Ahead of next week’s advisory panel convening, the FDA released some eye opening details related to the superbug outbreaks linked to dirty duodenoscopes. Reports of these outbreaks occurred at hospitals across the country, including Virginia Mason Medical Center in Seattle, WA
Federal regulators disclosed additional clues about the potential harm to patients from a controversial medical scope, providing 142 reports of contaminated devices and possible patient infections since 2010. This came out via a May 7, 2015 LA Times article.
The Food and Drug Administration (FDA) had previously said it received about half that many reports, 75, on duodenoscopes that caused patient infections in 2013 and 2014.
The number of patients involved could be far higher than 142 given that one adverse event report may include many individual procedures/people.
The FDA panel of medical experts is expected to recommend additional steps to regulators, device manufacturers and hospitals. These are steps needed to protect patients undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP.
Officials report that 669,000 ERCP procedures were performed last year on patients battling cancer, gallstones and other digestive issues.
As we have seen in the news, advocates and lawmakers are directing harsh criticism at the FDA and Olympus Corp., maker of duodenoscopes. Why did they not sooner and more emphatically to report these hospital outbreaks? This would have alerted the broader medical community about the risks of the scope procedure.
Investigations have revealed that patients were infected even when medical centers followed the manufacturers’ (Olympus, Pentax Medical, and Fujifilm) cleaning instructions. Health officials learned that deadly bacteria are easily trapped at the tip of these duodenoscopes.
“The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern,” the FDA states in its latest report.
Federal officials acknowledged that their surveillance system for medical devices has limitations and that incidents can be underreported by manufacturers.
Each week gets busier at our offices at Stritmatter Kessler Whelan. In today’s Seattle Times, one of the two* articles about SKW’s cases focuses on a senseless tragedy arising out of a routine procedure that 53 year old Lisa Miller had at Virginia Mason Medical Center in June 2013. Ms. Miller was the mother of two children and wife to Allen Miller. A VMMC doctor recommended to Lisa that she have a routine procedure (endoscopic retrograde cholangiopancreatography or “ERCP”) to get to the bottom of her recurrent pancreatitis. But, a few weeks after her second “routine” procedure, she died of acute necrotizing pancreatitis. The autopsy report points to Virginia Mason contaminated duodenoscope made by medical device manufacturer Olympus.
For several years, Olympus America had known that its instructions for cleaning its duodenoscopes were ineffective and had resulted in severe infections and death. But it had not timely disclosed this critical, life-threatening detail to medical centers around the country, which used its scopes.
Then, once VMMC learned (the news came out earlier this year) that Olympus America scopes had caused illness and death to some of its patients, it chose to sit on this information. VMMC, contrary to its well-publicized policy of “transparency,” chose not to tell the family that Ms. Miller died due to an infection caused by a contaminated Olympus duodenoscope.
When Allen read the initial news story in the Seattle Times, he reached out to our firm to pursue justice against the scope-maker, Olympus and against Virginia Mason Medical Center (VMMC). VMMC had never informed Lisa or Allen about the superbug outbreak or concerns about the routine procedure that was tied to a superbug outbreak among at least 32 VMMC patients.
*See previous blog post to learn about the other Seattle Times article that appeared on today’s front page.