Hot on the heels of calls from Congress, the President, and prominent medical device industry players to streamline the 510(k) approval process so as to make it easier for innovative treatments to make it to market, comes a new study from the Cleveland Clinic questioning the ability of current FDA safeguards to protect the public from potentially harmful medical devices.
A number of media outlets have covered the study – which was published in the Archives of Internal Medicine this past month – with a focus on its claims that the majority of recalled medical devices surveyed between 2005 and 2009 were initially cleared for public use through the 510(k) program. One of the authors of the study, Diana Zuckerman of the National Research Center for Women & Families, concluded that the 510(k) approval process must be reformed in order to better protect Americans from the potential negative health consequences associated with unsafe medical devices.
MDCI notes that the 510(k) process is only applicable to medical devices in the low moderate-risk categories, and that these devices must be demonstrably similar to previously-tested products already on the market.
The Cleveland Clinic’s conclusions have been contested by several in the medical device industry, with AdvaMed pointing to studies of its own indicating that 99 percent of 510(k) devices do not face any recall action of any kind. AdvaMed went on to state that the methodology used by the Clinic is essentially flawed as it only examines the number of recalled devices without placing them in the context of the number of products successfully introduced to the market. The FDA also commented on this particular aspect of the Cleveland Clinic study, noting that while 80 of 113 recalled devices between 2008 and 2009 passed through 510(k), 19,000 medical devices in total were approved during the same period through the same process, with no problems reported to date.
It could also be argued that the FDA has already adopted a strategy to handle at least some of the recently recalled medical devices which received 510(k) approval. Potential changes to regulations concerning defibrillator devices, which grabbed headlines earlier this year due to a number of deaths associated with recalled models, are currently being contemplated by the Administration. The FDA, in response to the Clinic’s report, also noted 25 changes that have been made to the 510(k) approval process in an attempt to further improve the safety of medical devices being offered in the United States.
Even in the face of the Cleveland Clinic recall story, AdvaMed has reiterated its position that the FDA needs to focus on accelerating the medical device clearance process in the United States. The group, which acts as a representative of the medical device industry, feels that FDA safety standards are currently in excellent shape but that administrative and procedural roadblocks are making it increasingly difficult for medical device manufacturers to compete in the marketplace.
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republished and adapted with permission from MDCI