We have now been in lockdown for several weeks due to the coronavirus health crisis. The collapse of A&E services, coupled with a shortage of equipment to tackle the pandemic, has led the AEMPS to grant immediate certification to certain medical devices that can help mitigate the effects of the coronavirus on the healthcare system. Would you like to know how these fast-track regulatory processes are working? Today we’ll tell you about the Leitat 1 ventilator.
Leitat 1 Ventilator – Over the past few weeks, we have watched – from home, under compulsory lockdown – as emergency medical services across Spain have become increasingly overwhelmed.
And that collapse of the healthcare sector can be explained by multiple perspectives:
- On the one hand, because of the lack of protective measures for healthcare professionals – such as surgical masks, gloves and protective clothing, eye and face protection, etc. – at the start of the coronavirus crisis.
- On the other hand, on the fregistration for PCR and rapid coronavirus tests, which was settled just a few days ago.
The shortcomings of the healthcare system in this regard have led to the 19,400 healthcare workers infected, according to the latest figures from the Health Alerts and Emergencies Coordination Centre (CCAES), which have yet to be verified by the Ministry of Health.
In addition to the enormous impact on healthcare professionals as a whole, the collapse has also affected the management of their facilities and infrastructure: The public health system does not have enough ventilators or enough beds to treat all those affected due to the pandemic.
And that structural deficit does not appear to be a problem that can be resolved in the short term.
The Leitat 1 Respirator: a short-term charity initiative to relieve pressure on A&E departments
However, there are a number of initiatives currently underway working towards that goal. For example, the Leitat 1 field respirator, a field ventilator project manufactured using 3D printers, which received approval from the AEMPS on Monday 6 April and can therefore begin production with a “daily output of 50 units, at a cost 10 times lower than that of a conventional ventilator”.
This medical device has been developed as a matter of urgency through a partnership project between the Free Zone Consortium (CZFB), HP y Leitat (Tecnio) together with CatSalut -the Department of Health of the Government of Catalonia-. This initiative has also received private contributions from Cellnex, Almirall and the Official College of Physicians of Barcelona (CoMB), as well as from the the CZFB’s infrastructure, HP’s production equipment, and support from the 3D Factory Incubator and the 3D Hub (IAM3DHUB).
And the aim of its creators is for it to be replicated anywhere in the world where the necessary technology is available for 3D printing the Leitat 1 ventilator model: for this reason, they have produced the design in open code, available to everyone. A true example of altruism to follow, at a time when solidarity and joining forces can save lives.
To find out more about this little “creative miracle” and to congratulate those behind this impressive initiative, we have been in touch with Dr Manel Balcells, Health Commissioner at Leitat, Director of CIMTI and Chair of the Advisory Council of the Department of Health of the Generalitat.
Interview with Manel Balcells.
Health Commissioner at Leitat and Chair of the CatSalut Advisory Board
Firstly, we would like to congratulate you on the recent approval of the ventilator. Given that, due to the current crisis in A&E services, the AEMPS has fast-tracked the certification of this medical device, could you explain how the approval process for Leitat 1 was completed in just a few weeks?
What the AEMPS has done is, in this emergency situation, to offer us a loophole to enable us to carry out the fast-track approval process: to present it as if it were a observational clinical study. In other words, we are not talking about a provisional CE marking, but rather it has been designed as an observational clinical study. And to that end, we have had to submit all the documentation as if it were a clinical trial.
Consequently, a clinical trial has been designed: we have approached our study as if Catalonia were a Single ICU, and therefore the observational study is being carried out throughout Catalonia, in all hospitals, as it is being organised by Leitat and Catsalut. A study has been proposed, its parameters have been defined and, of course, later on we will have to present the results.
Each hospital is a participant in the study, and every person connected to a ventilator is a patient in the study. This has been the loophole that has enabled us to obtain fast-track authorisation for the Leitat 1 ventilator from the AEMPS, meaning we do not have to go through the lengthy standard process of the CE marking.
Even so, it has been a difficult process for us, because some of the tests are very complex. And the paperwork is complicated and cumbersome, but we’ve finally managed it. This was the loophole – entirely legal – that the Agency itself suggested to us, to get this product approved.
At GTF, we believe it is good news that, in the current public health emergency, the AEMPS has found an immediate solution for the regulation of a field ventilator.
Of course, we must acknowledge and appreciate that The AEMPS has made an effort in this regardo. Even so, the certificates issued by the certification bodies must be completely up to date, and obtaining that documentation takes time.
We are aware that this urgent measure taken by the AEMPS can only be understood in this emergency situation which exists for certain types of equipment.
What are the intended uses of the Leitat 1 ventilator?
The truth is that the development of the ventilator’s design has been a very pleasant surprise. And whilst we initially thought it would be an emergency ventilator, intended to last just three or four days and used only as a very temporary measure, the end result is a semi-conventional ventilator.
The model consists of a 1m x 1m mechanical fan, produced using 3D printing, to which a fairly sophisticated electronic and sensor system – including flow sensors, volume sensors and pressure sensors – has been added, along with a control panel and a computer system that provide a high level of safety.
So it functions just like a standard ICU ventilator. The ventilator we have designed is no longer just for field use; it can also be used in an ICU (provided that the person operating it is an expert, as the settings must be adjusted manually).
So to speak, it is an intermediate ventilator, somewhere between a field ventilator and a conventional one. It can therefore be used both in health emergencies, in field hospitals, and in conventional ICUs. And we are very pleased because this product can meet the needs of the current situation, not only here, but anywhere in the world.
What do you think the outlook is for the healthcare products industry in the wake of the coronavirus?
The medical devices industry needs to engage in some serious reflection. We do not consider ourselves part of the industry: we are a technology centre which, in agreement with Catsalut, the health authority, has brought together a range of expertise and clinical staff to develop a product to meet an urgent need. We will then see whether it has commercial potential, but in any case that was not our intention.
What does the future hold for the industry? I believe this situation has shown that we cannot always rely on industries from beyond our borders. We must develop our own industry for medical devices, instrumentation and life-support equipment, because if there is another crisis like the current one, in which borders are closed, we must have the capacity to be self-sufficient as a country. We must have our own industry capable of producing, in accordance with quality standards, all the elements necessary for adequate healthcare.
In the wake of this situation… Will there be changes to national healthcare systems? Will emergency services need to be reorganised?
I think so, and not just in the context of emergencies. This situation has turned the healthcare system upside down. So we must learn from this.
I chair the Advisory Board of the Department of Health, and next week we have a meeting with the ‘consellera’. Our view is that this situation should enable us to change many of the ways we work. With this crisis Many preconceptions have been shattered, it has become clear that things can be done in other ways. And that the system can be ductile and malleable, which means that other paradigms must be addressed.
For example: at the moment, Telemedicine is now a reality. And it has been shown that this approach can ensure patient safety and confidentiality. All of this will evolve very quickly. Home care, the way hospitals are organised, the role of primary care in care homes… All of this must change. And it should give us pause for thought. I believe that after this crisis, nothing will be the same in our healthcare system.
What recommendations has the Health Department’s Advisory Council made to the Catalan Government to tackle the health crisis?
As an advisory board, we are responsible for studying and analysing the model for the healthcare system of the future. We are not a crisis advisory committee, which operates differently as its work is dictated by the emergency situation. We have therefore not made any recommendations in that regard.
We on the Advisory Board will continue to recommend that This public health model needs to be rethought, and I believe that the current situation will enable us to make rapid progress with its reorganisation. We need to start thinking about the day after the crisis. It is essential to start thinking about how this country will develop once we have overcome this.
One of the treasures to be preserved is the healthcare system, which we have seen has held up remarkably well, largely thanks to its staff. To those professionals We must look after them, care for them and protect them, just as much as we do the health system itself.
And, above all, to use this crisis as an opportunity to shift towards much more efficient ways of working, by redistributing the roles that have been established up to now. This summarises the recommendations we have put forward to the Government of Catalonia, which we will reiterate in the coming days.
You are a specialist in sports medicine. How do you think the sedentary lifestyle imposed by lockdown will affect the general health of the population?
There is one very important downside here. It is vital that people take part in physical activity, even if they are confined to their homes. I know it is difficult; many people live in small flats and find it hard to stick to an exercise routine, but It is essential to continue with a daily exercise routine. At the moment, we have the support of applications and telematics systems. And our own imagination, too. We just need to find a way to do it.
In this regard, I believe that the lockdown measures in many other countries have allowed people to go out for a walk on their own or with their partner, whilst maintaining an appropriate distance… Just as people are currently allowed to go out to walk their dogs, I would be in favour of people being allowed to go out, without making contact with others, to do an hour’s physical activity. There are many places where this is permitted, and that is important for one reason: We might not die from coronavirus, but we end up suffering from cardiovascular disease. And that can’t be right.