CRE, ERCP, FDA, but not you and me

I was struck by the need for an FDA announcement to users of duodenoscopes—the endoscopes used in endoscopic retrograde cholangiopancreatographies, or ERCPs–that they should be extra careful about cleaning the scopes to avoid transmittal of drug resistant bugs.

So I asked a friend who is a world expert in ERCPs.  This MD said, “This is specific to ERCP scopes as an enclosed wire channel for the elevator makes access difficult despite following all manufacturer’s recommendations.  We have been aware of this and very proactive for a long time.”

Well, and now, according to an article by Steven Ross Johnson at Modern Healthcare, the folks at UCLA say the FDA recommendation may not do the trick:

The FDA advised that strict adherence to manufacturers’ instructions would minimize the risk of infection.

“The fact that we’ve identified this infection in a couple of different hospitals now suggests that the routine process we were using was just not quite adequate even though at the time they were FDA approved,” Rubin said.

After Jan. 28, the hospital began using more stringent sterilizing measures and has seen no subsequent cases of infection.

Wow.  The questions this raises go on and on.

How can the device have been allowed on the market by the FDA without a thorough review of this issue?  After all, it is well known that the scope is going to travel through the stomach and beyond each time it is used.  Why wouldn’t the agency insist that the manufacturer’s recommendation about sterilization at the time the product entered the market be sufficient?

If, as UCLA suggests, the the manufacturer’s recommendation are not sufficient, why is the FDA not insisting on more rigorous approaches even now?

If some people in the field already recognized this problem, like my friend, why didn’t the GI medical association promulgate the news to its members?  It just published this johnny-come-lately article.  This might be a good time to ask whether the AGA or its faculty receive funding from scope equipment manufacturers.  Of course they do, as noted here.

At what point should the FDA recognize a problem and send out an advisory?  It notes, “In total, from January 2013 through December 2014, the FDA received 75 MDRs encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes.” What is the appropriate standard of review and action in such matters?

The FDA said:

The agency is continuing to evaluate information about documented and potential infections from multiple sources, including Medical Device Reports (MDRs) submitted to the FDA, the medical literature, the health care community, professional medical societies, and the Centers for Disease Control and Prevention (CDC).

But here’s a poster from the University of Pittsburgh suggesting that the usual level of disinfection was known to be inadequate.  Amusingly, one manufacturer, Olympus, suggested that the failure to clean was from use of a competitor’s scope washer.  The investigators found, to the contrary, that this was not the cause, and that a higher level of disinfection than recommended by Olympus was necessary to avoid the transmittal of bacteria.

So, people knew about this problem:  MDs, the AGA, the FDA, the manufacturers.  Everybody but you and me.  If you go to Wikipedia, bacterial infection isn’t even included as a common risk of the procedure.

I wonder if the “informed consents” used by GI doctors have included this other risk.  That University of Pittsburgh paper noted: “Post-ERCP bloodstream infections (BSI’s) and biliary tree infections are reported after 1-3% of procedures.”

I fear we have been let down by the profession, the equipment manufacturers, and their regulators.