More than 10 million endoscope procedures are performed in the United States each year. There is no doubt that these medical devices have been a major advancement in the treatment of gastrointestinal diseases. It has been well published about the link between inadequately cleaned duodenoscopes and infections. More recently, several studies and media reports have linked outbreaks of multi-drug resistant organ-isms (MDROs) to these devices without any findings of reprocessing breaches.
By Dawn England, MPH, CPHQ, CIC
More than 10 million endoscope procedures are performed in the United States each year.1 There is no doubt that these medical devices have been a major advancement in the treatment of gastrointestinal diseases. It has been well published about the link between inadequately cleaned duodenoscopes and infections. More recently, several studies and media reports have linked outbreaks of multi-drug resistant organ-isms (MDROs) to these devices without any findings of reprocessing breaches.2-4
While most of the attention has been turned toward duodenoscopes, a case study highlights the growing concern that other endoscopes, like gastroscopes, should also be looked at more closely. In an April 2016 letter to the editor of Infection Control and Hospital Epidemiology, “Documented Transmission of Extended-Spectrum Beta-Lactamase-Producing Klebsiella pnemoniae,” the authors report evidence of cross-contamination of ESBL-KP from a patient to a gastroscope with subsequent persistent contamination despite proper reprocessing technique.
The identified gastroscope had gone through 12 rounds of high-level disinfection and was used on nine patients before it was identified to be of concern. After reviewing the cleaning and disinfection practices in the endoscopy department, no gaps in following the manufacturer’s instructions for cleaning and disinfection were identified. None of the nine patients has shown evidence of ESBL-KP infection and are closely followed for signs and symptoms.
This finding demonstrates a need for more effective methods of cleaning and disinfection and consideration to move to sterilization whenever possible. Additionally, more research is needed regarding improving scope design that allows for better disinfection or sterilization and even moving toward single-use devices.
Until better technology or more sophisticated medical devices are developed, healthcare organizations must begin to critically examine all aspects of their endoscope reprocessing programs. Ensuring that staff are meticulously adhering to the cleaning and reprocess instructions is only one part of this.
A simple quality improvement tool called a Key Driver Diagram is one way organizations can begin to tackle this complicated and challenging topic. This is an effective way to pictorially display a structured roadmap to achieving the ultimate goal, a safe and reliable endoscope reprocessing program. Key driver diagrams work by organizing the goal and the associated tactics needed to accomplish that goal in a visually simplistic way.
One of the main reasons Key Driver Diagrams are so useful is because it helps to keep the project organized and remain focused on only identifying those key factors to reach the goal.
Figure 1 provides one example of a key driver diagram for endoscope reprocessing programs.
Leadership and Governance
In order to implement a comprehensive endoscope reprocessing program organizations must have a highly engaged executive leadership team that can be the source of will for improvement efforts. According to the Institute for Healthcare Improvement,6 establishing a leadership committee can set expectations and accountability for high performance. In the event of an identified scope related infection, who will make the final decision regarding patient notifications? What committees will review patient safety events and audit data as they relate to endoscope cleaning? If central reprocessing areas need additional resources to ensure that staff have the right tools to clean endoscopes properly, who will make that decision and where can concerns be escalated to? Organizations must ask themselves these important questions and address reprocessing efforts as a key patient safety initiative that needs the culture and infrastructure to make it successful. Only senior leaders can direct these efforts to create the culture and commitment to address this complex issue.
While each organization may have their own unique governance and committee structure, at a minimum representatives from risk management, C-level executives (CNO, CMO), surgeons, GI physicians, infection prevention, endoscopy leadership and perioperative leadership is one example of potential committee membership. It is also important for this committee to regularly review audit and compliance data and review and approve policies before reporting to quality and infection prevention committees.
In 2015, there was an endless stream of Food and Drug Administration (FDA) safety alerts, Centers for Disease Control and Prevention (CDC) public health advisories, news stories and published literature regarding concerns with endoscopes reprocessing. Organizations should identify clear communication pathways when new or important information about endoscopes is released. Who is the point person(s) at your organization to receiving this information and what is their role? What is the best means of disseminating this information (e.g., email, memo, committee report, etc.) and what departments or individuals need to receive them? In addition, it is important to set clear expectations for those receiving the information. For some, the communication may only serve as a notification and for other departments, like endoscope reprocessing areas, it may be important for them to implement or act on this information.
Education and Competency
Organizations that perform endoscopic procedures must provide comprehensive and intensive training for all staff assigned to reprocessing endoscopes to ensure that they understand the importance of proper reprocessing of all endoscopes used in your facility. In an FDA and CDC Public Health Advisory published in 1999, it stated “to achieve and maintain competency, each member of this staff should receive:7
a. Hands-on training with each written endoscope-specific reprocessing instruction for every endoscope model and AER used at your facility. Work should be closely supervised until competency is documented for each reprocessing task from cleaning through storage of the endoscope.
b. Additional training with documented competency for new models of endoscopes or AERs as they are introduced in your facility.
c. Strict warnings with frequent reminders not to deviate from the written instructions for preparing endoscopes for patient contact.
When setting up an education and competency program, there may be different needs for the various types of personnel who are cleaning and reprocessing endoscopes. The education and training required for a staff member who performs only bedside (pre-cleaning) cleaning and transports the endoscope to a central reprocessing area will be very different than staff working in the reprocessing areas. Education and training materials should be developed for the unique role each staff member plays.
A Feb. 19, 2015 FDA Safety Communication, "Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication,"8 recommended that organizations implement a quality control program for reprocessing duodenoscopes. It noted, “This program should include written procedures for monitoring, training and adherence to the program and documentation of equipment tests, processes and quality monitors.”
While this FDA safety communication specifically addressed concerns with duodenoscopes, a comprehensive endoscope reprocessing program should implement a similar approach for all types of endoscopes. This would include regularly scheduled audits, using a standard tool, of cleaning and high level disinfection steps. This audit data should be regularly shared with leadership and relevant quality and safety committees. Organizations should also have written policies and procedures that outline an action plan if a significant reprocessing failure are identified. In an article written by Rutala, et.al, the authors lay out a protocol for managing endoscope reprocessing failures that can serve as a starting point for this effort.9
Conducting surveillance for hospital acquired infections is part of every infection preventionist's job, however there is no standard definition set for determining if a patient acquired an infection from and endoscope. Regardless, organizations should make an attempt to include endoscope related infections into surveillance activities. One way to accomplish this is to work with automated surveillance systems to set up an alert based upon a positive culture from a normally sterile site and recent history of an endoscope procedure. This will at least alert the infection prevention department that a patient chart should be reviewed for previous case history, risk factors and overall timeline of events.
In an Aug. 4, 2015 Safety Communication, the FDA recommended that healthcare facilities evaluate their ability to perform microbiological culturing of duodenoscopes.10
This list of supplemental measures emerged from an expert led panel meeting to further reduce the risk of infection and increase the safety of duodenscopes. While implementing an endoscope culturing program is challenging, it could be considered as part of surveillance activities. Before embarking on setting up such a surveillance program, healthcare facilities should consider the resource intensive nature of this endeavor. Some facilities may choose to outsource this work, but this poses other unique issues with result interpretation and specimen collection. Organizations will need to understand the impact of sequestering devices while awaiting culture results, have clear policies and procedures documented if culture results are found to be positive and determine their methods for specimen collection and processing. While the microbiological surveillance program does not guarantee adequacy of each instrument cleaning cycle, it can assist in identifying areas of concern, but only as part of comprehensive reprocessing program. The CDC and the Queensland government have developed useful protocols and algorithms that are freely available to healthcare facilities for this purpose.11-12
Biomedical Engineering and Supply Chain
Endoscopes are complex medical devices that require maintenance and repairs according to the manufacturer’s instructions for use (IFU). In a September 2015 FDA Safety Communication regarding bronchoscopes,13 healthcare facilities were found to have continued to use scopes de-spite integrity, maintenance and mechanical issues being found with endoscopes. A comprehensive endoscope reprocessing program should ensure that the recommended preventive maintenance program is being followed and records of repairs are well documented.
Policies and Procedures
Written policies and procedures that address key aspects of an endoscope reprocessing program are important because they begin to standardize daily operational activities. Policies and procedures also play an important resource role for staff, particularly new personnel. Finally, formalizing aspects of your endoscope program with a policy demonstrate and promote compliance with regulations, statutes and recognized professional practice. At a minimum, healthcare facilities should have policies and procedures that address:
- High-level disinfection processes
- Known reprocessing failures
- Surveillance activities and quality monitoring
- Equipment testing
- Monitoring education, training and competency program
The series of FDA alerts and news coverage regarding infections linked to endoscopes has attracted national attention and prompted the ECRI Institute to list flexible endoscope cleaning and disinfection practices at the top of its 2016 Technology Hazards list. Ensuring a safe and reliable endoscope program requires a multi-disciplinary approach and is truly a team effort in order for it to be successful. Healthcare facilities cannot wait for device manufacturers to produce safer endoscopes. We must act now to do what we can to maintain patient safety and pre-vent exposure to endoscope-related infections.
Dawn England, MPH, CPHQ, CIC is the director of infection prevention at the University of Minnesota Health where she is responsible for providing strategic and operational direction for all systems and activities related to infection prevention. Her recent projects have focused on preventing C. difficile infections and development of a comprehensive high level disinfection program in a large academic health setting.Dawn is a frequent presenter at various national and international conferences, such as Institute for Healthcare Improvement, University HealthSystem Consortium, Association for Professionals in Infection Prevention and the International Forum for Quality Improvement and Patient Safety. Prior to her career in infection prevention, quality improvement and patient safety, she earned her BS degree in biology from Purdue University and her MPH in epidemiology from Boston University.
1. Weber DJ. Managing and preventing exposure events from inappropriately reprocessed endoscopes. Infect Control Hosp Epidemiol. 2012;33(7):657-660
2. Verfaille CJ, et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy. 2015 Jun;47(6):493-502. doi: 10.1055/s-0034-1391886.
3. Wendort KA, et al. Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak. Infect Control Hosp Epi-demiol. 2015 Jun;36(6):634-42. doi: 10.1017/ice.2015.66.
4. Kola A., et al. An outbreak of carbapenem-resistant OXA-48 – producing Klebsiella pneumoniaassociated to duodenoscopy. Antimicrob Resist Infect Control. 2015; 4: 8.
5. Epstein, et al. New Delhi Metallo-ß-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated With Exposure to Duodeno-scopes. JAMA. 2014;312(14):1447-1455. doi:10.1001/jama.2014.12720
6. Botwinick L, Bisognano M, Haraden C. Leadership Guide to Patient Safety. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; 2006
7. FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System, September 10, 1999
8. Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Commu-nication, February 19, 2015
9. Rutala WA and Weber DJ. Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines. Am J Infect Control. 2013 May;41(5 Suppl):S67-71
10. Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication, August 4, 2015
11. Queensland Government, Queensland Health. Section 6.4 Microbiological Testing. Endoscope Reprocessing. [Online] August 29, 2011. https://www.health.qld.gov.au/EndoscopeReprocessing/module_6/6_4.asp.
12. Centers for Disease Control and Prevention. Healthcare-Associated Infections: Interim Duodenoscope Culture Method. Centers for Dis-ease Control and Prevention. [Online] March 11, 2015. http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-culture-method.html
13. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication, September 2015.