Several factors may contribute to the growth in volume of adverse event reports. These include greater outreach by FDA emphasizing reporting requirements, along with greater manufacturer sensitivity to reporting requirements following notable recalls. Some of this growth may also be due to growth in the number of medical devices in use.
Bolstering the data that FDA currently collects with a few key additional pieces could greatly increase its utility and provide a fuller view of medical device quality. Gathering additional risk data from companies will likely paint a clearer picture of the associated level of risks for devices.