Call for Overhaul of FDA's Medical Device Clearance Process

The highly respected New England Journal of Medicine has joined a growing chorus within the medical profession that is calling for a major change to the way medical devices are cleared for the marketplace. Although medical device companies and some politicians are fighting this call for change, the NEJM makes it clear that patient safety must take priority. The defective medical device lawyers of Davis, Saperstein & Salomon, P.C., agree.

The article, “Medical Devices — Balancing Regulation and Innovation,” appears in the NEJM’s August 10 edition. It is available online. Dr. Gregory D. Curfman, the NEJM’s executive editor, and Dr. Rita F. Redberg, the editor of the Archives of Internal Medicine, are the authors. It’s an important piece.

Currently, medical devices can be cleared for the market through a U.S. Food and Drug Administration (FDA) process that is known as the “510(k) process.” This refers to a section of a 1976 law that allows clearance for medical devices that are “substantially equivalent” to other devices that have already been cleared for the market. No clinical trials or clinical data are required.

As the NEJM article points out, this process has led to dangerous medical devices being implanted in patients and causing painful consequences. The NEJM points to the DePuy ASR XL Acetabular System – a metal-on-metal artificial hip implant – as a prime example of how the 510(k) process fails patients.

Traditional artificial hip implants consist of a metal ball inserted into a plastic cup. With the DePuy ASR hip implant, however, both parts are made of a metal alloy. According to the NEJM, it was made by using a metal alloy cup from a different hip device, the ASR Hip Resurfacing System, which was already on the market. By arguing to the FDA that it was “substantially equivalent” to the predicate device, DePuy managed to get the hip implant cleared through the 510(k) process in 2005.

However, the DePuy ASR XL Acetabular System had only been bench-tested. It was unknown how it would hold up to the stress that would be placed on it in patients’ bodies. As it turns out, the results have been disastrous.

A report by the British Hip Society found that 1 in 5 of these metal-on-metal artificial hips have needed replacement, or “revision,” within four years of being implanted. After six years, the revision rate goes up to nearly 50 percent. Compare that to other devices, in which the revision rate is at 12-15 percent at five years after implantation.

According to the NEJM, the failure can be attributed to the metal flaking off and migrating into surrounding tissue and the bloodstream. In fact, due to this above-normal failure rate, DePuy Orthopaedics Inc., voluntarily recalled the artificial hip device in August 2010.

By that point, however, more than 93,000 of these medical products had already been sold around the globe, including 37,000 in the U.S., according to figures from the Wall Street Journal.

Because the DePuy ASR XL Acetabular System is classified by the FDA as a Class III device – the highest risk category – the NEJM authors argue that it should have been cleared through the FDA’s more stringent premarket approval (PMA) process, which requires clinical testing. As it stands, the NEJM says, the 35-year-old 510(k) process is “especially inappropriate for such risky devices.”

This echoes the conclusion reached in a FDA-commissioned report by the Institute of Medicine that came out in July 2011. The IOM found it was “impossible for 510(k) clearance to assure safety and effectiveness, because it assesses neither,” the NEJM says.

The IOM called for the process to be scrapped. The NEJM concurs.

“The 510(k) clearance process was established 35 years ago, and although it may have been a reasonable approach then, it surely is not today,” write the NEJM authors.

However, perhaps bowing to pressure from politicians and medical device manufacturers, the FDA is unlikely to abandon the 510(k) clearance system. Given that reality, the NEJM suggests three steps that can be taken right away to ensure the safety of patients:

• Stop using the 510(k) process for Class III devices, such as the DePuy ASR XL Acetabular System.
• Prohibit the use of “multiple predicates” for 510(k) clearance. For instance, some devices have been approved because they were “substantially equivalent” to other devices, which in turn had been cleared because they were “substantially equivalent” to another device.
• Establish a formal system for monitoring the safety and effectiveness of medical devices after they are cleared for the market. This will allow for quick identification of serious problems.

Although critics may say that greater regulation will stifle innovation, the NEJM wisely states that “no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients,” and at Davis, Saperstein & Salomon, P.C., we couldn’t agree more.

If you or a loved one has suffered serious injury due to a defective medical device, contact us today for a free initial consultation. We serve the New Jersey communities of Newark, Elizabeth, Paterson, Teaneck, Trenton and more, as well as the New York City area.