On the heels of a report from the General Accounting Office criticizing the way the Food and Drug Administration (FDA) handles approvals of medical devices (such as the DePuy artificial hip and the Myxo ETlogix annuloplasty ring), the U.S. Institute of Medicine has issued a report recommending an overhaul of the approval process.
The vast majority of medical devices cleared by the FDA (e.g., 90 percent in 2009) are reviewed under the 510(k) process. In this process, medical devices that are “substantially equivalent” to previous devices are exempt from the lengthy safety reviews required of new medical devices. A device manufacturer simply has to demonstrate that the device is similar to another device and does not pose “undue” safety risks. A manufacturer does not have to prove that the new device is effective or guarantee it will not cause injury to users
The report from the Institute of Medicine identified multiple aspects of the 510(k) process that are flawed. For example, the “previous device” to which the new device is styled as “similar” can itself have received FDA clearance as a 510(k) equivalent of yet another device, and may not, itself, have been tested for safety and effectiveness. Furthermore, drug and device makers may incorporate new technologies or “upgrades” to a new generation equivalent without submitting a full review.
According to a study published in the Archives of Internal Medicine, a disproportionate number of the medical devices that have caused health problems and patient deaths — like malfunctioning defibrillators and faulty insulin infusion pumps — have been approved through the 510(k) process.
The Institute of Medicine said in its letter to the FDA that “The 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness.” It advised that a new method be developed for testing medical devices before market.
The Medical Device Manufacturers Association has criticized the IOM report, alleging that efforts to overhaul the regulatory process would slow patient access to medical therapies. Not surprisingly, manufacturers want regulations loosened even further. “‘Safe’ means that the benefits of a drug or medical device outweigh its risks, not that it’s risk-free,” said Jack Lasersohn, a partner in a venture capital firm that funds the development of medical devices, in a story in the Los Angeles Times.
Industry spokespersons argue for less preventative measures and increased post market surveillance, essentially making consumers guinea pigs. They are lobbying for rules that weaken premarket testing and approval steps, claiming the FDA needs to develop a better way to track adverse reactions after the device is on the market.
Consumer groups such as Public Citizen disagree. They have criticized the 510(k) process, saying it favors the medical industry and puts consumers at risk as well as pointing out that there is currently no way to quickly analyze data in the FDA’s adverse-event reporting database.
But even if tracking was improved, after-market tracking is not enough. In written testimony to a Senate committee examining the FDAs processes, the main author of the Archives of Internal Medicine article stated that there is a need for more stringent testing of medical devices, particularly if they are “potentially dangerous in predictable ways.”
Although the FDA requested the Institute of Medicine analysis of its permitting process, it disputed the Institute’s conclusions. On July 27, it issued new draft guidance to clarify when modifications to a medical device would or would not require new premarket submission for FDA approval.
Changes that might require new submission for approval include:
These changes will not be adequate to safeguard the public from defective medical devices entering the market. There is ample room for improvement in FDA approval processes, both in more rigorous premarket approval and after-market tracking of patient problems and product defects.
Article provided by Walkup, Melodia, Kelly & Schoenberger
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