Regulatory Focus™ > News Articles > Brazil Launches New Adverse Event Reporting System

Brazil Launches New Adverse Event Reporting System

Posted 31 January 2014 | By Louise Zornoza 

Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products. 

Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form

The Municipal Hospital of Cuiabá was chosen to test the system, although any healthcare professional can post reports on the website, http://siac.justica.gov.br.  

The Ministry of Health plans courses to encourage adherence to the reporting requirement, and says that the process will be similar to the one currently used in hospitals to identify occurrences of violence against women. 

"We do not want to create another obligation," said Juliana Pereira, head of the National Bureau of Consumer Protection (Senacon), a department linked to the Ministry of Justice. "We hope to find new partners to expand oversight of unsafe products in Brazil, which are responsible for a lot of public and private healthcare expense in this country."

Health care providers will enter into the new system the patient's personal data, the product or service that caused the problem and the procedures adopted. There are specific fields to enter the brand, product model and supplier, but this information is not mandatory, because many times consumers themselves don't remember it. The data will be analyzed by the Ministry of Justice and the National Health Surveillance Agency (Anvisa) in order to evaluate the need for government action. The Ministry of Justice does not intend to make the reports public, unless government action is needed.

 

Government Statement

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