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Adverse Event Reporting Delays: Another Issue with Data

Medical device manufacturers learn about potential defects from a variety of sources, including healthcare professionals and patients themselves. But despite mandatory reporting requirements, a dozen hospitals were recently cited by the Food and Drug Administration (FDA) for not reporting information of a potential problem with a device in a timely manner.

Although the citations were limited, the FDA said it believes the findings were symptomatic of a larger problem at hospitals nationwide. The agency stated it intends to work more closely with these facilities to improve data collection. On December 5, the agency will hold a public workshop “to solicit input and advice on improving hospital-based surveillance systems and the broader role of using hospitals to evaluate how well devices work in the clinical setting.” They are also looking into whether unique device identifiers (UDIs) can be incorporated into electronic health records for more efficient tracking and reporting.

Medical device manufacturers are familiar with data challenges, but they often encounter them once a recall is initiated. If a patient or healthcare provider moves across the country, billing systems may be updated, but others may not. Since these systems often don’t talk to each other, it can make effective recall notification difficult.

Stakeholders will have to continue working through all the various communication roadblocks moving forward. In the meantime, manufacturers should keep up with any changes that could stem from the collaboration between the FDA and hospitals. Any increase in adverse event reporting could of course lead to more recalls, so it is crucial to be aware of the potential implications – and prepare accordingly.

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