Study Shows Nearly Half of Medical Devices Approved Before Studies Published

Many consumers believe that the Food and Drug Administration (FDA) carefully reviews clinical trials completed on a medical device before approving it for sale on the market. Manufacturers seeking approval are expected to perform careful trials that prove the safety and efficacy of their devices, and the FDA is thought to carefully vet those studies to be sure they’re of high quality and that the results support the manufacturer’s claims.

Well, the process may not be as careful as we think, according to a recent study published in the British Medical Journal. According to researchers, nearly half of the devices approved between 2004 were cleared for use before the clinical trials were even published.

The problem with that? Without published data, doctors and patients are left in the dark as to the benefits and risks of the product, having to rely strictly on the manufacturer’s materials, which are often skewed to highlight the benefits while downplaying the potential risks.

Nearly Half of Medical Devices Cleared Before Clinical Trials Published

For their study, the researchers searched PubMed to find clinical studies on new medical devices published between 2000 and 2004. They then searched the FDA medical databases for information on the devices clearances or approval.

They ended up with 218 studies that met the criteria. After reviewing these studies, the researchers found:

• 45 percent of the devices described in the studies ultimately received FDA approval.
• These included those products cleared through the so-called “fast-track” 510K process, which requires no clinical trials, but only that the product be proven substantially equivalent to one already on the market, as well as premarket approval for high-risk devices, and others.
• Of all these, 43 percent of the devices were actually cleared or approved before a clinical study was published.

“Without high quality clinical data available,” the researchers wrote, “informed shared decision making on the use of new medical devices is difficult if not impossible.”

Researchers Suggest Changes to Regulatory Approval Process

The researchers noted that because some medical devices can be harmful, the FDA should be careful to ensure the safety and effectiveness of new ones before they are allowed on the market. The standard method for gaining approval involves the following steps:

• Development of the device
• First in-human study
• Evaluation of the device in clinical trials
• Regulatory approval for use

According to this study, however, many new devices receive regulatory approval without clinical trial data supporting their safety and effectiveness—especially those approved through the 510(k) pathway.

The researchers suggest the IDEAL model of regulatory approval, which proposes staged introduction of new innovations, including randomized controlled trials that would assess safety and effectiveness.

“At present,” the researchers write, “few relevant randomized controlled trials are published, and fewer still meet currently quality standards for optimal reporting.” They suggest changes in the approval process that would require trials that prove safety and effectiveness.

A number of medical devices approved by the FDA over the last several years were found to be associated with serious harms after they reached the market and thousands of personal injury lawsuits filed as patients sought to recover damages for their injuries.