South Carolina Defective Medical Device Attorney

Medical Devices Defined

Medical devices can be as simple as a tongue depressor to as complex as a laser surgical device that is used by medical professionals in an operating room. Despite their variability, the U.S. Food and Drug Administration (FDA) uses the following criteria to classify medical devices:

• The device must be recognized by the United States Pharmacopoeia or be included in the official National Formulary.
• The intended purpose of the device must be to diagnose medical conditions or diseases, cure, mitigate or prevent them.
• The device must affect the way the body functions in some way.

If a medical device meets this criteria, it is subject to premarketing and post-marketing regulatory controls by the FDA.

Once a medical device falls under the FDA’s definition of being a medical device, it is then placed into one of three classes, based on the risks associated with using it. The first class of devices, or Class I medical devices, are deemed to have the lowest risk associated with use. Therefore, they are not as heavily regulated by the FDA. Examples of Class I medical devices include dental floss and bandages.

Between Class I and Class III medical devices are Class II medical devices. These types of devices require some level of regulatory control in order to ensure they are safe and effective to use. For instance, condoms are considered to be a Class II medical device.

The final class of medical devices is Class III. Because they are associated with having the most risk, they are subject to the most regulatory control by the FDA, and must typically receive approval from this organization before they can enter the market. Class III devices include heart valves, pacemakers and other more complex medical devices.

Not All Devices Are Heavily Reviewed by the FDA

Although there might be an assumption that all medical devices are heavily regulated by the FDA and approved before entering the market, this is not always the case. According to the FDA, some medical devices are considered to be “510(k) exempt.”

When a medical device is exempt from 510(k) status, it does not have to comply with various premarket requirements. However, it still has to meet certain criteria. For example, the device must be suitable for its intended purpose, and properly labeled and packaged. It must also be manufactured at a facility that uses quality systems and have certain forms filed with the FDA.

Defective Medical Device Recall

There are situations in which a patient might experience serious consequences due to a defective medical device. For example, patients might suffer from negative consequences if a faulty pacemaker fails to keep their heart at a proper rhythm or their heart valve implant leaks or breaks after insertion.

Patients may also experience adverse effects if they develop an infection because a surgical device was improperly made or if an insulin pump fails to work as intended. When a medical device allegedly harms patients, the device may be recalled. However, often this only occurs after many patients experience complications as a result of using the device and a large number of complaints are filed.

A South Carolina defective medical device lawsuit is an option for patients who suffered complications due to a defective medical device.