[NFBF-L] Fact Sheets for 2022 NFB Washington Seminar - 2 of 4 - Medical Device Non-Visual Access

Wed Jan 19 04:08:11 UTC 2022

Hello everyone,

I learned that, for some,  this previously sent email never made it out of
my computer. I think I have corrected the outbox issues and am going to try
and send this info to you again.

Also with all the resending that I am doing tonight, the email with the Fact
Sheet 3 of 4 might have had a subject line that did not match the attachment
or the body. Just focus on the attachment and the body of the emails and
don't get too hung up on the subject line, (it may confuse just a bit.sorry
about that).

Please forgive any duplicate emails with this subject and attachment.

Sincerely,

Russ

From: Russell Davis [mailto:russell at radiorusty.com] 
Sent: Monday, January 10, 2022 2:35 PM
To: nfbf-l at nfbnet.org; nfbf-leaders at nfbnet.org
Subject: Fact Sheets for 2022 NFB Washington Seminar - 2 of 4 - Medical
Device Non-Visual Access

Hello again everyone,

Please see attached the Medical Device Non Visual Accessibility Act fact
sheet in Microsoft Word format.

For your convenience, I've also pasted the text of the fact sheet to the
bottom of this email.

Please take the time to review the fact sheet as it will provide you with
valuable information about this bill.

Thanks so much for all you are doing to help move forward our mission and
our legislative efforts.

Respectfully,

Russ Davis,

Legislative Director, National Federaton of the Blind of Florida

Ph. 904-993-8433

Email: Russell at radiorusty.com

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.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.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
 <http://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-set
tles-in-at-20-or-less-of-medical-appointments/>
https://connectedmed.com/resources/post-pandemic-telehealth-utilization-sett
les-in-at-20-or-less-of-medical-appointments/ 
2See 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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