Issue—Inaccessible
digital interfaces prevent blind individuals from independently and safely operating
medical devices that are essential to blind people’s 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, oxygen, 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
digital displays or other interfaces. This new technology is
constantly being 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.
According to the Center for Connected Medicine, telehealth
currently makes up 20 percent of all medical visits, and more healthcare
providers are looking to expand telemedicine services.[1] According
to the Pew Research Center, Rural Americans live an average of 10.5 miles from
the nearest hospital.[2]
According to the Journal of the American Pharmacists Association, across the
United States, 8.3% of counties had at least 50% of residents with a distance
greater than 10 miles from the closest pharmacy.[3] 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 our sighted
counterparts.
Nonvisual
access is achievable, as demonstrated by several mainstream products. Apple
has incorporated VoiceOver (a screen reading function) into all of 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
tactile feature can make a product accessible at little to no additional cost
for manufacturers.
Current
disability laws have not been 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 a 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.[4] 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 with digital interfaces. 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 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 with digital interfaces
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 with digital interfaces they produce
are nonvisually accessible.
Authorizes
the FDA to enforce the nonvisual access requirements for Class II and Class III
medical devices with digital interfaces.
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.
Manufacturers 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 hardship for the company.
For more information,
contact:
Justin Young, Government Affairs Specialist, National
Federation of the Blind
Phone: 410-659-9314, extension 2210, Email: jyoung@nfb.org or visit www.nfb.org
