EDITORIAL
UDIs: Where’s the Risk?
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FDA wants to keep a better eye on the medical devices you package. The agency shared its plan in November to strengthen postmarket monitoring of medical devices. It includes “pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime.”
The idea of mandatory unique device identification (UDI) hasn’t been widely popular. “AdvaMed is working with FDA to identify a standardized data structure and content for a unique device identifier system,” says AdvaMed president and CEO Stephen J. Ubl. “However, we continue to believe that such a system should be voluntary, except in cases where there is a well-documented patient safety issue that could be best addressed through use of a UDI.”
Basing UDI requirements on risk certainly has its merits. “Differentiating them according international accepted risk classes (Classes I– III) could be a suitable method of resolution,” argues Volker Zeinar of B.Braun. Zeinar shares his perspective in this issue’s roundtable.
Risk concerns Joe Pleasant, chief information officer for Premier Inc. Every month, hospitals served by Premier Inc. get several recalls for medical devices that can only be tracked through manual chart reviews. For “every patient . . . [there] is a period of time that we don’t know that we can track that back,” he explained. Pleasant spoke during FDA’s CDRH public meeting on UDI.
And tracking recalls after procedures isn’t the only challenge. “A significant risk to patient care and safety is the possibility of implanting an outdated device or using an outdated device,” he said.
Differentiation by risk class would keep it simple. The greater the risk a device presents (and, most likely, the more it costs), the stronger the case for justifying the cost of UDI.
But more than class risk may be involved. “One large health system was recently adversely affected by three very public Class I recalls,” Pleasant said. “We have some documentation around what they went through . . . having to spend time trying to track those patients down.”
Perhaps the usual risk presented by a particular device cannot always be directly correlated to the risk of not finding that device in the event of a recall. When I was an editor for PMP News’ sister publication MD&DI in 1994, sponges and other cotton-based devices were found to be contaminated by Pyronema domesticum. Imagine the difficulty of tracking those sorts of low-risk, ubiquitous products whose contamination could have presented more than a low risk. (“Although Pyronema is not recognized as a human pathogen and no infections were reported, this episode raised some serious concerns about current sterilization practices and potentially resistant microorganisms,” wrote Joyce Hansen, Trabue Bryans, and other authors in a September 1997 MD&DI column.) Who’s to say that low-risk Class I devices will remain low-risk devices in the event of a recall?
Pleasant says that UDIs would help. “In terms of adverse-event reporting, accurate and reliable device tracking would enable all of us in the supply chain in healthcare to be able to better track potential device defects and be able to take a look at those adverse effects on our patients,” he argued.
Basing UDI rules on device class risk is a sound approach. But other risks must be still considered. And inaction presents even more risk.
Daphne Allen
Editor
