Portable blood glucose meters measuring blood glucose values are used by millions of people every day as an aid in diabetes self-management These devices are also used by healthcare professionals in a variety of clinical settings such as acute and chronic care facilities and in hospitals, physicians offices, assisted living facilities, and nursing homes.
So far, FDA www.fda.gov has not recommended submitting different types of information in premarket submissions for blood glucose monitoring systems when they are to be used by healthcare professionals as compared to over-the-counter Self-Monitoring Blood Glucose (SMBG) test systems
However, it is becoming increasingly clear that different use settings can have unique characteristics that can impact device design specifications. Manufacturers need to take these unique characteristics into account when designing their devices.
The FDA now has made recommendations for prescription use blood glucose meters to be used in point-of-care professional healthcare settings as opposed to those devices that are intended for use by lay users. As a result, FDA on October 11, 2016 issued two separate guidance documents for professional use and for use in the individual’s home.
Another concern that has been raised relates to infection control issues involving blood glucose meters and other devices. According to CMS www.cms.gov and CDC www.cdc.gov, blood glucose meters can transmit blood borne pathogens if these devices are contaminated with blood specimens and are shared between users without effective cleaning, disinfecting, and appropriate infection control measures.
Since, Blood Glucose Monitoring Systems (BGMS) are used in professional healthcare settings, the systems are more likely to be used on multiple patients. This type of use requires certain design features and capacity for cleaning and disinfection to prevent the spread of blood borne pathogens.
In addition, there are concerns regarding the inability of currently cleared BGMSs to perform effectively in professional healthcare settings because these devices have not been adequately evaluated in some of the populations where they are being used.
The FDA Guidance document titled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” originally issued in 2014 in draft form has now been issued in final form. The document can be found in the October 11, 2016 Federal Register www.federalregister.gov issue pages 70122-70124.
FDA is interested in comments and suggestions at any time. Go to www.regulations.gov for more information. Identify all comments with the docket number FDA-2013-D-1445.For questions on the document, email Leslie Landree at leslie.landree@fda.hhs.gov.