Here's the link:
In addition, I provide my own perspective on the article in the "Commentary" section below. I do not critique the article. I only attempt to expand on a few points from it.
But first, a brief summary of the article.
It has been noted by the FDA a large proportion of medical errors can be attributed to poorly designed medical device user interfaces. Since a fundamental mission of the FDA is increasing patient safety and reducing injuries and fatalities in the practice of medicine, the FDA has begun placing greater emphasis on improving the usability of medical device user interfaces.
This article provides measures that show the FDA's increasing emphasis on usability and human factors issues by showing the increasing frequency that companies seeking medical device clearance for the US market mention the terms "usability" and "human factors." Figure 1 from the article clearly shows the increasing usage of these terms in company filings.
The documents listed below are specifically targeted to defining and supporting the human factors engineering process and the development of the Human Engineer File that's included as part of a company's filing to the FDA.
- ISO 62366, Medical Devices - Application of Usability Engineering to Medical Devices
- AAMI / ANSI HE75:2009, Human Factors Engineering - Design of Medical Devices (General)
I'll discuss the documents above in greater detail and describe how they're intended to fit within the human factors engineering process when developing medical devices.
- IEC 60601-1-6 Medical electrical equipment - Part 1-6 General requirements for Safety - Collateral standard: Usability
- IEC 60601-1-8 Ed. 1, Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidance - General Requirements and Guidelines for Alarm Systems in Medical Equipment (General)
Without a doubt, the push by the FDA to define a human engineering process in the design and testing of medical devices, and to press for testing under actual or simulated conditions is needed. In many ways the FDA is mirroring many of the processes that have already been adopted by the US Department of Defense (DoD) in the area of human engineering. Admittedly, the DoD doesn't always get it right, there is an understanding within the DoD that it is important ... life saving, battle-winning important ... to insure that those at the controls can do their jobs quickly, effectively and with as few errors as possible. So from that standpoint, the FDA has adopted processes from programs that have proven effective. But the FDA has just passed the starting line. And much more will be required going forward.
ISO 62366 vs AAMI/ANSI HE75
As I mentioned earlier ISO 62366 and AAMI/ANSI HE75 should be consider complementary or companion documents. HE75 is a much larger document than 62366 and includes a significant amount of device design guidance and guidelines. 62366 is almost entirely a process document that's devoted to directing how to go about managing the research and development process of a medical device. In addition, the focus of 62366 is managing risks, risks in the realm of reducing use errors.
I found it interesting that references to HE75 were not increasing at the rate as references to 62366. I would have expected Figures 2 and 3 to have a similar appearance with respect to 62366 and HE75 in large part because the documents significantly overlap. In fact I might have reasonably expected references to HE75 to outpace 62366 because HE75 includes design specific guidelines in addition.
One possible reason for references to HE75 not being referenced in the same accelerated way as HE75 may have to do with the fact that the European Union has not adopted HE75, so it's required for medical devices that will be marketed in the EU (CE). (I am currently unaware of the regulatory requirements of other countries on this matter.) Medical device companies are international companies and the documents that they file in one country are generally the same in each country. Thus since the EU hasn't adopted HE75, references to HE75 and HE75's use as a foundational process and design document may be less.
I'm not sure that this is true at this point in time, but I am certain that the following will be true going forward at some time in the future. I believe that the FDA will hold companies to account for their user interface designs. I believe that the FDA will demand that companies clearly define how they came up with their user interface designs and that those designs are well-grounded in empirical evidence.
This is what I mean ... the FDA will demand that the design choices ... these include: controls, placement of controls, number of controls, actions performed by controls, the way the control responds, methods for interacting with the device (e. g., touch screen, buttons, mouse), size of the display, etc. ... for medical device user interfaces must be grounded in empirical data.
Commercial websites are often designed by graphic artists. Often times the design of webpages reflect the artist's aesthetic sensibilities. Layout appear they way that they do because they look good.
I believe that the FDA will require that user interface designs for medical devices have an empirically grounded design rationale. Companies will be required to point to specific research finding to justify the design and the design choices that they made. Furthermore, as the design of the user interface evolves with each iteration of testing, the FDA will require that changes to the design be based on research findings.
Finally, I believe that soon if it is not occurring already, that the FDA will require:
- That companies submit documentation to show in detail the full evolutionary design process beginning from product inception, including ...
- Detailed pre-design research ... population(s), method(s), research questions and rationale, etc ... as well as the findings and what they suggest for the design of the user interface
- A design that includes with a full discussion of the design rationale ... why was it designed the way it was ...
- A detailed description of the evolution of the design that include full and clear justification(s) for each change in the design ... and require that changes be grounded empirical data
- A full description of pre-commercialization testing process and method ... with a clear justification for why this testing meets FDA testing requirements
- And a complete and clear analysis of the testing data.