Iatrogenic infections occur as a result of medical treatment. According to the American Bar Association, iatrogenic infections kill as many as 99,000 patients in the United States, including New Mexico, every year. These infections commonly occur as a result of improperly sterilized medical equipment coming in contact with bodily tissues.
One type of medical equipment that has recently come under scrutiny is the endoscope. An endoscope is a flexible, tubelike instrument that has a light, a small camera and microsurgical equipment attached to the end of it for the purpose of entering bodily cavities and looking at internal organs, typically those comprising the alimentary tract, as well as obtaining biopsies or performing microsurgical procedures if necessary. There are two categories of endoscopes: colonoscopes and duodenoscopes. Doctors use colonoscopes to inspect the large intestine and check the colon for abnormal growths, whether benign or malignant. Colonoscopes enter into the body through the rectum. Duodenoscopes are different, in part because they enter the body through the mouth and, when threaded through the esophagus and stomach, allow doctors to inspect the upper part of the small intestine, known as the duodenum.
As a semi-critical piece of equipment that comes in contact with internal organs, endoscopes require a high level of disinfection and sterilization. However, keeping endoscopes clean and sterile is not an easy task. Endoscopes have channels or openings inside them, known as lumens, that can harbor disease-causing bacteria when sterilization procedures are inadequate or incomplete.
According to FindLaw, a manufacturer of medical equipment known as Olympus Corp has become the target of a number of lawsuits since 2012 alleging negligence in the production of one of its endoscopes known as the TJF-Q180V duodenoscope. Olympus designed the duodenoscope to make the instrument easier for physicians to use; however, it also made it more difficult to properly clean the endoscope. As a result, the instruments developed colonies of a “superbug,” known as carbapenem-resistant Enterobacteriaceae, growing within their lumens. When doctors performing endoscopic procedures made use of the contaminated duodenoscopes, patients became infected with bacteria that was resistant to antibiotics. Between 2012 and 2015, 250 people worldwide became ill as a result of endoscopic-related iatrogenic infections, the vector of infection in most of those cases being Olympus endoscopes.
Lawsuits against Olympus allege the company failed to alert health care professionals, as well as the general public, about the known possibility of iatrogenic infection resulting from their endoscopes. Initially, Olympus did not claim responsibility, claiming the fault was that of hospital staff that did not clean the instruments properly. Ultimately, however, Olympus provided updated instructions on cleaning the instruments to doctors and hospitals on the grounds that the previous instructions had been inadequate.