How is Automatic Identification Technology Being Used With Medical Devices?
One of the key reasons FDA declined to include medical devices in its 2004 rule on bar coding was the diversity of medical devices available on the market, and the potential challenges of implementing a program of automatic identification for medical devices. 4,5 In addition, not all potential uses of automatic identification technology may show the necessary benefit to justify the costs of implementation. 4,5,6 One key question to be answered is “Which medical devices will benefit from automatic identification technology?” The answer may differ depending on the perspective, whether one is looking at the question from the view of improving patient safety or from the view of streamlining supply chain, inventory control, and asset management processes, for example. It is important to note that there are limits to what FDA can implement within the definitions of its statutory authority, because, insofar as medical devices are concerned, its authority is premised on product safety and effe
