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Al Franken, Amy Klobuchar, Erik Paulsen, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Institute of Medicine, Medical device, Minnesota, US Congress
Editorial: The wrong prescription on medical devices
Article by: EDITORIAL , Star Tribune
Updated: August 6, 2011 – 6:19 PM
Report calls for blowing up key path for product approvals.

The prestigious scientific panel was supposed to fix flawed medical-device regulations. Instead, the Institute of Medicine experts recommended an unrealistic and unnecessarily harsh prescription: blowing up the current route to market for many moderate-risk products.
The stunning recommendation is nonbinding but could not be more ill-timed. Economic storm clouds are gathering again.
Instead of reducing the uncertainties faced by an industry providing well-paying jobs in Minnesota and across the nation, the panel amplified the unknowns with its call to scrap the decades-old 51-(k) clearance process and start over.
The process, concluded a panel of mostly academic experts, “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and … cannot be transformed into one.”
So much for enticing already scarce venture-capitalist dollars back to this industry. Or stemming the tide of research and development jobs moving offshore — something documented by a PricewaterhouseCoopers report earlier this year.
The panel’s work also did nothing to enhance patient safety — the most important concern of all. The U.S. Food and Drug Administration (FDA) began weighing changes to the process in part because of a small but highly publicized number of medical-device recalls.
Industry also has long been frustrated with the unpredictability of the process, its expense and lack of transparency.
Congress, given its political divisions and budget challenges, is unlikely to prioritize or agree on a device regulation overhaul. The FDA, which asked the IOM to help strike the best balance between patient safety and industry concerns, is on its own again after waiting nearly two years for clarity.
Good sense fortunately prevailed at the FDA after the report’s release. That same day, the agency issued a statement saying the 510(k) process “should not be eliminated.”
The report also drew bipartisan criticism from Minnesota Republican Rep. Erik Paulsen and the state’s Democratic Sens. Amy Klobuchar and Al Franken.
The IOM remains one of the most respected organizations in the scientific world. But this panel bizarrely not only failed to answer some of the FDA’s specific questions about process improvements, it didn’t even outline what the replacement process would be.
The 510(k) pathway is designed for medical devices similar to existing ones and is thought to be the more expedient route to market. Among 510(k) products: angioplasty catheters and hospital pumps.
The scrap-the-system proposal certainly is an industry rebuke. Device manufacturers have done themselves no favors with questionable consulting payments to doctors. Industry advocates also sometimes seem opposed to all regulation.
But at a minimum, the IOM panel should have made a safety-based case for such a radical change. It did not, admitting that continued use of these devices provides reason for “a level of confidence in their safety and effectiveness.”
Recall data provided by University of Minnesota Law School Professor Ralph Hall underscores that. Just 0.45 percent of 510(k) clearances from 2005-2009 were subject to Class I recalls, the FDA’s most serious recall category.
That drops to 0.22 percent when premarket issues only are considered. (Postmarket issues, such as manufacturing defects, likely wouldn’t have been prevented by scrutiny before the device’s sale.)
Perhaps a new system would improve upon this. But would the marginal gains justify the time and expense involved?
Not answering this fundamental question suggests the IOM panel chose idealism over pragmatism. The FDA and industry at least seem to agree on that. Leadership on both sides must now leverage this new common ground to find the best way forward.
Related articles
- 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
- US Congress Women Rosa L. DeLauro Takes FDA To Task Over Comments re IOM Report (earlsview.com)
- FDA’s 510(k) program should not be scrapped, say Minnesota politicians (medcitynews.com)
- Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? (earlsview.com)
- FDA Seeks Public Views on Proposed 510(k) Plans (earlsview.com)
- Report could sway FDA device review process (earlsview.com)
- How Safe Are Medical Devices? (earlsview.com)
- 510(k) approval process is too big to fail no matter how flawed it may be (earlsview.com)
- Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process (earlsview.com)
- U.S. advisers call for new medical device regime (earlsview.com)
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I spend a good part of my day keeping up with reading all the information re: hip & knee posted on your site.
The latest and greatest information regarding improving a antiquated system 510k plan, is so convoluted with this group or that group or this reg or that reg I get dizzy reading. A fire has been ignited, that great, only took the hip debacle to raise concerns. Apparently not enough concern to demand immediate actions. I read comments like one doctor, and I quote, ” if the device was ok’d by the FDA it is ok to use on my patients.” ( surgeon from California made this statement ). If I understand the group that votes on these devices is comprised of 12 people. 3 of which are lawyers, problem 1, I would think you need one lawyer, one that has knowledge an expertise in medical device law, and can answer questions that pertain to the law. 2 additional lawyers must represent companies for and against approvals I don’t know, extra money wasted unless they manufacturers are paying them, but that may be a conflict of interest. Then you have people that should be experts in developing a safe sytem with having a geuine concern for the patient not the company’s financial responsibilities to reporting favorable actions to their investors. These doctors, nurses or lay people should be tested as to knowledge of whatever approval process is instituted. Doctor’s are usually brilliant in their fields of practice and not so geniuos in business matters, unless they may have a vested interest, consultant for a medical device manufacturer or how ever they may have financial gains affiliated to a manufacturer, this is not always the case. We need common sense, logic, and a course of action, to be implimented now, not after 8 committees are formed or 20 new rules are added on top of the existing bad rules.
Rest a sure if a tragedy, I wish no harm to any one, involving a knee or hip device that I read about each day, should happen to someone way up on this food chain we would see the rath of hell, and the necessary changes would happen now, when it is defintely needed not ??? years from now.
I said this before and I will repeat myself again, and again, until somebody simplifies and impliments a course of action that will prevent this from destroying the quality of
one’s life, the necessary changes or even a new plan of approval process will take how many more unnecessary victems??
Respectfully
Howard Sadwin
Hi Howard – pleased you are getting some use out of the blog!
I have made your comments – good as usual – into the latest blog!
Keep writing – the more you write, the more I publish, the more you will become a recognised voice in the space & be picked up on Google searches.
PS – did I get the right photo of you?
Earl
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