Personal Injury Law

Medical Device Division of FDA Broke, Needs Fixing

By Jane Akre

Artificial hip joints

Device Arm Broken

The Food and Drug Administration's office that oversees medical devices is broken and needs fixing.

That is the overwhelming consensus that has initiated an internal FDA meeting today to decide the direction of the device center, reports the New York Times.

The agency has already asked medical device makers to justify that some of their products, already on the market, are safe.   

They include external heart defibrillators, dialysis catheters, hip joints, spinal screws and a heart pump. 

Companies such as Medtronic, Royal Philips Electronics, Zoll Medical Corp, Covidien, Zimmer Holdings, Johnson & Johnson, and Abiomed, have all been asked to provide additional proof of safety.  The companies may have to pay for additional clinical trials or have them reclassified as less risky.

Internal Dissent

As President Obama was taking office, nine scientists alerted him to the internal problems, accusing the agency of acting illegally by approving devices for sale, even when others objected because of safety issues. 

Devices mentioned included imaging equipment for breast cancer and an orthopedic knee device. 

Those concerns have now been passed onto the new FDA deputy commissioner Dr. Joshua Sharfstein, pleading for his intervention. 

Recent headlines have shown that a large number of medical devices, some implanted in patients, have never been tested for safety and effectiveness, and the agency has approved them for marketing after an exchange of correspondence.

IB News recently reported on the numbers of adverse reports from synthetic mesh used to repair hernias and to treat urinary stress incontinence.  Synthetic mesh has not been reviewed for safety as a condition for approval, but as a Class II medical device, can rely on a claim that it is "substantially equivalent" to some other product on the market under the agency's 510(k) approval process.  

Even when that "predicate device" has been removed from the market over safety concerns, as happened in the case of Ethicon's TVT mesh, there is no procedure within the agency to re-review the subsequent devices. 

Ironically the gaps in safety review of medical devices come after consumers lost their ability to take medical device makers to court following the Riegel v. Medtronics decision by the U.S. Supreme Court in February, 2008.  

GAO Critical Of Agency

At the same time, The General Accounting Office issued a report saying that the FDA has not finished a review of products allowed on the market without a rigorous premarket approval process (PMA).  

In 1990, Congress directed the FDA to require safety evidence before a Class III device could be sold, but the agency never finished the job.

By 1994, 149 Class III medical devices still had not had a rigorous review. The FDA has been reviewing and issuing new regulations for all but 27 devices. 

It is expected to take several years before the agency is finished with the reclassification process. 

Diana Zuckerman, a critic of the FDA and president of the National Research Center for Women & Families, says that of the 5,000 medical devices approved by the FDA's Center for Devices and Radiological Health (CDRH) last year, 98 percent were cleared through a "quick and easy" process that usually does not require clinical trials to prove that these medical devices are safe or effective.   # 

Full post as published by InjuryBoard on April 22, 2009 (boomark / email).