• Authorized by the Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, Consumption and Social Welfare.

• The only ventilator approved by the AEMPS alternative to conventional ones with CE marking in the field of clinical research in the framework of a clinical study promoted by IBIMA.

• The ANDALUCÍA-Respira pulmonary ventilator has been developed as a contingency measure in a scenario in which it is not possible to get enough conventional ventilators and in which the unavailability of a mechanical ventilation system compromises the life of the patient and has to limit the therapeutic support measures in the absence of these vital products.

• Indicated for invasive mechanical ventilation as a treatment for patients requiring mandatory mechanical ventilation with high flows, among others in the pathology of Acute Respiratory Distress Syndrome (ARDS) due to COVID-19.

‘Andalucía Respira’, an initiative born in Malaga by scientists with the need to respond to the health emergency of COVID-19

Thirty years ago, Ignacio Díaz de Tuesta, cardiovascular surgeon at the Regional University Hospital of Málaga, wrote his thesis on what would go on to become the initial idea behind the Andalucía Respira (formerly Málaga Respira) ventilator. At that time, nobody imagined that this thesis, which was made into a product and successfully tested 30 years ago, would end up being key in a global healthcare crisis, meeting a possible healthcare need in Andalusia as a result of the COVID-19 pandemic.

Díaz de Tuesta, who knocked on the doors of the Biomedical Research Institute of Málaga (IBIMA, for its initials in Spanish), was put into contact with a multidisciplinary team that includes engineers, intensive care physicians, anesthesiologists, collaborating companies, and more; an expert team with a common objective: save lives in the face of the incessant advance of a new disease that does not distinguish by class or borders.

Professionals from IBIMA, the University de Málaga, and the two public hospitals in Málaga: the Regional University Hospital of Málaga and the Virgen de la Victoria Hospital of Málaga, worked together to come up with a solution in record time. They also had the support of the Ministry of Health and Families of the Regional Government of Andalusia.

UMA engineers Víctor F. Muñoz Martínez and Carlos Pérez del Pulgar (along with engineer Antonio Santiago de Veolia) and healthcare workers José Luis Guerrero, María Victoria De la Torre, Emilio Curiel, Miguel Ángel Prieto, and Gonzalo Varela also collaborated on the project.

Furthermore, a coordination and management team from IBIMA also contributed. This team included the Innovation Unit (Isabel Guerrero Molina and María Mengual), Gloria Luque (member of the SCReN clinical trials platform), Juan Aranda (director of management), and David Gómez (press and communications). They also had approval from Science Management (Francisco J. Tinahones) and Management (José Miguel Guzmán de Damas) so that this project was able to become a reality in just over one week. The project also had help from Marina Fernández of the Regional University Hospital of Málaga’s Communications Unit and from Rafael Parodi for corporate identity aspects.

What’s more, the work of Ricardo González Carrascosa, specialist in animal health and veterinary medicine at the University of Málaga, played a key role in the trial in animals. Another group of professionals that should be recognized is the medical device team at the Virgen de la Victoria University Hospital.

At the same time, a large group of companies collaborated with the team of scientists. This facet of the project was launched thanks to the collaboration of the Andalusia Technology Park (PTA, for its initials in Spanish), with the invaluable help of its president, Felipe Romera.

The project continued moving forward thanks to the hard work of companies that collaborated with the cause, including Veolia, CATS, Ortoplus, Dekra, TMC, Tecnomeca, and IMG Trade, among others.

After the initial version of the ventilator completed a first test in an artificial lung and a second test in an animal model, the ventilator continued evolving until it became what the team called ‘Andalucía Respira 3,’ which was the final execution phase. Upon receiving approval from the Spanish Agency of Medicines and Medical Devices (AEMPS, for its initials in Spanish) and the Research Ethics Committee of the Province of Málaga, and after receiving the informed consent and authorization from the patients’ families, a clinical trial was carried out in two patients in Andalusia.

The final version, ‘Andalucía Respira 5,’ is lucky enough to have the advanced technology company Fujitsu to produce the devices, also in record time, in order to be prepared for a healthcare emergency. The rate of production is one device every two hours, or 50 units per week.

The device met all AEMPS requirements and was authorized on April 10, 2020. It is able to be used in intensive care units. Lastly, it is the only alternative to conventional ventilators with CE marking approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) in the scope of clinical research.