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??
- Sadwin Comments on Washington Post Article – Letter to Authors (earlsview.com)
- Sadwin Raises More Questions – Will They Ever Be Answered? (earlsview.com)
- Sadwin has a few other Pithy Points for the Orthopaedic “Big Guys”… (earlsview.com)
- Medical Devices – Balancing Regulation and Innovation (earlsview.com)
- Sadwin Doesn’t buy the BHR Story … (earlsview.com)
- Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process (earlsview.com)
- FDA Seeks Public Views on Proposed 510(k) Plans (earlsview.com)
- IOM Gives FDA The wrong prescription on medical devices & 510(k) (earlsview.com)
- 510(k) approval process is too big to fail no matter how flawed it may be (earlsview.com)
- FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units (earlsview.com)