Reports: Redesigned Olympus Duodenoscopes Tied to Infection Outbreak

By on 12:30 PM

An infection outbreak at a foreign health facility is linked to redesigned Olympus duodenoscopes, according to multiple reports from news organizations, including the Los Angeles Times.

Olympus redesigned its duodenoscopes following reported issues with cleaning, disinfection and sterilization of medical devices, particularly duodenoscopes. They feature a complex design that creates challenges for first-step cleaning and subsequent high-level disinfection. Several deaths have occurred as a result of highly resistant bacteria that were transmitted from patient to patient, primarily during a procedure known as endoscopic retrograde cholangiography (ERCP).

The outbreak happened in December 2016. According to an adverse event report submitted to the U.S. Food & Drug Administration (FDA), Olympus was informed that five patients tested positive for OXA48-producing Klebsiella pneumonia after having undergone ERCP using the EVIS EXERA II duodenovideoscope. One patient died, although the death was blamed on a pre-existing condition rather than the infection. The other four patients are reported to be doing well.

An FDA spokeswoman told the Los Angeles times that the agency was "was aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate."

Olympus announced it would voluntarily recall the original scopes in January 2016. This was after it received FDA approval for a duodenoscope with modifications to the device's design and labeling intended to help reduce the risk of bacterial infections. Olympus has also published new reprocessing instructions on cleaning the products to reduce infection risk.

Central Sterile Processing Infection Prevention

The Infection Control Consulting Services (ICCS) team, as part of it services to hospitals, ambulatory surgery centers and endoscopy suites, continues to closely scrutinize reprocessing practices, including disinfection of  scopes. ICCS consultants monitor central sterile technicians performing the step-by-step disinfection process. The ICCS consultant takes note of any deficiencies while providing feedback to the staff.

If your organization needs assistance with sterile processing compliance, contact ICCS. Our team of infection control consultants provides a wide range of services, including working with facilities to ensure they properly follow rules and guidelines for reprocessing of instruments and scopes, and monitoring of these processes.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.