The US Food and Drug Administration (FDA) recently released guidance to healthcare providers about possible contamination of urological endoscopes.
An endoscope is a medical device with a lighted flexible tube and camera attached. The device is small enough to be inserted into openings in the body, like the mouth, nose, or anus. Threading through the body, an endoscope offers physicians a good look at areas of concern.
A urological endoscope is a device adapted to use in investigation of the kidneys, bladder, ureters, and urethra. Types of endoscopes include ureteroscopes and cystoscopes. For example, a cystourethroscope is used to see the interior of the bladder and urethra. These specialized devices offer good anatomical views and can be used in treatment of urinary tract conditions.
Recently the FDA provided guidance in a letter to healthcare providers about the danger of contaminated endoscopes used for urological procedures. The FDA notes it has received more than 400 Medical Device Reports (MDRs) describing post-procedure infections or issues caused by potentially contaminated endoscopes.
Healthcare-associated infections (HAIs) are a serious problem in American healthcare. As multi-drug resistant bacteria proliferate in healthcare settings, inadequate maintenance or sterilization procedures harm and kill patients trying to get treatment for injury and disease. HAIs are associated with 1.7 million infections each year and kill an estimated 99,000 people each year.
In addition to the MDRs received by the FDA, the alert links urological endoscopes with the death of three patients outside of the US who suffered fatal infections as a result of device failure and contamination. While the FDA alert cites devices manufactured by Olympus Corporation and Karl Storz, the FDA states the danger of these devices when contaminated is not limited to these brands.
In all three cases, contaminated endoscopes led to fatal infection with Pseudomonas aeruginosa, a dangerous multi-drug resistant bacterium. In 2017, the CDC reports Pseudomonas aeruginosa was linked to 32,600 infections and 2,700 deaths in hospitalized patients in the US.
Notes Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, “We are very concerned about the three reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue.”
The FDA letter recommends healthcare providers and facilities maintain vigilance in reprocessing, maintaining, and using endoscopes. Suggestions include precleaning, leak testing, cleaning again, and sterilization. The FDA continues to review the potential for contamination—and infection—of patients through the use of endoscopes.
When improperly maintained, a useful medical device can become an instrument of injury and deadly infection. If you suffer a serious HAI—speak to our legal team.
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