have dealt with safety issues related to devices used with children, including incubators, cribs, ventilators, and automated external defibrillators.

Under contract to FDA, the organization developed the education and training materials for recognition, investigation, and root-cause analysis of medical device adverse events for the pilot MedSun program. ECRI also assists in the analysis of the MedSun problem reports. In addition, ECRI has a contract with FDA to help harmonize FDA’s medical device product codes with the Global Medical Device Nomenclature (GMDN). It recently drafted a white paper for FDA on the automatic identification of medical devices.


One theme of this report is that an effective regulatory program for evaluating and monitoring the safety of medical devices in general is a necessary foundation for efforts to safeguard children in particular. Thus, steps to improve FDA’s programs for the reporting of adverse device events overall should benefit children as well as adults. To promote more focused attention to pediatric issues, Chapter 7 includes a recommendation (7.1) that FDA identify a focal point of responsibility for pediatric issues within the Center for Devices and Radiological Health to evaluate the adequacy of the Center’s use of pediatric expertise and its attention to pediatric issues in all aspects of its work to promote medical device safety.

Another theme of this report is that medical device safety is a shared responsibility. The recommendations below start with FDA but extend to include manufacturers, health professionals, user facilities, and patients and families. Chapter 7 extends this discussion.

Within FDA, adverse event reporting and improvement should be understood in the entire context of the agency’s activities to protect patients and promote medical device safety from the early stages of device development through the end of a device’s useful life. These activities include guidance for developers of devices, premarket evaluations, systematic postmarket clinical studies of selected devices, public health notifications and additional information for users of devices, quality system inspections of manufacturers, and other strategies. The FDA program itself should be seen as part of a more expansive system of public and private programs and actions to safeguard patients and improve health outcomes.

FDA Adverse Event Reporting

As part of a larger system of postmarket surveillance and device safety regulation, a passive or spontaneous program of reporting has a role to play in detecting unexpected device problems (including problems with the use

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