Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report
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, 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.
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