By Eric F Shaver, PhD
In February, the International Electrotechnical Commission (IEC) published IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices, which revised and replaced both the IEC 62366:2007 and IEC 62366 Ed 1.1:2014. That same month the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI) approved and published it as ANSI/AAMI/IEC 62366-1:2015. Moreover, earlier this month the Food and Drug Administration (FDA) added both the IEC (RN 5-95) and ANSI/AAMI/IEC (RN 5-96) versions to their list of recognized consensus standards.
The updated standard divides IEC 62366 into two parts: IEC 62366-1 and IEC/TR 62366-2. The former is a normative standard that provides requirements on how to optimize medical device development through a Usability Engineering Process in order to mitigate use-associated risks. The latter, which hasn’t been published yet, is a technical report that offers guidance to medical device manufacturers on compliance with IEC 62366-1, along with in-depth information on appropriate methods to apply during the Usability Engineering Process. It is expected that this technical report will be approved and published in 2016.
IEC 62366-1 Overview
The 50-page document is divided into five sections (Scope; Normative References; Terms and Definitions; Principles; and Usability Engineering Process) and annexes (1 normative and 4 informative). While the basic overall structure is similar to the previous editions, numerous changes have been made to IEC 62366-1. The revisions were prompted for a number of reasons including: updating Usability Engineering concepts; streamlining the Usability Engineering Process; bolstering linkages with ISO 14971:2007; and harmonizing it with the FDA Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design. Some specific changes include:
- “Application Specification” changed to “Use Specification”
- “Usability Specification” changed to “User Interface Specification”
- “Frequently Used Functions” and “Usability Verification” removed
- “Primary Operating Functions” modified to focus on medical device safety
- “Formative Evaluation” added
- “Usability Validation” changed to “Summative Evaluation”
Usability Engineering Process
As noted previously, the standard requires that a company use a Usability Engineering Process to ensure development of a safe and usable medical device that minimizes the risks associated from use errors. The nine-step process includes:
- Prepare Use Specification
- Identify user interface characteristics related to safety and potential use errors
- Identify known or foreseeable hazards and hazardous situations
- Identify and describe hazard-related use scenarios
- Select the hazard-related use scenarios for summative evaluation
- Establish User Interface Specification
- Establish User Interface Evaluation Plan
- Perform user interface design, implementation and formative evaluation
- Perform summative evaluation of the usability of the user interface
All of the activities highlighted above are captured in the Usability Engineering File that becomes part of the overall Design History File for the medical device.
Compliance with standards is just one part of a robust human factors program for medical device development. But, on its own it is insufficient. It also requires, among other things, having skilled professionals with the appropriate training and experiences to ensure that medical devices are safely designed, developed, and deployed. But, not all medical device companies employee human factors experts. In those instances, an experienced human factors consultancy that focuses on the healthcare domain is needed.
Human Factors MD helps medical device and pharmaceutical clients create innovative products that are safe, usable, and effective. Our team of talented human factors experts supports our global clientele throughout the product development process. Contact us to learn how we can provide a custom solution that fits your specific needs.
ANSI/AAMI/IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. Arlington, VA: Association for the Advancement of Medical Instrumentation.
IEC 62366 Ed 1.1:2014. Medical devices – Application of usability engineering to medical devices [Consolidated Version]. Geneva, Switzerland: International Electrotechnical Commission.
IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission.
ISO 14971:2007. Medical devices – Application of risk management to medical devices.Geneva, Switzerland: International Organization for Standardization.
U.S. Department of Health and Human Services, Food and Drug Administration (2011, June 22). Draft guidance for industry and Food and Drug Administration staff – Applying human factors and usability engineering to optimize medical device design.