External Cardiac Defibrillators Under New FDA Scrutiny
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
A new report from the FDA has put external cardiac defibrillators under a microscope. The report puts the number of medical device reports associated with these devices at 28,000 over the period between 2005 and 2010. The number of reports filed each year has jumped from 4,210 in 2005 to 7,807 in 2009. The number of device recalls has jumped from 9 in 2005 to 17 in 2009.
The most alarming part of the report is that most of the adverse events and recalls could have been avoided. The FDA said in a letter to the industry:
"Many of the types of problems we have identified are preventable, correctable, and impact patient safety. We have concluded that there are numerous problems with industry practices for designing and manufacturing defibrillators, handling user complaints, conducting recalls, and communicating with users. Our analysis demonstrates that there are problems with how well firms control how they purchase and accept components used in the manufacture of external defibrillators."
Click here to read the letter to the industry.
If you or a loved one has been injured from a faulty medical device, contact the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP for free consultation.