Setting the Standards: Challenges in Endoscope Reprocessing

The Pulse | Monday, June 28, 2021

Candice Quillin, RN CGRN GTS

Sponsored content from Summit Imaging, Inc.

The Joint Commission — which collects data on organizations’ compliance with standards, including the National Patient Safety Goals and Accreditation and Certifications Participation Requirements — recently published the top five requirements identified most frequently as non-compliant during surveys performed in 2020. Infection control standards made the top of the non-compliant list for most organizations, as well as staff competency to perform their job duties and responsibilities.

Endoscope associated infection transmission is frequently linked to inadequate reprocessing. Therefore, regulatory focus on this area will continue. This begins with the proper handling and tracking of endoscope to procedure room, point-of-use cleaning, leak testing, manual cleaning, visual inspection, verification testing, high-level disinfection (HLD), drying and storage. This also includes adherence to Instructions for Use (IFUs), policies and procedures, professional guidelines, and training and competency verification and documentation.

Endoscopes are complex, diverse and essential devices that require meticulous cleaning and reprocessing in strict accordance with manufacturer guidelines before being reused on patients (Day et al, 2021). Gaps and variation in implementing infection prevention practices are common in endoscopy units across the United States, and compliance with reprocessing guidelines is inconsistent (Day et al, 2021).

Cori Ofstead et al have published numerous articles on factors contributing to challenges in achieving high-level disinfection. Some challenges noted include:

High level disinfectants commonly failing minimum effective concentrations (MEC)
IFUs are confusing and difficult to follow
Human factors contributing to non-adherence with guidelines
Inadequate time
That new approaches in quality improvement are needed to advance processes in HLD

How does your current quality management program address these challenges?

The 2021 Multisociety Guidelines stress the importance of staff education and competency tracking. Personnel assigned to reprocess endoscopes receive model-specific reprocessing instructions and training to promote proper cleaning and HLD/sterilization, as well as maintain proper documentation of all reprocessing steps. Staff should receive these instructions, training and have competency documented before being assigned to perform HLD or sterilization of those devices (Day et al, 2021).

The Multisociety Guidelines also identify the need for endoscope tracking in regard to repair, maintenance and loaner endoscopes. The endoscopy unit must comply with the manufacturers’ IFU regarding endoscope maintenance and repair and must have policies tracking the repairs and maintenance of equipment, including loaner devices (Day et al, 2021).

In addition, these guidelines support maintaining a log for each procedure — indicating the patient’s name and medical record number, the procedure and the serial number or other identifiers of the endoscope (and AER), the date and type of the procedure and the name of the person performing the cleaning and HLD/sterilization process to assist in the event of an outbreak investigation (Day et al, 2021).

So, where do you go from here?

What preventative measures are you improving to avoid being non-compliant during your survey, regardless of the accrediting body you use? What tracking/documenting are you implementing to help provide immediate proof that you are complying with any accrediting organizations’ infection prevention and education standards?

The healthcare system is a complex environment where collecting data can provide multifaceted insights into the operations of a facility. An endoscope tracking system is a reprocessing management tool that documents the endoscope workflow and can make compliance much easier.

Today’s traceability systems — web-based in particular — provide real-time tracking to help ensure facilities and staff provide the best quality care options to patients. Working with a web-based traceability system relegates the responsibilities associated with setting up and maintaining software to the service provider, who has the ability to provide real-time support for the software from a remote location. Custom developed/reportable data becomes easily accessible and secure, granting the peace of mind any facility can appreciate (Quillin, 2018).

In your search for a suitable tracking system, consider customization to meet your specific endoscope reprocessing workflow needs, validation documentation, ability to provide up-to-date information regarding IFUs, changes in policies, training/competencies, breaches of protocol, timed events, equipment utilized/tracked, safety data sheets, filter and maintenance tracking, etc., to meet all facility standards of operation recommended by federal and regulatory agencies.

ScopeCycle® by Summit Imaging, Inc. is a complete end-to-end scope tracking solution offering step-by-step customized scope reprocessing workflows to guide your staff through the cleaning process. ScopeCycle® provides detailed reports of usage statistics, reprocessing records and cleaning protocol compliance.

Resources:

Centers of Disease Control and Preventions. Healthcare Infection Control Practices Advisory Committee. Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee. June 28, 2017 Available at: https://www.cdc.gov/hicpac/pdf/Flexible-Endoscope-Reprocessing.pdf
Day, L., Muthusamy, V. R., Collins, J., Kushnir, V., Sawhney, M., Thosani, N. C., et al. Multisociety Guideline on Reprocessing Flexible GI Endoscopes and Accessories Gastrointestinal Endoscopy Vol. 93Issue 1p11–33.e6 Published in issue: January 2021
Ofstead CL, Hopkins KM, Buro BL, Eiland JE, Wetzler HP. Challenges in Achieving Effective High-level Disinfection in Endoscope Reprocessing. Am J Infect Control. 2020 Mar;48(3):309-315. doi: 10.1016/j.ajic.2019.09.013. Epub 2019 Oct 31. PMID: 31677925.
Ofstead C L, Quick M R, Wetzler H P, et al. Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes. Chest. 2018;154:1024-1034.
Ofstead, C.L., Doyle, E.M., Eiland, J.E. et al, Practical Toolkit for Monitoring Endoscope Reprocessing Effectiveness: Identification of Viable Bacteria on Gastroscopes, Colonoscopes, and Bronchoscopes. Am J Infect Control. 2016;44:815–819. https://doi.org/10.1016/j.ajic.2016.01.017
Suresh, S., Pande, M., Patel, K., Barringer, D., Sealock, R.J., Raju, G.S., et al. Education, Training and Knowledge of Infection Control Among Endoscopy Technicians and Nurses AJIC Volume49, Issue 6, P836-839, January 01, 2021 https//doi.org/10.1016/j.ajic2021.01.010
Quillin, Candice BSN CGRN Considering an Endoscope Tracking System? Be in the Know Before You Buy. Endopro Magazine November/December 2018 Vol 3, Issue 6, p 32-36 Endo Pro November December 2018 (omagdigital.com)
Top 5 most challenging requirements for 2020 | The Joint Commission
Manufacturers Instructions for Use - Addressing Conflicts Amongst IFUs for Different Equipment and Products | Ambulatory | Infection Prevention and Control IC | The Joint Commission
Manufacturers Instructions For Use - Responsibility for Ensuring Availability | Ambulatory | Infection Prevention and Control IC | The Joint Commission

Candice M. Quillin BSN CGRN has been a member of SGNA since 1989 and certified in GI since 1991. She worked in an Endoscopy Lab from 1989 until 2018, providing leadership and education at both a busy community acute care facility and a large teaching institution. Candice has served on numerous National SGNA committees and various officer positions at a Regional Society level. She has published numerous articles and participated in various National SGNA publications. Candice is currently employed by SMS and Zutron as a nurse educator and contact hour provider, clinical resource and quality specialist in gastroenterology.