It may not seem like the most exciting news this holiday season but the FDA has made markedly new functions to its searchable recall database for medical devices. Consumers Union has been working on a campaign to warranty hip and knee devices and these new functions will give us and many consumers access to more complete information from one database.
Improvements include a link to the medical device’s original approval form and that form will include the link to the recall. Linking these two databases saves time and helps the average consumer understand the approval and recall process.
Additionally, the status of the recall will be included. The status lets you know if the all devices in the recall have been removed from the market (FDA status “terminated”) or if the process is still “open.” The records will also include the FDA’s determination of the root cause of the recall which appears to be a general classification such as device design.
The FDA has added a link to the “Total Product Lifecycle.” This takes you to a page that includes all approved devices that are substantially equivalent to the recalled device, problems recorded about the devices and if any of these products have been recalled. In 2012 Consumers Union and other advocacy groups sought to eliminate the ability of a company to gain approval for a new product based on its similarity to a recalled device. Unbelievably, congress refused to include this provision in the 2012 medical device law. But at least these new links help determine which implants were approved based on their similarity to a recalled device and the kinds of problems reported to FDA’s adverse events database by patients and doctors.
And a final link will search for other premarket submissions from the recalling company so you can see if additional similar products have been approved after the recall.
Consumers, journalists and researchers will find this additional information very useful. It improves the understanding for the reasons and status of recalls. For instance, if one is to fully understand a recall of a hip implant, it is important to see the record of the device’s approval which includes similar or equivalent devices on the market. Also, giving the status of the recall lets you know if all units of the recalled device, associated components or tools have been removed from the market or the problems associated with the recall have been addressed. The number of units to be recalled is included on the form.
These new additions facilitate easier access to all information about a device. Previous to this update, every time we have tried to research the issues surrounding a device recall required us to search multiple databases and make calls to find out the status of the recall.