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Sadwin gets to the heart of the Issues with FDA 510(k)

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 system with having a genuine 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 genius 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 implemented now, not after 8 committees are formed or 20 new rules are added on top of the existing bad rules.

Rest assured, 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 wrath of hell, and the necessary changes would happen now, when it is definitely needed not ??? years from now.

I said this before and I will repeat myself again, and again, until somebody simplifies and implements 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 victims??


Howard Sadwin

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