CONTINUING EDUCATION :: DIABETES Glucose meters: current regulatory guidance

for manufacturers and providers FDA guidance documents and implications for use under CLIA ‘88 By Jeffrey A. DuBois, PhD, BCLD/CC (ABB), FAACC


herapeutic management of blood glucose in patients with diabetes in the home or in the hospital involves the use of glucose meters for the rapid assessment of whole blood glucose. On Oct. 11, 2016, the U.S. Food and Drug Administration (FDA) published guidance docu- ments for glucose meters.1,2

These guidance

documents are for manufacturers, not for providers. The Centers for Medicare and Medicaid Services (CMS) and its designees provide accreditation (certification) for and oversight of provider compliance under the Clinical Laboratory Improvement Amend- ments (CLIA) of 1988.3

This is an important

distinction for all stakeholders involved in the management of dysglycemia in hos- pitalized patients, many of who are on intensive insulin therapy to achieve safe and effective glycemic control. The FDA guidance documents make a clear distinction between devices that are designed, cleared, and classified for self-monitoring of blood glucose in the home and devices that are designed, cleared, and classified for blood glucose monitoring for prescription point-of-care (POC) use. It took six years for the FDA to publish these guidance documents for manufacturers. The initial process involved an open forum on March 16 and 17, 2010, followed by publication of draft guidance documents in January of 2014, which were circulated for public comment and finalized in October of 2016.1,2

A subsequent FDA advisory

panel meeting held on March 30, 2018, addressed the use of capillary whole blood testing with a glucose

Earning CEUs

See test on page 14 or online at under the CE Tests tab. LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to:

1. Recall which regulatory agencies are directly involved in the compliance of glucose monitors.

2. Discuss the sequence of events and process for the FDA to provide action and insight on the compliance of glucose monitors in healthcare institutions.

3. Discuss the process for approval for the use of off-label glucose meters in healthcare institutions.

4. Describe the liabilities of the use of off-label glucose meters that healthcare institutions may be subject to.


meter in vulnerable patient populations in acute care facilities.4

The trigger for the FDA’s actions was the

compilation of adverse events including numerous deaths in its MAUDE (Manufacturer and User Facility Device Experience) database.5

These events occurred

Figure 1. FDA Glucose Meter Guidance Documents

when self-monitoring blood glucose test systems (SMBG) for over-the-counter (OTC) use migrated into the hospital. During the six years when the FDA was developing new guidance for manufacturers, there was great debate about the performance criteria for glucose meters. Unfortunately, criteria were established by the International Organization for Standardization (ISO), Clinical and Laboratory Standards Institute (CLSI), FDA, and other standards organizations without sufficient evidence about device performance in all patient care settings with all specimen types by CLIA- waived operators. The FDA’s publication of two separate guidance documents clearly separates devices into two classes: 1. “Self-Monitoring Blood Glucose Test Systems (SMBG) for Over the Counter (OTC) Use” and 2. “Blood Glucose Monitoring Test Systems (BGMS) for Prescription Point-of-Care (POC) Use” (Figures 1, 2, and 3). To date, there is only one device that is cleared and classified by the FDA as a Blood Glucose Monitoring System (BGMS) for Prescription Point-of-Care (POC) Use (Figure 4).6,7

A series of articles were published after this device was cleared by the FDA on Sept. 24, 2016, k132121.8-10 articles11-13

Other called for a moratorium on the off-label use of

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