In a move to improve its oversight of medical devices once they reach the marketplace, the Food and Drug Administration announced plans last fall to pursue the creation of a unique identifier system that will allow devices to be tracked throughout their lifespan-a development that supporters say will ultimately improve patient safety.
David McCombsVice presidentERP-Supply Chain Operations, Bon Secours Health SystemMarriottsville, Md.For medical devices that are being implanted in patients or those that are part of a very invasive process, the bottom line is that today there is no uniform identification process from the manufacturer all the way down to the individual patient. If there's any subsequent problem with that device, there is no practical or accurate way to identify that device specifically for the patient who is affected. We owe it to patients and the clinicians who care for them to incorporate a uniform identifier with clear repositories for this data to track, monitor and, if necessary, trace devices back to a patient. How the UDI is applied, however, should be differentiated by the risk posed by the device. For some devices it might be satisfactory to have just a uniform manufacturing number, but where that line is drawn needs further study.
Dan VukelichExecutive directorAssociation of Medical Device ReprocessorsWashington, D.C.Clearly there may need to be exemptions for devices whose size may make this impractical, but if we could implement some sort of tracing system for the majority of devices, then I think that would be a step forward. There might be something here that reprocessors can offer the FDA. We've had unique proprietary device tracing mechanisms all along because we've always had to know which hospital a device came from and how many times it has been reprocessed. I would like to think that whatever technology we've developed may ultimately be similar to what is put into place by the FDA. Our companies are smaller than the major manufacturers, but we've already invested the money in technology to trace our devices, and we'll do it again when the FDA settles on a system. I would hate to think that a major leap in not only tracking but also patient safety would be held up because of cost.
-Brad Cain
Magazine
