Unlicensed usage of medical devices on patients: a case of accusations

From The Embassy of Good Science
Cases

Unlicensed usage of medical devices on patients: a case of accusations

What is this about?

The case is about a factual controversy that surrounded the experimental usage of a heart valve device called a Myxo ring. A doctor accused the inventor of the device of using the Myxo ring on patients with surgical needs without informing them the device is not licensed. The university refused the accusations arguing that the ring is FDA approved. Some conflict of interests issues are also discussed.

Why is this important?

The development of innovative materials and devices for better treatment and health care are significant goals of medicine. New materials and devices must be tested on patients in a professional infrastructure, in controlled settings while properly following the ethical and legal regulation on clinical trials on medical devices. Informed consent and independent REC approval are necessary conditions.

For whom is this important?