Introduction and Background

1. Public Participation and Request for Comments

The preamble includes questions that request comments on issues that the Access Board is particularly interested in receiving information from the public.  The Access Board encourages all persons interested in the rulemaking to submit comments on the proposed standards and the questions in the preamble.  Instructions for submitting and viewing comments are provided above under Addresses.  The Access Board will consider all comments and may change the proposed standards based on the comments.

2. Establishment of Advisory Committee

The Access Board has used advisory committees consisting of representatives of interest groups that are affected by its guidelines and standards to assist in developing the guidelines and standards.  Advisory committees provide significant expertise on issues and an opportunity for interest groups to reach consensus on issues.  The Access Board plans to convene an advisory committee when the comment period on the rulemaking closes to assist the Board in reviewing the comments and make recommendations on issues addressed in the rulemaking.  The Access Board will issue a separate notice in the Federal Register announcing the establishment of the advisory committee and seeking nominations for membership on the advisory committee to represent the interests of individuals with disabilities, medical device manufacturers, health care providers, standards setting organizations, and other interested parties.  Advisory committee meetings will be announced in advance in the Federal Register and will be open to the public.

3. Background

A. Access Board

The Access Board is an independent federal agency established by Section 502 of the Rehabilitation Act (29 U.S.C. 792).1 The Access Board is responsible for developing accessibility guidelines and standards under various laws to ensure that individuals with disabilities have access to and use of buildings and facilities, transportation vehicles, and information and communication technology.2 Pursuant to these laws, other federal agencies have adopted the Access Board's guidelines and standards as mandatory requirements for entities subject to their jurisdiction.3

B. Patient Protection and Affordable Care Act and Section 510 of the Rehabilitation Act

Section 4203 of the Patient Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 570) amended Title V of the Rehabilitation Act, which establishes rights and protections for individuals with disabilities, by adding Section 510.  Section 510 of the Rehabilitation Act (29 USC 794f) requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain minimum technical criteria to ensure that medical diagnostic equipment used in or in conjunction with medical settings such as physicians' offices, clinics, emergency rooms, and hospitals is accessible to and usable by individuals with disabilities.  allowThe statute provides that the standards must allow for independent access to and use of the equipment by individuals with disabilities to the maximum extent possible.  The statute lists examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment as examples of equipment to which the standards will apply.  However, this list is not exclusive and the statute covers any equipment used by health care providers for diagnostic purposes.  The statute does not cover medical devices used for monitoring or treating medical conditions such as glucometers and infusion pumps.

Section 510 of the Rehabilitation Act requires the standards to be issued not later than 24 months after the enactment of the Patient Protection and Affordable Care Act.  The Patient Protection and Affordable Care Act was enacted on March 23, 2010.  Accordingly, the statutory deadline for issuing the standards is March 23, 2012.  The statute also requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to periodically review and amend the standards, as appropriate.

Section 510 of the Rehabilitation Act does not require any entity to comply with the standards that the Access Board issues under this law.  Compliance with the standards becomes mandatory only when an enforcing authority adopts the standards as mandatory requirements for entities subject to its jurisdiction.  As discussed below, the Department of Justice (DOJ) may adopt the standards as mandatory requirements for health care providers pursuant to its authority under Titles II and III of the Americans with Disabilities Act.  Other federal agencies may adopt the standards as mandatory requirements for health care providers pursuant to their authority under Section 504 of the Rehabilitation Act.

C. Americans with Disabilities Act and Section 504 of the Rehabilitation Act

The Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act are civil rights laws that prohibit discrimination on the basis of disability.  Title II of the ADA (42 U.S.C. 12131 to 12165) applies to state and local governments, and Title III of the ADA (42 U.S.C. 12189 to 12189) applies to private entities that are public accommodations such as health care providers.  Section 504 of the Rehabilitation Act (29 U.S.C. 792) applies to recipients of federal financial assistance such as Medicaid and federally conducted programs.  DOJ is responsible for issuing regulations to implement Titles II and III of the ADA.4 Federal agencies that provide federal financial assistance are responsible for issuing regulations to implement Section 504 of the Rehabilitation Act for recipients of such assistance.  Federal agencies also are responsible for issuing regulations to implement Section 504 of the Rehabilitation Act for their federally conducted programs.  DOJ is responsible for overall enforcement of Titles II and III of the ADA, and Section 504 of the Rehabilitation Act as it applies to recipients of federal financial assistance from DOJ and federal financial assistance from other federal agencies when those agencies refer complaints to DOJ for enforcement purposes.5

D. Department of Justice Activities Related to Health Care Providers and Medical Equipment

Pursuant to the ADA and Section 504 of the Rehabilitation Act, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities.  DOJ has entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.6

In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act.  See Access to Medical Care for Individuals with Mobility Disabilities available at: http://www.ada.gov/medcare_ta.htm.  The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel.

In July 2010, DOJ also issued an advance notice of proposed rulemaking (ANPRM) announcing that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities.7 See 75 FR 43452 (July 26, 2010).  Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board.  DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities.  If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment.

E. Private Enforcement Efforts

Private parties, including individuals with disabilities, have also entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.8

F. Consultation with Food and Drug Administration

The Commissioner of the Food and Drug Administration has designated the Director of the Center for Devices and Radiological Health (FDA-CDRH) to consult with the Access Board on the development of standards for accessible medical diagnostic equipment.  The Access Board has worked closely with the FDA-CDRH in developing the proposed standards.  The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access Board's standards.  If the FDA-CDRH develops such a guidance document, it will provide the public notice and opportunity to comment on a draft of the guidance document in accordance with its procedures for issuing guidance documents.  See 21 CFR 10.115.  

G. ANSI/AAMI HE 75

In 2009, the Association for the Advancement of Medical Instrumentation issued ANSI/AAMI HE 75, a recommended practice on human factors design principles for medical devices.  Chapter16 of ANSI/AAMI HE 75 contains recommended practices regarding accessibility for patients and health care personnel with disabilities.  Chapter 16 of ANSI/AAMI HE 75 is available at: http://www.aami.org/he75/.

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 Chapter16 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.

Question 1. Are there other voluntary consensus standards for medical diagnostic equipment that address accessibility for patients with disabilities, or are considering addressing accessibility for patients with disabilities in future revisions to the standards?

H. Barriers Affecting Accessibility and Usability of Medical Diagnostic Equipment

The Rehabilitation Engineering Research Center on Accessible Medical Instrumentation conducted a national survey in 2004 to collect information on the types of medical equipment that is most difficult for individuals with disabilities to access and use.9 The survey was completed by a diverse sample of individuals with a wide range of disabilities, including mobility disabilities and sensory disabilities.  Survey respondents who had experience with specific medical equipment rated their degree of difficulty when attempting to access or use the equipment as follows:

  • 75 percent rated examination tables as moderately difficult to impossible to use;
  • 68 percent rated radiology equipment as moderately difficult to impossible to use;
  • 53 percent rated weight scales as moderately difficult to impossible to use; and
  • 50 percent rated examination chairs as moderately difficult to impossible to use.

Survey respondents reported difficulties with getting on and off the equipment, positioning their bodies on the equipment, physical comfort and safety, and communication issues.

A subsequent study that involved focus group sessions of individuals with diverse disabilities provided additional information on barriers that affect the accessibility and usability of examination tables, examination chairs, imaging equipment, and weight scales.10 The equipment characteristics that the focus group participants identified as affecting their ability to access and use the equipment included the dimensions of the equipment (e.g., height, width, length), contact surfaces (e.g., stiffness, comfort, color contrast), supports for transferring onto and off of equipment and positioning their bodies on the equipment (e.g., handholds, armrests, side rails), controls (e.g., ease of operation), and displays and devices (e.g., legibility, understandability).

The Access Board held a public meeting in July 2010 that featured panel discussions and presentations by experts and researchers on medical equipment accessibility, health care providers, medical device manufacturers, and other interested parties to provide information for developing the proposed standards.  The transcript of the meeting is available at: http://www.access-board.gov/medical-equipment.htm.

The technical criteria in the proposed standards address most of the barriers that have been identified as affecting the accessibility and usability of medical diagnostic equipment.  However, it is not possible to address every barrier in the proposed standards, especially given the statutory deadline for issuing the standards.  Research may be needed on some equipment characteristics that affect the accessibility and usability of equipment such as stiffness, comfort, and color contrast of contact surfaces.  Section 510 of the Rehabilitation Act requires the Access Board to periodically review and amend the standards, as appropriate.  The Access Board will address other barriers in future updates to the standards.

Question 2. What other barriers that affect the accessibility and usability of medical diagnostic equipment should be addressed in future updates to the standards? Comments should include information on sources to support the development of technical criteria to address the barriers, where possible.

4. Organization of Technical Criteria

Medical diagnostic equipment is typically designed to support patients in certain positions.  For example, imaging equipment can be designed for use by patients lying on a platform bed, in a standing or seated position, or seated in a wheelchair.  Examination chairs can be designed to recline and be used as examination tables.  The technical criteria for providing patients with disabilities access to and use of each of these equipment types would differ based on the patient positions that the equipment is designed to support.  Therefore, the technical criteria in the proposed standards are organized functionally by the patient positions that the equipment is designed to support instead of by types of equipment.  Where equipment is designed to support more than one patient position, the equipment would have to meet the technical criteria for each position supported.

The table below shows the four basic patient positions that medical diagnostic equipment can be designed to support; the equipment features that are addressed in the technical criteria for each of the patient positions; and the types of equipment to which the technical criteria apply for each of the patient positions.  For example, X-ray equipment that is designed for use in a standing position for certain procedures would have to meet the technical criteria for slip resistant standing surface and standing supports for patients who use mobility aids such as canes or crutches, or who have limited stamina or other conditions that affect their ability to maintain balance.  Mammography equipment that is designed for use by patients seated in a wheelchair would have to meet the technical criteria for wheelchair spaces, changes in level at entry to the wheelchair space, and height of the breast platform.  The types of equipment listed in the last column of the table are meant to be illustrative.  The technical criteria apply to any type of medical diagnostic equipment that is designed to support the patient positions indicated.

Patient Positions Equipment Designed to SupportEquipment Features Addressed in Technical CriteriaTypes Of Equipment To Which Technical Criteria Applies
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

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

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

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

The proposed standards also include technical criteria for supports (see M305), for instructions or other information communicated to patients through the equipment (see M306), and for operable parts used by patients (see M307).

Question 3. In organizing the technical criteria functionally by the patient positions that medical diagnostic equipment is designed to support, is it clear which technical criteria apply to different types of equipment? If not, how should the technical criteria be organized so it is clear which technical criteria apply to different types of equipment?