Strip safely!

July 2nd, 2013

As a PWD, I deal with more than my fair share of test strips … BG test strips, ketone test strips, more BG test strips. It seems that a rouge BG test strip follows me everywhere, and if I am anywhere for a prolonged period, chances are that someone will find the aforementioned rouge test strip somewhere in my vicinity.

What I shouldn’t have to worry about, as a PWD, is whether those test strips that seem to follow me everywhere, and that I use anywhere from 8-12+ times a day, are giving me accurate readings. I test my BG levels to keep myself safe, both now, and to prevent future complications. I can only do that when I’m armed with the best possible information to be able to keep my BG levels in the best range for me at any given time. If one meter will read 80, and another 150, that could mean two totally different treatment options! The current FDA standard is that test strips should be accurate +/-20%. That is a huge variance, and some strips can’t even hold to this standard!

Test strips are also highly unstable. The results can be impacted by cold, heat, exposure to air (yep, keeping them outside of the test strip container can impact the results!), not washing hands or having residue on hands before testing, expiration date, and some medications. That is a long list of possible things which can throw off your test results! Did you know that all of these things could impact your BG results?

There are newer meters on the market that have test strips with “improved” accuracy, but they are still only accurate to +/-15%. Also, FDA is not required to follow ISO standards for meter accuracy in the United States. This needs to change. This is why we need your help.

FDA does not have regulatory processes to insure that test strips in the US meet approved accuracy standards. Again, FDA does not have regulatory processes to insure that test strips in the US meet accuracy standards. This really needs to change.

We need you to help us change this. To help this effort, please write the FDA and congress to help hold our government accountable for the regulatory process, which they oversee.

With current standards, test strip accuracy can leave you with a wide range of results, and it is currently acceptable and approved to have this wide range of results. For example, if your BG is 100, the acceptable meter reading range is 80-120. If your BG is 150, your meter can read from 120-180. If your BG is 80, your meter can read from 64-96. If your BG is 200, your meter can read from 160-240. Think a treatment decision is difficult? Well, it is really difficult if you don’t know if you are getting correct information from your BG tests!

If you want to help change BG test strip accuracy, please head on over to http://www.stripsafely.com to find out more information about the Strip Safely campaign!

If you want to write your elected officials or write letters to the FDA, here is some contact information:

Find your Elected Officials at this site:
http://www.usa.gov/Contact/Elected.shtml

Leaders at the FDA:
Jeffrey Shuren, MD JD
jeff.shuren@fda.hhs.gov
Director, Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5442, Silver Spring, MD 20993

Katherine Serrano
katherine.serrano@fda.hhs.gov
Diabetes Branch Chief
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5646, Silver Spring, MD 20993

Alberto Gutierrez, PhD.
alberto.gutierrez@fda.hhs.gov
Director of the Office of In-Vitro Devices Evaluation and Safety
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5680, Silver Spring, MD 20993

Courtney Lias
courtney.lias@fda.hhs.gov
Director, Center for Devices and Radiological Health
Division of Chemistry and Toxicology Devices
Food and Drug Administration
10903 New Hampshire Avenue, WO66-5640, Silver Spring, MD 20993

Leaders at the CMS
Jonathan Blum
Deputy Administrative Director-CMS
Jonathan.Blum@cms.hhs.gov
7500 Security Boulevard, Baltimore, MD 21244

You can find sample letters at Strip Safely! http://www.stripsafely.com/?page_id=2


2 Responses to “Strip safely!”

  1. Scott K. Johnson on July 3, 2013 7:39 pm

    Thanks for helping spread the word, Aliza!

  2. Bennet on July 19, 2013 3:09 pm

    Thanks for the help and contacts. Finally getting time to get around and share my thanks for your jumping in with letters and contacts. Linked you back off of http://www.stripsafely.com/?page_id=78

    All the Best
    Bennet

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