PROTECTION OF MEDICAL DEVICES BY THE FDA
When a drug or medical device is approved, the FDA makes a judgment call about its safety. They rely on the manufacturer’s studies after following 500-3000 people over a few months. This called a small clinical trial. It is meant to measure the drugs safety and effectiveness in a targets small group of patients. They do not consider the wide variety of health problems the drug might pose when taken in a wide variety of conditions.
Only after a drug has been used for months or years by thousands of patients can true risks show up. This kind of surveillance is the most important phase of testing.
Implantable defibrillators were approved by the FDA in 2004 without any human clinical trials. The doctors raved about how tiny they were and how easy they could be implanted.
After 3 years on the market, and 279 thousand implants, it became apparent the implants were fracturing. The company quickly took the devices off the market.
Billions of dollars were at stake as the doctors and patients screamed about the poor performance of these devices. They wanted regulation to protect the patients from their use.
A lead in the device has to withstand hundreds of millions of heart contractions in a hostile human body. The device must deliver high voltage energy in a split second’s notice.
But when an intracardiac device, ICD, breaks, it fails to defibrillate and produces unnecessary shocks and death. When the lead failed, it was not removed from the patient and hence not returned to the manufacturer. This led to a gross underestimation of the failures of the leads. There was consequently no data after marketing the device to see if there was a performance problem.
The company sent an application for design changes in May 2007 and got approval from the FDA two months later. The old defective leads stayed on hospital shelves and continued to be implanted by unknowing surgeons.
Finally, 5 months later, after 5 deaths and 665 fractured leads returned, the company voluntarily recalled its product and asked all unused leads to be returned.
Well, lawsuits were flying immediately, alleging personal injury, negligence in manufacturing and failure to warn the patients about possible defects. The company continued to sell their inventory of potentially defective devices even after they saw the flaw and corrected the problem. Two other companies were involved in marketing their potentially defective devices without telling the patients.
The arrhythmia device industry routinely does not disclose risks to the patients. The FDA allowed a flawed product to be made while the manufacturer was submitting a revised design and waiting for its approval.
Some argue that the patients get a lot of reliable information and there is no need to make the patients anxious. They might not choose to have the device implanted when given information about its flaws.
Solution: Tell the patient about the risks and benefits and let them make their own decisions. This is called informed consent.
The FDA is to protect the public and give them information they need. Patients do not tolerate unnecessary and preventable risks. However, when given accurate easily understood information they will make informed decisions
It seems consumer medical protection is lacking. Protection of the consumer is present for airline travel, cable TV customers, and cell phone users. Yet when you receive a life sustaining medical device, there is no protection. There is no consumer representative or patient advocacy group to speak up for the patients.
Who protects the well being of patients? Who treats them ethically? Where is the informed consent and where is the disclosure of safety information?
The company’s first duty is to protect its shareholders and not the patients who are using their products. Who is around to protect you the patient?
Source NEJM 3.6.2008
What do you think?
Visit us @ www.drneedles.com for more medical information.
No comments:
Post a Comment