FDA Altering Approval Process of Medical Devices Due to Numerous Defects

The federal Food and Drug Administration (FDA) regulates more than just food and drugs. It also regulates the product safety of medical devices. Manufacturers of medical devices are generally required to obtain FDA approval of their devices before selling them to hospitals and medical practices for use on patients.

According to Fortune, the FDA is changing its decades-old approval process because the current process isn’t adequately protecting consumers and patients. The current FDA approval mechanism was to review how newly proposed devices compared to “older technologies.” Now, the FDA will be examining the merit of new products based on clinical tests. While the clinical testing analysis may take more time, the FDA thinks clinical testing will be safer in the long run.

The FDA hopes the new testing procedure will give it better data as to a medical device’s benefits and risks. The FDA’s new process (known as a 501(k) process will pressure medical device makers to “base new products on technologies that are 10 years old or less.”

As an example, the Fortune article cited an Associated Press (AP) study that found the defective spinal-cord stimulators have caused “more than 80,000 injuries since 2008.” Even worse injury results, according to the AP study, were found for insulin pumps and metal-hip replacements.

The FDA’s announcement of this change in policy closely follows that AP study. “The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.” More than 50 media organizations participated in the investigation.

Product liability and medical devices

Products, including medical devices, can be found defective if the design of the product was faulty, if the manufacturer of the product was defective, or the marketing was inaccurate. Inaccurate marketing includes instructions on use that are improper.

In product liability cases, the distributors and sellers of the products can be held strictly liable too.

When death or physical harm happens due to the use of a defective medical device, there are other reasons makers of the products and others may be liable. Companies can be negligent or in breach of any warranties if they fail to comply with a product recall. Hospitals and physicians may be liable for medical malpractice if they knowingly use a medical device that they know is reasonably likely to hurt their patient – especially, if they fail to obtain an informed consent from the patient.

If you or a loved one is experiencing pain due to an implant or use of any medical device, or if your loved one has died, you may have a claim against the manufacturer and other responsible companies. The experienced Oklahoma City medical product liability attorneys at Cunningham & Mears work with product safety professionals to help verify the medical products were and are defective. For help with any type of product liability case, please call 405.212.9234 or complete our contact form.

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