Rehabilitation Engineering Research Center (RERC) on
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Report of the Workshop on Accessible Interfaces for Medical Instrumentation: Draft Guidelines and Future Directions

Table of Contents

• Abstract
• Introduction
• Methods: Organization and Implementation of the Workshop
  • Breakout Themes and Bullet Generation Process
    • Breakout Theme A: Physical Positioning/Orienting of Patient to Device
    • Breakout Theme B: Interfaces for Monitoring Devices
    • Breakout Theme C: Interfaces for Home Healthcare Devices
    • Breakout Theme D: Emerging Interfaces for Patients with Disabilities
    • Breakout Theme E: Emerging Interfaces for Aging and Disabled Providers
  • Ranking of Bullet Points and Integration of Data
• Results
  • Vision 2010 Statements
  • Challenges and Barrier to Achieving Vision
• Discussion and Future Directions
• Acknowledgement
• Appendix: Special Workshop Contributions: Participant Commentaries
  • Appendix 1: Chairs’ Perspectives on Workshop Breakout Theme C (Interfaces for Home Healthcare Devices)
  • Appendix 2: Commentary on Distinguishing Accessibility from Accommodation
  • Appendix 3: Commentary on Data, Models and Procedures for Design of Accessible Medical Instrumentation
  • Appendix 4: Commentary on What is Accessibility? And What Does it Have to do with Medical Device Design?
  • Appendix 5: Commentary on the Difference Between “Usability” and “Accessibility” May Be the End Users

Published September 2006. Related version is available as Chapter 31 in Medical Instrumentation: Accessibility and Usability Considerations (Winters and Story, eds), CRC Press

Abstract

This document represents the final report of a state-of-the-science workshop that was held over two days in October 2005 at the FDA Headquarters builidng in Rockville MD, and serves to disseminate the results of the event. The workshop included intermittent brief plenary presentations, with the majority of the time dedicated to three breakout sessions that addressed specific questions and had targeted goals. The participants were divided into five heterogeneous theme groups that each addressed a specific aspect of accessible medical instrumentation. Each theme group generated bullet points in each of four topical areas, which are presented here. After the event, the workshop participants voted to select the most important bullet points. These results are presented and discussed in Section 3. At the end of the report, contributions of commentary from several individual workshop participants are presented.

1. Introduction

This report presents the final report of a state-of-the-science workshop 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). It serves to disseminate the results of this event, which was held in October 2005 at the conference facility at the FDA’s headquarters building in Rockville MD, and involved 61 participants with a diversity of expertise and backgrounds. 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 21 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 four year.

The aim of the RERC-AMI is 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. This is the first five-year cycle for this topic, and an interactive workshop format was selected instead of a more conventional conference because of the desire for a truly interactive exchange that could help provide guidance for this emerging field, especially in the areas of standards and guidelines development and future opportunities for integrating more accessible medical devices into society. Additionally, the unique opportunity to hold this event at the FDA reinforced the choice of format. Two other factors impacted on early planning: the decision to narrow the scope of the workshop through a focus on the human-technology interface, and the desire to focus on future possibilities for guidelines and innovative interface technologies.

2. Methods: Organization and Implementation of the Workshop

Prior to the workshop, the co-directors of the RERC-AMI held a series of planning meetings, including meeting at FDA facilities in Maryland. Based on such meetings, it was decided that the majority of the time would be allocated to breakout sessions. A previous 1999 home care technlogies workshop that was held at the FDA facility, organized by Jack Winters and the FDA with support from the National Science Foundation (NSF) as well, was used as a starting base in the planning discussions.

2.1 Breakout Themes and Bullet Generation Process

Five themes were identified as priority areas for the workshop:

1. Physical Positioning/Orienting of Patient to Device
2. Interfaces for Monitoring Devices
3. Interfaces for Home Healthcare Devices
4. Interfaces for Patients with Disabilities
5. Interfaces for Aging and Disabled Providers

The first three of these themes were grouped under the general area of Guideline Development, and the latter two under the area of Emerging Trends and Technologies.

For each of these themes, two colleagues with unique relevant expertise were recruited to co-chair the theme. Two of the ten co-chairs were from the RERC-AMI, and three were senior investigators with other RERCs. Other co-chairs included one person from the FDA, several university faculty members with special expertise in the area of a given theme, and several highly respected human factors consultants. Each of the five themes was also allocated a staff member or student from the RERC to assist the co-chairs in any way deemed helpful.

Also in preparation for the workshop, a core group of roughly 20 experts in human factors of medical devices and in accessibility were recruited to set the stage by producing drafts of the chapters associated with this book; the RERC-AMI also contributed a number of chapters. Drafts for roughly 80% of the 31 chapters that ended up in the CRC Press book entitled Medical Instrumentation: Accessibility and Usability Considerations were made available through a password-protected site prior to the workshop. Also on site at the workshop were several booths that demonstrated innovative approaches for future medical device interfaces.

The workshop started with Donald Marlowe, a key organizer representing the FDA, introducing the Director of the Office for the Science and Engineering Laboratories of the FDA, Dr. Larry Kessler. Dr. Kessler welcomed the attendees and provided a presentation that helped set the stage for the content of the Workshop. After Jack Winters provided an overview of the Workshop, four targeted presentations were given. The first two, by William Peterson and June Isaacson Kailes, provided perspectives of professionals with long histories in the disability field who are also individuals with disabilities who have first-hand experience with difficulties in receiving healthcare services. Peterson’s presentation included discussion of his role in creation of the priority for the funding opportunity for the RERC-AMI; and some of the presentation by Kailes related to material presented in Chapter 1 of the CRC Press book. The next presentation, by Jill Winters, summarized the results of the RERC-AMI’s national survey of over 400 individuals of their experiences as medical patients with disabilities; this presentation closely tied to Chapter 2 of the CRC Press book. The next presentation was by Ron Kaye from the FDA’s Human Factors Branch, which provided a general perspective of the FDA on medical device regulation procedures and human factors, as well as brief coverage of some of the material on accessibility and human factors of medical devices that is covered in Chapter 17 in the CRC Press book. Finally, the authors of this chapter, who also served as co-directors of the workshop, provided discussion of the five breakout session themes, group assignments, and logistics. This set the stage for the three break-out sessions that collectively totaled nearly five hours that represented the heart of this workshop. Distribution of participants between the five break-out groups was by assignment. This assignment was based on each participant completing a survey prior to the workshop where they listed their top three choices for themes, plus considerations of diversity of expertise; in all cases participants were assigned to one of their top two choices. At two stages, results were reported to the larger group, with the second of these consisting of formal presentations of bullets that served as the closing session of the workshop.

Each of the three break-out periods had targeted aims. The first breakout had a focus on the current state-of-the-art and future vision in the area of the theme, with roughly five high-priority bullet points to be identified in the area of future vision. The second session focused on discussions and bullet creation in the areas of challenges and barriers that might impede realization of the visions, and existing knowledge gaps in the theme area and action items that should be addressed. Finally, the third session addressed overriding recommendations and opportunities, and provided time to reach consensus on all of the four areas where a prioritized list of 3-5 bullet points were created. Some of these bullet points had multiple parts as groups integrated similar bullets together. During each of the three break-out periods, Jack Winters served as a rover who rotated between theme groups to help keep groups on focus and occasionally share information between groups or address any logistical issues. Of note is that different groups took varying strategies to meet these ultimate aims. A subset of bullet points was reported during the final session, with each theme group allocated roughly 10 minutes.

2.1.1 Breakout Theme A: Physical Positioning/Orienting of Patient to Device

This Theme was chaired by Robert Erlandson (Wayne State University) and Molly Follette Story (RERC-AMI staff, Human Spectrum Design, LLC), and involved a total of thirteen participants, including five from the RERC-AMI, three from other academic institutions and three from the FDA (see Table 1). The motivation for this theme, as defined prior to the workshop, follows:

“On the RERC-AMI's national survey of patients with disabilities, a majority of respondents reported having had significant difficulties with many categories of medical equipment (e.g., exam tables, weight scales, imaging equipment). Most of these difficulties are related to physical positioning and orientation, and are part of many of the most common medical procedures.”

Table 1. Theme Group Assignments for Participants at Workshop on Accessible Interfaces for Medical Instrumentation
Theme A	Physical Positioning/Orienting
Co-chairs:
Robert Erlandson, PhD	Wayne State University
Molly Follette Story, MS	RERC-AMI staff, Univ. of California-Berkeley
Support:
Brenda Premo, MSW	RERC-AMI staff, Western U. of Health Sciences
Melissa Lemke, MS	RERC-AMI staff/student, Marquette University
Participants:
Don Marlowe, MS	FDA/RERC-AMI Advisor/Workshop Coordinator
Tom Armstrong, PhD	RERC-AMI Advisor/University of Michigan
Jane Dorval , MD	Commission on Accreditation of Rehabilitation Facilities (CARF)
Jean Hinker	Midmark Corporation
Christie MacDonald, MPP	RERC-AMI staff, Western U. of Health Sciences
Amanda Maisels, JD	U.S. Dept. of Justice
Rochelle Mendonca, MS	RERC-AMI student, U. of Wisconsin-Milwaukee
Walter Scott, PhD	FDA
Donna Walsh, BBE	FDA
Becky Wassem, DNS	RERC-AMI Advisor
Theme B	Interfaces for Monitoring Devices
Co-chairs:
John Gosbee, PhD	VA-National Center for Patient Safety
Jay Crowley, MS	FDA
Support:
John Enderle, PhD	RERC-AMI staff, U. of Connecticut
Megan Conrad, MS	RERC-AMI student, Marquette University
Participants:
Larry Kessler, ScD	FDA
Alexandra Enders, OTR/L	RERC-AMI Advisor, U. of Montana
Erik Engstrom	ANS Medical
Ann Ferriter	FDA
Libby Grohmann	ANS Medical
Michael Mendelson, DDS, MS	FDA
Michael Wiklund, MS	Wiklund Research and Development
Stan Yarnell, MD	RERC-AMI Advisor, consultant
Theme C	Interfaces for Home Healthcare Devices
Co-chairs:
Daryle Gardner-Bonneau, PhD	Bonneau and Associates
Binh Tran, PhD	Catholic University of America
Support:
Jill Winters, PhD, RN	RERC-AMI staff, Marquette University
Eli Omiatek, BBE	RERC-AMI student, Marquette University
Participants:
Sue Bogner, PhD	Institute for the Study of Human Error, LLC
Jennifer Croft	FDA
William K. Durfee, PhD	RERC-AMI Advisor
Al Gilman	RERC on Information Technology
Judy Brewer	World Wide Web Consortium, MIT
Stephen B. Wilcox, PhD	Design Science
Theme D	Interfaces for Patients with Disabilities
Co-chairs:
June Isaacson Kailes, MSW	RERC-AMI staff, Western U. of Health Sciences
Michael L. Jones, PhD	RERC on Mobile Wireless Technologies
Support:
R. Sarma Danturthi, PhD	RERC-AMI staff, Marquette University
Tyre Feng, MS	RERC-AMI student, Marquette University
Participants:
Pascale Carayon, PhD	University of Wisconsin-Madison
Chris Duff	RERC-AMI Advisor
Robert Jaeger, PhD	NIDRR
Jim Leahy	RERC-AMI Advisor/RERC on Tech. Transfer
Joel Myklebust, PhD	FDA
William Peterson, MS	US Dept. of Homeland Security
Chuck Rich, PhD	Mitsubishi
Bill Schutz, PhD, MSW, MPH	NIDRR
Todd Schwanke, MS	RERC-AMI staff, U. of Wisconsin-Milwaukee
Theme E	Interfaces for Aging and Disabled Providers
Co-chairs:
Katherine D. Seelman, PhD	University of Pittsburgh
William Mann, PhD	RERC on Tech. for Successful Aging, U. Florida
Support:
Roger Smith, PhD	RERC-AMI staff, U. of Wisconsin-Milwaukee
Pawan Shroff, MS	RERC-AMI student, Marquette University
Participants:
David Baquis	U.S. Access Board
Jim Mueller, MS	RERC-AMI Advisor/RERC on Mobile Wireless
John Peifer, MA	RERC on Mobile Wireless Technologies
David Rempel, MD, MPH	RERC-AMI staff, U. of California-San Francisco
Erin Schweir, OTD	RERC-AMI staff, Western U. of Health Sciences
Linda van Roosmalen, PhD	RERCs on Wheelchair Transportation and Telerehabilitation, Pittsburgh

As seen in Table 2, Theme Group A’s vision statements reflected their concern for creating a national imperative for incorporating accessibility into the design of medical devices, and into standards that affect it, as well as into tools that are used in the design process. The challenges and barriers the group identified were financial, technical, social-political, attitudinal, and economic. They identified knowledge gaps in the areas of data, models, and assessment procedures; and they suggested three action items to improve education in accessibility and universal design, develop tools for designing for greater accessibility, and discover advanced technologies. Theme Group A’s recommendations addressed tool, standards, and curricula development, as well as advanced technology identification and increased consumer advocacy (see Table 2).

Table 2. Bullet Points for Workshop Theme A: Physical Positioning/Orienting of Patient to Device
	Vision Statements
A1	Create the national imperative for including accessibility in medical equipment design
A2	Have models and procedures that allow us to evaluate medical devices for accessibility, and design systems that are accessible to all
A3	Have standards developing organizations integrate accessibility into standards for medical equipment
	Challenges/Barriers to Vision
A1	Funding and mandate to create the national imperative for including accessibility in medical equipment design
A2	Technical: Absence of technologies that render current accessibility issues irrelevant
A3	Social-political: Public awareness of right to access; and medical vs. civil rights vs. functional models of disability
A4	Attitudinal: Within health care community; Disability community; Academic community; Acceptance of new technologies and change
A5	Economic: Cost, reimbursement, incentive policies (carrot & stick)
	Knowledge Gaps/Action Items
A1	Knowledge gap: Insufficient credible/validated disability data and projections
A2	Knowledge gaps: • Lack of models for simulating human performance • Lack of accessibility assessment procedures
A3	Action item: More education in accessible and universal design – helps address knowledge gap of accessibility and universal design
A4	Action item: Create … • Inventory of devices with accessibility features (helps address knowledge gap) • Models and procedures for evaluating accessibility • Performance based standards for accessible design • Legal requirements and incentives for providers to buy accessible equipment
A5	Action item: Identify new and emerging technologies that will render many existing procedures obsolete and eliminate accessibility issues
	Recommendations
A1	RERCs and other research organizations should develop models and procedures for evaluating accessibility with input from consumers with disabilities
A2	RERCs, other research organizations, and industry should partner with standards developing organizations to create performance based standards for accessible design of medical equipment • RERC-AMI should initiate steps to coalesce national imperative for including accessibility in medical equipment design
A3	RRTCs (Rehab Research & Training Centers), educators, and accreditation bodies should create curricula on accessibility and universal design appropriate for a variety of disciplines
A4	Major research organizations should identify new and emerging technologies that will render many existing procedures obsolete and eliminate accessibility issues
A5	Disability advocacy groups should increase awareness of right to equal access to healthcare

 

2.1.2 Breakout Theme B: Interfaces for Monitoring Devices

This theme was chaired by Jay Crowley (CDRH, FDA) and John Gosbee (VA National Center for Patient Safety), and involved a total of 12 participants, including 2 from the RERC-AMI, four from the FDA and three from industry (see Table 1). This group focused on interfaces for monitoring devices, especially as related to use by practitioners. This topic is clearly of key interest to the FDA and its mission. The motivation for this theme, as defined prior to the workshop, follows:

“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.”

Theme Group B participants included an intriguing mix of expertise in medical device regulation, accessibility and disability research, and biomedical engineering. As such, much of the first session was spent in cross-fertilization of ideas and in sharing conceptual frameworks. As seen in Table 3, Theme Group B’s visions included better education, development of an exemplary accessible monitor device, advanced technologies, sufficient application of standards, and development of better design guidance. The group identified challenges and barriers of economics, awareness levels, human factors concerns, job duties, and competitive marketplace issues. There was also frank discussion of the reality that there are both synergy and conflict between the aims of device regulation and maximizing device access. The knowledge gaps and action items they identified involved educating designers and industry, developing appropriate incentives and regulations, standards and guidelines, as well as design exemplars. Theme Group B’s recommendations were to use existing committees to advocate for accessibility, to have the FDA endorse the concept, and develop an award for good accessible medical device design (see Table 3).

Table 3. Bullet Points for Workshop Theme B: Interfaces for Monitoring Devices
	Vision Statements
B1	Universal design course required by clinical engineering students
B2	Good exemplars of an “accessible monitor” to lead, teach, test. Consider: • More of a systems solution … paperless documentation • Multiplex controls for patient information, vital signs monitoring [e.g., URC] • Wireless and other sensing • More of a choice of display: from PDA to fixed monitor to computer at home
B3	Innovations into design adaptations that help all of us (e.g., enhancement of visual display with audio supplement helping sighted and unsighted clinician)
B4	Applying the human factors standard HE-74 (and soon HE-75) in a sufficient manner (especially accurate user profile, e.g. diverse abilities)
B5	Harmony and tightening of usability and universal design guidelines
B6	Standardization of displays, icons, warnings, alarms
B7	Wireless and other sensing incorporated into devices
	Challenges/Barriers to Vision
B1	This is a commodity environment, not boutique, so change with cost can hurt
B2	Awareness factor by stakeholders in developing new or new versions of medical equipment
B3	Many devices already have issues with usability and designing to “true” needs of providers, so with just adding another modality (e.g., sound), these issues remain
B4	Identifying the boundary of suitability of the healthcare provider to accomplish the job tasks (e.g., anesthesiologist with visual impairment, neurosurgeon with tremor)
B5	Acceptance from marketing that accessibility changes would be competitive (make it sell)
B6	Design culture (given that most of technology is already there) where the product is a technology driven process (CEO, design process owner)
B7	Posing mutually exclusive goals (losing proposition) that are in stark contrast
B8	Lack of expertise and personnel in company to produce accessible equipment
B9	Off-the-shelf components may not exist (given processor and display are from consumer market)
B10	Workplace congestion and footprint size (reachability)
B11	Patient privacy issues
B12	Unauthorized use (by kids, pets) if equipment is physically accessible
B13	Income status of people with disabilities may be lower
	Knowledge Gaps/Action Items
B1	Educate/influence engineers, industry and others about universal design and accessibility: • Create the data necessary to make the “marketing” case; promote it to manufacturers • Improve understanding of “access” – both within the design process (manufacturers) and for purchasers
B2	Carrots and sticks – develop regulations (or “regulatory” bodies making “endorsing” statement) and (tax) incentives (IRS, CMS) to improve accessibility in (monitoring) devices – through collaboration with the disability (rehabilitation) community
B3	Develop HFE standards and guidelines incorporating accessibility issues (good design)
B4	Develop examples of good accessible design (as reference for manufacturers to use); and a registry of accessible components (include consumer products that incorporate accessibility, e.g., displays, controls)
B5	Study legal and regulatory issues around the “telecom model” and FEC voting booth model (usability guide) – to improve accessibility in component part design. Note: Section 255 and 508 apply to electronic and information technologies (E&IT), e.g., by 508 the Federal government can purchase only accessible E&IT products (with some exceptions)
B6	ABET does not require universal design, so make it required
B7	What exactly are the major accessibilities to be addressed (sight, hearing, mobility, or…)?
B8	Are we talking about all users, including maintenance, attaching and setting up cables?
B9	What is the major impact point? (FDA GMP, AAMI or ISO 60601-1-6 were the ones for usability.) ECRI might be an influence point
	Recommendations
B1	Use the AAMI Human Factors committee to strongly advocate for “accessibility”; develop a chapter in the proposed new standard; develop a “guideline” for accessibility; advocate at professional meetings
B2	Create an FDA endorsement of accessibility in device design
B3	Develop an “award” (mechanism for design excellence) for good accessible design
B4	Promote industry participation in addressing accessibility issues – in collaboration with disability community (e.g., use Blue Ribbon panels). [Promote device design that addresses patient accessibility.]

 

2.1.3 Breakout Theme C: Interfaces for Home Healthcare Devices

This theme was chaired by Daryle Gardner-Bonneau (human factors and accessibility consultant) and Binh Q. Tran (Catholic University of America), and involved a total of ten participants with very diverse backgrounds, with half being distinguished experts with a background that included considerable consulting activities in areas that are applicable to this theme (see Table 1). The motivation for this theme, as defined prior to the workshop, follows:

“This represents a large category of devices, the user of which is commonly the patient or their personal attendant or family member or friend, any one of whom may have a disability. Examples include vital sign monitors, blood glucose monitors and insulin dosers, infusion pumps, exercise equipment, and home telehealth equipment.”

Theme Group C had an interesting mix of human factors expertise, technologists and clinical expertise that resulted in considerable discussion of future possibilities for home-based healthcare (see also Appendix 1). As seen in Table 4, Theme Group C’s visions for the year 2010 included providing effective design guidelines and strategies to designers, development of scalable, customizable platforms and “smart” systems, a connected system of healthcare, and changes in reimbursement policies. The challenges and barriers they identified involved limitations in knowledge among designers, in technology, in user skills, as well as a practitioner-focused healthcare system and a lack of focus on prevention. The group identified two key knowledge gaps, to support decision-making and the process of implementing new device designs; they also identified three action items, to mandate accessibility, to make devices more customizable, and increase stakeholder involvement in the standards development process. Theme Group C’s recommendations were to create funding to support policy research, to develop an effective health platform, and to conduct research – on potential humanistic barriers, on “best practices” in accessible design, and on chronic disease prevention and management (see Table 4).

Table 4. Bullet Points for Workshop Theme C: Interfaces for Home Healthcare Devices
	Vision Statements
C1	Provide guidelines/strategies to designers for how to be “more inclusive” for various groups of end-users
C2	Scalable, customizable platforms enabling plug-and-play devices to be added for monitoring co-morbidities and for enhanced accessibility needs
C3	Connected care system – devices can be remotely accessed, monitored, controlled, maintained via telecom
C4	“Smart” systems to support disease management by all users (i.e. consumers, caregivers, clinicians)
C5	Changes in policy for reimbursement of home healthcare services – spurring innovation/utilization
	Challenges/Barriers to Vision
C1	For Vision #1 (Guidelines/strategies to designers): • Knowledge gap of who/how many subjects would be needed to represent [disabled] population • Gap in available specifications for design for various cohorts of end users • Lack of knowledge by designers regarding prevalence of disabilities & nature of functional deficits
C2	For Vision #2 (Scalable Platforms): • Currently limited multi-modal, multi-sensory communication and interface (input/output) with devices (device interoperability and standards for device communication)
C3	For Vision #2 (Scalable Platforms): • Humanistic barriers: skill levels, comfort level with technology, user diversity (e.g., language spoken/read)
C4	For Vision #3 (“Connected Care”): • Health care model: MD-focus vs. patient empowerment; • Reimbursement streams for model; • Privacy vs. increased connectivity; • Increased liability for clinicians.
C5	For Vision #5 (Policy Changes): • Lack of focus on prevention; • Resistance to change (bureaucracy); • Need for translation of knowledge: research to policy; • Lack of enforcement for accessibility; • Justification: reimbursement vs. abuse.
C6	For Vision #4 (Smart/Decision Support): • Increased involvement of patients in self-management [of healthcare]; • Need for knowledge translation: research to practice (best practices); • Bandwidth of interaction with users.
	Knowledge Gaps/Action Items
C1	Action item: Make accessibility a mandate for reimbursement
C2	Action item: Increased flexibility & adaptability of medical devices (customization)
C3	Action item: Increase involvement in standards process – stakeholders
C4	Knowledge gap: Develop “best practices” in decision support
C5	Knowledge gap: Areas for better (integrated) understanding of: • Reimbursement; • Introduction of new technology; • Profitability of manufacturers.
C6	Need to conduct research on appropriate “sample” of end users – accessibility testing.
C7	Need to know what patient empowerment information is needed for promoting self-management [of healthcare]
	Recommendations
C1	Policy-makers and granting agencies should fund research to support policy changes leading to • Mandated & enforced accessibility in design of medical devices • Reimbursement streams for home health medical devices and care to manage chronic diseases and disabilities • Business case for proactive “prevention” model (vs. reactive episodic model) of healthcare delivery
C2	Industry should develop a common interoperable, scalable, customizable health platform that enables: • Health information to be collected, analyzed & transmitted • Multi-modal, multi-sensory communication and interfaces (input/output)
C3	Further research is needed to identify and assess potential humanistic barriers (i.e., skill, comfort w/technology, and user diversity) to utilization of home health technologies for self-care
C4	Granting agencies should support research to develop evidence-based “best practice guidelines” to guide industry regarding how to design for accessibility, and to aid practitioners in purchasing and using accessible medical devices
C5	Granting agencies should support research to address knowledge gaps in chronic disease prevention and management for the purpose of developing “smart” routines for in-home decision support

 

2.1.4 Breakout Theme D: Emerging Interfaces for Patients with Disabilities

This theme was chaired by Michael L. Jones (Shepherd Rehabilitation Hospital, Atlanta) and June Isaacson Kailes (RERC-AMI staff, Western University of Health Sciences), and involved a total of 13 participants, including 4 from the RERC-AMI, 4 from different federal agencies, and two representing other RERCs (RERC on Mobile Wireless Technologies, RERC on Technology Transfer) (see Table 1). This theme focused on interfaces for patients with disabilities, especially as related to use by practitioners. The motivation for this theme, as defined prior to the workshop, follows:

“The focus 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.

Theme Group D spent considerable time discussing the tradeoffs and challenges of personalized interfaces, and of relationships between technology and access. Theme Group D’s visions were the adoption of new technologies (specifically the universal remote console, URC), regulations to support acquisition of accessible equipment, use of a personal profile in medical records, and better support for telehealth activities. The challenges and barriers they identified included a number of obstacles to adoption of the URC and to development of regulations. In the area of knowledge gaps and action items, Group D focused on the needs for inclusion of a personal profile in medical records and support for telehealth services. The group’s recommendations were to adopt the URC in medical device design, to develop regulatory requirements for accessible medical instrumentation, and implement an accessibility/accommodation profile as part of standard health information (see Table 5).

Table 5. Bullet Points for Workshop Theme D: Emerging Interfaces for Patients with Disabilities
	Vision Statements
D1	Adoption of universal remote console (URC) interface capability in some medical products, equipment, or devices with patient interfaces
D2	Regulatory requirements supporting acquisition of accessible medical products, equipment, or devices by Federal purchasers (i.e., VA) and non-Federal providers
D3	Personal accessibility/accommodation profile as part of standard health information collected (along with allergies, blood type, etc.)
D4	Network-based remote assistance available for medical instrumentation use, adjustment, etc.
	Challenges/Barriers to Vision
D1	Adoption of universal remote control (URC) interface capability in some medical products, equipment, or devices with patient interfaces • Resistance by manufacturers (cost, identity, control, liability), possible resistance or concern by regulators (e.g. controlling both a consumer device and medical instrument) • There needs to be a standard that tags features/tasks that can be controlled by the patient, patient or practitioner, or practitioner • Cost burden to manufacturer, provider, patient, payor • Relationship to consumer electronics market • Maturity of technology (reliability, security and usability concerns) • Lack of international standard (working on ISO 24752); lack of awareness
D2	Regulatory requirements supporting acquisition of accessible medical products, equipment, or devices by Federal purchasers (i.e., VA) and non-Federal providers • Need to define range (limits of) medical products, equipment, and devices that need to be controllable by the patient. • Federal government must get on board
	Knowledge Gaps/Action Items
D1	Personal accessibility/accommodation profile as part of standard health information (along with allergies, blood type, etc.) • Awareness - need for this information not appreciated • Lack of a profile meta-structure (don’t know what data is needed) • Public/private resistance; Privacy/security concerns
D2	Network-based remote assistance available for medical instrumentation use, adjustment, etc. • Privacy/security; Staffing, infrastructure • Lack of standards; Cost
	Recommendations
D1	Adoption of universal remote console (URC): • The URC Consortium should spearhead a campaign - across consumer electronics and medical instrumentation industries - to publicize advantages of URC adoption. • Federal funding sources (NIH, NIDRR) should establish SBIR (small business grants) invitational priority to support development of URC prototypes of accessible MI. • NIDRR should continue to support RERCs in development of real-world demonstrations of URC utility.
D2	Regulatory requirements for accessible medical equipment, products, and devices: • Congress should authorize the Access Board to develop accessibility/accommodation guidelines for medical instrumentation: RERC-AMI should define the range of medical instrumentation to be included, and Department of Justice (DOJ) should quickly adopt Access Board guidelines • Healthcare accrediting bodies (CARF and JCAHO) should adopt standards requiring accessible medical instrumentation.
D3	Accessibility/accommodation profile as part of standard health information: • RERC-AMI should form a task force to develop the accessibility/accommodation profile meta-structure • Entities responsible for health information data sets should be mandated to adopt accessibility profile meta-structure to the data set (RERC-AMI should identify entities) • Demonstration projects should be initiated by the VA.

 

2.1.5 Breakout Theme E: Emerging Interfaces for Aging and Disabled Providers

This theme was chaired by William Mann (RERC on Technology for Successful Aging, University of Florida) and Katherine Seelman (RERC on Telerehabilitation, University of Pittsburgh), and involved a total of 11 participants, including 4 from the RERC-AMI, 3 representing other RERCs (on Technology for Successful Aging, Telerehabilitation, and Mobile Wireless Technologies), and several from strategic bodies involved in technical implementation of accessibility standards (see Table 1). This group focused on interfaces for aging and disabled health care providers, especially as related to use by practitioners. The motivation for this theme, as defined prior to the workshop, follows:

“Some medical practitioners have congenital or acquired disabilities and others, as they age, may experience diminishing sensory and/or motor abilities. Ideally, medical devices should be designed to accommodate a range of abilities, and (as appropriate) enable practitioners to pursue or continue in their selected profession.”

Theme Group E was unique in its focus on providers. There was considerable early discussion about whether to include lay caregivers as providers within the theme, with an eventual decision that the primary focus should be on professional providers with disabilities since part of the motivation for the topic related to the RERC-AMI’s focus on employment of persons with disabilities in healthcare professions. As seen in Table 6, Theme Group E’s visions were that medical devices consider and be designed to accommodate greater diversity among healthcare providers, and that training activities do the same. They identified challenges and barriers of negative attitudes on the part of healthcare administrators, providers and patients as well as manufacturers and legislators, and a number of technological challenges. The group identified knowledge gaps about disability among healthcare practitioners, about the need for accessibility among industry and regulators, and about how and why to design for accessibility. Theme Group E developed three research and development recommendations, about evaluation methods, new interface technologies, and “zero-lift” solutions, one recommendation about education and training of stakeholders, and one policy recommendation about development of standards (see Table 6).

Table 6. Bullet Points for Workshop Theme E: Emerging Interfaces for Aging and Disabled Providers
	Vision Statements
E1	Medical instruments must address differences in abilities of providers, that is, they must address the broadest range of function in the design. • Provider needs should be considered early on in the design process.
E2	In designing medical instruments and applying principles of universal design, there must be consideration of “hooks” that permit individual personalization of interfaces
E3	Instruction, training, information, discovery: • Instruction and training for use of medical devices should be multi modal and follow the principles of universal design. • Accessibility and usability information and information about accessibility of technology should be available in product (medical instrument) documentation • Controls on medical devices should be easily discoverable (e.g. “stop” button is always round and red)
E4	Health care work environment for providers: • Must be modified to reduce musculoskeletal, visual and auditory stress (e.g. sustained awkward postures, heavy lifting, high grip forces and noise) • Should be transparent and responsive to the changes related to aging (including physical environment as well as management)
E5	Medical device companies integrate provider needs earlier on in the design process (e.g., devices should be safe, usable, accessible, desirable and comfortable)
E6	Job position descriptions in health related professions should become more function-based rather than physiology-based.
	Challenges/Barriers to Vision
E1	Communicating the technical and social issues related to accessibility and availability of medical devices to decision makers in government regulation and industry including manufacturers
E2	Prejudices and attitudes in the health care profession (management and patients) against employees and students with disabilities (if you are disabled you are viewed as a patient and not an employee)
E3	A belief that accessibility is expensive and difficult
E4	New technologies are introduced without considering accessibility, replacing older devices that may have been [more] accessible
E5	Technology challenges: • Wireless interference ( e.g. with information systems, security and medical devices) • RF-ID for medication tracking • Smaller devices present challenges for interfaces (e.g. visual displays are smaller) • Robotics/mechatronics and product design to assist with fine motor tasks • Assistive robotics development for health providers and patients lags far behind industrial robotic/mechatronic development • A need to increase the intellectual investment and development of automation strategies in healthcare delivery
E6	Lack of standards and inadequate enforcement of accessibility.
E7	Bridging the aging and disability communities (i.e. Aging and disability researchers and advocates and different funding streams and agencies for serving younger people with disabilities and older persons).
E8	FDA currently does not evaluate low-risk devices (e.g., Class I and Class II) for usability and safety.
E9	Need to develop testing protocols (e.g., usability, accessibility, safety, desirability and comfort).
E10	Assistive technologies almost by definition focus on a single impairment, often being inaccessible to [people with] other impairments or multiple impairments.
E11	Disability issues are [often] addressed through accommodation rather than accessibility (not understanding what accessibility is).
E12	Privacy and security related to Electronic Medical Records (EMRs) and other electronically transmitted information can be compromised. EMRs should be accessible within the HIPAA framework.
E13	A need to research and identify design strategies to improve cognitive access (e.g. e-information, consistency of interface, scalability/scaffold ability and personalized interfaces).
E14	Things like patient acceptance, safety, liability, reliability could be barriers to implementation of these technologies.
	Knowledge Gaps/Action Items
E1	Lack of knowledge about: • Causes of disability and disability retirement among health care professions (e.g. vision, hearing, dexterity and/or lack of environmental accessibility); • Hidden disabilities and their influence on retirement or avoidance of entering the profession.
E2	Assure the awareness of industry and regulators related to accessibility needs: • Keeps pace with technology development, • Collaboration on development of standards (include participation by the FDA, consumer community, research community, industry and government agencies) • Regulatory encouragement for developing an accreditation program for laboratory testing of accessibility and other factors of medical devices.
E3	Need for targeted research studies about the medical device field: • Decision studies related to medical device procurement. • Organization analysis or studies of the culture of various industries
E4	More knowledge transfer about: • (Accessibility) standards and guidelines among related technology fields (e.g. designers and manufacturers of medical devices adapting E&IT standards to blood pressure monitor design). • Capturing business and design experiences and best practices related to benefits and design of medical devices
E5	Research on technology/ environmental solutions to achieving zero lift and zero handling policies (with usability testing from perspective of both patient & provider)
E6	Need for assessment protocols to identify individual interface needs for health professionals using medical devices.
E7	Lack of knowledge of barriers for health professionals to successfully complete job tasks.
E8	Facilitate collaboration between the assistive technology industry and the mainstream technology industry to ensure interoperability.
E9	Lack of the knowledge of benefits and lack of skills for implementing universal design strategies among designers
E10	The scalability and reliability of wireless networks
E11	Study of things like patient/provider acceptance, safety, liability, reliability that could be barriers to implementation of automation of these technologies
	Recommendations
E1	Under Research & Development: Investigate and develop testing methodologies for evaluating the accessibility, usability, desirability, comfort and safety of medical equipment used by medical providers.
E2	Under Research & Development: Find and/or develop new interface methods and strategies relevant to accessibility of medical devices and information systems for health care providers. • Employ sensors and context-aware algorithms to produce secure and accessible interfaces to medical devices and data in the emerging integrated electronic medical records (EMR). • Study, develop and implement methods and guidelines for accessible EMR systems. • Research and identify design strategies to improve cognitive access (e.g. E-Information, consistency of interface, scalability/scaffold ability and personalized interfaces).
E3	Under Research & Development: Study and develop technology and environmental solutions to achieve zero lift and zero handling policies (with usability testing from perspective of both the patient and the provider).
E4	Under Education and Training: Provide education and training to health care management, educational settings and industry (R&D) on accessibility issues/standards related to medical devices, disability incidence, issues and effect on workforce of health care providers.
E5	Under Policy: Collaboration for development of medical device standards that include participation by the FDA, consumer community, research community, industry and government agencies. FDA is also encouraged to develop an accreditation program for laboratory testing to the standards of medical devices.
E6	Under Research & Development: Perform research to identify barriers for aging health care professionals and health professionals with disabilities to successfully complete job tasks.
E7	Under Research & Development: Perform outcome-based studies that show the benefit of accessible medical devices by providers in health care settings.
E8	Under Research & Development: [Conduct] decision studies related to medical device procurement by hospitals, VA, DOD.
E9	Under Education and Training: Implement more knowledge transfer (standards and guidelines) among related technology fields (e.g., designers and manufacturers of medical devices adapting E&IT standards to blood pressure monitor design).
E10	Under Education and Training: Implement more knowledge transfer capturing business and design experiences and best practices related to benefits and design of medical devices.
E11	Under Policy: Promote science agency practices related to inclusion of people with disabilities in research and development (e.g., randomized clinical trials).

 

2.2 Ranking of Bullet Points and Integration of Data

After the meeting the bullet points generated by each group were assembled and disseminated for voting to all participants of the workshop. From each of the four lists of 23 bullets, each rater was asked to select one top choice and up to four other high priority choices. The return rate was 45%, which was reasonable considering that most participants from government agencies felt that it was not appropriate for them to participate in the voting. In assembling results, the top choice was given double the weight of the other selections. The results were tallied and the bullets were ranked. Bullets with a score of at least 3 are included in the tables (see Tables 7 through 10, below).

Additionally, it was recognized that in many cases, different theme groups had bullets that overlapped. This was expected and indeed such overlap suggests areas of special importance. Raters had the option of identifying the “best” of a certain class of bullet, or if they really felt it was an especially important area to mark several similar bullets from workshop participants. Thus in addition to absolute ranking of bullets, the authors clustered similar bullets to identify overriding themes.

Table 7. Top-rated Vision Statements, in rank order
Number	Description	Total	First Choices
A1	Create the national imperative for including accessibility in medical equipment design	22	10
A3	Have standards developing organizations integrate accessibility into standards for medical equipment	22	6
D2	Regulatory requirements supporting acquisition of accessible medical products, equipment, or devices by Federal purchasers (i.e., VA) and non-Federal providers	14	3
A2	Have models and procedures that allow us to evaluate medical devices for accessibility, and design systems that are accessible to all	12	2
D1	Adoption of universal remote console (URC) interface capability in some medical products, equipment, or devices with patient interfaces	10	1
C1	Provide guidelines/strategies to designers for how to be “more inclusive” for various groups of end-users	8	1
D3	Personal accessibility/accommodation profile as part of standard health information (along with allergies, blood type, etc.)	8	1
E3	Instruction, training, information, discovery: • Instruction and training for use of medical devices should be multi modal and follow the principles of universal design. • Accessibility and usability information and information about accessibility of technology should be available in product (medical instrument) documentation • Controls on medical devices should be easily discoverable (e.g. stop button is always round & red)	7
E2	In designing medical instruments and applying principles of universal design, there must be consideration of “hooks” that permit individual, personalization of interfaces	6
E1	Medical instruments must address differences in abilities of providers, that is, they must address the broadest range of function in the design.	6	1
E4	Health care work environment for providers: • Must be modified to reduce musculoskeletal, visual and auditory stress (e.g. sustained awkward postures, heavy lifting, high grip forces and noise) Should be transparent and responsive to the changes related to aging (including physical environment as well as management)	5
E5	Medical device companies integrate provider needs earlier on in the design process (e.g., safe, usable, accessible, desirable and comfortable)	5
C5	Changes in policy for reimbursement of home healthcare services – spurring innovation/utilization	4
B2	Good exemplars of an “accessible monitor” to lead, teach, test. Consider: • More of a systems solution … paperless documentation • Multiplex controls for patient information, vital signs monitoring [e.g., URC] • Wireless and other sensing • More of a choice of display: from PDA, to fixed monitor, to computer at home	3
C2	Scalable, customizable platforms enabling plug-and-play devices to be added for monitoring co-morbidities and for enhanced accessibility needs	3
C3	Connected care system – devices can be remotely accessed, monitored, controlled, maintained via telecom	3

 

3. Results

Each of the 5 Theme Groups was allowed up to provide up to 5 final bullets in each of 4 areas, and thus up to 20 total. The actual number averaged 18.4 per group, with a range of 17-19. The final bullets, all of which required some degree of refining or reduction in number by the co-authors and organizers after the workshop, were previously presented in Tables 2 to 6. While these are numbered, they do not reflect a preferred order.

In this section the emphasis is on integrating results across groups, using the rating process as a tool for helping prioritize and synthesize these bullets. Tables 7 through 10 present the results of the ranking process. This is the focus of the remainder of this chapter, with an emphasis on each of the four focal discussion areas in which bullet points were generated. Of note in interpreting results is that often more general, sweeping statements scored higher than more specific statements or ones with more detail; this doesn’t imply that these are less important, but simply that more raters chose them. Also, there is no guarantee that more specific bullets were fully understood by participants, as each participant was part of only one group. Nevertheless, as will be seen this process does provide guidance regarding priorities and insights of the collective group.

3.1 Vision 2010 Statements

Vision statements that were less specific tended to score better. Thus the top two statements, A1 and A3 (see Table 7), both very general statements, would be expected to fare well with this group of experts, many of whom are invested stakeholders who were interested in participating in the workshop and had an inherent desire for greater inclusion of accessibility into medical equipment (A1) and into standards that affect such equipment (A3). The third statement, D2, on regulatory requirements that support acquisition of accessible medical products by purchasers, directly relates to the FDA and to expansion of language such as in Section 508 of the Rehab Act, and would clearly require new legislation. The fourth statement, A2, targets evaluation of devices for accessibility. (An example of such effort by the RERC-AMI is the MedAUDIT project). Interestingly, the latter 2 bullet points are related in that effective evaluation of accessibility seems a key step for effective regulatory action to occur.

The fifth ranked bullet, D1, specifically addressed the Universal Remote Console (URC) national standard that the RERC-AMI and three other RERCs, plus partners in industry, are working on that was demonstrated at a booth at the meeting, and is discussed in Chapters 25-28 of the CRC Press Book. This trend towards personalized interfaces for access was also described in bullet points submitted by three other groups that made this top list, including E2 (“hooks” for personalized interfaces), B2 (exemplars of an accessible monitor included paperless and wireless monitors and interface choices such as URC and PDA), and C2 (scalable, customizable platforms with plug-and-play monitoring devices). Of note is that two of the bullets from Theme Group E that made the top ten list addressed the need for solutions that apply the principles of universal design but also specifically address the need for multimodal “hooks” for personalized interfaces; this is consistent with insights provided in a number of the CRC Press book chapters [Chapter 9 (Smith et al), as well as concepts explicitly raised in Chapter 8 (Erlandson et al), Chapter 18 (Mueller), and Chapter 25 (Winters)].

Another theme that made the top ten list was the need to provide guidelines/strategies for more inclusive design (C1); a related bullet on the top list is E5, which emphasized a process that integrates user needs earlier into the design process. Together with the highly ranked A3, these point to the recognized importance of involving intended users with a diversity of abilities in the early stages of the interface development process.

Two other bullets that made the top ten list deserve special mention: the suggestion of including a personal accessibility/accommodation profile as part of health information collected (D3), and the need for educational resources and training materials (E3). The former would clearly benefit the development of personalized interfaces such as with the URC standard, while the latter noted that even instructional materials should be both multimodal and universally designed.

In summary, two broad, sweeping visions on accessible equipment were strongly affirmed by participants. Four additional clear visions emerged: regulatory action, effective evaluation of accessibility, personalized interfaces, and involving users with disabilities early in the design process. In addition, many useful, more targeted visions and insights emerged that are also of great value.

Table 8. Top-rated Challenges/Barriers Statements, in rank order
Number	Description	Total	First Choices
A5	Economic: Cost, reimbursement, incentive policies (carrot & stick)	21	8
D2	Regulatory requirements supporting acquisition of accessible medical products, equipment, or devices by Federal purchasers (i.e., VA) and non-Federal providers • Need to define range (limits of) medical products, equipment, and devices that need to be controllable by the patient. • Federal government must get on board	16	4
C1	For Vision #1 (Guidelines/strategies to designers): Lack of knowledge by designers regarding prevalence of disabilities & nature of functional deficits	12	3
A1	Funding and mandate to create the national imperative for including accessibility in medical equipment design	11	2
D1	Adoption of universal remote control (URC) interface capability in some medical products, equipment, or devices with patient interface • Resistance by manufacturers (cost, identity, control, liability), possible resistance or concern by regulators (e.g. controlling both a consumer device and medical instrument) • There needs to be a standard that tags features/tasks that can be controlled by the patient, patient or practitioner, or practitioner • Cost burden to manufacturer, provider, patient, payor • Relationship to consumer electronics market • Maturity of technology (reliability, security and usability concerns) • Lack of international standard (working on ISO 24752); lack of awareness	10	1
E3	A belief that accessibility is expensive and difficult	10	1
A4	Attitudinal: healthcare community; disability community; Academic community; acceptance of new technologies and change	9	1
C2	For Vision #2 (Scalable Platforms): Currently limited multi-modal, multi-sensory communication & interface (input/output) w/ devices	7	2
E5	Technology challenges: • Wireless interference ( e.g. with information systems, security and medical devices) • RF-ID for medication tracking • Smaller devices present challenges for interfaces (e.g. visual displays are smaller) • Robotics/mechatronics and product design to assist with fine motor tasks • Assistive robotics development for health providers and patients lags far behind in industrial robotic/mechatronic development • A need to increase the intellectual investment and development of automation strategies in healthcare delivery	7	1
A3	Social-political: Public awareness of right to access; and medical vs. civil rights vs. functional models of disability	6	1
B5	Acceptance from marketing that accessibility changes would be competitive (make it sell)	6
E1	Communicating the technical and social issues related to accessibility and availability of medical devices to decision makers in government regulation and industry including manufacturers	6
A2	Technical: Absence of technologies that render current accessibility issues irrelevant	5	1
B2	Awareness factor by stakeholders in developing new or new versions of medical equipment	3
E2	Prejudices and attitudes in the health care profession (management and patients) against employees and students with disabilities (if you are disabled you are viewed as a patient and not an employee)	3
E4	New technologies are introduced without considering accessibility, replacing older devices that may have been accessible	3

3.2 Challenges and Barrier to Achieving Vision

As might be expected, the challenges and barriers identified by the groups tied to the visions. Also, as with the vision bullets, the top ranked bullet, A5, was a very general statement that resounded with raters: economic realities (see Table 8). The clear choice for second-ranking, D2, was quite specific: the regulatory environment, and specifically challenges in setting the stage for the acquisition of accessible medical products, including both the challenges of addressing better information and evaluation capabilities and getting the federal government fully on board. This was followed by statement C1, the insight identifying a lack of knowledge regarding the prevalence and nature of disabilities, a barrier that clearly is something that the RERC-AMI could help address.

 

Two of the next three top-ranked bullets shared a common theme: funding. However, one (A1) emphasized a national funding mandate for accessible products while the other (E3) the commonly perceived belief that accessibility is expensive and difficult when this may not always be the case; in one sense these are opposite perspectives, but perhaps this depends on the type of product.

The fifth bullet, D1, related directly to the adoption of URC interface capability for some strategic lines of medical products; interestingly, despite a list of six rather prescriptive sub-bullets, this still ranked high. Importantly, this list of six bullets under statement D1, collectively produced by Theme D, provide a sort of roadmap for the URC/personalized design community, including the RERC-AMI project described in Chapter 28 (Danturthi et al.). Also of interest is that this relates very closely to the barrier of scalable, multi-modal platforms that was also in the top ten (C1). Two other bullets on the top list (E5, A2) also explicitly address the lack of innovative technologies as a key barrier to accessible medical products. Thus it is interesting that although cost and regulatory barriers appear as the top two themes for challenges/barriers, a significant subset of participants placed technical barriers high on their list.

Interestingly, most of the remaining bullets can be clustered under the theme of attitudinal barriers, expressed explicitly in statement A4. Others that fall under this umbrella include social-political awareness (A3), stakeholder awareness (B2), prejudices and attitudes within the healthcare profession (E2), and as mentioned above in another context, the attitudinal belief that accessibility is expensive (E3).

In summary, six overriding challenges/barriers are identified: economic, regulatory, knowledge of disability (as related to product use), URC adoption, low availability of accessible technologies, and attitudinal. For each theme, specific bullet points provide insightful details.

Table 9. Top-rated Knowledge Gaps/Action Items Statements, in rank order
Number	Description	Total	First Choices
A4	Action item: Create … • Inventory of devices with accessibility features (helps address knowledge gap) • Models and procedures for evaluating accessibility • Performance based standards for accessible design • Legal requirements and incentives for providers to buy accessible equipment	16	3
B1	Educate/influence engineers, industry and others about universal design and accessibility: • Create the data necessary to make the “marketing” case; promote it to manufacturers • Improve understanding of “access” – both within the design process (manufacturers) and for purchasers	14	3
B2	Carrots and sticks – develop regulations (or “regulatory” bodies making “endorsing” statements) and (tax) incentives (IRS, CMS) to improve accessibility in (monitoring) devices – through collaboration with the disability (rehabilitation) community	13	4
D1	Personal accessibility/accommodation profile as part of standard health information (along with allergies, blood type, etc.) • Awareness - need for this information not appreciated • Lack of a profile meta-structure (don’t know what data is needed) • Public/private resistance; Privacy/security concerns	13	1
A3	Action item: More education in accessible and universal design – helps address knowledge gap of accessibility and universal design	9	3
B4	Develop examples of good accessible design (as reference for manufacturers to use); and a registry of accessible components (include consumer products that incorporate accessibility, e.g., displays, controls)	9	1
C1	Action item: Make accessibility a mandate for reimbursement	9	2
A2	Knowledge gaps: • Lack of models for simulating human performance • Lack of accessibility assessment procedures	8	2
E1	Lack of knowledge about: • Causes of disability and disability retirement among health care professions (e.g. vision, hearing, dexterity and/or lack of environmental accessibility) • Hidden disabilities and their influence on retirement or avoidance of entering the profession	8	1
B3	Develop HFE standards and guidelines incorporating accessibility issues (good design)	7	1
E2	Assure the awareness of industry and regulators related to accessibility needs • Keeps pace with technology development, • Collaboration on development of standards, and • Regulatory encouragement for developing an accreditation program for laboratory testing of accessibility and other factors of medical devices.	7	2
E4	More knowledge transfer about: • (Accessibility) standards and guidelines among related technology fields (e.g. designers and manufacturers of medical devices adapting E&IT standards to blood pressure monitor design). • Capturing business and design experiences and best practices related to benefits and design of medical devices	5
E5	Research on technology/ environmental solutions to achieving zero lift and zero handling policies (with usability testing from perspective of both patient & provider)	5
C3	Action item: Increase involvement in standards process – stakeholders	4
E3	Need for targeted research studies about the medical device field: • Decision studies related to medical device procurement. • Organization analysis or studies of the culture of various industries	4	2
B5	Study legal and regulatory issues around the “telecom model”1 and FEC voting booth model (usability guide) – to improve accessibility in component part design. 1Section 255 and 508 apply to electronic and information technologies (E&IT), e.g., by 508 the Federal government can purchase only accessible E&IT products (some exceptions)	3
C5	Knowledge gap: Areas for better (integrated) understanding: a) reimbursement; b) introduction of new technology; c) profitability of manufacturers	3

3.3 Knowledge Gaps and Action Items

The motivation behind this priority is that research activities can help address knowledge gaps, and a consensus process including diverse expertise can help refine and prioritize research activities. However, there was also a recognition that some research and development (R&D) activities are not driven by the aim of generating new knowledge, and that certain challenges/barriers may require directed activities that are beyond R&D or that need R&D activities that help support a broad scope; hence identifying specific action items is also appropriate. Of the 17 top-ranked bullet points, 13 were knowledge gaps and 4 were action items. Interestingly, however, three of the top seven in terms of ranking were action items (see Table 9).

The top bullet in this category, A4, was an action item: create an all-inclusive resource that includes a product inventory, approaches for evaluating accessibility, standards and legal requirements and incentives. Given that the RERC-AMI is currently involved in the early stages of all of these activities and that Theme Group A had heavy participation by RERC-AMI staff, it is perhaps not surprising that this item was generated and subsequently scored well; nonetheless, it does provide affirmation for this strategy and its importance. Also of note is that all three of the other action items on this top list had similar themes, specifically of developing regulations and incentives (B2), mandating accessibility for reimbursement (C1), and involving stakeholders in the standards process (C3).

The highest-ranked statements of knowledge gaps, which in different forms scored second (B1) and tied for fifth (A3), related to educational approaches that would help address knowledge gaps about accessibility and universal design. While each of the knowledge gaps is unique, they cluster into several general themes. One is the need for R&D that addresses the knowledge gap of “good design” for accessibility: statement B4 addresses the need for R&D that produces good examples of accessible design, A2 address the lack of knowledge of models for simulating performance and effective assessment procedures, B3 targets using insights from good designs to help develop standards and guidelines that incorporate accessibility issues, E4 addresses similar knowledge transfer themes, and E5 addresses the need for research that yields solutions that achieve zero lift and handling policies.

Another collection of knowledge gaps can be classified under disability and policy research, with three of four statements generated by Theme Group E; of note is that this theme had four RERC’s represented, and also had a special focus on providers with disabilities. While not ranked as high overall, the fact that four of their bullet points made the top list reflects their importance, especially for understanding barriers to employment in the healthcare profession. These knowledge gaps included: better understanding of the causes of disability and retirement of among healthcare professionals and the impact of hidden disabilities (E1), the need for broad awareness of accessibility needs (E2), the need for targeted research about the practices and culture of the medical device field (E3), and the need to study legal and regulatory issues in the context of accessibility guidelines (E4).

3.4 Recommendations and Opportunities

Recommendations represent the key aims of the Workshop, with the previous three sets of bullets designed to help set the stage for determining, refining and prioritizing recommendations. Six recommendation bullets were scored considerably higher than all others. Five key classes of recommendations emerged, each with specifics that were identified under two or more recommendation bullets.

By far the top recommendation of the Workshop related to collaboration on standards that tie accessibility with medical device design (see Table 10). Indeed, the top recommendations, statements D2, A2 and E5, from three different groups, were all variants on this theme, and a fourth group had a version of this (C1) that was not quite as highly scored. The top recommendation of the Workshop (D2) explicitly tied standards to regulatory requirements, and suggested a process that also included various federal agencies. The next two (A2 and E5) emphasized partnership and collaboration that involved research, industry and governmental entities, including the sponsors of this Workshop, the RERC program and the FDA. One of these recommendations (A2) suggested that the RERC-AMI should help initiate this effort; the other (E5) mentioned a key role for the FDA in implementing a laboratory testing program, similar to the type of evaluation capability that was identified as a key knowledge gap. Two other recommendations support this, including one from Theme Group B, which focused on medical monitors and had the largest representation from the FDA, that recommended the creation of a FDA endorsement of accessibility in device design (B2). This same group also recommended that the AAMI Human Factors Committee strongly advocate for accessibility in their work on the new guidelines (B1); as an aside, the RERC-AMI has now taken the lead in working with this committee to add a strong accessibility component to the emerging HE-75 standard [see CRC Press Book Chapter 15 (Gardner-Bonneau) and Chapter 16 (Wiklund)].

Table 10. Top-rated Recommendations Statements, in rank order
Number	Description	Total	First Choices
D2	Regulatory requirements for accessible medical equipment, products, and devices: • Congress should authorize the Access Board to develop accessibility/accommodation guidelines for medical instrumentation: RERC-AMI should define the range of medical instrumentation to be included, and DOJ should quickly adopt Access Board guidelines • Healthcare accrediting bodies (CARF and JCAHO) should adopt standards requiring accessible medical instrumentation.	19	5
A2	RERCs, other research organizations, and industry should partner with standards developing organizations to create performance based standards for accessible design of medical equipment • RERC-AMI should initiate steps to coalesce national imperative for including accessibility in medical equipment design	16	5
E5	Under Policy: Collaboration for development of medical device standards that include participation by the FDA, consumer community, research community, industry and government agencies. FDA is also encouraged to develop an accreditation program for laboratory testing to the standards of medical devices.	12
D1	Adoption of universal remote console (URC): • The URC Consortium should spearhead a campaign - across consumer electronics and medical instrumentation industries - to publicize advantages of URC adoption. • Federal funding sources (NIH, NIDRR) should establish SBIR (small business grants) invitational priority to support development of URC prototypes of accessible MI. • NIDRR should continue to support RERCs in development of real-world demonstrations of URC utility.	11	1
E1	Under Research & Development: Investigate and develop testing methodologies for evaluating the accessibility, usability, desirability, comfort and safety of medical equipment used by medical providers.	11	2
C1	Policy-makers and granting agencies should fund research to support policy changes leading to • Mandated & enforced accessibility in design of medical devices • Reimbursement streams for home health medical devices and care to manage chronic diseases and disabilities • Business case for proactive “prevention” model (vs. reactive episodic model) of healthcare delivery	10	2
A1	RERCs and other research organizations should develop models and procedures for evaluating accessibility with input from consumers with disabilities	7	3
A3	RRTCs (Rehab Research & Training Centers), educators, and accreditation bodies should create curricula on accessibility and universal design appropriate for a variety of disciplines	7	1
A5	Disability advocacy groups should increase awareness of right to equal access to healthcare	7	2
B2	Create an FDA endorsement of accessibility in device design	6	1
E4	Under Education and Training: Provide education and training to health care management, educational settings and industry (R&D) on accessibility issues/standards related to medical devices, disability incidence, issues and effect on workforce of health care providers.	6	1
B3	Develop an “award” (mechanism for design excellence) for good accessible design	5
D3	Accessibility/accommodation profile as part of standard health information: • RERC-AMI should form a task force to develop the accessibility/accommodation profile meta-structure • Entities responsible for health information data sets should be mandated to adopt accessibility profile meta-structure to the data set (RERC-AMI should identify entities) • Demonstration projects should be initiated by the VA.	5
B1	Use the AAMI Human Factors committee to strongly advocate for “accessibility”; develop a chapter in the proposed new standard; develop a “guideline” for accessibility; advocate at professional meetings	4
C3	Further research is needed to identify and assess potential humanistic barriers (i.e., skill, comfort w/technology, and user diversity) to utilization of home health technologies for self-care	4
B4	Promote industry participation in addressing accessibility issues – collaboration with disability community (e.g., Blue Ribbon panels). [Promote device design that addresses patient accessibility]	3
C5	Granting agencies should support research to address knowledge gaps in chronic disease prevention and management for the purpose of developing “smart” routines for in-home decision support	3	1
E3	Under Research & Development: Study and develop technology and environmental solutions to achieve zero lift and zero handling policies (with usability testing from perspective of both the patient and the provider).	3

 

Another of the top five recommendations was D1, the adoption of the URC standard and its implementation for strategic classes of medical devices, including the importance of identifying funding sources for this activity. The Theme Group responsible for this recommendation, Emerging Trends and Technologies (Theme D), also promoted the need for an accessibility/accommodation profile as part of the standard health information, with the RERC-AMI recommended as an appropriate entity for coordinating a task force to develop a profile metastructure (D3). This is an insightful approach, since for the URC standard to be used for personalized interfaces, such user profile data is critical. This also affirms the approaches described in Chapter 27 (Feng and Winters) and Chapter 28 (Danturthi et al.).

Another of the top five recommendations, E1, addressed the need for testing methodologies for evaluating the accessibility (plus usability, desirability, comfort and safety) of medical devices. This bullet ties to another recommendation that mentions the importance of involving input from consumers with disabilities (A1).

The sixth-ranked recommendation, C1, targets the need for granting agencies and policy-makers to fund targeted disability-related research that could support policy changes. While this was the only recommendation of this type that made the top group of six bullets, also supporting this were recommendations for research to identify and access the humanistic barriers to utilization of home healthcare technologies for self-care (C3), research that addresses chronic disease prevention and management for developing smart in-home decision support (C5), and approaches that promote collaboration between industry and the disability community (B4).

The final core recommendation did not make the top six overriding bullets, but represents the theme of two bullets that made the top ten: the need for educational and training materials and programs. This included the creation of curricula (A3) and the provision of educational and training infrastructure (E4). Chapter 8 (Erlandson et al.) of this book directly address this issue, and of note is that the process of addressing this issue has begun, with two ongoing activities: a textbook that is being written by Erlandson on universal and accessible design that will also be published by CRC Press, and a planned expansion of educational resources through the RERC-AMI’s web pages that goes well beyond the current training materials associated with the RERC-AMI’s annual student design competition that is also described in Chapter 8 (Erlandson et al.).

4. Discussion and Future Directions

Perhaps the overriding take-home message of this Workshop is that there is much work to be done. There is much to be done to achieve the consensus vision statements that were described in Section 3.1, to overcome the challenges and barriers identified in Section 3.2, to implement the R&D activities associated with the knowledge gaps of Section 3.3, and to implement the recommendations of Section 3.4. All of these stand on their own merit. This section briefly summarizes some of the key outputs of the Workshop, and then briefly discusses some of the intangible outputs of the Workshop that are not necessarily captured by bullets. Of note is that the co-chairs for Theme Group C briefly disseminate, in Appendix 1, highlights of the internal discussions for their group. Other insights are reflected in commentaries in the Appendices, written after the workshop by individual attendees in response to the event, and in the fact that a number of chapter authors made modifications to their chapters after the Workshop that in many cases were directly based on observations or insights from the Workshop.

As planned, there were two sweeping themes from this Workshop, one related to standards and guidelines that comprised of Theme A, Theme B, and Theme C, and the other on emerging trends and technologies that related to Themes D-E. At least that was our original intent. It is interesting, however, that two of the top three recommendations of the entire workshop, both related to standards, came from groups D and E! Clearly there is a tight relationship between guidelines/standards, especially ones with enforcement support, and emerging technologies. Through the assembled bullet points related to standards, the RERC-AMI and other stakeholder entities have a clearer vision of paths to take to address the challenges and opportunities in this area.

An advantage of having the type of melting pot of expertise that was assembled at this state-of-the-science Workshop is that ideas can be distilled and refined in a way that can compress or redirect the evolutionary process. Of note is that participants to the workshop included, by invitation, leaders in the practice of human factors and the development of disability/accessibility standards; interestingly, in many cases these individuals were meeting each other for the first time, despite decades of work in standards that in principle should already have had overlap. This is the type of “value-added” intangible that cannot be captured on paper, but can have an impact over time. In relation to existing standards that cut across these areas, CRC Press book Chapter 15 (Gardner-Bonneau) is of especial value; Chapter 19 (Carayon et al.) provides a practical sense of the challenges associated with standards implementation.

Themes D and E did take leadership in the area of emerging trends and technologies, and of all of their discussions, the concept of personalized interfaces that build on the URC standard seems to resonate the most. This is an intriguing development, and points out the reality, at least in the eyes of many [e.g., CRC Press book Chapter 25 (Winters)], that both personalized design and universal design will have key roles in the future as strategies for achieving accessible medical instrumentation. The challenge is in the details; for example, determining which product lines should emphasize which approaches, and why.

Both personalized design and universal design relate tightly to another overriding theme, and that is the need for solid methods of evaluating accessibility of specific products. This theme, while never at the top of any bullet list, was a recurring theme for all four focal area lists. It is the motivation behind the RERC-AMI’s MedAUDIT approach (Chapter 22, Smith et al.) that is still at a sufficiently early stage that it can be impacted by insights from the Workshop.

In summary, much work remains to be done to achieve the top two general visions of creating a national imperative for including accessibility in medical equipment design, and having accessibility integrated into standards that are effective and enforceable. But this was to be expected. This Workshop helped define, refine and prioritize the future directions for this area, and the organizers are grateful to the participants for their involvement, enthusiasm and ideas.

Acknowledgement

This work is supported by the RERC-AMI, funded by the National Institute on Disability and Rehabilitation Research (NIDRR) of the U.S. Department of Education under grant number H133E020729. All opinions are those of the authors. The authors also thank the Office of Science and Engineering Laboratories, which is under the Center for Devices and Radiological Health of the Food and Drug Administration, with special thanks to the leadership of Larry Kessler and Don Marlowe. The authors also thank the theme co-chairs (Robert Erlandson, Jay Crowley, John Gosbee, Daryle Gardner-Bonneau, Binh Tran, Mike Jones, June Issacson Kailes, Kate Seelman and William Mann) for their hard work in coordinating theme sessions. Finally, while many members of the RERC-AMI staff and students were involved in this project, three stand out, without whose work this event would not have been possible: Brenda Premo, Melissa Lemke, and Erin Schwier.

Appendix: Special Workshop Contributions: Participant Commentaries

Workshop co-chairs and participants were invited to provide targeted commentary on topics related to the workshop. This appendix presents perspectives by the co-chairs for Theme C, plus by a few individual workshop participants who accepted the opportunity to provide specific commentary after the event. The editors appreciate their taking the time to document their thoughts. In all, there are five appendices.

• Appendix 1: Chairs’ Perspectives on Workshop Breakout Theme C (Interfaces for Home Healthcare Devices)
• Appendix 2: Commentary on Distinguishing Accessibility from Accommodation
• Appendix 3: Commentary on Data, Models and Procedures for Design of Accessible Medical Instrumentation
• Appendix 4: Commentary on What is Accessibility? And What Does it Have to do with Medical Device Design?
• Appendix 5: Commentary on the Difference Between “Usability” and “Accessibility” May Be the End Users