Workshop on ...

Accessible Interfaces for Medical Instrumentation: Draft Guidelines and Future Directions

Summary

This page serves to document and disseminate the results of this Workshop, which was held October 20-21 in 2005 at the conference facility within the FDA’s headquarters building in Rockville MD, and involved 61 participants with a diversity of expertise and backgrounds. This state-of-the-science Workshop was organized by the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation (RERC-AMI) in conjunction with the Center for Devices and Radiological Health (CRDH) of the U.S. Food and Drug Administration (FDA). The host from the FDA was the Office of Science and Engineering Laboratories. Also active in planning has been the FDA's Human Factors Program.

This dissemination directly responds to a requirement by the National Institute on Disability and Rehabilitation Research (NIDRR) of the United States Department of Education that each of its 22 RERC’s sponsor such an event during the third year of a five-year grant cycle, and then disseminate the outputs of the event during the fourth year. The Final Report of the Workshop is available from the RERC-AMI as an html document, and also as Chapter 31 within a CRC Press book that is entitled Medical Instrumentation: Accessibility and Usability Considerations, in which over 90% of the chapters were written by participants of the Workshop (most with drafts that were distributed prior to the event).

The achive that follows is maintained to document planning activities related to the event.

---

Archive

| Background | Aims | Participants | Content | Logistics (e.g., Registration, Hotel) | Format & Timeline | Directions to FDA Site

Background:

The RERC-AMI strives to increase access to and utilization of healthcare instrumentation and services by individuals with disabilities, as well as access to employment in healthcare professions by such persons. The RERC-AMI, based at Marquette University with sub contractual partners in California (UC-San Francisco/UC-Berkeley, Western University of Health Sciences), Milwaukee (UW-Milwaukee) and Connecticut (U. Conn), is one of 22 RERCs funded by the National Institute on Disability and Rehabilitation Research (NIDDR) of the U.S. Department of Education. (The portfolio of ongoing RERC-AMI research and development activities can be reviewed at http://www.rerc-ami.org.)

All RERCs are required to host a state-of-the-science conference during the third year of their five-year awards, which for the RERC-AMI is during 2005. As its state-of-the-science conference, the RERC-AMI will conduct a workshop that will bring together participants with a diversity of expertise to address accessibility and usability of medical devices, with a particular emphasis on user-technology interfaces. The outcomes of the workshop are published as Part 5, Chapter 31 within a book that is entitled Medical Instrumentation: Accessibility and Usability Considerations. Parts 1-4 of this book consists of about 30 invited chapters, primarily from workshop participants. Drafts of most (if not all) of these chapters will be available to participants prior to the Workshop, and the book will be published by CRC Press during the summer of 2006.

The host from the FDA is the Office of Science and Engineering Laboratories. Also active in planning has been the FDA's Human Factors Program.

Aims:

The RERC has three primary goals for this workshop:

1. To generate ideas and draft priorities for user-device interface design guidelines that may broaden device accessibility and improve patient safety;
2. To identify and discuss current trends in user-device interfaces, and anticipate emerging accessibility and safety issues for such interfaces in the future; and
3. To create a stimulating environment that offers value to each participant, including the acquisition of new knowledge.

Participants:

The 61 participants that represent, in roughly equally proportions, academia (e.g., biomedical engineering, human factors engineering/ergonomics, health/disability policy), federal government agencies (e.g., NIDRR, FDA, DoJ, VA, NIH, NSF) and other RERC Directors, the medical device industry, and RERC-AMI staff/students/advisors. This includes a core of over 30 invited and confirmed experts who are co-chairing breakout themes, contributing book chapters, etc.

Content:

The State of Science conference will have two general themes: guideline development (addressing Goal 1) and emerging trends and technologies (addressing Goal 2). In both cases the primary focus is on user-device interfaces.

Each theme will include several breakout groups that over the course of three working sessions will generate a document that consists of prioritized bullets in targeted discussion areas. The tentative areas follow:

• Under Guideline Development:
  1. Physical Positioning/Orienting of Patient to Device (Co-Chairs: Molly Story and Bob Erlandson)
  • Motivation: As has been documented by the RERC-AMI's national survey of patients with disabilities, there are many categories of medical equipment where over 50% of respondents expressed significant difficulties, and most of these related to physical positioning and orientation challenges (e.g., exam tables, beds, weight scales, imaging equipment). Many of these are part of process of performing medical procedures (e.g., pelvic exam, dental services, eye exam).
  2. Interfaces for Monitoring Devices (especially for practitioner use) (Co-Chairs: John Gosbee and Jay Crowley)
  • Motivation: This also represents a large category of devices, but here the focus is on displays and controls of interfaces that are most often operated manually, often for assessment (e.g., physiologic monitoring devices) and therapy (e.g., infusion). The primary focus is on monitoring devices used by practitioners in hospitals and clinics.
  3. Interfaces for Home Healthcare Devices (Co-Chairs: Daryle Gardner-Bonneau and Binh Tran)
  • Motivation: This also represents a large category of devices, only here the user is commonly the patient with disability or the caregiver (who also may have disabilities). Examples include vital sign monitors, glucose monitors and insulin dosers, infusion pumps, oxygen equipment, home exercise equipment, and home telehealth equipment.
• Emerging Trends & Technologies:
  4. Interfaces for Patients with Disabilities (Co-Chairs: Jerry Miller, June Isaacson Kailes, and Mike Jones)
  • Motivation: The focus here is on the approaches for maximizing the accessibility of instrumentation commonly used by patients. This includes consideration of alternative strategies as appropriate for certain classes of devices, such as use of universal design strategies or multi-modal interfaces that enhance certain abilities while minimizing the impact of disabilities.
  5. Interfaces for Aging and Disabled Providers (Co-Chairs: Kate Seelman and Bill Mann)
     • Motivation: This focus is framed by the practical reality that as practitioners age they may, often gradually, present with changing sensory and/or motor abilities. Medical devices of the future should, ideally, be designed to accommodate for such changes, and (as appropriate) enable the person to continue in their selected profession.

  Glossary of Terminology (available to participants, designed to help address diversity of backgrounds)

Logistics (Location, Registration and Hotel Information):

This workshop will be held in Rockville MD (Washington DC metropolitan area) on October 20-21 2005, starting at 1 PM on Thursday and ending on Friday at 3 PM on Friday. The address is 5600 Fisher Lane, Rockville MD, 20857. Directions to FDA from Metro and Doubletree Hotel

The RERC-AMI Advisory Council meeting will start after this workshop at the FDA, and then continue on Friday evening and the morning of Saturday October 22 at the hotel.

| Logistics flyer in pdf | Logistics flyer as text | Registration form in pdf | Registration form as text |

The deadline for the block of hotel rooms at the Doubletree has passed. Registration continues through Monday October 17, after which there is only registration if some breakout themes are not full.

To register by phone, contact Erin Schwier by e-mail at eschwier@westernu.edu or directly call toll free 1-800-832-0524.

Format and Timeline:

This workshop is designed as a goal-directed and participatory event. Most of the time is spend in breakout theme groups. There is purposely some overlap between the themes. Each theme of roughly 15 participants has two co-chairs. These co-shairs are assisted by one senior member of the RERC-AMI staff and one student. Presentations, some to the full workshop and others to breakout groups, are intended to help set the context.

Day 1 (Thursday):

11:30 AM: Open for Registration (FDA cafeteria available for lunch)

12:00 PM: Start of hotel pick-up to FDA

1:00 PM: Welcome by Larry Kessler, introduced by Don Marlowe

1:15 PM: Overview (Jack Winters)

1:30 PM: Presentations (Bill Peterson/June Isaacson Kailes, Jill Winters, Ron Kaye)

2:30 PM: Discussion of breakouts, logistics (Molly Story, Jack Winters)

2:45 PM Break

3:00 PM: Theme Breakout #1 (focus: Current state of the art & future vision – What is the current status of relevant medical technology, and where is the “field” now? Where should it go?)

• 3:00 - Discussion of aims, process, resource materials, possibly short summary presentations
• by 3:30 - Brainstorming process should have started (Theme Co-Chairs may break group into sub-groups)
• by 4:30 - Focus should have shifted to synthesizing results into key bullets

5:15 PM: Session completed, start of van pickup to hotel

5:15 PM: Bar open at hotel

5:30 PM: Food available at hotel

7:00 PM: Food and bar closed

Day 2 (Friday):

7:15 AM: Start of hotel pickup, with breakfast available at FDA cafeteria

8:15 AM: Last hotel pickup

8:30 AM: Start of Session - Brief reports of preliminary bulleted lists (current status, trends)

9:00 AM: Group Panel Discussion: Terminology and Forms of Guidance

9:30 AM: Break

9:45 AM: Breakout Themes #2 (focus: Challenges/barriers, knowledge gaps – What isn’t being done that should be happening? What’s getting in the way?)

• Theme Co-Chairs may choose to spend part of the time in mini-breakouts (sub-groups) for brainstorming

11:30 AM Break for lunch

12:45 PM Breakout Themes #3 (focus: Recommendations, opportunities – What should be done next, and who needs to do it? What are the opportunities? What are the priorities?)

• Theme Co-Chairs may choose to spend part of the time in mini-breakouts (sub-groups) for brainstorming
• By the end of this breakout, each Theme is to have their top 3-5 bullets on a powerpoint slide for each of six areas, ready to be reported by a Co-Chair during the final session:
  • current status, with particular focus on access to and effective use of medical interfaces by individuals with diverse abilities
  • key relevant standards/guidelines activities (groups A-C) or technology/societal trends (groups D-E)
  • 2010 vision statements
  • key challenges/barriers to achieving these visions
  • key action items / knowledge gaps
  • overriding recommendations and opportunities

2:00 PM Break

2:15 PM Final Plenary Presentations, by a Theme Co-Chair, Discussion

3:00 PM End of Workshop, start of van pickup to hotel

---

Meeting of the RERC-AMI's Advisory Council

3:15 PM Brief Advisory Debriefing Meeting (at FDA)

4:15 PM Break

6:00 PM Advisory Dinner (at hotel)

Day 3 (Saturday):

8:30 AM General advisory meeting (at hotel)

11:00 AM End of Advisory Meeting

 

---

Invitation to participants to submit commentary, as a rich text file (rdf) or as pdf file