The FDA’s first priority is patient safety.
The FDA has been working for several years to reduce the risk of patient infections associated with reusable endoscopes — small, flexible lighted tubes that allow doctors to see inside patients and treat certain medical conditions in a less invasive manner than traditional surgery. The devices, which include duodenoscopes, are reprocessed, or cleaned and disinfected, for use between patients.
In 2009, the FDA, Centers for Disease Control and Prevention and the Veterans Administration issued a safety communication cautioning about the risks to patients if flexible endoscopes and their accessories are not cleaned properly and recommending steps to help reduce these risks. The communication, in part, responded to reports of infections associated with endoscopes — including ones in Florida in 2008 — linked to the failure of user facilities to properly follow manufacturers’ reprocessing instructions.
In the fall of 2013, the CDC alerted the FDA to a potential association of multidrug resistant bacterial infections and duodenoscopes. In some cases, it appeared that device contamination occurred even though the medical device’s cleaning and disinfection instructions had been followed.
The FDA convened an expert team of scientists and public health officials and initiated a comprehensive review, which included analyzing adverse event reports, identifying and studying the devices, collecting information from manufacturers and facilities where outbreaks occurred, and conducting an engineering assessment of the devices.
After a thorough review of the evidence, the FDA issued a safety communication to alert heath care professionals and patients of risks associated with duodenoscopes and provided recommendations to improve their safe use. This month, the FDA provided supplemental recommendations in another safety communication intended to further reduce the risk of infection and increase the safe use of these important devices for necessary and potentially life-saving procedures.
Dr. William Maisel is the deputy director for science and chief scientist at FDA’s Center for Devices and Radiological Health.