The State Control Center for Medicines, Equipment and Medical Devices (Cecmed) has authorized the clinical use of Combiovent high-performance ventilation equipment, the first of its kind to be manufactured in the country, developed by the company Combiomed, owned by BioCubaFarma.
This was announced on Tuesday -as part of the 15th health for all fair, which takes place at the Pabexpo exhibition center-, engineer Alejandro César González Urquiza, member of the team that developed the ‘device, which clarified that the license It was awarded after a rigorous validation process.
Previously, he explained, two satisfactory experimental tests were carried out on pigs, which were ventilated under the supervision of the regulatory authority. Subsequently, a stability diagnosis of the equipment was approved, which was put into service for a long continuous period, without showing any failures.
After all the validation process carried out with Cecmed, where tests were carried out on the software, the pneumatic system and the electronics of the equipment, the entity granted the authorization for use in humans, in order to testing it in patients with ventilatory needs. .
Professor Alberto Martínez Sardiñas, anesthesiologist, intensivist and project manager, indicated that two of these devices are already located at the Calixto García Hospital and the Neurology Institute, respectively, while the third, which is now on display at the Fair, He will be transferred to the Hospital Miguel Enríquez, also in Havana.
He specified that within ten days clinical trials should begin in ventilated patients of these hospitals, with medical personnel previously trained and advised by the developers of the device.
Martínez Sardiñas pointed out that this equipment represents a possible solution to provide all forms of ventilation to severe and critical patients in Cuba. It was born from the difficulties of importing these devices, which during the covid-19 acquired a high cost.