Defib Lead Recall

• by TSmith
• 2007-11-20 11:11:16
• General Posting
• 1327 views
• 1 comments

Thought to ponder......

As a defib with Fidelis lead patient, should we be upset with Medtronic? Before we all jump to answer yes before thinking about the following. Every medical device from pacemakers to tongue depressors are required to go through some form of testing for FDA approval (at least in the US). The manufacturing companies are spending millions of dollars to perform R&D (concept), pre-clinical (animals/simulation), clinical (human trials), and some even support post-market (once approved by the FDA) evaluations of their medical device. Not to mention the amount of money it takes to apply for the use of the "research" devices, the annual progress reports, end-point report, and final report. Feel free to go on to the FDA site and search for the dollar amounts for approving or attempting to approve medical devices. We continue to blame the medical device manufactures for issues that occur, but in fact, the group we should be concerned with should be the FDA. The FDA is the overall approver of all medical devices. If the system is flawed, let's look at the big picture. What are they missing when all the information is provided from lead type, material it is constructed from, how well it performs in animals, and how well it performed in the clinical human trial? Do we need to revamp our FDA "experts"?

I too am a patient, but I am very thankful for all the medical technology that has been provided for me. I am able to live longer and spend more time with my family!