In response to recent infections and deaths from tainted medical scopes, U.S. lawmakers are looking to reform the FDA’s oversight processes. Members of Congress, federal officials and health-policy experts agree that the FDA’s surveillance system for devices is inadequate and relies too heavily on manufacturers to report problems with their own products. Patient advocates are skeptical of the FDA’s commitment to reform. Federal auditors have criticized the agency’s oversight of devices since the 1990s. The latest push for changes came from Senator Patty Murray (D-Wash.), who issued a report exposing failures by the FDA, device makers and hospitals that contributed to the nationwide spread of antibiotic-resistant infections from a gastrointestinal scope. Senate investigators cited 19 superbug outbreaks in the U.S. that had sickened nearly 200 patients from 2012 to 2015.
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