What caused the CRE outbreak? The bottom line

It's been well over a century since Ignaz Semmelweis and Joseph Lister discovered that the vast majority of hospital-acquired infections were preventable.

So why, after nearly unimaginable leaps and bounds in healthcare technology and innovations over the past 125 years, are patients still dying from such infections?

At least 13 patients at the UCLA Health system and Virginia Mason Hospital & Medical Center have succumbed to infections linked to duedonoscopes contaminated with carbapenem-resistant Enterobacteriaceae (CRE), the Los Angeles Times reports. That bacteria is an integral part of the human gut. But since it is antiobiotic-resistant, it kills about half of all humans if it winds up outside their digestive systems and infects them. It was introduced in this manner due to the improper sterilization of the duodenoscopes that were then reused.

A team of reporters at the LA Times, led by the affable but dogged Chad Terhune, have been on top of this story. And their coverage has painted a disquieting picture as to why these outbreaks occurred.

The manufacturer of the suspect duodenoscopes is Olympus, the big Japanese firm. It currently controls about 70 percent of the world market in gastrointestinal endoscopes, according to the  LATimes, and sales were up nearly 25 percent in its most recent fiscal year.

Yet Olympus didn't focus so intently on the medical instrument business because of charitable intentions. It did so because sales of its cameras were dropping and its brand was damaged by a major accounting scandal that unfolded three years ago, the LA Times reported. And, the publication noted,  the company apparently smoothed potential bumps in the highly competitve medical instrument market by making donations of well into the seven figures to the American Society for Gastrointestinal Endoscopy.

Meanwhile, there were abundant warnings about the potential bacterial hazards of these instruments. The FDA had received at least 135 warnings between January 2013 and last December about contaminated scopes, according to the LA Times. But it didn't issue an advisory that the scopes may not be completely cleanable until news of the UCLA and Virginia Mason deaths surfaced. And now hospitals from all over the country are reporting cases.

No surprise about that--the FDA has been a punching bag for big healthcare in recent years with blows delivered from pharmacy company executives who fear their massive profits might be impinged if one of their miracle drugs came under too much scrutiny or the medical device sector for supposedly harming its ability to innovate and compete in a cutthroat marketplace. The agency no doubt feared taking another rain of blows if erred too much on the side of caution.

Meanwhile, Virginia Mason decided to resolve its own duedonoscope crisis by purchasing another 20 Olympus units (at a cost of of $37,500 each), providing enough down time for each one to ensure they can be properly sterilized, the Seattle Times reported.

That Olympus reaped additional hundreds of thousands of dollars from Virginia Mason due to design flaws in its product did not go unremarked by Andrew Ross, M.D., the hospital's chief of gastroenterology. It "certainly seemed ironic from our perspective," he told the LA Times.

If there are specific reasons why healthcare delivery costs twice as much in the U.S. than in other developed nations, the last six paragraphs are as good as any to cite.

Now the inevitable patient lawsuits are being filed. The payouts will likely be many multiples more than if the hospitals had spent the money to properly sterilize these pieces of equipment in the first place, or buy them from a more reliable vendor, or simply tell the manufacturers their products were unsafe and the design needed to be improved.

But that's what we get in the U.S. healthcare system. The checks and balances are entirely dictated by big business and the bottom line over regulatory zeal, allowing the companies and executives to fail upward. The considerations of the actual patients are pushed aside. – Ron (@FierceHealth)

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