OR leaders chart new territory for resuming elective surgery
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…
FDA issues guidance to prevent device shortages during COVID-19 pandemic
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…
Siemens Healthineers’ COVID-19 assay given approval for use in Europe
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…
Triaging OR capacity amid COVID-19: Lessons from the field
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…
FDA updates actions taken in response to COVID-19
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…
FDA encourages recovered COVID-19 patients to donate plasma for development of therapies
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…
Safe Flight Instrument Corporation creates ventilator splitter
Editor's Note Safe Flight Instrument Corporation (White Plains, New York), a company that develops aircraft safety and performance technology, has developed the Quad/Vent Splitter that allows four patients to use one ventilator simultaneously, the April 13 Aviation International News Online reports. Using 3-D printing, the device has four independent ports…
FDA issues COVID-19 update
Editor's Note The Food & Drug Administration (FDA) on April 7 issued an update on actions the agency has taken in its ongoing response to the COVID-19 pandemic. The actions include: a guidance for remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider…
HHS: FDA issues emergency authorization of anti-malaria drugs for COVID-19 treatment
Editor's Note The Department of Health and Human Services (HHS) announced on March 29 that the Food & Drug Administration (FDA) had issued an emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19. The FDA allowed for the drugs to be “donated to the Strategic National Stockpile…
FDA acts to increase COVID-19 supplies with instructions for manufacturers importing PPE, devices
Editor's Note The Food & Drug Administration (FDA) on March 24 took action to increase US supplies in response to the COVID-19 pandemic by providing instructions to manufacturers importing personal protective equipment (PPE) and other devices. The instructions to manufacturers clarify the types of PPE and devices they can import…
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