STAT+: Federal advisory group rejects proposal to make medical device tracking easier
“It’s a setback in patient safety and surveillance,” one expert said, "and will leave us with an insufficient regulatory system for identifying unsafe devices."
Every medical device has its own unique code, allowing manufacturers to keep track of their products once they enter the market. But while these codes are critical for recalling faulty devices or issuing updates, they rarely make their way into health records.
For years, experts have argued for a simple fix: adding device identifiers to insurance claims forms, which doctors use to request reimbursement for medical services. That, they say, would make it easier to reach patients at risk of flawed devices, and allow long-term study of device efficacy, safety, and cost.
But the idea is being held up by the slow-moving process of updating Medicare claims forms. It suffered another setback on Wednesday when the National Committee on Vital and Health Statistics, a group that advises the federal health department, voted not to recommend a slew of updates to claims forms — including the device identifier addition.
“It’s a setback in patient safety and surveillance,” said Sanket Dhruva, a cardiologist at the University of California, San Francisco, and device safety expert. “It will leave us with an insufficient regulatory system for identifying unsafe devices and performing comparative evaluations.”
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