Missouri Defective Medical Device Attorney

What is a Medical Device?

According to the U.S. Food and Drug Administration (FDA), the maker of a medical device may only apply for official recognition if the device meets the following guidelines:

• The device must replace the body part or organ of a human being or animal after the initial organ or body part ceases to function properly.
• The United States Pharmacopeia or the National Formulary must officially recognize the instrument or device.
• Diseases or injuries can be treated, cured or prevented by the device, or a disease or condition can be diagnosed by the device.

If the machine, implement, or tool meets the aforementioned standards, the FDA approval process can officially start.

FDA Device Approval Process Criticism

According to the The Washington Post, numerous members of the public, physicians and patients have become wary of the FDA approval process following the failure of several, prominent medical devices. One of those concerns regards a special FDA program known as “fast-track,” which has a remarkably high approval rate of 90 percent. As long as the medical device is similar to ones that are already on the market, it can be approved for distribution and marketing in 90 days or less. The program is open to many devices that do not require clinical testing on humans.

The article also points out that in less than five years over 112 million medical devices have been recalled. Another disturbing aspect of these recalls is the fact that the fast-track program approved over 70 percent of these recalled devices, many of which were proven to be life-threatening. Despite such overwhelming statistics, many people, primarily pharmaceutical lobbyists, claim that the FDA approval process is too long and that it hinders patients from accessing potentially life-saving medical devices and treatments.

Gaps in the Approval System

A Bloomberg article detailing government criticism of the FDA referenced the failure of a popular endoscopic device. After the device was linked to the spread of deadly bacteria, investigators uncovered several problems, including:

• Initial infection patterns were not noticed by the FDA.
• When infections were noticed, hospitals failed to report them properly.
• Neither the device manufacturer nor the FDA understood the scope of the infection threat.
• American hospitals were not warned about the potential for deadly device complications.
• It took too long for an official warning to be issued.

The endoscopic device eventually claimed dozens of lives and spread bacteria throughout several hospitals. The FDA, which is responsible for ensuring the safety of these devices before they are marketed, was harshly criticized by members of the Senate. Such events have led numerous critics to classify the FDA medical device approval process as a complete failure.