Medical device adverse event reports are often incomplete, inaccurate and delayed

Permitting medical device manufacturers to submit bulk summary reports of adverse events to the U.S. Food and Drug Administration (FDA), rather than reporting individual cases, often fails to promptly detect potential safety signals, finds a study published by The BMJ. This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety and meet FDA standards.

Read it at Medical Xpress ↗

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