A Comprehensive Framework for Post-market Electrical Safety Testing and Performance Assessment of Medical Equipment in Healthcare Facilities

摘要

This paper presents a comprehensive framework for electrical safety testing and performance assessment of medical equipment, to be conducted as routine tests in healthcare facilities by clinical engineering personnel. The rationale for it is that very little has been published in terms of protocols, guidelines, policies and/or technical standards for post-market evaluation of medical equipment. Whilst type tests prescribed by current technical standards ultimately aim at ensuring minimally optimal safety and performance conditions for marketing medical devices, the lack of a harmonized framework for post-market routine testing combined with the fact that medical electrical equipment, especially in the developing and least developed world, is subject to sub-optimal conditions of electrical power systems, equipment maintenance and user education, altogether can compromise patient safety. A methodology consistently elaborated and implemented, thoroughly validated by clinical engineering personnel, making use of commercially available analyzers and simulators, yielded the proposed framework.