Consumer Reports Brings Public Scrutiny Over Medical Devices to Light

Consumer Reports Brings Public Scrutiny Over Medical Devices to LightConsumer Reports, which has been reviewing the safety of automobiles, refrigerators and other appliances for 76 years, is currently attempting to rouse the public into urging the U.S. Food and Drug Administration to change the way medical devices are approved in the country, Reuters reports.

According to the news source, there has been a constant effort on the part of lawmakers for the past couple years to change the way health regulators approach medical devices using  the fast-track process that still have the potential  to cause injury or death.

"It's a nightmare scenario," Jim Guest, Consumer Reports president, wrote in an email that was sent to nearly 1 million Americans in 2011. "The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you."

While Guest's warning may sound hyperbolic, the email was based on fact, the news source stated. Currently, millions of medical devices such as artificial hips, contact lens solution, heart stents and pacemakers are being recalled, at a rate of roughly 700 different products every year. What's more, many of these recalled products were found to have never been tested for safety in humans, as the manufacturers claimed the product was similar to a device already on the market.

The process has been around for decades, and allows certain devices to be cleared by the FDA without any human testing, which manufacturers have found can be time-consuming and costly. The fast-track approval process, known as Pre-Market Notification, or 510(k), is intended for low-risk medical devices, such as blood pressure cuffs and hypodermic needles, as well as moderate-risk devices, the media outlet stated.

However, the process is being used for a number of high-risk devices, including hip implants and heart valves, which have been cleared only to be found to cause life-threatening incidents later, Guest said.

Across the country, organizations and agencies are pushing for the FDA to make changes to the process. The Institute of Medicine, which provides medical advice to the legislators and the public, stated the 510(k) process is "fatally flawed," and should be canceled.

Changes to the approval process could come in the next year, the news provider stated, as Congress is currently reviewing the fees the medical device industry pays the FDA for quicker review times. In February, U.S. congressmen Edward Markey, Henry Waxman and Jan Schakowsky introduced a bill that would allow the FDA to reject a manufacturer's application for a new device if it is based on a product that has previously been recalled.

Guest stated that any new law should require extensive testing, and cited the 93,000 people who have been implanted with DePuy's ASR hip system, which has led to more than 2,000 defective medical device lawsuits that have been filed against Johnson and Johnson.

"When clients call, they are livid when they find out how [the device] was approved. They say 'I don't understand how this was able to get on the market in the first place,'" said one attorney from a New York law firm. However, she added, such patients are typically too distraught by the health problem to go about raising awareness.

According to Bloomberg, U.K. researchers have found metal-on-metal hip implants, such as Johnson and Johnson's, are more likely to fail than devices made from other materials, and have called for the products to be banned.

"Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted," wrote study leader Ashley Blom. "All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads."