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Rolls-Royce announced Half Year results on Thursday 1 August 2024.

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The COVID-19 pandemic has led to an unprecedented response from UK industry to support healthcare workers and reduce the risk to their health at work. From start-ups and small family owned companies, to large multinational corporations and Formula 1 teams, all organisations are united in their shared aim to support the NHS and healthcare workers.

In just under a week, a team from Rolls-Royce working with medical specialists from the Royal London Hospital and engineers at The Manufacturing Technology Centre (MTC) in the UK have developed, tested and put a shield into clinical trial. The shield has been developed to reduce the exposure to COVID-19 of front-line healthcare staff undertaking Aerosol Generating Procedures (AGPs) without compromising healthcare delivery. The fast-make prototype activities were supported with funding from Innovate UK.

Evidence from previous viral outbreaks suggests the initial dose and the amount of virus correlates with illness severity. Healthcare workers who undertake AGPs in patients with COVID-19 are at risk of exposure to high viral load due to these procedures. AGPs are medical procedures such as intubation. These procedures have the potential to aerosolise the viral particles found in the patient’s airway exposing the healthcare practitioner to viral load, but also causing contamination of the surrounding environment.

Concept to design

The design concept was a shield for use in AGPs to reduce the healthcare workers’ exposure. This concept was first trialled by a doctor in Taiwan in early March 2020.

Medical specialists found that undertaking AGPs on COVID-19 patients in full surgical PPE inevitably took longer than usual. This is due the time involved in pre-procedure preparation when time was of the essence in many cases. Dr Ian Renfrew, Consultant Interventional Radiologist, with his medical colleagues, sketched preliminary designs of a shield which they provided to the Rolls-Royce team, led by Andy York, to convert into an engineering solution for clinical use. This was the first time the MTC and Rolls-Royce engineers had worked on an engineering solution for the healthcare industry, as they predominantly work together on projects for the aerospace industry.

The design requirements for the shield included:

Visibility of the patient behind a physical barrier with a flexible rear curtain that conforms around the patient
Multiple access points for assisted procedures
Sufficient space for equipment required
Access points for oxygen delivery
Capable of being left in place after the procedure to maintain containment without compromising continued patient care
Re-usable and easily cleaned using standard hospital cleaning materials
Minimal certification requirements to expedite implementation
Scalable
Lightweight

The time from initial design to prototype concept and production for bench trials was a day. Usually this process would take at least a week.

Dr Ian Renfrew, Director of Interventional Radiology, the lead medical specialist whose initial call stimulated the request, commented: “Great to witness the willingness of numerous industrial partners uniting in the best example of multidisciplinary working I’ve seen to bring the AGP Shield to fruition. Thanks also to the early adopters in over 30 hospitals whose feedback and contributions are now creating a growing body of experience that is being shared and documented.”

Design and Prototype testing

Using medical education equipment, from a teaching hospital, the first prototype was tested at the MTC, with guidance and input from doctors from the Royal London, Coventry and Bridgend Hospitals, who joined in person, recognising the current guidelines and virtually. The engineers were taught to intubate using medical simulation models. The team also focused on the ergonomic aspects of undertaking AGPs including the space required for the various items of equipment needed during the procedure, tailoring the solution in real-time.

With the results from the bench trials, further design iterations were completed in collaboration with the existing MTC production supply chain. This was to enable small batch production suitable for testing in a hospital or clinical setting. In parallel guidance was sought from Medicine and Healthcare Products Regulatory Agency (MHRA) and BSI, the UK national standards agency, on the categorisation of the shield. Both organisations were supportive, and the designs comply with their recommendations.

Testing in a clinical setting

The shields produced in the first production batch were distributed to four hospitals, within a week of initiating the project. The MTC/Rolls-Royce team personally delivered each shield, with usage and cleaning instructions, backed up with videos produced by the medical team involved. This enabled each of the four hospitals to quickly implement staff training in the use of the AGP Shield and subsequent trial use in a clinical setting.

Feedback from use of the AGP shield in a clinical setting was overwhelmingly positive with a growing interest from other hospitals. This resulted in a growing demand to produce the AGP Shield at volume from within and outside the UK. The team is using this ongoing feedback to make further improvements to the shield; the latest design, which is 70% lighter and stackable to enable transportation and cleaning, is now ready for dispatch. There are in excess of 200 units in use across 30 hospitals in the UK at present.

Performance assessment of the AGP shield in a computer simulation environment

The shield essentially creates a negative pressure environment where local extraction used in the procedure helps to facilitate the rapid removal of airborne particles including viral particles. ARUP, who provide specialist services to the NHS, performed computational fluid dynamics (CFD) simulations in a 3D theatre environment for the performance assessment of the AGP shield. The CFD simulations show a large (~85%+) reduction in viral load exposure during AGPs. There are plans to publish the results of simulation testing of the AGP shield.

Manufacture

As previously highlighted, initial manufacture was as a small batch utilising the existing MTC production supply chain capability. To scale production volume, the MTC Team redesigned the AGP Shield to enable manufacture using a variety of techniques and materials, based on available resources. The Rolls-Royce team engaged a wider and larger supply chain network, including Aston Martin’s Leather & Trim team to support volume manufacture.

Andy York from Rolls-Royce commented that: “All the staff from the MTC and Rolls-Royce have been fully invested in modifying the initial design to a now scalable, lightweight model. This model can help reduce risk to the health of clinicians such as Ian and his colleagues while they care for patients both in the UK and abroad. The dedication and dynamism of the team has been incredible. This is truly multidisciplinary working and the best of human kindness.”

The MTC has open sourced fabrication versions of the patented design and manufacturing details on its website, enabling global manufacture of the shield. This coupled their own production capability for direct requests for a one-piece lightweight version of the shield, will help reduce the exposure risk of healthcare workers undertaking AGPs as they care for patient with COVID-19 in their communities.

The MTC have started work on customised versions of the AGP shield for use in other clinical settings beyond anaesthesia such as dentistry and endoscopy.

If you are interested in understanding more about the project and the MTC, and/or wish to request an AGP shield or access the design documents please visit the MTC website: http://www.the-mtc.org/news-items/intubation-shield-supporting-our-frontline-nhs-workers