Amidst controversy, FDA under pressure to overhaul medical device approval process  The U.S. medical industry is under heavy pressure to cut costs and boost efficiency. Although there have been reports of recalled medical devices over the past few months that have caused injuries and an uptick in business costs for many hospitals, there are increasing calls for the Federal Drug Administration to speed up its approval process for the devices, according to a recently published report.

The Los Angeles Times reports that analysts and industry watchers alike have come together to criticize the way in which the FDA approves medical devices. Over the past few years, the FDA has been mired in controversy following its approval of high-risk devices that were later deemed defective and required large-scale recalls. For example, an artificial hip produced by Johnson & Johnson left shredded metal in patients.

Last year, the FDA ordered manufacturers to recall 90,000 artificial hips after a study showed that one out of every eight recipients required replacements. Consumer health advocates contend the FDA hastily approved the devices and that its inability to effectively protect consumers led to the recall.

Some experts, however, assert that like any industry, there are bound to be mistakes made, and that the FDA is being unfairly targeted for its approval process. Vertical Group partner Jack Lasersohn said the calls to overhaul the approval process were unnecessary. "We fly airplanes, right?" he asked. "There are failures. Airplanes do crash occasionally. We don't shut the entire industry down."

The burgeoning controversy mostly centers on a loophole that allows certain high-risk devices to enter the market through an abbreviated approval process because similar products were introduced to the market before the newer laws existed.

Nonetheless, some worry that if the FDA were to tighten those rules, it could lead to a halt in innovation and supply disruptions as it would take longer for medical devices to gain regulatory approval. Further, some contend such a lengthening of the approval process would drive manufacturing jobs to other countries as medical device makers work to bypass the most stringent rules.

What the FDA may ultimately need to do is figure out a way to analyze and synthesize information in its adverse-reporting database more effectively, said ECRI Institute vice president for health technology Jim Keller. "There currently is not a good way to do that," Keller told the newspaper. Improving the post-market surveillance is key to cutting risks, according to Diana Zuckerman, the president of the National Research Center for Women and Families.

If the FDA does that, lives could be savesd, patients would spend less time recuperating in hospitals, "and billions of Medicare dollars could be saved as well," Zuckerman said to a Senate committee investigating the issue last week.

For its part, the FDA has publicly acknowledged the complaints against its approval process, but it has also defended itself, affirming the process if complex. "We know that medical device development is expensive," said Jeffrey Shuren, the head of the FDA's medical device office. "And we agree that, in many areas, insufficient clarity, consistency and predictability on our part contributes to those expenses."

However, Shuren said the FDA has proposed a process that would streamline the approval process for low-risk medical devices. Until then, Shuren said "we don't use our people as guinea pigs in the U.S."

Editorial Correction:  Please see this post: Revisited: Overhauling the FDA’s approval process for medical devices
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