Labelo joined group that will certify products to contain Covid-19
The Specialized Laboratories in Electro-Electronics Calibration and Testing (Labelo) have joined a network of laboratories and product certification bodies to support the fight against Covid-19. The project is intended to help official health agencies and society in the development of electromedical equipment and individual protection products, such as face masks and accessories. The infrastructure was made available at no charge.
The initiative is organized by Israel Dulcimar Teixeira, director of Labelo and vice president of the Brazilian Association of Conformity Assessment (Abrac), which joins the project along with the Ministry of Science, Technology, Innovation and Communications (MCTIC).
“Abrac has realized that several of its associates were being contacted by companies interested in developing lung ventilators. Because we have vast experience in health care, Labelo was highly requested, and we headed the initiative of the network together with the Eldorado Laboratory, in Campinas ”, the director says.
Labelo is developing tests on lung ventilators and emergency support devices. Because of the large number of ongoing initiatives, based on different designs and projects, it is important that each manufacturer knows the functional and prototype performance. This allows for the quick identification of any necessary adjustments to equipment in an intermediate stage of development. This saves time – an important resource at this time.
As they are critical life support products, the measurement reliability is extremely important. All tests simulate the normal use of the device, exposing it to real, but controlled and known conditions. The parameters of artificial lungs, for example, vary from person to person, such as complacency and resistance – organ characteristics related to the patient’s pulmonary efficiency.
There are several steps to be taken so that medical equipment and individual protection products can be put to use, in order to ensure their quality. “As the network components can be widely applicable, we are able to provide assistance in the stages of regulation and management systems, to conducting development tests”, Israel Teixeira adds.
The equipment must be manufactured by a company accredited by Anvisa; or by a Medical Device Single Audit Program (MDSAP)-certified company; or have Quality Management System certification. Additionally, it must follow good manufacturing practices (GMP).
Research and clinical validations, as well as the records of the usability evaluation of the equipment must be presented. Development tests, even if using recognized standards and methods, do not substitute testing for certification, since they are used for different purposes. While the first aims to implement improvements and technical checks to identify potential flaws and inconsistencies in the operation of the product, the second aims to show that the product meets the technical requirements applicable to the product.