nizations and collaborations include some form of adverse event reporting as part of programs to improve the quality of health care and protect patient safety. Some of these efforts involve children’s hospitals and pediatric professionals.

Just as reporting and responding to adverse events is a distributed responsibility, so is the systematic study of the safety and effectiveness of marketed devices used with children. In addition to postmarket studies ordered by FDA or undertaken voluntarily by manufacturers, NIH, the CERTs overseen by AHRQ, private foundations, pediatric professional societies, and other groups interested in child health should promote and support safety and effectiveness studies and the databases (e.g., registries) needed to support such studies. The involvement of patient, family, and consumer groups is particularly important for devising strategies to adapt device surveillance to the difficult realities of identifying, understanding, and preventing adverse events with devices used at home and in the community.

To support both adverse event reporting and systematic studies, FDA has been exploring how to use developing statistical tools and exploit large automated patient care databases to identify, understand, and prevent problems with the use or design of medical devices. As discussed in Chapters 4 and 6, initial results have been less promising than hoped, partly because patient records often do not contain information that identifies individual medical devices. Creating feasible coding systems and procedures for including such information has, however, proved daunting. Recommendations in Chapter 6 focus on steps to improve the usefulness of electronic patient records for device surveillance and strengthen FDA research capacity. In any case, university-based and other biostatisticians and epidemiologists can contribute by helping, first, to improve and apply the methods for formal clinical studies of medical devices and, second, to refine the tools for detecting and analyzing adverse events in large databases and developing the field of medical device surveillance.

Notwithstanding the responsibilities and essential contributions of other parties, FDA has an unparalleled combination of authority and expertise to promote more comprehensive, efficient, and effective medical device surveillance. It must use its position both to strengthen its own programs and to encourage others to recognize and meet their shared responsibilities for identifying, understanding, and preventing problems with the design, evaluation, manufacture, maintenance, and use of medical devices. As stressed throughout this report, successful programs of postmarket surveillance to protect all those whose health depends on safe and effective medical devices are an essential foundation for efforts to protect children in particular.



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