Medical Devices Contain Antibiotic Resistant “Superbug” CRE

The Centers for Disease Control and Prevention call it the “nightmare bacteria.” It has been implicated in the deaths of hospital patients in both Los Angeles, California and in Seattle, Washington. It is also the basis for new lawsuits against medical device manufacturers.

The “superbug” is Carbapenem-Resistant Enterobacteriaceae (CRE), bacteria which “kill up to half of patients who get bloodstream infections from them” and which is almost entirely resistant to antibiotics. CRE has popped up in cases around the country over the past few years, with two new lawsuits against Olympus Medical Systems, the manufacturers of “duodenoscopes, a device with a camera on the end that's placed down the throat of a patient to investigate gastrointestinal complaints.”

The basis of the lawsuits

The problem is the design of the scopes makes it very difficult to kill bacteria in them, even with repeated cleaning and disinfecting. The scopes are also too sensitive to be sterilized with heat the way many other medical devices are. The lawsuits allege that the scopes had a design flaw which makes it difficult to successfully sterilize them, which led to the transmission of the dangerous bacteria from one patient to another. According to the Washington Post, the FDA and the manufacturers have known about this problem for years. Since as far back as 1983, doctors, hospitals, and even the CDC have repeatedly warned the FDA about the problem with duodenoscopes being contaminated with bacteria despite being disinfected. Unfortunately it has taken the outbreak of the superbug for the FDA to begin to act on these complaints.

Signs of a CRE infection

CRE bacteria infect different parts of the body, which means the symptoms can be hard to diagnose. There are some illnesses, however, that seem to present more often than others when a person has the CRE bacterium in his or her body. If you have developed pneumonia, a urinary tract infection or sepsis since your time in the hospital, your doctor should test for CRE.

For more information about CRE bacteria or about medical malpractice and products liability cases, please contact us today.