Addenbrooke’s Hospital registers CE mark for clear COVID mask

Addenbrooke’s Hospital in Cambridge has officially registered its clear COVID face mask as a CE marked medical mask with the Medicines and Healthcare Regulatory Agency (MHRA).

Developed and designed by the hospital’s Clinical Engineering Innovation team, the Panoramic Mio-Mask™ now officially conforms to health, safety, and environmental protection standards in Europe.

That official registration means the clear mask can also be used by other hospitals, care homes, and primary care providers across the UK and the European mainland.

The mask has the same level of bacterial filtration and splash protection as blue surgical masks but is clear at the top, with three-ply polypropylene filter material below the chin. It also features an anti-fog membrane and, as it contains no metal, it can also be worn during MRI scans and in operating theatres.

It’s hoped that the medical covering will improve communication between patients and staff, particularly for those who are hard of hearing or work in speech and language clinics, where the ability to lip read or see mouth movements is important.

The clear PPE began to be developed last April after a staff member, Junior Sister Emma Ayling, highlighted the need and lack of an existing product. She said of the results: “Within Gynaecology, we undertake outpatient diagnostic services as well as consultations. I am able to lip-read patients and staff wearing the clear mask, optimising my level of care, compassion and communication.”

Clinical Engineering department lead, Professor Paul White, added: “This is another example of how my team is able to develop an unmet clinical need by working with clinicians and nursing staff at CUH, and linking with industry.

“There has been a need for a clear mask, which meets our functional, bacterial and viral requirements, across the whole health and care system since the start of the pandemic last March.

“The mask has now gone through clinical evaluation, and independent viral and bacterial testing. It could be used across the NHS and Europe and there is no reason why it could not be used worldwide, with appropriate regulatory approval.”

Manufacturing partner, LJA Miers, also helped to make the mask suitable for mass manufacture. The company’s commercial director, Tony Barber, said it “completely repurposed its facilities at the start of COVID-19 to assist with the supply of visors” and was “delighted” to be doing its part in the fight against COVID-19.

See how the face mask works in the NHS video below: