Surveillance Success!

Good News!

The Diabetes Technology Society (DTS) this week announced the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.

For details please see: http://diabetestechnology.org/surveillance.html

Initially the program is being supported by Abbott but DTS says that other BG Monitor manufacturers are currently looking into coming on board.  They (and I think all of us in the community) would welcome funding from other sources that recognize the importance of and wish to lend their support to surveillance of cleared BG Monitoring systems to obtain information about the performance of these products.

The announcement says there will be patient advocates involved. I asked DTS who that would be and they replied, "Patient advocacy groups will be selected based on recommendations by the Steering Committee and the Board of DTS." I may have thoughts on the matter too. 

Finally I asked, what do we need to do to make surveillance mandatory, because, I assume it will start as voluntary?

DTS's reply was, the program can be made mandatory if a special rule is developed by FDA or if a law is passed by Congress.

So there is still advocacy work to accomplish.  

Yo DOC! How do ya feel about 400?

Comments that is.

We are at 342.

If posts to the FDA docket on personal use glucose meters were held to the 2003 ISO standards for glucose meters, I could claim we have 400 comments and consider that an accurate reflection of 342.   342+20%=410.

That's bogus. Let's get a real 400. Commenting is easy. It takes two minutes.

The docket is open to May 7.
That's one place where a 400 is something to feel good about:

Please:

Comment on the Guidance

Add a Second Comment on Generic Strips

Watch the #DOCasksFDA Chat.

FDA has Trending List. DOC is On It

Howdy DOC.

We're trending.

No not anyplace super cool. At regulations.gov. Yeah, they have that and here we are:

The SMBG docket is open to May 7. Let's keep it up. Draft comments here: http://www.stripsafely.com/sample-page/guidance/

Y'know, maybe this super cool.



Update 4.11.14.
Like any trend, we fell off. That isn't to say we can't get back.
StripSafely has new comments you can send about third party strips
and who is responsible for what.  Sent them, even if you have sent
other comments already It is our health, we have a say.

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 

Moo II / Moo Too. Keep Meters in the ER.

Will there be a blood glucose meter in the Emergency Room? 

I have borrowed ideas from Christel’s blog post on posting comments to the FDA open meter docket. The one with this great picture: 

Articles published last week are timely and relevant to the the professional / in hospital use FDA Meter guidance. Some of the stuff last week was rather startling. What's got me worrying is the remote possibility there will be no blood glucose meter in the ER. 

FDA's in hospital guidance proposes very tight variance standards. There are interesting comments about FDA’s in hospital use guidance posted at diaTribe. I liken the comments to something approximating, "Hey theses are so tough that nobody may make the meters, then what are ya gonna do?" That, combined with the article on emergancy room visit for hypos, I wrote about in this post, are the basis for the following additional comments to the "Prescription Point-of-Care Use" guidance docket. 

Please, feel free to copy them, add you 2¢, and post them to the FDA docket here:

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001

[Copy]

I am concerned the proposed standards for "Prescription Point-of-Care Use" blood glucose meter may not be not feasible. If so the the result could be a deterioration of in-hospital care for people with diabetes. 

Dr. David Sacks of NIH, Bethesda, MD is quoted by diaTribe saying, “These are incredibly stringent [standards]…I hope that the FDA listens to the complaints, because clearly there will be lots… I think that it’s going to be very difficult for manufacturers to meet these criteria. If they don't make them more lax, there will be no glucose meters approved in the future.”1 

“No glucose meters approved in the future,” is very concerning. 

I worry that if the standard for in clinic/hospital blood glucose meters use is not reachable there will not be devices for inpatient care. No meters may cause delays in emergancy department treatment for people with diabetes. These delays could stem from the need to use slower draw-blood-and-take-it-to-the-lab processes to meet these "incredibly stringent" requirements, as opposed to reasonably rapid finger stick devices in the treatment of patients needing emergancy care. 

Geller et al in a March 10 2014 JAMA article, National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations, estimate over ninety-seven thousand insulin-related hypoglycemia and errors induced emergancy room visit in the United States annually. Of these 29% result in hospital admission. Additionally "Severe neurologic sequelae were documented in an estimated 60.6% (95% CI, 51.3%-69.9%) of ED visits for IHEs" 2

Time matters, appropriate rapid care is needed to minimize lasting harm from hypos. 

FDA should avoid rules with such possible unintended consequence. Result from this guidance that should be improved accuracy in clinical settings from meters. Maters are a valuable tool in professional care setting just as patients need for accuracy in dosing the very dangerous drug insulin outside the is clinical setting. Both need accurate, economical  and timely devices. 

I agree with diTribe’s conclusion on personal use meters, “We are glad to see the FDA trying to improve glucose meters and look forward to formal adoption of the standards in whatever form they ultimately take... the home use accuracy standards are fairly reasonable and should enhance patient safety.”  I also share their concern that if, “... no meter can meet these new accuracy requirements for healthcare facilities, we will not see any of these innovations make it to the market.”

1 http://diatribe.org/issues/61/new-now-next/3

2 https://archinte.jamanetwork.com/article.aspx?articleid=1835360

[/copy] Go here. [paste]

Moo.

Learn more:
http://theperfectd.com/2014/03/14/moo-moo-moo/
http://www.stripsafely.com/sample-page/guidance/

Yo! DOC - FDA is Listening, Let's Speak Up

Public Policy on Diabetes Needs Our Help, Our Voices.

FDA is listening for our comments about glucose meters 'till April 7. They have two dockets open.

Please comment on FDA’s meter guidance proposals. Open dockets are a very important and rare time that the FDA is explicitly and officially focused on listening. Let’s be heard. Just as important as what we say, is that our community's message is repeated to be clear over voices that may seek to maintain the unacceptable status quo for their proprietary gain.

Through the dockets we can:

• Support FDA’s efforts for higher accuracy.
• Call for the same accuracy in both patient and clinical use.
• Ask that only the new level of accuracy be labeled to dose insulin.
• Suggest that only devices meeting new accuracy levels be considered DME by Medicare.
• Repeat the call for robust post market enforcement.

Learn more about the guidance.

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

See how to steps to posting on a FDA docket. (It is easy.)

http://www.stripsafely.com/sample-page/comment2fda/

Here's links to the open dockets and one set of sample comments to post to both.

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

The current set rules for glucose meters is from 2003. It may be another decade before we get another chance. These dockets are open to April 7. Now is the time to join the community and speak up.

Please help build momentum for the effort by sharing that you posted to the docket through your favorite social media channels with the hashtag #StripSafely.

New Proposed FDA Meter Regulations

From StripSafely.com

Proposed new guidance is out today from FDA on blood glucose meter systems (BGMS).  There are two documents. One for patent users and one for use in clinical settings such as hospitals. I am still reading them but I thought other may wish to do so too..

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf

Starting at line 420, page 11,

... you should demonstrate that 95% of all SMBG results in this study are within +/- 15% of the reference measurement across the entire claimed measuring range of the  device ...

There are actually two pieces of proposed guidance, over the counter (linked above) and point of care. The later is at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf

That document for BGMS use by HCPs in clinical stetting states (starting at line 277, p9):

Although many manufacturers design their BGMS validation studies based on the International Standards Organizations document 15197, FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices.

I Love it When a Plan Comes Together (or at least starts to)

My first reply to a StripSafely letter from Congress was a long piece that included the history of the FDA and nothing about the subject to which the good Senator was replying, meter accuracy. I shared it with some friends who were a little disappointed. 

Not to worry, regardless of sequesters and partisanship, Congress sorts and counts. If we get enough letters to them, they will start sorting and counting diabetes accuracy messages. They don’t need to know or understand anything about diabetes care, at first, they need to start counting. Maybe they have. 

Yesterday I received a letter from my Congresswoman. (Yes, woman. Cool right?)  She (or her staffer more accurately) wrote specifically about FDA  post market oversight. Citing exactly the three points FDA wants me to hear; inspections, MDRs and recalls. That is glorious. That can only mean the Congresswoman’s office reached out to FDA. The FDA had some explaining to do to the Hill. 

Each episodes of the “A-Team” ended with Hannibal saying, “I love it when a plan comes together.” The joke being that things may not go as planned but the A – Team gets results, typically with a lot of action.

I know the FDA has action hero-ish special abilities. On September 5th the Agency published a story of how twenty one individual, potentially contaminated, candy bars from New Zealand were tracked down by FDA to keep American consumers safe.  FDA should just as actively use its powers for good to Americans safe from test strips that fail to deliver the accuracy on our fingers that those test systems had to demonstrate to be approved for sale.

If anything is clear from the Diabetes Technology Society meetings on May 21 and September 9, it is that we know there is a problem. We know firms fail to comply with MDRs and other parts of FDAs existing regulatory controls. Committees, commissions and post market studies to know more, without enforcing more, is unacceptable.

We need acton for plan to come together.

People with Diabetes are starting to get the FDA’s attention. StripSafely is still in the opening of the third act. Regular viewers know what is needed, action, lots of it.

If you get a reply from you Congresswoman (or man) that mentions three parts of a  post market program, write back. Tell congress we need more action, independent inspection. We have a letter for that. Face and BA are in shed beating the Strip Safely Twitter page into shape too.

The third act is always the most fun.

(My lodging to attend the September 9 meeting was paid for by the Diabetes Hands Foundation.)

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