Manufacturer and User Facility Device Experience (MAUDE)
See the following -
Complaints about Electronic Medical Records Increase
Last month, the nation’s largest union of registered nurses sent a letter to the FDA asking for broader and more stringent oversight of electronic records systems and of computerized physician-order entry systems, which allow clinicians to log treatment instructions for patients. The National Nurses United, as part of its broader campaign highlighting the potential dangers of “unproven medical technology,” says FDA officials should test electronic medical records as rigorously as they might a new drug or an artificial hip implant...
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FDA Releases Device Adverse Event API
Under its openFDA project, the U.S. Food and Drug Administration has released a new application programming interface that returns data from its Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that contains medical device adverse event reports...
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