[NFBMO] Medical Device Nonvisual Accessibility Act

[millerdennis893 at gmail.com]

Medical Device 
Nonvisual Accessibility Act 

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; when accessibility for blind
consumers is omitted from the medical technology landscape, the health,
safety, and independence of blind Americans are in imminent danger.

 

Telehealth currently makes up 20 percent of all medical visits, and more
healthcare providers are looking to expand telemedicine services.[i] The
National Center for Health Statistics also reported in 2021 that 37 percent
of all adults used telehealth, illustrating an increase in telehealth
visits.[ii] Unfortunately, these visits assume that a person has easy access
to accessible medical devices to take their own vital signs. 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 several mainstream
products. Apple has incorporated VoiceOver (a text-to-speech function) into
all its 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.[iii] This trend
of inaccessibility will continue if accessibility solutions are ignored.
Only a fraction of medical device manufacturers have incorporated nonvisual
access standards into their product design, while others continue to resist
these solutions.

 

Solution-Medical Device Nonvisual Accessibility Act:

 

Calls on the Food and Drug Administration (FDA) to promulgate nonvisual
accessibility regulations 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 suggest style guide for numbers
means twenty-four months after the date of enactment of the act, the FDA
will publish the final rule including the nonvisual accessibility
requirements.

 

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 the Class II
and Class III medical devices they produce are nonvisually accessible.

 

Authorizes the FDA to enforce the nonvisual access requirements 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. Manufactures may file for an exemption
for one of two reasons: clear and convincing evidence that making the
medical device nonvisually accessible would fundamentally alter the use of
the product; or proof that modifying the medical device would create an
undue burden for the company.

 

 

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

 

Sponsor the Medical Device Nonvisual Accessibility Act.

 

For more information, contact:

Justin Young, Government Affairs Specialist, National Federation of the
Blind

Phone: 410-659-9314, extension 2210, Email: jyoung at nfb.org
<mailto:jyoung at nfb.org>  or visit www.nfb.org <http://www.nfb.org> 

 


  _____  

[i] 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/

[ii] See National Center for Health Statistics, Telemedicine Used Among
Adults: United States, 2021. Available at
https://www.cdc.gov/nchs/products/databriefs/db445.htm

[iii] 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

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