New bills reform medical device review processes

Members of congress have introduced a package of bills to reform the review process for medical devices and increase access to legal recourse for patients effected by unsafe devices

Congressman Mike Fitzpatrick and Congresswoman Louise Slaughter announced the introduction of the Ariel Grace’s Law and the Medical Device Guardians Act earlier this week.

Fitzpatrick said: “While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences on patients.

“I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market and provide legal recourse for those impacted.”

The Ariel Grace’s Law allows patients negatively effected by faulty medical devices to seek legal recourse and ensures medical device manufacturers are incentivised to maintain the safest and most effective products for all patients.

This law comes into place after the permanent sterilisation device Essure led to the death of at least four women and nearly 300 unborn children, including Ariel Grace who was stillborn following failure of the device, according to Slaughter.

The Medical Device Guardians Act codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, which recognises that physicians are in the best position to identify and report unsafe devices.

This law came about after laparoscopic power morcellators, used for hysterectomies and to treat uterine fibroids, hit an undetectable fibroid cancer and spread the cancer throughout the body, like shrapnel – taking Stage 1 cancer immediately to Stage 4.

Despite there being occasions where this fault had previously occurred, no one reported this defect to the Food and Drug Administration (FDA) until a doctor underwent morcellation and her cancer spread throughout her body. The woman submitted her patient report to the FDA.

This was the first adverse event report received by the FDA regarding morcellators, despite the same hospital having a patient harmed by a morcellator one year earlier, according to Slaughter.

Slaughter said: “These bills are about saving lives. We’ve seen firsthand how devastating it is when a medical device has an unintended, adverse consequence. It’s time for Congress to make commonsense changes to protect patients and give them the information that could help save lives.”