04:46 AM

Media Statement Regarding CRE and Duodenoscope

CORRECTION: The total number of patients that Cedars-Sinai is mailing letters to out of an abundance of caution is 71. Our initial statement today stated 68. Of the 71, the total number of patients who had a CRE transmission, four, was correctly stated in the news release.

(UPDATED 6 p.m. PST) 
March 4, 2015
- Despite the fact that Cedars-Sinai meticulously followed the disinfection procedure for duodenoscopes recommended in instructions provided by the manufacturer (Olympus Corporation) and the FDA, the medical center's infection-control specialists announced today that their investigation has identified a total of four patients who had a CRE transmission (carbapenem-resistant enterobacteriaceae) linked to an ERCP procedure. The same duodenoscope was used in all four patients, whose ERCPs occurred between August 2014 and January 2015.

Cedars-Sinai is the latest hospital around the nation to have identified CRE transmission linked to duodenoscopes. Last week, the FDA asked duodenoscope manufacturers to provide evidence that their recommended disinfection methods work. In news reports, the FDA's chief scientist, Stephen Ostroff, MD, said that "institutions appear to have been doing the recommended disinfection procedures, and doing them extremely well."

Cedars-Sinai removed the particular duodenoscope from use and is continuing to use enhanced disinfection procedures for duodenoscopes -- above and beyond the manufacturer's recommendations -- as it has since first hearing reports from other hospitals on Feb. 19 that the manufacturer's disinfection recommendations may not be sufficient to protect patients.

The Cedars-Sinai analysis has been reviewed in collaboration with the Los Angeles County Acute Communicable Diseases Division, the California Department of Public Health and the U.S. Centers for Disease Control. One of the four patients died from their underlying disease and not from CRE, as their CRE infection had cleared. No other duodenoscopes at Cedars-Sinai have been linked to CRE, and there is no evidence at this point that any additional patients had a CRE transmission linked to a duodenoscope at Cedars-Sinai.

However, out of an abundance of caution, and to keep patients informed, Cedars-Sinai is mailing letters this week to all 71 patients who had a duodenoscope procedure with that particular scope between August 2014 and February 2015. Although most people who are exposed to CRE do not develop an infection and will clear CRE from their bodies, and there is no evidence at this point that anyone other than the four patients acquired CRE from a duodenoscope, Cedars-Sinai is offering the 71 patients a free home testing kit for CRE that can be sent to Cedars-Sinai for analysis.

Given the potential insufficiencies of the manufacturer's disinfection instructions, and the current absence of updated national guidelines, Cedars-Sinai is using additional measures to protect patients who need to undergo a procedure involving a duodenoscope. These include enhanced monitoring techniques involving microscopic laboratory analysis (including cultures) of the duodenoscopes, both before and after procedures. These are in addition to the cleaning and high-level disinfection recommended by the manufacturer. Cedars-Sinai's infection-control specialists are continuing to review and monitor to ensure the highest level of safety for its patients. They are also continuing to explore other techniques and options to ensure the protection of patients, and they are in ongoing communication with local, state and federal government agencies (including the Los Angeles County Acute Communicable Diseases Division, California Department of Public Health and the U.S. Centers for Disease Control).

In their analysis, Cedars-Sinai used molecular analysis that can identify the unique "fingerprint" of specific strains of bacteria. This technology helps infection-control specialists track down the source of specific infections and can be crucial in identifying whether there may be a common source for this type of transmission.

[Duodenoscopes are used to drain fluids from pancreatic and bile ducts blocked by cancerous tumors, gallstones or other conditions. Information from the FDA and CDC indicates that other types of scopes, such as arthroscopes, have not been linked to the bacterial problems recently reported in duodenoscope procedures.]

Cedars-Sinai also announced today that it would resume non-urgent (elective) duodenoscope procedures, which were halted starting Feb. 19 when Cedars-Sinai first learned of reports from other hospitals that that the manufacturer's disinfections instructions may not be sufficient. The decision to resume was based on consultation with other academic medical centers around the nation, as well as with government agencies, about the additional monitoring techniques, including a waiting period for duodenoscopes after disinfection, to allow for an additional bacterial analysis of the duodenoscope before use.