1. Introduction

1.1 Statutory Authority, Scope, and Objectives of Committee

Section 4203 of the Patient Protection and Affordable Care Act (Public Law 111-148, 124 Stat. L. 119), which became law on March 23, 2010, amended Title V of the Rehabilitation Act of 1973 (29 U.S.C. 794f) by adding Section 510. This new section requires the Architectural and Transportation Barriers Compliance Board (U.S. Access Board), in consultation with the Food and Drug Administration (FDA), to issue accessibility standards for medical diagnostic equipment (MDE). Section 510 considers "medical diagnostic equipment" to be equipment that is used by health care professionals in medical settings for diagnostic purposes

As described below (Section 1.3), the U.S. Access Board published a Notice of Proposed Rulemaking (NPRM) proposing MDE accessibility standards (see 77 FR 6916, February 9, 2012). The draft standards proposed minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities. At its January 11, 2012 meeting, the Access Board voted to establish an advisory committee to make recommendations to the Board on issues raised by the comments it would receive and responses to questions included in the February 2012 NPRM (the comment period extended through June 8, 2012).

The Access Board published a notice of intent in the Federal Register (77 FR 14706, March 13, 2012) to establish this advisory committee and to seek nominations from a variety of stakeholder organizations, including:

  • Medical device manufacturers;
  • Health care providers;
  • Standards setting organizations;
  • Organizations representing individuals with disabilities;
  • Federal agencies; and
  • Other organizations affected by the providers.

The March 2012 notice indicated, “The number of Committee members will be limited so that the Committee’s work can be accomplished effectively. The Committee will be balanced in terms of interests represented” (p. 14707). The MDE Advisory Committee members would not be considered special government employees and therefore would not need to file confidential financial disclosure reports. However, the Committee would operate in accordance with the Federal Advisory Committee Act, 5 U.S.C. app 2, and each meeting would be open to the public. Notices announcing each meeting would be published in the Federal Register at least 15 days beforehand.

1.2 MDE Advisory Committee Membership

In the July 6, 2012 Federal Register (77 FR 39656) the U.S. Access Board published the list of organizations selected for representation on the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (the MDE Advisory Committee). Table 1.2 lists the 24 organizations selected; each organization could designate a primary representative and a secondary representative who would participate in the absence of (or at the discretion of) the primary representative. The Department of Justice, Department of Health and Human Services (Food and Drug Administration), and the Department of Veterans Affairs were selected to serve as ex officio members.

Table 1.2
Organizational Members of the Medical Diagnostic Equipment Accessibility Standards Advisory Committee

Committee Member Organizations

  • Boston Center for Independent Living, Lisa I. Iezzoni, MD, Committee Chair
  • The ADA National Network, Don Brandon and Bernard Fleming
  • Brewer Company, Jack DeBraal and Mary Adkinson
  • Conference of Radiation Control Program Directors, Inc., Mary Ann Spohrer and Jennifer Elee
  • Duke University and Medical Center, Tamara James and Yeu-Li Yeung
  • Equal Rights Center, Kat Taylor and Kristen Barry
  • Evan Terry Associates, P.C., Kaylan M. Dunlap
  • GE Healthcare, John Jaeckle and Steven Kachelmeyer
  • Harris Family Center for Disability and Health Policy at Western University of Health Sciences, June Isaacson Kailes and Brenda Premo
  • Hausmann Industries, Inc., David Hausmann and Christian Hendrickson
  • Hill-Rom Company, Inc., Renée Kielich and Dee Kumper
  • Hologic, Inc., John LaViola and Michelle Lustrino
  • Medical Positioning, Inc., JB Risk and Tracy Hockenhull
  • Medical Technology Industries, Inc., Jeffery Baker and Bradley Baker
  • Midmark Corporation, Jon Wells and Bob Menke
  • National Council on Independent Living, Mark E. Derry and Roger Howard
  • Paralyzed Veterans of America, Maureen Simonson and Robert Herman
  • Philips Healthcare, Elisabeth George and Jim Liu
  • Scale-Tronix, Inc., Joseph Drago
  • Siemens Medical Solutions USA, Inc., Hans Beinke and John Metellus
  • Stryker Medical, Kevin Patmore and Austin Schreiber
  • Sutter Health, Carol Bradley and Janice Carroll
  • United Spinal Association, Kleo J. King and Jennifer Perry
  • University of the Sciences in Philadelphia, Department of Occupational Therapy, Rochelle J. Mendonca

Ex Officio Committee Member Organizations

  • U.S. Department of Health and Human Services/U.S. Food and Drug Administration, Molly Follette Story and Joel B. Myklebust
  • U.S. Department of Justice, Zita Johnson-Betts, Jim Bostrom and Sarah DeCosse
  • U.S. Department of Veterans Affairs, Dennis Hancher and Zoltan Nagy

Access Board Representative and Staff

  • Matthew McCollough, Board Member Liaison
  • Rex Pace, Designated Federal Office for the Committee/Staff Member
  • Earlene Sesker, MDE Rulemaking Lead/Staff Member
  • Marsha Mazz, Director of the Office of Technical and Information Services/ Staff Member
  • James Raggio, General Counsel/Staff Member
  • Rose Bunales, Staff Member

Only MDE Advisory Committee members could participate in full Committee meetings. The July 6, 2012 Federal Register notice indicated that nonmembers could participate in Subcommittees if any were formed by the MDE Advisory Committee.


1.3 MDE Accessibility Standards NPRM

1.3.1 Overview of NPRM

The U.S. Access Board published a Notice of Proposed Rulemaking (NPRM) proposing MDE accessibility standards (see 77 FR 6916, February 9, 2012). Box 1.3.1 contains the summary of this NPRM. The NPRM requested responses from the public by June 8, 2012, and it announced two hearings to seek public comments: March 14, 2012 in Washington, DC; and May 8, 2012, in Atlanta, GA.

Box 1.3.1

The Architectural and Transportation Barriers Compliance Board (Access Board) is proposing accessibility standards for medical diagnostic equipment. The proposed standards contain minimum technical criteria to ensure that medical diagnostic equipment including examination tables, examination chairs, weight scales, mammography equipment and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities. The standards will allow independent entry to, use of and exit from the equipment by individuals with disabilities to the maximum extent possible. The standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However other agencies referred to as an enforcing authority in the standards may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards.

Summary. Architectural and Transportation Barriers Compliance Board, Notice of Proposed Rulemaking, RIN 3014-AA40 Medical Diagnostic Equipment Accessibility Standards, February 8, 2012, p. 3.

 

The NPRM organized its technical criteria around seven areas, starting with the four basic approaches for positioning patients on MDE (Table 1.3.1(a). Table 1.3.1(b), taken from the NPRM, provides details about equipment features that the technical criteria would address so that patients could achieve proper positioning for diagnostic testing; it also gives illustrative examples of the types of equipment covered.


Table 1.3.1(a)

Organization of MDE Accessibility Standards Technical Criteria in
U.S. Access Board 2012 Notice of Proposed Rule Making

M301

Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position

M302

Diagnostic Equipment Used by Patients in a Seated Position

M303

Diagnostic Equipment Used by Patients Seated in a Wheelchair

M304

Diagnostic Equipment Used by Patients in Standing Position

M305

Supports

M306

Communication

M307

Operable Parts

 
Table 1.3.1(b)

Equipment Features by Patient Position and Examples of MDE Types

Patient Positions Equipment Designed to Support

Equipment Features Addressed in Technical Criteria

Types of Equipment to Which Technical Criteria Applies

Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position (M301)

Transfer surface, including height, size, and transfer sides

Transfer supports, stirrups, and head and back support

Lift compatibility 

 

Examination tables 

Imaging equipment designed for use with platform beds

Examination chairs designed to recline and be used as examination tables

Diagnostic Equipment Used by Patients in a Seated Position (M302)

Transfer surface, including height, size, and transfer sides

Transfer supports, armrests,
and head and back support

Lift compatibility

Examination chairs

Imaging equipment designed for use with a seat

Weight scales designed for use with a seat

 Diagnostic Equipment Used by Patients Seated in a Wheelchair (M303)

Wheelchair space, including orientation, width, depth, knee and toe clearance, and surface slope

Changes in level at entry to wheelchair space, including ramps

Components capable of examining body parts of patients seated in a wheelchair, including height of breast platforms

 

Imaging equipment designed for wheelchair use

Weight scales designed for wheelchair use

 
Diagnostic Equipment Used by Patients in Standing Position (M304)

Slip resistant standing surface

Standing supports

Imaging equipment designed for use in standing position

Weight scales designed for use in standing position

 


 SOURCE: Architectural and Transportation Barriers Compliance Board, Notice of Proposed Rulemaking, RIN 3014-AA40 Medical Diagnostic Equipment Accessibility Standards, February 8, 2012, pp. 10-11.

The NPRM mentioned ANSI/AAMI HE 75, the 2009 report from the Association for the Advancement of Medical Instrumentation that recommends human factors design principles for medical devices. In addition, Chapter 16 of ANSI/AAMI HE 75 recommends practices regarding accessibility for patients and health care personnel with disabilities. The NPRM stated:

The Access Board is committed to using voluntary consensus standards where practical and consistent with the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note). The Access Board has considered the recommended practices in Chapter 16 of ANSI/AAMI HE 75 in developing the technical criteria for the proposed standards. The technical criteria are generally consistent with and supplement the recommended practices in Chapter 16 of ANSI/AAMI HE 75. The Access Board seeks to promote harmonization of its guidelines and standards with voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75. (NPRM p. 8)

In addition to seeking general comments on the recommended accessibility standards, the NPRM requested public responses to 46 specific questions.

1.3.2 Focus Following NPRM Comments

U.S. Access Board staff reviewed the comments submitted in response to the NPRM. This review identified four major issue areas for the MDE Advisory Committee to address, as follows:

  • Transfer surface height and size
  • Permitted obstructions to the transfer surface
  • Transfer support location and configuration
  • Depth of wheelchair spaces

The Advisory Committee, during its deliberations, added dimensions to these issues and raised other topics (see Section 5). Access Board staff found that transfer surface size and height were among the highest priorities of all commenters across many interests. The MDE Advisory Committee spent the largest portion of its time on these topics, although all topics received full consideration.

1.4 Overview of Report

This report presents the recommendations of the MDE Advisory Committee for accessibility standards. The report is organized into eight sections including this introduction. The ensuing seven sections address the following:

  • Section 2, Background, describes important contextual issues that guided the thinking of various Committee members about the need for and potential nature of accessibility standards.
  • Section 3, MDE Advisory Committee Approach, gives an overview of Committee deliberations (starting with refining the members’ understanding of MDE) and Committee logistics, including the role of six Subcommittees.
  • Section 4, Background Information for Broad Equipment Types, provides initial information about the features of the five broad categories of equipment (examination tables and chairs, stretchers, imaging equipment, mammography equipment, and weight scales) the Committee considered in making its accessibility standards recommendations.
  • Section 5 presents the recommendations for accessibility standards along with the rationale and comments specific to different equipment categories.
  • Section 6 briefly introduces the standard about which Committee members did not reach consensus: the minimum transfer surface height. It refers readers to Minority Reports appended to this report for the unedited perspectives of various Advisory Committee members on the minimum transfer surface height standard.
  • Section 7, Diagnostic Imaging Equipment Accessibility Considerations, provides more detail about features of imaging equipment that affect their accessibility and describes a concept developed by some Committee members for “imaging system accessibility configurations” that aim to facilitate access of persons with disabilities to current imaging machines.
  • Section 8 concludes by discussing issues that the Committee did not address and concerns that merit future attention.

Finally, although ensuing sections address these issues in greater depth, several key points up front might guide review of this MDE Advisory Committee report. First, by necessity, the Committee could only consider existing medical diagnostic equipment and technologies, such as diagnostic imaging systems. Future technological advances can only be imagined. However, as is clear throughout the report, with some important exceptions, current equipment designs rarely accommodate fully persons with disabilities. Therefore, improving accessibility will require new equipment designs and engineering, as well as perhaps ways of thinking about diagnostic evaluations. The Advisory Committee urges equipment designers and manufacturers to be forward thinking, perhaps pushing aside historical design techniques to devise new methods to best accommodate the growing population of persons with disabilities in the U.S. The Advisory Committee also recommends that equipment designers and manufacturers work closely with persons with disabilities as they address accessibility accommodations. Just as designers and manufacturers seek input from various scientists, engineers, and health care professionals while developing new equipment, individuals with disabilities could offer critical insights about accessibility features.

Second, this rulemaking explicitly excluded pediatric diagnostic equipment, despite the increasing number of children living with disabilities. The Advisory Committee itself decided that it did not have the time, information, or resources to fully address medical diagnostic equipment accessibility standards for a critical subpopulation of individuals with disabilities: adults with severe obesity. Future efforts will need to look in-depth at accessibility standards for this group of people, which is also increasing in numbers in the U.S.

Lastly, the Advisory Committee often did not have specific and credible evidence to guide its decisions. Few studies have addressed explicitly the particular issues raised in this rulemaking. The Committee instead relied upon studies concerning related topics, previous accessibility standards approved by the U.S. Access Board, and the informed opinions of a wide range of individuals who gave presentations to the Committee and then discussed various topics with its members. Importantly, a major source of information for Committee members was the open sharing of views among Committee members, who represented a range of stakeholder perspectives. Across nine months, Advisory Committee members worked collaboratively to develop the standards recommended here, reaching consensus in all but one instance. Thus, the standards recommended by the MDE Advisory Committee represent consensus among members from a range of stakeholder organizations.