FEMA extends/modifies scarce PPE allocation order
Last week, FEMA issued a temporary final rule
designating specific medical resources exclusively for domestic use to ensure front line healthcare workers have the supplies they need during this pandemic. Through December 31, the rule allows FEMA to review and hold for domestic use: masks (both N-95 respirator and surgical); surgical and exam gloves; as well as isolation and level 3 and 4 surgical gowns.
In related news, the FDA released an updated list of supplies and equipment in short supply
nationally. Per the CARES Act, manufacturers must notify the FDA of discontinuances or delays that impact the country’s supply chain during this public health emergency. PPE supplies, testing equipment and supplies, and ventilator equipment made up the list of shortage items.
Protocol for saliva-based test to be open source
A new saliva-based test
for COVID-19 received emergency use authorization (EUA) from the FDA on Saturday. The new test eliminates the need for specialty kits, which are in short supply.
The SalivaDirect test, developed by the Yale School of Public Health, is authorized for use with different combinations of common reagents and instruments allowing it to be processed in most high-complexity labs. Yale announced that it will provide the protocol as an “open source”, meaning that any designated lab could use the protocol to obtain the needed components and process the SalivaDirect test. In addition, collection of the test specimens can be done in any sterile container and be self-collected by the patient under observation of a health care professional, reducing the risk of transmission.