According to the FDA, manufacturers of endoscopes linked to recent “superbug” outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements. The agency cited Olympus Corp, Pentax Medical and Fujifilm Holdings Corp with multiple violations found during inspections of their U.S. and foreign facilities. Violations range from not properly evaluating cleaning, sterilization and testing procedures to failure to report infections and other problems. These devices are used in hundreds of thousands of procedures each year.
FDA attributes spread of superbug to endoscope
In particular, the FDA focused its attention on duodenoscopes. The specialized scopes consist of a flexible fiber-optic tube that is inserted down the throat into the stomach and small intestine to diagnose and treat conditions in the pancreas and bile ducts. The tip of the scope includes movable instruments designed to remove tumors, gallstones and other blockages. This complex design also makes the instruments difficult to clean. Bodily fluids and other debris can stay in the device’s joints and crevices even after cleaning and disinfection.
The FDA first warned of their potential to transmit antibiotic-resistant germs in 2009. Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company’s scope in 2012. Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks. Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them. The infections reported to the company involved a bacterial strain called pseudomonas, which can cause pneumonia, severe sickness and death in hospital patients.
The FDA has already offered hospitals advice on ways to improve cleaning the scopes, which have been linked to at least 13 deaths and dozens of infections at U.S. hospitals. An expert panel convened by the agency in May determined that duodenoscopes, the devices linked to outbreaks at UCLA Medical Center and Virginia Mason Medical Center, aren’t reliably safe. But the agency has declined to take them off the market, citing the needs of patients for sometimes lifesaving procedures.