Clinicians, service providers and researchers have issued an urgent call for an innovation in personal protective equipment (PPE) – the ventilated hood – to be made available to remote health services.
Without the hoods, the risk of coronavirus transmission within remote healthcare services and communities is grave, warn Dr Simon Quilty, Dr Forbes McGain, Sarah Brown, Dr Tejas Bhatelia and Professor Geoff Dobb.
The warning is timely, amid international concerns about the resurgence of the coronavirus and the likelihood that it will pose an ongoing threat for some time.
Below, they suggest that including the ventilator hoods in the National Medical Stockpile may help address regulatory and commercialisation delays that are holding back their wider availability.
Simon Quilty, Forbes McGain, Sarah Brown, Tejas Bhatelia and Geoff Dobb write:
During the first several months of the pandemic, we have heard much about the difficulties of infection control in hospitals in Melbourne and other cities around the globe. But the immense challenges facing remote healthcare services and communities have received relatively little public attention.
The greatest challenge for rural hospitals and clinics will be in reducing healthcare worker infection rates so that critical healthcare services can continue to be delivered.
Being a healthcare worker is very risky and PPE is proving to be far from fail-safe, with senior doctors around Australia claiming that current measures to protect these workers are inadequate.
In Victoria, as of late August there had been 2,692 healthcare workers infected, or 15 percent of the total number of infections for that state. Melbourne hospitals coped with the sudden loss of critical staff by scrambling together solutions between hospital networks, but such events would very predictably cripple rural and remote hospitals that have far less staffing redundancy than in cities.
However, there is an Australian innovation, the ventilated hood, that will almost certainly reduce healthcare worker exposure.
Two devices have been developed in parallel: a low-cost ventilator hood developed by Curtin University and Royal Perth Hospital that was published as open access to be available anywhere in the world; and a more advanced design that has come from University of Melbourne and is currently in a multi-site trial.
The Federal Government has acknowledged this promising solution, and is backing urgent research for the most advanced design.
But the low-cost hood is currently stuck in limbo because of delays with the regulatory and commercialisation process.
Remote clinicians believe this device is a game-changer, and that the Federal Government’s financial support for research needs to be rapidly expanded to get the low-cost ventilated hood through Therapeutic Goods Administration (TGA) approval and commercialisation so that it is available for all healthcare settings, to protect staff and support clinics and hospitals cope with further outbreaks.
The concept was developed by loosely affiliated scientists in Melbourne at the start of the outbreak, and the principle is remarkably simple.
A transparent plastic hood sits over the bed on a frame, and inside the hood, all of the air is constantly evacuated through a port before passing through a viral filter that removes virtually all of the virus from this air. It is effectively a negative pressure space that sits over the patient, preventing the spread of droplets to staff and other patients in the vicinity of that bed.
The two versions are shown below.
Purple House perspective
The sun is peaking up over Women’s Mountain in Walungurru (Kintore), gradually warming the desert. Breakfast fires are being lit, damper made, and kids are getting ready for school.
Joe has hopped on his scooter ’my little car!’ and is heading for dialysis at the Purple House, his baker’s dozen of much-loved dogs bouncing along beside him.
We are 540 kilometres due west of Alice Springs and the nearest hospital.
In our little dialysis unit of four chairs, Joe will shower, breakfast, and pop his washing in the machine before settling in to a dialysis chair with other senior Pintupi men, to chat, watch old movies while his blood is being cleaned.
This is his place, the money to start this service was raised by him and other artists 20 years ago this year.
For Pintupi people, being on country, with family and ‘holding people close’ is paramount.
Early in 2020, when stories started to circulate about this new sickness, this coronavirus, people were worried.
They remembered other sicknesses from years ago. The first death from swine flu in Australia was in Kiwirrkurra, a remote community a further two hours west of Kintore.
Old people remember when measles first came to Central Australia and no one had immunity. The effects were catastrophic.
So, when in March there was talk about closing roads to remote communities and keeping people safe in isolation, leaders thought this was a great idea. They helped family to get home before the roads closed and they made sure their stores had plenty of supplies. They planned trips to take their young people out to country and to take this extra time to teach them how to look after waterholes and other sacred sites.
Of course, it made some things tricky. It tested the infrastructure on remote communities and highlighted the need for more and better housing.
Our nurses cancelled their leave and settled in for the long haul. In our remote communities, people felt safe in the knowledge that the roads were closed and the numbers of people in Alice with COVID were low with no community transmission.
But communities couldn’t stay shut up forever.
Plans had to move to look at how to manage suspected cases in small communities with little clinics and small numbers of staff. For Purple House we KNOW that our patients are unlikely to fare well if they catch this bug. If intensive care units are getting close to full, dialysis patients are unlikely to have priority.
So the idea of a simple, affordable, accessible technology that can make our nurses and other patients less likely to get sick is something we are pretty keen on!
The idea of a ‘shield’ – kutitji makes sense to people.
But we need it NOW!
People are watching on their TVs what is happening in aged care, what is happening in other places and they are scared. No one knows when, how or how much.
WE CAN’T WAIT the usual two years for clinical trials.
So just as people pushed on to get dialysis in their communities so that people could be home on country, Purple House directors are offering some of their hard-earned cash to encourage manufacturers in Melbourne to get the low-cost ventilator hood through the TGA so that it can be used.
It’s not a lot of money, we don’t have a lot to spare, but we are hoping that it will start this work and encourage others to help. We know this will be good for remote communities across Australia and help people to stay safe on Ngurra (country).
Lessons from history
These hoods almost certainly reduce the impact of COVID-19 in terms of healthcare worker infection, but there are serious issues about human behaviour and the conservative hierarchy of medicine that must be discussed urgently if remote clinics will have access to this device in time for them to be of use.
Wash our hands, all the time, we are told. Never before has hand hygiene been such an important aspect of day-to-day healthcare.
The layers of irony are thick. It was Semmelweis in the late 19th century who discovered that washing hands could prevent death. Before microscopes were powerful enough to see bacteria, he deducted with scientific techniques that became the very foundations of epidemiology, that washing hands in chlorinated lime solution reduced death rates in hospitals to a third.
Yet at the time, his findings were considered so controversial that the medical fraternity completely rejected his thesis of hand washing as a means of reducing death, and ostracised him as some kind of hierarchical pariah.
As a result of the establishment’s refusal to accept this unorthodox technique now called science, many more people succumbed to infectious diseases before the concept of hand washing became accepted.
It might sound like a far reach to liken the hood to Semmelweis, but it seems that a similar phenomenon appears to be blocking opportunities to reduce staff infection from COVID.
Since the onset of this pandemic, the medical profession as a whole has doubted whether the virus can be airborne or not, assuming that it probably isn’t – which turns out to be the wrong assumption.
The hood is designed specifically to control airborne spread, and subsequently sits within the significant global politics of this wrong-call quandary.
Problems with PPE
Under traditional infection control practices, if a person with a highly infectious disease – measles, tuberculosis, influenza – needs to be in hospital, they will be placed in a negative pressure room. The suction out of these negative pressure rooms through the air conditioning vents means that the total volume of air in that space turns over 10 times an hour.
When the door is opened for a doctor to visit or nurse to take a set of observations, the negative pressure means that the air contained within that room does not spill out into the corridor, but instead flows constantly in only one direction, inwards.
The staff who need to go into this contaminated room need to gown up and put on masks to remain protected from the contagion that remains only in that room; however, the space outside that room – corridors, clinical rooms, lifts and administrative areas – remains contagion-free.
With the current pandemic, there are some big problems with keeping spaces contagion-free. This is what has contributed to the extreme rates of staff infections in places like Melbourne.
Firstly, hospitals are not designed for pandemics like COVID and there is a limited number of negative pressure rooms that rapidly fill when there is community transmission. So they have had to rely on the only other available means of infection control – hand washing and the wearing of personal protective equipment – masks, goggles, gloves and gowns.
The problem is that this PPE all gets coated in virus, and taking it off, even with meticulous care, is dangerous. Ripping the plastic gown from your own neck using the proscribed technique can easily result in a single strand of plastic breaking and brushing, dirty side first, against skin or clothes, then taken to the staff tea room or the bathroom tap, or back home to family.
When removing goggles or mask, a single touch of the face can leave an invisible but potentially deadly fingerprint. PPE is inherently anti-human, beyond ergonomics.
PPE does work, but it is far from perfect, only as perfect as the shaky hands of an exhausted healthcare worker who has been working long shifts in a highly stressful environment all night.
Behind the news
The ventilated hood is a brilliant and yet simultaneously simple concept.
Most Australians have probably seen images of the ventilated hood in action, and may presume that it is now regularly deployed in hospitals. All you need to do is Google “ICU, Melbourne, COVID” and most of the images depict the University of Melbourne ventilator hood.
Despite the many TV news bulletins that feature images of patients under hoods, the truth is that only a very small number of hospitals in Australia currently have access to these devices.
University of Melbourne medical and engineering researchers have undertaken sophisticated engineering design, and have demonstrated models to prove that almost nothing leaks from inside the hood, making the external space around the patient, where doctors and nurses spend most of their day, much safer from the potential of infection.
When working around this external space, in ICU wards and other parts of the hospital, people are still required to wear PPE, but as a second line of defence, not a first. The chance that a glove is contaminated is far less than if there was no hood over the patient.
But the images on the nightly news of patients under hoods do not reflect the wider reality, and things need to accelerate so the hoods are available. These devices need to be made available to rural and remote settings when they will be of greatest utility – before the pandemic arrives, not after the fact.
Why the wait?
Given that a prototype was demonstrated in Alice Springs Hospital in March of this year, the question must be asked, in comparison to the ruthless pace of a global pandemic, why do innovative solutions like this hood take so long to become available?
It’s not just a Semmelweissian problem; the challenges are also regulatory, commercial and industrial.
The Therapeutic Goods Administration has never before been asked to act so quickly to allow new COVID-related devices and vaccines to come to market. And although the TGA is pulling down barriers in real efforts to get products like the hood to hospital beds, the regulatory frameworks are not fit for purpose when a global pandemic is setting the pace.
However, perhaps the primary issue with the lack of progress of the hood has been due to the Australian political culture around manufacturing and innovation.
The lack of government support for local manufacturing of medical equipment, which has to compete with very cheap imports, means the manufacturing industry is cautious about developing new products. Complex business decisions, around risks of tooling up a factory at significant expense to manufacture a device that is yet to have a proven market, happen very slowly.
So here we are approaching October, lamenting the extreme rates of healthcare worker infections, with devices that will almost certainly reduce this toll still not in widespread use.
Remote clinics and rural hospitals need to prepare in order to protect their staff so that services can keep running if and when the pandemic arrives. Staff in busy emergency departments and intensive care units around Australia need them immediately.
The tool to reduce staff infection – the ventilated hood – could be made available right now.
What if the hood was placed on the National Medical Stockpile along with the 2,000 ventilators ready to be rolled out in case of a pandemic surge?
Here is a way to ‘flatten the curve’ without the massive personal and economic cost of lock-down.
Dr Simon Quilty is a remote specialist physician with a background in engineering who is running multi-site trial at Alice Springs Hospital for the University of Melbourne Hood, and has contributed to the design of the low-cost hood.
Dr Forbes McGain is an anaesthetist and ICU physician in Melbourne. He is a co-inventor of a personal isolation hood (the ‘McMonty) with Professor Jason Monty et al (University of Melbourne). The University of Melbourne/Western Health have a patent for this TGA listed personal isolation hood.
Sarah Brown has been CEO of Purple House for the past 17.5 years.
Dr Tejas Bhatelia is a senior research fellow at Curtin University, an expert in Computational Fluid Dynamics.
Professor Geoffrey Dobb is Head, Intensive Care Unit, Royal Perth.