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Medical Device Nonvisual Accessibility Act Legislative Imperative

Background

The majority of home-use medical devices and outpatient equipment utilize digital display interfaces that are inaccessible to blind and low-vision 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.

On March 1, 2023, Rep. Jan Schakowsky (D-IL) introduced the Medical Device Nonvisual Accessibility Act (H.R. 1328) in the House of Representatives. The goal of this act is 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 incorporate accessible design in the beginning stages of development for home use medical devices. This bill has 53 co-sponsors and is bipartisan with 4 Republicans and 49 Democrats. On January 18, 2024, a bipartisan Senate companion bill (S. 3621) was introduced by Senators Maggie Hassan (D-NH) and Mike Braun (R-IN).

Call to Action

ACB calls on Congress to support and pass the Medical Device Nonvisual Accessibility Act in the House of Representatives and 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.