Because only a BGMS has been cleared and classified by the FDA for use in vulnerable patient populations, the off-label use of other glucose meters with critically ill patients could also present legal risk for providers.

Legal consequences include but are not limited to: Liability for patient negligence 1. Tort liability for negligence could occur if facility physicians, nurses, staff, or laboratories use a glucose meter off label with a critically ill patient and an inac- curate reading results in patient injury. 2. Off-label use of a glucose meter could be used as evidence that providers breached the standard of care, particularly in light of safety communications on this topic issued by the FDA, CMS, and other agencies. 3. The doctrine of informed consent requires that pro- viders disclose the nature of a proposed procedure and its benefits and risks, as well as any feasible alternatives.

whether a hospital using a glucose meter off label has satisfied a reasonable standard of care for its patient Liability under CLIA ‘88 and compliance under: 1. CLIA waiver: a. Conditions for CLIA-waived status b. Glucose meter loses its status as CLIA-waived test

if used off label 2. CMS’s guidance (risk to Medicare reimbursement [loss]) a. High complexity testing not properly performed under CLIA ‘88 3. State guidance, regulations, non-compliance actions impacting accreditation and possibly reimbursement. Agencies include but are not limited to: a. New York and Washington State health departments b. The Joint Commission c. CAP d. ECRI

Conclusion In summary, the off-label use of a glucose meter or any medical device can result in charges against providers and hos- pitals for negligence and medical mal- practice as a result of not following the doctrine of informed consent or main- taining the standard of care, which can result in medical board investigations. Non-compliance with CMS can possibly affect accreditation (license) and reim- bursement including liability for false claims.

Figure 4. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

a. If a provider uses a glucose meter off label and does not inform a patient of the known risks of an inaccurate glucose reading, there is a risk that the patient’s consent does not meet the informed consent standard. b. Under the theory of respondeat superior or vicarious

liability, the medical facility could be liable for these and other actions of its physicians, nurses, staff, or laborato- ries with respect to the off- label use of glucose meter in critically ill patients.

Liability for hospital corporate negligence 1. In some states, medical facilities could also be directly liable for a patient’s injuries, independent of the actions of its providers. 2. Under the corporate liability doctrine, hospitals have a duty to oversee the practice of medicine within its walls. 3. The fact that the majority of U.S. hospitals choose FDA-cleared devices for testing in their critically ill patients is one that courts could consider when assessing


The StatStrip Glucose Hospital Meter System is a professional BGMS for pre- scription POC use that is cleared and classified (Produce Code PZI) for use in all patient care settings with all specimen types by CLIA-waived staff. As of today, based on device limita- tions and NBW classification, the use of all other glucose meters in acute care facilities is considered off label by the FDA. The patient safety, legal, and regu- latory consequences for off-label use are significant and should be avoided. It is important for institutions to consult their risk man- agement and legal offices regarding off-label use of a glucose meter.

Please visit for references.

Jeffery A. DuBois, PhD, BCLD/CC (ABB), FAACC, serves as Vice President Medical and Scientific Affairs, Nova Biomedical Corporation.

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