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WASHINGTON — U.S. health officials said Monday they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments.

The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients.

The FDA’s move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period.


“We believe that newer devices should be compared to the benefits and risks of more modern technology,” FDA Commissioner Scott Gottlieb said in a statement. Gottlieb said the changes under consideration would push companies to compare their devices to more up-to-date technology, rather than referencing decades-old products.

Some of the reforms proposed by the FDA could take years to implement, in some cases requiring new guidelines and regulations for manufacturers. And the most substantive changes could require action by Congress.


The FDA’s framework for clearing more than 95 percent of devices on the U.S. market dates to 1976 and has long been criticized in reports from government watchdogs and independent medical experts. Unlike new pharmaceuticals — which are tested in patient studies — most medical devices only have to show that they are similar to devices already on the market. Only a handful of truly new devices must undergo extensive clinical testing to verify they are safe and effective.

Defective devices cleared through the streamlined system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

As generations of devices have been cleared via the FDA’s main review process, medical products have become increasingly complex and often barely resemble the decades-old “predicates” they claim to reference. Devices cleared through this system, known as the 510(k), include imaging scanners, computerized drug pumps, artificial joints and spinal implants.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

The Advanced Medical Technology Association, the industry’s chief lobbying group, said in a statement that some of the FDA’s proposals “could prove arbitrary.”

“While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved,” the group said.

— Matthew Perrone

  • The devious cover up of these failed devices, is another areas the FDA or some other agency should be looking into. The FDA failed to compile the many complaints they got over years, due to industry bribes and interference.

    Physicians took bribes and kick backs while they Gas Lighted patients. They instructed other physicians to remain silent, while the Hospitals has a protocol for dealing with less than satisfied patients. They are doing a secret recall of the Surgical Rods, they implanted in surgical patterns spines, even though a lot of these patients are dead. Patients reporting problems were denied follow up appointments or sent to other physician who lied too. Nurses were told these patients were merely drug addict or complainers.

    These devious criminals used the so called opiate epidemic, both the blame patients for the defective devices, and to sell them dangerous pain pumps. Regulators looked the other way just like they did when the big pharmaceutical companies were diverting opiates to the black market.
    The US healthcare system is run like a criminal conspiracy, thanks to corporate greedy, sleazy doctors and surgical centers out to profit from people’s pain. Patients that were forced to go to the ER with these defective implants were sent away, accused of being criminals, because one the main symptoms was pain. They paid psychological researchers to blame the patients for their criminal behavior. The FDA took years to respond, just like they did with leaking Fentanyl patches that killed people, and the criminal pharma executives. A lot of the deaths were attributed to opioids so they could hide the facts.

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