Sometimes I wonder, what can any of us really do to stay safe in hospitals? Take “superbugs”, for example. “Superbug” is the cute-sounding term used today to identify anti-biotic resistant bacteria that infects and kills people. Actually, superbugs kill about 23,000 Americans each year. Adorable.
Last month, two huge Los Angeles hospitals, UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center, reported a superbug outbreak that has left a number of patients infected and/or dead. (Hospitals in Connecticut, Pittsburgh and Illinois have reported similar outbreaks.) These patients underwent a procedure known as ERCP, which uses a scope called a “duodenoscope." Explains ABC,
Duodenoscopes are inserted through the mouth to access a patient's small intestine and ducts in the liver and gallbladder. They contain a light, a camera, a catheter and other tiny equipment used in 500,000 procedures a year, according to the U.S. Food and Drug Administration. Unlike scopes used in colonoscopies and upper endoscopy procedures, duodenoscopes used a complex elevator wire channel to access the tiny ducts.
But now it turns out that scope manufacturers, including FujiFilm, Olympus and Pentax, had somewhat recently redesigned their device hoping to make them easier to clean and in doing so, made them pretty dangerous. To make matters worse, reports CNN, at least one manufacturer never got the FDA’s permission to sell it!
Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.…
In a statement, Olympus said it didn't think needed the FDA's permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending.…
The TJF-Q180V duodenoscope, used to check out ducts in the gastrointestinal system, includes a modification to the exact part of the device that's been implicated in the superbug outbreaks.
With this new model, Olympus sealed up that part of the device, known as the elevator channel, hoping to make it more impervious to infection.
"The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Riley said.
Yes, I would say so. Meanwhile, in the long saga of Johnson & Johnson’s McNeil labs, the company has finally “agreed to plead guilty to a misdemeanor and pay a criminal fine of $20 million for selling adulterated infant and children products.” (See some of our earlier coverage here and here.)
And yesterday, it was reported that a company called Specialty Compounding LLC reached a settlement with the FDA after it became clear that the company’s “sterile injectable drugs had tested positive for bacterial contamination.” That’s some definition of sterile.
The company recalled batches of sterile drugs in August 2013, after the FDA received reports of 17 patients developing bacterial infections after being given an infusion of calcium gluconate made by the company.
The FDA inspected the company's Cedar Park facility in Texas in August and September 2013, and found unsanitary conditions and numerous other violations.
Under the settlement, the company is barred “from producing and selling sterile drugs until it receives written approval from the agency.”
In other words, these days it seems like things are “sterile” - except when they’re not.