Will the FDA Require Sterilization of Scopes?

The FDA is considering requiring the sterilization of duodenoscopes after recent cases of infection transmission.

The transmission of infection by poorly cleaned endoscopes, especially duodenoscopes has been a hot topic of discussion including this blog. The problem lies in the complexity of these scopes that makes cleaning somewhere between very difficult and impossible even when following the manufacturer’s instructions. At least a half-dozen U.S. outbreaks of carbapenem-resistant Escherichia coli (CRE) and related superbugs since 2012 that were linked to contaminated duodenoscopes. In the latest outbreak, duodenoscopes spread antibiotic-resistant bacteria to seven patients at a University of California at Los Angeles (UCLA) hospital, contributing to two deaths.

The FDA and hospitals nationwide are watching the situation, trying to decide what to do. A few hospitals have taken the lead. The University of Pittsburgh Medical Center (UPMC) issued a statement saying that all their endoscopes are now sterilized with ethylene oxide (EtO) and since that change they have not seen any more infections. UCLA also recently announced that it is now also sterilizing all its scopes with EtO also and no new infections have occurred.

According to the Wall Street Journal the FDA is considering requiring sterilization of all duodenoscopes instead of the current high level disinfection because it is so difficult to clean them thoroughly. Since several hospitals have shown that sterilization is possible, it is difficult to argue that it is impractical. Infections caused by dirty endoscopes is not a new issue and investigations documenting the causal relationship with hospital acquired infections go back decades.

EtO is not the only answer. The Virginia Mason Medical Center in Seattle, adopted a new non-EtO scope-cleaning protocol and now requires that all scopes be quarantined after cleaning, then tested for any residual bacteria before they can be reused. The entire process takes about two and a half days, even longer than EtO sterilization. They had to spend about $1 million purchasing additional scopes, but since implementing this new protocol no new infections have occurred.

In conclusion, there is a serious problem with scopes contaminated with antibiotic resistant bacteria that are not fully removed by standard cleaning techniques. Some hospitals have taken the initiative and absorbed the significant cost of improving their scope disinfection/sterilization process and shown significant improvement. The FDA should strongly urge manufacturers to require hospitals to sterilize or their scopes or otherwise demonstrate that their process renders their scopes pathogen free.  This action should apply not just the duodenoscopes, but any scopes with difficult to clean crevices and lumens; because another infection from an uncleaned endoscope is just unacceptable.