It gives the deaf or hearing impaired access to full facial expression to aid understanding, setting it apart from the limited number of approved surgical masks with a window over the mouth.
The Panoramic Mio-Mask™ has been given the thumbs up following the NHS England/Improvement Technical Assurance process and Four Nations Review Panel, which aims for high standards of health and social care research.
Experts spent months reviewing product documentation and quality management systems, and mask samples were sent to a clinical reviewer for further specialist feedback.
The mask has already been 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.
It went through a battery of tests which focused on the filtration efficiency, breathability, splash resistance and microbial cleanliness. It underwent visibility tests and independent evaluation of the biocompatibility of its constituent materials.
Work on the mask began in response to a need highlighted by Junior Sister Emma Ayling. She managed a busy Rosie Hospital Outpatient Department, wears hearing aids, and is an accomplished lip-reader.
Other system partners highlighted the clinical need for a transparent mask, but the procurement teams found there was nothing on the market that gave them the level of protection and function required.
Addenbrooke’s Clinical Engineering Innovation Department, headed by Professor Paul White, took on the challenge and design and innovation engineer Abi Bush was appointed project lead with clinical scientist Dr Tom Griffiths, and medical physicist, Dr Hannah Price.
Stakeholder workshops were set up to review various designs and St Neots-based manufacturing partner, LJA Miers - which provides face visors for Addenbrooke’s - gave valuable input to make the mask suitable for mass manufacture.
Abi, who is now joint head of Clinical Engineering Innovation, said: “This was an incredible example of clinical staff, engineers and industry working together to find a practical solution to a very real problem.
“The mask will drastically improve communication between patients and staff, and be of particular use in speech and language and audio clinics where it is important to see mouth movements or lip read.
“We are really grateful to Tony Barber and his team at LJA Miers for their persistence in working through this process, which we are delighted to see come to a successful conclusion.”
Professor White added: “I am incredibly proud of my team, and grateful to our partners, for all that we have achieved at what has been a very challenging time for the NHS.
“In addition to other benefits, the absence of metal component means the mask can be worn by patients and those administering MRI scans, and in operating theatres where communication between surgeons is especially challenging using non-transparent PPE.”
Emma, who shortly takes on the new role of gynaecology matron added: “We are so looking forward to being able to use these masks in a clinical setting where we know they will be much appreciated by patients who reply on lip reading to effectively communicate with others.”
Tony said his company was expecting considerable interest from other hospitals adding: “We are aware of other approved masks that are generally of classic Type IIR design with a small window. Our mask offers a panoramic view of the wearers face, rather than just the lips. The feedback we have had from the hearing impaired who have used our mask shows that the design of the Panoramic Mio-Mask is favoured where lip reading, expressions and facial cues are all essential.”
For more information on the mask email CW@ljamiers.co.uk
