What stands out most about the outbreak is the causative agent:
First, CRE is not resistant to disinfectants, and certainly not high-level disinfectants such as OPA. Therefore, the CRE was either not reached by the disinfectant or it was protected by a biofilm, which can increase disinfection resistance by several orders of magnitude. Since biofilms are a major contributing factor to disinfection resistance, FDA should consider incorporating biofilm testing into the suite of tests required for high-level disinfectants.
Second, CRE happens to be rare, deadly, and easily isolated from the fecal flora expected to contaminate endoscopes during use. The presence of CRE on properly processed endoscopes, coupled with anecdote from endoscopic surgeons and microbiologists who have sampled processed endoscopes, suggests that they may be frequently contaminated after reprocessing.
It is worth noting that more than 500,000 ERCPs are performed each year in the United States to clear bile ducts, remove cancers, etc., so the net benefit of the procedure is overwhelming despite existing infection risks.