Medical Device Problem Reporting:
A Case Study of a Home Apnea Monitor
T-PEMD-90-10: Published: Jul 17, 1990. Publicly Released: Jul 17, 1990.
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GAO discussed the Food and Drug Administration's (FDA) implementation of the medical device reporting regulation, focusing on reporting problems involving a home apnea monitor. GAO noted that: (1) the monitor's manufacturer received at least 70 complaints associating the monitor with patient deaths between 1983 and 1989; (2) although the manufacturer maintained records of complaints, it did not fully comply with the regulation's reporting requirements; (3) although FDA conducted eight formal inspections between 1984 and 1989, it did not identify or attempt to resolve underreporting problems until 4 years after the regulation went into effect; (4) FDA cited the manufacturer for noncompliance, reviewed the manufacturer's original problem-reporting policy, and concluded that its revised policy was adequate; (5) primary users of the monitors were not always adequately informed of the device's limitations and risks; (6) the manufacturer attributed its noncompliance to differences in interpreting the reporting regulation; (7) FDA inspection procedures did not include any systematic evaluation of trends in the frequency, type, or severity of complaints made to the manufacturer; and (8) FDA did not compare the rates of complaints among manufacturers of similar devices.
Jan 21, 2021
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Rural Hospital Closures:
Affected Residents Had Reduced Access to Health Care ServicesGAO-21-93: Published: Dec 22, 2020. Publicly Released: Jan 21, 2021. -
Health Care Funding:
Federal Obligations to and Funds Received by Certain Organizations Involved in Health-Related Services, 2016 through 2018GAO-21-188R: Published: Dec 21, 2020. Publicly Released: Jan 21, 2021.
Jan 14, 2021
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Medicaid:
Data Completeness and Accuracy Have Improved, Though Not All Standards Have Been MetGAO-21-196: Published: Jan 14, 2021. Publicly Released: Jan 14, 2021.
Jan 4, 2021
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Medicare Severe Wound Care:
Spending Declines May Reflect Site of Care Changes; Limited Information Is Available on QualityGAO-21-92: Published: Jan 4, 2021. Publicly Released: Jan 4, 2021.
Dec 22, 2020
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Defense Health Care:
Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective CareGAO-21-143: Published: Dec 22, 2020. Publicly Released: Dec 22, 2020.
Dec 16, 2020
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Medicaid Long-Term Services and Supports:
Access and Quality Problems in Managed Care Demand Improved OversightGAO-21-49: Published: Nov 16, 2020. Publicly Released: Dec 16, 2020.
Dec 14, 2020
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Drug Pricing Program:
HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B RequirementsGAO-21-107: Published: Dec 14, 2020. Publicly Released: Dec 14, 2020. -
Substance Use Disorder:
Reliable Data Needed for Substance Abuse Prevention and Treatment Block Grant ProgramGAO-21-58: Published: Dec 14, 2020. Publicly Released: Dec 14, 2020.
Dec 10, 2020
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Indian Health Service:
Actions Needed to Improve Oversight of Provider Misconduct and Substandard PerformanceGAO-21-97: Published: Dec 10, 2020. Publicly Released: Dec 10, 2020. -
Clinical Labs:
Studies Suggest Biopsy Specimen Misidentification and Contamination Errors Are InfrequentGAO-21-59: Published: Nov 10, 2020. Publicly Released: Dec 10, 2020.
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