Medical Device Safety Concerns Rheumatologists

This has led to many devices never being subjected to close scrutiny by the FDA or anyone else. “Today we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing two years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976,” wrote Dr. Challoner in a recent Perspective for the New England Journal of Medicine. “But that original device might never have been assessed for safety and effectiveness, nor perhaps any subsequent ones in the family tree.”²

The definition of what constitutes a predicate device can be very broad. For example, the metal-on-metal hip prosthesis marketed by DePuy as the ASR XL Acetabular System was authorized because it was deemed to be substantially equivalent to other approved predicate devices. This was despite the fact that the ASR system used two metal parts instead of the plastic-on-metal of most previous devices.

Different Regulatory Systems

The regulatory environment for medical devices is substantially different from approval of pharmaceuticals. Perhaps the biggest difference is the use of the predicate device. The equivalent in drug approval would be requiring the first-in-class to go through the New Drug Approval process, while allowing the follow-on, or “me too” drugs, to be marketed by just pointing out their similarities.

The FDA has stated, and no less an authority than the U.S. Supreme Court has agreed, that a finding of substantial equivalence is not a determination of safety and efficacy. Again, this is a much less stringent requirement than seen in pharmaceutical regulation.³

IOM Reports on Process

Because of this and other concerns, the FDA in 2009 asked the Institute of Medicine (IOM) to review the 510(k) approval process. The IOM’s Committee on Public Health Effectiveness of the FDA 510(k) Clearance Process was tasked to look at whether the current system protected patients while still allowing for innovation and improvement of devices. If not, they were asked to formulate suggestions for policy, legislative, and other changes that might help bring that about.

In 2011, the committee published its findings. Among them:

• The FDA should design a new program that replaces substantial equivalence with a pre- and postmarket surveillance system to follow safety issues throughout the device’s life cycle;
• The FDA should develop a strategy to collect, analyze, and then act on postmarket performance;
• The FDA should review current processes to identify limits on postmarket authority and determine how to address these limits; and
• The FDA should look into the viability of a modified de novo process to evaluate the safety and effectiveness of Class II devices.

“We are hoping to make the public aware of the current defective rationale that just because a new device is similar to something else it should be marketed,” says Dr. Challoner, who was also chair of the IOM committee. “We can’t have the kinds of premarket trials that the drug companies undergo, but if we have sensitive, rapid, and transparent postmarket surveillance attached to these devices, we can know much earlier on if there is a problem.”

Aftermarket Studies

The current environment may be especially conducive to making this kind of aftermarket study possible. Large healthcare systems are evolving that can track the devices going into individual patients, and many healthcare systems already do. As electronic medical records are rolled out nationally, this will be easier to accomplish.