The ventilator, developed by researchers from the Medical Robotics Research Group of the University of Málaga in a record time of 20 days, is already being manufactured, after receiving authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).
‘Andalucía Respira’ offers a real alternative to the ventilators which are currently being used in intensive care units of hospitals, since it is based on common low-cost industrial parts (of air conditioning, irrigation or from the tyre industry) and contains no mobile components, which reduces the risk of mechanical failure. The prototype can be manufactured in approximately two hours.
Before obtaining the authorization of the AEMPS, this device had to pass multiple tests, the last two of a technical nature, under the supervision of a certification company. The first one tested the electromagnetism, which is especially important since it has direct bearing on the device safety, both for patients and for its interference in the rest of the medical equipment in an intensive care unit. The second test aimed at proving the device autonomy with an uninterruptible power supply required to avoid breakdowns due to sudden power surges, which resulted in a duration of 48 hours.
In conjunction with these technical certifications, the ventilator had to pass two clinical tests on humans. Both tests were carried out for four hours on patients affected by COVID-19 and admitted to the ICU, resulting in success indicators that validated this technology.
Previously, after an execution phase of the first prototype developed in two days, it was successfully tested on an artificial lung and an animal model.