SANTOS, C. F.; SANTOS, Cleber Ferreira dos.
Résumé:
Medical device’s Brazilian regulation, compresis the materials for use in healthcare,
medical equipment and in vitro diagnostic, widely used in hospitals and even home
environments, should contain essential principles of safety and efficacy that these
products have to meet. In order to meet these commandments we seek to verify how
such devices comply with the requirements in national or international standards. The
universe of medical devices is huge, estimated at over eight thousand items, and the
standards currently available to this group of devices, which is estimated at more
than 800 standards, making it difficult to identify the health aspects related
specification and safety. This it is a major challenge for the ANVISA, responsible for
controlling and also for the evaluation of these products by laboratories, promote this
control. This paper aims to present a systematic model for the establishment of the
relevant universe of health products in terms of knowledge of material properties and
characterizations of the currently proposed technical specifications. This proposition
will allow health surveillance activities been focused on the critical points of the
sanitary control of each or group of medical devices, increasing the effectiveness of
this control and giving transparency to the action of the Regulatory Agency.