On July 3, 2012, the US Food and Drug Administration (FDA) released the long-awaited proposal regarding the implementation of a unique device identification system for medical devices. The proposal stipulates that most medical devices will require a unique device identifier (UDI) that will include a device identifier a unique code specific to a particular device model and a production identifier, which will contain production-related information such as a device's expiry date (if applicable) or a batch number.

Physicians and hospital groups are understandably excited about this development for a number of reasons. As described in the FDA's press release, UDIs can provide many benefits to improve the quality of health care. Most notably, having UDIs on medical devices can improve the accuracy in reporting and tracking adverse effects, which can improve postmarket surveillance patient outcomes from a medical device can be monitored or used for postapproval studies, helping to fulfill the general consensus that regulatory bodies need to do more in terms of postmarket surveillance to improve patient safety. To put it simply, UDIs might help more quickly identify if a device is safe or not.

UDIs will also make it easier for the FDA, manufacturers, health care providers, and patients to track product recalls. UDIs can also help reduce medical errors because it will be easier for physicians and other health care providers to identify a medical device and its approved indications. Another advantage is that UDIs can allow medical devices to be tracked through the supply chain, helping to prevent and detect counterfeits. Health care facilities can also better track their inventory of medical devices to avoid shortages or overstocking devices, which may have to be thrown out if they have expiry dates. In fact, the UDI system is expected to reduce medical supply chain costs by $16 billion.

It is worth noting, however, that the full benefits of UDIs may only be realized if accompanied with the widespread and effective use of electronic medical record (EMR) systems it would be pretty hard to track a patient's progress if information is stored in a paper-based chart or in a manner that cannot be easily shared within or across facilities. Although EMR systems are being adopted quickly across the US, the path to their widespread use has been a bit bumpy, as we've discussed before.

In any event, there's still a lot of time before the benefits of UDIs can be realized the system would be phased in over seven years. As expected, patient safety advocates think that UDIs should be put in place long before then. But hey, these things never happen fast, and the proposal definitely represents a step in the right direction.

Pivoting a product launch during the pandemic

View Now