The medical device industry and inadequate regulat... - Page 2

Caligurll · ‎07-20-2014

I saw that documentary on Netflix, and thought it was quite disturbing. There was no reason for me to question the information being presented. I did recommend a friend and her husband watch it since he is facing a hip replacement in the not so distant future. Another friend's husband had complications with his; it's been several years and I don't remember the details on that one.

Mindy D · ‎05-23-2010

@Caligurll wrote:
I saw that documentary on Netflix, and thought it was quite disturbing. There was no reason for me to question the information being presented. I did recommend a friend and her husband watch it since he is facing a hip replacement in the not so distant future. Another friend's husband had complications with his; it's been several years and I don't remember the details on that one.

Doctors also assume there’s a high level of device testing. One doctor that participated in the documentary, Dr. Steven Tower an orthopedic doctor, is a patient himself and is currently suffering from cobalt poisoning metallosis. He had no idea that his implant was similar to a previously recalled device. That’s what I found most disturbing. According to the film, 98% of medical devices go through the 510(k) premarket submission process. This skips testing of the new products. This process was supposed to be the exception, however, today it’s become the rule. In other words, while the premarket approval process requires testing in humans, devices can be exempt using the 510(k) loophole if they are substantially equivalent to one’s that were previously proven safe and effective, even if those previously proven devices were later recalled because they were dangerous. “Substantially Equivalent” is the term that is most worrisome.

hckynut · ‎03-10-2010

@Mindy D

Not really sure if you have an agenda. Just hard for me not to notice the many negative threads your have started that have some connection to almost every part of the medical profession.

I won't list all of them because there are just too many. Some are copy/paste etc., while others seem to be just your opinion. Some I have read do not comport with my facts, especially those specifically suggesting doctors are in some way in their profession only for the $$$.

I have quit reading most of your threads because of the above. Seems to me that you, for some reason not seen or known by me, have to be spending a lot of time researching for negativity in relation to most things with a connection to the medical industry.

While I respect everyone that has strong and genuine beliefs, I also expect the same in return.

hckynut

hckynut(john)

Zhills · ‎11-15-2011

@Mindy D Do you know of any work or line of products that is absolute perfection? Of course, some products fail. They are made by people and people aren't perfect either!

It is not surprising that what appears to be a big break through in controlling a condition can have failures. How many years should they test it and how many will die waiting for the tests to be over?

It's sad when one pump fails, but that same pump saved hundreds of other people. Life isn't perfect!

Mindy D · ‎05-23-2010

@Zhills wrote:
@Mindy D Do you know of any work or line of products that is absolute perfection? Of course, some products fail. They are made by people and people aren't perfect either!

It is not surprising that what appears to be a big break through in controlling a condition can have failures. How many years should they test it and how many will die waiting for the tests to be over?

It's sad when one pump fails, but that same pump saved hundreds of other people. Life isn't perfect!

The failure due to inadequate requirements for new implantable devices is the point of the thread. A new product does not need to go through any testing in humans if there’s been a previous device, even one that killed thousands, that obtained approval since 1974. This is due to a loophole in the approval process called the 510 (k). The loophole needs to be closed and the testing requirements changed to ensure product safety. This is not about the failure of a device that has been TESTED. It’s about allowing implantable devices to be used in patients that have not been tested just because something similar to the device was allowed in the past, even if that previous device proved dangerous, did not work, was pulled from the market. It’s about ZERO testing by sneaking around this loophole.

Would you allow a device to be implanted inside you if you were told that the device has never been tested in a human? Would you proceed with surgery if you were also told that all devices with similarities to this device were previously pulled from the market ten years previous because hundreds of patients developed metallosis? Would you at least expect to be notified of these things? Would you hope that your doctor had been notified of these issues with the product?

If if you answered yes to any of th she questions,then you also want to see modifications to the device approval process to protect the public.

Mindy D · ‎05-23-2010

For much more on the device approval process including criticism of the process see https://www.sciencedirect.com/science/article/pii/S2452302X16300183

Trinity11 · ‎11-16-2014

@Mindy D wrote:
For much more on the device approval process including criticism of the process see https://www.sciencedirect.com/science/article/pii/S2452302X16300183

Knowledge is power @Mindy D . The more informed we are the better. Thank you for opening up discussion about medical devices and following through with reliable sources.

Zhills · ‎11-15-2011

@Mindy D Would you volunteer to be the first " tester" so it could be tested in humans? Like I said, "Nothing is perfectl". That is why they practice medicine. Fortunztely, todzy, many of the test can be done with computers.

Mindy D · ‎05-23-2010

@Zhills. Hi. No I’d not want to volunteer, but I do expect implantable devices to be tested at least as diligently as the FDA requires for new drugs. Right now, this loophole for implantable device approval is so huge that most of the new implants have not had any testing at all. I can’t believe that you, yourself, would want devices implanted inside you that were completely untested. Consumers Reports addresses this issue and recommends:

How to fix the system

Consumers Union, the advocacy arm of Consumer Reports, agrees with the Institute of Medicine that the current system of medical-device regulation doesn’t protect patients from harm. Consumers Union recommends that the FDA

Have you had a problem? Tell us about it now. If you’ve had a problem with an implant or a medical device, please tell Consumer Reports about your experience. Your information is kept confidential (unless you indicate otherwise) and your story helps us monitor medical problems, research future articles, and push for reform.

To help, go to SafePatientProject.org and click on “Share Your Story” or click on “Act Now” to help us work for change.

Mindy D · ‎05-23-2010

@Zhills wrote:
@Mindy D Would you volunteer to be the first " tester" so it could be tested in humans? Like I said, "Nothing is perfectl". That is why they practice medicine. Fortunztely, todzy, many of the test can be done with computers.

Sorry, Zhills. Something went wrong while I was writing you and now I can’t finish editing the post. Google ConsumerReports medical devices to find the article so you can spread for yourself. https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index...