Editor's Note: The Centers for Disease Control and Prevention on May 8 updated it weekly surveillance summary of COVID-19 activity in the US for week 18. Among the updates: The percentage of specimens testing positive for SARS-CoV-2 decreased at public health, commercial, and clinical laboratories. Labs have confirmed 832,238 positive…
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…
Editor's Note The Centers for Disease Control and Prevention (CDC) on May 1 announced the launch of the “SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES)” consortium. This network of laboratories will speed the release of SARS-CoV-2 sequence data into the public domain for use by public…
Editor's Note The Centers for Disease Control and Prevention on May 1 updated its weekly surveillance summary of COVID-19 activity in the US ending April 25. Among the updates: The percentage of specimens testing positive for SARS-CoV-2 decreased at public health and commercial laboratories and remained similar at clinical labs.…
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…
Editor's Note The Occupational Safety and Health Administration (OSHA) on April 24 issued interim guidance on the reuse and decontamination of N95 and other filtering-facepiece respirators during the COVID-19 pandemic. OSHA notes that the National Institute for Occupational Safety and Health (NIOSH) has identified research that suggests the following methods…
Editor's Note The Joint Commission on April 23 announced that it supports the Centers for Disease Control and Prevention’s new recommendations that healthcare facilities “. . . implement source control for everyone entering a healthcare facility (eg, healthcare personnel, patients, visitors), regardless of symptoms . . .” Source control involves…
Editor's Note: The Centers for Medicare & Medicaid Services (CMS) on April 19 issued recommendations on how hospitals and healthcare systems can protect their staff and patients as they reopen for nonemergent care. The new recommendations update earlier guidance on limiting nonessential surgical and medical procedures and are specifically targeted…
Editor's Note The Centers for Disease Control and Prevention (CDC) on April 14 released a Morbidity and Mortality Weekly Report on the characteristics of healthcare workers (HCW) with COVID-19 in the US. From February 12 to April 9, 2020, there were 9,282 cases of COVID-19 reported among HCWs. The median…
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…