Extended Presoak-Delayed Reprocessing of Endoscopes Evidence Based Practice Recommendations?? Chad Keller, MSEd, RN, BSN, CRMST SPS/OR RME Coordinator-Nurse Educator Sterile Processing Service Department of Veterans Affairs Robert J. Dole VA Medical Center Wichita, Kansas

Introduction Question by SPS Staff: “What is the best process for delayed reprocessing of endoscopes?” This led me to research the topic to see if there is an Evidence Based Practice Protocol for delayed reprocessing of endoscopes. Olympus released letter December 2, 2014 with guidance for the standard Olympus Procedure for “Presoak for Excessive Bleeding and/or Delayed Reprocessing”. Delayed processing is defined as a scope that has not been reprocessed within 1 hour of the procedure that it was used in. Delayed reprocessing can result in increased bioburden formation in the internal channels and on the exterior of the endoscope, thus making the endoscope more difficult to clean, high level disinfect or sterilize and ultimately result in increased risk of patient infection.

Organizational Standards ANSI/AAMI ST58:2013 6.61 (f): Some manufacturers have specific recommendations for delayed decontamination. If decontamination is delayed, it may be difficult to effectively reprocess the instrument. Note-The device manufacturer’s written IFU should be followed. 1 SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes 2016-Section 3 Manual Cleaning Note: All steps should be completed sequentially immediately following the procedure. Refer to the manufacturer’s recommendations for delayed re-cleaning and reprocessing. 2 AORN Guideline for Processing Flexible Endoscopes: 2016 IV.d.1. : When it is not possible to initiate the cleaning process within the endoscope manufacturer’s recommended time to cleaning, the manufacturer’s IFU for delayed processing should be followed. 3

Olympus Guidelines Delayed Reprocessing Procedure: Not intended for routine processing Pre-cleaning Leakage testing Presoak for Delayed Reprocessing Manual Cleaning Disinfection or Sterilization Olympus Letter states: Do not immerse the endoscope in the detergent for more than 10 hours. Also, please note when determining how long of an extended soak to perform for a flexible endoscope, if debris has loosened on the external surface of endoscope, then the conditions on the inside of the channels should be the same as on the surface since the channels are manually filled with detergent solution. Therefore, if the debris on the external surface is confirmed to have been loosened by visual inspection, then the appropriate soak time has been achieved. 4

Research Articles Agrawal (2011) wrote letter to editor in the Journal of Gastrointestinal Endoscopy, stating the question: “What is the preferred strategy in delayed reprocessing?” “The only recommendation available is if precleaning is not initiated within 1 hour, the endoscope should be soaked in appropriate enzymatic detergent according to manufacturer’s recommendations before continuing mechanical cleaning and then terminal processing. He reports review of data and personal communication suggests the extended soak should be 2 to 5 hours, but < 10 hours. He reports further research is needed, as “It is understandable that there are no guidelines on delayed endoscope reprocessing, because it is not an optimal method, but in the real world it occurs, and some recommendations should be made.” 5 Choi and Cho (2015) state in their article “Endoscope Reprocessing: Update on Controversial Issues” that there are still no guidelines on whether delayed reprocessing and extended soaking may harm endoscope integrity or increase the bioburden on the external or internal device surfaces. 6 Alfa and Howie (2009), found in their research data, that “the ability of organisms to replicate in enzymatic detergent at the manufacturer’s recommended use-dilution when held at room temperature” for extended periods of time. 7

Problems Identified Extended soaking longer than the recommended duration may result in increased bioburden, potential biofilm formation, and endoscope damage due to moisture, especially if it was not first leak-tested. 5 There are currently no standards or guidelines on whether delayed reprocessing and extended soaking may harm endoscope integrity or increase the bioburden on its external or internal surfaces. 6

Discussion Currently there are no established evidence based practice guidelines for delayed reprocessing and extended soak times for flexible endoscopes. By following the Olympus letter, if you were to have a clean external surface of the scope that the sufficient soak time has been achieved. How can one know this unless they are inspecting the inner lumens and channels to check for bioburden? Right now those who are in the field do not have great guidance, expect to follow manufacturer’s IFU’s which are ambiguous at best. Further research initiatives must be developed to improve this infrequent but sometimes necessary process of delayed endoscope reprocessing.

Robert J. Dole Medical Center, Wichita, Kansas." References ANSI/AAMI ST58:2013 6.61(f). (2013). Arlington, VA: American National Standards Institute. Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes. (2016). Retrieved October 19, 2016, from http://www.sgna.org/Portals/0/Standards for reprocessing endoscopes_FINAL.pdf Guideline for processing flexible endoscopes. (2016). AORN Journal, 103(1), IV.d.1. doi:10.1016/s0001-2092(15)01158-8 Drosnock, M. A., MS, CIC, CFER, RM (NRCM). (2014, December 2). Information Regarding the Procedure for Performing Presoak in Detergent Solution for Cases of Delayed Reprocessing and Excessive Bleeding for use with Olympus Flexible Endoscopes [Letter to Dear Health Care Practitioner]. Olympus America, INC., Center Valley, PA. Agrawal, D., & Muscarella, L. F. (2011). Delayed reprocessing of endoscopes. Gastrointestinal Endoscopy, 73(4), 853-854. doi:10.1016/j.gie.2010.09.028 Choi, H. H., & Cho, Y. (2015). Endoscope Reprocessing: Update on Controversial Issues. Clinical Endoscopy, 48(5), 356. doi:10.5946/ce.2015.48.5.356 Alfa, M. J., & Howie, R. (2009). Modeling microbial survival in buildup biofilm for complex medical devices. BMC Infect Dis, 9(1). doi:10.1186/1471-2334-9-56 "This material is the result of work support with resources and the use of facilities at the Department of Veteran Affairs Robert J. Dole Medical Center, Wichita, Kansas."

About the Author Chad Keller, MSEd, RN, BSN, CRMST is the SPS/OR Reusable Medical Equipment Coordinator Nurse Educator. He has been working in the field of sterile processing since 2015 at the Robert J. Dole VA Medical Center in Wichita, Kansas. He enjoys reading evidence based research and staying abreast of the latest information regarding endoscope reprocessing and patient safety. "This material is the result of work support with resources and the use of facilities at the Department of Veteran Affairs Robert J. Dole Medical Center, Wichita, Kansas."