How Are Defective Medical Devices Removed from the Market?

Medical devices play a role in all levels of treatment. Such devices can be something as simple as a surgical glove all the way up to more complex devices that sustain human life, such as pacemakers. The Food and Drug Administration (FDA) reviews medical devices before they enter public use.

However, even reviews are not complete. Sometimes a medical device will show complications or dangers to patients while in use after the FDA has approved the device for the market. In these cases, a device may be subject to removal from the market.

Types of Removal

Depending on the type of danger the device poses, the stage in availability, and action taken, there are three main types of removal of a defective medical device from the market:

  • Recalls – Recalls occur when a device is in violation of the FDA’s standards. The company will often volunteer to remove their device from all stages of the market, including those that are already with patients.
  • Withdrawals – Market withdrawal occurs when a company removes or corrects a medical device. Unlike a recall, withdrawals apply when minor or no violations have occurred, and the device poses no risk to patients.
  • Recoveries – Stock recovery occurs when a company corrects or removes a device that is not yet available on the market and is still under the control of the manufacturer.

Often, the severity of the problem affects the action taken. The FDA will recall devices that pose a danger to patients, but those that do not may only be subject to a market withdrawal. Since they only involve the manufacturer level, market withdrawals do not receive the same widespread attention as recalls.

Why Do Products Need to Be Recalled After FDA Approval?

The FDA conducts what they call the premarket approval (PMA) process before allowing a medical device on the market. In theory, this test covers most of the major complications that can come from a medical device. Those with FDA approval are supposed to be safe for use, though sometimes violations may occur unexpectedly after the device is in widespread use.

In addition, some products can go through the 501(k)-approval process, which does not have as strict requirements as the PMA process. Devices approved through 501(k) may not be as safe and can become the subject of later recalls.

What to Do if a Medical Device Is Recalled

For patients with pacemakers, artificial hips, and other medical device implants, an FDA recall on their product can create additional hardships. Sometimes, additional treatment and surgeries may be necessary when the FDA recalls an implant. Patients facing such processes after receiving a notice of recall should discuss the situation with the involved professionals:

  • Doctors – A doctor can help determine what additional treatments may be necessary, as well as give alternate implant options.
  • Health Insurance Companies – Some insurance plans cover associated processes, while others may not. Contacting a health insurance professional allows the chance to see what costs an insurance plan covers and which the patient will need to pay out of pocket.
  • Attorneys – Some recalls leave manufacturers liable for lawsuits. An attorney can determine the right to compensation, estimate potential outcome of the claim, and provide representation in court.

Medical Device product liability cases are complicated processes. The manufacturer, doctor or surgeon, and the FDA are all involved parties, and other patients may be filing lawsuits for similar injuries. Consulting with a lawyer can help you make an informed decision on how to proceed, and allow the patient to focus on recovery.