It is called SYSVent OM1 and it is “a ventilator developed specifically for intensive care”, it reads in the statement of the Order of Doctors (OM).
The Regional Council of the North of the Portuguese Medical Association presented the equipment today, after having been tested in April. In the same note from OM, compliance with the requirements for obtaining certification, in accordance with the European Medical Devices Directive, “namely administration and control of oxygen mixture, pressure and volume control, both in mandatory and in control mode, is confirmed. in assisted mode ”. That is, the ventilator allows those who operate it to control various parameters in the patient.
The ventilator is by the company SYSADVANCE, which is currently the only Portuguese company that holds the level of certification for the development and production of Class IIb Medical Devices – Life Support and was developed by “highly differentiated engineers” in partnership with a specialized team in intensive care of the Portuguese Medical Association. The company specializes in the development and production of Medicinal Oxygen generation systems in situ, “ie, produced on site,” being certified by SGS Belgium in accordance with ISO 13485 – Quality Management System for Medical Devices.
Still on the fact that SYADVANCE is the partner in the production of the ventilator now presented, Miguel Guimarães, president of OM, stresses that it is very important to have “a ventilator that guarantees the safety of patients”. And he added, at the conference that took place today, that “this fan was designed to respond and compare with the market reference fan”.
“Basically, it is a ventilator exclusively prepared for intensive care, in order to be able to actually perform its function, together with those who manipulate it, naturally, to give an answer that is suitable for any patient”, he adds.
Miguel Guimarães added that the fan will be available when the equipment “has the CE mark”. The CE mark is an indication of mandatory compliance for products marketed in the European economic area.
The next step is to see the initial objective fulfilled: to strengthen hospitals across the country. The expectation of those responsible is that the certification of SYSVent OM1 will be completed in November, including the phase of audits and tests, and that the ventilator will be available on the market by the end of the year.
“We are mobilizing great efforts to have it certified by November and produce it by the end of the year,” said administrator José Vale Machado, adding that he has already had international contacts and expressions of interest from Brazil, Saudi Arabia and Peru, among other countries.
Part of the fans are destined to reinforce the National Health Service (SNS). The protocol signed between the “Todos por Quem Cuida” fund and SYSADVANCE, this morning, describes that. “Thirty units [são] exclusively to offer to the SNS ”, says Miguel Guimarães. “Our goal is that each Portuguese hospital, which has intensive care, has a fan like this”
The 30 ventilators will cost around 210 thousand euros to the fund “Todos por Quem Cuida”, created by the Order of Doctors and Order of Pharmacists, with the support of the Portuguese Association of the Pharmaceutical Industry (Apifarma) and various civil society organizations.
The value corresponds to about 7 thousand euros for each unit. About this price, José Vale Machado said that this is “a significantly lower cost, less than half, that of the market-leading equipment”.
“The first unit was made in two weeks, then improvements were made to meet the requirements of the OM team with regard to the precision and reliability of the equipment and today we have equipment that is more accurate and more reliable than the market leader This is not a pandemic device, it is a device for massive use in intensive care “, described José Vale Machado, general director and chairman of the board of directors of SYSADVANCE.
The intensive care physician who led the medical team that monitored the development of this ventilator, António Carneiro, described that “intensive care ventilators are the most differentiated and demanding” and that what was intended was to make equipment “not just for the pandemic” .
Another important function is the ability of SYSVent OM1 to be controlled remotely, which in a pandemic or infectious environment is considered very important by the medical community, since it allows healthcare professionals to work with greater distance.
OM member Miguel Guimarães says that the ventilator is “an asset for the country, for our National Service and Health, and above all for our patients and companies.” The private sector will also be able to purchase the fans as soon as possible.
“Having capacity and autonomy, not being dependent on other countries, to have access to essential equipment in a health crisis is very important for the country”, says Miguel Guimarães, adding that these characteristics are valid not only in the area of health.