standards for accessible medical diagnostic equipment (mde ... · standards for accessible medical...
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Standards for Accessible
Medical Diagnostic Equipment
(MDE)
&
Access to Quality Pelvic
Health Care for Women with
Mobility Impairments
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Barriers Affecting Accessibility and
Usability of Medical Diagnostic
Equipment
• 75% - examination tables moderately difficult
to impossible to use
• 68% - radiology equipment moderately
difficult to impossible to use
• 53% - weight scales moderately difficult to
impossible to use
• 50 % - examination chairs moderately
difficult to impossible to use
Rehabilitation Engineering Research Center on Accessible
Medical Instrumentation 2004 national Survey 2
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• Section 4203 of Patient Protection and
Affordable Care Act
– (Public Law 111-148, 124 Stat. L. 119)
• Added Section 510 to the Rehabilitation Act of
1973 on March 23, 2010
• Title: “ESTABLISHMENT OF STANDARDS
FOR ACCESSIBLE MEDICAL DIAGNOSTIC
EQUIPMENT”
MDE - Background
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• Examination tables and
chairs
• weight scales, x-ray
machines
• radiological
and mammography
equipment
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MDE - Background
Rule does not cover personal devices or
positioning aids – “diagnostic equipment” only
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MDE - Background
• Mandate is to establish technical criteria
• Scope issues not addressed:
when, how many, and existing equipment
issues determined in appropriate regulatory
or administrative context
• Final Standards issued by Access Board will
be voluntary
• Must be adopted by DOJ to be enforceable
under Americans with Disabilities Act
• Reference Standard for FDA to verify labelling
of MDE 6
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Federal Partners
• U.S. Food and Drug Administration,
Department of Health and Human
Services
• Disability Rights Section, Department
of Justice
• Department of Veterans Affairs
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MDE - Background
• ANSI/AAMI HE75 – 2009
Human Factors Engineering
– Design of Medical Devices
Chapter 16 –Accessibility
Considerations
• RERC on Accessible
Medical Instrumentation
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MDE - Background
ADA and ABA
Accessibility
Guidelines
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Research Data
Principle Source:
Data Collected for the
Wheeled Mobility
Anthropometry Project
Additional:
Study on The Impact of
Transfer Setup on the
Performance of
Independent Wheelchair
Transfers (Phase I)
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MDE - Rulemaking Steps
• Notice of Proposed
Rulemaking (NPRM)
• Comment Period
• Public Hearings
• Advisory Committee
• Final Rule
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Responses to NPRM
• 46 questions were posed
in the preamble
• 51 commenters
• Range of comments
112
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MDE - Advisory Committee
Advise on matters addressed in the NPRM
for the proposed Standards and issues raised
in public comments.
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Advisory Committee
Recommendations
• 55 Recommendations Made
• 9 Issue Areas Addressed
• Final Report
http://www.access-board.gov/guidelines-and-
standards/health-care/about-this-
rulemaking/advisory-committee-final-report
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Overview of
Standards
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Organization of Standards
• M1 Application and Administration
• M2 Scoping Requirements
• M3 Technical Criteria
By patient position supported
– Supine, Prone, or Side Lying
– Seated
– in Wheelchair
– Standing
Across all types of equipment
– Communication
– Operable Parts 16
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Key Issues:
transfers, obstructions
supports, and lift use
Supine, Prone, or Side-
lying
Position - M301
Seated
Position -
M302
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Transfer Surface Height
17 inches minimum and 19 inches maximum proposed – could be fixed height
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Low Height
High Height
Transfer Surface Height
Committee recommended
• height adjustability for transfers:
• “high” height of 25”
• “low” height – no consensus
options for 19”, 18”, and 17”
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M301.2.2 Size
Transfer Surface Size
M302.2.2 Size
two distinct requirements proposed for each
equipment category – difference is width
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Advisory Committee Recommendations
Transfers at End
28” wide min. by
17” deep min.
Transfers at Sides
28” wide min. by
28” min. deep
Transfer Surface Size – M301
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The Standard
does NOT
address clear
floor space for
transfers
Wheelchair Spaces
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Advisory Committee
Recommendations
Transfer Surface Size – M301
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M301.3 and M302.3 Supports
Proposed provisions
for:
• transfer supports
• leg supports –
stirrups
• head and back
support – reclined
positions
Positioning supports
not addressed
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Non-circular Cross Section Circular Cross Section
1 ¼”-2”
Example of relevant ADA-ABA
2004 Guidelines provisions
Section 609 Grab Bars cross
section specifications
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Transfer Supports
structural strength not
addressed as ADA and
ABA Standards do for
grab bars
More variables,
Industry Standards
address
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Committee recommended more detailed
provisions based on ADA/ABA Standards
and discussion in NPRM
Location and Configuration for
Transfer Supports
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Stirrups
Committee recommended: Alternate
method to support, position, and secure
patient’s legs. Method to supplement or
substitute stirrup.
Proposed provision:
Method of supporting,
positioning, and securing
patient’s legs.
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Portable Lift Compatibility
around base
clearances
in base
clearances
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Portable Lift Compatibility
around base
clearances in base
clearances
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Overhead Lifts
Committee Recommendation:
overhead lift in lieu of base clearances where not
feasible for imaging equipment
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Questions?
Board’s webpage about the
MDE Rulemaking:
www.access-
board.gov/guidelines-and-
standards/health-care/about-this-
rulemaking