FDA: Medical Device Registration a Daunting Task

Given all the issues confronting an overworked and underfunded federal agency such as the FDA, the mammoth project of registering medical devices is at best a daunting task. So says Jay Crowley CDRH senior advisor for patient safety and head of FDA’s unique device identification (UDI) initiatives. Crowley is quoted in the Gray Sheet, “At 50,000 feet, unique device identification is very simple. We could get it done tomorrow, we could get it out there, we could get UDI on medical devices,” says Jay Crowley, CDRH senior advisor for patient safety and head of FDA’s unique device identification (UDI) initiatives.
“But if it’s not implemented, if it doesn’t work its way through the supply chain, through distributors, into hospitals, to that point of patient encounter – we haven’t done anything.”
However, other countries have devised and implemented such a system. That’s not to say it would be easy but in terms of patient safety and medical device information and effectiveness, it’s well worth the effort.
Such obstacles were the subject of the Global GS1 Healthcare Conference held in Washington, DC on June 16. Crowley and other industry experts note that a barcode system would be necessary in order to track devices from the point of manufacture to delivery to the client. The myriad medical devices from artificial hips, knees, and cardiac defibrillators would have to be tracked from the time of creation to their eventual implantation in a human patient. The tracking would continue as long as the patient used the medical device.
Even for layperson, this is indeed a daunting task. Yet, it’s crucially important in order to ensure the safety of the consumer. Let’s hope the FDA perseveres in this task.