FDA Approved Deadly Superbug Devices

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FDA superbug fiasco

Photo: University of Dhaka, Department of Microbiology in 2007

It has been reported that at least two deaths are believed to have stemmed from faulty devices used in a UCLA hospital and that the United States Food & Drug Administration knew of the deadly risks and did nothing to order a fix to the problem.

The regulators had known since at least 2009, according to a recent report from Reuters news wire service. The news began spreading through Twitter and the world is watching as one young 18-year-old woman struggles to stay alive at the hospital. The medical devices are said to be responsible for a so-called superbug outbreak that, so far, has 179 confirmed cases at Ronald Reagan UCLA Medical Center in California. Though the FDA knew of this deadly health concern, the agency did not recommended any new safety requirements. This has outraged many inside and outside of the medical community. They say it threatens the safety of patients.

Indeed, as one source has reported, a little girl in the hospital is in critical condition as medical staff try to preserve her life. The patients were exposed to antibiotic-resistant carbapenem-resistant Enterobacteriaceae, also known as CRE, during endoscopic procedures using duodenoscopes. The Duodenoscopes are inserted into the throat of the patient. The procedures took place between October 2014 and January 2015.

The FDA received at least 75 reports of adverse affects associated with the devices that are manufactured by Japanese companies like FujiFilm and Olympus (both companies also make digital cameras). Several hospitals began taking more stringent steps in handling and sterilizing them, according to reports, but many doctors want to the FDA to step up its standards as well.

Fox News reported that lawsuits are likely to follow this crisis. These pathogens are serious because they are not effected by antibiotics for the most part. As many as half of the badly infected patients are vulnerable to fatality as a result, it has been reported. The Center for Disease Control and Prevention claims that almost all states have had reports of CRE infections. The struggling 18-year-old student's parents are considering a lawsuit against Olympus.

On Thursday, the FDA issued a warning to health care providers stating that the medical devices capable of spreading infectious superbug diseases are extraordinarily difficult to clean and sterilize. These camera-laden devices are used in about a half million procedures in the U.S. and may leave many patients vulnerable to attacks from these parasites.

Pentax also develops such devices. They also make digital cameras for consumers. The FDA could require manufacturers to redesign the medical devices. There are also other ways of cleaning the devices, such as using a special gas. Whatever, they decide, it will be of major concern to hospitals and insurance companies. The devices are already expensive, costing up to $80,000 per unit. Adding a new way to clean them will boost the price even further. According to the Reuters report, not all infections developed at the hospital, but many of them are believed to have been developed there.

ABC News
Fox News
Image: WikiMedia Commons, Muntasir du

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