facilities (because they did not experience them or because they either did not detect them or did not report them). It is important for FDA to audit participant performance, including the periods when initial participants rotate out of the program and new facilities replace them.

Recommendation 4.3: FDA’s plan for evaluating MedSun’s performance as a replacement for and improvement on mandatory user facility reporting should include, among other elements:

  • assessment of ongoing program and participant facility success in educating facility personnel about identifying, evaluating, and reporting adverse device events and improving the quality, timeliness, and usefulness of event reports;

  • determination of the extent to which the sample of MedSun participating hospitals—including children’s hospitals—represents the relevant range of facility characteristics and experiences, including representation of both academic medical centers and community hospitals and sufficient representation of facilities with device-oriented specialties and procedures;

  • comparison with the mandatory user facility reporting system, including the extent to which either program produced reports for FDA or manufacturers of emerging hazards, important close calls, or other significant events (including those involving children) that were missed or delayed by the other; and

  • evaluation of the active surveillance components of the program in reducing harm to patients, promoting constructive communication between facilities and FDA, and improving timely knowledge of the nature and extent of selected device problems, including errors in the use and design of devices.

Prior to formal evaluation of MedSun, the committee encourages FDA efforts to extend to other institutions the lessons the agency and participants learn as they implement the program. For example, after their value has been assessed and revisions considered, the training materials developed for MedSun participants could be made more widely available. It is reasonable to provide MedSun participants with incentives to participate, but the written materials used in the program are only a small part of these incentives. Likewise, FDA should consider whether the information in the newsletter provided for MedSun participants could be used, at least in part, as a communication tool to inform interested parties in other facilities and encourage timely, complete, and appropriate reporting of adverse device events and other device problems to manufacturers and FDA. Despite the agency’s claim

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