The Advancing Patient Safety Coalition (APSC) is pushing the Food and Drug Administration (FDA) to require health care device manufacturers to assign standard unique device identifiers (UDI) in the name of enhancing medical device safety.
The broad-based coalition -- including such consumer groups as the AARP, hospital and physician associations, vendors and The Joint Commission -- wants manufacturers to register each device in a central database, as food producers and drug makers do already.
Currently, manufacturers take individual responsibility for numbering and tracking health care devices from pacemakers to blood-pressure meters to ear swabs, each in its own proprietary way. On top of that, many distributors and hospitals track them separately with their own bar codes or radio frequency identification (RFID) tags.
The FDA Amendment Act of 2007 gave the agency a mandate to create UDI rules for health care devices but did not set a deadline. The health care reform bill that passed the House last year gave the FDA six months to enact such rules. Another version of the bill is working its way through the Senate. The APSC wrote to Speaker of the House Nancy Pelosi on Jan. 14, urging her to keep UDI mandates in the final health care reform bill.
A central UDI database would enable quicker recalls when products are contaminated or defective, and eliminate the need for separate tracking by distributors and hospitals, the APSC said. One industry group, in fact, is already voluntarily adopting a standard from the nonprofit GS1 US group for medical device tracking.
The big advantage of standardized device-numbering is enhanced patient safety; safety bulletins and recall notices can get into the hands of all patients and hospitals that purchased devices, instead of just whatever subset of purchasers that filters down through the various proprietary numbering systems in place today, said Blair Childs, senior vice president of public affairs at coalition member Premier Inc. in Charlotte, N.C.
A significant secondary benefit is painting for regulators a full picture of the issues arising from defective products -- or those with design flaws, Childs said. The FDA’s current system of adverse-event reporting gives only a partial picture because not every potential patient and health care provider knows they have a problem device, he said.
“You can trace E. coli-contaminated spinach right back to the field it was grown in,” said Childs, whose company represents 2,300 nonprofit hospitals for group purchasing and quality improvement initiatives. “You can’t do that with a medical device, because there is no uniform numbering system.”
The IT ramifications for hospitals would add up to, at most, a few more data points to track -- where devices go once they are put into service, for example, and which devices sit unused in inventory. Most hospitals already track such information on paper or electronically both for inventory purposes and to comply with FDA’s adverse-event reporting system.
UDIs would likely reduce tracking for hospitals maintaining their own systems of bar codes and RFIDs for supply chain management, or at least make the process more automated, Childs said.
Making EHR more relevant
Government-mandated standard identifiers could reduce tracking logistics and make it more likely that a single defective device won’t fall through the cracks because someone scanned the wrong bar code at some point between manufacturer and patient, or because a data-entry error made the device invisible to database searches once it was used.
You can trace
contaminated spinach right back to the field it was grown in. You can’t do that with a medical device, because there is no uniform numbering system.
Blair Childs, senior vice president of public affairs, Premier Inc.
A related benefit of UDIs for health care practitioners, Childs pointed out, is reduced exposure to lawsuits, because defective devices could be pulled out of inventory more quickly than they are today. He said UDIs will make it more likely that all defective devices will get pulled out of service during recalls, not just the ones that can be tracked with current proprietary systems.
Moreover, the UDI system would enhance federally mandated electronic health record systems, Childs said, by making them more relevant. UDIs eventually would ensure that manufacturer recall data is pushed all the way down to patients, as the health care system builds out an EHR infrastructure and gives individuals access to their own medical data -- a feature that’s key to reaching patients who have moved or changed providers.
UDIs also will make physicians and hospitals more proactive about potential problems with patients who received defective or recalled devices as they are given more detailed, accurate data about the devices they use.
Let us know what you think about the story; email Don Fluckinger, Features Writer.