FDA issues Emergency Use Authorization to Thermo Fisher On Friday, the FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. The FDA issued an EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive an EUA during … [Read more...]
Henry Schein offers outlook for product availability
March 16, 2020 Henry Schein Chairman and CEO Stanley Bergman told customers in a March 12 letter that the company is working to procure products from existing as well as alternate suppliers, but to expect some product shortages in the weeks ahead. The company is rationing shipments of product to existing customers only, he added. Bergman provided Henry Schein’s outlook … [Read more...]
Coronavirus News – March 13
Johnson & Johnson’s business continuity statement Johnson & Johnson today released a business continuity statement in relation to the COVID-19 pandemic. “Johnson & Johnson is closely monitoring the COVID-19 (coronavirus) situation and taking steps to help prevent the spread of the virus as well as exploring the potential for a vaccine,” the company wrote. “We … [Read more...]
FDA to providers: Be strategic, be safe in your use of surgical masks and gowns
No surprise here: The need for personal protective equipment (e.g., surgical masks, surgical and isolation gowns, and scrub suits) may outpace the supply available to healthcare providers during the COVID-19 outbreak. That word came from the FDA in a March 11 letter to providers. So what are providers to do? First of all, they should RESIST the temptation to toss out all the … [Read more...]
Coronavirus News – March 9
U.S. healthcare conferences disrupted by coronavirus A growing number of conference organizers are cancelling, postponing or transitioning to virtual meetings as the coronavirus spreads across the globe and the U.S. This week’s HIMSS Conference (Orlando, FL) was canceled for the first time in its nearly 60-year history. President Donald Trump was scheduled to speak at … [Read more...]
Coronavirus News – March 6
CMS develops additional code for coronavirus lab tests CMS took additional actions to prepare to respond to COVID-19, developing a second Healthcare Common Procedure Coding System (HCPCS) code that can be used by laboratories to bill for certain COVID-19 diagnostic tests to help increase testing and track new cases. CMS has released new fact sheets that explain Medicare, … [Read more...]
Coronavirus News – March 5
Study to test safety of Moderna vaccine -WSJ Healthy Seattle area volunteers have been asked to participate in the first clinical trial of an experimental coronavirus vaccine developed by biotech company Modera (Cambridge, MA). Kaiser Permanente Washington Health Research Institute (Seattle) aims to enroll 45 adults from the region to determine the safety of various doses of … [Read more...]
Coronavirus News – March 4
World Health Organization urges for 40% in increased production on protective gear The World Health Organization (WHO) has urged manufacturers to urgently increase the production of personal protective equipment (PPE) worldwide. The scarcity of gloves, medical masks, respirators, goggles and face shields are leaving frontline clinicians poorly equipped to encounter COVID-19 … [Read more...]
Coronavirus News – March 3
HSCA statement on Senate HELP committee hearing on the coronavirus HSCA President and CEO Khatereh Calleja released the following statement in conjunction with “An Emerging Disease Threat: How the U.S. is Responding to COVID-19, the Novel Coronavirus,” a hearing before the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP): “HSCA and its member … [Read more...]
Coronavirus News – March 2
Hospital industry wants Congress to quickly pass emergency funding The hospital industry warned policymakers in Washington, D.C., this week that Congress needs to quickly pass emergency funding for the coronavirus crisis and direct some of the funding to plug anticipated gaps in hospital operating budgets. In the event of widespread sickness, costs would soar for isolation … [Read more...]