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ATBCB RIN: 3014-AA40 Publication ID: Fall 2011 
Title: Accessibility Standards for Medical Diagnostic Equipment 
Abstract: This regulation will establish minimum technical criteria to ensure that medical equipment used for diagnostic purposes by health professionals in (or in conjunction with) physician's offices, clinics, emergency rooms, hospitals, and other medical settings is accessible to and usable by individuals with disabilities. 
Agency: Architectural and Transportation Barriers Compliance Board(ATBCB)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 30 CFR 1197 (New) 
Legal Authority: 29 USC 794(f) 
Legal Deadline:
Action Source Description Date
Final  Statutory  29 USC 794(f)  03/22/2012 

Statement of Need: The Access Board is required to issue accessibility standards for medical diagnostic equipment by section 510 of the Rehabilitation Act. The standards will reduce health and safety risks to individuals with disabilities by making medical diagnostic equipment accessible.

Summary of the Legal Basis: 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 U.S.C. 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 are accessible to and usable by individuals with disabilities. The 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 commonly used by health professionals for diagnostic purposes. The statute does not cover medical devices used for monitoring or treating medical conditions such as glucometers and infusion pumps.

Alternatives: The Access Board has considered alternatives proposed by stakeholders at public hearings and identified in research. In addition, the Access Board has consulted closely with the Department of Justice and the Food and Drug Administration in the development of these draft standards. The Access Board has also considered approaches contained in the Association for the Advancement of Medical Instrumentation's ANSI/AAMI HE 75:2009, "Human factors engineering--Design of medical devices" in developing the proposed standards. ANSI/AAMI HE 75 is a recommended practice that provides guidance on human factors design principles for medical devices. Chapter 16 of ANSI/AAMI HE 75 provides guidance on accessibility for patients and health care professionals with disabilities. Chapter 16 of ANSI/AAMI HE 75 is available at: http://www.aami.org/he75/. The proposed standards do not reference the guidance in chapter 16 of ANSI/AAMI HE 75 because the guidance is not mandatory. The Access Board seeks to promote harmonization of its standards and guidelines with voluntary consensus standards and plans to participate in future revisions to ANSI/AAMI HE 75.

Anticipated Costs and Benefits: The Access Board is seeking input from the public on costs and benefits associated with these standards. Section 510 of the Rehabilitation Act does not address who is required to comply with the standards. Compliance with the standards is not mandatory unless other agencies adopt the standards as mandatory requirements for entities under their jurisdiction. In July 2010, the Department of Justice issued an advance notice of proposed rulemaking (ANPRM) announcing that it was considering amending its ADA regulations to ensure that equipment and furniture are accessible to individuals with disabilities. See 75 FR 43452 (Jul. 26, 2010). The ANPRM noted that the ADA has always required the provision of accessible equipment and furniture, and that the Department has entered into settlement agreements with medical care providers requiring them to provide accessible medical equipment. The ANPRM stated that when the Access Board has issued accessibility standards for medical diagnostic equipment, the Department would consider adopting the standards in its ADA regulations. The ANPRM also stated that, if the Department adopts the Access Board's accessibility standards for medical diagnostic equipment, it would develop scoping requirements that specify the minimum number of accessible types of equipment required for different medical settings.

Risks: The rule is intended to reduce health and safety risks to individuals with disabilities by making medical diagnostic equipment accessible.

Timetable:
Action Date FR Cite
Notice of Public Information Meeting  06/22/2010  75 FR 35439 
NPRM  02/00/2012   
NPRM Comment Period End  04/00/2012   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Information URL: www.access-board.gov/medical-equipment.htm   Public Comment URL: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
James Raggio
General Counsel
Architectural and Transportation Barriers Compliance Board
Suite 1000, 1331 F Street NW., Suite 1000,
Washington, DC 20004-1111
Phone:202 272-0040
TDD Phone:202 272-0062
Fax:202 272-0081
Email: raggio@access-board.gov

 
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