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Classifying Medical Devices
Although many different types of medical devices exist, the Medical Device Amendments of 1976 require all medical devices to be classified under one of three regulatory classes, according to the U.S. Food and Drug Administration (FDA). When a medical device enters the market, the class it is categorized under depends on how much control is needed to ensure its safety and effectiveness. The three regulatory classes include the following:
- Class I—These medical devices are the simplest in design when compared to Class II and Class III devices and include things like elastic bandages and enema kits. Approximately 47 percent of medical devices on the market today are categorized as Class I.
- Class II—Some of the medical devices that fall under this category include certain pregnancy test kits and powered wheelchairs. Approximately 43 percent of medical devices are considered Class II devices.
- Class III—Examples of Class III devices include breast implants and implantable pacemakers. About 10 percent of medical devices fall under this category, and these devices are generally used to support or sustain life.
Not all devices are required to receive FDA clearance before entering the marketplace. The FDA states that if a medical device is considered a Class I device and it meets other specifications, a premarket notification as well as clearance from this organization is not required.
Injury Due to Defective Medical Devices
When the use of a medical device causes unnecessary physical harm or emotional injury, patients may be entitled to recover damages for lost wages, medical expenses and pain and suffering. For example, the FDA has received 921 adverse reports involving the use of IVC filters since 2005. In many of these reports, this type of medical device migrated to another part of the body, perforated or fractured after insertion, causing patients to experience adverse clinical outcomes.
The FDA believes that often, these devices are not removed even after the use for them is no longer needed. As a result, patients who have an IVC filter in their body for an extended period of time are at a risk for lower limb deep vein thrombosis.
Who Can Be Held Responsible For a Defective Medical Device?
When a medical device is believed to be defective, many different parties can be held liable. For example, the manufacturer of a medical device, the laboratory where the medical device was tested at and the medical sales representative who sold a health care facility the device can all be held responsible for a device’s failure to serve its intended purpose. Retail suppliers, medical professionals and hospitals can also be held liable for a defective medical device.
Who is responsible for a defective medical device is often dependent on how the defective liability claim developed. For example, if a medical device became defective as a result of a shipping problem, an error at the manufacturing facility or due to an error that occurred at a hospital, the manufacturer, supplier or hospital could all be held liable for any adverse consequences the device causes. Or, if a medical device is improperly marketed and adequate warnings about its potential dangers are not revealed, the sales representative for the device or the manufacturer could be held liable for the use of the product.
A Michigan defective medical device attorney can assist patients who suffered complications due to a defective medical device.
How a Michigan 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.
Patients who are injured by defective medical devices may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a loved one dies after complications from a defective medical device, family members may be able to pursue claims for wrongful death damages, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Affected patients and their families are encouraged to seek the advice of a Michigan defective medical device attorney to discuss their legal rights and options for compensation.