Evaluation of good manufacturing practices in the elaboration of enteral formulas in public hospitals of Santiago (Chile) [Evaluación de buenas prácticas de manufactura en la elaboración de fórmulas enterales en hospitales públicos de Santiago, Chile]
Lara Gonzalez S.,Hospital Clinico San Jose |
Domecq Jendres C.,Hospital Clinico San Jose |
Atalah Samur E.,University of Chile
Nutricion Hospitalaria | Year: 2013
Background: The development of enteral formulas (FE) is subject to various risks of contamination. The World Health Organization (WHO) and the Food and Agriculture Organization (FAO), have worried about alerting, recommendations and documents released to prevent contamination the FE, suggesting the standardization and protocols for all procedures involved. Objetives: The study was aimed to evaluate compliance with the technical criteria contained in a Guideline for Good Practice of Manufacture in relation to the development, maintenance and administration of enteral nutrition in hospitals of Santiago, in the Metropolitan Area. Material and Methods: The verification criteria considered Physical Plant, Equipment and Implementation, Hygienic and Sanitary Standards, Human Resources, Organization and Management, Safety and Warranty Quality Assurance. 639 criteria were defined, 309 risk Type 1, by mayor risk of producing pollution. The study was conducted by observing Central Units Enteral Formulas and interview with the caregiver. Medium of compliance for each group of criteria risk 1 and overall, was analyzed. Results: A total of 14 public hospitals were studied. The degree of compliance with the 639 reached a median of 33.2% (p25-75 31.6% -40.4%), with the lowest value for physical plant with 27.9% (p25-75 23.9% -38.2%) and the highest for human resources with 52.4% (p25-75 44.1% -52.4%). Median compliance for risk criteria Type 1 was only 31.8% (p25-75 27.5% - 41.2%). Conclusion: Most of the units tested, meets less than half of the internationals recommendations, or the Ministry of Health of Chile. It should develop protocols and train staff to ensure quality and safety in the development of enteral formulas and reduce risk of infection.