endoscopy services must be aware of the risks, benefits, and alternatives to all factors relative to the choice for endoscopes and their care. Second, endoscopy care-providers must be educated as to the reasons supporting all-product information, regulations, and guidelines for conformity to standards to be consistent.
Guidelines and regulations can be used as an advocate for changes relative to capital equipment, supplies, environment, and practices as the request for modifications are substantiated to administrative and financial personnel who may have fiduciary responsibilities.
Application of guidelines and higher conformity to practices lead to enhanced efficiencies, and better-functioning, less expensive endoscopes that all results in safer patient care outcomes.
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