Imagine a medical device, implanted permanently in your body, that’s not been required to provide proof of safety?
That’s what has happened at the Center for Devices and Radiological Health (CDRH), which oversees medical devices under the Food and Drug Administration (FDA).
The FDA now wants companies to submit data on certain older, unproven medical devices to determine their risk to consumers. Medical devices to be reviewed include parts for pacemakers, spinal screws, a heart pump, and a dialysis catheter, among others.
In 1976, the Food and Drug Administration enacted a medical device law that classified latex gloves, catheters, heart pumps, and surgical mesh into categories depending on their level of risk. Class I were the least risky such as medical gloves while Class II were more risky such as surgical mesh.
Some Class III devices, inherently more risky were told they needed more testing, but were allowed to be left on the market and grandfathered in under the 510(k) process. Under 510(k), the manufacturer contends the product is substantially similar to a “predicate device” already on the market.
In 1990, Congress directed the FDA to require safety evidence before a Class III device could be sold, but the agency never finished the job.
By 1994, 149 Class III medical devices still had not had a rigorous review. The FDA has been reviewing and issuing new regulations for all but 27 devices.
Federal regulators said Wednesday these 27 potentially risky devices now need to prove their safety and efficacy. It is the same sentiment echoed in January by a Government Accountability Office (GAO) report critical of the FDA for failing to address the pre-1976 devices, also known as legacy devices.
Makers of 25 of these legacy devices have 120 days to detail the device’s safety and effectiveness. Two other devices will be reviewed by the FDA.
Manufacturers have the option of seeking a reclassification as a Class I or Class II device, if it qualifies.
InjuryBoard News has reported on synthetic surgical mesh, a Class II medical device, that was approved for marketing after it was found to be similar to another mesh that had been taken off the market as faulty.
Critics of the FDA’s CDRH have long urged a system-wide overhaul.
Talking to the New York Times, Diana Zuckerman, president of the National Research Center for Women and Families says, “It’s great that FDA is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness.”
Zuckerman believes the Center for Devices is broken and needs a major overhaul.
In January, a group of FDA doctors wrote to President Obama’s transition team that managers inside the Center “have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods.” Their words were passed to FDA then-Commissioner Andrew von Eschenbach in a letter sent by Iowa’s Sen. Charles Grassley.
The Wall Street Journal reports that the request for evidence of safety will cover Medtronic Inc’s external heart defibrillator, Royal Philips Electronics NV and Zoll Medical Corp; dialysis catheters from Covidien; hip joints from Zimmer Holdings; spinal screws from Medtronic and Johnson and Johnson; and a heart pump from Abiomed Inc.
The companies likely will have to cover the cost of clinical trials to prove the safety of the devices. #