patient safety Archives

Do Standard User-Centered Design Methods Work in Health Care?

April 24, 2015 By Eric Shaver Leave a Comment

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.

Panelists

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.

HFES 2015 Health Care Symposium Program

April 23, 2015 By Eric Shaver Leave a Comment

The program for the 2015 Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes is now available for download. The event will be held next week (April 26th – 29th) at the Baltimore Marriott Waterfront Hotel. It should be a great event!

Top 10 Health Technology Hazards for 2015

December 5, 2014 By Eric Shaver Leave a Comment

The ECRI Institute has recently published their Top 10 list of Health Technology Hazards for 2015. They include:

Alarm Hazards: Inadequate Alarm Configuration Policies and Practices
Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems
Mix-Up of IV Lines Leading to Misadministration of Drugs and Solutions
Inadequate Reprocessing of Endoscopes and Surgical Instruments
Ventilator Disconnections Not Caught because of Mis-set or Missed Alarms
Patient-Handling Device Use Errors and Device Failures
“Dose Creep”: Unnoticed Variations in Diagnostic Radiation Exposures
Robotic Surgery: Complications due to Insufficient Training
Cybersecurity: Insufficient Protections for Medical Devices and Systems
Overwhelmed Recall and Safety-Alert Management Programs

It’s an interesting report worth reading. If you’re interested in receiving you own copy, click on the image above or this link.

Health Care Needs Human Factors Professionals

August 27, 2014 By Eric Shaver Leave a Comment

Overview

In November 1999, the Institute of Medicine (IOM) released a report entitled, “To Err is Human: Building a Safer Health System,” in which they reported that between 44,000 and 98,000 patients die each year in U.S. hospitals due to medical errors. Although this revelation took many in the health care community by surprise, there were individuals sounding the alarm in the past (e.g., Cooper, et al., 1978; Leape, 1994). Moreover, Lucian Leape understood that methods from human factors might facilitate a decrease in medical errors when he stated:

“Can the lessons from cognitive psychology and human factors research that have been successful in accident prevention in aviation and other industries be applied to the practice of hospital medicine? There is every reason to think they could be” and “Error prevention strategies for the practice of medicine can be modeled after the theories of cognitive psychologists and human factors engineers” (Leape, 1994).

History of Health Care and Human Factors

The human factors discipline has been interested in understanding and mitigating the occurrence of human error within complex systems for decades (e.g., Norman, 1981; Reason, 1990). With respect to health care, although research was performed within the discipline prior to the IOM report (e.g., Bogner, 1994; Cook, et al., 1998), it didn’t move to the forefront until the beginning of the 21st century. Some of the actions that brought it into the spotlight included an editorial by the Human Factors and Ergonomics Society (HFES, 2000, February), an opinion piece by a former president of the Society (Woods, 2000, May), and the creation of a Task Force on Health Care (HFES, 2000, October).

The HFES has been a driving force in facilitating the advancement of health care human factors for a number of years. For instance, the Health Care Technical Group with 600+ members “…is interested in maximizing the contributions of human factors and ergonomics to medical systems’ effectiveness, patient safety and the quality of life for people who are sick or functionally impaired. We seek to bring together people who share our interests.” Also, starting in 2012, the Society has held annual symposia that bring together human factors professionals from around the world to meet and share their latest research. The 2015 Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes will feature health care topics in four tracks: Health-Care Provider and Patient Safety; Clinical and Consumer Health-Care IT; Medical and Drug Delivery Devices; and Clinical Care Settings.

Human Factors Areas of Focus in Health Care

The last 15+ years has seen significant human factors research and interventions focused on a variety of domains, topics, and targets, including:

People (e.g., nurses, patients, pharmacists, physicians, technicians, etc.)

Specialties (e.g., anesthesiology, critical care, emergency medicine, gynecology, nursing, pharmacy, radiology, surgery, etc.)

Settings (e.g., emergency departments, home care, intensive care units, nursing homes, operating rooms, pharmacy departments, physician offices, etc.)

Topics (e.g., build environment, care coordination, checklists, health information technology, infection prevention, medical devices, medication, organizational culture, patient satisfaction, simulation, teamwork, telemedicine, training, etc.)

More Work Is Needed

While human factors professionals have made great strides in assisting the health care community with mitigating the negative consequences of medical error, additional work is still needed. As noted by Woods (2000, May), “Health care is an opportunity for human factors, but only if we are up to the sacrifices involved in building, extending, and deepening the ways we can help people create safety” (p. 5). I have no doubt that the our professionals are up to the challenge of tacking this worthy endeavor and working with others to provide practical solutions that can be implemented by the health care community.

To Learn More

Interested readers are encouraged to review the following resources to learn how human factors researchers and practitioners have assisted with decreasing medical errors and increasing patient safety within health care while also increasing efficiency and decreasing overall costs.

Books

Carayon, P. (2011). Handbook of human factors and ergonomics in health care and patient safety (2nd ed). Boca Raton, FL: CRC Press.
Dekker, S. (2011). Patient safety: A human factors approach. Boca Raton, FL: CRC Press.
Reason, J. (2008). The human contribution. Burlington, VT: Ashgate Publishing Company.
Salas, E., Frush, K., Baker, D.P., Battles, J.B., King, H.B., & Wears, R.L. (2013). Improving patient safety through teamwork and team training. New York, NY: Oxford University Press.
Woods, D.D., Dekker, S., Cook, R., Johannesen, L., & Sarter, N. (2010). Behind human error. Burlington, VT: Ashgate Publishing Company.

Chapters

Carayon, P., Alyousef, B., & Xie, A. (2012). Human factors and ergonomics in health care. In Gavriel Salvendy (Ed.), Handbook of Human Factors and Ergonomics, 4th (pp. 1574-1595).
Morrow, D., North, R., & Wickens, C.D. (2005). Reducing and mitigating human error in medicine. In R.S. Nickerson (Ed.), Reviews of Human Factors and Ergonomics, Vol. 1 (pp. 254-296). Santa Monica, CA: Human Factors and Ergonomics Society.

Reviews

Morrow, D.G. (Ed.). (2013). Reviews of Human Factors and Ergonomics (Vol. 8). Santa Monica, CA: Human Factors and Ergonomics Society.

Journals

Bagnara, S. (2007). Patient safety – An old and a new issue. Theoretical Issues in Ergonomics Science, 8, 365-369.
Barach, P. (2007). A team-based risk modification programme to make health care safer. Theoretical Issues in Ergonomics Science, 8, 481-494.
Buckle, P., Clarkson, P.J., Coleman, R., Ward, J., & Anderson, J. (2006). Patient safety, systems design and ergonomics. Applied Ergonomics, 37, 491-500.
Carayon, P., Wetterneck, T.B., Rivera-Rodriguez, A.J., Hundt, A.S., Hoonakker, P., Holden, R., & Gurses, A.P. (2014). Human factors systems approach to healthcare quality and patient safety. Applied Ergonomics, 45, 14-25.
Friesdorf, W., Buss, B., & Marsolek, I. (2007). Patient safety by treatment standardization and process navigation – A systems ergonomics management concept. Theoretical Issues in Ergonomics Science, 8, 469-479.
Healey, A.N., & Vincent, C.A. (2008). The systems of surgery. Theoretical Issues in Ergonomics Science, 8, 429-443.
Karsh, B., Holden, R.J., Alper, S.J., & Or, C.K.L. (2006). A human factors engineering paradigm for patient safety: Designing to support the performance of the healthcare professional. Quality and Safety in Health Care, 15 (Suppl I), 59-65.
Leape, L.L. (2004, Summer). Human factors meets health care: The ultimate challenge. Ergonomics in Design, 6-12.
Russ, A.L., Fairbanks, R.J., Karsh, B., Militello, L.G., Saleem, J.J., & Wears, R.L. (2013). The science of human factors: Separating fact from fiction. BMJ Quality and Safety, 22, 802-808.
Salad, E., Baker, D., King, H., & Battles, J. (2006). Special section commentary: Opportunities and challenges for human factors and ergonomics in enhancing patient safety. Human Factors, 48, 1-4.
Salas, E., Rosen, M.A., & King, H. (2007). Managing teams managing crises: Principles of teamwork to improve patient safety in the emergency room and beyond. Theoretical Issues in Ergonomics Science, 8, 381-394.
Schutz, A.L., Counte, M.A., & Meurer, S. (2007). Assessment of patient safety research from an organizational ergonomics and structural perspective. Ergonomics, 50, 1451-1484.
Weaver, S.J., Salas, E., & King, H.B. (2011). Twelve best practices for team training evaluation in health care. The Joint Commission Journal on Quality and Patient Safety, 37, 341-349.

Proceedings

Websites

References

Bogner, M.S. (Ed.). (1994). Human error in medicine. Hillsdale, NJ: Lawrence Erlbaum Associates.

Cook, R.I., Woods, D.D., & Miller, C. (1998). A tale of two stories: Contrasting views of patient safety. Boston, MA: National Patient Safety Foundation.

Cooper, J.B., Newbower, R.S., Long, C.D., & McPeek, M. (1978). Preventable anesthesia mishaps: A study of human factors. Anesthesiology, 49, 399-406.

Human Factors and Ergonomics Society (2000, February). Patient safety and human factors/ergonomics. Human Factors and Ergonomics Society Bulletin, 43(2), 1-2.

Human Factors and Ergonomics Society (2000, October). Human factors and patient safety, continued. Human Factors and Ergonomics Society Bulletin, 43(10), 1-2.

Kohn, L.T., Corrigan, J.M., & Donaldson, M.S. (Eds.). (2000). To err is human: Building a safer health system. Washington, D.C.: National Academy Press.

Leape, L.L. (1994). Error in medicine. The Journal of the American Medical Association, 272, 1851-1857.

Norman, D.A. (1981). Categorization of action slips. Psychological Review, 88, 1-15.

Reason, J. (1990). Human error. New York, NY: Cambridge University Press.

Woods, D.D. (2000, May). Patient safety and human factors opportunities. Human Factors and Ergonomics Society Bulletin, 43(5), 1; 4-5.

Human Factors Resources for Medical Devices

June 28, 2014 By Eric Shaver Leave a Comment

[Updated 8.18.16]

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.

FDA Regulations

Standards

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.

Books

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.

Chapters

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.

Journals

Proceedings

Trade Publications

Courses

Association for the Advancement of Medical Instrumentation (AAMI): Human Factors for Medical Devices (3 Day Course)

Presentations – Conference

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)

Websites

Human Factors as an Innovation for Patient Safety

March 7, 2014 By Eric Shaver Leave a Comment

In 2010, Pascale Carayon published an article in Applied Ergonomics entitled Human Factors in Patient Safety as an Innovation.

It’s an important article for a couple reasons. First, it provides one of the best justifications I’ve seen for why Human Factors and Ergonomics (HFE) should be considered an innovation. As the article notes, this is important to assist with “…the uptake and use of HFE tools, methods, concepts and theories in order to speed up and improve patient safety efforts” (p. 657).

Second, it provides a list of recommendations for HFE professionals, researchers, and educators that should be heeded “…in order to improve the spread of HFE innovations for patient safety” (p. 663). The only thing I would add is that most of the recommendations shouldn’t be constrained just too patient safety. Instead, they are mostly applicable to all aspects of health care, let alone other industries where HFE efforts have been implemented. The recommendations include:

HFE Professionals

Be aware of barriers to systems thinking; develop approaches for dealing with those barriers
Know the complexity of HFE tools and methods; appropriately simplify HFE tools and methods
Use an incremental approach to implementation of HFE innovations: from simple to complex; from low to high knowledge
Use HFE knowledge to improve work and working conditions of healthcare professions
Work on patient safety projects with healthcare organizations that have strong leadership, strategic vision and climate conducive to experimentation and risk
Be aware of professional boundaries and social networks within healthcare organizations
Conduct significant preparation work before applying HFE tool and method, including assessing potential impact of HFE innovation and evaluating support and resources
Be aware of innovation adoption stages (i.e. awareness, information and training, and feedback); adapt HFE innovation to the adoption stage
Be flexible
Evaluate patient safety impact of HFE innovations
Get involved in healthcare policy development
Communicate with healthcare leaders and top managers about HFE and its (potential) benefits for patient safety; establish formal programs for disseminating HFE in healthcare and patient safety; work with ‘boundary spanners’ [For national and international HFE associations]
Share best practices and lessons learned about patient safety improvement projects

HFE Researchers

Develop evidence of the impact of HFE innovations on patient safety: criteria, research designs, generalizability, role of context
Develop and test simple, reliable and valid HFE tools and methods
Conduct research on significant patient safety issues
Develop models and theories about mechanisms between work system characteristics and other HFE variables and patient safety
Disseminate research results to different types of healthcare organizations (e.g., small and large hospital)
Work on multidisciplinary research projects
Conduct action research with cycles of learning and feedback
Develop HFE tools and methods adapted to different healthcare settings and to the complexity and cultural and structural characteristics of healthcare organizations
Get involved in healthcare policy development

HFE Educators

Teach about healthcare culture (e.g., scientific inquiry)
Teach diverse knowledge of HFE
Teach about working in multidisciplinary teams
Teach about innovation process and stages of adoption
Develop HFE students’ ability to deal with uncertainty and ambiguity in innovation process
Teach communication skills, in particular communication with top management and leadership
Encourage HFE students to work on practical projects in healthcare
Train healthcare professionals in HFE
Teach HFE students how to be change agents

References

Carayon, P. (2010). Human factors in patient safety as an innovation. Applied Ergonomics, 41, 657-665.