ECRI and FDA step up against coronavirus epidemic

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ECRI and FDA step up against coronavirus epidemic

John R. Fischer, Senior Reporter | February 07, 2020
Emergency Medicine

“In terms of emotional and spiritual support, we also recommend including resources for staff and the community, such as involving pastoral care, psychology, team building, and crisis resources, and adapt them to the current risks,” said Davis, adding that ECRI also recommends “that healthcare providers evaluate the source of information, and seek trusted resources, like ECRI, the CDC, CIDRAP, and your local and state health departments.”

Another organization lending a hand is the FDA, which has issued an emergency use authorization (EUA) for CDC-qualified labs across the country to make emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel.

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Only allowed in CDC laboratories prior to the EUA, the 2019-nCoV Real-Time RT-PCR Diagnostic Panel is a reverse transcriptase polymerase chain reaction (PCR) test that confirms the presence of the novel coronavirus through nasal or oral swabs of respiratory secretions. Positive findings indicate likely infection, with patients told to consult their healthcare providers about managing symptoms and how best to protect people around them. Negative results, however, do not mean that a person is not infected and must be combined with clinical observations, patient history and epidemiological information.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S. government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Dr. Stephen M. Hahn in a statement. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test.

In accordance with the EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high-complexity tests.

ECRI plans to add more evidence-based resources for the public as the epidemic evolves. More information on the center can be found at

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