Anyone that follows my blog knows that I’m a fan of Tom Fishburne’s cartoons. Well, he has done it again with his April 1st cartoon poking fun at how the Apple product line has ballooned since the passing of Steve Jobs.
Over the years I’ve become more of a user of Apple products. It started with an iPad, followed by an iPhone, and now I write this on a Mac. For the most part, I like their products. But, I haven’t fully consumed the Kool-Aid. I have no problem being frustrated – and making it known – when their product designs go off the rails. And, in my opinion, removing all ports besides Thunderbolt (USB-C) on the Mac is a perfect example.
I still want a “normal” USB port – or two! And it drives me nuts that they’ve removed the HDMI port. I’ll take a thicker Mac that includes those ports. Now I realize all this can be solved by purchasing expensive dongles, but it shouldn’t be necessary. Plus, I REALLY don’t want to pack them around the country when I work.
What’s interesting is they used to be a company focused on the customer experience. Now they’re transitioning their focus to identifying opportunities – numerous at times – for selling expensive accessories to maintain compatibility with other devices. What a pain! Hopefully this will change, but it’s not looking promising.
On September 6th, the FDA issued the guidance document Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
According to the document:
“This guidance is intended to highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices: 1) designing systems with interoperability as an objective; 2) conducting appropriate verification, validation and risk management activities; and 3) specifying the relevant functional, performance, and interface characteristics in a user-available manner such as labeling.” (p. 3)
For those new to the topic, they define interoperability “…as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” (p. 2)
With respect to human factors, it highlights a couple areas of importance for our discipline, including:
- “Validate the user(s) interface. Determine that the user(s) are capable of correctly using the interface(s)” (p. 11)
- “Validation of labeling regarding the use of the electronic interface should consider human factors as appropriate.” (p. 17)
It’s good to see that the FDA understands the challenges associated with interoperability and that human factors is an important part of designing, developing, and deploying interoperable technology that allows users to safely and effectively perform their duties.
On November 3rd and 10th, I’ll be presenting a two-part webinar on Warnings and Safety Information in Device Labeling for the AAMI University Distance Learning program.
Part I will introduce attendees to the science of warnings and safety information. Part II will focus on highlighting the best practices of designing and presenting warnings and safety information in device labeling. Each session will last 90 minutes and start at 11:00 am EST.
To learn more about the webinar, including how to register, visit the following link.
In their book, Creative Confidence, Tom and David Kelley discuss the importance of balancing three factors (technical factors, business factors, and human factors), often referred to as the IDEO Three Lens of Human-Center Design, when undertaking innovation initiatives. While they go into detail about all three, for myself, their commentary about the third element – human factors – is most interesting. They state:
The third element involves people, and is sometimes referred to as human factors. It’s about deeply understanding human needs. Beyond just observing behaviors, this third aspect of successful innovation programs is about getting at people’s motivations and core beliefs. Human factors aren’t necessarily more important than the other two. But technical factors are well taught in science and engineering programs around the world, and companies everywhere focus energy on the business factors. So we believe that human factors may offer some of the best opportunities for innovation, which is why we always start there. (pp. 20-21)
I completely agree that deeply understanding human factors is vital for successful innovation. It’s great to see respected professionals in the design community write about the importance of this topic.
Kelley, T. and Kelley, D. (2013). Creative confidence: Unleashing the creative potential within us all. Crown Business: New York, NY.
Next week the Human Factors and Ergonomics Society (HFES) will hold the 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes (#HFESHealth2015) in Baltimore, Maryland.
The event, which is hosted by the John Hopkins Armstrong Institute for Patient Safety and Quality, will be held April 26th – 29th at the Baltimore Marriott Waterfront Hotel. More than 450 attendees will have the opportunity to attend 77 oral presentations, 9 discussion panels, and 117 posters (see full program here) in four tracks:
- Clinical and Consumer Health-Care IT Track
- Clinical Care Settings Track
- Medical and Drug-Delivery Devices Track
- Patient and Health-Care Provider Safety Track
One of the discussion panels is titled Do Standard UCD Methods Work in Health Care? and will take place on Tuesday the 28th between 3:30 and 4:30 pm. The panel is chaired by Ross Teague, PhD, and will include Rollin J. (Terry) Fairbanks, MD, MS, Christina C. Mendat, PhD, and Eric F. Shaver, PhD as panelists (see bios below for additional details).
This interactive panel will address the question Do Standard User-Centered Design Methods Work in Health Care? from the perspectives of a health care software vendor, consultant, clinician/researcher, and medical device vendor. An additional bonus is that each of the panelists have extensive experience applying UCD methods in and outside of the health care domain.
We’re planning to include input from attendees in the form of Twitter questions and comments posed prior to and during the session using the #UCD4HC hashtag, along with questions from audience members. Also, it’s our hope that the discussion will continue in the networking session that will follow our panel.
It should be a great panel (and audience) discussion! We hope you’ll be able to join us. But, if not, please tweet your questions and thoughts using the #UCD4HC hashtag – or post a comment – and we’ll attempt to answer them during the session.
Ross Teague, PhD
Dr. Teague is the manager of the User Experience organization at Allscripts where he leads a team of researchers and designers in the creation of products and services that improve patient and provider lives. He’s led the effort within Allscripts to create a User-Centered Design process that teams throughout the organization can follow to receive value whether they have expertise in UCD methods or not. Ross has been leading research and design efforts for medical devices and healthcare software for more than a decade. He’s also worked as a product design strategy consultant in the areas of consumer, industrial and commercial products.
Rollin J. (Terry) Fairbanks, MD, MS (@TerryFairbanks)
Dr. Fairbanks is the director of the National Center for Human Factors in Healthcare and of MedStar Health’s Simulation Training & Education Lab (SiTEL), Associate Professor of Emergency Medicine at Georgetown University, attending emergency physician at the MedStar Washington Hospital Center in Washington, DC, and Adjunct Associate Professor of Industrial Systems Engineering at the University at Buffalo. He is a human factors/safety engineer, board certified emergency physician, former private pilot, and former paramedic and EMS Medical Director. His work focuses on applying the science of safety to medical systems, based within MedStar Health, a 10-hospital $4.7B non-profit healthcare system in the Baltimore and Washington DC region.
Christina C. Mendat, PhD (@christinamendat)
Dr. Mendat is the Director of Human Factors at Human Factors MD. Her work is focused on leading clients successfully through the human factors regulatory process. Christina’s passion is helping clients who are new to human factors or have had unsuccessful human factors programs or submissions. She takes great pride in leveraging the science of human factors with a practical application. This year she is serving as co-chair of the Medical Device Track.
Eric F. Shaver, PhD (@ericshaver)
Dr. Shaver is a Human Factors Lead with FUJIFILM SonoSite. His work has emphasized achieving an optimal fit between people, technology, and work systems to facilitate their safety, performance, and satisfaction. His professional interests include health care innovation, leadership development, team performance, and applied decision making. He blogs at ericshaver.com and actively engages with others on Twitter @ericshaver.
Last month, the IEC (International Electrotechnical Commission) published IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices (purchase here or here). As noted in the Forward:
This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). (p. 4)
IEC/TR 62366-2, Medical devices – Part 2: Guidance on the Application of Usability Engineering to Medical Devices, is still in draft form and should be published in 2016. The Forward further explains the difference between -1 and -2 by stating:
Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE USER INTERFACES. (pp. 4-5)
I first learned about the standard being divided into two parts from a presentation (.pdf) Ed Israelski, PhD gave at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap.
I’ll post a more in-depth review of the standard after I’ve had some time to fully digest it.
The science of Human Factors & Ergonomics is vital to assisting in the design, development, and deployment of safe, usable, and delightful medical devices.
Below are several resources that are relevant for individuals interested in learning about medical device human factors, companies looking to incorporate a comprehensive human factors program in their organization, and seasoned professionals that need a repository of readily accessible information.
This post will be updated as additional, relevant resources are identified. If you have suggestions, please contact me.
- ANSI/AAMI HE75:2009 (2010). Human factors engineering – Design of medical device. Arlington, VA: Association for the Advancement of Medical Instrumentation.
- IEC 60601-1 Ed. 3.1 (2012-08). Medical electronic equipment – Part 1: General requirements for basic safety and essential performance. Geneva, Switzerland: International Electrotechnical Commission.
- IEC 60601-1-12 Ed 1.0 (2014-06). Medical electronic equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. Geneva, Switzerland: International Electrotechnical Commission.
- IEC 62366-1 Ed 1.0 (2015-02). Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission.
- IEC/TR 62366-2 Ed 1.0 (2016-04). Medical devices – Part 2: Guidance on the application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission.
- ISO 14971:2007 (2010). Medical devices – Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization.
Supplementary Information Sheets (SIS)
- IEC 62366-1 Edition 1.0 2015-02. Medical devices – Part 1: Application of usability engineering to medical devices [Recognition Number: 5-95]. Federal Register publication date: 08/14/2015.
- AAMI/ANSI/IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices [Recognition Number: 5-96]. Federal Register publication date: 08/14/2015.
FDA Guidance Documents
- Guidance for Industry and Food and Drug Administration Staff – Applying human factors and usability engineering to medical devices (February 3, 2016).
- Draft Guidance for Industry and Food and Drug Administration Staff – List of highest priority devices for human factors review (February 3, 2016).
- Guidance for Industry and Food and Drug Administration Staff – Reprocessing medical devices in health care settings: Validation methods and labeling (March 17, 2015).
- Guidance for Industry and FDA Premarket and Design Control Reviewers – Medical device use-safety: Incorporating human factors engineering into risk management (July 18, 2000).
- Guidance for Industry and FDA Staff – Infusion pumps total product life cycle (December 2, 2014).
- Guidance for Industry and FDA Staff – Recognition and use of consensus standards (September 17, 2007).
- Guidance for Industry and Food and Drug Administration Staff – Design considerations for devices intended for home use (November 24, 2014)
- Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers (April 19, 2001)
- Sawyer, D. (1996). Do it by design: An introduction to human factors in medical devices. Silver Spring, MD: Food and Drug Administration.
Technical Information Reports
- AAMI TIR50:2014 (2014). Post-market surveillance of use error management. Arlington, VA: Association for the Advancement of Medical Instrumentation. [see here for additional details]
- AAMI TIR51:2014 (2014). Human factors engineering – Guidance for contextual inquiry. Arlington, VA: Association for the Advancement of Medical Instrumentation.
- AAMI TIR55:2014 (2014). Human factors engineering for processing medical devices. Arlington, VA: Association for the Advancement of Medical Instrumentation.
- Carayon, P. (2011). Handbook of human factors and ergonomics in health care and patient safety. Boca Raton, FL: CRC Press.
- Tullis, T., & Albert, B. (2013). Measuring the user experience: Collecting, analyzing, and presenting usability metrics. Waltham, MA: Morgan Kaufmann.
- Weinger, M.B., Wiklund, M.E., & Garner-Bonneau, D.J. (2011). Handbook of human factors in medical device design. Boca Raton, FL: CRC Press.
- Wiklund, M., Dwyer, A., Davis, E. (2016). Medical device use error: Root cause analysis. Boca Raton, FL: CRC Press.
- Wiklund, M.E., Kendler, J., & Strochlic, A.Y. (2016). Usability testing of medical devices (2nd ed.). Boca Raton, FL: CRC Press.
- Morrow, D.G., North, R., Wickens, C.D. (2005). Reducing and mitigating human error in medicine. In R. Nickerson (Ed.), Annual Review of Human Factors and Ergonomics, Vol .1 (pp. 254-296). Santa Monica, CA: Human Factors and Ergonomics Society.
- Proceedings of the 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes
- Proceedings of the 2014 International Symposium on Human Factors and Ergonomics in Health Care: Leading the Way
- Proceedings of the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause
- Proceedings of the 2012 Symposium on Human Factors and Ergonomics in Health Care
- Association for the Advancement of Medical Instrumentation (AAMI): Human Factors for Medical Devices (3 Day Course)
Presentations – Conference
- HFES 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future
- HFES 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes
- HFES 2014 International Symposium on Human Factors and Ergonomics in Health Care: Leading the Way
- HFES 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause
- HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap
Presentations – FDA
- What’s new in human factors pre-market review (Ron Kaye, M.A., March 2013)
- Human factors engineering of combination products and the FDA (Molly Follette Story, Ph.D., July 2012)
- FDA perspectives on human factors in device development (Molly Follette Story, Ph.D., June 2012)
- FDA human factors draft guidance document: Agency expectations for human factors data in premarket submissions (Molly Follette Story, Ph.D., March 2012)
- Human factors review perspectives for premarket submissions FDA/CDRH: A tale of two submissions (Ron Kaye, M.A. and QuynhNhu Nguyen, B.S., March 2012)
- Identifying use errors and human factors approaches to controlling risks (Molly Follette Story, Ph.D. and QuynhNhu Nguyen, B.S., September 2011)
- Human factors/usability for medical devices: An historical perspective (Ron Kaye, M.A., June 2011)
- Enhancing the quality of device labeling (Molly Follette Story, Ph.D., April 2011)