Virginia Defective Medical Device Attorney

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.