FDA Oversight of Medical Devices Faces Scrutiny

When your doctor tells you that something is wrong with your health, you immediately want to know how best to attack the problem. You trust that your doctor has your best interests in mind, and will develop a treatment plan that gives you the best chance at recovery. You trust that everything he or she suggests will not prevent you from getting well.

For some patients, a treatment plan may involve major surgery in an effort to correct serious health problems. Surgeons may need to insert medical devices to help a patient return to their ordinary daily lives. When it becomes necessary to perform these extremely serious operations, physicians rely upon devices that have been specifically approved by the U.S. Food and Drug Administration (FDA).

Unfortunately, it is not uncommon for these devices to have slipped through the administrative cracks on their way into the marketplace. Recent recalls, such as the DePuy hip replacement, as well as an implantable defibrillator by Medtronic have shown how difficult it can be when widely used products are found to be ineffective. Both manufacturers have instituted recalls to correct the problems caused by the devices.

Even when it is determined that a recall is necessary, it is no guarantee that a defective product will be completely removed from use. Devices may be unable to be located, or the risks to a person's health may be too serious to perform additional surgeries. Doctors may be unwilling to subject themselves to medical malpractice lawsuits by creating further complications.

An audit of recalls occurring from 2005 through 2009 by the U.S. Government Accountability Office (GAO) determined that there were 21 high-risk recalls in which devices were not corrected or removed after problems were discovered. The GAO called on the FDA to take a closer look at the types of devices that consistently faced recalls in an effort to reduce harmful products from being approved.

Getting to Market: The Approval Process

Medical devices began to be more heavily regulated after several high-profile cases underscored the devastating consequences that can result if something goes wrong. At first, medical devices did not have any specific rules in place restricting their use. In 1976, legislation was passed that established separate rules for medical devices, and these rules have evolved over time.

The FDA is tasked with overseeing that companies comply with these regulations. Currently, the FDA splits medical devices into three risk-based categories, which are:

  • Class I: The lowest risk devices, which include items such as tongue depressors or bandages
  • Class II: Slightly more of a risk to the user, including devices such as electrocardiographs or tools used in surgery such as bone drills
  • Class III: The most potential risk to patients, can be life-threatening if they do not perform properly, including replacement heart valves or pacemakers

Each class is subject to a different review process before it can go on the market. For Class I devices, it may only be necessary for the manufacturer to inform the FDA that it has placed the item on the market. Class II products will be subject to a process known as 501(k) notification. Class III items will generally be subject to a more rigorous review called premarket approval.

There is a great disparity in the amount of work required under 501(k) and premarket approval. The 501(k) notification does not require manufacturers to undergo extensive clinical testing before the product can be used. Additionally, if a product is similar to one already being used, the company may begin to sell the device 90 days after notifying the FDA. This is permitted even if the device is being used may have a high level of risk for the end user. The premarket approval process requires products to undergo substantial clinical tests. The manufacturer needs to prove that the device will actually work and not place patients at increased risk.

Every day that a medical device spends in a premarket approval clinical trial costs companies money, which may result in lengthy delays prior to its use. With 501(k), the device can be on the market and available for use 90 days after notification. Many manufacturers attempt to get their products out in this fashion, which can lead to devices being used without a full understanding of the risks involved.

The FDA may be reluctant to devote significant time and energy to the review of products that seem to be similar to devices with established safety records until issues arise. By this time, the device could already be being used in a widespread fashion. Patients may begin to experience serious health complications before knowing that it is the device that is causing the problems.

What this Means for You

Your health should be your first concern. If the device is essential to your survival, it is important to have any issues corrected as soon as possible. Once you are healthy, you can determine how best to move forward. Subsequent surgeries or having new devices implanted can be very expensive, and patients need to know who is responsible for these costs.

Patients who have been subject to improperly tested or defective medical devices may have a claim for compensation against the manufacturer. These cases are extremely complex, and can involve issues concerning both state and federal law. It is important to work with an experienced personal injury attorney in your area, as any delays may lead to your claims being denied.