FDA Knew Medical Devices Transmit Superbugs but Did Not Act
Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements.
The latest outbreak involving duodenoscopes may have exposed 179 patients at UCLA’s Ronald Reagan Medical Center in Los Angeles to drug-resistant bacteria and contributed to two deaths, Reuters reports. This is not the first time the sometimes-fatal infections have been traced to the devices, which are inserted down the throat to diagnose and treat pancreatic and bile duct diseases. Duodenoscopes are manufactured by the medical divisions of Olympus Corp, Pentax, and Fujifilm. The UCLA hospital uses an Olympus model.
In 2013 and 2014, the Food and Drug Administration (FDA) said it received 75 reports of adverse events associated with the devices, resulting in harm to 135 patients. Because healthcare providers do not always submit such reports, this is likely an underestimate of such events, according to Reuters.
In 2012, four patients in Florida were treated for antibiotic-resistant infections after undergoing duodenoscope procedures at Tampa General Hospital and there was an outbreak at Advocate Lutheran General Hospital near Chicago, Reuters reports. Forty-four patients were infected with the virulent, antibiotic-resistant bacteria CRE (carbapenem-resistant Enterobacteriaceae), the strain in the UCLA outbreak. Virginia Mason Medical Center in Seattle reports that a bacteria spread through contaminated scopes infected 32 people over two years and 11 died.
After such outbreaks, hospitals that began sterilizing endoscopes more rigorously than recommended say they have not had any further transmissions of dangerous microbes, according to Reuters. Dr. John Greene, an infectious disease specialist at Moffitt Cancer Center in Tampa, where one of the outbreaks occurred, said he would favor “the FDA putting out more stringent rules.”
Last week, the FDA issued a safety communication warning that the complex design of duodenoscopes may impede effective sterilization, Reuters reports. Even when hospitals adhered to the manufacturers’ instructions for sterilization, patients have contracted multidrug-resistant bacterial infections from the devices. Bodily fluids can lurk in microscopic crevices at the tip of the device after standard disinfection. The FDA has not yet required more stringent safety procedures or changes to the scope’s design but an agency spokeswoman said the FDA is exploring “additional potential strategies to reduce the risk of infections.”
