On January 7, the Federal Drug Administration (FDA) issued draft guidelines which would make changes to blood glucose monitoring test systems (BGMS) in both hospitals and long-term care facilities.
This draft guidance document describes studies and criteria the FDA recommends for BGMSs which are for prescription point-of-care use. When finalized, the FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types. Portable blood glucose monitoring test systems (glucose meters) that measure blood glucose concentrations are widely used in hospitals as well as in a variety of other clinical settings including both acute and chronic care facilities, general hospital wards and intensive care units, physicians’ offices, assisted living facilities and nursing homes.
Historically, the FDA has not recommended different types of information in premarket submissions (510(k)s) for blood glucose meters used by medical professionals as compared to over-the-counter self-monitoring devices intended for use by lay users. In recent years, however, concerns have been raised including infection control issues related to point-of-care glucose meters. According to the Centers for Medicare & 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 blood-borne pathogens.