Given the appearance on the island of the first cases of COVID-19 in the month of March last year, the Cuban government attempted to purchase ventilators from the Swiss companies IMT Medial AG and Acutronic, as part of plans adopted to guarantee the resources needed to confront the epidemic.
But when these suppliers were acquired by the U.S. company Vyaire Medical Inc. both firms cancelled their commercial relations with Cuba, submitting to the provisions of the criminal economic blockade imposed by the United States on our country six decades ago.
It was then that the country’s leadership entrusted to the Cuban Neuroscience Center (Cneuro) the mission of developing a ventilator in record time, to ensure that no one would be left without this vital means of emergency medical assistance, should he or she need it.
The plan required putting together a multidisciplinary team of specialists from Cneuro, the Union of Military Industries’ Grito de Baire facility, the Combiomed Digital Medical Technology Enterprise, the Center for the State Control of Drugs, Equipment and Medical Devices (Cecmed) and the National Design Office (ONDI).
Dr. Mitchell Valdés Sosa, general director of Cuba’s Neurosciences Center, answered a few questions about the innovative project.
What types of ventilators have been developed and how are they used?
We have worked on two models of pulmonary ventilators: one basic invasive model and a non-invasive one. The first of these, called Pcuvente, is an automatic device designed for emergency ventilation for short, uninterrupted periods of time.
It is suitable for Intensive Care Units (ICU) or post-surgical recovery rooms, and during transfer in or out of the hospital. It allows for controlled and assisted volumetric ventilation, and uses a battery, which provides independent functioning for more than an hour.
With the non-invasive ventilator, the patient breathes spontaneously within an air pressure environment higher than the atmospheric level, with the generation of a continuous positive air pressure flow to the airway, so it is not necessary to intubate the patient.
It is designated for use primarily in cases of mild respiratory distress, contributing to improvement of alveolar ventilation and, above all, reduces the frequency of intubation. It is currently in the development stage.
Can the Pcuvente be used in treating COVID-19 patients?
Since it is a basic ventilator, which only includes the volumetric form of ventilation, and given the severity with which COVID-19 acute respiratory distress syndrome usually develops, its use is not recommended for patients with this disease.
However, its introduction in intensive care units (ICU) can provide coverage for cases with less severe respiratory distress and high-end ventilators can be redirected to serve patients with COVID-19, reducing the chances of ICU collapse due to a lack of pulmonary ventilators. It has been approved by Cecmed for use in post-surgical recovery rooms and testing in intensive care is being conducted at this time.
We plan to manufacture 250 units, of which 77 have already been delivered to the national public health system. An equal number of non-invasive ventilators will also be produced.
It should be noted that the design of the first model is based on open codes published on the internet by researchers at the Massachusetts Institute of Technology, in the United States; while the noninvasive ventilator was based on open codes made available on the net by University College London. But the software and the industrial design are the work of Cuban experts.
How long did this take?
The design and development process began in the last days of March 2020, and by June, we had a prototype ready for animal testing. In October we began the human trials, that is, only six months after the project was conceived.
How have the ventilators been certified?
They underwent several stages of testing. First, their operation was studied in animals (pigs), specifically to evaluate their safety during ventilation.
The device provided adequate alveolar ventilation, maintaining arterial oxygenation. Respiratory effort was reduced and no manifestations of bronchial spasms or hemodynamic instability occurred in the sedated animal.
We then moved to studies with patients, which required obtaining an emergency use permit from Cecmed. The trials were conducted at the Manuel Fajardo, Miguel Enriquez, and Calixto Garcia hospitals, and included 16 patients in anesthesia recovery, in which the ventilator proved to be safe (no adverse events were identified during the time of the trial) and effective in replacing natural respiratory functioning.
Based on the results observed, in December of 2020 Cecmed granted a special-purpose use authorization, specifically in anesthesia recovery rooms. Although this is not an application directly associated with COVID-19, it frees up more sophisticated ventilators that can be redirected to intensive care units.
The design, development, production and introduction of the Pcuvente in such a short time would not have been possible without the multidisciplinary and multi-institutional alliance created for this purpose.
Equally noteworthy is the role of all the hospitals mentioned, as well as the contribution made by Dr. Juan Carlos Rivero López, head of the Provincial Group and secretary of the National Intensive Care Group, who has served as the clinical investigator responsible for the preclinical and human studies, and has accompanied the Cneuro team from the earliest stages of the project.
FOR YOUR INFORMATION
The Neuronic/Pcuvente v 1.0 emergency pulmonary ventilator is the result of a commendable effort by engineers and technicians at the Cuban Neurosciences Center, in collaboration with other enterprises and institutions in the country. They have produced an emergency pulmonary ventilator based on mechanical and automatic compression of a self-inflating resuscitator, originally for manual use, which can be used in the event of acute respiratory failure, when the patient is short of breath or very distressed, requiring support for a short period of time. This model can be used with adult patients who have been intubated previously via an endotracheal tube and are not on a conventional mechanical pulmonary ventilator. The Pcuvente was authorized by Cecmed for use in post-surgical patients with shortness of breath or respiratory depression in post-anesthesia recovery rooms, by personnel qualified in resuscitation, and trained in its use under the supervision of an anesthesiologist, critical care or emergency room physician. (Dr. Humberto Sainz, head of the National Expert Group on Anesthesiology and Resuscitation of the Ministry of Public Health, and Cecmed expert evaluator of medical equipment and devices)
Engineer and Master of Science Arlem Lesmes Fernández Sigler, director of the Combiomed Digital Medical Technology Enterprise, reports that work is underway on the development of a third high performance pulmonary ventilator, to be used in ICU with COVID-19 patients in serious or critical condition, or who have other types of complications. This is, he stated, the most complex project undertaken by the company in its more than 35 years of work in the field of medical technology, and specifically in its more than 25 years of experience in creating equipment for monitoring patients and life support in our country. This Cuban high-end pulmonary ventilator will incorporate the features of standard ventilations available worldwide, and will offer attractive and safe visualization, operation and connectivity options. All the electronic, pneumatic, mechanical, industrial, graphic, firmware and software design solutions are the work of Cuban science. The first prototypes are expected to be ready in March, and will be introduced in our National Public Health System later in the year, after necessary, compulsory testing has been completed to confirm their safety and effectiveness, as part of the process for sanitary registration in Cuba. This ventilator should play an important role in replacing imports, with a cost less than half of the price for similar models on the international market, while also representing potential for export.
(Taken from Granma)