Posts Tagged ‘FDA to the rescue’

By R.C. Seely

“WARNING SIGNS OF UNSAFE OR LOW-VALUE CARE are detectable with existing data but often are overlooked,” charges Dr. Andrew M. Ibrahim. “Rather than duplicate and collect more data, health care leaders should renew their focus on better use of available data.” Sounds logical and makes perfect sense.

Ibrahim goes on to say, in his article for JAMA, that the laproscopic gastric band is one example of the necessity of more due diligence from the medical community in regards to safeguarding the public from faulty medical equipment.

“The advent, increase, and decrease of the laproscopic gastric band to treat morbid obesity … was approved by the US Food and Drug Administration (FDA) in 2001 and peaked in usuage in 2008. However, use of the device gradually declined as reports emerged describing complications and variable effectiveness [leading to the need to] … remove the device.” The FDA approved the device and the device failed, also makes sense. Under the FDA 100,000s of people die annually because of their guidelines keeping drug choices low. Dr. Ibrahim has more faith in the agency than I do.

“Before a class III medical device in the United States can be brought to market, it must undergo a series of premarket trials that are submitted by the FDA,” typically performed on a sample of sufferers of the condition being treated by “experienced clinicians.” But due to limited sample size and inefficient follow-up the trials results are somewhat unreliable. That is also true, most studies have extremely small samples making it difficult to properly gauge their merit as a measuring tool.

What’s the proposed solution? More post approval monitoring by the FDA. Increasing the awareness of the health care device manufacturers and hospital care givers of the monitoring system currently in place for medical devices, and encouraging faster reporting of malfunctions to the FDA. A congressional evaluation of the current system ended with concerns. Mostly tied to backlogs of data from so many reports coming in and not being addressed.

Another solution is increasing the number of medical devices with a “unique device identifier,” the before mentioned gastric band doesn’t have one. Obviously such a marker would make cataloguing complaints easier. “Legislation that would require all FDA approved devices to be trackable within data that are already collected could be a useful strategy to help ensure that … the warning signs of … widely adapted devices are not missed,” Ibrahim states. If Ibrahim is right, the news on solution number two is not great.

“The majority of medical devices used in practice today … cannot be identified within existing administrative data because they lack device specific … Current Procedural Terminology codes.” So the same agency that has such a horrible track record should be trusted with providing a situation to a problem they more than likely caused? Sorry doctor, but the FDA is not the right direction to turn for monitoring medical devices, they have difficult enough time with what they have to do now. Ready to explore free market alternatives yet?

R.C. Seely is the founder of americanuslibertae.com and ALTV. He has written books about pop culture, the most recent Victims of White Male: How Victim Culture of Victimizes Society is available on Amazon.