FDA Aims to Better Distinguish Between Home and Hospital-Use Blood Glucose Monitoring Systems

On Jan. 7, the U.S. Food and Drug Administration (FDA) released a draft guidance document on blood glucose monitoring test systems for prescription point-of-care use. The draft describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring test systems (BGMSs) which are for prescription point-of-care use. When finalized, FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types.

This guidance is not meant to address self-monitoring blood glucose test systems for OTC use by lay persons. The agency intends to issue another draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” to address those device types.

Historically, the FDA has not recommended different types of information in 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, the agency reported it has become concerned that there is not enough distinction between home use and hospital use devices in terms of device design requirements. Patients in professional healthcare settings can be acutely ill and medically fragile and are more likely to present physiological and pathological factors that could interfere with glucose measurements as compared to the lay population. Considering these devices serve distinctly different populations, the agency would like to see clearer definitions—hence the upcoming draft guidance on self-monitoring blood glucose test systems.

“In the last 10 years there has been much advancement in the development of glucose meters,” said  Courtney Lias, director of the Division of Chemistry and Toxicology Devices within the Office of In Vitro Diagnostics and Radiological Devices at FDA’s Center for Devices and Radiological Health, in a Jan. 9 blog post. ”They are now smaller, require a smaller blood sample for each test and produce faster results. However, their accuracy has improved little.”

In recent years, concerns have been raised including infection control issues related to point-of-care glucose meters. According to the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), blood glucose monitoring devices can transmit bloodborne pathogens if these devices are contaminated with blood specimens and are shared between users without effective cleaning, disinfecting and appropriate infection control measures. Because BGMS devices, which are 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 bloodborne pathogens.