# Presentation: 311957

## Global Challenges in Human Factors and Medical Systems

**Human Factors/Medical Device Mini-Symposium**
**August 2-3, 2000**
**International Ergonomics Association and **
**Human Factors and Ergonomics Society**
**San Diego, California**
**Cornelia Rooks, M.A.**
**U.S. Food and Drug Administration**

## Cornelia Rooks

**Division Director**
**Division of Device User Programs and Systems Analysis**
**Office of Health and Industry Programs**
**Center for Devices and Radiological Health**
**U.S. Food and Drug Administration**

## Objectives

*Identify requirements*
*identify areas of need for human factors principles*
*Identify next generation technologies*
*Identify gaps in human factors science*
*Foster the exchange of scientific expertise *

## Session #1

*Medical Device Requirements for the Global Market* **(Chair: **_**Col. Valerie J. Rice**_**)**
- _Charles Sawyer,_  *Medical Device Requirements, Human Factors, and the Food and Drug Administration (FDA)*
- _Carl Wallroth_, *Handling of Use Errors with Medical Devices* _Denis G. Roy_,  *Medical Device Requirements: A View from Canada*

**Notes:**
This session will summarize requirements for medical devices in the global economy with emphasis on human factors and ergonomics and safety and effectiveness.  An interactive panel discussion with the audience will then identify common requirements, gaps in requirements, and areas where harmonization of requirements may be needed.
Summarize requirements
Human Factors
Safety and Effectiveness
Identify
Gaps in requirements
Areas in need of Harmonization and
New Issues

## Session #2

*Global Standardization of Human Factors for Medical Devices and Systems *_**(**_**Chair:**_** Michael Wiklund,**_
- _Michael Wiklund_, *Overview of Medical Standards Development Efforts*
- _Daryle Gardner-Bonneau_, *Part 1 of the AAMI/ANSI HE-48 1993 Revision - The Human Factors Engineering Process*
- _Peter B. Carstensen_, *IEC Develops Collateral Standard for Medical Device Design*
- _Matthew B. Weinger, _*How Will New Standards Affect Medical Practice?*

**Notes:**
This session will summarize current domestic and international standards for medical devices and systems.  An interactive panel discussion with the audience will then identify overlaps and conflicts in standards, opportunities for harmonization and potential areas where standards are needed. 

Summarize standards activities
domestic
international

Identify
Overlaps and conflicts
Opportunities for harmonization
New issues for standards

## Session #3

*Human Factors Perspectives on Medical Device Information in the Global Market  *_**(**_**Co-Chair#1:**_** Michael**_ _**S. Wogalter, **_**Co-Chair #2:**_** James R. Callan.**_
- _Michael J. Kalsher and Michael S. Wogalter_, *Warnings and Instructions:  Design Factors for Medical Devices and Systems*
- _Ruth Day_, *Cognitive Tasks for Medical Device Evaluation*
- _James R. Callan and David A. Kobus_, *Misadventures of Medical Labeling: Lessons Learned*
- _Judy Edworthy_, *Medical device alarms:  Equipment or patient-centered?*
- _James R. Callan and Michael S. Wogalter, _*Discussion on the Future Prospects of Medical **Device Information*

**Notes:**
This session is expected to explore cutting-edge research and innovative means of designing and delivering effective labeling and instruction for the correct and safe use of medical devices and systems.  Suggested topics include:  user attributes such as cognitive changes and capabilities, aging effects, integration with complex technology, use of icons and symbols and potential issues related to standardized labeling elements.

Explore research research and innovative means of designing and delivering effective labeling and instruction for the correct and safe use of medical devices and systems 
Discuss intergration with new technologies

## Session #4

*Advanced Technology Applications for Product Design ***(Chair:  **_**William H. Muto)**_
- _Dwight Holland, _*Evolving Medical Issues and Technologies for Preserving Human Performance During Long-Duration Spaceflight*
- _Ron Kaye_, *Human Factors in Medical Device Use Safety:  How to Meet the New Challenges*
- _Corinna Lathan, _*Home Care Technologies of the Future*
- _Frank Tendick, _*Advanced Interfaces for Minimally Invasive Surgery*
- Discussant, _Barry H. Beith._

**Notes:**
This session will explore innovative designs and cutting-edge technologies including robotics and telemedicine systems in the next generation of medical devices and systems.  Discussions should also include consideration of individual differences in user capabilities for home and institutional use and the impact of integrating new technologies on the incidence of use errors.
Explore innovative designs and cutting-edge technologies
robotics
telemedicine

Identify potential
human factors issues
gaps in expertise
areas of research

## Session #5

- Beyond 2000:  Charting a Course for User-Centered Medical Devices and Systems  **(Chair:  **_**Anne Mavor, **_
- _Col. Valerie J. Rice_,  *Key Outcome/Lessons On Medical Device Design And Labeling For The Global Market*
- _Michael Wiklund, _*Global Standardization of Human Factors and Medical Devices and Systems*
- _Michael S. Wogalter, _*Labeling and Instruction for Global Marketing*

**Notes:**
This colloquium is an opportunity for open exchange among experts and professionals representing industry, medicine, consumers/patients, academia, government agencies, and the human factors professional community regarding use errors with medical devices and systems. It is hoped to result in recommendations for research, technical standards, and guidance and to identify technical issues that need to be addressed, and opportunities for collaboration and partnering.  

opportunity for open exchange
experts and professionals representing
industry, medicine, consumers/patients, academia, government agencies, and the human factors professional community
regarding use errors with medical devices and systems

## Session #5 (continued)

- _William H. Muto, _*Advanced Technology Applications for Product Design*
- _Christopher Wickens, _*Human Factors in Aviation—Lessons Learned and Transferability*
- _Kim J. Vincente, _*Human Factors Lessons Learned----Other Industries*
- _Najmedin  Meshkati_, *Human Factors Lessons Learned----Other Industries*

## Session #6

- Transferring Successful Human Factors to the Medical Context  **(Chair:  Anne Mavor)**
- _David Gaba, _*Key Issue Areas in Medicine to Which Human Factors Can Contribute—from the Medical Perspective*
- _Karlene Roberts, _*Key Issue Areas in Medicine to Which Human Factors Can Contribute—from the Perspective of the NRC Committee on Human Factors*
- _John Gosbee, _*Barriers and Enabling Factors Associated with Integrating Human Factors into Medicine—Next Steps for the Human Factors Community*

## Outputs

*Summary of the recommendations*
*Agenda for the future*
*Working group Committees*

**Notes:**
recommendations for research, technical standards and guidance 
to identify technical issues that need to be addressed, and opportunities for collaboration and partnering.
To set an agenda for the future
working group committees