Maintenance Management Requirements in Medical Technology

Abstract

Clinical Engineering applies methodologies that guide maintenance management systems so they can comply with regulations and standards. In many healthcare institutions, these guidelines are difficult to follow strictly due to different factors. The objective of this study was to define the requirements that a maintenance management system must complete, following national regulations and international accreditation standards. To achieve this goal, we conducted a web search to identify the standards associated with national and international medical devices. The World Health Organization was taken as a benchmark to compare them. In our search, we identified significant similarities, concluding that regulations in Colombia follow international standards, but there is still a long way to go, and studies like this are vital in order to achieve it.