Off-label use of medical devices in pediatric interventional cardiology: prerogative or necessity?

Abstract

The history of medicine is characterized by innovation, through the application of the latest in biomedical science and technology to the bedside. In many ways, using approved medical devices for off-label indications exemplifies this spirit of innovation. Yet there are clear drawbacks to this practice, which include the safety to the patients themselves, the entrepreneurial nature of industry and educational support for clinicians. The issue of off-label use of devices is especially prescient among pediatric cardiac populations in which the majority of patients who undergo interventional catheterization procedures are treated with a device for an indication outside of its labeled uses. The scope of this practice has recently been documented and defined, helping to bring attention to the need for pediatric-specific devices. There remains a critical need to enhance cardiac device review and approval processes to include pediatric applications.