Integrating Usability Assessments into Medical Device Evaluations

Abstract

ECRI, a non-profit dedicated to advancing effective, evidence-based healthcare globally, has been evaluating medical devices for over a half century. Project officers develop evaluation criteria and then perform laboratory tests to assess device performance, safety, and reliability. To help incorporate usability assessments into ECRI’s evaluations, a human factors consultant provided guidance on selecting assessment technique(s) based upon the type of device being evaluated, the nature of the environment in which it is used (e.g. operating room, intensive care patient area, nursing station), the target user population, and the resources available to support the evaluation. The consultant also developed a decision-tree to help ECRI project officers select among seven freely-available standardized usability questionnaires.