Addenbrooke's clear COVID mask secures CE mark
The development of a clear facemask designed by the clinical engineering innovation team at Addenbrooke’s Hospital in Cambridge has passed another major milestone – and will help in the fight against COVID-19.
The mask is now officially registered with the Medicines and Healthcare Regulatory Agency (MHRA) as a CE marked medical mask, meaning it conforms to health, safety, and environmental protection standards in Europe.
Now registered the mask can be utilised by other hospitals, care homes, and primary care in this country and Europe. It could be attractive to countries worldwide if it can be proved to also meet their standards.
The Panoramic Mio-Mask includes the same level of bacterial filtration and splash protection as the blue surgical masks most commonly worn in medical settings.
Once in production the mask, which is clear at the top with three-ply polypropylene filter material below the chin, will drastically improve communication between patients and staff who are hard of hearing, and be of particular use in speech and language and audio clinics where it is important to see mouth movements or lip read.
The absence of metal component means it can be worn by patients and those administering MRI scans, and in operating theatres where communication between surgeons is especially challenging using non-clear PPE.
Work on the mask started last April in Addenbrooke’s clinical engineering department led by Professor Paul White. The project was in response to a need highlighted by junior sister, Emma Ayling, who manages a busy outpatient department, wears hearing aids, and is an accomplished lip-reader.
NHS England (NHSE), and other system partners also highlighted the clinical need for a clear mask, but the procurement teams found there was nothing on the market that gave them the level of protection and function required.
Stakeholder design workshops were set up to review the advantages and disadvantages of seven designs and national face measurement data, known as anthropometric measurements, was used to optimise facemask size.
The work was made possible thanks to manufacturing partner, LJA Miers. The Trust has worked with the company on a number of projects since the start of COVID-19, notably on the manufacture of face visors, and LJA Miers will be the legal manufacturer of the Panoramic Mio-Mask mask.
Professor White, said: “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."
Design and innovation engineer, Abi Bush, who led on the project with clinical scientist Dr. Tom Griffiths, and medical physicist, Dr. Hannah Price, said: “Achieving CE marking is a really important step for us and makes all the work worthwhile. It has been a massive team effort.”