Beyond Indications

Abstract

In September of this year, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health published a document entitled, “Strengthening Our National System for Medical Device Postmarket Surveillance.”1 In addition to summarizing the current process and mechanisms for monitoring medical devices after commercial approval, the document proposed the following specific actions to improve the efficiency and quality of postmarket surveillance of medical devices in the United States: > 1. Establish a unique device identification system and promote its incorporation into electronic health information; > > 2. Promote the development of national and international device registries for selected products; > > 3. Modernize adverse event reporting and analysis; and, > > 4. Develop and use new methods for evidence generation, synthesis, and appraisal. [1, p. 4] The intended focus of this initiative is laudable and much needed, as the current system, discussed in this journal earlier this year,2 is widely believed to be overly time consuming and expensive, and to place the United States at a competitive and technological disadvantage to many other countries. As with many of the investigational mechanisms used to assess new medical technologies, these initiatives are likely to lend themselves most easily to devices that are used widely and in relatively consistent applications. With the introduction and evolution of this forward thinking upgrade of the postmarket medical device surveillance system, let us hope that low-volume, off-label, and other marginal device use remains within its purview so that we can collectively move toward a better understanding and oversight of such device applications, as well as those with broader market applications. It is no secret that the majority of transcatheter interventions for congenital heart disease in the United States are performed with devices that are not …