Consumer Reports is taking a look at the approval process for medical devices. The 76-year-old publication is trying hard to galvanize the American public into protesting the way these devices are approved by the U.S. Food and Drug Administration. It was pointed out that during the past couple of years, there has been a steady drumbeat of concerns by some lawmakers that health regulators are doing too little to protect consumers from hastily approved devices that can cause injury or even death. Consumer Reports President Jim Guest wrote in an email blast to 1 million Americans earlier this year:

It’s a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you. This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled — 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.

For decades, certain devices have been cleared by the FDA without the manufacturers ever having to test them in human beings in clinical trials, which take time and money. The fast-track approval process is known in the industry as Pre-market Notification, or 510(k), named for the numbered section of the Food, Drug and Cosmetic Act. Intended for low- and moderate-risk medical devices, such as blood pressure cuffs and hypodermic needles, too many high-risk devices, such as hip implants and heart valves, were cleared through the 510(k) process and later found to cause life-threatening incidents, according to Guest.

Consumer Reports, an independent nonprofit, publishes a monthly magazine, as well as newsletters focusing on a number of areas, including safety, health, money, and other topics. It has a total of 8 million subscribers to all of its publications and 800,000 for its On Health monthly newsletter, which was established in 1989. While On Health maintains its own medical experts, it also uses outside physicians.

Consumer Reports’ advocacy arm, Consumers Union, says that its campaign to change the medical device approval process is a top priority. The campaign was launched late last year at its annual Patient Safety Summit. The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as “fatally flawed” and said it should be “scrapped.”

Even the FDA believes that the current device-approval process could stand some improvement. Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said 510(k) should not be eliminated, but that changes to the process are in order. Since only Congress has the authority to change the way devices are approved, FDA cannot change the process. But the FDA can change the way it classifies devices. Hip implants and heart valves, for example, are categorized as “moderate risk,” which allows them to go through the 510(k) process. That’s most significant.

Most new medical devices – some 4,000 in 2009 – are cleared through the accelerated program. AdvaMed, the trade group representing medical device makers, is against more regulation, but it apparently agrees that streamlining the process is necessary to move the large volume of products awaiting approval through the system.

Possible changes to medical device regulations are especially relevant this year, as Congress is reviewing the fees the industry pays to the FDA in exchange for speedier review times. Since fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, the bill often serves as a vehicle for broader FDA-related changes. Republicans Edward Markey (D-Massachusetts), Henry Waxman (D-California) and Jan Schakowsky (D-Illinois), have introduced legislation – the Safety Of Untested and New Devices Act of 2012, dubbed SOUND Devices Act – that would give the FDA more authority to reject a manufacturer’s application for a new device if it was based on a similar product that was recalled.

Mr. Guest said any new law should also require rigorous testing of the devices upfront and a national registry that would track device performance over time. Raising manufacturers’ user fees that fund FDA could help fund a registry, he said. Some 93,000 people have been implanted with DePuy’s ASR hip system worldwide and J&J faces more than 2,000 lawsuits in state and federal court.

AdvaMed cites a September 2010 study by Battalle, a research organization it commissioned to look at the issue, that found that Class 1 recalls, the most serious kind, accounted for only 77 out of 46,690 (0.16%) of the medical devices – including low risk devices – that were cleared through the 510(k) process between Jan. 1, 2005 and May 1, 2010. But Consumer Reports points out that a more recent study of the same data had a far different result. The study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen, the cardiovascular medicine chair at Cleveland Clinic, was published in the peer-reviewed medical journal, Archives of Internal Medicine, in February 2011.

Dr. Zuckerman said Battalle understates the problem because many products are often recalled after they have been on the market for five years or more. In addition, she noted that the Battalle study only looked at raw numbers of device approvals and did not consider how many people were affected by recalls. Dr. Zuckerman observed:

If you care about public health, you look at how many devices were recalled and how many lives were put at risk.

Dr. Zuckerman said her study concluded that more than 70% of the high-risk recalls were for medical devices that the FDA categorized as “moderate risk” and therefore went through the 510(k) process for approval. AdvaMed, however, said the real problem at FDA is growing delays and inconsistency in product reviews.

Sources: Consumer Union and the Claims Journal