What isn’t being published is the truth regarding the medical device world.
by Howard Sadwin
If we obtained data in USA re: hips 2004 – 2008, procedures, adversities reported to surgeons, FDA etc. we could be better prepared to deal with this disaster. Also enlighten people with all the FDAs new ideas and actions.
Unfortunately, the FDA neglects to face facts: there does not seem to be any control of basics now and back in time regarding medical device manufacturers. All these new actions, new punishment, new data on devices, etc. if you paid for all the information firstname.lastname@example.org it would cost me thousands of dollars and all I would be getting is proposed actions to be taken and under tight scrutiny of FDA a lot of paper, when in reality it appears the medical device world dictates the rules.
By the time anyone can agree right and wrong and implementation of an established penalty system and an understanding of what the FDA is trying to say, a medical device could fail, be replaced by another, it could fail etc. on the good side there will be more success stories than failure stories.
I mentioned once before if you go through a red light, you pay a fine, go to jail or go to court, end of story if your medical device harms a human being because of the product, you pay a fine ( high enough to rattle the board of directors) and put a stop to the medical device world dictating the rules.
Mr. Blumenthal is a positive note for changing this system, however, monitoring these devices was a stipulation made in approval of some hip devices, why was this not acted upon when these same devices began hurting people, if proper action wasn’t implemented back then, how are they going to change the necessary actions to be taken against a device manufacturer when it fails ?
Why do we make things so difficult; what is the harm in publishing and broad casting the truth, “ If you have a metal on metal hip and are experiencing problems seek professional help”.
Repetition of this type of information will help a fair amount of people, as you know, and this is one of the most important things we can hope to accomplish quickly.
The comment in Barry’s article as spokeswoman for the FDA Karen Riley studies had shown that current 510k approval process was remarkably safe. I ask myself what is she basing her comment on?
People need to be informed about who runs the show, the FDA or the medical device world . Getting new devices on the market is great the quicker the better, who is this better for Market Share or humans?
- FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY) (fda.gov)
- Austen BioInnovation Institute, FDA to partner on medical device regulation (medcitynews.com)
- Bill Would Require More Monitoring of Implants – NYTimes.com (earlsview.com)
- Cosmetic Dermatology Center to Offer Cellulite and Contouring Treatments with Viora’s Reaction™, a Leading RF-Based Bi-Polar Medical Aesthetics Device (prweb.com)
- Sadwin gets to the heart of the Issues with FDA 510(k) (earlsview.com)
- St. Jude Medical hit with Class I recall for faulty defibrillator leads (medcitynews.com)
- Handheld brain bleed detector gets FDA approval (medcitynews.com)
- QuickMedical Introduces The Samaritan Pad Public Access Defibrillator (prweb.com)
- Stop Misbranding Lap-Band In Your Advertising, FDA Warns Companies (medicalnewstoday.com)
- Doctor in Oklahoma Gets 17 Day Review and Approval for EZ Vein-Non Invasive Device To Help With Inserting IVs & Finding the Veins (ducknetweb.blogspot.com)