MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that,
“The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you. This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.”
Consumer Reports is taking aim at the 510(k) process, a fast-tracked way that medical device makers choose to get their products approved for market sooner. Cheaper, easier, the 510(k) requires an exchange of paperwork, an application to market and a named predicate device, that the new device claims to be “substantially similar” to. The fast-tracked 510(k) is known within the FDA as Premarket Notification, or an approval to market.
This is substantially different from Premarket Approval, another FDA designation which means the device maker must provide evidence of safety and efficacy of the product.
Consumer Reports president, Jim Guest, says in his email that low and moderate risk medical devices are cleared through 510(k), but so are high risk permanent implants such as metal hips and heart valves.
The advocacy arm of Consumer Reports, Consumers Union has made the campaign to change the medical device approval process a top priority.
Among the changes the group wants are requiring all permanently implanted medical devices to undergo Pre-Market approval (PMA), the more stringent review, rather than the 510(k) process. Consumers Union also wants any predicate device found to be faulty to no longer be used as a predicate; to eliminate the “least burdensome” when the agency asks for more information; and to raise the PMA approval standard from a “reasonable assurance” of safety to “substantial evidence” of safety.
Backing the effort is a report issued by the Institute of Medicine last summer that claimed the 510(k) was “fatally flawed” and should be abandoned.
Consumer Unions Safe Patient Project, launched in February brought device injured people to Washington, D.C. to meet face-to-face with lawmakers to put a face on the complications.
Synthetic survival mesh used for pelvic organ prolapse and stress urinary incontinence was cleared for market under the 510(k) process, even though the named predicate device was recalled in 1999. There is no mechanism within the FDA to reexamine devices when their predicate is found to be defective.
Medical Device Approval Changes
This is a particularly crucial time for a revamping of the way the FDA approves medical devices. Congress is overseeing the fees the industry must pay to the FDA to have the device reviews done more quickly. Rep. Edward Markey (D-MA) introduced legislation (the Safety of Untested and New Devices Act of 2012 or Sound Devices Act) (story here) that would give the FDA the authority to reject an application for a new medical device if fit names as a predicate a device that was recalled.
The lobbying group for medical device makers, AdvaMed, is a constant critic of the so-called slow and inconsistent reviews of products, delaying their entry into the market and stifling innovation in the U.S. Recently the group reached a tentative agreement with the FDA over a new budget doubling the review budget for the FDA to $595 million (background story here), or one-third of the FDA's device review budget. In exchange, the industry wants a commitment to move approvals faster through the system. #