The Food and Drug Administration has issued a warning letter to Battelle Memorial Institute, the manufacturer of a decontamination unit for N95 masks that North Dakota is using.
North Dakota was among several states that received one of 60 decontamination units for N95 masks that were distributed nationwide by the federal government. Their operation is funded by the federal government, as is the staff to operate them.
The warning letter that FDA sent out chastised Battelle for not having the proper procedures in place for reporting adverse events to the FDA. Those reports are integral to the emergency authorization procedure to ensure authorization of the systems remains safe and appropriate.
Reportable events include things like allergic reactions or irritation to eye, mouth, or nasal tissues, adverse reactions to hydrogen peroxide residuals, loss of the respirator’s shape or other problems that cause a decontaminated respirator to no longer perform its essential function, infection in respirator wearers, or malfunctions of the generator used to decontaminate the respirators.
The warning letter gave Battelle 15 days to address the situation.
North Dakota Department of Health Section Chief for Health Resources and Response Tim Wiedrich said the state so far has had no reports of issues with the Battelle system.
“We had some isolated reports of some of the masks having some odor to them,” he said. “But nothing resulting in any issues.”
North Dakota received its Battelle system in April after the device received an emergency authorization from the FDA.
It can decontaminate up to 10,000 N95 masks at once using a hydrogen peroxide system under pressure. The company says masks can survive up to three rounds of this type of decontamination without loss of fit or function.
North Dakota has been using it to decontaminate masks at no charge for health care organizations, EMS agencies, public health, public safety agencies, funeral homes, dental offices, optometry and chiropractic clinics, and so forth.
Health care professionals and consumers should report any adverse events related to the devices to the FDA using its Adverse Event Reporting System, online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
Here are other things to know about COVID-19 this week:
Bioscience innovation grants awarded
An at-home antibody test and nanodisc-based anti-SARS-CoV-2 vaccines were among bioscience projects receiving $577,800 in grants from North Dakota to advance coronavirus research in the state.
The grants were part of an overall $5 million allocated earlier this year to advance coronavirus research, the bulk of which was awarded by a committee led by North Dakota Department of Agriculture Commissioner Doug Goehring earlier this year in July.
Companies receiving grants this time around included:
Biomed Protection ND, LLC — $45,000 for development of an electronic biology-based computational platform to design diagnostics to detect autoimmunity in COVID-19 patients
• Genovac Antibody Discovery, LLC — $412,800 for the rapid development of novel Nanodisc-based anti-SARS-CoV-2 vaccines and multiple target antibodies for diagnostics and therapeutics
• Checkable Medical, Inc. — $40,000 for development of a COVID-19 at-home rapid antibody test and clarity diagnostics
• Core Health Strategies — $30,000 for research into Bovine Interleukin-10 as a primary suppressor of the Cytokine Storm Cascade in patients with COVID-19
• Core Health Strategies — $50,000 to develop an Immunological Wellness Program for COVID-19
Telemedicine, other grants coming
The US Department of Agriculture awarded $985,399 to Avera Health to make upgrades to telemedicine software.
The upgrades are planned for several counties in the state including Williams County. Other counties include Bowman, Cavalier, Divide, Grant, McIntosh, Mountrail, Nelson, Ramsey, Towner, Walsh, Ward, and Wells Counties.
The Federal Emergency Management Agency (FEMA) also awarded $10.6 million to the North Dakota Department of Health under the Stafford Act. It will be used by for expenses related to coronavirus disease 2019 (COVID-19) response efforts, including increased testing, laboratory capacity, supplies, software and warehousing facilities.
CDC affirms airborne transmission of virus
While the CDC is still maintaining the primary means of transmitting COVID-19 is between people in close contact with one another, it has confirmed that coronavirus can be spread through airborne particles that can linger in the air for minutes or even hours, even among those who are more than 6 feet apart.
This airborne transmission means ventilation of enclosed spaces is also important, along with wearing masks indoors, for slowing the transmission of coronavirus to help preserve hospital capacity.