Amid the recent, deadly outbreak of Carbapenem-resistant Enterobacteriaceae (CRE) associated with the use of dudenoscopes, the Food and Drug Administration (FDA) is under fire for what some call inadequate regulation of the medical devices. But an even bigger regulatory gap may be the fact that the federal government doesn't require hospitals to tell patients that they've been exposed to pathogens like CRE, Bloomberg reports.
Because the federal government only requires hospitals to track and report rates of six types of infections--and CRE is not included in this list--investigations into outbreaks like those that have sickened and killed patients in Seattle, Pittsburgh, Chicago, California and North Carolina can go on for months before the public knows about it, according to the article. Only 10 states monitor the prevalence of superbugs such as CRE, FierceHealthcare has reported, though the Joint Commission does have a "Sentinel Event Policy" that encourages hospitals to report adverse events that result in patient deaths, permanent harm or severe temporary harm.
The "nightmare" CRE bacteria, which kill about 50 percent of patients who get bloodstream infections from them, are especially dangerous because they are resistant to last-resort antibiotics, according to the Centers for Disease Control and Prevention (CDC).
While a 2013 report indicated that medical errors cause as many as 400,000 deaths a year, recent CDC data indicate that hospitals made progress on reducing hospital-acquired infections. And the only way to continue this trend is to increase disclosure of these adverse events, Lisa McGiffert, director of the Safe Patient Project at Consumers Union, told Bloomberg.
"It wasn't motivating enough that tens of thousands of people were dying every year," McGiffert said. "It was the public disclosure that motivated [the improvement]."
For its part, the FDA issued a warning about the CRE infection risk associated with duodenoscopes shortly after news broke of a deadly outbreak at UCLA's Ronald Reagan Medical Center. It updated the warning last week to emphasize that it will not take duodenoscopes off the market for fear it would lead to a shortage of devices used for potentially life-saving endoscopic retrograde cholangiopancreatography (ERCP) procedures.
In accordance with the FDA's advice for providers, Brigham and Women's Hospital in Boston tells patients about the risk of infection associated with ERCP procedures and has written policies on infection control, according to the Boston Herald. "We have to weigh the risks and benefits of what we do," said John Saltzman, M.D., director of endoscopy at the hospital. "These procedures can be life-saving."
To that end, both the American Society for Gastrointestinal Endoscopy and American Gastroenterological Association (AGA) have made the issue of duodenoscope safety a top priority, the Washington Post reports. The AGA, for example, plans to convene federal officials, venture capitalists and device makers to work out a solution, AGA President John Allen told the newspaper.
"We're putting them all in a closed room," he said, "and saying, 'What do we have to do to innovate our way out of this and drive the infection rate to zero?'"