The U.S. Food and Drug Administration (FDA) has rejected a petition to reclassify certain MRI safety incidents, specifically projectile events, as "malfunctions." Currently, these incidents are classified as "use errors," which means they do not require reporting from manufacturers. Tobias Gilk, an MRI safety expert, argued that reclassifying these incidents would enhance patient and staff safety by ensuring reporting, even for non-harmful events. However, the FDA stated that their guidelines only necessitate reporting for equipment malfunctions that could cause serious harm or death. Although the FDA acknowledged that near miss events related to user error do not need to be reported, manufacturers are encouraged to report them voluntarily. Gilk expressed disappointment over the FDA's decision in a LinkedIn post.
Mon, 27 Jul 2026 20:59:21 GMT | Radiology Business