sistently to achieve desired results. In the context of medical device safety and postmarket surveillance, a systems perspective also means looking beyond individual errors with medical devices to identify the human factors and system characteristics that contribute to such errors.

Another dimension of improving the quality of care involves strengthening the evidence base for clinical practice and the translation of that science base into guidelines and other tools, processes, or systems that successfully influence practice. Many common medical practices—for example, a range of unlabeled uses of drugs and medical devices with children—have not been subjected to systematic clinical investigation to document their safety and effectiveness in practice.

In response to the particular shortfalls in the knowledge base for pediatric care and in the availability of medical products evaluated for use with children, Congress, FDA, NIH, and others have sought to create a mix of incentives and requirements to expand pediatric research and reduce barriers to the development of drugs, devices, vaccines, and other medical services that improve children’s health and well-being. The next chapter describes why children’s needs and characteristics warrant special attention and pose challenges to those developing, evaluating, and monitoring medical devices.

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