[NFBMT] Fact Sheet: Medical Device Nonvisual Accessibility Act, 2 of 4

Wed Jan 19 11:23:18 UTC 2022

Medical Device Nonvisual Accessibility Act (H.R. 4853)

Issue-Inaccessible digital interfaces prevent blind individuals from
independently and safely operating medical devices that are essential to
their daily healthcare needs.  

Medical devices with a digital interface are becoming more prevalent and less
accessible for blind Americans. The rapid proliferation of advanced
technology is undeniable. Most new models of medical devices, such as glucose
and blood pressure monitors, along with the emergence of in-home devices that
offer medical care options, such as chemotherapy treatments and dialysis,
require consumers to interact with a digital display or other interfaces.
This new technology has been and continues to be developed and deployed
without nonvisual accessibility as an integral part of the design phase,
which creates a modern-day barrier. The inaccessibility of these medical
devices is not a mere inconvenience; if accessibility for blind consumers is
omitted from the medical technology landscape, the health, safety, and
independence of blind Americans will be in imminent danger.

Telehealth currently makes up 20 percent of all medical visits, and more
healthcare providers are looking to expand telemedicine services.
<https://nfb.org/programs-services/advocacy/washington-seminar/washington-sem
inar-priorities/medical-device#a1> 1 Unfortunately, these visits assume that
a person has easy access to accessible medical devices in order to take their
own vitals. As a result of inaccessibility, blind and low-vision Americans
are at a distinct disadvantage when it comes to receiving the same virtual
healthcare as their sighted counterparts.

Nonvisual access is achievable, as demonstrated by a number of mainstream
products. Apple has incorporated VoiceOver (a text-to-speech function) into
all of their products, making iPhones, Macbooks and Mac desktops, and iPads
fully accessible to blind people right out of the box. Virtually all ATMs
manufactured in the United States are accessible, and every polling place is
required to have a nonvisually accessible voting machine. Frequently, a
simple audio output or vibrotactile feature can make a product accessible at
little to no additional cost for manufacturers.

Current disability laws are not able to keep up with advancements due to the
expeditious evolution of medical technology and its incorporation into
medical devices. Although the Americans with Disabilities Act and other laws
require physical accessibility for people with disabilities (e.g., wheelchair
ramps, Braille in public buildings), no laws protect the blind consumer's
right to access medical devices. The National Council on Disability concluded
that accessibility standards lag behind the rapid pace of technology, which
can interfere with technology access.
<https://nfb.org/programs-services/advocacy/washington-seminar/washington-sem
inar-priorities/medical-device#a2> 2 This trend of inaccessibility will
continue if accessibility solutions are ignored. Only a fraction of medical
device manufacturers has incorporated nonvisual access standards into their
product design, while others continue to resist these solutions.

Solution-Medical Device Nonvisual Accessibility Act (H.R. 4853):

Calls on the Food and Drug Administration (FDA) to promulgate nonvisual
accessibility standards for Class II and Class III medical devices. The FDA
will consult with stakeholders with disabilities and manufacturers and issue
a notice of proposed rulemaking no later than twelve months after the date of
enactment of the act. No later than 24 months after the date of enactment of
the act, the FDA will publish the final rule including the nonvisual
accessibility standards.

Requires manufacturers of Class II and Class III medical devices to make
their products nonvisually accessible. Manufacturers will have twelve months
following the publication of the final rule to ensure that all of the Class
II and Class III medical devices they produce are nonvisually accessible.

Authorizes the FDA to enforce the nonvisual access standards for Class II and
Class III medical devices. Any manufactured device found to be out of
compliance, whether by a public complaint to the FDA or by an independent FDA
investigation, will be considered an adulterated product under the Federal
Food, Drug, and Cosmetic Act.

GOAL-END UNEQUAL ACCESS TO MEDICAL DEVICES FOR BLIND AMERICANS.

Cosponsor the Medical Device Nonvisual Accessibility Act (H.R. 4853)

To cosponsor H.R. 4853 contact:
Gidget Benitez, Health Policy Counsel, Rep. Jan Schakowsky (D-IL-09)
Phone: 202-225-2111, Email:  <mailto:gidget.benitez at mail.house.gov>
gidget.benitez at mail.house.gov

For more information, contact:
Jesa Medders, National Federation of the Blind
Phone: 410-659-9314, extension 2207, Email:  <mailto:jmedders at nfb.org>
jmedders at nfb.org
 <https://www.nfb.org/> www.nfb.org

1.	See Center for Connected Medicine, Telehealth utilization settles in
at 20% or less of medical appointments, available at
<https://connectedmed.com/resources/post-pandemic-telehealth-utilization-sett
les-in-at-20-or-less-of-medical-appointments/>
https://connectedmed.com/resources/post-pandemic-telehealth-utilization-settl
es-in-at-20-or-less-of-medical-appointments/
2.	See NATIONAL COUNCIL ON DISABILITIES, National Disability Policy
Progress Report: Technology that enables access to the full opportunities of
citizenship under the Constitution is a right at 19 (October 7, 2016),
available at
<https://ncd.gov/progressreport/2016/progress-report-october-2016>
https://ncd.gov/progressreport/2016/progress-report-october-2016

Joy Breslauer, Advocacy and Public Policy

National Federation of the Blind of Montana 

Web Site: http://www.nfbofmt.org <http://www.nfbofmt.org/> 

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