The MAUDE database consists of reports of device-related deaths, serious injuries and device malfunctions - the three major types of adverse medical events reported to the FDA. The database includes both voluntary and mandatory reports. The section on 'Postmarket Surveillance' of Chapter 2 in this book gives a brief historical perspective on voluntary and mandatory medical device reporting, describes the reporting requirements for manufacturers, user facilities and importers, and defines reportable events. Injuries or illness are defined as serious injuries or illnesses that are life-threatening, result in permanent impairment of a body function or permanent damage to a body structure, or necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure . Malfunctions are defined as a failure of a medical device to meet its performance specifications or otherwise perform as intended. The sources of AMDE reports are mandatory reports from device manufacturers, user facilities, and importers, and voluntary reports from healthcare professionals, device users, and others. User facilities include, among others, hospitals, nursing homes, ambulatory surgical facilities, and diagnostic and treatment facilities. As noted in Chapter 4, the FDA Modernization Act of 1997 repealed mandatory reporting by device distributors and suggested that FDA develop a network from a '... subset of user facilities that constitutes a representative profile of user reports ...'. In response, the Medical Product Surveillance Network (MedSun; see Chapter 5) was established in 2002 to obtain a subset of user facilities, which join the network voluntarily. The reports submitted through MedSun are included in MAUDE.
Most of the AMDE reports FDA receives are sent by medical device manufacturers, based on reports they receive from customers, which may include healthcare providers, patients and others. Manufacturers are required to report deaths, serious injuries and malfunctions to FDA. User facilities are required to report deaths and serious injuries to the manufacturer and deaths to FDA. If the manufacturer is not known, the user facility must send the report to FDA . Relatively few AMDEs are reported directly to FDA by healthcare providers or patients. The MAUDE database includes information about the patient, the event or problem, the device and the outcome of the event, the reporter, and the user facility where the event occurred (see Table 20.1). For additional details regarding the data collection form, the review of reports and actions taken by FDA, and the limitations of the FDA MDR system, please see Chapter 2. Modified versions of the MAUDE database, MDR database [formerly called the Device Experience Network (DEN) database], and MedWatch database are available to the public [8,9].
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