NIOSH eyes EHMR usage in lieu of N95 masks
The U.S. National Institute of Occupational Safety and Health (NIOSH) has posted a request for information regarding the use of elastomeric half-mask respirators (EHMRs) in health care settings and during the provision of emergency medical services in lieu of N95 masks. EHMRs are those devices that use replaceable filters or cartridges to meet the same level of protection as provided by N95 masks, and NIOSH noted that it had broached the subject in 2018, although the notice advises that such masks are not deemed medical devices under the 1976 or any subsequent amendments to the Food, Drug and Cosmetic Act. Health care professionals have used EHMRs when N95 shortages arose, and hospital administrators are said to have indicated that these masks are inexpensive, easy to use, and can be reprocessed. The proposal would be to add EHMRs to the list of items to be added to the U.S. Strategic National Stockpile for provision to health care institutions in fixed numbers. NIOSH, a division of the CDC, is taking comment through Oct. 14.
CDC announces date for clinical lab improvement adcomm
The U.S. CDC said it will convene a two-day meeting of the clinical lab improvement advisory committee, which will be largely focused on testing in the context of the COVID-19 pandemic. The Oct. 28-29 meeting will be convened electronically (http://www.cdc.gov/cliac) and will include updates from the FDA and the Centers for Medicare and Medicaid Services. Parties who wish to present during the hearings should contact the CDC at least five days prior to the meeting at CLIAC@cdc.gov.
House members press FDA on testing standards
A group of members of the U.S. House of Representatives have penned a Sept. 10 letter to the FDA requesting that the agency provide expedited authorization and lower sensitivity standards for rapid antigen tests for the SARS-CoV-2 virus. The legislators, including Rep. Ro Khanna (D-Calif.), noted that several developers have advanced lateral flow assay strips that would allow home testing with a test turnaround time of 15 minutes. The potential price point of $1 per strip suggests that the strips could be mass produced and distributed with the potential to allow daily testing or testing on alternating days. The letter presses the case for a “broad public health strategy that allows for consistent monitoring of institutions and communities,” and that the current sensitivity standards for polymerase chain reaction diagnostic testing is unduly burdensome and suppresses effective surveillance testing. They also recommended that the FDA and other federal agencies undertake a public information campaign to broaden awareness of the differences between diagnostic and surveillance/screening testing.