The Alliance For Natural Health

The FDA Ignores Medical Device Safety Concerns


The last few years has seen antibiotic-resistant “superbug” outbreaks in major hospitals that have killed dozens of patients and sickened hundreds more. Some of these outbreaks are linked to contaminated endoscopes—medical devices used to diagnose and treat diseases of the liver, bile ducts, pancreas, throat, stomach, and the intestines. Similar devices are used in colonoscopies, which means that the colonoscope risk is just as bad.

Especially worrisome is that the “superbug” we know to be spread by the contaminated scopes, Carbapenem-resistant Enterobacteriaceae (CRE), is often completely untreatable and has a mortality rate of 40% or more. Since 2009, there have been four major CRE outbreaks in American hospitals.

The design of the scopes makes them difficult to clean. “Biological debris” can get stuck in microscopic crevices on the instruments and can remain there for the next patient—even after the instruments are cleaned and disinfected following the FDA-approved instructions from the manufacturer.

Between 2004 and 2009, over 11,000 colonoscopies were performed at three different Veterans Administration hospitals using inadequately cleaned equipment—and as a result of these colonoscopies, thirteen veterans tested positive for hepatitis B, thirty-four for hepatitis C, and six for HIV.

FDA slow to take action

Almost from the start, the FDA has chosen simply to look the other way. During the 2009 outbreak in Florida, health experts from the CDC together with other epidemiologists warned the FDA that the problem was likely not limited to Florida, and that action should be taken to warn hospitals of the danger. Only months later did the FDA issue any warning whatsoever—a measly two sentences buried in the fifty-seventh paragraph in a general advisory on the proper cleaning of medical scopes!

Not until February of 2015—six years after they themselves were warned, and after at least twenty-eight people had died and dozens more had been made sick—did the FDA finally issue a proper warning that the endoscopes that are linked to superbug outbreaks may still transmit infections even when cleaned as directed by the manufacturers.

A subsequent US Senate investigation found twenty-five outbreaks between 2012 and 2015 linked to duoendoscopes that infected at least 250 people in four countries and ten states. The FDA had previously reported only nine outbreaks linked to the scopes.

This March the FDA completed a guidance with additional measures to improve the safety of endoscopes and other hard-to-clean devices. But—and this is a big but—while the guidance may make the equipment safer, it still won’t make them sterile.

Why is the FDA so reticent on this subject? Could it be because endoscopy and colonoscopy are such enormous businesses, producing tens of billions of dollars of revenue per year? Powerful special interests do not want to see any changes in this area of medicine—no matter what the risks are for the patient.