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The Food and Drug Administration is proposing separate guidelines for over-the-counter blood glucose meters compared to those used at the doctor's office or in other healthcare settings.
Historically, the FDA has not offered different guidelines, but, agency officials say that "it has become increasingly clear that these different use settings create distinct intended use populations with unique characteristics and device design requirements."
By making a distinction between the two uses, the FDA hopes to encourage glucose meter designs that better meet the needs of both populations, leading to improved safety and efficacy.
The proposed guidelines for both devices outline stricter disinfectant regimens, specifically more infection control to prevent the risk of transmitting blood borne pathogens such as hepatitis.
Because point-of-care devices are more likely to be used to test multiple patients, these meters should have design features in place making them easy to clean and disinfect, while home devices should be designed for single-patient use.
Home devices should also be sturdier and more reliable to account for the way the instruments are traditionally handled and stored in a home setting, according to the new guidelines.
Professional devices should be designed with greater accuracy--and less likelihood of inaccuracies--since patients in a healthcare setting are more likely to be seriously ill, and in greater danger if a device yields inaccurate readings.
"Previously, most blood glucose monitoring devices, even those intended to be used by healthcare professionals, were submitted to FDA with claims for OTC use," the guidelines say. "Thus, they were evaluated for self-use by diabetes, and the specific issues that occur in the professional healthcare setting were never addressed."
The proposed guidelines--open for comments for 90 days and aimed primarily at blood glucose monitor manufacturers--are offered only as recommendations, not as legally enforceable requirements.
0 comments - Jan 23, 2014