• focus more attention on adverse device events, including events involving children;

  • promote linkages between adverse event reporting systems, various FDA databases, and other safety programs;

  • update product labeling, patient information, and other communications to promptly reflect safety-related findings from analyses of adverse event reports; and

  • issue yearly reports on results from adverse event analyses, including findings involving children.

Recommendation 4.2: FDA should continue educational and communication programs to promote recognition and useful reporting of serious adverse device events and device problems by hospitals and other user facilities. Such encouragement should continue whether or not requirements for mandatory reporting by user facilities are eventually eliminated with the effective implementation of the MedSun program. Reporting by user facilities of events possibly related to devices should continue to include deaths, serious injuries, and device malfunctions.

In addition, as suggested earlier in this chapter, FDA should continue its efforts to educate providers about HIPAA and the legality and value of providing information to support postmarket surveillance. Such information includes not only adverse event reports but also data for required postmarket studies as discussed in Chapter 6.

The legislation creating pilot MedSun program provided that mandatory reporting requirements for user facilities should end when the program is fully implemented. Before that happens, the evaluation of the program should consider MedSun’s performance both as an active surveillance system (e.g., responding to FDA inquiries, conducting special studies) and as a spontaneous reporting system for detecting serious unexpected device events. Given that many manufacturer investigations and reports of adverse events start with reports from user facilities, one question is whether it is prudent to eliminate mandatory reporting for these facilities, even if the limitations of such reporting are recognized and facilities are not sanctioned for failure to report. It would be unfortunate if user facilities felt even less responsibility to report serious events and deaths in the future.

The careful evaluation of the pilot MedSun program will be critical. Although a formal evaluation is premature given that the pilot program is not fully implemented, FDA should be putting in place the data collection resources it will need for the evaluation. The evaluation should include an assessment of the extent to which reporting by non-MedSun facilities generates signals of significant device problems that are not reported by MedSun



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