We Are the FDA and We Are Here to Help

Remember the words of Reagan, when he said the The nine most terrifying words in the English language are, ‘I’m from the government and I’m here to help?”

While busily kowtowing to Big Pharma and “protecting” Americans from all those dangerous drugs that just might happen to save some lives of those in extremis, the Federal Drug Administration, which oversees medical devices as well as drugs, failed to take energetic action in 2009 when they learned of a serious risk from one device. Reports began arriving that duodenoscopes, an endoscopic device that is inserted in the throat to examine the upper gastrointestinal system could transmit lethal infections including a new “superbug.”


By 2013 and 2014, the agency had received  75 reports of adverse events associated with the devices, resulting in harm to 135 patients. The FDA admitted that because healthcare providers do not always send in reports, these numbers likely underestimated the magnitude. These duodenoscopes were made by Japanese companies like Olympus, Pentax and Fujifilm Holdings Corp.

Smart hospitals, which cared more for patient safety than the bottom line (or perhaps  cynically were more concerned about lawsuits), proceeded to sterilize the scopes more rigorously than recommended by the FDA and the manufacturers. These hospitals did not have any more outbreaks of drug-resistant superbugs from use. Others, like Tampa, Advocate Lutheran General Hospital (Chicago) where 44 patients were infected and the Univ. of Pittsburg Medical Center had outbreaks. Just last month, the Virginia Mason Medical Center in Seattle reported infections over the past two years in 32 people of whom 11 died. The Ronald Reagan Medical Center, University of California, Los Angeles had a case in October 28, 2014.  In the third week of February, 2015, this hospital begin notifying patients who had examinations with the devices.  UCLA took this action after confirming exposure to the superbug CRE (carbapenem-resistant Enterobacteriaceae ) in seven patients of whom two had died. An additional 179 UCLA patients at this point are being notified of the potential for infection.

If you wonder why not every hospital began to take more stringent measures, you are a bit naïve. The reason, of course, is money. “Duodenoscopes cost about $40,000 and as much as $80,000, and when they are taken out of service for gassing or quarantining a hospital may need to spend an additional $1 million to have enough available,” according to  Lawrence Muscarella, a healthcare consultant in Pennsylvania and author of a 2014 paper on superbug transmission via duodenoscopes.*
 
Instead of getting serious, the FDA issued a safety communication to warn healthcare providers that the complex design of these duodenoscopes may [italics mine] impede effective sterilization. At this point, the FDA is “exploring options” (a popular phrase in the Obama administration) but is not mandating procedures that are more stringent.

The nine most terrifying words in the English language are, ‘I’m from the government and I’m here to help?'”

*Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy, World Journal of Gastrointestinal Endoscopy, 2014 Oct 16;6(10):457-74.