The Consumers Union, the policy and advocacy division of Consumer Reports, has put out a statement applauding the federal Food and Drug Administration’s proposed regulation to establish a “unique identification system” for medical devices marketed in the U.S.
The proposal calls for high-risk devices to carry identification numbers. For most medical devices, the UDI will include a device identifier, which is a unique code tied to a specific device model, and a production identifier, which includes production information for the device.
The release quotes Lisa Swirsky, senior policy analyst for Consumers Union, as saying: “These regulations are long overdue and are critical for protecting patients from faulty and dangerous medical devices. Effective post-market surveillance of medical devices depends on having UDI in place. Once it is fully implemented, this system will enhance the FDA’s ability to identify problem medical devices more quickly and inform patients when their safety is at risk.”
The Consumers Union has long advocated for the policy, pointing out that similar systems in Australia, England and Wales allowed regulators in those countries to identify serious problems with metal-on-metal hip implants years before their counterparts in the U.S.
Metal-on-metal hip implants – consisting of both a ball and socket coated in cobalt and chromium – have generated thousands of lawsuits over their high early failure rate and tendency to leave toxic metal debris in patients’ bodies.
The FDA has proposed phasing in the implementation of the UDI system beginning with the highest risk medical devices first. Low-risk devices will be exempt from some or all of the regulations. The FDA is seeking public comment on the proposed regulations for 120 days.
You should consult with a doctor if you have any ongoing symptoms or health concerns from a metal-on-metal hip implant. If you have significant injuries, you should also consult with a DePuy hip lawyer to discuss your legal rights.
See the news release here: