Duodenoscopes — Carbapenem Resistant Enterobacteriaceae (CRE) — and the Food and Drug Administration (FDA) — Does Regulatory Laxity Make Sense?

03 March 2015

Duodenscopes that cannot be properly sterilized — even according to the manufacturer’s recommendations — resulted in two deaths and potentially 179 infected patients at UCLA’s Medical Center

In CNN’s words:

Two patients died at the Ronald Reagan UCLA Medical Center in a superbug CRE outbreak, caused by two medical scopes that still carried the bacteria even after they were disinfected.

In addition to the two victims, seven hospital patients were infected with the deadly superbug between October and January. The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria.

The superbug, carbapenem-resistant Enterobacteriaceae, or CRE [see here], can kill up to half the patients who contract them, the Centers for Disease Control and Prevention says.

Afterward, the Food and Drug Administration belatedly got involved

But not in an especially meaningful way:

The Food and Drug Administration never reviewed data from manufacturers regarding the procedures needed to clean the complex medical devices that recently infected seven patients with drug-resistant bacteria, an agency official acknowledged on Wednesday.

Now the F.D.A. has asked manufacturers to provide evidence that their recommended disinfection methods work, said Dr. Stephen Ostroff, the agency’s chief scientist.

The gist of the problem is that bacteria can hide in a duodenoscope’s crevices, as currently designed

Endoscopes are used to maneuver a tiny camera around inside the body. A duodenoscope is a variant that can perform a delicate procedure called endoscopic retrograde cholangiopancreatography (ERCP):

It is typically inserted down the throat of an anesthetized patient to examine the very small ducts that drain the liver or gallbladder.

The inner tubing is intricate and difficult to clean, and can harbor up to 10 billion individual bacteria, said William A. Rutala, an infection control specialist . . . .

Why didn’t anyone think to come up with a better design — for either the scope or the ways in which to disinfect it?

Keep in mind that drug resistant bacteria have been around for a long time. In recent years, everyone and their siblings have known that some deadly bacteria are now impossible to kill with any antibiotic.

One would think that the problem of properly disinfecting endoscopes of this type would have been foremost on their designers and federal agency regulators’ minds.

But no.

The Food and Drug Administration’s overview of medical devices is lax at the best of times. You may (for example) recall 2010’s revelation that essentially unregulated inferior vena cava filters were disintegrating inside patients with deadly results.

Like the splintering vena cava filters from 2010, the duodenoscopes that infected UCLA’s patients are also categorized as Class II medical devices. Which means that no one actually thought to do anything substantive to make sure that they could be properly cleaned between uses:

Under a 1996 federal guidance, the companies were required to attest only to the effectiveness of cleaning these reusable instruments when they initially brought them to market.

Regulators also said Monday that Olympus never sought the necessary government approval for a redesigned duodenoscope it introduced in 2010.

The agency said it won't pull the device now while a belated application is under review because that could make instruments too scarce for the ERCP procedure.

"We view Olympus as having made a good-faith effort in complying with the rules," Riley said. "They manufacture a significant number of duodenoscopes so we were concerned that could lead to a potential shortage."

Lisa McGiffert, director of Consumers Union's Safe Patient Project, said the agency's handling of this crisis reflects an agency culture that's too secretive and too protective of industry.

"This is a real flawed system," McGiffert said. "It is outrageous that the FDA is giving them a third try to prove these devices can be cleaned properly and the public didn't know about it till today."

“Outrageous” — indeed

Just as the FDA’s handling of the inferior vena cava filters had been before 2010.

This is not difficult stuff

It just appears to be so because Congress and the FDA are in bed with the industries that they pretend to regulate.

For example, take this ridiculous piece of federal reasoning:

Ronald Reagan U.C.L.A. Medical Center and Advocate Lutheran General Hospital have begun sterilizing their instruments with a gas called ethylene oxide. Neither has had additional cases of CRE since instituting the procedure.

At the moment, however, the F.D.A. is not willing to recommend ethylene oxide sterilization on a routine basis.

“This agent itself could potentially be quite toxic, not only if not thoroughly aired afterward but in the longer term to people doing the cleaning,” Dr. Ostroff said.

Dr. Srinivasan of the C.D.C. said the toxic residue could be mitigated by letting the duodenoscope sit unused for perhaps 12 hours after it is exposed to the gas. But many hospitals would find such a procedure impractical; duodenoscopes are sometimes needed for emergency procedures.

Did you catch that?

The “poor” hospitals cannot be burdened with the expense of having to buy an extra scope.

Lawsuits make no reforming difference

The total in liability payouts is much outclassed by the volume of continuing profits.

The moral? — If you are scared when you go to the hospital, you probably should be

If we, as a society, are too stupid and greedy to anticipate that bad things happen with poorly designed medical devices, we will be writing off thousands of patients each year.

Put it down to the cost of doing profitable business.

PeteFree.com

Duodenoscopes — Carbapenem Resistant Enterobacteriaceae (CRE) — and the Food and Drug Administration (FDA) — Does Regulatory Laxity Make Sense?