U.S. Plans to Track Medical Device Safety
The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. The proposal comes five years after Congress first mandated the codes.
While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices.
The FDA said under the rule, device makers like Boston Scientific Corp and Medtronic Inc would put the special code on most of their products, starting with the riskiest, like implants or pacemakers. Over-the-counter or low-risk devices, like bed pans, would not need the code.
The FDA would then put the codes, known as unique device identifiers (UDI), in a public database online. Doctors and regulators could detect safety problems more quickly and inform patients about flaws or dangers. Companies and hospitals could pull faulty devices from the market faster and more cheaply by knowing which products are affected.
Unique codes would also prevent counterfeit or stolen devices from entering the supply chain, the FDA said.
Jeffrey Shuren, head of the FDA’s devices center, said the administration’s current monitoring system relies heavily on ad hoc reporting from doctors or companies. But it is often unclear exactly which devices have an issue and whether the problem just affects one batch or an entire model, he said.
“We’ve never been able to make that link between the device, and the patients’ or practitioners’ experience with that device until we have the UDI,” he told reporters on a call.
“The UDI is really the lynchpin for modern post-market surveillance for medical devices.”
The code will be printed on device labels and packaging and also go directly onto implanted devices.
People have 120 days to comment on the proposed rule. The FDA will consider the comments before it makes the rule final, which must happen within six months after the comment period.
AdvaMed, the medical device industry group, said it is reviewing the rule and plans to submit comments.
“We will be paying particular attention to whether the proposed rule follows a risk-based and least burdensome approach to implementing the UDI system, as we believe such an approach is essential given the huge diversity of medical devices and the cost and complexity of implementation,” said Janet Trunzo, AdvaMed’s vice president for technology and regulatory affairs, in a statement.
The FDA estimates it would cost U.S. companies about $550 million in total to implement the proposal over a ten-year time frame.
Recent problems with medical devices include all-metal hip implants from Johnson & Johnson which failed at a higher-than-expected rate and caused some patients to have joint dislocation or nerve damage.
There have also been problems with vaginal mesh implants from companies including J&J and Boston Scientific, and exposed electrical wires in defibrillators from St. Jude Medical Inc .
Critics said the FDA was slow to implement the changes, since Congress first directed the agency to develop the device codes in 2007.
“The bottom line is that having unique identifiers will save lives and save money for patients and companies,” said Diana Zuckerman, president of the National Research Center for Women and Families, which advocated for Congress to pass the device codes five years ago and first pushed for it in the early 1990s.
“Unfortunately, it will be years before those lives are saved because studies can’t be done until the identifiers are widely used,” she said, which could take three to five years.
The FDA said it took time to figure out the rules because it had to first test the codes in a pilot program, and also agree on standard international codes with regulators abroad, including Canada, the European Union, and Japan.
Shuren said those countries, as well as others such as Brazil, are working on similar systems.
Last month, Congress failed to agree on a similar national “track and trace” plan for medications, after regulators, companies and others could not agree on the details.