Tag Archives: Strip Safely

#StripSafely Is Opening Doors Again.

March 28, 2014 – 9:06 am

I just have a minute to get this down before running to catch a flight out of town… Monday is a big day for all of us who have been pounding the Strip Safely drum for nearly a year.

The best part is that you get to be part of it.

Bennet Dunlap and FDA expert Courtney Lias will head up a conversation with us. Yes, us too—we’re invited! You can register for this important call and listen to, and engage in, direct conversation between the Diabetes Community and the Food & Drug Administration (FDA).

Click here to register for this one-of-a-kind event.

Find out more about how the FDA regulates medical devices. Find out more about what the FDA is doing to ensure accuracy of blood glucose meters. This is your chance to hear the answers to any number of diabetes-related questions directly from the FDA.

I know many of you have expressed frustration, feeling like the FDA doesn’t listen to us. Well, in fact… lately, they are listening.

Monday’s conversation is a golden opportunity for the Diabetes Community to grab the ear of the government agency here in the USA that regulates our meters, our pumps, our CGMs, and more.

It promises to be a very important hour. Don’t miss it. Don’t miss sharing this with everyone you know. As Christel said yesterday, this is where all the cool kids will be on Monday.

The chat happens Monday, March 31st from 1:30p.m. to 2:30p.m. Eastern Time.

Click here to register for this meaningful event.

In case you didn’t know… This is a big deal. This kind of access is miles beyond what we could have imagined just a couple of years ago. Please take advantage of this unique opportunity, and don’t forget to share it with your DOC friends. Your voice is needed and appreciated. Be part of the conversation, or just listen in.
 
 
 

By StephenS | Posted in Events | Also tagged , , , | Comments (0)

A window of opportunity is closing.

March 21, 2014 – 10:37 am

I really didn’t expect to write about this again, but… This still needs to be talked about. And for various reasons, this may be my last chance to write about it before our window of opportunity closes.

The U.S. Food and Drug Administration is in the process of drafting guidance for manufacturers of blood glucose meters. The guidance will be for future production of both over-the-counter meters (the ones we, as individuals, use), and the ones used in a clinical, point-of-care (i.e., hospital) setting.

As of right now, the FDA has opened up these draft guidance documents for public comment.

In other words, they want our input, and they’re even welcoming it.

But they will only accept our input until April 7. So please… Right now… Do something for me:

Go now to this one page, follow the instructions, take two or three minutes, and add your voice to something that will be extremely meaningful to me for years to come.
 
 
As I publish this post, only 167 comments have been posted on the OTC guidance.

As I publish this post, only 101 comments have been posted on the point-of-care guidance.

Every man, woman, and child in America with an internet connection should be commenting on this guidance.
 
 
Are you living with diabetes? Is someone you care about living with diabetes? Do you work with someone living with diabetes? Do you drive on a roadway with someone living with diabetes? Do you interact ever with someone living with diabetes? Are you starting to understand why this is important and critical and time-sensitive?

Maybe you don’t care about making meters more accurate. Or maybe you do.

If you’re living with diabetes, improving meter accuracy is important to you, and you know it, and you can do something about it.

If someone you care about is living with diabetes (and someone you care about is), improving meter accuracy is important to you, and you know it, and you can do something about it.

If you aren’t affected by diabetes at all, improving meter accuracy is important to you, and you know it, and you can do something about it.

Do something about it.

Go now to this one page, follow the instructions, take two or three minutes, and add your voice to something that will be extremely meaningful to everyone for years to come.

Future lives hang in the balance of blood glucose meter accuracy, and you can help win the day.

Thanks again to Christel Marchand Aprigliano and Bennet Dunlap for opening my eyes on this issue and leading the charge up the Hill of Guidance.
 
 
I now return you to your regularly scheduled day.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (4)

Make your voice heard. Today. Now.

March 7, 2014 – 9:22 am

SSGuidance

Maybe you’re one of those people who says, “That FDA—they never listen!”. Or maybe you say, “If the FDA wouldn’t wait so long, we could see products come to market sooner!”. Well, glucose meters and test strips are not made in a day. Okay, maybe they are, but bear with me here.

The U.S. Food and Drug Administration (the FDA) is in the midst of an arduous process to update guidance to companies on future manufacture of blood glucose meters. From the Strip Safely website:

“FDA has two draft guidance documents about blood glucose meters that are open for comment until April 7, 2014. A “draft guidance” is basically a preview of what standards the FDA is considering requiring in order for blood glucose meters to be cleared — the law requires that FDA open its draft guidance documents up for comment before publishing a final version.”

So if you’re one of those people who says, “That FDA—they never listen!”, here’s your chance.

The FDA has two open dockets right now through Monday, April 7th. You have an opportunity to raise your voice with the rest of the Diabetes Community, engaging in public discourse and helping the FDA get it right.

The best part is, it’s so easy to lend your voice to this important issue. As usual, Strip Safely has everything you need to know. And not in a creepy, big-brother, overbearing government kind of way. Head on over there now and you’ll find super easy instructions that will help you lend your voice to this increasingly critical guidance.
(hint: read the instructions carefully, or you might miss something important)

If you’re worried about not having enough time to comment, don’t. Strip Safely has links to the dockets for personal use meters and in-clinic meters. And they even have language you can use to join the chorus of D-people who are weighing in on this topic. After rewriting part of the prepared comments and submitting them to the FDA, I looked at my watch to find that a mere fifteen minutes had gone by from start to finish.

If you’re worried about your privacy, don’t. You can submit your comments anonymously. Or you can give them your name and e-mail address. Your choice.

If you’re worried about not making an impact, don’t. We need to submit as many comments as possible. More comments get more notice, making more of an impact. And after April 7, we may not get the chance to comment on this for another ten years. That’s the way it works at the federal level, folks. Your voice on this topic is appreciated and valued and necessary.

One other thing: After you submit your comments, don’t forget to tell everyone you know that the FDA is accepting public comments on guidance for over-the-counter blood glucose meters, and meters designed for healthcare providers in an office or hospital setting.

It’s not often you can do something tangible that you know will have a positive effect on People With Diabetes for years to come. But you know what? This is your chance to do just that. It’s easy. And we need you.

Many thanks to Christel Marchand Aprigliano and Bennet Dunlap for leading the charge up the Hill of Guidance.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (0)

Diabetes Art Day, #StripSafely edition.

August 26, 2013 – 9:38 am

Today is an extra-special-important version of Diabetes Art Day! Thanks to Lee Ann Thill, today is a day for all of us to put our creative minds to use to help spread the word about the importance of meter and test strip accuracy.

The Strip Safely initiative has really taken off, and today’s D-Art Day is another chance for us to shout about the fact that meter and test strip accuracy is not nearly what it should be.

To find out more, visit the Strip Safely site at www.stripsafely.com.

You are encouraged to create your own art using test strips… upload your work of art HERE. You can also go there to view other special pieces of D-Art.

Without further ado, here’s my art, if you can call it that. I’m among the most art-challenged people on the planet, so I did a little photo thing that turned into kind of a public service announcement. Oh well. Here it is… And don’t forget to check out the other great works of art on Diabetes Art Day– Strip Safely edition.

SS-DArt
 
 
 

By StephenS | Posted in Diabetes Art Day | Also tagged , , | Comments (0)

#StripSafely Update. And a question.

August 5, 2013 – 9:34 am

Safety of the test strips we use, and the meters we plug them into, is a great big deal to everyone living with diabetes. It also means a lot to the people who love me and count on me to be there for them.

So I aligned my views with those in the Diabetes Online Community who also believe that A) The 20 percent +/- factor that’s currently allowed for test strips is NOT NEARLY GOOD ENOUGH, and B) The fact that the FDA has no post-approval mechanism in place to verify the continued accuracy of test strips they approved earlier, or pull them from the market if they’re not, IS NOT OKAY.

As a measure of support, and to help in getting these wrongs righted, I wrote my elected officials in Washington. U.S. Representative Dutch Ruppersberger, D-MD, and U.S. Senators Barbara Mikulski and Ben Cardin, also D-MD, received e-mails from me expressing my concern and asking them to assist.

That was nearly three weeks ago.

But hey– a week ago I received an e-mail response from Senator Mikulski, the longest-serving woman in United States Senate history. I’ll share it right here, but be sure to come back after reading, because I want to ask about something.

Letter

Other than the fact that this was pretty much a form letter, I was actually happy to have received a response at all. Seriously, even if they’re not busy all the time, senators get requests from a seemingly endless stream of attention-grabbers and favor-seekers on a constant basis.

No, what really struck me were the two images at the bottom of the letter. You know, the Facebook and Twitter icons.

So I want to ask: What if a coordinated effort was put together to bombard Facebook and Twitter accounts of U.S. Representatives and U.S. Senators for the #StripSafely cause? It could start with House and Senate committee members responsible for FDA oversight, and perhaps move on to people with oversight of the U.S. Commerce department. Somewhere in there, we could get around to House Speaker John Boehner and Senate Majority Leader Harry Reid.

I don’t know… Maybe it all sounds a little too “Mr. Smith Goes to Washington”. But don’t we believe in our own cause just as much as Jimmy Stewart did in that movie? And I have to ask: Don’t you think that together, we could make some kind of impact? If there are so many people in on the #DSMA Twitter Chats every Wednesday, wouldn’t the same kind of numbers all tweeting or messaging at the same time, about the same thing, to the same people, get an elected official to take notice?

What do you think, Diabetes Online Community? Good idea? Bad idea? Feel free to leave your ideas below.

For more on this important issue, visit the Strip Safely central at www.stripsafely.com
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , , , | Comments (2)