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Medical Device Testing
According to the U.S. Food and Drug Administration (FDA), medical devices are classified into Class I, II, III, and regulatory control increases as class increases. All medical device manufacturers are required to comply with certain regulatory requirements before and after their devices are available for distribution in the United States.
All manufacturers (domestic and foreign) must register their establishments with the FDA, and all registration information must be verified at certain times of the year. Manufacturers must also list their medical devices with the FDA and provide information regarding the various areas of distribution and manufacturing. Depending on a device’s class, manufacturers may need to submit a request for either premarket notification or premarket approval. Following premarket approval, a device will be used in a clinical study to collect safety and effectiveness data to support the claims set forth by the manufacturers. Following approval, manufacturing facilities will undergo FDA inspections to meet requirements and manufacturers will provide product labeling for doctors and consumers.
In some instances, testing may not be sufficient or complications may arise even when a device has been used as intended. When defective devices cause injury, patients and doctors are urged to report the defective nature and harms associated with them. Medical devices may contain flaws, and the public may have had no knowledge of the serious risks associated with them.
Defective Medical Devices
An Oregon defective medical device attorney notes that some medical devices may be found to adversely impact patient health and safety, regardless of a device’s proposed benefits. Devices that have been alleged to be defective include:
- Bair Hugger Forced Air Warming Blankets – Bair Hugger warming blankets are a type of forced-air warming (FAW) system used to regulate and maintain patient body temperature and prevent unintended hypothermia during certain surgical procedures. Bair Hugger warming blankets are one of the most widely used FAW systems on the market, however, some patients have claimed that the device has led to serious complications, including severe infections.
- IVC Filters – IVC filters are small, cone-shaped devices used to catch blood clots and prevent them from traveling to the heart and lungs. In some cases, however, patients have alleged that IVC filters has led them to experience dangerous risks, including fractured filters, filter migration, and perforation.
- Power Morcellators – Power morcellators are electric medical devices used to remove and divide the uterus or uterine fibroids during minimally invasive surgical procedures, including hysterectomies and myomectomies. Morcellators have been allegedly associated with unintentional spreading of cancerous tissues.
- Metal Hip Replacements – Metal-on-metal hip replacements are meant to restore mobility in patients that receive them, however, some patients claim to have experience serious complications, including dislocation, infection and blood poisoning.
How an Oregon Defective Medical Device Attorney Can Help
Device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective medical devices may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.