2023 Medical Device Nonvisual Accessibility Act

Carla Ruschival

Pasted below and attached is the backgrounder on the Medical Device
Nonvisual Accessibility Act. As part of the ACB DC legislative
seminar, the Kentucky Council of the Blind will be meeting soon with
our Congressional offices to discuss this legislative imperative along
with the other three ACB imperatives. Find out how you can help by
calling KCB at 502-895-4598. If you don't live in Kentucky but you
would like to be involved, call the American Council of the Blind at
202-467-5081 or contact your state ACB affiliate.

Legislative Imperative:

1703 N. Beauregard St., Suite 420
Alexandria, VA 22311
Tel: (202) 467-5081
Fax: (703) 465-5085

Medical Device Nonvisual Accessibility Act Legislative Imperative


The majority of home use medical devices and outpatient equipment
utilize digital display interfaces that are inaccessible to blind and
visually impaired users. Devices such as glucose monitors, blood
pressure readers, and at-home chemotherapy treatments do not have any
non-visual accessibility features like text to speech output, tactile
markings, or audible tones built in. As a result, blind and visually
impaired individuals cannot use them safely, making it difficult for
these individuals to manage their health independently.

According to the Centers for Disease Control and Prevention, adults
with vision loss are at a higher risk for further health complications
and co-morbid conditions. Diabetes-related vision loss and old age are
two of the leading causes of vision loss in the United States, both of
which could lead to further health complications. It is therefore
imperative that blind and low-vision individuals have access to the
equipment and devices necessary to manage their health and prevent
further health complications, and that the equipment and devices are
accessible with speech output and tactile markings. The COVID-19
pandemic has also underscored the need for accessible medical
equipment and the need for blind and low-vision individuals to be able
to manage their health and wellness safely and independently,
especially during a public health emergency.

In 2021, Rep. Jan Schakowsky (D-IL) introduced the Medical Device
Nonvisual Accessibility Act (H.R. 4853) in the House of
Representatives. The goal of this act was to make home use medical
equipment and devices accessible to blind and visually impaired
individuals in the United States. If passed, this legislation would
amend the federal Food, Drug, and Cosmetic Act to establish non-visual
accessibility standards for Class II and III devices with digital
interfaces. Class II and III devices include devices that are more
invasive and involve a higher risk of injury or death, so it is much
more important that these devices are used safely and as directed. The
FDA would, in consultation with the U.S. Access Board, set regulations
and a final rule according to those standards. The passage of this
legislation would make it easier for people who are blind and low
vision to manage their health safely and independently by ensuring
that product manufacturers incorporated accessible design in the
beginning stages of development for home use medical devices. At the
end of the 117th Congress, this bill had 63 bipartisan co-sponsors (60
Democrats, and 3 Republicans).

Call to Action

In the 118th Congress, ACB calls for reintroduction of the Medical
Device Nonvisual Accessibility Act in the House of Representatives,
and introduction of a companion bill in the Senate. When speaking with
your member of Congress, be sure to describe the challenges you have
faced while using inaccessible home-use medical devices such as heart
rate monitors, glucose monitors, pulse oximeters, blood pressure
readers, insulin pumps, etc., and explain to them what having access
to these devices would mean to you, especially when it comes to
managing your health and well-being, both privately and independently.

Carla Ruschival
Treasurer, Kentucky Council of the Blind
Phone: (502)895-4598