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The ‘Andalucía Respira’ respirator, created by doctors and engineers in the south of Spain has received approval from Spain’s national medicines and health products body and can now enter the manufacturing phase before being deployed to fight the battle against Covid-19 coronavirus.
The Junta de Andalucia’s Ministry of Health and Families has received authorisation from the Spanish Agency of Medicines and Health Products (AEMPS) after exceeding all the necessary requirements for its approval in a satisfactory manner.
The device has successfully passed various tests under the supervision of a certifying company, improving the results every day. The last one tested the electromagnetism of the equipment, a matter of special importance since it directly affects the safety of the device, both for the patient and for interference with the rest of the medical equipment in an intensive care unit. This has resulted in a fifth model of ‘Andalucia Breathes’, which has already become an industrial prototype that will serve as a guide in the production of respirators that can be used in hospital ICUs to cope with healthcare in the COVID-19 crisis.
After completing its homologation process, it is estimated that it will have a manufacturing rate of about 50 respirators per week, a process in which companies from Sevilla, Jaén and Cádiz would participate, in addition to Malaga, the city where the idea started, positively influencing the economy in this crisis situation, by providing jobs to technology companies.
Clinical trials in patients, animals and artificial lung
The respirator has had numerous tests to reach its final approval by the AEMPS. Initially, after an execution phase of the first prototype in two days, the artificial lung test was successfully completed; then in one animal and two human clinical trials were subsequently carried out.
The first of these patient trials took place at the Antequera Hospital on Monday, March 30, and the second at the Virgen de las Nieves Hospital in Granada on Thursday, April 2. Both patients, diagnosed with COVID-19 and hospitalised in the ICU, were accompanied by a specialist physician to assess possible variations in their vital signs in case they needed to use a conventional respirator at any time through a simple manoeuvre. Both trials, which were essential to advance the approval of the respirator, were made possible thanks to the consent of the patient’s relatives.
Multidisciplinary team of professionals
This prototype respirator has been devised by a team of professionals from different fields driven by the desire to improve the current situation of patients with COVID-19 and collaborate with health professionals. Ignacio Díaz de Tuesta, a cardiovascular surgeon, and Miguel Ángel Prieto, intensivist, both from the Regional University Hospital of Malaga, participated with José Luis Guerrero Orriach, an anaesthetist at the Virgen de la Victoria University Hospital in Malaga. This medical team also had the advice of Gonzalo Varela Simó, thoracic surgeon and scientific advisor at the University Hospital of Salamanca.
In order to transfer the original design of the idea to engineering applied to health, taking into account the parameters indicated by health professionals, Víctor F. Muñoz, and Carlos Pérez del Pulgar, professors of Engineering from the University of Malaga and responsible for programming the automation. Likewise, the UMA professor María Victoria de la Torre, the intensivist of the Malaga Regional Hospital Emilio Curiel and the veterinarian of this institution, Ricardo González-Carrascosa, as well as a good number of companies that, in solidarity, have participated contributed to contribute material to be able to produce this prototype, among which are Veolia, CATS and Dekra.
Also participating in the development of this prototype are the scientific director of IBIMA, Francisco J. Tinahones, as well as Isabel Guerrero and María Mengual, from the Innovation Unit of this Malaga research institute, Juan Aranda, its managing director, Gloria Luque, member of the SCReN clinical trials platform, and the IBIMA manager, José Miguel Guzmán.
