Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers
The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The makers of the specialized gastrointestinal scopes, which are … [Read more...] about Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers
Medical Scope Makers Warned in the Wake of Superbug Outbreaks
Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in some instances, failed to ensure the … [Read more...] about Medical Scope Makers Warned in the Wake of Superbug Outbreaks
