Medical devices alerts as an input data for the health technology assessment

OBJECTIVE: To verify if medical devices manufacturers treat equally users of their technologies in developed and developing countries, regarding their products safety information.
METHODS: Retrospective and comparative study between the manufacturers communications to the Brazilian Health Regulatory Authority – Anvisa, and the medical devices priority safety alerts published by the Emergency Care Research Institute – ECRI database, from September 26^th to October 26^th 2007.
RESULTS: We have identified that 32.40% of 108 High and Critical priority alerts published by ECRI were related to medical devices available in the Brazilian market and their manufacturers have not communicated them to Anvisa. Such alerts involved 51.43% High Risk class products and 5.71%, 25.71% and 17.14% of Maximum, Medium and Low Risk, respectively. The majority of these products were manufactured in the United States of America and Sweden. This confirms Brazil as   consumer of health technologies developed and manufactured elsewhere. The Brazilian Law mandates the manufacturers to communicate the risks associated with their products.
 CONCLUSIONS: Medical devices manufacturers and registry holders disobeys the law, omitting safety information about their products to the Brazilian users. Considering that these products presented high level of risk, increased potential for health harm, including fatalities; users, patients and health professionals should not be deprived of such safety information and alerts recommendations. This unequal treatment to our consumers led Anvisa to discuss new technical regulations making compulsory the reports of medical devices adverse effects by its registry holders in Brazil. Compulsory alerts will contribute to the assessment, monitoring and medical devices regulatory decisions in the Brazilian market.