Editor's Note The Food and Drug Administration (FDA) on June 10 released a COVID-19 update announcing the following actions taken in its response to the pandemic: The FDA and National Institutes of Health have updated the CURE ID crowd-sourcing app to make it easier for healthcare providers to share their…

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Editor's Note Citing a response to public health concerns, the Food & Drug Administration (FDA) on June 7 reissued certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination and reuse. The FDA determined that certain respirators should not be decontaminated for reuse by healthcare professionals during…

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Editor's Note The Food & Drug Administration on May 11 took new actions to accelerate the development of novel prevention and treatment options for COVID-19. The agency is providing guidance documents to make the process for submitting applications to initiate studies for new drugs and biological products more efficient. The…

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Editor's Note The Centers for Medicare & Medicaid Services (CMS) on May 11 released a proposed rule that increases Medicare inpatient prospective payment system (IPPS) rates by a net of 3.1% in FY 2021, compared to 2020, for acute care hospitals participating in the Hospital Inpatient Quality Reporting Program that…

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Elective surgical procedures that were temporarily suspended in mid-March are now on the table—or soon will be—at some US facilities. The ban, announced on March 18 by the Centers for Medicare & Medicaid Services (CMS), was enacted to free up resources for facilities overwhelmed by surges of COVID-19 patients. On…

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Editor's Note The Food & Drug Administration (FDA) on May 6 issued a guidance to implement section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) as it relates to shortages and potential shortages of medical devices occurring during the COVID-19 pandemic. Manufacturers are required to notify…

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Editor's Note European regulators have approved Siemens Healthineers’ molecular Fast Track Diagnostics SARS-CoV-2 Assay, which has 100% specificity and sensitivity. The new assay uses real-time polymerase chain reaction (PCR) to detect ribonucleic acid (RNA) from this virus. The company plans to ship more than 1.3 million tests per month worldwide…

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Health systems nationwide are examining policies and procedures related to their resources, staffing, and scheduling to prepare for anticipated patient surges due to COVID-19. In late March, I talked with perioperative physicians and administrators from two health systems with rapid increases in COVID-positive cases, which have prompted significant changes in…

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Editor's Note Among the actions announced April 15 by the Food & Drug Administration (FDA) in response to the COVID-19 pandemic are: Issuance of two new emergency use authorizations (EUAs) for serology tests, to detect for presence of coronavirus antibodies, to Ortho-Clinical Diagnostics, Inc, and Chembio Diagnostic systems, Inc. Issuance…

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Editor's Note The Food & Drug Administration (FDA) on April 16 provided an update on a potential treatment for COVID-19, called convalescent plasma, and encouraged those who have recovered from the coronavirus to donate this antibody-rich plasma to help others fight this disease. Patients who have fully recovered for at…

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