According to new research, 70% of all medical devices recalled since 2005 were approved by the FDA through a controversial “fast-track” process, which only requires the manufacturer to provide minimal data on safety and effectiveness.
The study was published this week in the Archives of Internal Medicine. Researchers found that there were 113 medical devices recalled from 2005 through 2009 that the FDA decided could cause serious injury or death, however only 21 of those medical devices were approved through the agency’s rigorous premarket approval (PMA) process.
The vast majority (80) of the recalled devices were quickly approved through the FDA’s 510(k) process, which only requires that a medical device be “substantially equivalent” to a device that is already on the market. Another 8 devices were not subject to any oversight at all before they were made available to consumers.
The most commonly recalled medical devices were cardiovascular devices, particularly automated external defibrillators (AEDs), which are used to resuscitate patients suffering cardiac arrest. Most of those devices went through the 510(k) process.
Some researchers estimate that as many as 20% of all AEDs have been recalled by the FDA and AED malfunctions have been linked to hundreds of deaths. Last month the FDA announced that it was considering more stringent requirements for external defibrillators due to the high rate of problems.
The 510(k) process has been under fire from outside and within the FDA for years. The expedited process allows medical devices onto the market with virtually no trials for safety and effectiveness if the manufacturer can show they are substantially equivalent to existing medical devices. However, many critics say that the process is too widely used and that the definition of what is substantially equivalent is too vague and often used to approve devices that are radically different from previous medical devices.
Manufacturers are also frequently allowed to model their new devices and fire them through the process based on old devices that were also approved through the 510(k) process; meaning that some medical devices have gone through as many as three or more generations of improvements, changes and alterations without having to go through PMA requirements.
In June 2009, a study by the Government Accountability Office (GAO) found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.
This latest study comes less than a month after the FDA announced that it was streamlining the medical device approval process to make it even easier to get some medical devices onto the market. The announcement came as a shock to some experts, who were expecting the FDA to crack down on 510(k) approvals.
“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” the researchers concluded.
In their conclusion, the study’s researchers recommended that the FDA update how it defines “high-risk” medical devices to include the potential of injury when they fail, enforce existing laws that require all “life-saving and life sustaining” medical devices to the PMA process, and expand its inspection of the manufacturing, post-marketing surveillance, performance standards and guidance to devices approved under the 510(k) process.