Modelo para la inspección, vigilancia y control sanitario con enfoque de riesgos en Colombia

Colombian Ministry of Health Resolution 1229 of 2013 established that health inspection, surveillance, and control (IVC, Spanish acronym) should be based on a risk-focused approach. In 2014 Colombia’s National Food and Drugs Surveillance Institute (INVIMA) designed and implemented a risk-based health surveillance model called IVC-SOA. This model measures the risks of drugs, medical devices, food, and cosmetics by taking into account three factors: severity of the product (S), occurrence of product failure (O), and the potentially affected population (A) - hence its name, SOA. The model incorporates 40 variables and statistical methods that make it possible to create a risk profile for each entity surveyed, and thus to generate a ranking to determine which should be inspected. The objective of this report is to describe the methodology and results obtained following the design and implementation of the IVC-SOA model created by the regulatory agency in Colombia, and its impact on health surveillance effectiveness.