Jennifer Whitney , Editor06.12.06
As 2005 came to a close, 27 class I recalls were reported to the FDA; in 2004, there were 26 recalls of this nature. Interestingly enough, between 2001 and 2003, a combined total of only 18 recalls were reported. By any measure, this represents a startling increase.
A class I recall is the most serious of the classes and involves situations in which there is a reasonable probability that use of the product could cause serious injury or death.
Speaking at this year’s MassMEDIC annual meeting, held in Boston, MA on May 2, the FDA’s CDRH Director, Larry Kessler, PhD, said, “We don’t quite understand why some very large companies that we thought had credible quality system regulations and design controls in place are failing to meet the requirements imposed by such systems. We’re seeing corporate-wide warning letters, and I don’t think it’s the flavor of the month. Seeing two years of 23-plus class I recalls is something of considerable concern.”
Amid all the recalls, the number of adverse events being reported from use of medical devices is also increasing—as many as 176,000 annually. “Injuries are going up a lot,” Kessler noted, “and it seems that it might not be unrelated to the increased amount of recalls. There may be some synergy here.”
Associate Editor Chris Trembath, who attended this year’s MassMedic meeting and reported to me about Kessler’s remarks, wisely observed that the rise in Class I recalls and adverse events is somewhat staggering, when you consider that the US healthcare system is regarded as the best in the world. (Don’t miss Trembath’s “Final Thoughts” on page 114 to learn more about the MassMEDIC meeting.)
So what could be the cause of these incidents? Is this just an intermittent blip on the recall radar screen? Are manufacturers cutting corners as pressures mount to get devices to market before the competition? Is technology making devices too complicated and difficult to manage? Are protection systems failing? Is there too much bureaucracy to weed through? The questions are numerous.
Let’s hope 2006 returns or goes below 2001 levels. In the meantime, I would love to hear your own viewpoints on the topic. Feel free to e-mail me at jwhitney@rodpub.com.