The FDA recently warned health care providers that improperly sterilized scopes are infecting patients with deadly, drug-resistant bacteria. The so-called "super bug" has already killed dozens of patients and caused hundreds others to fall ill. Medical device lawyers at Pintas & Mullins detail this outbreak below.
The drug-resistant family of bacteria is known as CRE (carbapenem-resistant Enterobacteriaceae) typically infect patients in hospitals and nursing homes - and particularly patients dependent on catheters or breathing tubes. The deaths and injuries associated with CRE have occurred at the Ronald Reagan UCLA Medical Center in Southern California and the Virginia Mason Medical Center in Seattle, Washington.
The duodenoscopes at the center of this outbreak have crevices and parts that are extremely difficult to reach with cleaning brushes, making total disinfecting almost impossible. These scopes are inserted into patients' throats, down into the stomach and small intestines to diagnose and treat liver, bile duct and pancreas diseases. About 500,000 of these types of procedures are performed each year in the U.S.
When these devices are not properly disinfected, bodily fluids and debris can remain on the scopes, exposing any patients undergoing an endoscopic procedure thereafter to contamination and infection. About 180 UCLA patients who underwent this procedure between October 2014 and January 2015 have been notified of their possible exposure.
CRE germs affect bodily systems broadly, infecting patients who are otherwise healthy and able-bodied. If CRE spreads, it can affect patients even with minor infections, like UTIs or small cuts, and cause fatal complications. Unfortunately, CRE is becoming increasingly common in American hospitals.
Currently, CRE infects about 9,300 people in the U.S. every year and kills about 610 patients. Whenever a CRE infection is confirmed, hospitals take aggressive measures to contain the bug, including: isolating patients, dedicating specific rooms, staff and equipment, and requiring higher hand-washing standards for staff.
On February 19 the FDA issued a safety alert stating it was closely monitoring the situation and the association between these duodenoscopes and the infection of drug-resistant bacteria. The agency reportedly received about 75 complaints over the last two years regarding these duodenoscopes and bacterial infections in more than 130 patients. Almost all infections were resistant to antibiotic treatments.
The agency is stopping shy of issuing a national duodenoscope recall, since there are no alternative devices hospitals can use to treat and diagnose diseases of the liver, bile duct and pancreas. Three manufacturers sell these devices: Olympus, Fujifilm, and Pentax Medical. Nevertheless, members of congress are urging the House Committee on Oversight and Government Reform to hold a hearing on the outbreak.
The deaths in Seattle also caught the attention of Congress, enacting Washington senators who urged the FDA to provide better guidance on sanitation practices.
The medical scope at the center of California outbreak is made by Olympus America, who was just hit with a lawsuit by an injured patient. The patient, Aaron Young, is alleging that Olympus failed to instruct UCLA Medical Center on how to properly disinfect the duodenoscopes. Olympus is being targeted because the hospital reportedly did sterilize the scopes according to the company's standards.