The Clinical Engineer's Role in Promoting Medical Device Safety

摘要

Hospital engineers are often involved in the entire lifecyde of a medical device within a healthcare facility. From providing input during the initial compilation of purchasing requirements to the eventual disposal and removal from service, clinical engineers observe the full spectrum of device introduction, use, maintenance, and eventual obsolescence. Clinical engineers are well equipped to identify problems that may appear with a product because they are familiar with the technical and clinical aspects of medical device design and use. By detecting, reproducing, and reporting these problems, hospital engineers can assist device manufacturers as well as the Food and Drug Administration in ensuring that these problems are adequately addressed and resolved. This article outlines the role of the clinical engineer in promoting medical device safety and provides case studies that highlight contributions made by clinical engineers in making devices safer.