As reported on September 4, 2015, by the Chicago Tribune, relatives of the late Renate Winkler have filed a wrongful death suit, alleging that she died, after contracting a carbapenem-resistant enterobacteriaceae (CRE) infection in 2013. The complaint maintains that Winkler’s infection was linked to her undergoing endoscopic retrograde cholangiopancreatography (ERCP). ERCP is used to examine, diagnose, and treat certain diseases of the duodenum, the first part of the small bowel, and is performed more than 650,000 times per year in the US.
On August 12, the agency issued warning letters to the three manufacturers of duodenoscopes—Fujifilm, Olympus, and Pentax—citing a number of quality and reporting issues. One of the reporting violations is the rather significant matter that the companies failed to obtain proper 510(k) regulatory clearance for most of the scopes currently on the market. Of concern here is a design change affecting the distal end of the scopes, which include the parts most difficult to “reprocess.”
Frankly, “reprocessing” in this connection is a weasel word that allows one to avoid uttering “sterilization,” while implying that the medical device undergoing such “reprocessing” has been “high level disinfected.” High level disinfection (HLD) refers to treatment of medical devices to remove all viable microorganisms except a small residual of spores. Bear in mind that in every single case of scope-related infection, HLD was not achieved—even if the scope was reprocessed.
Such reprocessing is typically done with automated endoscope reprocessors (AERs), also regulated by the FDA.
The distal end of the scope includes the elevator mechanism and elevator recess, and before 2004, the elevator wire channel was unsealed in all of the units. In 2004, Fujifilm started to seal the channel, with Pentax following suit in 2008, and Olympus in 2010. Sealing the channel was supposed to make the devices safer, and easier to clean and reprocess. However, this proved not to be the case, and none of the manufacturers submitted this design change for regulatory clearance.
You may well ask why HLD, rather than sterilization (the removal of all microorganisms and other pathogens, including spores) is the accepted standard for the reprocessing of flexible GI endoscopes. Seemingly lost on the non-governmental organizations that come up with these quite ironically named consensus standards, is the plain fact that most of the people who undergo ERCP are sick and immunocompromised. Perhaps HLD, and all that this implies, is not adequate. Indeed, now that push has come to shove, the FDA is suggesting that true sterilization for these scopes with ethylene oxide might be the answer.
In light of the sundry violations, virtually all duodenoscopes extant are “misbranded” under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, and have been so for several years. More than that, as reported by infection control guru Lawrence Muscarella, PhD, the FDA is turning up the heat on AER manufacturers. In at least one case, the agency found that the company had not validated the performance of its AER for reprocessing duodenoscopes with sealed elevator wire channels. It is likely not the only one.
Those familiar with the FDA’s normally rapid and aggressive posture in sending out warning letters are puzzled by the time frames involved here, especially in light of the seriousness of the matter. As to ethylene oxide sterilization of the scopes, the agency is strangely equivocal.
In a document released on August 4, 2015, entitled “Supplemental Measures to Enhance Duodenoscope Reprocessing,” the agency both recommends and piles extreme caution on this technique. To make matters worse, and through no fault of FDA, ethylene oxide sterilization has been ridiculously demonized, with highly touted replacement methods not cutting the mustard.
The good news in this affair is that a range of enhanced safety/high efficiency ethylene oxide sterilization systems are currently under review by FDA. From what I hear, they will be a game-changer. Stay tuned…