Friday, February 18, 2011

A recent post about recalls and 510(k) - What's missing? (maybe demoninators)

A recent published article takes the FDA's 510(k) process to task showing that "Most Recalled Medical Devices Went through FDA Fast-Track Process".  A finding of the referenced study is stated that "findings reveal critical flaws in the current FDA device review system..."

Perhaps someone should educate the article authors about the concept of demoninators and a smewhat critical flaw in their analysis as well as the actual numbers.

OK, so in the study 113 devices were recalled from 2005 through 2009.  80 of the 113 (70.1%) were cleared via 510(k)s, 12 (10.6%) were approved via PMAs and 8 (0.07%) were not subject to any review.  ON the surface these numbers suggest that there are 7 times more recalls of 510(k) cleared devices than for OMA approved devices.

So how many devices were on the market in the US from 2005 to 2009.  No telling really, but we can look at the number of devices cleared by FDA in that same time period.  FDAs own database shows that there were:

510(k)s cleared   2005-2009  = 15,733  (There were 127,239 510(k)s cleared since 5/28/1976)
PMAs approved  2005-2009  =  ~150  (There were 1,125 PMAs approved since 5/28/1976, with an average of 32 original PMAs per year over the 35 year history)

Numerator    =        80   510(k) devices recalled that were cleared in 2005-2009 divided by
Denominator = 17,733   510(k) devices cleared in 2005-2009 (CDRH only) = ~0.005%

Numerator    =   12   PMA devices recalled that were cleared in 2005-2009 divided by
Denominator = 160   PMA devices approved estimated for 2005-2009 (CDRH only) =  ~0.075%

By these calculations a device approved by a PMA has approximatley a 15x more likelyhood to have been recalled that a device that was cleared by a 510(k).  Demoninators make all the difference.

NOTE = Most denominators will probably be flawed in several respects. Factors such as the follwing come to mind.
Of the devices recalled, were all of them devices that actually were cleared during 2005-2009?

Were the devices that were cleared since May 28, 1976 to 2005 not included?  Presumabley they were still beign sold and could have been recalled.

What about the devices that did not have to go through any review process (those on the market before May 28, 1976 and those exempt from any FDA submission)?

Some 510(k)s and PMAs are reviewed by CBER (as opposed to CDRH) and these are not reported here.  Were any of the recalled devices CBER reviewed?

etc., etc., etc.

Where is a statistician when you need one?

The article abour the published article.
News and Information about Personal Injury Lawsuits

Most Recalled Medical Devices Went through FDA Fast-Track Process: Study

feature photo
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.


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