The US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for Self-Contained Negative-Pressure Environments (SCONE) device to prevent the spread of transmissible diseases.

SCONE is an advanced technology developed by SCONE Medical Solutions (SMS) in partnership with Mayo Clinic to contain infectious diseases in hospitals.

The device works to minimise the risk of infectious transmission for health care workers (HCWs) during Aerosol Generating Procedures (AGPs), specifically in the acute care/triage setting, said the company.

With the FDA granting EUA, SMS is currently manufacturing the SCONE devices in the US, with plans to commence the distribution across the country by the end of this year.

SCONE Medical Solutions CEO Mike Adams said: “We are pleased to collaborate with Mayo Clinic experts as we bring the SCONE device to market. The demand for barrier protection in hospitals has shown itself in a substantial way during this pandemic.

“The SCONE works not only as a protective barrier, but through the use of negative-pressure, actively reduces the spread of pathogenic aerosolized particulates that cause diseases like Covid-19.”

SCONE device designed for quick deployment and disposal

The company said that its SCONE device is designed to be quickly deployed for use and quickly disposed of after treatment.

According to the company, the small capacity, low cost, disposable device leverages negative pressure to pump out the aerosols emitted around a patient’s head and neck, and adds an extra layer of active barrier protection for healthcare workers while treating potentially infectious patients.

The SMS team has advanced the designing, developing, and testing of the new SCONE device during the spring of 2020, and was ready to launch a full-scale manufacturing process in North Carolina, since the fall of 2020.

The SCONE device reduces the burden on hospitals by providing small-capacity negative pressure units that facilitate safe treatment, triage, and patient transport, said the company.

SCONE chief medical officer Brandon Lawrence said: “The widespread demand from HCWs for barrier protection devices, even the old ones without negative pressure, was overwhelming during the start of the pandemic.

“Adding negative-pressure technology allows patients to be more safely placed on CPAP/BIPAP, receive aerosolized nebulizer treatments, undergo emergent procedures if their Covid-19 status is unknown, and possibly allow end of life care visits with family.”