New Regulatory and Accreditation Issues that Affect Hospital Glycemic Management Programs

Course overview

Glycemic management programs are the standard of care in every hospital in the world, and bedside glucose monitoring systems (BGMS) are central to program success. The industry became aware of significant patient safety concerns when hospital deaths directly attributed to BGMS use were reported to the FDA. Regulatory and accreditation bodies around the world have now reacted, and created new regulations and guidelines to improve patient safety and reduce risk. In October 2016, the FDA issued a new guideline requiring BGMSs to be virtually equivalent to central laboratory methods and, for the first time, separating BGMS from self-testing of blood glucose (SMBG) meters. This program will: • Review background leading to the new FDA guideline, including new labeling for glucose meters “Not evaluated with the critically ill” • Examine regulatory and accreditation changes affecting hospital BGMS and their impact on inpatient glycemic manage programs. • Discuss how hospitals have addressed recent changes and how they can maintain accreditation for their point of care glucose programs.