Mechanical respirators #InnspiraMED receive Invima’s endorsement for clinical trials in humans

The three mechanical ventilators developed by the InnspiraMED initiative, intended for the care of critical patients affected by Covid-19, received the authorization of the National Institute of Drug and Food Surveillance (Invima) to conduct clinical trials on 15 patients in three hospitals and clinics in Medellín.

Following evaluations by Invima, the three prototype mechanical ventilators that are part of the InnspiraMED initiative were authorized to start clinical trials in humans.

“Invima, keeping in mind that this is an issue of national interest and of health public policy, as a Regulatory Agency, welcomes these national initiatives, and continues to be attentive to prioritise and contribute to the evolution of the procedures, while maintaining sanitary rigour, and safeguarding the individual and collective health of Colombians”, said the control entity in a statement this Thursday, July 16, in which they issued the following concept:

After analyzing and evaluating the related information, through the cases 20201120008 dated June 30, 2020 and 20201120029 dated July 13, 2020, the Specialized Room of Medical Devices and In Vitro Diagnostic Reagents, the development of Phase I of the protocol is approved “Performance evaluation of a standard mechanical ventilator model to meet ventilatory assistance needs during the health crisis due to infection with SARS-COV-2 COVID-19” of the INNSPIRAMED innitiative.

InnspiraMED is an initiative that carries out interdisciplinary and collaborative work coordinated by the Mayor’s Office of Medellín, through Ruta N and that has the funding of Postobón with a contribution of $ 9,000 million pesos and the IBD Lab. The ventilators were produced by three research and development teams (Universidad de Antioquia, Industrias Médicas Sampedro and EIA University ), each consisting of engineers, intensivists and pulmonologists, among others. Likewise, HACEB and Auteco Mobility lead the production of the devices.

An initiative articulated by the City of Medellín, through Ruta N, which has funding from Postobón and IBD Lab.

“We are going to give everything that is in our hands  to fight until the last moment so that no Colombian lacks a ventilator, a specialist and an intensive care bed, if so needed. I want to thank the whole team that has been fighting this battle and continues to do so,” said Medellín Mayor, Daniel Quintero.

According to Invima, clinical trials will be conducted in two phases in order to confirm safe and reliable ventilation in patients. The first phase will be carried out with a small group of patients and, after an evaluation by the regulatory entity, the second phase will be entered with a larger group of patients.

Once these two evaluation stages  are completed, they will be distributed to different regions of the country; this has been drawn up with the support of the National Government. It should be noted that the devices are in the process of industrialization while these tests are provided.

“Today, the InnspiraMED initiative takes a step forward in its purpose of providing the country with mechanical ventilators, needed for the care of the health emergency caused by the COVID-19 Coronavirus. Since the beginning, we have focused on maintaining scientific rigor so that the three equiptments we have designed are safe and very reliable, while we advance in their production and distribution, so that they can be used at the right time”, explained the manager of the InnspiraMED initiative, Gabriel Sanchez.

The institutions in which human trials will take place are the San Vicente Hospital Foundation, the Las Americas Clinic and the UPB University Clinic.

We must note that the initiative trained, under the clinical simulation model, more than 350 health professionals from the Aburrá Valley and other regions of the country in the management of the equipment, the correct use of personal protection elements, technical skills for advanced airway management in patients with respiratory distress caused by Covid-19 and the use of ventilators, among other topics. In addition, engineers who accompany and support the technical support of the intensive care units of health institutions were trained.