Written evidence submitted by Big Pharma, UK advanced manufacturers, UK NHS Medical Professionals various and others, HPAPI Project Services Limited, JJP Protection Limited (CLL0031)

Sir/Madam

I head a small ad-hoc but highly expert small group of individuals who have been working pro-bono since March 2020 to try and bring our unique experience to bear, primarily to protect healthcare workers for their own health reasons, but also to preserve them and liberate them to provide healthcare for us all.

We are potent drug and highly potent drug occupational health and safety globally recognised experts.  We spend our professional time doing all the things, from
A to Z, designed to protect healthy workers from exposure to high-hazard pharmaceutical substances.  We chair conferences, present at conferences and publish in this specialist and niche area.  We are consultancy limited companies, big pharma employees, medical doctors and UK and USA advanced manufacturing companies capable of delivering the technology described below at scale and immediately.

The COVID-19 pandemic has created direct exposure risk for healthcare professionals including doctors, nurses, dentists, dental hygienists, emergency response personnel, medical technicians, care home, hospice and support staff that must deal with infectious and potentially infectious patients.  COVID-19 continues to present infection potential and its spread is growing globally as of this date.  In addition to patients’ need for COVID-19 care, millions of medical consultations and treatments have been lost across the medical spectrum due to the inability to reliably protect both the healthcare provider and the patient during necessary face-to-face consultations and delivery of medical procedures.  There is a massive drive globally to establish a ‘new normal’, where safe medical healthcare can be delivered for current, future and catch-up purposes.  Long established barrier technology described below can be applied to many of these areas inexpensively and with superior performance to standard personal protective equipment (PPE).

As a benchmark, [criminal] occupational health safety laws around the world say that the last thing one should do to protect people from high hazard substances is use personal protective equipment (PPE). There is a reason for this. It is ‘fragile’ in use (look around you in a COVID-19 context!), has limited performance capability and is a last line of defence. The entire COVID-19 healthcare response has been ‘PPE’ centric. Please Google ‘hierarchy of control’ – or look at eg https://www.hse.gov.uk/construction/lwit/assets/downloads/hierarchy-risk-controls.pdf. The UK law reference is The Control of Substances Hazardous to Health Regulations 2002 (as amended); Regulation 7 (3).

Those same laws say, and what we know from our vast experience, is that engineering controls at source are a much more effective solution.

We applied our knowledge and experience to use one form of engineering control, advanced flexible film barrier containment, to protect healthcare workers. This technology has been used for decades in pharma, in high-value use, for protecting workers handling highly potent and toxic drug substances We prototyped and constructed in <3 days and have been trying to get it in front of the Cabinet Office, government, NHS, HSE and various related parties but with essentially ZERO RESPONSE. We have the tech installed in Ireland and the USA. We have UK advanced manufacturers (one recently acquired by US interests) and supply chains do not cross PPE supply chains. The tech is scalable vertically and horizontally.

A couple of main headlines are that:

• Most importantly, it is much more protective and more effective than PPE
• It is ergonomically much better than PPE
• It is a tiny fraction of the cost of PPE
• It generates a tiny fraction of the waste that PPE does

We have innovated and adapted long-proven engineered flexible film, barrier containment to protect an at-risk healthcare worker from a potentially contagious COVID-19 patient in face-to-face settings, for example in a medical doctor surgery, dental or other healthcare setting.  Application of this technology is highly flexible and can be adapted to very many different working environments, including care homes and end-of-life hospice settings as well as field settings where temporary protection makes sense.

As an engineered barrier control device, it will provide a highly effective degree of protection (in comparison to versus PPE) and in particular protection against the inhalation and skin contact exposure pathways.

The barrier containment approach (described below) is derived from implementation of the same type of flexible barrier containment that has been used for decades for protecting workers from potent and toxic active pharmaceutical ingredients (APIs) and highly potent APIs (HPAPIs) in the biopharmaceutical and fine chemical sectors.

The device establishes a CLEAN side and a POTENTIALLY CONTAMINATED or “DIRTY” side.  The attending health professional is setup and REMAINS on the CLEAN side.  This has many advantages and in particular TWO KEY advantages:

1. The health professional is in an environment of HIGH PROTECTION, likely many orders of magnitude higher than PPE (including respiratory protective equipment (RPE)) could deliver.
2. The health professional resides in a safe CLEAN area that remains clean and which does not need frequent decontamination on the CLEAN side. (Decontamination of the DIRTY side to protect patient to patient transmission is straightforward using standard infection control procedures.)

As an engineering control it is at the top of the “hierarchy of control”.

The healthcare barrier has been designed and progressed with the following driving attributes:

• It must deliver a much higher level of protection than PPE/RPE in absolute terms and even more so given prevailing PPE conditions.
• It must be sufficient to enable a health professional (e.g., medical doctor, nurse or technician) to conduct a sufficiently detailed multi-endpoint medical examination.  This has been shown to be the case in mock-up testing and is in use in real-world medical settings, with qualified medical practitioners currently on “the front line” of COVID-19 response.
• Prevention of cross-infection from patient to patient with basic administrative and disinfection practices.
• To be effectively implemented the device must be simple and straightforward to manufacture.  For standard healthcare settings, design is not complicated.  An early prototype was designed and fabricated in less than eight hours.
• Manufacturing capacity must be available, and it must be rapid and scalable.   High-quality advanced manufacturing is available at multiple international locations.  Devices can be made rapidly and at scale and subject to further scaling in other companies.

As part of trying to get the tech seen, we applied for funding via UKRI, but NOT FOR RESOURCES NEED PURPOSES. Rather we tried to get our technology and know-how noticed. In one funding round we were astonished and shocked to learn that £50K grants of UK public money had been awarded to the following:

• ‘A cutting-edge entertainment platform, allowing performers like bands, theatre productions and comedians to perform on a digital stage streamed directly to global audiences via TV or mobile devices.  Surely this is YOUTUBE already
• ‘The next generation of personal protective equipment with viral-stopping capabilities based on nanofibers for face masks to increase their effectiveness and allow them to potentially be re-used – this will ensure key workers like doctors, nurses and carers have access to the latest advances and protecting them against the disease’.  This must be years out with no guarantee of success and PPE is the bottom of the law hierarchy of control (see above).
• ‘A social media app that aims to strengthen local communities and allow volunteers to target support to the most vulnerable members in the local neighbourhood’. Surely this is WHATSAPP.
• ‘New software to help UK schools connect with their pupils to deliver teacher-led, structured and interactive home learning’.  Surely this is TEAMS, ZOOM etc already
• ‘Innovative virtual-reality solutions enabling surgeons to remotely train and virtually perform surgery to treat patients, keeping medical studies going and helping them to teach the next generation of surgeons. OK
• ‘A new virtual farmers’ market to replace traditional markets closed down as a result of the COVID-19 outbreak and social distancing restrictions, providing a platform for local businesses and farmers to sell produce’. Surely this is eBay, Gumtree, Schpock and many other sales platforms.

We are truly astonished that panels have awarded such grant funding when a field military-type response is needed to preserve critical healthcare.

We have extensive videos, 3D renders, plans, procedures, literature and other information about application of this tech to healthcare settings (which would include GP surgeries, dentists, clinical podiatrists, care homes, hospices, hospitals (such as reinstating mammography), etc), but we just can’t get heard. We have been reticent to go to the press and express our views.

We recognise that this technology and its application will be unfamiliar to many, but it is straightforward. In our dealings, we have not come across people with the vision, power or apparently the capacity to understand what is being offered. We understand that Cabinet Office decision makers are being led by management consultants who are rolling out ‘PPE’ approaches to the omission of anything else. The public should be alarmed.

We can provide access to all that we have done.  Most effective would be via a TEAMS/ZOOM meeting where we can describe the tech and point to the resources described above and show how flexible barrier containment can protect healthcare workers in a COVID-19 context.

Please please listen to us.  We can make a difference.

Justin Mason-Home, FRSC

HPAPI Project Services Limited

JJP Protection Limited

Nov 2020