GHTF Proposal On Reporting "Use Errors" Hurts Safety - Public Citizen
This article was originally published in The Gray Sheet
Executive Summary
A proposal under consideration by the Global Harmonization Task Force's Study Group Two which would not require reporting of adverse events involving device use errors that do not result in death or serious injury represents "a significant weakening of current standards" and should not be implemented, according to consumer advocacy group Public Citizen.
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