Medical grade transparent face masks receive DHSC approval

South Yorkshire manufacturer, Bluetree Medical, is the first UK manufacturer to achieve approval from the four home nations’ and DHSC for two medical grade transparent face masks: BrillianSee and Visib.  

The four home nations and Department for Health and Social Care (DHSC) have approved two of Bluetree Medical’s innovative transparent face masks for medical use, as part of its Dynamic Purchasing System (DPS) pilot. 

The BrillianSee and Visib masks offer improved communication compared with traditional Type IIR medical use masks because they provide visibility of facial expressions, allowing for improved reading and interpretation of non-verbal cues. Better communication in healthcare settings improves safety, patient outcomes and inclusion for everyone. 

Around half of Brits (46%) are believed to lip read as part of everyday communication, with a third stating seeing whole faces makes them feel more comfortable (29%). A recent 2,000 person survey on face mask wearing found 26% of people believe they miss important information; 23% say they have difficulty understanding when they can’t read lips and 22% put it down to not seeing the whole facial expression. This is particularly important in a healthcare setting, where doctors and nurses may have limited time to relay information to their patients. 

BrillianSee was developed in partnership with Alder Hey Children’s NHS Foundation Trust, after speech & language therapist, Wendy Blumenow, found children in her care had difficulties in her speech therapy classes because they could not see her face during therapy sessions. Compared with other transparent masks, BrillianSee provides much greater visibility whilst allowing for unencumbered movement of the lower face. The masks have been used by numerous departments across Alder Hey to date, but the Trust is thrilled that usage can now expand to medical use settings.  

Iain Hennessey, consultant paediatric and neonatal surgeon and clinical director of the Innovation Hub at Alder Hey said: “Transparent masks improve communication between everyone, not just in people who rely on lip reading. As we now pay more attention to the personal protective equipment we wear in healthcare, we have to think how it can be improved, making masks transparent is one of those steps” 

Visib was developed in partnership with a professor of otology and neurotology at University of Sheffield, and consultant ENT surgeon at Sheffield Teaching Hospitals.  

The professor said “With 1 in 4 adults projected to have some form of hearing loss by 2050i, Visib is a game-changer in the world of medical grade facemasks. The transparent window is large enough to provide clear visibility of the mouth, enabling lip reading and emotional cues. And Visib is extremely comfortable for the wearer, without fogging or looking alien. Mask wearing is set to continue in healthcare settings for the considerable future, and Visib ensures that healthcare provision is inclusive for all.” 

Jon Constantine-Smith, managing director, Bluetree Medical comments “We’re incredibly proud that not one, but two of our innovative transparent masks have received DHSC approval, providing better healthcare experiences for many more patients and providers. One of Bluetree Medical’s key strengths is to ensure healthcare professionals are integral to product development and testing, ensuring products such as BrillianSee and Visib can be developed and address unmet needs.” 

A statement from Paul Chivers, head of PPE innovation & sustainability read; “Congratulations Bluetree Medical for all their hard work and responsiveness to requests for documentation, clarification and further submissions in response to TRA requests when assessing their transparent products; BrillianSee and VISIB, against the Transparent Face Mask Specification, as listed on Gov.UK and with the MHRA Essential Health & Safety Requirements (EHSR). 

"Following the 4 Nations Review Panel (4NRP) on Tue 26/07/2022, I’m delighted to say that both the BrillianSee mask and the VISIB mask are now compliant against the Transparent Face Mask Specification and with the MHRA EHSR.” 

Bluetree Medical, based in Wath upon Dearne, near Rotherham, South Yorkshire, researches, develops and manufactures high quality medical consumables. The first UK manufacturer to deliver Type IIR surgical masks to the NHS during the pandemic, Bluetree has invested over £18m in establishing its UK based manufacturing facility which includes an onsite laboratory and in-house meltblown production. Bluetree is an innovator, investing time collaborating with the NHS and health care professionals to develop products that truly meet the needs of their users.  

The products are UKCA and CE marked medical devices registered with the MHRA and offer protection comparable to a Type IIR surgical mask.