FDA Public Workshop - Medical Device Patient Labeling - I may mention VW.

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:

Medical Device Patient Labeling 

• September 29, 2015: https://collaboration.fda.gov/plpw092915/  
• September 30, 2015: https://collaboration.fda.gov/plpw093015/

Directions for mobile access to the meeting

1. Download the Adobe Connect Mobile App
2. Enter Meeting
3. Log-in as a Guest: Enter Name
4. Accept disclaimer

A key part of what I have to say will be your views shared with YDMV .

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL

*http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm



Here are some of the slides I will be using:

What's Missing from HHS Report on Test Strip Costs

A report, just out this month, by the Department of Health and Human Services Office of Inspector General looks at Medicaid costs for diabetic test strips. My search tool couldn't find in it the following words:

 Hypoglycemia, Hyperglycemia, Accurate, Safe

Have a look. It is here. Let me know if I am wrong. (they do say diabetic but not diabetes.) It seems they are missing the real point. Feel free to list any other key words NOT in the report in a comment below. 

I am 100% for saving money. 

To me saving is all about getting the right things at the right prices. Test strips exist so people with Diabetes can manage blood sugar in a safe, target range, minimizing Hypoglycemia and Hyperglycemia. To do that test strips need to be Accurate within the standards for which they were approved. Not all strips preform as approved and there is evidence that suggests some may achieve low prices by failing on quality. 

The cost of diabetes care is not test strips. As Bill Polonsky says, "Well controlled diabetes is the leading cause of nothing." On the other hand, insulin overdose is estimated to puts 97,000 plus Americans in the Emergency Room every year (more than Meth!) at a cost of well over a half a billion dollars. Estimates including the cost of diabetes complications are in the range into hundreds of billions.

To me, the Inspector General's report is the wrong track.  It is penny wise and pound foolish. I suggest that the best thing to do, to save money in diabetes care, is avoiding the big costs of complications by investing in cheap stuff, like accurate strips with the education and support necessary to use them effectively. Sadly I can't think of much that can be done right now about the Inspector General or Medicaid. They take the position that FDA regulates meters and all FDA approved meters are created equal. 

They are not. See http://www.stripsafely.com/strip/

We can do something about test strips, right now. We can comment to FDA's open dockets on new test strip guidance. They are open to April 7, 2014. We can talk about the importance of accuracy, post market evaluations, that only meter meeting new and safe guidelines should be approved to dose insulin and more. To make it easy there are copy and paste comments with a link to the FDA dockets here:

http://www.stripsafely.com/sample-page/guidance/

http://oig.hhs.gov/oas/reports/region5/51300033.pdf 

StripSafely & Tim Gunn's Sports Jacket.

Who doesn't love a sequel to a summer block buster?

OK it may be a stretch to call StripSafely a summer block buster but a guy can dream right?

DSMA's Blog Carnival is revisiting the Strip Issue with this prompt:

What would your comment be on meter accuracy at the Diabetes Technology Society meeting? 

I actually commented as a panelist at the meeting.

Here s a little video clip.
http://www.youtube.com/watch?v=SK0HWO7-JXk

So since there are already comments on record, I will share some of my hopes and make a confession. Let's start with that confession part. I had an ulterior motives creating the campaign.

I wanted to see if we as a community could come together and make a difference through action. 

We can.

We should do it a lot more often.

Here is how I know. The FDA called me, on a Friday evening well after business hours. Nobody work late on Friday unless the boss has bee in their bonnet. Also I got a letter back from my Congresswoman and it was very clear she reached out to FDA and got the official FDA response.

An official response and after hour calls on a Friday are an indication that we, the DOC, managed to get their attention. We need to keep it and use that attention for good. Good to means getting tighter accuracy standards AND requiring all meters systems sold to meet the new standard. No old stuff at or not quite at the old standard still sold. Yes - they could pass a new standard for new products but leave all the old stuff approved in the market. No we should not sit quietly if they do.

Keep int attention to me means moving to include positive feed back into the program. Show the regulatory process some lovin' when they take positive steps. Those of us outside the beltway (and the FDA campus is outside too) know the truth of what the great political commentator and sage Mick Jagger said, "you can't always get what you want, but if you try sometime, you just might find, You get what you need."

We are not going to get everything we want as fast as we want it from FDA. We are more likely to get it if we ask, often. It is a revolutionary concept in DC process, I know but saying thanks will help.

So, I think, we the DOC will need to keep writing about StripSafely. DC has it little temper tantrums and forgets everything outside their little ticky tack world. We don't have to play that game. We may have differences politically but we all speak BG and all will benefit form better meter systems.

There are other issues too. Ones maybe a little more complex than StripSafely, like approving new insulins or better devices. Our voices as patients can help policy makers serve us, their constituents. Let use some of the lesson learned form StripSafely like;

• serious and solemn are the same thing so we can have fun with our advocacy 
• policy makers listen if enough of us speak up
• it helps to have a central source of information and base request on peer reviewed papers
• it is a marathon not a sprint 

I'll close with an idea I heard from a leader of a community leader. We have more skin in the game than anyone. We need to learn to wear our emotion not as our heart on our sleeve but as sports jacket. Something that adds a professional appearance to the stature of the facts we present.

Yeah I know a fashion metaphor. I am a regular Tim Gunn (bet seriously, who knows better how to wear a jacket?)

“This post is my October entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at http://diabetescaf.org/2013/09/october-dsma-blog-carnival-3/“

New Kind of Mail - With Stamps!

I just put stamps on letter to my Senators, Congresswoman and the President.

Real snail mail letters based on this Sample Letter at StripSafely.com. 

I am asking my policy leaders to send a staffer to the 9.9.13 Diabetes Technology Society meeting. That aide can help my elected officials understand that there is an issue with test strip accuracy.

You can help. You can write too (Hint: Use the sample!) BUT can you find cooler stamps than these Pixar gems?

It is Not OK.

Sometimes, I may be prescient. I know that came as a shock to me too.

Back in 2010 I wrote a piece about medical devices approved by the FDA. In it I joked about the OK Meter saying, “No pretensions of greatness at all. It is just OK.”

Maybe it isn’t so OK.

OK Biotech and Prodigy Diabetes care “Aligned Ownership.” In their announcement they were clear about opportunities with Centers for Medicare and Medicaid Services bidding.

Yesterday Prodigy Diabetes Care was disclosed as the recipient of a FDA warning letter in the FDA press release, “FDA alerts companies to stop illegal sale of treatments for diabetes.”

I strongly urge people with diabetes to read that FDA letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm
In part it says:

Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.

That said:
Emergency technicians confirmed that the patient had a low blood glucose level of less than 20 mg/dL - And - 

An MDR should have been submitted for this complaint.

That means one was not.

That is NOT OK.

How far below 20mg mg/dl does someone have to go to get a Medical Device Report filed? How much lower can someone go and recover?

 Thanks FDA for the letter.

One question - Does warning mean they are still selling strips to CMS?


If meter accuracy matters to you join the campaign at www.StripSafely.com