Mick Clifford: Battle is on to maintain supplies of ventilators [Podcast]

“We were wondering what we could do to help with the current situation and the subject of ventilators came up,” he says.

“We have a team of interesting engineers and, in the course of our work, we’ve built things that are unusual and strange and sometimes stuff that nobody else would try to make. What does the world, and this country, need now? Ventilators.”

John made a few calls to people he knows in medicine and engineering. He got a good, if cautious, response. That was a week ago.

Since then, he has been calling on contacts, putting the word about, and assembling a team to design what he calls a “battlefield ventilator”.

Now operating under the title Covid Response Team, the not-for-profit group has put together a crowd-funding platform that is receiving donations.

John has also had positive soundings from government agencies and is awaiting a formal response. From his base in Tuamgraney, east Clare, he and his team have been working round the clock on this new venture.

“The consultants we’ve spoken to are saying that it would have to be on a risk basis,” he says.

“The protocol we’re looking at is if a patient comes in and needs to be ventilated, if she is going to die, and the only option is one of these battlefield ventilators, then there is a chance of saving a life and a risk to be taken,” John says.

“The idea is that the battlefield ventilator can be built anywhere in the world, without worrying too much about a supply chain that is already deteriorating rapidly and will get worse.

“It will be professionally built, with serious input from an exceptional team of engineers, but, also, the most important frontline practitioners saving lives.

"We hope it is never needed, but if the battle turns out to be as some fear, then what we are trying to achieve should save lives,” John says.

In ordinary times, such an approach to medicine in the developed world might be regarded as reckless.

Ventilators are sophisticated machines, designed and built by about a dozen companies worldwide and conforming to strong regulations.

But these are not ordinary times.

The nature of Covid 19 is that large numbers of people end up requiring intensive care and the assistance in breathing offered by ventilators.

Already, in Italy, medics are faced with the horrendous decision of selecting patients to be ventilated on the basis of who has the best chance of survival.

There is a worldwide shortage of the machines to tackle this pandemic.

In the UK, the prime minister, Boris Johnson, has issued a call for all engineering disciplines to put shoulder to the wheel to come up with innovative ways of producing ventilators in as short a time as possible.

Construction, car-making, and airplane engineering firms have been contacted to that end.

Last Sunday, the UK health secretary, Matt Hancock, said that engineering firms should consider switching some manufacturing to help ramp up ventilator production.

He noted that this was the type of policy normally reserved for times of war.

One report in the UK media suggested that Johnson had discussed with a ventilator manufacturer the possibility of sharing intellectual property.

The situation is no less daunting on this side of the Irish Sea.

There are approximately 1,030 ventilators in public hospitals, with another 200 in private hospitals.

The HSE has ordered 900 to meet expected demand. But if the projection of the spread of the virus turns out to be accurate, and if the measures already taken do not flatten the curve, there could be a ventilator shortage.

The demand for ventilators could easily be a multiple of the availability.

Should that come to pass, then the spectre of what is unfolding in Italy would be repeated here.

Efforts are being made across the medical manufacturing sector to innovate in a time of crisis.

Dr Martin O’Halloran is senior lecturer in medical electronics in NUIG.

He and a team of 26 engineers are attempting to find ways in which usage of the stock of ventilators can be maximised.

“We’re looking to see if we can modify ventilators to be used across multiple patients at the same time,” Dr O’Halloran says.

“There is a shortage of ventilators, but doctors would be more comfortable with that than bringing in totally unapproved ventilators.”

Dr O’Halloran and his team are also examining ways in which, if the demand for ventilators far outstrips supply, patients could be assisted with breathing through a system called high-flow oxygen, delivered through a non-mechanical device.

“We are trying to make those devices less prone to infections, because that might give doctors more options that are acceptable,” Dr O’Halloran says.

John Wallace has been in touch with Dr O’Halloran and he offered whatever support he could.

“I think that project is challenging. But there is a shortage of ventilators and an urgent need for them, so approaches to increase supply are definitely required. It’s good that that is being led by industry,” Dr O’Halloran says.

As chance would have it, a high proportion of ventilators worldwide are manufactured here.

US firm Medtronic has its HQ in Dublin and employs 250 in its Galway manufacturing plant.

Last week, the company issued a release, pointing out that it had already ramped up its manufacturing capacity by 40% and intended to keep increasing output, particularly in its Galway facility.

“The company currently has over 250 employees dedicated to ventilator manufacturing (in Galway) and plans to more than double that number, including transferring staff from other Medtronic sites to support ramp-up activity.

"Additional manufacturing shifts have been put in place and new manufacturing shift patterns are being introduced to bring the plant to 24/7 operation.

"With a strong commitment across Medtronic and its suppliers — combined with increased staff — the company expects to be able to more than double its manufacturing capacity for ventilators.”

Even if these targets are met, the expected demand will greatly outstrip supply. Filling this vacuum are people from all different disciplines of engineering, like John Wallace.

They want to make any contribution that may help.

Ivan Hayes, a consultant in anaesthesia and intensive care medicine at Cork University Hospital, was contacted by Wallace about the project.

“It is completely left-field,” he says.

“There is an established industry and a lot of regulation, and trial-and-testing that goes into these machines, but we are in extraordinary times and everything is worth considering,” Mr Hayes says.

There has been huge co-operation in the medical and engineering fields, in trying to source all the required equipment to deal with the expected, increased level of admissions from the pandemic, he says.

“It is a very difficult market, at the moment. Even attempting to source simpler stuff, like personal protective equipment, is becoming difficult.

"Anybody thinking outside the box, at a time like this, is welcome,” Mr Hayes says.

Flattening the curve to void a ventilator shortage is crucial.

“We have equipment orders in and a huge amount of effort is also being put into retraining and upskilling staff.

A lot of collaborative work is going on behind the scenes, but the really key message is everything must be done to flatten the curve and minimise the surge,” Mr Hayes says.

The co-operation is reaching across the border. Sean McHenry, a trauma and orthopaedic surgeon in Belfast’s Royal Victoria Hospital, came across Wallace through a colleague in Cork.

“I was talking to a plastic surgeon, and I mentioned ICU and how many ventilators were available, and he told me about John and I said to pass on my details,” Dr McHenry says.

“I spoke to him and we’ve been trying to get something going up here, as well. I’ve been in touch with a guy who ran an electronics company, and a friend in Armagh who is an electronics guy, and I’ve spoken to anaesthetists, who were really helpful.

"They know far more about this than I do, but everybody is pulling together. Apart from issues over ventilators, though, we are really facing into problems with a shortage of personal protective equipment,” Dr McHenry says.

“There is an Irish term, ‘meitheal,’ which could be summarised as ‘community spirit and resources at a moment of crisis.’ That is what we have here.

"People are volunteering their knowledge and experience,” Dr McHenry says.

One of the glaring impediments to the use of a battlefield ventilator at a time of crisis is legal liability.

Medical-negligence is a minefield right across the health spectrum.

Take a scenario where a patient requires ventilation, but there is simply no availability, apart from one of these improvised devices.

If the patient dies — which would always be a possibility for someone who required that level of intervention — where stands the legal liability of the hospital, the doctors, the manufacturers?

Such a scenario would require government intervention, with legislation.

There have been occasions when the state has indemnified companies or entities for liability.

It wouldn’t be straightforward, and if the pandemic did deteriorate rapidly, it would require any laws to be rushed through the Oireachtas. But these are desperate times.

One man for whom none of this has come as a surprise is John Dingley, a recently retired consultant anaesthetist and associate professor of medicine at Swansea University.

Ten years ago, Dingley and a few colleagues developed a prototype ventilator that could be used in “medical emergencies” like the one we are currently experiencing.

“Our research has demonstrated that it is possible to make a gas-efficient ventilator costing less than £200,” Dr Dingley says.

“Such a device could be mass-produced for crises where there is an overwhelming demand for mechanical ventilation and a limited oxygen supply.”

Dingley’s prototype never went further than design stage, as he was busy designing other medical devices and it wasn’t taken up by anybody else.

The prototype could be utilised for the current situation, but would require a few modifications.

“I would do it slightly differently now,” he says. “I could build it in a week and put the plans on the web, but the problem, at the moment, is that you could have massive litigation against you.

“What we need is the wartime spirit. Look at the difference between modern life and that during World War Two.

"Now, everybody is worried about litigation and liability. How bad does it have to get before people start thinking about what is needed,” Dr Dingley says.

The liability problem is exacerbated, because even with the assistance of a ventilator, many patients would still die.

“It’s pretty brutal for somebody to come along and tell a family member about an elderly relative, ‘sorry, I don’t think he has a chance, so we won’t ventilate him.’ You might prefer if it was possible to say, ‘we’re going to ventilate him on this basic machine here.’ At least then, they tried.

Being really honest, the chances of many surviving are not good anyway.”

John Wallace holds a similar opinion.

“It’s not ideal, but that is the position we are in. If we can save lives with a ventilator that had to be built for these times, that will be worth it,” he says.

Wallace also advocates examining earlier technology. Last Friday, he travelled to Cork to look at an earlier model of ventilator, with a view to replicating the technology.

“We’re going back to the days of old to look at how they did things more simply back then.

"This is an emergency and we have supply chain issues, so we have to work with what we have,” Wallace says.

Time is the enemy.

He says that he would hope to have a prototype design within a week or ten days. Manufacturing is the next step, but he estimates this could also be done in a highly expedient manner, in response to the emergency.

“There are other groups of engineers in this country, and abroad, trying to do something along similar lines,” Wallace says.

“We’re all in contact with each other. It shows that there is a nurturing of co-operation, in the spirit of all hands to the pump.”