Blood and blood components; error and accident reports--Food and Drug Administration. Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations concerning blood and blood components to require the submission of certain error and accident reports to the agency by licensed and unlicensed blood etablishments. These reports of error and accidents are being limited to those related to the issue of hepatitis-reactive blood and blood components and the accidental infusion of the wrong red blood cells to a donor during plasmapheresis. Certain other reports of error and accidents would no longer be required to be submitted to the Director, Bureau of Biologics, by these blood establishments. The agency is also proposing to amend the current good manufacturing practice (GMP) regulations for blood and blood components to provide a uniform procedure for reporting and maintaining these records.
D001771:Blood Banks / Q000592:standards*; D005161:Facility Regulation and Control; D006801:Humans; D011996:Records; D065227:Transfusion Reaction; D014481:United States; D014486:United States Food and Drug Administration