North Carolina Defective Medical Device Attorney

How are Medical Devices Classified?

According to the U.S. Food and Drug Administration (FDA), a medical device is any implant, instrument or apparatus that cures, mitigates, treats or prevents disease, or affects the structure or the way the body functions in any way. The FDA has established three regulatory classes that determine how much risk a medical device poses to patients. These include:

• Class I devices—this class of medical devices is considered to pose the lowest risk to patients. Some devices classified under this category include handheld surgical tools, examination gloves and elastic bandages.
• Class II devices—devices classified under this category are not entirely devoid of risk, and are subject to special controls. Powered wheelchairs, surgical drapes and infusion pumps are all examples of Class II medical devices.
• Class III devices—these devices generally pose the greatest amount of risk to patients and include things like implanted cerebellar stimulators, replacement heart valves and silicone gel-filled breast implants.

Ultimately, how much control the FDA exhibits over a medical device is determined by which class it falls under.

The Medical Device Recall Process

The FDA states that the recall process exists to remove or correct medical devices that violate regulations set forth by the agency. In most cases, the manufacturer or distributor of the medical device will initiate the recall voluntarily, but in others, the FDA may demand that the manufacturer move forward with the recall process.

When a medical device recall is initiated, the FDA begins the process by conducting a health hazard evaluation. This evaluation considers a variety of different factors, including whether the use of the device has already injured or harmed patients, whether certain conditions could contribute to the device being a health hazard and how serious the effects of using the medical device are. How likely it is that the hazard will continue is also analyzed, as well as if use of the device leads to short- or long-term consequences. Once the health hazard evaluation is complete, the FDA can then determine whether to issue a Class I, Class II or Class III recall.

After the recall has been classified, the manufacturer of the device is able to come up with a recall strategy, which can be based on a number of different factors. These can include the results of the health hazard evaluation, how obvious the device’s defect is to consumers, and how much the device is used among patients and the medical community as a whole.