The device, designed in Málaga and advanced by the Ministry of Health and Families and the University of Málaga, moves on to the manufacturing process
The Ministry of Health and Families has received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS, for its initials in Spanish) for the ‘Andalucía Respira’ respirator after the device successfully completed all the necessary requirements for its approval.
The device successfully completed various tests under the supervision of a certifying company and yielded better results each day. The final test was on the machine’s electromagnetism, an issue of particular importance given that it directly affects the device’s safety, both for the patient and in terms of interference with the rest of the medical equipment in an intensive care unit. The result of these tests is the fifth model of the ‘Andalucía Respira’ respirator, which has already been converted into an industrial prototype that will serve as a guide for the production of respirators that can be used in hospital ICUs in order to meet the demand for healthcare during the COVID-19 crisis. After having completing the approval process, it is estimated that it will be manufactured at a rate of about 50 respirators per week. Companies in Seville, Jaén, and Cádiz along with companies in Málaga—where the idea for the device emerged—will participate in this process. This will have a positive economic effect during this crisis, as it generates work for technology companies.
Clinical trials in patients, animals, and artificial lungs
The respirator has undergone numerous tests in order to receive final approval from the AEMPS. Initially, after completing the execution phase of the first prototype in two days, it was successfully tested in an artificial lung. Afterwards, it was successfully tested in an animal model and later, two clinical trials in human beings were performed.
The first of these trials in patients took place at the Antequera Hospital on Monday, March 30. The second took place at the Virgen de las Nieves Hospital of Granada one week ago on Thursday, April 2. Both patients, diagnosed with COVID-19 and hospitalized in ICUs, were accompanied by a specialist physician over the course of 4 hours in order to evaluate possible variations in their vital signs so that they would be able to be switched to conventional respirator at any moment through a simple maneuver. Both trials, which were fundamental for moving forward with approval of the respirator, were made possible thanks to the consent of the patients’ family members.
Multidisciplinary Team of Professionals
This respirator prototype was invented by a team of professionals from different fields who were moved by a desire to improve the current condition of COVID-19 patients and to collaborate with healthcare professionals. The team includes Ignacio Díaz de Tuesta, cardiovascular surgeon, and Miguel Ángel Prieto, intensive care physician—both from the Regional University Hospital of Málaga—as well as José Luis Guerrero Orriach, anesthesiologist from the Virgen de la Victoria University Hospital of Málaga. The medical team was advised by Gonzalo Varela Simó, thoracic surgeon and scientific adviser at the University Hospital of Salamanca.
Víctor F. Muñoz and Carlos Pérez del Pulgar, engineering professors at the University of Málaga who were responsible for programming the automation, participated in the transfer of the idea’s original design to healthcare engineering, taking into account the parameters indicated by the healthcare professionals. Likewise, UMA Professor María Victoria de la Torre; Emilio Curiel, intensive care physician at the Regional University Hospital of Málaga; and Ricardo González-Carrascosa, UMA Veterinarian, also participated, along with numerous companies who contributed by voluntarily providing material in order to produce the prototype, including Veolia, CATS, and Dekra.
IBIMA Scientific Director Francisco J. Tinahones along with Isabel Guerrero and María Mengual, from the Innovation Unit of the Málaga research institute; Juan Aranda, its director of management; Gloria Luque, member of the SCReN clinical trials platform; and José Miguel Guzmán, director of IBIMA, also participated in the development of this prototype.