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High Risk Medical Devices Modified Without Oversight or Data

high risk medical devices


In my last post, I wrote about the significant dangers of the accelerated drug approval process.  The situation concerning the modification of medical devices is actually worse.

A new study by researchers at the University of California San Francisco and Yale School of Medicine found that modifications to approved high risk medical devices can be modified without scientific data to demonstrate the safety and benefit of the modification.

“This means that many Americans have high-risk devices, which are often implanted in which we cannot be sure of safety and effectiveness,” says study senior author Rita Redberg.

Adding insult to injury (literally), these devices are not subject to lawsuits when they fail and injure patients.  “This means,” the researchers wrote Aug. 15 in JAMA, “that patients lack legal recourse if a (high-risk) device is faulty and adversely affects health outcomes. Thus, it is vital to ensure safety and effectiveness by requiring high-quality clinical data before high-risk devices reach the market. The findings that few supplementary changes require clinical data, and that when they do the data are often low quality, raise uncertainty about performance of many commonly used devices.”

The court decision that barred lawsuits involving the safety of devices that have gone through the FDA’s more detailed review process is based on the assumption the process is “already an assurance of safety and effectiveness,” Redberg said. It is important, she added, that the process have “high quality data on which to base that assurance.”

“There’s a lot of pressure on the FDA to speed things up, to let innovative or life-changing treatments go to market,” said Redberg, who is a professor of medicine at UCSF author, “but you don’t know if they’re innovative or life-changing until you’ve done a careful study. These were short studies, with low-quality data, and little follow-up after approval.”

After high-risk medical devices are cleared through the FDA’s premarket approval (PMA) process, any change or supplement is required to be submitted to the agency for review. Individual devices frequently have hundreds of changes.

According to the new study, for example, between 1979 and 2012, there were more than 5,800 supplements for 77 approvals for cardiac implantable electronic devices. This means “many high-risk devices differ substantially from the originally approved device,” according to the study. And the total number of device approvals has been increasing over time.

This accelerated approval process only benefits one constituency-the medical device industry and leaves the patient vulnerable to serious injury.

“Almost all PMA (pre-market approval) devices, which range from orthopedic knee replacements to cochlear implants and infusion pumps, accumulate several—and often hundreds—of supplements,” They wrote. “Companies often submit changes to a device one supplement at a time instead of submitting multiple changes in a single application. As a result, each submitted modification is evaluated separately, a process that makes it difficult, if not impossible, to take into account the cumulative effects and interactions of multiple modifications. Because the PMA supplement process is piecemeal, the accumulation of supplements may result in a final product that differs significantly from the original device. Clinicians are generally unaware that the device they are considering for their patient has been modified (and often not tested) since they read about the original, unmodified device in published clinical trials.”

What can patients do to protect themselves?

“Patients should have a discussion with their physician about risks and benefits and the quality of evidence to support any device or procedure that has been recommended,” Redberg noted. “That discussion should be part of informed consent for device implantation.”

As in the pharmaceutical industry, the medical device industry operates in a world designed for its own benefit with little or no regard to the patient.  

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