Medical Device Recalls: Get it Right the First Time

Below are excerpts from an editorial written by the Chief Editor of The Archives of Internal Medicine on medical device recalls:

Consumers are justifiably upset when their cars, toasters, and baby food bottles are recalled.  Recalls make us all question the safety of the products we take for granted.  But what about the products permanently implanted in side our bodies?  Surely they have been sufficiently tested to ensure that no one will need to bring their thorax to the shop for removal and replacement.  It is sad and troubling to learn that we cannot count on this assurance for some medical devices…..

Zuckerman and colleagues demonstrate the dangers to patient safety posed by these innumerable device misclassifications.  They review the approval pathway for all high-risk recalls of medical devices from 2005 through 2009. …

Cardiovascular devices were the most common category for high-risk recalls.  For example, hundreds of deaths have been attributed to AED malfunctions, while it remains unclear how many lives these devices may have saved.  Another worrisome example is the Sprint Fidelis, an implantable cardioverter-defibrillator approved by the FDA in 2004 without any premarket clinical testing.  It was subsequently implanted in 268,000 patients over 3 years before being voluntarily withdrawn by the manufacturer owing to the possibility of lead fracture, which led to inappropriate shocks or loss of function….

Undoubtedly, some recalls are unavoidable as our knowledge and experience with a device grows.  However, we must make sure that before devices are approved and widely disseminated, we have done due diligence to determine that they are safe and effective…..

Doing the right thing will require withstanding the pressure of industry lobbyists.  Without any data to support their statements, the lobbyists suggest that the proposed FDA changes – which could improve public safety – will “chill device innovation.”…  Unfortunately, as Zuckerman et al demonstrate, the public deserves better protection.

To read the entire editorial, click here.