FDA Advisory Committee

FDA reveals duodenoscope procedures likely infected far more than initially reported

Why didn't FDA and hospitals come out earlier and more forcefully about the risks of scope procedure?

Why didn’t FDA and hospitals come out earlier and more forcefully about the risks of scope procedure?

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.

About Us

This blog is maintained by attorneys at Stritmatter Kessler Whelan (SKW), focused on important legal issues, news, and developments... MORE
Connect
   
Subscribe

Add this blog to your feeds or subscribe by email using the form below.

Favorite Quotation

If thou faint in the day of adversity, thy strength is small.
— Proverbs 24:10

Intense love does not measure, it just gives.
— Mother Teresa

The test of a civilization is the way that it cares for its helpless members.
— Pearl S. Buck

You may trod on me in the very dirt. But still, like dirt, I'll rise.
— Maya Angelou

The worst sin towards our fellow creatures is not hate them, but to be indifferent to them; that's the essence of inhumanity.
— George Bernard Shaw

Without justice, courage is weak.
— Benjamin Franklin

Injustice anywhere is a threat to justice everywhere.
— Martin Luther King, Jr.

Fairness is an across-the-board requirement for all our interactions with each other ...Fairness treats everybody the same.
— Barbara Jordan

I consider trial by jury as the only anchor ever yet imagined by man, by which a government can be held to the principles of its constitution.
— Thomas Jefferson

Why should there not be a patient confidence in the ultimate justice of the people? Is there any equal hope in the world?
— Abraham Lincoln

I don’t know what kind of a future life I believe in, but I believe that all that we go through here must have some value.
— Eleanor Roosevelt

The basic proposition of the worth and dignity of man is the strongest, the most creative force now present in the world.
— Franklin D. Roosevelt

Justice is the end of government. It is the end of civil society. It ever has been and ever will be pursued until it is obtained, or until liberty be lost in the pursuit.
— James Madison

There is no truth existing which I fear, or would wish unknown to the whole world.
— Thomas Jefferson