Medical Device Recalls 101

According to the FDA, a recall “is an action taken to address a problem with a medical device that violates FDA law”. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. When a medical device is recalled, it does not always mean that the product has to be placed out of commission. It can sometimes just mean that the medical device needs to be checked, adjusted or fixed. A correction recall addresses a problem with a medical device in the place where it is used or sold. A removal addresses a problem with a medical device by removing it from where it is used or sold. Examples of the type of actions that may be considered recalls are:

• Inspecting the device for problems
• Repairing the device
• Adjusting settings on the device
• Re-labeling the device
• Destroying the device
• Notifying patients of a problem
• Monitoring patients for health issues

Most often companies recall medical devices on their own and notify the FDA of the correction or removal. In rare circumstances, the FDA can legally require that a company remove a device that is associated with significant health problems or death.

When a medical device is recalled, the responsible company directly contacts the customers who have received the product from them, and takes steps to reach others who need to be notified. They also supply information to help users identify the problem, take steps to minimize health consequences and take action to ensure that the problem will not happen again. The FDA’s responsibilities during a medical device recall include:

• working with the recalling firm to obtain detailed information about the product, the problem, the recall strategy and the steps taken to prevent future events
• conducting audits to make sure that recall efforts are appropriate and effective
• ensuring that the company does in fact take the necessary actions to prevent the problems from happening again

There are three different classifications of medical device recalls. The classification is usually given after the medical device recall has been initiated. The classification is assigned by the FDA, and it determines the number of checks the company has to make and the number of audits that the FDA will conduct to ensure the effectiveness of the recall action.

Class I recalls are the most serious type of recalls. This classification is assigned when there is a reasonable probability that the product will cause serious health problems or death. When a device is given this type of recall the company’s responsibilities are:

• to notify their customers, and directs them to notify the intended recipients of the device (vendors, hospitals, nursing homes, outpatient facilities, doctors or individual patients)
• provide a phone number for questions related to the recall
• issues a press release to notify the public

Class II recalls are issued when there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. In a Class II recall, the company notifies their customers but the recipients may or may not be notified. The FDA does not issues a press release and the company is not required to notify the public unless a specific need to do so has been identified.

In a Class III recall, there is little chance that using or being exposed to the device will cause health problems. However, since FDA law has been violated, there is still need to take action to rectify the situation. The companies do need to notify their customers but there is no need to issue a press release.

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Reference Used:
U.S. Food and Drug Administration: Center for Devices and Radiological Health; Learn About Medical Device Recalls (2005) Retrieved from http://www.fda.gov/cdrh/recalls/learn.html

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