Industry leader weighs in on glucose monitor regulation controversy

Jan. 21, 2016

Editor’s note: In the October 2015 issue of MLO, I wrote a “Washington Report” titled “AACC urges CMS to delay enforcing glucose monitor regulations” (MLO. 2015;47(10):50) The essay outlined reasons why AACC and other lab stakeholders have advised the Centers of Medicare and Medicaid Services to, in the words of former AACC president David C. Koch, “take a pragmatic, educational approach to this situation.” This month’s “Washington Report” is a response to that column, written by John F. McHale, Vice President, QA/RA and Technical Support, Nova Biomedical Corporation, provider of the Nova StatStrip Glucose Hospital Meter System and Nova StatStrip Xpress Glucose Hospital Meter System.

The October 2015 MLO “Washington Report” touches on a complex subject that is extremely important to many readers. The risky, off-label use of glucose monitors with critically ill patients is under close scrutiny by the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), with virtually every hospital reevaluating its options for glucose testing.

However, the article overlooks several important facts pertaining to glucose monitor use with critically ill patients. I believe that providing these additional facts will give readers a better understanding of the FDA/CMS enforcement actions, and what alternatives are readily available to hospitals for glucose testing with critically ill patients.

The October article’s conclusion may have been reached because several very important facts and options for hospital point-of-care (POC) glucose use were overlooked.   These omissions may lead to a different conclusion. To explain further, I respond to three statements within the article.

Statement 1. “In a painful irony, the Center for Medicare and Medicaid Services’ proposed action, taken to protect patients, would actually threaten the quality of care.”

The reason for the FDA/CMS action is to protect patient care. CMS enforcement decisions came after more than 13 deaths attributed to hospital glucose monitors had been reported to the FDA.1 Two additional deaths were later reported, causing the New York State Health Department in January 2014 to declare the use of hospital monitors for critically ill patients as “off label” in that state.2 Also in January 2014, the FDA issued a draft guidance document that highlighted the agency’s concerns with the use of POC blood glucose monitors for critically ill patients.3 Since that time both the FDA and CMS have taken actions to warn industry that they wanted to reduce the adverse events associated with off-label use of blood glucose monitors, which were never tested or cleared by the FDA for use with critically ill patients.

As indicated in their product labeling, glucose monitors have interferences from substances or hematocrit abnormalities that are often found in the blood of critically ill patients, and this can result in the overestimation of glucose and overdosing of insulin. According to the FDA, “Errors in BGMS (blood glucose monitoring systems) device accuracy can lead to incorrect insulin dosing, which, when combined with other factors, can lead to increased episodes of hypoglycemia. For hospitalized patients who may be seriously ill, any inaccuracies in the meters would further increase the risk to these patients.”3

Statement 2. “That is, the change would suddenly make many hospitals’ use of the glucose monitor an ‘off-label’ use, and thus turn glucose monitoring into a high complexity test that could not be performed by nurses and other bedside caregivers. Faced with this situation hospitals might have little choice but to discontinue the point-of-care testing altogether.”

This statement implies that hospitals have no practical POC glucose alternative other than discontinuing the use of off-label glucose monitors for critically ill populations. This comment overlooks the fact that the FDA has already cleared two CLIA-waived glucose monitors for POC use with critically ill patient populations: “This waived status will allow a broad variety of healthcare professionals, such as nurses and technicians, to perform the test at the point-of-care, such as at a patient’s bedside, instead of requiring that the test be performed in a hospital lab (or other lab) that meets the CLIA [Clinical Laboratory Improvement Amendments of 1988] requirements for high complexity testing. The CLIA waiver will also allow hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing.”4

Statement 3. “In the comment letter, AACC asserts that a transitional period will allow hospitals to adjust policies, procedures, and workforce to ensure compliance with the new regulatory requirements.”

As stated earlier, the FDA issued its new draft guidance document for hospital POC glucose monitors nearly two years ago, and CMS subsequently communicated its intention to enforce off-label use of glucose monitors. More than half the hospitals in the U.S. have already transitioned to the FDA-cleared POC glucose monitor that is cleared for all patients, including critically ill. The downside of an additional transition period would perpetuate the risk of using untested glucose monitors on critically ill patients when a safe, FDA-cleared solution already exists.

AACC’s rationale that the implementation of the FDA/CMS decision would cause patient harm is contrary to the facts. Off-label use of glucose monitors has been shown to cause adverse events including deaths. A delay in the enforcement will unnecessarily perpetuate the risky use of glucose monitors that have not been cleared for use with critically ill patients when immediate, FDA-cleared, CLIA-waived products exist.

In summary, these FDA/CMS actions do not adversely affect the quality of patient care; they improve the quality of patient care. Neither do these actions result in prohibiting POC glucose testing. Hospitals have a choice of either using a POC glucose monitor tested and cleared for critically ill patients or following the regulations for off-label use in this population. Half of U.S. hospitals have already employed the FDA-cleared monitor.


  1. Harper CC. FDA/CDRH Public Meeting: Blood Glucose Meters. Presented at the meeting of the U.S. Food and Drug Administration/Center for Devices and Radiological Health, Gaithersburg, MD. 2010. Accessed December 30, 2015
  2. New York State Department of Health. Off-Label Use of Glucose Meters. 2014.
  3. Food and Drug Administration. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff. 2014. Accessed December 30, 2014.
  4. Food and Drug Administration. FDA clears glucose monitoring system for use in hospital critical care units. 2014. Accessed December 30, 2015.