Endoscopic Procedures

Could the FDA have done more?

 

Ms. Bigler lost her husband and only learned about the superbug outbreak at Virginia Mason from the news. (Photo:  Steve Ringman/Seattle Times)

Ms. Bigler lost her husband and only learned about the superbug outbreak at Virginia Mason from the news. (Photo: Steve Ringman/Seattle Times)

 

As potential clients continue to call our firm, more details about what the FDA knew and didn’t do with its knowledge continue to surface. When I first learned about the “dirty duodenescope” problem at Seattle’s Virginia Mason, I wondered how much information that the FDA had regarding these duodenescopes used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. Then, when the latest news broke about the UCLA Medical Facility’s similar issues with improperly cleaned duodenescopes, I realized that this issue extends well beyond just a couple of medical facilities. The problem relates to the fact that these thin, flexible scopes are extraordinarily difficult to clean. Even UCLA’s latest announcement of using a toxic gas to clean these duodenescopes are doubtful per the FDA. This begs the question, then, why hasn’t the FDA done more to ensure that devices are not used until a more practicable ways to clean the device are identified?

Now, remember when Obama signed an Executive Order last fall to combat antibiotic resistant bacteria? I do. So do some federal lawmakers, who are now asking Congress to investigate what the U.S. Food and Drug Administration and device makers are doing to prevent further patient deaths and infections. Earlier this week, Rep. Ted Lieu (D-Torrance) sent a letter to the House Committee on Oversight and Government Reform, pointing out that outbreaks related to contaminated medical scopes “have national security ramifications.”

In an LA Times interview, Rep. Lieu reminded us of Obama’ executive order, issued this past September that made it a national security priority to combat antibiotic-resistant bacteria such as CRE (which stands for Carbapenem-resistant Enterobacteriaceae). The California congressman pointed out that an FDA safety alert issued last week post the UCLA incident does not give the public assurance that further outbreaks can be prevented, “While federal agencies such as the Centers for Disease Control and Prevention are combating superbugs, the current recommended sterilization procedures would continue to result in superbug outbreaks and deaths.”

The FDA acknowledged that cleaning the ERCP duodenoscopes to the manufacturers’ specifications may not remove all of the deadly bacteria that can be passed from patient to patient.

In the meantime, family members of Virginia Mason patients who now know about the link between these ERCP procedures and the recent superbug outbreak are asking important questions. For example, the Biglers’ heartbreaking story came out last week in the Seattle Times. Mr. Rick Bigler, a 57 years old insurance exec, was suffering from pancreatic cancer. Only after his wife, Theresa, requested his medical records, did she find out that he had suffered from an E.coli infection. As the Seattle Times article points out, ERCP procedures are linked to these types of infections. What is alarming is that the Seattle outbreak is the largest of its kind in the U.S.  But, unlike the UCLA Medical Facility, which was also recently reported to have similar issues with the superbug-dirty-duodenescope issue, Virginia Mason did not reach out to its patients. While UCLA had informed 180 individuals about the possible contamination, the Seattle medical facility insisted that its situation was somehow different because the outbreak apparently spanned over a larger period of time.

Understandably, family members of Virginia Mason patients who likely contracted the superbug, have many questions that they want answers to: Some of them have contacted our law firm, given SKW’s track record as renowned attorneys in the areas of products liability and medical negligence. If you have questions, we are interested in comparing your stories with the ones that we’ve already learned about. Email us at Counsel@Stritmatter.com or call us at 206.448.1777.

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