Post-market evaluation of medical electrical equipment

PURPOSE: The present paper discusses the technical assistance for electrical equipment under sanitary surveillance by analyzing Brazilian regulations and legislation and proposes an improved post-market approach based on international standards. METHODS: Brazilian legal and regulatory documentation was the basis of this research. The time span from 2000 to 2020 was used to review the legislation. The actual post-market practice in Brazil was examined in detail, and it was pointed out that there is a clear dichotomy between the legal foundation and the patient protective practice. RESULTS: The Brazilian National Health Surveillance Agency regulates and the Brazilian National Institute of Metrology, Quality, and Technology owns the conformity assessment scheme of medical electrical equipment under a sanitary surveillance system. The conformity assessment is based on a certification process using technical standard series IEC 60601. The certification in its present form does not consider any active post-market surveillance, which is a potential risk for the final users because of the varied medical electrical equipment. From the consumer protection perspective, the objective responsibility of service providers includes accountability to the eventual harm caused by the equipment in normal operation. Therefore, a clear regulation or legislation on post-market technical assistance is of interest to the medical industry and technicians. CONCLUSION: The prospective assurance of the safety and performance of the well-being of citizens would be much more probable to be assured with the renewing of legislation on the post-market evaluation of medical electrical equipment, mainly if international technical standards are used. The dissemination of available medical electrical equipment technology would consequently help public health. Revising the post-market surveillance approach could lead to a better response to deal with medical electrical equipment maintenance issues.