Somnetics Gets FDA Emergency Use Authorization for BiPAPs and Respiratory Circuits
Makers of the Transcend line of positive airway pressure devices for sleep apnea, Somnetics International Inc has received authorization from the US Food and Drug Administration (FDA) for the immediate distribution of BiPAP machines and respiratory circuits to medical facilities for use in the fight against COVID-19 under the Emergency Use Authorization (EUA) issued by the FDA.
The Minnesota-based CPAP manufacturer is supporting local and regional medical communities with an emergency supply of EUA BiPAP devices purchased by the state of Minnesota and South Dakota medical facilities. The company is prepared to supply the healthcare system nationwide as it works to quickly produce as many BiPAP machines as possible.
“We believe it’s our responsibility to do everything we can to support the medical community with the vital medical supplies they need during this time of crisis, and we are diverting production to this effort,” says Clarence Johnson, CEO of Somnetics, in a release. “It’s our honor, as well as our obligation, to provide this support to medical care providers fighting on the front line to manage this public health crisis.”
As the healthcare system battles a surge of COVID-19 patients, experts predict there will be a shortage of critically needed mechanical ventilators. Although ventilator manufacturers have increased production of these devices, they are not expected to meet the surging demand.
Somnetics has responded to these concerns by repurposing its Transcend CPAP machines into EUA BiPAP machines to assist patients that have trouble breathing as a result of the COVID-19 virus. The Somnetics team of engineers has also designed a new breathing circuit for use with its EUA BiPAP device to help control aerosolization of virus particles to help protect healthcare workers.
Medical experts have recently recommended less reliance on invasive ventilation for the treatment of COVID-19 patients, as some physicians have expressed concerns that hospitals have been too quick to adopt this treatment. Some physicians have suggested, instead, using a phased approach to treatment with the use of non-invasive ventilators, such as those provided by Somnetics.
The FDA issued the EUA, dated March 24, 2020, authorizing the emergency use of continuous positive airway pressure machines (CPAPs)—like those Somnetics has repurposed—in healthcare settings to treat patients during the COVID-19 pandemic. While the FDA has not granted traditional clearance or approval for the Somnetics BiPAP machines, it has authorized the use of these devices by medical facilities for the duration of the EUA for ventilators during the COVID-19 pandemic.
from Sleep Review https://www.sleepreviewmag.com/sleep-treatments/therapy-devices/cpap-pap-devices/somnetics-gets-fda-emergency-use-authorization-for-bipaps-and-respiratory-circuits/