meningitis in children in 2002 indicated that complications of particular concern to children can arise and that trends can go undetected for years.91 It also appears that complications unique to children can arise after highly variable periods of time following surgical implantation, thus necessitating follow-up for indefinite periods of time. For example, the current database on pediatric cochlear implant users is not sufficiently robust to enable a formal determination of meningitis risk going forward as new implant types are introduced. These observations emphasize the need for mandatory reporting requirements and better quality reporting to facilitate the early detection of health-related complications in cochlear implant users.
Manufacturer-based reports on cochlear implant complications are often supplied in direct correspondences and in newsletters to clinicians. However, such reports are often provided in the context of marketing device durability, suggesting that some datasets may go unreported in manufacturer communications. In addition to reports, independently-tracked data are needed to provide a more useful profile. The above summary of pediatric cochlear implant complications from the peer-reviewed literature represents the best efforts of clinicians to gather information about complications from case series, and manufacturer and FDA datasets.
The cornerstone for FDA’s postmarket surveillance of medical devices is the information provided by both voluntary and mandatory device-related adverse event reports to the Agency. (For additional description, see Chapters 3 and 4 of the Institute of Medicine report in which this appendix appears.151) Voluntary reporting to FDA began in 1973, and the current MedWatch Program, created in 1993, provides a mechanism for consumers and health care professionals to voluntarily report problems with medical devices by phone, mail, or online completion of an adverse event form. More recently, FDA has developed partnerships with major health care organizations in the United States to promote reporting adverse events through this program, particularly those of a serious nature.
In 1984 FDA implemented the MDR (Medical Device Reporting) regulation, which requires manufacturers and importers to report all device-related deaths, serious injuries, and malfunctions to the Agency. Additionally, under the Safe Medical Devices Act of 1990 and other subsequent legislation, user facilities (e.g., hospitals, nursing homes) are also now required to report: (1) device-related deaths to both FDA and the manufacturer, (2) device-related serious injuries to the manufacturer (or to the FDA if the manufacturer is unknown), and (3) an annual summary report of deaths and serious injuries to FDA. Although legal enforcement of these mandatory reporting requirements is possible and FDA does inspect manufacturer facilities for compliance with adverse event record keeping and reporting, FDA has relied on the goodwill and cooperation of manufacturers and user facilities to ensure compliance with the regulation and charac-