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Re: [IP] Seeing the bar for Blood Glucose Meter Performance

If I could have one wish come true (aside from a cure, or course), it would
be that glucose monitors were more accurate.  Sometimes I get three totally
different readings one right after the other.  Never quite sure which one
is accurate.  FRUSTRATING.  Susan

On Thu, Jan 9, 2014 at 3:58 PM, Yerachmiel Altman <
email @ redacted> wrote:

> Posted on January 9, 2014 by FDA Voice
> By: Courtney Lias
>  Courtney Lias is Director of the Division of Chemistry and Toxicology
> Devices
> within the Office of In Vitro Diagnostics and Radiological Devices at FDAb
> s
> Center for Devices and Radiological HealthMany of the nearly 19 million
> Americans diagnosed with diabetes must monitor their blood glucose (sugar)
> frequently throughout the day using an at-home meter to make sure that
> their
> blood glucose is within a safe range. The ability to measure blood glucose
> at
> home has given people with this serious and chronic condition the ability
> to
> better control their blood sugar and thus avoid potential complications.
>  In the last 10 years there has been much advancement in the development of
> glucose meters. They are now smaller, require a smaller blood sample for
> each
> test and produce faster results. However, their accuracy has improved
> little.
>  At FDAb s public meeting in March 2010 on this topic, the clinical and
> patient
> communities challenged the agency to improve performance of glucose meters.
> Feedback gathered from that meeting directly informed the creation of two
> draft
> guidance documents released this week. These documents set forth
> recommendations, which are justified to help ensure that these important
> devices
> are designed to be more accurate and reliable for the patients who need
> them. To
> address this need, this week we are proposing new recommendations for
> labeling,
> meter performance evaluation, manufacturing controls, and cleaning and
> disinfection procedures to help improve the accuracy and performance of
> blood
> glucose meters.
>  FDA recognized the need to optimize the safe use of blood glucose meters
> in two
> distinct settings: self-monitoring using devices purchased
> over-the-counter, and
> use in a clinical setting by health care professionals. FDA believes that
> by
> distinguishing where these devices are used, they can be better designed
> to meet
> the needs of their intended populations and ensure greater safety and
> efficacy.
>  Historically, devices used in these two settings have been studied using
> the
> same methods and standards. However, it has become increasingly clear that
> meters used in these different settings have unique characteristics and
> different design specifications. For example, critically ill patients in
> health
> care settings may have physiological variables, like abnormal oxygen
> levels,
> that could interfere with the accuracy of the blood glucose meter.
> Patients who
> use over-the-counter glucose meters and test strips at home vary in age,
> how
> much they know about how to use blood glucose tests, and other critical
> factors
> that might affect the accurate use of the device.
>  To distinguish between FDA recommendations for blood glucose meters used
> in
> health-care facilities, and those intended for self-monitoring by
> lay-persons,
> the agency is issuing separate draft guidances for each one, that is:
>  prescription-use blood glucose meters, for use in point-of-care
> professional
> health-care settings, and
>  blood glucose devices purchased over-the-counter, intended for
> self-monitoring
> by lay-persons.
>  We believe that these recommendations will help ensure that glucose
> meters meet
> critical standards for accuracy in the hands of people with diabetes, who
> rely
> on them to manage their disease. Please help us in this effort by providing
> specific comments to these draft guidance documents to let us know if you
> agree
> with our recommendations or whether you have suggestions to further improve
> them.
>  Improving the quality of blood glucose meters will not solve all
> challenges for
> those who live with diabetes, but it may help millions of people to avoid
> complications and better achieve their health goals
>  - See more at:
> .
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