Healthcare Provider COVID-19 Info
Healthcare Provider COVID-19 Information
- FEMA compiled the best practices and lessons learned that communities have already faced fighting COVID-19. FEMA will continue to add content and highlight key areas where communities can benefit from learning. To learn more about Coronavirus Emergency Management Best Practices, click here.
FBI and CISA issued a warning to organizations researching COVID-19 of the likely targeting and network compromise by the People’s Republic of China. The guidance warned health care, pharmaceutical, and research sectors working on COVID-19 response that they are the prime targets of activity and should protect their systems. (Here)
- Crisis Text Line recently launched “For the Frontlines” to support health care professionals and essential workers on the front lines of the pandemic who are risking their health every day to help other people. Now these workers can access fast, free 24/7 crisis counseling simply by texting “FRONTLINE” TO 741741. To learn more, click here.
For Updated Information for Blood Establishments Regarding the Novel Coronavirus (COVID-19) Outbreak, click here (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-blood-establishments-regarding-novel-coronavirus-covid-19-outbreak)
FDA issued an Emergency Use Authorization for the Ascom telecare IP Nurse Call System for use by health care providers and patients in health care environments, including temporary hospital facilities, to facilitate remote communication between patients and health care providers. This may reduce the amount of contact by health care providers with patients who are in isolation rooms, thereby reducing health care provider risk of exposure to SARS-CoV-2. (Here)
FDA provided new guidance documents that aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety. One guidance outlines a more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. The second guidance provides the FDA’s current recommendations on later state clinical trials intended to establish safety and effectiveness for COVID-19 products. To date, more than 130 clinical trials of potential COVID-19 related drugs and biological products are underway with FDA oversight. (Here)
FDA issued an Emergency Use Authorization for use of the Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients older than 16 who require mechanical ventilation in an ICU during the COVID-19 public health emergency. The virus that causes COVID-19 has led to an increased number of people with severe respiratory illness. As a result, there is a shortage of FDA-approved drugs such as propofol that are used for sedation of mechanically ventilated patients. (Here)
FDA approved two Abbreviated New Drug Applications, one indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and another indicated for mild to moderate infections caused by designated, susceptible, bacteria that cause certain sexually transmitted diseases and mycobacterial infections. Both ANDAs are relevant to COVID-19, and both medicines are listed in the FDA Drug Shortage Database. (Here)
FDA issued a revised Emergency Use Authorization for disposable filtering facepiece respirators manufactured in China that do not meet NIOSH standards. FDA is concerned that certain filtering facepiece respirators manufactured in China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19. These concerns are based on test results from NIOSH showing that some of these respirators did not meet the expected performance criteria of greater than or equal to 95 percent particulate efficiency. (Here)
HHS has extended the deadline for health care providers to attest to receipt of payments from the Provider Relief Fund and accept the Terms and Conditions. Providers will now have 45 days, increased from 30 days, from the date they receive a payment to attest the Terms and Conditions or return the funds. With the extension, not returning the payment within 45 days of receipt of payment will be viewed as acceptance of the Terms and Conditions. (Here)
CMS released a new toolkit developed to aid nursing homes, Governors, states, departments of health, and other agencies who provide oversight and assistance to these facilities, with detailed resources and direction for quality improvement assistance. The toolkit can also help in the creation and implementation of strategies and interventions intended to manage and prevent the spread of COVID-19 within nursing homes. CMS has also contracted with 12 Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs) to work with nursing homes across the country on data-driven quality improvement initiatives designed to improve the quality of care for beneficiaries across the United States. (Here)
The U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The FDA is sharing early information available about potential inaccurate results in the spirit of transparency. The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test.
The FDA looks at a variety of sources to identify and understand potential patterns or significant issues with the use of the Abbott test. No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly.
The agency is aware of some scientific studies that have identified accuracy issues with Abbott ID NOW and is investigating whether it could be due to the types of swabs used or the type of viral transport media (material used to transport the patient’s specimen). While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use, an important part of scientific research. This is why external scientific studies are one part of the FDA’s overall evaluation of a diagnostic performance.
The FDA has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency is reviewing these reports. It’s important to note that the adverse event reports the FDA receives from manufacturers, health care providers, health care facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.
Moving forward, Abbott has agreed to conduct post-market studies for the ID NOW device that each will include at least 150 COVID-19 positive patients in a variety of clinical settings. The FDA will continue to review interim data on an ongoing basis. The information gathered from the post-market studies can further help the agency understand the cause or patterns of any accuracy issues and inform any additional actions the company or the FDA should take.
The FDA will keep working with Abbott to further evaluate these accuracy issues and will publicly communicate any updates.Consumers or healthcare providers can reach Abbott directly at (224) 667-6100 or by email