Having covered the dangers that hospitals pose (on several occasions) and the previousfailures of the FDA to keep consumers safe (again, on several occasions), it will come as no surprise to readers to learn that the topic of this post brings the two together. Several hospitals–spanning from coast to coast–have announced outbreaks of what the press are calling superbugs: antibiotic-resistant bacteria. (In total, the CDC claims superbugs are responsible for about 23,000 deaths in this country every year). The common culprit in each of these hospital cases is an instrument called a duodenoscope (named for the duodenum, the highest section of the small intestine), a device that enters a patient’s system through the throat and carries “a light, a camera, a catheter, and other tiny equipment.” The scope is used in a diagnostic technique called ERCP, which is meant to diagnose and treat jaundice, pancreatitis, gallstones, and tumors.
Three manufacturers, according to ABC News, have within the past eleven years redesigned their products to make them easier to clean. In the process, the instruments may now trap harmful bacteria even after they have been cleaned as directed. What’s remarkable is that one of these three companies–Olympus–re-engineered and sold its new products without seeking the FDA’s consent. (The FDA requires manufacturers to seek its permission when potential changes “could significantly affect the safety or effectiveness of the device.”) A spokesperson for the FDA explained that Olympus “clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer.”
Over the past two years, a reported 350 patients have tested positive for antibiotic-resistant E. coli or for CRE, another superbug. CNN notes that the outbreak began with Olympus instruments at UCLA Medical Center, where two patients died from exposure to CRE. What is perhaps most troubling about this case is that most doctors and health policy experts agree that the potentially dangerous duodenoscopes–used in over half a million crucial procedures every year–cannot be taken off the market. As a high-ranking member of the American Gastroenterological Association remarked, “The value of the procedures performed utilizing these devices far outweighs the unfortunate events that have occurred.”
Some watchdog groups have raised speculation about the FDA’s role in this outbreak, alleging that it failed to take action even in the face of mounting suspicion about the scopes. The LA Times now reports that a bipartisan group of representatives “sent a letter to the FDA demanding answers about what the agency knew about the infection risk beforehand and for how long.” The spokesperson for the FDA cited above also mentioned that she does not know whether Olympus will face consequences for selling the unapproved instrument. This has led one medical device safety expert to compare companies like Olympus to unruly children: “How do you teach your children to behave if there are no consequences when they misbehave?”
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