Flexible Endoscope Processing Issues and Hazards

Written by Harry Mullen CRCST, CIS, CHL, CER

Flexible endoscopes are indispensable tools in modern medicine, used for diagnostic and therapeutic procedures. However, they are also among the most challenging medical devices to clean and disinfect. Improper processing of these instruments can lead to healthcare-associated infections (HAIs), as residual biological material or pathogens can remain in the endoscope channels, posing risks to patients. Despite guidelines and manufacturer recommendations, lapses in cleaning procedures have led to serious infection outbreaks.

This article will review some significant cases where improper flexible endoscope reprocessing contributed to HAIs and outline the recommended standards for endoscope processing.

Case Studies: The Hazards of Improper Endoscope Cleaning

1. Duodenoscope-Associated CRE Outbreak (2013-2014)

In multiple hospitals in the United States, improper cleaning of duodenoscopes was linked to outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE). These infections were caused by improper reprocessing, which left residual bacteria in the complex channels of the duodenoscopes. The outbreaks resulted in multiple patient deaths. The FDA and CDC later issued warnings, and this led to major recalls and redesigns of the duodenoscopes.

• Outcome: Widespread patient infections and deaths, calls for redesign of the devices, and regulatory changes in reprocessing practices.

2. Philadelphia VA Medical Center (2003-2005)

At the Philadelphia VA Medical Center, a series of errors in endoscope reprocessing over a two-year period resulted in Hepatitis C infections among veterans. Investigation revealed that the staff failed to follow proper reprocessing protocols for colonoscopes and other endoscopic devices.

• Outcome: Multiple patients contracted Hepatitis C, and the facility faced legal and regulatory repercussions. It highlighted the importance of strict adherence to cleaning protocols.

3. Seattle VA Medical Center (2009)

A similar issue occurred at the Seattle VA Medical Center, where bronchoscopes were inadequately cleaned, resulting in an outbreak of pseudomonas aeruginosa infections. Faulty practices, including failure to manually clean the scopes before high-level disinfection, were discovered.

• Outcome: Several patients developed pneumonia, some of whom died. This case further emphasized the need for rigorous manual cleaning and inspection before sterilization.

4. ERCP Scope Contamination (2008)

In an Australian hospital, ERCP scopes were improperly reprocessed, leading to the transmission of Hepatitis B and C to several patients. The complex design of the ERCP scope, combined with failure to follow manufacturer cleaning instructions, allowed for residual contamination to remain.

• Outcome: Multiple infections resulted in the hospital implementing stricter endoscope reprocessing protocols and led to industry-wide scrutiny of ERCP scope cleaning practices.

5. Gastroscope-Related Salmonella Outbreak (2016)

A gastroscope used in a hospital in Germany was linked to an outbreak of Salmonella. The hospital’s internal audit revealed that improper drying techniques allowed for bacterial growth in the scope’s internal channels after disinfection, highlighting that even after proper cleaning, incomplete drying can foster pathogen survival.

• Outcome: Several patients developed infections, prompting the hospital to revise its drying protocols and increasing awareness of the importance of complete drying post-disinfection.

Processing Standards for Flexible Endoscopes

Society of Gastroenterology Nurses and Associates (SGNA) Recommendations:

The SGNA provides detailed guidelines for the reprocessing of flexible endoscopes, including the following key steps:

1. Pre-Cleaning: Immediate cleaning of the scope post-procedure using enzymatic solutions to prevent drying of organic material.
2. Leak Testing: To ensure the integrity of the scope, leak testing must be performed before full cleaning.
3. Manual Cleaning: Each scope must be manually brushed and flushed to remove residual debris before automated processing.
4. High-Level Disinfection (HLD): After manual cleaning, high-level disinfection should be performed using appropriate disinfectants as recommended by the scope manufacturer.
5. Rinse and Drying: After disinfection, scopes must be thoroughly rinsed with sterile water and dried completely to prevent bacterial growth during storage.

Manufacturer-Specific Recommendations:

Manufacturers often provide detailed reprocessing instructions specific to their devices, which should always be followed rigorously:

• Olympus recommends thorough manual cleaning with specially designed brushes and detergents before HLD for their endoscopes.
• Pentax advises checking all internal channels for residual matter post-cleaning and encourages air drying to prevent microbial contamination.
• Fujifilm emphasizes frequent leak testing and advises using automatic reprocessors that meet their specific design requirements.

Conclusion

The improper reprocessing of flexible endoscopes can lead to life-threatening HAIs, as seen in the case studies above. The complexities of these devices require strict adherence to guidelines set by organizations like SGNA and manufacturers’ recommendations. Facilities must prioritize training, compliance, and regular audits to ensure the safety of endoscope processing.

Failure to do so not only endangers patient safety but can also lead to significant legal and financial ramifications for healthcare institutions.