Glucose meters: current regulatory guidance for manufacturers and providers

The initial process involved an open forum on March 16 and 17, 2010, followed by publication of draft guidance documents in January of 2014, which were circulated for public comment and finalized in October of 2016.1-2 A subsequent FDA advisory panel meeting held on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 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 when self-monitoring blood glucose test systems (SMBG) for over-the-counter (OTC) use migrated into the hospital. If a facility wishes to use a BGMS off label (e.g., in a critically ill patient population when a manufacturers' instructions contain a limitation on critically ill patients), laboratories with a [CLIA waiver] may: a. Obtain a CoC or CoA b. Establish performance specifications [(i.e. accuracy, precision, analytical sensitivity, analytical specificity including interfering substances, reportable range of test results, reference intervals, and any other performance characteristic required for test performance) for use in their patient population]; and c. Meet the additional CLIA regulatory requirements for high-complexity testing and any applicable State regulations. 3. A laboratory/hospital performing high complexity testing that doesn't meet the requirements is subject to a notice of deficiency. a. This requires submitting a corrective action plan to CMS or its designee, the College of American Pathologists (CAP). b. CMS can suspend or revoke a Certificate of Waiver (CoW). c. CMS can cancel a provider's approval for Medicare reimbursement for failure to comply with the corrective action plan in a timely manner. 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. The doctrine of informed consent requires that providers disclose the nature of a proposed procedure and its benefits and risks, as well as any feasible alternatives. 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 supe