Expert Recall

By Brett Berty

Nearly three years ago Congress proposed a simple numbering system as a mechanism to track medical devices – everything from syringes to heart valves to MRI machines – as they traveled through the supply chain. Now, many in the industry and the FDA are still wondering how this is going work and what it is going to mean.

The promise of unique device identification (UDI) is its ability to help protect consumer safety by allowing quick removal of the affected devices from the market in the event of a recall or field corrective action, particularly when these devices are implants. That promise is only recognized if the tracking information from the UDI labels are effectively captured along each step of the supply chain, from manufacturer to distributor to purchasing organization to hospitals to their individual departments, and captured in a way that allows immediate retrieval of the data.

Clearly, this was the vision of Congress when it mandated the use of this technology through the FDA Amendment Act of 2007. However, there was no identified timeline for completion and the consensus of industry experts is that we are still a couple of years away from full implementation.

Jay Crowley, Senior Advisor for Patient Safety with the Center for Devices and Radiological Health in the FDA, addressed an audience on October 21st in Orlando about the FDA’s role and the likely timelines for bringing the mandate by Congress to reality. He spoke about using existing technologies like bar coding or radio frequency identification tags to bring this promise to market, not only in the U.S. but also globally through the Global Harmonization Task Force.

Crowley also spoke about some unintended but inevitable consequences of the tracking technology, like comparative effectiveness of one device over another. When you can track large numbers of devices and follow the patient/product lifecycle it will enable analysis and ultimately comparisons between one implantable device to another. This could have serious market ramifications to the manufacturers. And it’s this issue that has the industry moving cautiously to implement UDI.

Depending upon the technology used, RFID for instance, patient privacy could become a very real issue as well. A hallway mounted scanner designed to pick up signals from supply stock as it moves throughout the hospital would also be able to pick up the signal from an implanted pacemaker.

Who sees the data? How is it gathered? How is it stored? How is it shared? These are the bigger and often unspoken issues surrounding implementation. It will be interesting to see how this balance between protecting patient safety and protecting proprietary commercial data plays out. Where it stands today is as an elusive promise for tomorrow.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.