device (with problem documentation) to a manufacturer or vendor. It could provide links to reports on safety problems with a device that is the subject of a consumer’s report. The committee recognizes that it is not feasible to provide individualized feedback for each consumer report, but information technologies have the potential to allow more than a computerized thank you or acknowledgment of a report.

Recommendation 4.8: FDA should continue to improve and expand its medical device safety resources for patients and families and its focus on devices used in the home and community by

  • working with patient, family, and consumer organizations, providers, and industry to make it easier for patients or their families to report device problems to manufacturers or FDA and to learn about resources to support the safe use of medical devices;

  • making online reporting and information resources more accessible by using language and directions appropriate for lay users; and

  • enlisting hospitals, home care agencies and vendors, and other professional and provider groups to promote patient and family understanding of how to use devices safely, when and how to seek help, and when and how to report problems.

The recommendations above cover many areas for improvement in the agency’s adverse event reporting program for medical devices. At the same time, Congress and FDA deserve credit for past and continuing efforts to improve the program. These efforts include, for example, creating an online reporting option, developing computerized aids to screen reports and identify problems, creating a more active surveillance initiative in the pilot MedSun program, and using adverse event reports to inform the agency’s human factors research program.

In addition to continuing efforts to improve the existing program and fully implement the MedSun program, FDA is investigating additional forward-looking or prospective strategies based on automated patient information systems that would not only improve the detection and investigation of adverse events but also identify device hazards or hazardous practices before they cause harm to patients. The agency recognizes that this strategy requires improved means of identifying medical devices for purposes of analyzing and responding to adverse event reports. In particular, codes for use in the medical record should allow identification of both the manufacturer and model of a device rather than, as now, a general category of device (e.g., apnea monitor).

The next chapter of this report shifts attention to a different dimension of postmarket surveillance of medical devices. It examines the monitoring by FDA of postmarket studies required by FDA.

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