CAJICA, Colombia –The government of Costa Rica issued guidelines recently that will allow the country’s social security system to source the country's hospitals with ventilators produced by the faculties of the universities of the Latin American country, during the COVID-19 outbreak. The guidelines were released as an emergency measure to face the second wave of infections that is predicted to hit the country soon.
"Our projections have shown us that the number of severe cases could at some point exceed the amount of resources available for mechanical ventilation, putting the lives of people who develop severe respiratory failure at risk," said Daniel Salas, minister of health of Costa Rica, in a letter sent to the head of the Social Security in the Central American country.
According to the Ministry of Health, the ventilators produced by the University of Costa Rica (UCR), as well as those designed and produced by the Costa Rica Institute of Technology (ITCR for its acronym in Spanish, but also known as the TEC), are now fully authorized to reach the ICU´s, if needed, even without having completed the clinical trials phases to prove their safety and efficacy.
“[Due to] the situation of the pandemic, already declared as a national emergency, and faced with a disease whose evolution and outcome could be fatal, thus justifies in emerging conditions the use of all available means to safeguard the life of a person, except in cases where people expressly have said otherwise; in such an eventuality, the principle of autonomy is respected,” the minister explained in the letter.
With a population of about 5 million inhabitants, the tiny country stands as 24th in the world with most cases per million of inhabitants. It only has about 105 ventilators available at the ICUs. 75 were bought abroad at the beginning of the outbreak.
At the TEC, a team of engineers and designers has been working around the clock for months, since March, in a bid to find a solution to supply the country's hospitals with more ventilators.
“We are in the preclinical phase, in which we will be able to evaluate the quality of the ventilators. We are going to do the tests on animals, and we are working simultaneously on developing the protocols for the clinical trials,” Adrian Quesada, professor and a leader of the team in charge of producing the ventilators at the Faculty of Science and Engineering of the Materials form the TEC, told BioWorld.
“The preclinical phase is scheduled to start on Oct. 6, and it will last for that whole week ... it’s possible that in November we could be asking the Ministry of Health for authorizations to initiate clinical trials,” he said.
Meanwhile, the country is bracing for a second wave of contagions of SARS-CoV-2, as the engineers join forces with the private sector to prepare to manufacture the ventilators under an emergency scenario.
Costa Rica stands as Latin America´s second largest med-tech exporter, just behind Mexico. A strategic location, political and economic stability and skilled manpower have positioned the Central American country as a site for large companies to set up large manufacturing facilities in free trade zones located in provinces like Alajuela, on the outskirts of San Jose, the capital city.
The country´s med-tech sector exported almost $3.7 billion worth of goods in 2019, accounting for 32% of the country's total exports.
Medtronic plc, from Dublin, Royal Philips Healthcare, from Best, Netherlands, Abbott Laboratories, from Chicago, Cardinal Healthcare, from Dublin, Ohio, Baxter International, from Deerfield, Ill, Smith & Nephew, from Watford, England and Boston Scientific, from Marlborough, Mass., are just some of the companies with large manufacturing facilities in the country that is home to seven of the largest global original equipment manufacturers and to about 70 other med-tech companies.
However, not only med-tech companies are weighing in on the much-needed help that the TEC requires. Most of the life sciences sector is committed to helping the country to overcome the pandemic.
Hoffmann-La Roche, from Basel Switzerland, which operates a manufacturing facility in the city of Heredia, already offered its installed capacity to help to develop the ventilators, should they be required.
“Roche has greatly supported the two initiatives, from UCR and TEC. We were able to conduct the overhauling of the mechanical ventilator into an electronic one, thanks to a grant from them. They have their lab ready to start producing the equipment,” said Quesada.
UCR already manufactured 10 ventilators at its own facilities.
“The universities have the capacity and the environmental conditions to produce them. However, if the required production is too high, we can now rely on Roche for their support,” he added.
Quesada estimated that their locally produced ventilators will cost about $3,000. The TEC owns the designs and intellectual property of the ventilators it is producing. However, the university is willing to release the designs to the public under an open source license, so that anyone can replicate their project.
“We would be releasing not only the plans and designs of the equipment, but also the whole programming code, so that the device can be reproduced as faithfully as possible, anywhere,” Quesada said.