Tags
FDA, Food & Drug Administration, hip, Human, Manufacturing, Market Share, Medical device, UNited States
Recent Information from the FDA on Failures
This information came from FDA news.
The FDA says approximately 44% of device recalls are due to faulty design.
Recalls are expensive, embarrassing, and often lead to more serious financial consequences—not only from the FDA but also from courts and unhappy stockholders.
The comments continue, this ends by asking you to enroll in available programs of training in order to comply with the NEW regulations, Experts who offer FDA compliance Boot Camp learn how to develop a by the book quality management program. Leave the guessing to your competitors.
I receive 6-12+ daily FDA news comments describing all the new actions to be taken by the FDA to make sure we, the human beings are better protected. The new actions and new information are extensive enough to fill a library.
It would take a genius to interpret what these actions are trying to say.
Then the information indicates if you, a medical device manufacturer get caught doing something wrong, woe is you. Letters will be sent to you, then maybe a slap on the wrist, then maybe a small fine.
In the interim innocent people are being hurt physically, mentally, financially etc. I realize payrolls may limit the work force responsible for following up on these actions and implementing fines, however probably a good portion of the existing work force doesn’t have to be there to begin with; example: how often have you driven by a city, county or province work project, and there are 6 people hanging around while one or two people are doing the work ( wasted taxpayers monies).
Just as all these new actions will require God-may-know how many new groups will be necessary in order to implement, these actions and don’t forget we will need new groups to watch the old and new groups (spy system). It goes on and on and sadly enough we continue to suffer unnecessarily and nothing changes.
Wake up time, you can patch a leaky roof for only so many years, then believe it or not you need a new roof. I have yet to see any indication, that there is some form of control of the FDA never mind the medical device manufacturers, as they continue sell their devices. Yes I’m talking to all about these metal on metal hip devices. The one’s that have devastated the live of myself and many others.
I believe some hip devices were placed incorrectly, so is this surgeons faulty or a reflection of the manufacturers training program ?
There are surgeons that have done everything as per specs on patient, yet the device failed, poor design, materials, physiology etc. The doctors know only what the device manufacturer wants to tell them, some may know more, as we all know money does funny things to people’s minds. The manufacturers can’t get their products into our bodies quick enough. Yet, probably there is insufficient data in many of these newly approved devices, and there probably are quite a few from pass approvals. Doctors may use one new device over another simply because the device is being used by more people than less.
And then there are financial arrangements between certain doctors, hospitals, distributors, kickbacks! some doctors.
Perhaps the device manufacturer has withheld data in order to have their device approved or given questionable results, in order to speed up the approval of their device project. So once again I find myself being used a lab rat with the new hip I received 10/10/2011. The data is limited, this time I know the medical device game much better.
In my researching, it appears that MOM hips used during 2002 to present (in USA) have had devastating outcomes to the lives of many. This is why it is so important for you to come forward share your stories and then the key to making changes in our systems to prevent anything like this from happening again is up to me and you.
This will require a joint effort by all of us, if not, nothing will change; if you are suffering from a hip procedure make sure your doctor is reporting the problem to the proper government office and in the hands of the people that can make the changes.
There is a flaw in our systems only we can correct these flaws and better protect human life.
Just received another FDA news text that discusses risk management. It seems these device companies are being asked to submit their risk management plans, why aren’t they being told this is the law, if you break it you will be fined, go to court, or go to jail, we need to stop tiptoeing around and lay down the law, rules regulations, and follow them and enforce them. Who is in charge here human beings or the medical device world ?
This will require contacting people that will listen to your story and hear your words and are in a position to move forward in change now.
Don’t get discouraged by being turned off by a doctor or anyone else, get answers that you can believe and act accordingly.
It is tough enough to live this nightmare of nightmares, however I try to direct my energy into a positive sense so that I can be instrumental in change.
If we as human beings are to prevail as being more important than Market Share and Finances and satisfying those investors, it is entirely up to us, regardless of the device manufacturer.
Metal on Metal Hips are hazardous to your life, see the proper doctor to eliminate or correct the problem, get well, healthy, then act accordingly.
Respectfully
Howard Sadwin
Related articles
- Howard Sdwin: What isn’t being published is the truth regarding the medical device world (earlsview.com)
- FDA seeks to include more women in medical device trials (earlsview.com)
- Howard View – on a few things (earlsview.com)
- US Drug Watchdog Calls Its Identification of All ASR DePuy Hip Implant Recipients Its Most important Recalled Medical Device Initiative of 2012 (prweb.com)
- “FDA at a Crossroads” conference (thebovine.wordpress.com)
- FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline (earlsview.com)
- “FDA, You Were Wrong!”, a Timely Story Documenting the Impact of Government Regulations upon the General Public is Released by Dr. Robert Christensen (prweb.com)
- The regulatory standards for the approval of medical devices in Australia – Senate Inquiry (earlsview.com)
- Howard’s View – Get Your Health Right is Number One Priority (earlsview.com)
- Forget the FDA and launch your medical device in the UK (medcitynews.com)
You are SO RIGHT-on all that you have posted.Re the FDA-Medical guinea pigs-My own Phrase/pertaining to NZ -Medical, Orthopaedic world, and FDA.
COLLECTIVELY They too often ‘Put Band Aids/over festering wounds where TRUTH is not in any way permitted to ‘come out’ (Could upset Trade-at the highest level), at the lowest-we over protect Medical (particularly Orthoapaedic world) when they STUFF UP.
eg- My own personal enquiries from our small country-has revealed, that my own prosthesis was purchased, under a kick back scheme, that there is no proof, that this was not a generic product device-as the cost was lowered twice. That by then was known in NZ that at the very least, the liners were known to disintegrate within 2 years from implant date, causing other systemic problems.
That the SURGEON involved was offered technique training, as to placement of said device-back in 2004, in the appropriate manner considered for the Zimmer Durom Cup Prosthesis – where as well as multiple nerve, tissue, muscle damage, noted within HOURS not days, or weeks, but no concerns addressed, and that the stem is far too long, for my BMI, body shape, size anatomy, and is felt with every step I take.
That was KNOWN and recorded, I bled heavily, without a blood transfusion, and bonding, using every piece of additional methods of fixture were trialled.
Our Health and Disability Dept did not want to know”-still don’t, and at the highest level, those of us affected in this country, are silenced as much as can be.
HOW Howard, can one small fish in a BIG pond, bring this to FDA attention,where like other tragic cases-they just don’t want to know, and will find ANY/ALL excuses of denying culpability..
So many don’t know what to do, or how to go about it-even with the groups we have formed. At GP level-we cannot involve them too much, or they don’t want us as patients, and as for the Orthopaedic world, that rule the medical fraternity in this country of my birth, Truth and Facts are plain ans simply NOT ACKNOWLEDGED.
I thank Earl for finding me,I thank you for exposure in the country, that sells 90% of varying well known brand names.
Like others-I even asked-was my body trying to reject the prosthesis”- but considered an impossibility THEN, and was talking HIP REVISION-a few days after surgery of 6/9/2004.
Feel more emotionally equipped now to deal with this huge disaster, globally of the last decade, but How, without an appropriate Legal Qualification.
Have every Faith in your knowledge, and research, just as I have with Earl, and input from professionals overseas, that I have been dealing with myself.
Global exposure-needs to be addressed, and as soon as possible..
Please advise what a small group can do-and we will do it.
Jill.NZ
Jill, remember David and Goliath; my suggestion would be to gather as many people suffering with their hip procedures as you can. The source of their problems,( human error, design flaw, materials not compatable with the human body,etc.) and have this information delivered verbally to some one in politics that can help make change. This is not going to be easy, remember it has been going on for years, however this time the device world has hurt too many people for them not to be held accountable. Persistence, strong will people with determination to do what ever is necessary is the only way change can be made.
Howard Sadwin
Pingback: Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. « Earl's View
Pingback: FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra « Earl's View