Patient safety advocates are urging federal officials to issue an overdue final rule on unique device identification. In the absence of a rule, "patients are being harmed," says one.
It's been six years since Congress ordered the U.S. Food and Drug Administration to require simple unique markings like bar codes to track potentially harmful medical devices, like pacemakers, artificial hips or heart valves. And it's been more than a year since the FDA proposed one.
But there's still no final rule, though the congressionally mandated deadline passed on June 19. And there's no good reason for the delay, insist several large organizations that often disagree on healthcare policy.
The long-anticipated regulation has apparently hit a snag in the Office of Management and Budget, prompting industry leaders and consumers to wonder if the industry has been successful in delaying or weakening the effort. Contacted for comment, an OMB spokeswoman said the agency's policy is "not to comment on rules under review."
"Unfortunately, however, the UDI (unique device identification) rule has encountered delays at every step of the process," says a July 3 letter from 18 consumer groups, including Breast Cancer Action, Public Citizen, and Consumer's Union, to Sylvia Mathews Burwell, OMB director.
"We are anxious to see the UDI system up and running, and contributing to patient safety efforts as soon as possible," says another letter signed by 21 healthcare organizations, including two large healthcare group purchasing organizations, Premier Inc. and VHA Inc., as well as the Federation of American Hospitals and the Association of American Medical Colleges.
"We think medical devices should have these codes," Michael Carome, MD, director of Public Citizen Health Research Group says in a phone interview. "They should be device- and unit-specific, so in the post-marketing period, one can adequately enhance the tracking of these devices, so if there's a need for recall, that can be communicated to the doctors, with timely reporting of adverse events."
In the absence of this rule, he adds, "patients are being harmed."
"I believe the industry has expressed concerns about the burdens of the rule, and how they need time to implement systems in their various procedures for making devices—whether the unique identifier is going to appear directly on the device, which for many deices, particularly those implanted will be a requirement, or on the packaging or both," Carome says.
"It's like the agency got significant pushback and concern from the industry about the burdens of doing this… there may be concerns about overregulating."
Blair Childs, a vice president at Premier, which drafted the healthcare industry's letter, says that currently, "it's like a monopoly. There's only one entity that has all the information, and that's the manufacturer."
When there's a recall of a medical device, like a defibrillator or a pacemaker, it's nearly impossible to identify which patients received it, Childs says.
"If you ever talk to people in hospitals when there's a recall, no one wants to be anywhere in sight, because it's one of the more cumbersome processes that goes on in a hospital. Who knows how many are in that lot of affected products?"
Gregory Daniels, Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform at the Brookings Institute, says that a UDI rule is "critical for assuring device safety and effectiveness." The idea is that it would work in a way similar to the National Drug Code for pharmaceutical compounds.
"On the manufacturer side there are concerns," Daniels says. "For example, are they going to be required to make sure the devices are labeled appropriately? The other stakeholders in the healthcare system, one of their big concerns is making sure the UDI is developed and documented in a way that other stakeholders can efficiently use the information.
But such a tracking system isn't that complicated, and would in essence do for life-sustaining and potentially dangerous medical devices what has already been implemented for dog food and peanut butter, a simple bar code-like marker that's linked "to a central database so that the product can be easily identified," wrote Premier's Mike Alkire, Premier's COO, in an article in Infection Control Today.
"Today, in the event that a safety problem becomes clear, a non-existent tracking system means that recalls are usually ineffective," Alkire wrote. "Recall notices go out to hospital sand healthcare facilities, but finding all the affected devices is next to impossible. Hospital materials managers have to comb through shelves of products to find a defective device. This takes tons of time, and is a manual, mistake-laden process."
Alkire added: "In fact, of the 700 device recalls initiated a year, the Government Accountability Office estimates that half the time (53%) companies are unable to remove all the faulty devices from the market, largely because there is no uniform way to track medical devices electronically in the supply chain."
Hospitals and other healthcare organizations also want the tracking system to better control inventory.
One study from Arizona State University's Carey School of Business "estimates that the increased efficiency and accuracy of a UDI system will save manufacturers, distributors, and healthcare providers $16 billion annually," says the letter from 18 consumer groups.
The consumer groups insist that when the rule is published, it specify that unique identification must be on the devices themselves, not just on the package the device came in, which the industry might prefer because it might be less expensive.
But, the consumer groups wrote, "medical devices are often separated from their packaging before they are used by patients, and the packaging is often discarded…A UDI is essentially useless if it is only on packaging that has been lost or discarded…[and] would undermine the effectiveness of the entire UDI system."
A representative from the Medical Device Manufacturing Association could not be reached for comment.