Postmarketing surveillance is either “passive” or “active.” In a passive system, the regulator must depend on data from manufacturers and healthcare providers. The provision of data can be required by statute or be voluntary, but the role of the regulator is to collect and analyze the data that are provided. In an active system, in contrast, the regulator seeks information on adverse events, device malfunctions, and product effectiveness and takes advantage of opportunities to enhance data collection.

It is important to note that for most of the programs discussed below there is no reliable information about the number of devices (referred to as the denominator) on the market in clinical use. The lack of denominator information limits the ability to analyze potential safety concerns.


Mandatory and Voluntary Adverse-Event Reporting

Reporting requirements for the FDA are summarized in a 2009 Department of Health and Human Services (HHS) Office of the Inspector General (OIG) report (OIG, 2009), which states that

regulations require device manufacturers to report to the FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue. Regulations also require user facilities, such as hospitals and nursing homes, to report deaths to both the manufacturer, if known, and the FDA within 10 working days. User facilities must report serious injuries to the manufacturers (or the FDA if the manufacturer is unknown) within 10 working days. User facilities must also submit annual reports to the FDA of all adverse event reports sent to manufacturers or FDA in the past year.

The vast majority of MDRs are reported by manufacturers; user facilities and others provide a small proportion of the reports received by the FDA (see Table 5-1). As a general matter, patients, caregivers, and healthcare professionals are not legally obliged to report adverse medical events. Consumers, such as healthcare providers and patients, can provide voluntary adverse-event reports to the FDA through its MedWatch program (FDA, 2009b).

TABLE 5-1 Medical-Device Adverse-Event Reports, 2003–2007

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