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FDA Mandates ID for Implants (Again?)

Wednesday, September 25th, 2013 | Health Care In General, Types of Metals | No Comments

 

62-Hip Implants Cli ArtThe New York Times reported the FDA latest attempt in helping patients with implant failures. As quoted, ” The Food and Drug Administration published new rules on Friday that require most medical devices sold in the United States to carry a unique code, identifying the make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.”

To read the article in its entirely, click on the link:

http://www.nytimes.com/2013/09/21/business/fda-to-require-tracking-codes-in-medical-devices.html?emc=edit_tnt_20130920&tntemail0=y&_r=0

CCD NOTES: My mom’s implants had and have unique code, identifying the make, manufacture date and lot number and expiration date. How is the a new innovative idea? I want to believe patients best interest is being considered when announcements like this one are broadcast, but if you were not aware of metal implants ALREADY being identified, perhaps the general public would believe this to be an “excellent idea!”

She previously had a unnecessary pacemaker implanted, according to her cardiologist that gave her a second opinion after the first cardiologist stated, “Ms. Harton could easily go out into the ER parking and fall over without a pacemaker.” As a family were told this was a necessity for her to keep living at a function pace. It was not true, which I share in Steel Standing: Surviving Metal Allergies with medical proof to illustrate the trouble.

However, her explanted pacemaker (which I have in my possession) was also labeled with the Maker’s ID and a serial number, plus the tracking that occurs with pacemakers is required on a quarterly basis.

Since the article is shorter than my blog, I may be missing some information or misunderstood how incredible the FDA new requirement is for patients with implants.

The best news is the tracking system.

Of course, that mandate was imposed on all leading orthopaedic manufacturers to track and work with medical facilities to create a orthopaedic data registry in May 2011. I’m keeping an open mind to new information in hopes the tracking system will show FDA how many cases are not reported that fail due to the device.

I’ll be extremely grateful when the reporting system includes the failures due to the “types” of metals, as in my mom’s case.

For more information:

www.fda.gov

www.nytimes.com

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