Eric Shaver

Human Factors Professional

Medical Device Design and Human Factors

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Handbook of Human Factors in Medical Device Design

In 2011, CRC Press published the Handbook of Human Factors in Medical Device Design.  The book is edited by Matthew B. Weinger, Michael E. Wiklund, and Daryle J. Gardner-Bonneau and includes the following chapters:

  1. General Principles
  2. Basic Human Abilities
  3. Environment of Use
  4. Anthropometry and Biomechanics
  5. Documentation
  6. Testing and Evaluation
  7. Controls
  8. Visual Displays
  9. Connections and Connectors
  10. Alarm Design
  11. Software User Interfaces
  12. Workstations
  13. Signs, Symbols, and Markings
  14. Packaging
  15. Device Life Cycle
  16. Hand Tool Design
  17. Mobile Medical Devices
  18. Home Health Care
  19. Cross-National and Cross-Cultural Design of Medical Devices

This resource should be on the bookshelf of all human factors professionals involved in the design, development, and deployment of medical devices.  Moreover, it’s also a good resource for systems engineering and regulatory professionals.

References

Weinger, M.B., Wiklund, M.E., & Garner-Bonneau, D.J. (2011). Handbook of human factors in medical device design. Boca Raton, FL: CRC Press.

Health Care Needs Human Factors Professionals

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Medical Team Working On Patient In Emergency Room

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 Should Contribute to Company Strategies

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The July 2009 issue of Applied Ergonomics includes an article entitled, “Ergonomics Contributions to Company Strategies,” by Jan Dul and W. Patrick Neumann.

The authors contend that one of the reasons why human factors and ergonomics hasn’t seen greater acceptance within the business community stems from a failure to explicitly demonstrate how interventions support company strategies and business goals.  Moreover, they state:

  • “…if ergonomics contributes directly to the company’s strategy, and in the language of the company, it will be more accepted by business managers; it will be better embedded (internalized) in the organization; and its full potential as described in the IEA definition [5] will be better actualized.” (p. 746)
  • “…attention to ergonomics can be an important element of how a company realizes its competitive advantage.” (p. 749)
  • “Capturing the full benefits of ergonomics therefore will require the deliberate integration of ergonomics into core strategy arenas of the organization.” (p. 749)
  • “…we believe that explicit linking of ergonomics to the strategy and desired business outcomes is a promising way to realize sustainable growth for firms without the high social costs due to work-related ill health.” (p. 749)

The authors divide the concept of strategy into three areas where human factors and ergonomics can add value, including:

Business Function Strategies and Ergonomics

  • Product design and innovation – “…ergonomics can be linked to strategies for product design and innovation by assuring that the products fit with the end-users and are easy to produce.” (p. 747)
  • Operations engineering and process innovation – “…ergonomics can be linked to strategies for operations engineering and process innovation in order to assure that both production goals and worker well-being are safeguarded.” (p. 748)
  • Marketing and communication – “…ergonomics can be linked to marketing and communication strategies by providing reasons for positive (well-being) consumer associations with the company’s products and production processes.” (p. 748)
  • Human resource management – “…ergonomics can be linked to HRM strategies by assuring good working conditions and by engaging in participatory and job design approaches.” (p. 748)

Cross-Functional Strategies and Ergonomics

  • Downsizing, lean production, business process re-engineering – “…ergonomics may help companies to control the negative human effects of the downsizing, lean production and business process re-engineering strategy in order to obtain the real benefits from this strategy.” (p. 748)
  • Total quality management – “…ergonomics may contribute to TQM by ensuring that people contribute to quality.” (p. 749)

Corporate Strategies and Ergonomics

  • Differentiation strategy – “…ergonomics could be linked to a company’s differentiation strategy by adding user-friendly and affective features to products and services.” (p. 749)
  • Cost strategy – “…ergonomics could be linked to a company’s cost strategy by increasing labor productivity and reducing labor costs.” (p. 749)
  • Resource-based view of the firm – “…ergonomics, with its ability to support employee retention, can help provide firms with a sustainable competitive advantage in the form of experienced, skilled employees who can perform their best for the company.” (p. 749)
  • Service profit chain – “…by increasing employee wellbeing, ergonomics can be linked to a service profit chain strategy.” (p. 749)

The authors also address a couple key points to human factors and ergonomics researchers, educators, and practitioners, including:

  • “We believe that ergonomists in research, education and practice (both internal ergonomists that are part of the organization and external consultants), who accept the broad definition of ergonomics presented in the introduction have a crucial role in: (a) developing the possible links between ergonomics and company’s strategies; (b) finding evidence for these links; and (c) communicating the links to the business stakeholders who are involved in strategy formulation and implementation.” (p. 750)
  • “The successful ergonomist in research, education or practice is aware of business strategies and desired business outcomes; knows who are main stakeholders; knows what the benefits of ergonomics may be for these stakeholders; knows how ergonomics can be implemented to realize these benefits; and can communicate with the stakeholders in their own language and networks.” (p. 750)

References

Dul, J. & Neumann, W.P. (2009). Ergonomic contributions to company strategies. Applied Ergonomics, 40, 745-752.

Human Factors Resources for Medical Devices

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Surgery

[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

Supplementary Information Sheets (SIS)

FDA Guidance Documents

Technical Information Reports

Books

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

Presentations – Conference

Presentations – FDA

Websites