By Susan K. Urahn, Allan Coukell, Joshua Rising, M.D., Kirsten Paulson, Naomi Herz, Naomi Aronson, Ph.D., and Art Sedrakyan, M.D.
Medical devices in the United States are a pillar of a world-class system for medical care. These devices range from the infusion pumps that deliver medications to hospitalized patients to lifesaving cardiac valves to implanted devices that can restore hearing or vision. Patients rely on the Food and Drug Administration to ensure the safety and efficacy of new medical devices. However, recent high-profile failures of these technologies, including metal-on-metal hips and implantable cardiac defibrillators, are a reminder that this country lacks a robust system for assessing the safety and effectiveness of medical devices once they enter the market.
In 2012, FDA issued its report “Strengthening Our National System for Medical Device Postmarket Surveillance,” which outlines four key steps for creating a national surveillance system that would quickly identify poorly performing devices. The system would also generate real-world evidence of the benefits of such technologies of devices on the market and support future device development. The four steps are:
- Establish a unique device identification system and promote its incorporation into electronic health information.
- Encourage the development of national and international device registries for selected products.
- Modernize adverse event reporting and analysis.
- Develop and use new methods for evidence generation, synthesis, and appraisal.