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Year 2000 Computing Challenge: Concerns About Compliance Information on Biomedical Equipment

T-AIMD-99-209 Published: Jun 10, 1999. Publicly Released: Jun 10, 1999.
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Highlights

Pursuant to a congressional request, GAO discussed the year 2000 compliance status of biomedical equipment, focusing on: (1) the status of the Food and Drug Administration's (FDA) Federal Year 2000 Biomedical Equipment Clearinghouse; (2) compliance status information on manufacturers' web sites referred to in FDA's clearinghouse; (3) FDA's efforts to address GAO's recommendation to obtain and review the test results supporting manufacturers' compliance certifications for critical care/life support medical devices; and (4) information on the biomedical equipment compliance status of health care providers.

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Clearinghouses (information)SoftwareSoftware verification and validationEmbedded computer systemsMedical equipmentMedical information systemsStrategic information systems planningSystems conversionsY2KCompliance oversight