In Peruvian hospitals, vaccines are not the only eagerly awaited good. So are the Wayrachis, an oxygen distribution system produced in our country that has made the difference between the life and death of many seriously ill patients from COVID-19. But, right now, its manufacture is at risk due to bureaucratic state regulation.
On February 4, from Piura, Essalud reported that “half of the patients with severe coronavirus pictures who used the Wayrachis high-flow oxygen devices recovered without the need to enter the Intensive Care Unit (ICU).”
Dr. Luis Chucas Asencio, head of Emergency Critical Care at the Edgardo Rebagliati Hospital, pointed out to Peru21 that “the goodness of this team is that it provides high-flow oxygen therapy.” In other words, it is a ventilatory cannula that prevents the patient from getting worse and is connected to a mechanical ventilator, which is now lacking in the country.
Camilo Parra, Daniel Akamine and Fernando Sato are the Peruvian engineers who began to produce these Wayrachis since April last year, thanks to the support of the private sector. These high-flow regulators have been donated to the Ministry of Health and Essalud, but now a regulation of the General Directorate of Medicines, Supplies and Drugs (Digemid) – the same one that was involved in the VIP vaccines scandal – has caused the production stops and that more Wayrachis do not arrive where they are needed, the country’s hospitals.
In January 2021, Digemid included medical oxygen regulators in the list of medical products that need a sanitary registration to be distributed. During 2020, these regulators did not need Digemid’s bureaucratic seals. That is why its manufacture began without major inconvenience.
In other words, if engineers Parra, Akamine and Sato now want to continue producing these equipment for donation, they must initiate a procedure with the entity – which depends on the Minsa – which would have to grant them the green light. The problem is that at the moment, researchers continue to receive requests from various hospitals that the Wayrachis need to save lives, and the regulation keeps their hands tied.
“In the midst of a pandemic, asking for regulations is illogical. Lives are saved in emergencies. Who is going to question if I have saved lives? It’s illogical. Authorities may say not to be used until the quality of the equipment is tested, but that should be when the pandemic is brought under control. At the moment it has not been controlled, ”says Dr. Chucas.
Lida Hildebrandt Pinedo, director of Medical Devices and Health Products at Digemid, points out that “for a security issue, whether it is given, donated or whatever, they must have Digemid monitoring.”
“They are used in humans and it has to be registered in any way for a security issue. As a prospective patient, I would like to know how safe that medical device is, ”Hildebrandt said. The official added that if the engineers who manufacture the Wayrachis want to continue doing so, they must initiate a process through the virtual window.
“They should have all the technical information at hand. It is not a trap. If they have all the documentation, it comes out in two days (the authorization), ”Hildebrandt said.
KEEP IN MIND
- Wayrachi is a Quechua word that in Spanish means ‘ventilation’.
- To date, around 500 Wayrachis have been manufactured and distributed nationwide.
- The Wiese foundation has managed and financed a significant donation of these equipment to Essalud.