Metodologia de implementação de um laboratório de calibração de equipamentos médico-hospitalares

Abstract

Metrological control of health-care environmental equipment is essential for the assurance of their results. In Brazil, there is a lack of specific laboratories able to perform metrological control of such equipment. The purpose of this research is to introduce a methodology to establish the infrastructure and laboratory calibration modus operandi for medical equipment. The developed proposal is based on the requirements of ABNT NBR ISO/IEC 17025 standard, officially adopted by INMETRO, besides other specific publications about medical equipment management, and laboratories certification criteria established by ANVISA. The achieved results are: a guideline for the establishment of a medical equipment uncertainly measurement; a calibration procedure for sphygmomanometers; and performance indicators for the laboratory. The resultant methodology allows the laboratory candidate to reach its accreditation goal up to INMETRO and ANVISA, with an approach which covers the definition of the laboratory area, its politics and responsibilities, documentation and accreditation requirements. Then, the process to obtain the qualification of a calibration laboratory will be reached, fulfilling the existing gap in the quality system of health-care environment.