Ergonomic Design is the Best Weapon to Reduce Risk

Abstract

“Do it by Design” written by Dick Sawyer and the CDRH work group is a premiere reference and introduction to human factors in medical devices published by HHS, FDA CDRH. In this publication, the relationship of device design to safe and effective use is described and then built upon in subsequent key industry standards such as ANSI/AAMI HE 75. Yet the importance of completing good design and considering all the possible usability aspects continues to be overlooked or under-represented in the design process. Information for safety is required to be provided to medical device users (MDR 2017, FDA 21 CFR 801). However, risk mitigations in the form of training, labeling and instructions for use (IFU) are required to be used as a last resort, avoided or used sparingly (MDR 2017 and ISO 14971). Instead devices should be inherently safe by design and construction as well as implement adequate protection measures, such as alarms, for those risks that cannot be eliminated. As often observed in usability studies, users disregard labeling and instructional information or do not even realize it is provided to them. In cases where information for safety is the risk control method, can it be considered effective in reducing risk and should they be acceptable to medical device manufacturers? This article discusses rules of thumb in good product design that limit or eliminate the reliance on instructions and when that’s not possible, the rules of design for instructional materials that provide solid support for users.