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.
But
according to Dr. Zachary Rubin, UCLA Medical's director of clinical
epidemiology and infection prevention, his hospital's bacteria outbreak
and several others involving duodenoscopes suggest the problem may lie
with the recommendations from product makers.
UCLA officials said
their investigation found no deficiencies in the facility's internal
cleaning processes for the devices and that the staff fully adhered to
the manufacturer's recommendations on properly sterilizing them.
“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.