Havana, Cuba.- The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) authorized the clinical use of the high-performance ventilatory equipment Combiovent, the first of its kind to be manufactured in Cuba.

The announcement was made during the 15th ‘Health for All’ Trade Fair taking place at Pabexpo in Havana by engineer Alejandro César González Urquiza, a member of the team that developed the device at the Combiomed Company, a branch of BioCubaFarma business group.

The specialist explained that the permit was granted after a rigorous validation process. “Previously, two satisfactory experimental tests were carried out on pigs, which were ventilated under the supervision of the regulatory authority. Afterward, a stability diagnosis of the equipment was approved, which was put into operation for a long and continuous period, without any failure,” he said.

He added that after the whole validation process carried out with CECMED, where tests were performed on the software, the pneumatic system, and the electronics of the equipment, the entity granted permission for its use in humans, to be tested on patients with ventilatory requirements.

Professor Alberto Martínez Sardiñas, anesthesiologist, intensivist, and project leader, informed that two of these devices are already located at the ‘Calixto García Hospital and the Neurology Institute, while the third one, which is now being exhibited at the Fair, will be transferred to the ‘Miguel Enríquez’ Hospital, also in the Cuban capital.

He commented that in about 10 days clinical tests should begin on ventilated patients at these hospitals, with medical personnel previously trained and advised by the developers of the device.

Martínez Sardiñas said that this equipment represents a possible solution to supply all the ventilatory forms of serious and critical patients in Cuba. Its creation was motivated by the difficulties to import these devices acquired at high cost during COVID-19.