Advocacy Updates

06/29/2020

FDA Updates List of Authorized Ventilators under Umbrella EUA

The FDA has updated the list of authorized ventilator, ventilator tubing connector, and ventilator accessory products that meet the criteria for the umbrella emergency use authorization (EUA) to expand availability of ventilators to treat COVID-19 patients. The umbrella EUA was issued in March 2020. Read the EUA and the updated Appendix B list of authorized … Continue reading “FDA Updates List of Authorized Ventilators under Umbrella EUA”

06/29/2020

FDA Warns Curativa Bay Corp about Fraudulent COVID-19 Products

The FDA sent a warning letter to Curativa Bay Corporation to cease sale of Advanced Hypochlorous Skin Spray, a topical hypochlorous acid-containing product which is intended to mitigate, prevent, treat, diagnose, or cure COVID-19. FDA reminds consumers that there are currently no FDA-approved products to prevent or treat COVID-19. Read the FDA warning letter.

06/29/2020

FDA Letter to HCP and Lab Staff: Stop Using Certain COVID-19 Antibody Tests

The FDA issued a letter to clinical laboratories and healthcare providers recommending that they stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage.  The “removed” test list includes: tests where significant clinical performance problems were identified that cannot be or have not been … Continue reading “FDA Letter to HCP and Lab Staff: Stop Using Certain COVID-19 Antibody Tests”

06/18/2020

FDA Revokes EUA for Chembio Antibody Test

The FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Read the FDA statement.

06/18/2020

Webinar June 24: Treating COVID-19

Continuing education units will be available for the webinar, “Learning to Treat COVID-19: Clinical Trials and Developing Therapeutics During a Pandemic.” The webinar, sponsored by the National Academy of Medicine and the American Public Health Association, will discuss how clinicians are learning to treat COVID-19. It will include presentations on how scientists have adapted clinical trials … Continue reading “Webinar June 24: Treating COVID-19”

06/18/2020

Joint Commission Resumes Limited Surveys

The Joint Commission (TJC) resumed limited survey activities this month. The primary focus will be on elements of performance related to inspection, testing, and maintenance of equipment and utilities that could raise serious safety concerns during the public health emergency. Read the TJC announcement.

06/18/2020

FDA Issues Warnings to Fraudulent COVID-19 Test Manufacturers

The U.S. FDA has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely … Continue reading “FDA Issues Warnings to Fraudulent COVID-19 Test Manufacturers”

06/16/2020

APIC Provides Comments on NHSN COVID-19 Module

APIC responded to a request for comments on CDC’s NHSN COVID-19 Patient Impact Module. The information request is used to assess the necessity, quality, utility, cost, and burden to the user of the module. Read APIC’s comments.

06/15/2020

CMS Nursing Home Training Series Update

This week’s topic for the weekly CMS National Nursing Home Training Series is “Clinical Care: Managing COVID-Positive Residents.” The webinar will be Thursday, June 18 at 4-5 pm Eastern time. Register for the webinar.

06/15/2020

FDA Warns of Potential Drug Interaction with Remdesivir

The FDA is warning healthcare providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the … Continue reading “FDA Warns of Potential Drug Interaction with Remdesivir”