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What is a Medical Device?
According to the U.S. Food and Drug Administration (FDA), a medical device does not involve a chemical action that is then metabolized in a person’s system as a drug does. Instead, it is an article or part that affects a body’s structure or function through prevention, diagnosis, treatment, relief or cure of a disease. It may take the form of a tool, machine, implant or some other article, such as sutures or tongue depressors, and it must meet the standards set by the U.S. Pharmacopoeia Convention, which are enforced by the FDA.
Requirements for Medical Devices
All facilities where medical devices are manufactured or distributed must register with the FDA if the products are to be used in the United States. As a part of this process, most businesses must identify all the devices they produce and how this is accomplished. The product must be classified and approved or cleared by the agency.
The FDA explains that medical devices are also subject to labeling regulations. These include information on the packaging, but the same rules apply to the product’s printed advertisements also. Labeling must be proofread carefully, and it must also be unique to prevent the device from being confused with another. Expiration dates must be noted. When a product is sterile or must be sterilized, that information must also be included.
Questions of Safety
In spite of all the steps taken by regulatory agencies to ensure that medical devices are safe for use, there are times when they cause injury because of some issue in the design or manufacture of the product. For example, according to Bloomberg, the U.S. Senate claims that the FDA was not alerted to problems with flaws in the design of certain endoscopes that prevented thorough sterilization. However, one manufacturer did provide an alert about the issue to people in other countries who purchased the devices.
The Senate investigation found that the scopes caused infections that may have led to many preventable patient deaths. Even though this illustrates the limited scope of the current system, the FDA continues to depend on the device manufacturers to identify problems and pull them from the market.
Defective Medical Device Recall
The FDA is working on developing a better system for identifying flawed medical devices and preventing their introduction to the market. Meanwhile, the agency urges those who have been harmed because of a defective device to report the problem through its adverse event reporting system.
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.
Faulty Medical Devices and Litigation
When a defect in a medical device causes harm to many people, the number of civil suits against the company may merit consolidation. The U.S. Judicial Panel on Multidistrict Litigation must approve the cases that may be included in this process, which is known as multidistrict litigation. It benefits plaintiffs who are involved by allowing evidence to be combined and presented at a single trial. This significantly expedites the justice process and may lead to faster settlement results.
How a Virginia 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.