Our Blog / the diabetes online community on accuracy

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.

Much consideration of cleaning and disinfection of devices, particularly for transition of HIV, Hep C & B.

Love to see other’s thoughts in comments to this thread.

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.

and

Line 432, page 13:

In order to demonstrate that a BGMS device is sufficiently accurate to be used safely by health care professionals, you should demonstrate that 99% of all values are within +/- 10% of the reference method for glucose concentrations > 70 mg/dL, and within +/- 7 mg/dL at glucose concentrations < 70 mg/dL.

 

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11 Comments

  1. So are they enforcing +/- 15% or +/- 10%? It’s a little unclear. But a great move in the right direction no matter how you slice it!

    Thanks to Bennett & Strip Safely for pushing on this critical issue.

    Reply
  2. Phyllis Roth

    It sounds to me like less rigorous accuracy for home use. Thinking of the #s then a blood glucose of 80 could actually be
    65 or 95? Interventions at these different levels are very different. I think home use standard should be at least as rigorous as health care providers.

    Reply
  3. Marcy Marks

    I agree with the previous commenter. Standards for glucose meters at home should be the same as for health care providers. If I’m injecting insulin based on my readings, they’d better be accurate!

    Reply
  4. Thanks for the comments. I encourage you to send those to FDA in the Guidance docket. I get link up soon to do that.

    FDA did suggested in a call about the guidance that the would love to see the hospital standard become the home one too. However they recognized that the production capacity for more accurate devices and strips would need to expand to make that possible.

    I have seen some, with more of a science background than I, suggest that the error margin on the reference device (+/- 2-4 % depending on where you read it – I don’t know myself – yet) makes the 10% target statistically very changeling.

    I would like to see more accuracy be economically viable so that it is available in the volumes needed for good diabetes care fro all.

    Keep the comments coming!

    Reply
  5. Elizabeth Merker

    Of course standards should be the same for home & health care use. How much do you suppose it costs for that extra 5%? I will be more than happy to make that point to the FDA.

    Reply
  6. I like that they want to tighten accuracy, but I resent the fact that they are ignoring the 99.99999999% of testing done by the patient….at home.
    I hate to say it, but the doctors are rarely making life & death decisions based on blood sugar levels compared to that of the person with diabetes. We need the accuracy at home.

    Reply
  7. Denis Jones

    If medical providers are to be reimbursed or denied payment based on patient compliance and meeting target goals i.e. A1c values, there must be some standard for accuracy of blood glucose measurement. You cannot punish providers or their patients for not meeting wellness goals if not given accurate tools to manage diabetes. At home clinical decisions should be based on the same standard as in hospitals.

    Reply

So, what do you think ?