Millions of Americans are walking around with artificial joints, pacemakers, stents and other implants. But federal regulators know more about where a pallet of dog food went than a batch of hip replacements.
Unlike prescription drugs or, for that matter, food at the grocery store, medical devices have no uniform labeling system – like a bar code – that would allow a central, computerized database to keep track of them.
The result is that when a device is found to have problems, tracking down which hospitals have them, for instance, and in which patients they were implanted, can be extremely slow, labor-intensive and incomplete.
And problems occur. The Food and Drug Administration recalled more than 40 devices last year, including implantable defibrillator leads with the potentially lethal risk of pulling out of a patient’s heart and failing. They were distributed for more than nine years before the flaw was discovered and the recall was issued last November.
A solution approved by Congress nearly five years ago is stuck in the federal regulatory maze for reasons that are unclear.
It’s a pick-your-sad-joke kind of situation.
“We can recall tainted dog food faster than a pacemaker,” said Amanda Forster, a senior communications director at Premier, an alliance of 2,500 hospitals that is advocating for fast implementation of a universal labeling system. “It’s just shocking.”
Congress voted overwhelmingly in 2007 for the FDA to create a uniform device identification system – standardized coding that would make tracking devices relatively simple with the same basic scanning technology used at the checkout counter.
It would bring other efficiencies – like inventory management for hospital systems – to bear as well. And the device industry is likely to benefit despite the significant upfront investment to put the systems in place.
The FDA has been coordinating with device regulators around the world in a push to develop a uniform code that would be a regulatory relief for an increasingly globalized industry.
“A unified system internationally is a big advantage for companies because we wouldn’t have to deal with 200 different sets of rules,” said Jeff Secunda, vice president for technology and regulatory affairs at AdvaMed, the industry’s major trade association.
The catch: After working for four years on the problem, the FDA sent its proposal last July to the Office of Management and Budget for review, and it’s been stuck there ever since. And the OMB has offered no explanation for the delay, to the growing frustration of industry, health care providers and consumer groups, who want to see the system in place soon.
That can’t happen before OMB releases the proposed rule, all of the stakeholders put in their two cents and the regulation becomes final.
In September, the original target date for the review, a group of hospital associations, specialty societies and others wrote a letter to then-OMB Director Jack Lew asking for quick action. They got no response.
Sen. Herb Kohl (D-Wis.) is drafting a letter to press OMB, too.
“[Unique device identifiers] provide an important post-market safety tool that would help track problems and allow recalled devices to be quickly located,” Kohl said in a statement to POLITICO, adding: “For every day that we wait on putting UDIs in place, a significant number of patients are placed at risk.”
OMB declined to comment, but a representative said it’s not uncommon for review periods to be extended for far-reaching regulations.
The delay raises the likelihood that other countries will “get frustrated waiting” and install incompatible systems of their own, AdvaMed’s Secunda said.
“If the FDA were to publish their proposed rule tomorrow, other countries would know what they had to work with,” he said.
For health care providers and the consumer perspective, the frustration is in the continued threat to patients from a piecemeal tracking system.
Although many medical device companies have modernized their labeling to include much of the information the bar code will contain, it’s been done in an ad hoc manner, company by company. In addition, distributors, group purchasing organizations and some hospitals have their own coding systems, which can make the pedigree of a given device very hard to trace. A patient may read of a pacemaker recall, for instance but not know what brand of pacemaker is keeping his heart beating.
While the FDA is proposing to eventually require labeling for medical devices with few exceptions, much of the concern is understandably about devices that are implanted in patients.
By the time that happens, the record of what device is in what person often still exists in a written – or typed – note, said Dennis Byer, senior director of standards at Novation, requiring a manual search of medical records to track a faulty device. Having a bar code “opens up all the possibility of scanning technology,” he said.
That could include an automatic alert of all patients affected by a recall, for instance.
There is also the potential for reducing medical errors upfront, he said, with computer programs that can automatically check a scanned device against a patient’s electronic health record to make sure it hasn’t been recalled and also for potential hazardous interactions.
Also, there’s the standardization of device registries that could enable better reporting of device malfunctions, review of those malfunctions and if warranted, faster and more thorough recalls.
“There is a lot of potential for that data to improve the FDA’s post-market surveillance,” a Senate investigator told POLITICO.
When the FDA does initiate a recall, the manufacturers are responsible for contacting the affected patients. But it’s not easy to get the information.
“Without a standard numbering system, it’s very difficult for providers to find the devices and pull them off the shelves, and it’s very difficult to find them if they’ve been implanted,” said Premier’s Forster. “Right now, [the tracking of devices] is a largely manual process, and manual processes are littered with errors.”
This standardization is already in place for drugs under the National Drug Coding system, which, for instance, assigns a number to every bottle of pills, which identifies the drug, the dosage and even the lot number from the manufacturing facility.
“This would basically bring devices up to par with PhRMA,” Byer said.
With the OMB silent, everyone is guessing at the cause of the delays. Some speculate that the Obama administration may not want to unleash a substantial industry regulation that could become an anti-regulation Republican talking point, however popular the rule seems to be.
“They have announced their concern about red tape and it is an election year,” said Heather Pierce, senior director for science policy and regulatory counsel at the Association of American Medical Colleges.
“Considering the safety components that are on the line here, if this is mired in some sort of a political debate, that would be kind of sad,” Forster said.