A Solution in Search of a Problem, Part II

By Jennifer D. Newberger –

Perseverance can be an admirable quality, except when it is misguided.  So it seems to be with Representative Edward Markey and Senator Jeff Merkley, who seem intent on convincing the public that devices cleared through the 510(k) process pose great risks that must be remedied.

We previously posted on a bill introduced by Rep. Markey and Senator Merkley, the Safety of Untested and New Devices (“SOUND”) Act of 2012.   As we noted in that post, the bill seemed to be presenting a solution in search of a problem.  The latest efforts by Rep. Markey and Senator Merkley continue to search for a chimera: badly designed devices, cleared through the 510(k) process, regularly causing death and serious injury. 

On August 15, the congressmen sent a letter to Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (“CDRH”), expressing their concern “about weaknesses in the premarket review process used to evaluate most medical devices.”  To fix these “weaknesses,” the congressmen request CDRH “overhaul and streamline its Recalls and 510(k) Premarket Notification databases to provide publically available and easily searchable information regarding the safety of devices that rarely undergo clinical trials in humans prior to being sold on the market.”  Their premise is that the 510(k) process is substantially flawed.

Yet, when the Institute of Medicine released its report on the 510(k) process last summer (see here), one finding was very clear: there is not a “public-health crisis related to unsafe or ineffective medical devices.  Although the safety and effectiveness of preamendment Class II devices have not been systematically reviewed, their continued use in clinical practice provides at least a level of confidence in their safety and effectiveness.”  It would seem that this committee of experts—a committee notably lacking any industry representatives—is better qualified to assess the risks posed by 510(k)-cleared devices than the two congressmen.

Nevertheless, they will not let their cause go undeterred.  In the letter to Dr. Shuren, the congressmen assert that “thousands of patients have been harmed – in some cases grievously and irrevocably – by medical devices that were modeled after recalled devices.”  To remedy this purported “problem,” they believe FDA’s authority should be expanded “to enable it to reject clearance if a device repeats design flaws that have led to the voluntary recall of early products.”  Such expanded authority was proposed in the SOUND Act, which appears to be stalled in the House of Representatives.  Given the failure to move that bill forward, the congressmen sent the letter to Dr. Shuren, proposing ways to increase “transparency” about “devices recalled for serious design flaws.”

Specifically, the letter proposes the following measures:

• Update the 510(k) database to reflect if the device was the subject of a recall “because of a serious design flaw that negatively affected safety of [sic] effectiveness.”  It asks that FDA update the database within 30 days of learning that a “flaw triggering the recall was a serious one that could adversely affect safety or effectiveness.”

• Update the 510(k) database to reflect whether the device “was cleared on the basis of a predicate recalled for a serious design flaw that negatively affected safety or effectiveness.”

• The database should provide “a link to information about the predicate’s adverse event reports and recall, so that consumers and doctors can determine the nature of the earlier problem.”

• The database “should be updated retrospectively to reflect previous recalls due to serious design flaws, to the extent that reliable information about older recalls is available.”  It does not specify how many years back the database should be updated, but notes that if the database “does not include serious recalls going back at least several years, its usefulness to companies attempting to ascertain which predicates to avoid will be severely limited.”

The letter also suggests that if a new device “repeats the same serious design flaw that caused the predicate to be recalled,” FDA should notify the sponsor in writing that the failure to fix the design flaw “puts the device at risk of being deemed misbranded or adulterated[.]”  This notion is particularly misguided, since it implies that FDA would be willing to clear a device that it knows, prior to clearance, would be misbranded or adulterated by virtue of its design. 

The letter also asks that FDA revise the 510(k) database to indicate whether a device “repeats the same design flaw that caused a predicate’s recall,” and “develop a mechanism for identifying certain 510(k) entries to reflect instances where a device’s clearance traces back to a predicate recalled for a serious design flaw adversely impacting its safety, even if the original problematic device is not the immediate predicate.” 

Our conclusion stated in the prior blog post remains true: Congress, industry, and FDA should all consider how to best assure that marketed devices are safe.  However, the proposals in this letter (and the SOUND Act) do nothing to further that goal.