Colonoscopy is an overly expensive, overused, and dangerous colon cancer screening procedure. It’s an especially poor choice when you compare it to all the safe, inexpensive alternatives.
Investigations over the last year show endoscopes (the kind of 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.
As I reported last year, an investigation linked high-profile outbreaks in Los Angeles and Seattle to endoscopes manufactured by Olympus, a Japanese company that dominates the U.S. market. Despite this evidence, the FDA decided to keep the faulty devices on the market. But that was a fatal decision. It turns out these devices pose a far greater infection risk than originally thought.
According to a new report by the Associated Press, at least 300 patients have been sickened by life-threatening infections from contaminated medical endoscopes. Keep in mind, we are not talking about common GI infections that keep you in bed for a few days. These are dangerous, difficult-to-treat infections that can — and do — kill patients.
Doctors and patients typically try to avoid infections like the plague, so to speak, everywhere else in the hospital. So it baffles me that they continue to order and perform these dangerous endoscopic procedures, despite the evidence. (Lest we forget, these procedures can also cause intestinal perforations, liver lacerations, and other deadly injuries.)
According to another investigation by Kaiser Permanente Health System, the numbers are even worse. They say as many 350 patients in 41 medical facilities were infected or exposed to contaminated GI endoscopes from January 1, 2010 to October 31, 2015.
Regulators are almost certain there are many more cases of people getting infected as a result of these procedures. But hospitals don’t report them because they don’t screen patients for antibiotic-resistant “superbugs.” (But they are happy to keep screening for colon cancer using colonoscopies that can spread superbugs.)
Interestingly, I seem to read more in the national news about problems with duodenoscopes, the device used to look into the upper intestines, than endoscopes. But in my view, contaminated endoscopes ultimately pose a far greater threat because many more people receive routine colonoscopies.
We need to clamp down on the dangers of colonoscopies before the health and safety of Americans goes further “down the tubes” due to contaminated GI medical devices.
Finally, Congress steps up to the plate
In a surprising turn, the U.S. Congress is actually pushing the FDA to do more. The U.S. House of Representatives Committee on Oversight and Government Reform is even taking action.
During the late 1990s and early 2000s, when Rep. Dan Burton (R-IN) chaired the committee, I testified at least three times at his various hearings. I also attended many more hearings with my colleagues Bill Chatfield and Beth Clay. This important congressional committee has a wide scope, so to speak, and routinely investigates dangerous drugs, vaccines and medical devices.
Now, Rep. Ted Lieu (D-Torrance, CA) of the same committee just introduced two bills to tighten regulations of reusable medical devices. A separate bill would require companies to scientifically confirm the effectiveness of their recommended cleaning procedures, much like the FDA requires data on safety and effectiveness of drugs.
A separate Senate investigation earlier this year found more problems with endoscopes looking at a shorter time period from 2012 to 2015. And Sen. Patty Murray (D-WA) submitted similar legislation to the Senate last month.
In the meantime, federal prosecutors continue to investigate Olympus, as well as Pentax and Fujifilm for their role in the deadly outbreaks. (These investigations bring new concerns to the label “Made in Japan.”) According to the LA Times, Olympus kept selling these faulty endoscopes despite warnings of a “superbug” outbreak related to their devices in the Netherlands in 2012.
When issues like this come up, the voice of many is stronger than the voice of one. Which is why I’ve decided to launch 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 step is a petition that 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.