FDA Looking at Ways to Improve Medical Device Safety
Last week, U.S. Food and Drug Administration (FDA) officials held what the New York Times called a “rare” meeting to discuss the many controversies surrounding the agency's device safety record; medical attorneys think the meeting is past due.
The director of the FDA’s Office of Device Evaluation, Dr. Donna-Bea Tillman, called for an “all hands meeting,” to include all scientists in the device evaluation section. Shockingly, a meeting like this has not been held at the FDA in years. Then again, when you consider the agency's medical device safety record, it really is not very surprising.
The meeting is the most recent in a series of developments surrounding the FDA's record in approving devices. At least 9 scientists this year wrote to Principal Deputy Commissioner, Dr. Joshua Sharfstein, alleging that approval procedures in the device section were being "severely distorted." The letter also alleged that scientists at the agency, who were raising their voice against such unethical practices, were facing retaliation by FDA higher-ups. The matter has been serious enough to warrant a Congressional investigation. Soon, the Institute of Medicine could also begin probing these serious concerns about the device section.
Things seem to be heating up at the medical device section of the FDA. Two things are apparent at this point:
- There are serious failures in the medical device division of the FDA.
- These problems are not going to be solved by mere patch-up work. Rather, the section needs a complete overhaul to root out unethical practices, and make approval processes corruption-proof.
Any changes that come about at the medical device division cannot be a day too soon.
Defective Medical Devices
It is the FDA's responsibility to protect American consumers from dangerous medical devices. If they fall down on the job and let corrupt individuals get in the way of important safety evaluations, we are all at risk.
If you or a loved one has been injured by a defective medical device, a medical injury attorney can help you recover physically, emotionally, and financially.
Contact a medical injury lawyer, at Arnold & Itkin LLP for a free consultation and to find the answers to any questions you might have.
Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:
In January, Baxter sent a letter to customers informing them of the failures in the pumps. The warning included an alert that the pump could overheat, resulting in fire and smoke if not properly cleaned. The letter also underscored the importance of proper battery care, pointing out that failure to do so could cause the device to malfunction.