Main Newsletter
Mastery Series
Therapy Series
 
Bookmark and Share | Print Article | Items for the Week Previous | All Articles This Week | Next
This article originally posted and appeared in  Safety and Error PreventionMedicationBG ControlMedical DevicesInsulinGlucose MonitoringIssue 730

AACE: FDA's Proposed Improvement in Accuracy of Glucose Meters a Burden?

At present the FDA allows an error rate of blood glucose meters at 20%.... 

Advertisement

The American Association for Clinical Chemistry (AACC) has responded to the FDA's recent draft proposal to reclassify usage guidelines for prescription blood glucose meters, saying that the changes would limit opportunities to monitor blood glucose in critical care scenarios.

The organization supports the FDA's initiative to enhance patient care but recommends improving clinical protocols in critical care rather than increasing regulatory requirements for the equipment.

The FDA's draft guidance proposed that prescription blood glucose meters be categorized with a complexity rating that would necessitate operation by health care providers with appropriate qualifications. AACC said in an online statement that such a change would be detrimental to patient outcomes.

James H. Nichols, PhD, medical director of clinical chemistry at Vanderbilt University Medical Center and chair of AACC's Government and Regulatory Affairs Committee, said that, "Although we support the [FDA's] objective, reclassifying prescription-use blood glucose monitors will add to the regulatory burden for health care providers by increasing their personnel documentation, proficiency testing, and method performance certification requirements," said in a press release. "We do not believe that this will improve patient outcomes. In fact, we are concerned that the opposite may occur if glucose meters are suddenly removed from critical care settings, where they are effectively used to measure and manage glucose levels, thus contributing to better patient outcomes."

AACC said in a press release that, overall, the FDA could benefit patients the most by increasing performance criteria for prescription blood glucose meters, but not to an extent that would limit or encumber use of the devices. Previously, AACC worked with the FDA in a March 19 webinar that outlined new blood glucose meter guidelines.

Presented at AACE May, 2014 

Publishers Comment: Improving the accuracy of blood glucose meters can have a major impact on those that are pro-active in doing basal bolus insulin treatment. The more accurate the meters are, the better control we will see for our patients. It will also bring the artificial pancreas closer to reality. 

Advertisement


 

Bookmark and Share | Print | Category | Home

This article originally posted 23 May, 2014 and appeared in  Safety and Error PreventionMedicationBG ControlMedical DevicesInsulinGlucose MonitoringIssue 730

Past five issues: Diabetes Clinical Mastery Series Issue 211 | Issue 751 | Humulin Insulin Special Edition October 2014 | Diabetes Clinical Mastery Series Issue 210 | Issue 750 |

2014 Most Popular Articles:

FDA Approves Once-Weekly GLP-1 Diabetes Treatment Regimen for T2DM
Posted September 25, 2014
Stanley Schwartz, MD: A New Way of Classifying Diabetes - The Beta-Cell Centric Approach
Posted September 29, 2014
Two Positive Phase 3 Trials for ITCA 650 (Exenatide, a GLP-1 Agonist) in Type 2 Diabetes
Posted October 10, 2014
GLP-1 Agonist Medications Chart
Posted September 23, 2014
EASD: Insulin Pumps Lower Mortality Rate 29% Compared to Multiple Injections in T1DM
Posted October 03, 2014
Best Insulin Regimen for Type 1's
Posted October 10, 2014
FDA Approves an Eye Drug for Diabetic Patients
Posted September 25, 2014
Handbook of Diabetes, 4th Edition, Excerpt #11: Diabetic Ketoacidosis, Hyperglycaemic Hyperosmolar State and Lactic Acidosis
Posted September 27, 2014
Best Glycemic Control for T2DM Attained with GLP-1 Agonist + Insulin
Posted September 25, 2014
Non-Caloric Artificial Sweeteners May Induce Glucose Intolerance
Posted October 10, 2014


Browse by Feature Writer & Article Category.
A. Lee Dellon, MD | Aaron I. Vinik, MD, PhD, FCP, MACP | Beverly Price | Charles W Martin, DD | Derek Lowe, PhD | Dr. Brian Jakes, Jr. | Dr. Fred Pescatore | Dr. Tom Burke, Ph.D | Eric S. Freedland | Evan D. Rosen | Ginger Kanzer-Lewis | Greg Milliger | Kristina Sandstedt | Laura Plunkett | Leonard Lipson, M.A. | Louis H. Philipson | Maria Emanuel Ryan, DDS, PhD | Marilyn Porter, RD, CDE | Melissa Diane Smith | Michael R. Cohen, RPh, MS, ScD, FASHP | Paul Chous, M.A., OD | Philip A. Wood PhD | R. Keith Campbell, Professor, B.Pharm, MBA, CDE | Richard K. Bernstein, MD | Sheri R. Colberg PhD | Sherri Shafer | Stanley Schwartz, MD, FACP, FACE | Steve Pohlit | Steven V. Edelman, M.D. | Timothy S. Hollingshead |

Cast Your Vote
Do your teenage patients manage their diabetes well?
CME/CE of the Week
Marie Williams, DPM

Category: Wound Care
Credits: .75



Search Articles On Diabetes In Control