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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.



Howard Sadwin