FDA drops important recall in dangerous endoscope fiasco

I have been warning you about the many dangers associated with “routine” colonoscopy screenings for colon cancer. Colonoscopy is an especially poor choice when you compare it to all the safe, inexpensive alternatives.

Plus, investigations over the last year show endoscopes (the medical devices used to perform colonoscopies) routinely spread bacteria from one patient to the next. In fact, it seems even when staff follow proper sanitation procedures, the devices still harbor bacteria. Some believe the devices’ flawed design makes them impossible to properly sterilize.

But instead of issuing a recall for the devices themselves, the FDA issued a recall for some 2,800 endoscope-cleaning devices around the country last November. A top FDA scientist said the recall was “necessary to protect health.”

The FDA ordered the equipment off the market because it said the manufacturer repeatedly violated federal safety statutes and placed patients at risk. The FDA then repeated the recall last January, after a U.S. Senate report linked endoscopes to several deadly “superbug” outbreaks around the country. In fact the U.S. Senate and House of Representatives are preparing legislation to make safety standards more stringent for these devices.

But last month, the FDA dropped the recall on the machines, basically thumbing their noses at law makers and public safety. They now say the dangerous machines can remain in the field, placing thousands of patients at risk, while “regulatory issues are being addressed.”

Just what have they been “addressing” since last November?

Things are so bad, the former Director of Infection Control at one medical device manufacturer said, “It is certainly troubling for the FDA to order the removal of a medical device it has linked to patient injuries and deaths, and then to abruptly reverse course with no clear explanations.” He left the company in 2013, after 18 years, over what he said were safety concerns.

I have to wonder what will happen to FDA professionals who speak out about this abrupt flip-flop? Will they lose their jobs too?

Interestingly, I seem to read more in the national news about problems with duodenoscopes, the type of endoscope used to look into the upper intestines, rather than colonoscopes. But in my view, contaminated colonoscopes ultimately pose a far greater threat because many more people receive routine colonoscopies.

Tragically, the problems with these devices are nothing new…

Endoscope scandal a decade in the making

Way back in 2007, Custom Ultrasonics — a company that makes the machines that clean endoscopes — signed an agreement in federal court, admitting  its “actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients.”

Then, in 2011, the FDA ordered Custom Ultrasonics to cease operations. It barred the company from manufacturing or shipping new products. Next, in November 2015, the FDA issued a recall order, accusing the company of repeatedly violating federal law and the consent decree.

Yet, astoundingly, as I mentioned earlier, the company was “pleased to announce” the FDA lifted the recall and will allow the machines to continue to operate in the field after all.

One step forward, two steps back

So here we are, almost 10 years after the first federal decree, and the FDA is still dithering, with one step forward and two steps back. In the meantime, the manufacturer continues to make money selling these machines, spreading deadly “superbug” infections, and killing unsuspecting patients.

A new report suggests that manufacturers are not the only ones making money from these bureaucratic delays and misdirections.

During recent testimony to Congress, former FDA Commissioner Margaret Hamburg admitted that in addition to collecting “user fees” from big pharma, the FDA caters to those industry players willing to pay the most money.

Of course, Hamburg and her husband have been accused of criminal behavior and bending the FDA rules while she was FDA Commissioner to benefit their own medical business. Does this remind you of another Washington, D.C. “power couple”?

Speaking of which, when President Clinton was elected to a second term in 1996, VP Al Gore, Sen. Bernie Sanders (D-VT), Sen. Tom Harkin (D-Iowa), Sen. Arlen Specter (R-PA), and others asked me to serve as the new FDA Commissioner.

I had just gotten out of Washington, D.C., and taken a new private sector job in Philadelphia. A senior physician there counseled me that I “had the head and the heart, but not the stomach” for the job.

And he was right.

What can you do to help?

As I told someone recently, things are definitely not copasetic, or should we say “colonos-copasetic” when it comes to endoscopic procedures and devices.

How long will it take before a leader of the executive branch of government comes along and finally tells these bumbling bureaucrats, “You’re fired!”

In the meantime, please help me encourage Congress to take further action to keep the FDA’s feet to the fire. On Monday, I launched a new citizen campaign called the Safe Colon Cancer Screenings Initiative to urge the FDA to improve oversight, regulation and patient safety for endoscopes, as well as to increase public awareness of the safe, effective alternatives to colonoscopies.

And the first part of this initiative is a petition we intend to send to the U.S. House of Representatives Committee on Oversight and Government Reform.

Please consider supporting this important movement — and adding your name to this petition. You can read more about the Safe Colon Cancer Screenings Initiative and sign the petition here.

Sources:

“FDA targeted maker of scope-cleaning machines long before superbug outbreaks,” LA Times (www.latimes.com) 5/29/2015

“Custom Ultrasonics’ AERs to Remain in Field,” PR Newswire (www.prnewswire.com) 5/16/2016


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