Sign up for our complimentary
weekly e-journal

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The FDA's draft guidance proposed that prescription blood glucose meters be categorized with a complexity rating that would necessitate operation by health care providers with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: Issue 796 | Diabetes Clinical Mastery Series Issue 255 | Issue 795 | SGLT-2 Inhibitors Special Edition August 2015 | Diabetes Clinical Mastery Series Issue 254 |

2015 Most Popular Articles:

Coffee Consumption Proves Potential in Reducing Type 2 Diabetes Risk
Posted August 07, 2015
Impaired Glucose Uptake in the Brain May Increase Alzheimer's Disease Risk
Posted August 07, 2015
First Non-Surgical Weight Loss Procedure for Mild-to-Moderate Obesity
Posted August 07, 2015
Ketoacidosis Not as Great as Thought in Diabetes Patients Taking Invokana
Posted August 13, 2015
Impact of Switching Insulin Glargine to Insulin Detemir in T2 Patients
Posted August 14, 2015
GLP-1 Agonist Semaglutide Completes Phase III Trial with Positive Results
Posted August 07, 2015
SIgnificant Weight Gain Associated with Laparoscopic Sleeve Gastrectomy
Posted August 14, 2015
Two New Possible Methods for Diagnosing and Monitoring Diabetes
Posted August 07, 2015
Diabetes Combination Drug LixiLan Meets Main Target in Late Stage Trial
Posted August 07, 2015
Soybean Oil Causes More Obesity and Diabetes Than Fructose
Posted August 20, 2015


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
What percentage of your patients have reached goal for A1c, BP and cholesterol?

CME/CE of the Week
Marie Williams, DPM

Category: Wound Care
Credits: .75