NEWS 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 components means it can be worn by patients and those administering
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, were used to optimise facemask size.
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
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.”
COVID-19 pandemic worsened pregnancy outcomes
Pregnancy outcomes for mothers and babies have worsened during the COVID-19 pandemic, according to a review of data from 40 studies representing 17 countries. Findings varied by country but analysis of pooled data showed stillbirth and maternal mortality rates increased by approximately one-third during the pandemic compared to life before COVID-19 took hold (stillbirth rates: during pandemic 1099/168,295 pregnancies vs before pandemic 1325/ 198,993 pregnancies; maternal mortality rates: during pandemic 530/1,237,018 pregnancies vs pre-pandemic 698/ 2,224,859 pregnancies).
Mental health outcomes also worsened during the pandemic. Of the 10 studies included in the analysis that reported on maternal mental health, six reported an increase in postnatal depression, maternal anxiety, or both.
Overall, outcomes were worse in low- and middle-income countries, compared to high- income countries, and the researchers say immediate action is required to preserve safe maternity care worldwide, especially during the global emergency.
Although the study did not analyse
deaths and disease caused by the virus itself. “It is clear from our study and others that the disruption caused by the pandemic has led to the avoidable deaths of both mothers and babies, especially in low- and middle- income countries. We urge policymakers and healthcare leaders to prioritise safe, accessible, and equitable maternity care within the strategic response to the pandemic and aftermath, to reduce adverse pregnancy outcomes worldwide.” Dr. Erkan Kalafat, a co-author of the study
the impact of COVID-19 infection during pregnancy, it provides the first global assessment of the collateral impact of the pandemic on antenatal, birth, and postnatal outcomes. Professor Asma Khalil, lead author of the
study, of St George’s University of London, said: “The COVID-19 pandemic has had a profound impact on healthcare systems around the world. Disruption to services, nationwide lockdowns, and fear of attending healthcare facilities mean that the adverse effects of COVID-19 are expected to have health consequences that extend beyond the
10 l
WWW.CLINICALSERVICESJOURNAL.COM
from Koc University, Turkey, said: “We have an unprecedented opportunity to learn from the experiences of the COVID-19 pandemic to plan for a future of inclusive and equitable maternity care worldwide. One such learning opportunity will be to investigate the mechanisms underlying the apparent reduction in pre-term births observed in high-income settings during the pandemic, with a view to identifying new preventative interventions that could potentially benefit all women worldwide.”
The findings were published in The
Lancet Global Health journal. http://www.
thelancet.com/journals/langlo/article/ PIIS2214-109X(21)00079-6/fulltext
MAY 2021
©Natalya Lys -
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