By: William Maisel, M.D., M.P.H.
For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass of water. But devices can—and do.
In recent months, FDA has reviewed a number of noteworthy products for people with disabilities. And it has approved, cleared or allowed manufacturers to market several new devices.
Products that have met FDA’s premarket requirements include:
• The DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous, powered movements controlled by electrical signals from electromyogram (EMG) electrodes;
• The Nucleus Hybrid L24 Cochlear Implant System, which can help people aged 18 and over (who don’t benefit from conventional hearing aids) with a specific kind of hearing loss; and
• The Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with vision loss from advanced retinitis pigmentosa (RP).
FDA is committed to encouraging such innovation that benefits patients. We foster an approach that enables our staff to interact with device manufacturers and clarify our agency’s expectations for product evaluation. This communication can help new devices get to market in a timely fashion. We also listen to patients’ feedback, which helps us determine which devices may be particularly useful.
When it comes to regulatory decisions, we carry out tailored reviews that protect public health while advancing innovation. Each of the products recently approved or cleared by the agency has benefits that outweigh its risks. For example, in June we allowed marketing of ReWalk, a first-of-its-kind, motorized device. Risks associated with the exoskeleton-like device include pressure sores and injuries from falls. But the big benefit is that it can help patients with complete or partial paraplegia to actually walk in their homes and communities.
We have seen amazing advances in technology in recent years. These advances make it possible for manufacturers to address longstanding disabilities in innovative ways. That said, we will continue to acknowledge that all medical therapies have benefits as well as risks. So, when making regulatory assessments, we’ll make every effort to make sure our decisions are balanced, and to ensure that approved or cleared devices can aid the patients who use them.
In addition to helping patients across the country, we are committed to empowering agency employees. For instance, FDA Commissioner Margaret A. Hamburg, M.D., recently held a meeting with the agency’s Advisory Committee for Employees with Disabilities (ACED). There, the committee provided an annual update and discussed topics that impact employees with disabilities, including making sure all buildings are accessible and facilitating access to assistive and adaptive technologies through a new Ergonomic Resource Center at our headquarters. And this month the committee held an additional, internal roundtable event to focus on continued awareness, timed to National Disability Employment Awareness Month.
People with disabilities make many important contributions to our agency and to society at large. It’s our goal and commitment to help them maintain an active lifestyle and enjoy a good quality of life.
William Maisel, M.D., M.P.H., is FDA’s Deputy Center Director for Science and Chief Scientist for its Center for Devices and Radiological Health.