Healthcare facilities performing endoscopic procedures face stringent infection prevention requirements following multiple documented outbreaks linked to inadequate scope reprocessing. Understanding current regulatory expectations and implementing effective compliance programs requires evidence-based approaches supported by verified clinical protocols.

The Documented Outbreak History

The UCLA Ronald Reagan Medical Center outbreak in early 2015 highlighted critical vulnerabilities in endoscope reprocessing protocols. Two patients died and 179 patients were potentially exposed to carbapenem-resistant Enterobacteriaceae (CRE) between October 2014 and January 2015. Seven patients at the medical center were confirmed infected with CRE after routine endoscopic treatments.

From January 2010 to October 2015, more than 400 patients were infected nationwide, with dozens more exposed and several deaths reported, according to a U.S. Senate investigation. At least 36 hospitals around the United States experienced superbug outbreaks between 2010 and 2015, including facilities at Virginia Mason Medical Center, UPMC Presbyterian, and Cedars-Sinai Medical Center.

Importantly, an internal review at the UCLA Medical Center found that the cleaning protocols set by the FDA and scope manufacturers still didn’t remove the superbug from the devices, with CRE “embedded” in the scopes even after cleaning. This finding demonstrated that following existing guidelines didn’t guarantee infection prevention.

Current CDC and FDA Requirements

The CDC has established specific interim surveillance protocols for duodenoscope reprocessing. Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to manufacturer’s instructions, paying particular attention to the elevator mechanism at the distal tip.

The CDC interim protocol recommends that facilities choosing to perform surveillance cultures can consider doing so periodically, such as monthly or after every 60 procedures for each duodenoscope. However, routine culturing of endoscopes is not part of current U.S. guidelines.

The FDA has issued multiple safety communications regarding duodenoscope reprocessing. To reduce the risk of duodenoscopy-associated pathogen transmission, the FDA advised four supplemental reprocessing measures: double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization, and liquid chemical sterilization.

Joint Commission Standards Evolution

Recent updates to Joint Commission infection prevention requirements reflect increased regulatory focus. Effective July 1, 2024, The Joint Commission approved new and revised requirements for the “Infection Prevention and Control” (IC) chapter for both critical access hospitals and non-critical access hospitals. The IC chapter underwent a full rewrite and will replace the current IC chapter for both accreditation programs.

New multi-society guidance reviews and clarifies evidence on sterilization and high-level disinfection of reusable medical devices, developed by the Society for Healthcare Epidemiology of America (SHEA) in partnership with seven other professional organizations, including The Joint Commission.

Documentation and Tracking Requirements

Comprehensive documentation remains a critical compliance requirement. Each endoscope must have a unique identifier to facilitate tracking, including the ability to determine when specific endoscopes were used for specific patients, loaned to other units or facilities, reprocessed, or repaired.

Documentation providing complete traceability must be maintained. This includes verification that automated endoscope reprocessors (AERs) have been validated for reprocessing specific endoscope models and components.

Ongoing Contamination Challenges

Despite strict adherence to current reprocessing standards, contamination issues persist. Reported duodenoscope contamination rates after reprocessing range from 0.4 to 35.8%, depending on sampling methods and contamination definitions used.

Experience from Australia and New Zealand, where duodenoscopes are cultured every 4 weeks, found that only 6 of 1,468 (0.3%) GI endoscope cultures performed over a 5-year period at a single center yielded a positive result. However, approximately 5% of cultures at Virginia Mason Medical Center, where duodenoscopes are cultured after each use following high-level disinfection and drying, yielded a positive result.

Current Industry Solutions

Technology advances are addressing some reprocessing challenges. Single-use duodenoscopes have received FDA approval, and the STERRAD System, a low-temperature hydrogen peroxide gas plasma sterilization system, is increasingly favored by institutions seeking a reliable method to sterilize flexible endoscopes.

However, current evidence does not support policies requiring duodenoscopes to undergo double high-level disinfection or sterilization, according to recent multi-society guidance. The guidance recommends that facilities “begin developing an institutional process for converting from HLD to sterilization” for these devices.

CMS Reporting and Financial Implications

Current CMS requirements focus primarily on antimicrobial resistance reporting rather than specific endoscope-related infections. Under CMS regulations, reporting antibiotic use and resistance data became mandatory for virtually all acute care and critical access hospitals on January 1, 2024.

CMS reminds hospitals that intentionally reporting incorrect data or deliberately failing to report data that are required to be reported may violate applicable Medicare laws and regulations. While this applies to general infection reporting requirements, specific endoscope-infection penalties were not identified in current CMS documentation.

Evidence-Based Recommendations for Compliance Programs

Based on documented regulatory requirements and outbreak investigations:

Essential Documentation Elements:

• Unique scope identification and tracking systems
• Complete traceability records for all reprocessing steps
• Quarterly review of reprocessing protocols
• Staff competency validation records

Quality Assurance Measures:

• Consider implementing surveillance culturing based on facility risk assessment
• Evaluate sterilization alternatives to high-level disinfection
• Develop protocols for positive culture response and scope quarantine

Staff Training and Oversight:

• Regular competency validation for reprocessing staff
• Standardized protocols across multiple facilities
• Clear manufacturer instruction adherence verification

Technology Integration:

• Comprehensive endoscope tracking from storage through reprocessing
• Step-by-step workflow guidance that eliminates manual documentation
• Advanced reporting capabilities for staff competency status

Endoscope reprocessing compliance requires comprehensive programs based on documented regulatory requirements rather than speculative future penalties. The documented outbreak history demonstrates that following existing guidelines may not guarantee infection prevention, making additional quality assurance measures essential for patient safety.

Healthcare facilities should focus on implementing evidence-based protocols supported by robust documentation systems, staff training programs, and appropriate technology solutions. Advanced endoscope tracking platforms like ScopeCycle® offer comprehensive solutions that address many compliance challenges by providing step-by-step workflow guidance, electronic documentation of all reprocessing steps, and advanced reporting capabilities for staff competency and scope utilization. Success depends on consistent execution of verified requirements rather than reactive responses to potential regulatory changes.