In 2007, the FDA was tasked with developing a system for identifying and analyzing the risks associated with medical devices after they entered the market. The Sentinel Initiative was launched in 2008 in an effort to track the necessary information in a federal database. In February, the most advanced form of the Sentinel Initiative became fully operational, yet there are some concerns that the tracking and monitoring capabilities of the current system do not go far enough.
Unique Device Identifiers
The FDA Commissioner has called for the incorporation of UDIs (unique device identifiers) as part of a more robust monitoring system. Eventually each medical device will include a UDI that can be read by machines and humans. This is to ensure those using the device are able to easily identify the pertinent device information and to allow that information to be directly scanned and uploaded with minimal effort into the UDI database. The UDI system began to be phased in in 2014. The final implementation is scheduled for 2020.
Once fully operational, the benefits of the system are expected to be substantial. It will allow the FDA to more accurately report, review, and analyze adverse effects of devices or device malfunction. It is anticipated that a reduction in medical errors will occur by facilitating the use of the proper equipment more quickly and allow those devices that have been recalled to more quickly be identified.
National Evaluation System for Health Technology
NEST, the National Evaluation System for Health Technology, is an effort by the FDA to take the voluntary reporting of the Sentinel Initiative to a higher level. It was first discussed in 2012 to rapidly identify defective devices. NEST would offer a more comprehensive view of the medical device ecosystem by pooling data from more sources. The information from the Sentinel Initiative, electronic health records, device registries, and UDI data would be easily accessible to healthcare systems, healthcare providers, and patients.
In part, the renewed interest in a NEST system is due to the issues patients have experienced as a result of this type of data not being readily available to them or their healthcare providers. The slow reporting system currently in place allows more patients to use products which have demonstrated safety issues.
Unfortunately, while the need for a more advanced system has been clearly demonstrated by government officials and healthcare experts, the ability of the government to implement such a system could take years. Approval for the change, changes to healthcare documentation and procedures, and the full incorporation of new technology to accommodate the tracking and reporting must all be resolved.