ECRI and the FDA have each taken respective steps to help providers manage and protect patients and staff against the coronavirus

ECRI and FDA step up against coronavirus epidemic

February 07, 2020
by John R. Fischer, Senior Reporter
A number of healthcare organizations are taking action to address and protect individuals from the novel coronavirus epidemic, which has affected thousands worldwide and cost close to 500 their lives.

Among these organizations is the ECRI Institute, which has developed a Coronavirus Outbreak Preparedness Center to help hospitals protect healthcare workers and patients from the epidemic.

“If the staff and community know healthcare practitioners are prepared, they will feel safer, thus alleviating anxiety,” James Davis, senior infection prevention and patient safety analyst/consultant at ECRI Institute, told HCB News. “For internal and external responders (nurses, docs, ems, etc.), fear is alleviated through drilling and testing the system. Identify the weaknesses and implement solutions. Our healthcare stakeholders have all learned a lot form SARS, Mers-CoV, Ebola, and the flu and they will learn and adapt with this threat as well.”

Originating within Wuhan City in the Hubei province of China, the disease has been nicknamed the “Wuhan coronavirus” and the “novel coronavirus”. It belongs to the same family of viruses as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). The World Health Organization first detected its presence in December when it was made aware of several cases of a respiratory illness clinically resembling viral pneumonia.

It recently declared it to be an epidemic that has affected at least 24,000 in China to date, as well as individuals in other countries, according to NBC News. A twelfth case was recently confirmed in the U.S., with the first instance of person-to-person spread confirmed on January 30. The result has led countries to suspend flights to China, due to most reported cases outside of China being linked to residence in or travel to Wuhan. It should be noted, however, that federal health official continue to believe the threat to the general American population is relatively low.

The center offers a variety of resources to the public for free, with no membership or other payment required. Among them are preparation and patient handling checklists; equipment and alternative suppliers; patient care equipment evaluations, including portable ventilators; recommendations for infection control; and resources from Centers for Disease Control and World Health Organization.

“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.

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