Artificial respirators made in Spain: why their certification is so slow when so many lives depend on them

It is estimated that around 5% of those infected with the coronavirus will require intensive care and the help of a respirator. This percentage depends on the number of tests and there are studies that question its effectiveness, but beyond statistics, the truth is that respirators have become one of the most necessary devices in this crisis. And there are not enough to serve all patients.

These respirators or "mechanical ventilators" allow you to save time for the treatment to take effect, ventilating the patient and oxygenating the lungs. They are machines that we can find in the ICUs of hospitals, but their price can exceed 15,000 euros and their availability is insufficient.

The Government of Spain has requested the purchase of 4,000 respirators, but the arrival of the shipment is not being easy. Faced with the complicated obtaining of respirators abroad, Spanish companies and universities such as SEAT, URJC or the University of Malaga have started the production of artificial respirators. A race to produce new respirators in the shortest time possible, as many lives depend on them. But these projects have encountered an added problem: their certification.

Who is responsible for the production of respirators

According to the count made by the Spanish Society of Intensive Nursing and Coronary Units (SEEIUC), Spain had 2,487 fans, an average of 17 by ICU. This is not the total number, but the response of 59% of ICUs in this country. And the problem is that there was no official number of respirators available in Spain.

That was at the beginning of the crisis, but the number of seriously hospitalized people has clearly exceeded the number of ventilators. A repeated problem worldwide, which has caused the price of these respirators to double and global demand to skyrocket. A demand well above production that has caused a stock break.

Along with 35 million masks and more than half a million kits to perform PCRs, Spain has requested thousands of respirators through joint purchasing processes of the European Union, but it is estimated that these could take several months. And in the fight against COVID-19, time is a key factor.

The main producers of respirators in Europe are Medtronic (Ireland), Dräger (Germany), Getinge (Sweden) and Hamilton Medical (Switzerland), but their total production, estimated at about 10,000 units per year, is not enough. To compensate for this, the governments of the main countries have encouraged different companies to produce their own emergency respirators. And which companies can produce them? Mainly automakers, because they can adapt engines and components to produce mechanical fans.

Large auto companies are re-engineering their engines and factories to produce artificial respirators.

This has led companies like the FCA group and Ferrari to manufacture respirators for Italy, PSA and the manufacturers Peugeot and Citröen to manufacture up to 10,000 respirators for France, Mercedes Benz to reuse its Formula 1 technology, Ford to produce 50,000 units for The US or even Dyson's digital motor has been adapted to meet the requirements and produce 15,000 fans.

They are not the only private companies that are collaborating in the production of respirators. The Zurich group has donated € 200,000 to drive the development of new models of emergency respirators and manufacturers such as Medtronic have decided to release the development of their PB 560 portable respirator.

What artificial respirators need to be approved

With the need for respirators, many companies have launched to try to collaborate but not all projects work. The Ministry of Health has warned that only those who comply with the necessary approval and provide the documentation and tests requested will be authorized.

This certification is important, since without it these respirators do not have the requirements to be able to connect with the health system and therefore cannot be used in ICUs designed to care for critically ill patients.

Several of the ongoing projects are based on industrial parts and components used in automobile manufacturing. In the case of SEAT, the windscreen motor has been retrofitted for its mechanical respirator, although the entire device has more than 80 electronic and mechanical components.

Although it fulfills the function of helping to ventilate, we are not dealing with a last generation respirator and the authorization is not trivial. It has been the circumstance that while companies and research groups worked against the clock to keep them in mind before, from Health they wanted to be sure of their correct functioning. A difference of positions that has led the SEAT works council to criticize "excess bureaucracy at a time when the important thing is to save lives."

From the Spanish Medicines Agency (AEMPS) they explain that these respirators are "very precise and complex invasive equipment". They indicate that "its design and functionality must guarantee, in addition to fulfilling its original function, that its use does not compromise the clinical status or safety of patients, nor the safety and health of users."

Faced with the numerous projects to manufacture respirators, both 3D printing and new adaptations or prototypes, the AEMPS explains that, as in the rest of the countries of the European Union, in order to market these devices they must be "provided with the CE marking, a distinctive mark that declares the conformity of the product with the safety, efficacy and quality requirements established in the legislation ".

However, due to the health crisis, the AEMPS are aware of the increasing number of patients and therefore have prepared a document indicating the technical documentation and minimum tests that must be carried out on these prototypes. Recalling that "even in emergency conditions, it is only possible to use them in the context of clinical research that identifies their efficacy and safety profile."

The first step in receiving certification is to submit detailed technical documentation, including technical specifications, design, identification of similar equipment, a brief risk analysis, identification of security requirements, a description of the manufacture and results of preclinical tests. These should include running tests on human models with artificial lungs, the results of validation in pigs, and functional safety tests of the prototype.

The Spanish Medicines Agency has created a document with the technical information that the different respirator projects must send to receive their certification. Preliminary tests include tests with artificial lungs and validation with pigs.

Once these results have been received, the next step is to request a clinical investigation regulated by Royal Decree 1591/2009 on medical devices and RD 1616/2009 on active implantable medical devices.

Among the aspects that the AEMPS remembers with these artificial respirators is that it must be taken into account that, like all electromedical equipment, "mechanical ventilators emit electromagnetic radiation that can affect the operation of the rest of the patient's equipment." Equivalently, "it must be verified that the operation of the prototype is not affected by the electromagnetic emission of the rest of the usual equipment in an ICU". The latter, the electromagnetic certificate was precisely what has most delayed respirator projects such as SEAT.

The Spanish Medicines Agency works with six projects

On April 1, the Spanish Medicines Agency reported that "6 projects are being worked on in a fairly advanced state." Beyond these six chosen projects, there are others that are in the earlier stages of their development but have not yet passed the requirements to continue with their trial.

To all of them, the AEMPS has offered "continuous technical support and support in order to speed up development and secure prototypes that can be tested within clinical research protocols in hospital centers."

Some of these projects arose through a WhatsApp conversation, which led to the creation of the Innovative Breathing Aid (AIRE) forum, as described by the Sinc Agency. The group is led by Jorge Barrero, CEO of the Cotec Foundation. As a result of the initiative, the AEMPS created the technical requirements document so that these projects knew what they must meet in order to be of help with their respirators.

Among the different projects, the only ones that have received the green light to start their large-scale production at the moment are the SEAT and Hersill respirators. Beyond the two companies, these are some of the Spanish projects that are working on artificial respirators to help deal with COVID-19.

Andalusia Breathe

A group of engineers from the University of Malaga (UMA), together with researchers from the Institute of Biomedical Research of Malaga (IBIMA) and doctors from the Regional University Hospitals of Malaga and Virgen de la Victoria are responsible for the Andalucía Respira project. It is one of the artificial respirators that is in the process of being evaluated by the Spanish Medicines Agency.

Ignacio Díaz de Tuesta, cardiovascular surgeon of the center and author of the original idea of ​​the respirator, which he himself captured in his doctoral thesis, explains, together with the general secretary of Research, Development and Innovation of the Ministry of Health and Families, Isaac Tunisia, that They expect their respirator to be produced within seven to ten days, "once a second clinical trial is successfully performed on a real patient and passes the latest technical tests."

In a statement, on April 3 the group reported that this second human trial has been successfully passed. Specifically, "the prototype of this device has been tested in a patient with Covid-19 who is in the ICU of this Andalusian public health hospital," explained the IBIMA researchers.

Initial tests include a trial with a patient admitted to the ICU of the Antequera Hospital and a test on an artificial lung. It was also experimented in an animal model and on April 2 in a patient with acute respiratory failure in the ICU of the Virgen de las Nieves Hospital in Granada.

The prototype has a two hour run time and has no moving components. The electric controller is based on commercial automatons and has been certified by the AEMPS after sending the technical documentation. Among the tests that remain to pass to be officially applied is the electromagnetism certificate and a test of autonomy of the device with UPS, which must last 48 hours.

The Andalucía Respira team has already received several proposals for its preparation by companies in Cádiz, Jaén, Málaga and Seville, which could launch an average of 50 respirators per week each. One of them is Fujitsu, who is already adapting his production line in Malaga.

Team resistance

Another project that is pending validation by the Ministry of Health is the Reesistencia Team, within the 'Coronavirus Makers' group. Their work is based on the open source Jackson Rees system and these days they have received the collaboration of the Renault company to start the production of their respirators through 3D printers. A help that not only reaches the manufacturing level, but the group of the company itself has proposed several improvements to the valve of the prototype.

With the coordination of the Ministry of Science and the University of Oviedo, these days the prototype respirator is being clinically tested at the Central University Hospital of Asturias (HUCA).

Leitat

The Leitat1 project is carrying out clinical and safety tests this weekend, with the intention of trying to implement it in five days. The Catalan company Leitat, together with the Barcelona Free Zone Consortium, HP Spain, Almirall and the Terrasa Health Consortium have collaborated for the project.It is a field respirator, not a UCI, which they assure that they will be able to produce between 50 and 100 units per day in case they receive the necessary approval.

Initially, the prototype, made with 3D printers, was intended to intubate a patient for three or four days but not longer, because the air pressure was not adjustable. But in the latest models, volumetric sensors, pressure sensors and oxygen alarms have been added to improve your safety.

The # Leitat1 continues endavant amb les proves cliniques i de seguretat aquest cap de setmana. It is planned to implement it in 5 🏥 in the propers dies.

Amb joined by @Leitat @ConsorciZF @ CSTerrassa @ parctauli @HPEspana @cellnextelecom @salutcat # Almirall # RespiraLeitatX # COVID19 pic.twitter.com/6nmLLu9SfY

- Breathe Leitat X (@respira_leitatX) April 3, 2020

The Open Ventilator

This is a project devised by Javier González, a materials engineer at the Rey Juan Carlos University (URJC). The Open Ventilator is a joint work of the Faculty of Health Sciences.

As the creators describe, "The Open Ventilator can be mass-produced with the tools commonly found in any machine shop, not even 3D printing required. All components used are also European certified." It is an open prototype and has been powered by Celera, a national network of young talent. These days, the Official Central Laboratory of Electrotechnics has granted them approval to continue with their production.

Acute-19

The Acute-10 project is presented by Oximesa Nippon Gases together with the Veterinary Faculty of the CEU Cardenal Herrera University and the La Fe University and Polytechnic Hospital of Valencia. It is a turbine respirator and on April 3 they reported that they had completed phase 3, after testing without patients at a clinical simulation station and testing the prototype on animals.

"The Acute-19 turbine ventilator demonstrates its ability to maintain ventilation in a severe respiratory distress model, while also allowing weaning and supporting patient ventilation with CPAP."

Phase 3 is complete and the ACUTE-19 turbine ventilator demonstrates its ability to maintain ventilation in a model of severe respiratory distress, further allowing weaning and supporting patient ventilation with CPAP. # acute19 pic.twitter.com/mUQ1KrNthE

- ACUTE-19 (@ 19Acute) April 3, 2020

The turbine respirator will be available in open source and is expected to begin mechanization for production in about 15 days.

Other projects

Other projects that are having more difficulties in receiving the approval of the Spanish Medicines Agency are the project of the Catalan company Noel, with an electronic control for air inspiration, and the project of the Aragonese engineer Jorge Cubeles, who has developed a respirator with internet connection. An addition that would enable the status of patients to be analyzed from a remote control station.

However, these electronic add-ons have been an added difficulty in obtaining its approval, despite having the support of companies such as Balay, willing to offer its machinery. And it is that of the 40 proposed respirator projects, only six are still under evaluation and only two already have full approval to start production.

SEAT starts production of its artificial respirator: up to 300 units per day

The largest artificial respirator project is OxyGEN, the result of the joint work of Protofy.xyz, SEAT, the Germans Trias i Pujol Hospital and Research Institute, the Hospital Clínic, and other companies and administrations such as the University of Barcelona, ​​Recam Laser, Doga Motors, Luz Negra, LCOE, Ficosa, Bosch, IDNEO, Secartys, Cuatrecasas, Espiroflex, Gaso and the bodies of the National Police, Guardia Civil, Urbana and Mossos d'Esquadra. As we see, a project that has brought together multiple organizations and teams to achieve an approved and functional artificial respirator.

The Spanish Medicines Agency has chosen OxyGEN as one of two respirators that can already be produced on a large scale to be applied in hospitals. As announced by the Minister of Health, Salvador Illa, SEAT will produce over the next few days up to 300 emergency respirators a day on the SEAT León assembly line in Martorell.

The last step to obtain the certification has been to obtain the static magnetic electricity test of the device to ensure that it does not interfere with the rest of the ICU equipment. During these days, SEAT teams have worked against the clock to pass the required tests.

SEAT has produced these assisted respirators by adapting a motor to the windscreen wipers. A total of 150 employees from different areas started working for a week on the development of this prototype, after 13 different models.

"Each SEAT respirator has more than 80 electronic and mechanical components and passes extensive quality control with UV sterilization."

"Each respirator has more than 80 electronic and mechanical components and undergoes extensive quality control with UV sterilization," explains the company. The device has been designed by the free hardware company Protofy.xyz under the medical direction of doctors Dr. Manel Puig Domingo (Germans Trias i Pujol Research Institute), Dr. Oriol Estrada (Germans Trias i Pujol Hospital), and Dr Josep María Nicolás (Hospital Clínic).

Parameters that are measured include heart rate, blood pressure, body temperature, inspiratory air volume and pressure provided by the respirator, oxygen saturation, and CO2 in exhaled air.

Two of these respirators are already in Can Ruti and can be used after receiving permission from the Spanish Medicines Agency. SEAT directly thanks the director of the agency and the Minister of Health for their personal involvement. After momentarily halting production due to the uncertainty of its certification, SEAT will finally be able to manufacture this respirator on a large scale, adapt its production lines, adapt shifts and help health services.

Hersill and its VIATE 40: the largest national producer is commissioned by the Government

Located in Móstoles, founded in 1987 and with 60 workers, the Madrid SME Hersill was already the largest producer of respirators nationwide. But its production level was below what this crisis needs.

Your VITAE 40 pulmonary ventilator weighs less than 1.4 kg and is designed to be held in one hand. The emergency respirator includes "all ventilation modes, integrates capnography options (including an interface for volumetric capnography) and wireless communications (bluetooth and wifi) for selective downloading of ventilation logs for real-time or remote analysis from the hospital. It also includes specific ventilation modes for CPR and exclusive assistants (CPR wizards) according to the latest ERC and AHA guidelines. " A complete and approved respirator that has received a significant boost to face the COVID-19.

Military engineering firm Escribano Mechanical & Engineering has teamed up with Hersill to produce up to 5,000 lung ventilators over the next 8 weeks. A request that arises directly from the General Secretariat of Industry.

Last Friday, the President of the Government, Pedro Sánchez, together with the Minister of Health, Salvador Illa, paid a visit to the Hersill facilities to observe first-hand this initiative to manufacture respirators. In total, Escribano and Hersill aim to produce about 100 respirators per day. That is, multiply by ten the production of 10 units a day that Hersill maintained to date.

If the plans continue as planned, Spain will be able to supply itself with respirators in June and it could even be possible to create a surplus. Devices that could be exported to those countries that are in a similar situation to the one that now affects Spain.

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