William Hyman: UDI Database Offers Roller Coaster Experience with Device Descriptions

A beta version of the government’s unique device identifier (UDI) database, called AccessGUDID, is available online. After some initial poking around, I have a few observations.

A basic search function allows you to search by device identifier, company name, or device brand name, among other options. Using keywords (which might be covered under “name”) brings up categories of devices including whatever keyword you used. Among those I tried was “pumps,” which gave me up a number of subgroups to choose from, including both generic names and specific devices. I chose “centrifugal circulatory assist pump, electric,” which provided listings from three manufacturers, although one had two versions of itself. The first company had two brand names listed with a total of four entries for the pumps themselves and one “tray” product. The second company had two listings for the one brand name, while the third had five listings under one brand name and a separate listing for another.

One of the fields in the database is “device description,” which offered highly variable content. One company had a cryptic description along the lines of “pump,” followed by model name and what may be some keywords or model designations. The second company had “no description” in the description field which seems curious. The third company also had “no description” in its entries. Is device description an optional field? This description discrepancy occurs elsewhere. For example, looking under “ventilator, high frequency,” I found one company with the minimalist description of “(brand name) high frequency ventilator model xxx.” Another company offered similar information.

It took some searching to find a device with an actual description. For example, one manufacturer of apheresis filters had the following: “The … plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting.” Another description under this device name offered: “The … is a disposable, extracorporeal circuit for use with the … system having selected ‘TPE’ therapy. The … set is indicated for use only with the … control unit, after having selected TPE therapy (therapeutic plasma exchange). The … set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.” A third company had “… precipitate filter (US).” This category included a tubing set with a 200-word description from another manufacturer.

Other fields that often provided no information were “sterilization method” and “storage and handling.”

AccessGUDID is still a toddler and perhaps detail in the information provided can be expected and/or may be demanded as the database matures. In the meantime, the information provided in “device description” ranges from none to minimal to a detailed paragraph. One wonders if anyone is monitoring what is getting posted. If the description is supposed to be informative, including to the public, then a lack of any description clearly doesn’t cut it—nor in most cases do a few words that repeat the device type and model number. On the other hand, multiple sentences reflect an effort by the manufacturer to actually describe the device in a way that informs the reader. Perhaps this will become the norm as expectations and enforcement gear up, unless those already doing it discover that they needn’t bother.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.

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