IOM slams the FDA’s 510(k) medical device review process

MASSDEVICE ON CALL — Nearly two years and $1.3 million dollars after the FDA asked the Institute of Medicine to review the watchdog agency’s fast-track 510(k) medical device clearance process, the IOM’s conclusion on how to improve the system is to get rid of it completely.

The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, is not binding on the agency but is sure to cause a stir in med-tech circles.

The agency last summer adopted a slate of less-controversial changes to the program, by which most medical devices are cleared for the U.S. market, but punted on implementing some of its more controversial proposals until publication of the IOM review.

"It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying it again will not help," said David Challoner, who chaired the committee that wrote the report. "The 510(k) process cannot achieve its stated goals – to promote innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with the statutes that govern how FDA must implement the process."

With that out of the way, all eyes are on the agency as it digests the IOM’s recommendations and charts its course for what could be further, radical changes to the program.

FDA officials reacted quickly to the IOM’s recommendations, issuing a statement saying that while none of the institute’s edicts were binding, the agency would be planning a public meeting in the coming weeks. Officials at the agency have been somewhat distancing themselves from the report for several weeks now in both congressional hearings and negotiation meetings for reauthorization of the Medical Device User Fee and Modernization Act with industry.

"We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," said Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health said in a prepared release.

The FDA wants to make reusable medical devices cleaner and home devices more user-friendly.

The FDA has taken an interest in home-use and re-use medical devices this month on concerns that reusable devices are a risk point for infections and home devices are at risk of misuse.

The FDA released draft guidance recommending more stringent review of reusable medical devices like surgical suction tips and endoscopes to ensure that reprocessing or sterilization techniques are sufficient to protect patients from infection.

The watchdog agency also conducted a webinar to address what it sees as a growing trend of medical devices entering the home where risks of misuse is heightened by factors like instructions that are too complicated for a lay user and an unpredictable environment that may include power outages, vermin and children.

The FDA plans on releasing additional guidance on home medical technology later this year.

San Francisco scientists turn skin cells into functioning brain cells

Researchers have managed to turn human skin cells into functioning brain cells with a novel method that marks one of the first documented experiments of transforming an adult human’s skin cells into functioning brain cells.

"This work could have important ramifications for patients and families who suffer at the hands of neurodegenerative diseases such Alzheimer’s, Parkinson’s and Huntington’s disease," said Dr. Lennart Mucke, who directs neurological research at Gladstone, in a press release. "[Lead author] Dr. Ding’s latest research offers new hope for the process of developing medications for these diseases, as well as for the possibility of cell-replacement therapy to reduce the trauma of millions of people affected by these devastating and irreversible conditions."

Computers cause problems for mammograms

Computer-aided detection technology lead to more false-positives without detecting more cases of breast cancer, according to a study published in the Journal of the National Cancer Institute.

The study considered 1.6 million mammogram conducted at 90 centers between 1998 and 2006. A quarter of the centers used computer-aided detection, which is intended as a backup to a radiologists reading of a mammogram, the Wall Street Journal’s Health Blog reported.

Health care spending to make up nearly 20 percent of U.S. economy by 2020

Health spending will account for nearly one-fifth of the U.S. economy by 2020 and the government will pay about half of the costs, according to a report published in the journal Health Affairs.

The report warns that the projections are highly uncertain and depend heavily on constantly changing economic conditions, Healthwatch reported.