Superbug Outbreak Puts Medical Manufacturer in Spotlight



Superbug Outbreak Puts Medical Manufacturer in Spotlight


This past February, news of a deadly “superbug” outbreak at UCLA Ronald Reagan Hospital circulated throughout Southern California. The bacteria, known as CRE (carbapenem-resistant Enterobacteriaceae) infected seven hospital patients between October and January, two of whom later died.

UCLA first discovered the virus in late January and linked the bacteria to contaminated medical scopes used at the hospital. The duodenoscopes, typically used in endoscopic retrograde cholangiopancreatography (ERCP) to view ducts in the gastrointestinal system, were manufactured by Olympus Corp. of Americas. Late in February, the FDA learned that Olympus never obtained permission to sell its duodenoscope.

Although the device has been on the market since 2010, Olympus only applied for clearance to sell the scopes last year at the FDA’s request, stating that they did not think their company needed permission to sell its product.

“Why didn’t we notice it? I don’t know,” deputy director of strategy for the FDA’s Office of External Affairs Karen Riley said.

How It Started

The superbug outbreak can be traced back to a unique design flaw in Olympic Corp.’s device. In the duodenoscope’s newest modification, the company covered part of the device, the elevator shaft, in an effort to make it more resistant to infections. This modification, however, proved to be the device’s biggest flaw as it was the same part linked to the superbug’s origin at UCLA.

“The company clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer,” Riley said.

Two weeks after the events at UCLA, Cedars-Sinai Hospital reported that four patients had been infected with CRE originating from Olympus Corp. duodenoscopes. The only patient death at Cedars from CRE was not conclusively linked to the bacteria.

Since then, Cedars has stopped all procedures with the device and Olympus has worked with the hospitals and the FDA to fix its problem.

At around the same time as the UCLA outbreak, in late January, a Seattle hospital reported 11 deaths from CRE originating from Olympus duodenoscopes, as well.

The Outbreak as a Reflection of UCLA’s Health Score? 

How do these recent events reflect the behavior of UCLA hospital as a whole? One way to try and answer that question is to look at the hospital’s health score.

In a survey conducted by The Leapfrog Group, a nonprofit that creates health scores that have been cited in the New York Times and MSNBC, the UCLA Ronald Reagan Medical Center received an overall grade of “C” in the fall of 2014. In four of the five major categories created by the health score, UCLA either is on par or exceeds national averages, these categories being “Safety Problems in Surgery”, Staff Follows Steps to Make Surgery Safer”, “Right Staffing to Prevent Safety Problems” and “Hospital Uses Standard Safety Protocols”.

However, in the one remaining category, “Infection and Safety Problems”, UCLA performs below average in five of seven sub-categories, including “Surgical site infection after colon surgery”.

Extrapolating from that information what you will, one way to defend UCLA against its health scores and observe this superbug outbreak as an isolated incident could be to simply look at the health score of the other superbug infected hospital, Cedars-Sinai.

Cedars-Sinai received an overall health score of “A” from the Leapfrog Group in the fall of 2014, performing above average in a majority of categories. So perhaps superbug outbreaks cannot be linked to a hospital’s normal behavior?

It may be important to note, however, that Cedars-Sinai, like UCLA, still received a below average rating in the sub-category “Surgical site infection after colon surgery”, remembering that CRE infections originated from tools used in the same system.

About CRE and the Future of Superbugs

Carbapenem-resistant Enterobacteriaceae describes a family of microorganisms that has a high resistance to antibiotics. Enterobacteriaceae includes the species E. Coli and other bacteria common to the human gut.

The antibiotic used to normally control enterobacteriaceae, carbapenem, is used as a “last resort” for most bacterial infections. This relatively strong antibiotic has little effect on CRE.

In its evaluation of CRE, the CDC refers to one report thats cites the superbug can contribute to death in nearly 50 percent of those infected. For reference, Staphylococcus aureus (MRSA), one of the deadliest bacteria in the world, has a mortality rate ranging from 20-50 percent.

The future of superbugs worries many scientists and researchers as it becomes more and more apparent that the increased use of antibiotics in medicine has sped up survivability of microorganisms in antibiotics, and bacterial mutability seems only to be speeding up. A report from Health Care Dive states “Antibiotic-resistant bacteria kill at least 700,000 people per year and the anticipated death rate is rising rapidly, with projections of another 10 million deaths by 2050 unless a solution is found.”

In lieu of the recent Ebola outbreak, Bill Gates has become one major spokesperson on behalf of a solution to difficult to treat diseases, from bacteria and viruses alike.

“A more difficult pathogen [than Ebola] could come along; a form of the flu, a form of SARS, or some type of virus that we haven’t seen before,” Gates said. “We don’t know [if] it will happen, but it’s a high enough change that one of the lessons of Ebola should be to ask ourselves: Are we as ready for that as we should be?”


-Arman Zadeh

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