The ongoing roll out of unique device identifiers (UDIs) promises several expected benefits derived from medical devices possessing UDI codes. The Food and Drug Administration (FDA) recently published Medical Device Safety Action Plan that describes one such benefit. The plan predicts that UDIs will provide “a mechanism to reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the device’s characteristics, which also prevents confusion between similar devices that can lead to device misuse.”
However, I can’t quite picture a scenario where this occurs. Would a healthcare professional hold a device in their hand but not know what it is? Is the device not otherwise labeled, and they don’t have the packaging? In that case, how did the device get in their hand? Now that it’s there, they are apparently expected to read the UDI and type it—possibly up to 22 characters—into the GUDID database. Or, maybe they have the capability to scan it in.
If we accept the starting premise of possessing a device but not knowing what it is, what important information do we expect they will receive now that they’ve accomplished the task of entering in the UDI? The answer to this question is limited by the content design of the UDI database and how many of the data fields are actually filled in. To examine the value of the UDI’s information, I experimented with a particular cardiac ablation catheter.
To my surprise, many of the already limited data fields were empty. One of the items in the “device identifier” block is “device description.” But a common entry there is “no description.” Under “device characteristics,” there is the question “what MRI safety information does the labeling contain?” The answer may often be “labeling does not contain MRI safety Information.” Another data category is the “FDA premarket submission number (PMA).” The most common answer? “Premarket submission number not available/not released,” with the additional information that the device is not exempt from premarket submission. It is not clear why the PMA number (in the case of a Class III device) would not be available since it can be found in the FDA PMA database.
I found several other examples where information was missing. Sterilization includes the data block “sterilization method,” where the entry may say “no sterilization method found.” The “storage and handling” block may also say “no storage/handling found.” Now consider “clinically relevant size.” It may say, “no device sizes,” but does that mean there is only one size, or that the information is just missing? Having not learned very much about the device, one might seek solace in the data block “customer contact.” Alas, the entry says, “no customer contact currently defined.”
Well, you might say that at least I found the name of the manufacturer and could now go to the company’s website for further information. In my admittedly random sample of a single device, I did just that. I entered the product name in the website search box and got no hits. I then tried the model number—again, no hits. However, it turned out that this wasn’t a fair test because I then discovered that the same result occurs no matter what you type into the search box!
Being curious about this, I emailed the manufacturer at the provided customer service address. I received an autoreply that that address I used was meant for capital equipment-related orders. A telephone number was provided, however. So, if we return to the initial scenario of a healthcare professional who possessing a device and its UDI but doesn’t know what the device is, they would be able to make a phone call.
It is perhaps not unusual for programs such as UDI to be accompanied by hype about how wonderful it will be. However, this is not that same thing as it actually being wonderful.
William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.