While the debt limit debate dominated the weekend news cycle, another story was unfolding that could have its own, considerable impact on health care for years to come — the Institute Of Medicine's analysis of the 510(k) regulatory process for approving some new medical devices.

The IOM's researchers, who were charged by the FDA with analyzing whether the current process protects patients and promotes innovation, concluded that the current system "was not intended to evaluate the safety and effectiveness of medical devices with some exceptions." The report also said it was difficult to determine what impact, if any, the current system has had on regulation, and ultimately called an end to the current process — which it characterized as not a "wise use of the FDA's scarce resources." Going forward, the IOM report called for a new system that both promotes innovation and better ensures the safety and effectiveness of the devices.

Initial response to the report has been mixed. Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement that the FDA does not agree with the main premise of the report.

"FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.

Meanwhile, the Premier healthcare alliance welcomed the report, and noted that the FDA has a strategy in place to analyze the performance of pharmaceuticals after approval; a similar system is needed for medical devices, the group argued.

"We need this type of system in place for medical devices as well, and the FDA is making progress toward implementing a rule for a unique device identification system to improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting," the Premier statement said. "As an industry, we need to ensure that only those devices that are safe and effective make their way into the market, and we need ongoing research on the efficacy of those products after they have been put into use."

Unsurprisingly, the Medical Device Manufacturers Association was skeptical of the need for new regulations. MDMA President and CEO Mark Leahey said in a statement that the current process "has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted. We remain concerned about reform efforts that would create additional uncertainties and slow patient access to medical therapies."

Consumers Union, the nonprofit publisher of Consumer Reports, also weighed in, noting the importance of effective devices for patient safety and trust:
"When a device is recalled, patients must endure additional physical, emotional and financial stress. It is critical that the results of the IOM study are not prejudged and are given a fair and thorough examination."

Future steps for the report aren't clear. Many of the recommendations would require congressional approval to go forward; for the time being, the FDA is calling for public comment on the process. Still, the conclusions of the report are pretty stark — painting a picture of a regulatory system that neither protects patients nor promotes innovation. What do you think? E-mail your thoughts to hbush@healthforum.com.