Glucose Monitoring Guidance

Portable blood glucose monitoring test systems for measuring blood glucose concentrations are used by millions of people every day. The devices are currently used in a variety of clinical settings including both acute and chronic care facilities, general hospitals, intensive care units, physicians” offices, as well in assisted living facilities and nursing homes.

In the past, the FDA has not recommended different types of information for premarket submissions for blood glucose meters used by medical professionals as compared to over-the-counter self-monitoring devices intended for use by lay users. However, it has become clear that these different use settings present different issues.

In recent years, concerns have been raised about infection control issues related to point-of-care glucose meters. According to CMS and CDC, blood glucose monitoring devices can transmit blood borne pathogens if the devices are contaminated with blood specimens and are shared between users without effective cleaning, disinfecting, and appropriate infection control measures.

Since the devices used in professional healthcare settings are more likely to be used on multiple patients, this type of use requires certain design features and cleaning capability to prevent the spread of blood borne pathogens.

Also, self-monitoring blood glucose devices and the associated test strips used by lay persons are more likely to undergo more varied storage and handling conditions as compared to devices used in professional settings. These devices need to be designed to be more robust and reliable to accommodate actual use conditions.

FDA on January 7 released two separate draft guidance documents for industry and FDA staff available for comments related to blood glucose monitoring devices:

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

 

For more information go to www.fda.gov/MedicalDevices/default.htm.

 

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