AAMI 2018 Conference & Expo

Sessions Speakers Exhibitors Floor Plan Buzz

Human Factors and Reprocessing: a Case Study (Room CC, 101A)

In recent years, AAMI and the FDA have provided guidance on how to incorporate human factors principles so that medical devices are safer and easier to use and the instructions for use (IFU) are clear. However, reusable medical devices, by design, necessitate multiple end users, both clinicians and reprocessing technicians, and often the IFU is created with only the clinicians in mind. As a result, reprocessing IFUs can be developed that do not meet the varying needs and capabilities of reprocessing personnel. Additionally, as the use of technology grows in healthcare facilities, adapting IFUs into more accessible and electronic forms will be important. We will provide a case study of issues identified through human factors evaluations with reprocessing IFUs for reusable medical devices and the development of a prototype for an electronic IFU.