Senate report: FDA partly to blame for spread of deadly superbug

A Senate investigation found America’s system for ensuring medical device safety failed repeatedly to prevent dirty endoscopes from spreading deadly superbugs. And the number of patients harmed far exceeds previous estimates from federal regulators, according to the investigation.

A specialized endoscope, called a duodenoscope, is responsible for the infections. Doctors across the United States use duodenoscopes to reach small ducts in the intestinal tract to diagnose or treat conditions like pancreatic cancer or gallstones. More than half a million endoscopic procedures take place each year in the U.S.

While medical officials acknowledged the duodenoscopes pose some infection risk, they recommended at a meeting in Washington last May that the scopes remain on the market because of their use in potentially life-saving procedures that have no better alternative. Olympus, which makes 85 percent of the duodenoscopes used in the U.S., opted not to participate in those meetings.

Duodenoscopes frequently cause infection due to their specialized tip, which is extremely hard to sanitize even after the most rigorous cleaning procedures.

“Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented,” said Sen. Patty Murray, D-Wash., who initiated the investigation.

Released Wednesday, the Senate report blames device manufacturers, hospitals, and the Food and Drug Administration for at least 25 outbreaks affecting more than 250 people worldwide since 2012. The infections may have contributed to dozens of deaths caused by bacteria called CRE, which is resistant to practically all available antibiotics and has an almost 50 percent fatality rate in blood-borne infections.

Aaron Young, an 18-year-old high school student and sickle cell patient, became ill with pancreatitis and underwent an endoscopy to place a stent in his bile duct. Within days, Young’s temperature soared to 104, and a ventilator kept him from pulmonary collapse. He shivered under cooling blankets while his parents kept an anxious bedside vigil. After 84 days in the hospital, Young recovered. Doctors identified a CRE infection, but had no idea where it came from. After two weeks, Young returned to the hospital to remove the stent. This time, doctors assured Young’s parents the endoscopy would go much smoother.

“They said it would be a walk in the park,” his father, Glenn Smith, told the Los Angeles Times.

Instead, his parents lived a repeat of their previous nightmare and doctors feared he would not survive. Sixty-seven days later, Young returned home, but only briefly. A red-hot, swollen foot sent him back to the hospital for a 60-day round of antibiotics. Young likely faces a future of frequent hospitalizations because antibiotics will never fully rid his body of the deadly bacteria.

UCLA Medical Center identified the endoscope that infected Young. The nearly new, $40,000 device had been cleaned in accordance with the manufacturer’s instructions, but it still transmitted the bacteria to Young and several others.

Outbreaks of CRE from dirty scopes occurred years before the FDA alerted hospitals and the public to the risk. In 2013, healthcare workers in Washington and Illinois reported to the FDA the endoscopes could be spreading a deadly infection. It took the agency 17 months to alert other hospitals to the risk.

“It’s just shocking that so many people were affected by this without anything being done about it,” Lori Smith, Young’s mother, told the LA Times.

The Senate report also blames manufacturers. In 2009, Olympus warned customers in Europe the design of the scopes could make them particularly challenging to clean, but the company “left American doctors and hospitals in the dark,” according to the report.

While science seems to have failed Young, he has begun to take solace elsewhere, making plans with his pastor to be baptized.

“All this tells me it’s time,” he told the LA Times. “I thought I was going to die.”