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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.
How a South Carolina Defective Medical Device Attorney Can help
Device makers have a duty to design and produce safe products, and to warn of possible risks associated with their products. Failure to fulfill that duty can result in injuries to patients, and the device maker being held liable for those injuries.
People injured by a defective medical device may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
If a medical device causes the death of a patient, family members may be able to pursue a claim for the wrongful death of their loved one and seek compensation for funeral costs, medical expenses and pain and suffering experience prior to death, loss of economic support, and loss of the deceased person’s companionship.