FDA turns blind eye to deadly superbugs in endoscopes

Last week, I told you about how patients at UCLA Medical Center acquired superbug infections, and even died, because of exposure to contaminated endoscopes. (Endoscopes are instruments used to examine the GI tract. And colonoscopy is by far the most common endoscopic procedure.)

It turns out the FDA knew these endoscopic devices spread fatal superbugs since at least 2009, but did nothing about it.

It also turns out the outbreak at UCLA Medical Center is far from the first time these problems have occurred. Cedars-Sinai Medical Center experienced a similar outbreak earlier this month. Also, I did a little digging at our local Cancer Center in Tampa, Florida. In 2012, four local cancer patients developed antibiotic-resistant superbug infections after undergoing endoscopic procedures.

During 2013 and 2014, the FDA received 75 reports of adverse events associated with these devices, causing harm to 135 patients. The doctors who filed these reports complied with the FDA’s paperwork requirements. But the FDA essentially did nothing with the information.

Well, let me clarify.

They did issue a “safety communication” advising health care providers that the “complex design” of these endoscopes may impede effective sterilization. They even admitted when hospitals follow the manufacturer’s recommended safety procedures, patients can still contract superbug infections from these devices.

Despite making these statements, and suggestions, the FDA still doesn’t actually require hospitals to follow more rigorous safety procedures.

Translation: You actually can’t properly sterilize these devices due to poor design and ineffective sterilization instructions, but you can still keep using them!

It’s not as if real experts on infection control don’t know how to sterilize the instruments…

In fact, over the last few years, responsible healthcare professionals at several hospitals across the country acted on their own to impose more rigorous sterilization procedures on these devices–more than recommended by the device manufacturers or by the FDA. They identified three effective options.

First, hospitals can sterilize their endoscopes with ethylene oxide gas after each use. The University of Pittsburgh Medical Center, a leading national medical center, now uses this technique.

Second, hospitals can simply swab down the devices after each use to collect any lurking superbugs. Virginia Mason Medical Center (VMMC) in Seattle now uses this approach. (VMMC is a progressive, patient-centered hospital, I’ve written about before.)

Third, hospitals can quarantine devices until they are tested as being sterile.

Of course, neither Virginia Mason nor Pittsburgh has had any problems since improving their own sterilization procedures. But others say such procedures are too expensive!

Now, let’s think about that argument for a moment. Endoscopes cost $40,000 to $80,000 each. The procedures cost patients thousands of dollars each. But it’s too expensive to use effective sterilization procedures that will save lives?!

The FDA knows and admits the devices are poorly designed. The moving parts have crevices where superbugs hide out. So they must also know that ultimately the only real solution is to redesign these flawed devices.

The Japanese companies Olympus Corp, Pentax and Fujifilm Holdings Corp make these endoscopes. And UCLA uses an Olympus model. Clearly, the device’s design needs improvement. When I was a child, the words “Made in Japan” were taken as a sign of poor-quality products. It seems today it can be a sign the product may be lethal, at least when it comes to these medical devices.

So, what is the FDA doing?

They say they are “monitoring” the situation. And they set a meeting date for mid-May to “review” all the safety problems with these devices.

How appropriate. Another worthless government meeting.

How many more people need to get sick and die before the responsible parties take meaningful action?

This scandal is just one more reason to avoid endoscopic procedures. As I mentioned earlier, colonoscopies are, by far, the most common endoscopic procedure. They have many dangerous outcomes, in addition to this potential new problem for transmitting an untreatable superbug infection. Fortunately, you have several safe and effective alternatives to colonoscopy. You can learn all about these alternatives by clicking here. [insert hyperlink to colonoscopy promo]


1. “FDA knew devices spread fatal superbug but does not order fix,” Medscape (www.medscape.com) 2/20/2015