FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities
In the wake of widespread reports of dangerous and sometimes deadly infections occuring from repeated use of the devices, on October 5, 2015, the FDA ordered the three medical duodenoscope manufacturers in the U.S. to begin conducting surveillance studies to increase understanding of precisely how the devices are cleaned (reprocessed) in the real world.
“This is a significant step in the effort to combat infections spread through duodenoscopes,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “These studies will provide critical information … to protect the public health and help reduce the risk of infections.”
Olympus America, Fujifilm Medical, and Hoya Corp. will have 30 days to submit postmarket surveillance plans to the FDA. The proposals must detail the manufacturers’ plans to conduct studies to evaluate how well health care personnel follow instructions to clean and disinfect duodenoscopes between patients.
Duodenoscopes are flexible, lighted tubes that are used to treat patients undergoing endoscopic procedures. More than 500,000 such procedures are performed every year in the U.S. These procedures often are critically important, but the FDA has identified evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant “superbug” infections, to patients.
Lieff Cabraser has successfully represented thousands of patients across America injured by defective and dangerous medical devices. We currently represent patients who developed superbug CRE infections after undergoing endoscopic retrograde cholangiopancreatography, as well as the families of patients who died as a result of such infections.
Learn more about Lieff Cabraser’s work on behalf of patients injured by endoscopic superbug infections. You can also use our online form to contact a Lieff Cabraser endoscope infection injury attorney, or call us toll-free at 1 800 541-7358.