In January of this year the US Food and Drug Administration (FDA) released a document titled, “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” (GPSV). While much of this document covers programming issues, a significant part specifically requires incorporating human factors/ergonomic design principles into software development for medical devices.
Ever since the FDA adopted their current Quality System Regulations in 1996, human factors processes are being pushed as part of proper design controls: “To ensure that the design requirements are appropriate and address the intended use of the device, including the needs of the user, patient, and, for verifying and validating the device design, to ensure that devices conform to the users needs and intended uses.” [emphasis by the FDA, “Human Factors Points to Consider for IDE Devices”].
After studying thousands of medical device recalls the FDA has realized that many end-use problems (over 7% from 1992-1998 were traced to software issues) can be eliminated or mitigated through user-centered design principles, and almost 60-80% of all recalls could be caught in the design phase of a new device by following good design principles.
A guidance document from the FDA is designed so that manufacturers and FDA reviewers know the basics of what is needed for acceptable validation. While a guidance document does not cover every situation, nor does it tell explicitly how something is to be done, it provides an expected framework.
This new GPSV is quite broad in its application, covering “