Brazilian Health Devices

The health products area is formed by a universe of different complexity levels that includes from a simple infrared bulb passing by compresses, prosthesis and means of culture up to equipments such as tomography and MRI. Therefore, they are items used to perform medical, dental, and physiotherapy procedures, as well as to the diagnosis, treatment, rehabilitation or monitoring patients.
Brazil has mechanisms that actuate to promote and protect the health. Anvisa – National Agency of Sanitary Vigilance is the governmental organ that has the responsibility to assure the sanitary safety of the health services and products, participating in the construction to its access. For this, it actuates from the registration and authorization of these products and services to reach the market up to following-up their performance during the next post-commercialization phases.
The Good Manufacturing Techniques (GMT) are Anvisa’s specific rules that set the applicable techniques to the manufacturing of medical products from their methods and controls used to the design, purchase, manufacturing, packaging, labeling, storage, up to their installment, usage and technical assistance of all products of the sector. Such legislation determines that every medical-hospital product supplier must fulfill all requirements to assure the safety and effectiveness of its usage. Besides, such certification aggregates value to products and equipments, establishing rules to implant a culture of preventive actions to minimize corrective actions.
By means of local sanitary vigilances, periodic auditing are performed in those certificated companies, but despite the mandatory feature of fulfilling the GMT, the own consumer market has been more demanding in such certification. Brazil already has an association that works intensively aiming to incentivate the industry to certify its products with the Good Manufacturing Practices, It is the Brazilian Association of Certified Companies, that actuates providing support to bid processes, and promoting a permanent interaction between its associates and Anvisa.
After analyzing and approving, it is issued a commercialization authorization for a period during which the product will be subject to usage and performance tests in big scale, a fundamental assessment to base subsequent revalidations or the withdrawn from the market, in the event it is verified damages to the health or adverse effects related to its use.
In order to grant the prorogation concession and for new certifications, the criteria assess whenever a company has any occurrence that must demanded a sanitary measure. The Anvisa techno vigilance, through Hospitais Sentinelas of health professionals or the consumers may receive a problem notification of the health product. Therefore, the post-market assessment is another controlling tool that allows analyzing possible claims, and whenever they are proved to exist, it is settled the need to implement corrective measures.
The Hospitais Sentinelas project was first created in 2002, formalizing a partnership with big-sized hospitals, mainly public universities, to implant the vigilance on inputs used in hospitals. The network of hospitals incorporated the systematic data collection of adverse events and non-conformities related to such health products, further of counting on capable professionals to identify errors in working processes of the health services, and to check any suspicious in the quality of these inputs, and in such cases, to notify Anvisa.
The formation of the Rede Sentinela has set a limited amount of hospitals to make the contract and the cash repassing. But later, it was enlarged by means of the adhesion of collaborator services that receive training and notify events to the system. The formation of the network had as basis the voluntary adhesion through an invitation which is sent to big size and high complexity hospitals involved with assistance, teaching, and research, distributed in every Brazilian state. During these years, improvement plans were implanted taking care of the rational use of medications and technologies, added to the hospital quality and safety to patient’s plans.
Such work was revealed to be an interesting low cost strategy to the diffusion of the vigilance concept in health and hospital services. While it incentives the notification of adverse events and technical claims related to health products, it facilitates the introduction of new focus on the controlling actions for hospital infection, propitiating the enlargement of the vigilance to different events, contributing to the increase of the effectiveness, safety and sustainability of the country’s hospitals.
Crowning the struggle of such initiative, Anvisa and Projeto Sentinela were rewarded with the third place in the 11th contest “Public Sector Innovation” of the National School of Public Management (ENAP) as one of the most important and innovative initiatives of the Federal Government.