Use of ChannelCheck™ 3-in-1 Residual Soil Test Strips to Verify Cleaning of Flexible Endoscopes
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Use of ChannelCheck™ 3-in-1 Residual Soil Test Strips to Verify Cleaning of Flexible Endoscopes - 1

Use of ChannelCheck™ 3-in-1 Residual Soil Test Strips to Verify Cleaning of Flexible Endoscopes A study conducted by M.A. Drosnock and B.J. Catalone Ph.D. Olympus America, Inc. ABSTRACT MATERIALS & METHOD OLYMPUS SURVEY RESULTS Endoscopes are complex medical devices that require strict adherence to manufacturer instructions and professional guidelines. However, few quality control tools currently exist for users to verify that their endoscope reprocessing procedure is effective. One method to demonstrate effective reprocessing is to verify the removal of residuals using ChannelCheck 3-in-1 Residual Soil Test Strips. The following sample collection procedure was performed prior to and after manual cleaning: A total of 79 Olympus endoscopes were sampled using the collection procedure. Table 1 demonstrates the number and type of each endoscope sampled. ChannelCheck test strips test for three common organic soils at once: protein, carbohydrate, and hemoglobin. An issue of critical importance in the reprocessing of a reusable medical device is to ensure that it has been adequately cleaned prior to high-level disinfection or sterilization. As demonstrated by the study results, use of ChannelCheck test strips allows personnel to easily verify that adequate cleaning has been achieved. A survey was conducted by Olympus to evaluate end-user responses to the product. Responses of 6 end-users to a survey regarding use of ChannelCheck 3-in-1 test strips are listed below. The purpose of this study was to evaluate the use of HealthMark Industries’ ChannelCheck 3-in-1 test strips in detecting residual carbohydrate, protein, and hemoglobin remaining on endoscopes after manual cleaning in a clinical environment. Endoscopes are complex medical devices that require reprocessing prior to use on subsequent patients. Proper cleaning is critical to reduce the organic load and bioburden on the endoscope prior to high-level disinfection or sterilization. One method to demonstrate compliance with accepted cleaning practices is use of the ChannelCheck test. This is a simple, easy-to-use test which verifies that adequate cleaning has been achieved. A field study was conducted at ten clinical facilities using 79 patientused endoscopes. The reprocessing procedure at each facility was evaluated prior to the study and was determined to be in compliance with professional guidelines and manufacturer’s instructions. For this study, testing was performed prior to and after manual cleaning in order to demonstrate the effectiveness of the product and the cleaning process. Type of Endoscope Tested Number of Endoscopes Tested Inject 10mL of sterile water through the instrument channel followed by the 10mL of air in order to aid in complete flushing of the fluid. Collect all of the fluid that drains from the distal end into the sample collection container. Mix the sample well. With the 3 pads fully submerged, stir the recovered water sample for 10 seconds with the test strip. According to the ChannelCheck results, 17 endoscopes tested positive for residual protein prior to manual cleaning; 8 endoscopes tested positive for residual carbohydrate prior to manual cleaning; and 36 endoscopes tested positive for residual hemoglobin prior to manual cleaning. Each of these endoscopes was then manually cleaned and retested using ChannelCheck test strips. No (0) endoscopes tested positive for protein, carbohydrate, or hemoglobin after manual cleaning had been completed. These results indicate that ChannelCheck test strips will detect residual carbohydrate, protein, and hemoglobin on endoscopes following patient use and were negative after manual cleaning in a clinical environment. Remove the test strip. Dab the side of the test strip on an absorbent surface (e.g. paper towel) to absorb excess moisture. After 90 seconds, compare the colors on the test strip to the color indicator chart provided on the test strip bottle. Record the results for all 3 pads on the data sheet. If any of the pads indicate that there is residual soil, re-clean the device and then retest. Record results on data sheet indicating that it is a re-clean. Endoscopes Testing Positive for Residuals Using ChannelCheck 80 ■ Before Cleaning ADDITIONAL STUDIES Number of Responses for Each Level (Levels = 1-5) 1 Patient safety is a major concern for all medical facilities. One approach to improving patient safety is the use of monitoring tools that verify proper device reprocessing. Flexible endoscopes are complex devices that are cleaned primarily using a manual process that is both labor-intensive and prone to variability. Visual inspection alone is inadequate to ensure proper cleaning, and the presence of multiple internal lumens that are highly contaminated during patient use emphasizes the need for an objective method to verify endoscope cleaning. How easy was this product to use?** How likely are you to incorporate use of test strips into your process?*** How easy was it to interpret the results?** How satisfied are you with this product?* Response Levels: * 1 = Not Satisfied, 5 = Very Satisfied ** 1 = Very Difficult, 5 = Very Easy *** 1 = Not Likely, 5 = Very Likely In a study conducted by HealthMark Industries1, 99 endoscopes were tested after manual cleaning had been completed. 66 of these endoscopes were manufactured by Olympus. The study demonstrated that residues remaining on endoscopes after manual cleaning could be detected with use of ChannelCheck test strips. ChannelCheck 3-in-1 test strips detect the presence of low levels of carbohydrate, protein, and hemoglobin residues found within the lumen of patient-used endoscopes. Therefore, ChannelCheck test strips can be utilized within healthcare facilities to verify that their manual cleaning process has been performed properly. This will help to ensure that subsequent high-level disinfection or sterilization of the endoscope has properly occurred. Another study conducted by HealthMark Industries1 demonstrated the recovery efficiency of each residue type using 10mL sterile water for lumen flushing. The study verified that a 10mL flush is an adequate volume of water for utilization of the ChannelCheck test strip. ChannelCheck test strips would also be an effective tool for users to easily test and validate their cleaning process as recommended in AAMI TIR 122. This would be an important part of an Infection Control program as users would be able to record the results of the test strips, allowing for a robust Quality System. An additional study was conducted to determine the detection limits for each residue type. The lower limits of detection as reported in the study are 210 µg/mL for carbohydrate, 120 µg/mL for protein, and 0.25 µg/mL for hemoglobin. The limits of detection reported by HealthMark Industries in their validation literature are ≥ 300 µg/mL of carbohydrate, ≥ 115 µg/mL of protein, and ≥ 0.5 µg/mL of hemoglobin1. Residual Types The use of ChannelCheck 3-in-1 test strips would be an excellent training tool for new employees, as well as a competency-testing and auditing tool. ChannelCheck test strips provide facilities of any size with a simple-to-use tool to test cleaning efficacy, verify staff competency, and train new personnel. Endoscopes Testing Positive for Residuals Using ChannelCheck Whitfield, Natalie (2011). ChannelCheck Verification Test as a Tool to Assess Endoscope Cleanliness. Infection Control Today. www.infectioncontroltoday.com. Retrieved 4/22/11. ChannelCheck test strips are an easy-to-use method for monitoring the effectiveness of endoscope cleaning. ChannelCheck would also be an ideal component of a comprehensive Infection Control program as an auditing, competency, and training tool for ensuring effective endoscope reprocessing. Using a 30mL syringe, draw 10mL of air followed by 10mL of Sterile DI water into the syringe, drawing the syringe to the 20mL level. With the distal end of the endoscope held lower than the instrument channel, place the distal end of the endoscope inside a clean collection container. ChannelCheck tests for three common organic soils at once: protein, carbohydrate, and hemoglobin. In order to assess the effectiveness of ChannelCheck in the clinical environment, Olympus conducted a field study at 10 clinical facilities on 79 patient-used endoscopes prior to and after manual cleaning. The results of the study indicated that ChannelCheck test strips detected residual soil prior to manual cleaning and confirmed effective reprocessing after cleaning. AAMI TIR12. (2004). Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities. AAMI TIR12:2004. Arlington, VA: Association for the Advancement of Medical Instrumentation.

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