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</o:shapelayout></xml><![endif]--></head><body lang=EN-US link="#0563C1" vlink="#954F72"><div class=WordSection1><p class=MsoNormal>Medical Device Nonvisual Accessibility Act<o:p></o:p></p><p class=MsoNormal>article<o:p></o:p></p><p class=MsoNormal>Issue—Inaccessible digital interfaces prevent blind individuals from independently and safely operating medical devices that are essential to their daily<o:p></o:p></p><p class=MsoNormal>healthcare needs. <o:p></o:p></p><p class=MsoNormal>Medical devices with a digital interface are becoming more prevalent and less accessible for blind Americans.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>The rapid proliferation of advanced technology is undeniable. Most new models of medical devices, such as glucose and blood pressure monitors, along with<o:p></o:p></p><p class=MsoNormal>the emergence of in-home devices that offer medical care options, such as chemotherapy treatments and dialysis, require consumers to interact with digital<o:p></o:p></p><p class=MsoNormal>displays or other interfaces. This new technology is constantly being developed and deployed without nonvisual accessibility as an integral part of the<o:p></o:p></p><p class=MsoNormal>design phase, which creates a modern-day barrier. The inaccessibility of these medical devices is not a mere inconvenience; when accessibility for blind<o:p></o:p></p><p class=MsoNormal>consumers is omitted from the medical technology landscape, the health, safety, and independence of blind Americans are in imminent danger.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Telehealth currently makes up 20 percent of all medical visits, and more healthcare providers are looking to expand telemedicine services.1 <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>The National Center for Health Statistics also reported in 2021 that 37 percent of all adults used telehealth.2 Unfortunately, these visits assume that<o:p></o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>at a distinct disadvantage when it comes to receiving the same virtual healthcare as their sighted counterparts. <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Nonvisual access is achievable, as demonstrated by several mainstream products.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Apple has incorporated VoiceOver (a screen reading function) into all of its products, making iPhones, Macbooks and Mac desktops, and iPads fully accessible<o:p></o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>a nonvisually accessible voting machine. Frequently, a simple audio output or tactile feature can make a product accessible at little to no additional<o:p></o:p></p><p class=MsoNormal>cost for manufacturers.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Current disability laws are not able to keep up with advancements due to the expeditious evolution of medical technology and its incorporation into medical<o:p></o:p></p><p class=MsoNormal>devices.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Although the Americans with Disabilities Act and other laws require physical accessibility for people with disabilities (e.g., wheelchair ramps, Braille<o:p></o:p></p><p class=MsoNormal>in public buildings), no laws protect a blind consumer’s right to access medical devices. The National Council on Disability concluded that accessibility<o:p></o:p></p><p class=MsoNormal>standards lag behind the rapid pace of technology, which can interfere with technology access.3 This trend of inaccessibility will continue if accessibility<o:p></o:p></p><p class=MsoNormal>solutions are ignored. Only a fraction of medical device manufacturers have incorporated nonvisual access standards into their product design, while others<o:p></o:p></p><p class=MsoNormal>continue to resist these solutions.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Solution—Medical Device Nonvisual Accessibility Act:<o:p></o:p></p><p class=MsoNormal>Calls on the Food and Drug Administration (FDA) to promulgate nonvisual accessibility regulations for Class II and Class III medical devices.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>The FDA will consult with stakeholders with disabilities and manufacturers and issue a notice of proposed rulemaking no later than twelve months after<o:p></o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>the nonvisual accessibility requirements.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Requires manufacturers of Class II and Class III medical devices to make their products nonvisually accessible.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>are nonvisually accessible.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Authorizes the FDA to enforce the nonvisual access requirements for Class II and Class III medical devices.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>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<o:p></o:p></p><p class=MsoNormal>evidence that making the medical device nonvisually accessible would fundamentally alter the use of the product; or proof that modifying the medical device<o:p></o:p></p><p class=MsoNormal>would create an undue burden for the company.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>GOAL—END UNEQUAL ACCESS TO MEDICAL DEVICES FOR BLIND AMERICANS.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Sponsor the Medical Device Nonvisual Accessibility Act.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>For more information, contact:<o:p></o:p></p><p class=MsoNormal>Justin Young, Government Affairs Specialist, National Federation of the Blind<o:p></o:p></p><p class=MsoNormal>Phone: 410-659-9314, extension 2210, Email: <o:p></o:p></p><p class=MsoNormal>jyoung@nfb.org<o:p></o:p></p><p class=MsoNormal> or visit <o:p></o:p></p><p class=MsoNormal>www.nfb.org<o:p></o:p></p></div></body></html>