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What is the recall process for medical devices?

On Behalf of | Aug 1, 2018 | Products Liability

When we think of the products that consumers use, we often think of automobiles, household items and tools. In addition to these products, many consumers also purchase medical items, such as prescription drugs and medical devices. These items, like other products, could be subject to defects. When this occurs, these items are recalled. The hope is that by taking them off of the market, consumers will not suffer harm from these items. Additionally, it allows certain consumers to take action to avoid harm by having a medication or medical device replaced.

What is the recall process for medical devices? To begin, medical devices serve many purposes and the FDA is tasked with reviewing and recalling them. Medical devices are divided into three categories.

The first is Class I. These are devices deemed important for treatment and are unlikely to cause serious injury. These are items such as surgical gloves and scalpels. Class II is made up of devices found important to treatment and, when used as directed, will probably not cause serious injury to a patient. These include items such as wheelchairs and surgical pumps. Devices that support or sustain life fall under Class III. These devices do not have general controls to assure sufficient safety.

When the FDA learns that a medical device presents danger to the health of a patient, a recall is issued. The FDA can discover this information through its own investigation or because a claim or complaint was filed. When a recall is issued, the FDA will work with a manufacturer to ensure that the device is taken off of the market. Depending on the severity of the matter, a recall may not cause a complete removal. If it is minor, the recall may only effect those at the wholesale level. On the other hand, if the defect is severe, this could result in the FDA recalling devices from retail stores and even from patients’ homes and even the patient themselves.

A defective medical device can be a serious matter. If harm is caused to a patient, a products liability action might be a necessary step to take. This legal action helps hold a negligent manufacturer accountable while also providing a means to recover compensation for losses suffered.