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Rev Panam Salud Publica. 2017 Aug 21;41:e105.

[Model for a risk-focused approach to health inspection, surveillance, and control in Colombia].

[Article in Spanish]

Author information

1
Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogotá, Colombia.

Abstract

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.

PMID:
28902265
[Indexed for MEDLINE]
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