Blood Glucose Meter Testing Guidance Proposed

Over the past several years, regulators have monitored the facility processes for disinfecting the glucose monitoring devices between patient uses, and cautioned practitioners on the potential for blood borne pathogens to be transmitted during multi-patient use.  Most facilities have processes currently to disinfect the devices between patient uses.

The new proposed guidance contains additional considerations related to cleaning and disinfection of the device, including consideration of the seams on the exterior of the device.  Disinfection and cleaning procedures used by the facility must be evidence based practices, and must also be compliant with the manufacturer to ensure that the chemicals used will not affect the overall performance of the device.   

The guidance further delineates labeling requirements about the use of lancing devices, and the intention of those devices to be single use, and not intended for multi-patient use.  

The draft guidance details the numerous requirements that would have to be met by the health care facilities and by manufacturers.  The draft guidance was published Jan. 7, 2014 in the Federal Register, and comments are being accepted for 90 days. 

Contact:  Michelle Synakowski, msynakowski@leadingageny.org , 518-867-8850