FDA draft guidances on BG meters   (January 13, 2014)

The US Food and Drug Administration (FDA) has just issued two draft guidances about blood glucose meters:

• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
  and
  
• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
  
  

These documents are drafts that are open for comments and suggestions from consumers, manufacturers, and anyone else, for 90 days. They’ll probably then be revised, and eventually issued as guidances for manufacturers who make BG devices and for the FDA staff who review them.

Thereafter, newly-developed meters will have specific standards to meet, which will be different for meters intended for home (or in FDA-speak, “Over-the-Counter”) use than for meters intended for what the FDA calls “prescription point-of-care use” (professional healthcare settings such as hospitals, physician offices, and long term care facilities)

The FDA points out that these two types of meters have different issues.

1) Home use of meters involves use by “individuals with wide ranges in age, dexterity, vision, training received on performing testing, and other factors that can be critical in the patient’s ability to accurately use the device and interpret test results.”
2) Contrariwise, hospital use of meters involves meters used on multiple patients; the patients are fragile; the risk of spreading bloodborne pathogens such as hepatitis is greater, and may have factors that could interfere with BG measurements.

The FDA documents are limited to devices which typically use capillary whole blood from fingersticks or alternative anatomical sites, and do not address blood glucose monitoring test systems such as clinical chemistry analyzers, implanted or continuous glucose sensors, nor devices that do not require removal of a blood sample from a fingerstick or other anatomical sites.

Many of the suggested recommendations are pretty technical, and include factors that have been implicated as affecting meter performance, such as ambient temperature, humidity, and altitude. Parameters for studies using the proposed device are described (e.g., “You should include at least 350 different subjects in your method comparison study”). And suggested labeling statements are provided, such as “Critically ill patients should not be tested with a glucose meter because results may be inaccurate. Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.”

It will be interesting to see the response to these suggestions from meter makers. Will they readily accept the draft guidances? I would hope so; although the proposed requirements are pretty strict, they seem reasonable.

Use of BG meters is now a fact of life in diabetes care, and the better the meter, the better the diabetes care.