Hospitals Prefer Existing Mechanisms To Report Device Safety Issues, Says AHA
Executive Summary
The American Hospital Association says US FDA should build on existing safety efforts to gather evidence about medical device adverse events "rather than relying on a potentially duplicative event reporting structure," and the Medical Imaging Technology Alliance blamed device equipment servicing companies for failing to pass on information to the agency and manufacturers about equipment failures, in comments and testimony on the agency's plan to modernize evidence generation for device evaluation.
You may also be interested in...
Market Intel: Infusion Pump-Makers Look to Improve Safety Through Interoperability
While infusion pumps are vital to patient care and used in abundance in hospitals, they are also associated with numerous errors. One of the keys to addressing this problem lies in improving the devices’ interoperability with hospital IT systems, and as those changes are starting to materialize, so are opportunities for new players in this space.
FDA Turns Adverse-Event Reporting Scrutiny On Hospitals
The US agency detailed potential adverse-event reporting violations at 15 hospitals in FDA-483 forms that were posted online by FDA to highlight the need to shift to an active, electronic based device surveillance system.
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.