Supporting regulatory approval for a novel powered respirator
“Wessex AHSN has been a great help, working with us from the start to identify a route through regulatory approval, signposting to potential procurement routes, and spreading the word through webinars, newsletters and personal contacts.
“Wessex AHSN was instrumental in helping us formulate a testing plan for proving out the decontamination instructions which the HSE approved.”
Tom Baynham, Baynhams (PeRSo manufacturer)
Challenge / Problem Identified
Early in the pandemic there was an urgent need for additional sources of PPE to ensure trusts had appropriate levels of protection readily available for staff. This resulted in Trusts individually searching for suitable suppliers with demand exceeding supply, and there were concerns about the quality and reliability of some sources.
It was also becoming clear that staff discomfort wearing masks intended for short-term use and hastily designed face-shields, and the impact these were having on communication with patients, would become unsustainable.
To address these issues a team at Southampton University, University Hospital Southampton and Baynams, a local manufacturer, designed PeRSo – Personal Respirator Southampton. From the outset this was intended to be an open-source, affordable PPE device combining the safety of mask and face-shield, comfortable during extended wear and patient-friendly, able to be built rapidly and at scale from available components. The full-face visor and over-ear hood design improves communication with patients and staff, and makes it suitable for staff using stethoscopes or phones, whilst the fan-driven supply of HEPA-filtered air ensures their safety. Further resources here.
Wessex AHSN were approached by the team to support early development – outline plans had been drawn up but there was no prototype, and no view on how or where the device would fit within PPE guidelines. Critically, there was only limited collective understanding of the fast-changing regulatory pathway.
Wessex AHSN took an active role in the cross-organisational project team. Specifically, they brought in expertise to understand the pathway to regulatory approval, and engaged directly with the British Standards Institution as the notified body to ensure the design met regulatory requirements, including the newly-emerging accelerated conformity assessment process. With ongoing practical support and advice from Wessex AHSN, PeRSo achieved the appropriate CE mark and subsequent HSE approval.
Once launched Wessex AHSN hosted a webinar for health service leads across South of England on the development of PeRSo and its availability for use, and publicised it through its networks. A subsequent information-gathering meeting with NHSE’s Sustainable PPE team was facilitated by Wessex AHSN.
Impacts / Outcomes
PeRSo was a rapid product development and Wessex AHSN played a significant part in accelerating its progress. Key achievements include:
- Receiving regulatory approval – CE mark and HSE approval for use
- Webinar hosted describing the development and availability, with around 80 delegates in senior NHS roles (mainly IPC leads)
- 5,000 units manufactured locally for University Hospital Southampton
- Feedback from staff is excellent
- 15,000 units sold nationally to 30 NHS Trusts
- All training and usage protocols are in place, with validated instructions for use and disinfection to enable re-use
- The manufacturer’s production-line staff were able to return to work by wearing the product they themselves were building
- Open-source plans available on the multi-lingual PeRSo Developing World website for other manufacturers globally to achieve same
- Co-designers awarded MBEs in Queen’s Birthday Honours (Oct 2020) and Royal Academy of Engineering President’s Special Award (Aug 2020) for this work.
The project team has taken an academic idea to commercial design and specification, testing, regulatory approval, training roll-out and spread. It is safe-guarding jobs despite the lockdown, providing local contracts likely to run into £millions, and will almost certainly save the lives of NHS colleagues.
“With the hood on I feel safe to go closer to my patients so I can hear them properly, especially the soft-spoken elderly patients. The response from one of my dementia patients was excellent. I also had a patient who is quite deaf and was a lip-reader. It was difficult to establish care with the surgical mask on. With the hood, since my lips are visible, I was able to improve my care plan whilst working with the patient because he is able to clearly read my lips.”
Future Plans / Next Steps
The project team is now working on improved technical designs with wider applications, including protection of patients being cared for as well as the staff wearing the respirator. Wessex AHSN is supporting this work with both regulatory and market insights.
“PeRSo is a triumph of ingenuity at a time of global adversity and national emergency thanks to the collaborative efforts of like-minded colleagues from across the University of Southampton and key partners from industry.”
Professor Mark Spearing, Vice-President (Research and Enterprise) at the University of Southampton