Navigation Links
National Diabetes Volunteer Leadership Council (NDVLC) Urges FDA to Enforce Stringent Accuracy Standards for Blood Glucose Monitoring Systems
Date:9/9/2013

BETHESDA, Md., Sept. 9, 2013 /PRNewswire-USNewswire/ -- Today, representatives from the U.S. Food and Drug Administration (FDA), industry and the diabetes advocacy community will convene at a Diabetes Technology Society meeting in Bethesda, Md., to discuss possible solutions for verifying the accuracy of self-monitoring blood glucose (SMBG) systems. The following statement can be attributed to Larry Ellingson, spokesperson for the National Diabetes Volunteer Leadership Council (NDVLC) and past chair of the American Diabetes Association board (2005):

"On behalf of the NDVLC and the 25.8 million Americans living with diabetes, we applaud the efforts of the Diabetes Technology Society to examine the very serious and potentially life-threatening issue of inaccurate SMBG systems. Patients with diabetes rely on these systems to guide the decisions they make multiple times a day about their disease management, and it is crucial that the information is accurate to avoid putting their health at risk.

We look forward to hearing from the FDA today on ways they plan to enforce accuracy standards equally among all SMBG manufacturers. It is simply unacceptable that up to 45 percent of the systems marketed globally to patients with diabetes do not meet the minimum accuracy requirements post-approval and that some manufacturers have failed to provide the FDA with the requisite medical device reporting (MDR) of adverse events.

The NDVLC encourages the FDA to closely examine and enforce the approval and testing processes for these devices to create a safer environment for patients living with diabetes. The FDA should use their existing authority to ensure the health and safety of patients with diabetes while considering any new approval standards, validation, and continuous monitoring of SMBG systems post-clearance. Only once we have applied these higher standards to new and existing products can we ensure that diabetes patients across the country have access to the safe meters that they deserve. In the interim, products that fail to meet standards should not be commercially available."

The meeting, "Verifying the Performance of Blood Glucose Monitors Following FDA Clearance," will be hosted September 9 at the Hyatt Regency hotel in Bethesda, Md., beginning at 8:30 a.m. EDT. For more information, visit www.diabetestechnology.org/bgm.

About National Diabetes Volunteer Leadership Council
The National Diabetes Volunteer Leadership Council is an organization comprised of former chairs of the board and past officers of the American Diabetes Association who are committed to ensuring the well-being of diabetes patients across the country.

 


'/>"/>
SOURCE National Diabetes Volunteer Leadership Council
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Metabolic Solutions Development Company presents Phase 2a clinical trial results at the 14th International Conference on Alzheimers Drug Discovery
2. WIKA Process Solutions, Deer Park, Texas Acquires Gayesco International.
3. The Partnership at Drugfree.org Comments on National Survey on Drug Use and Health, Statement of Steve Pasierb, President and CEO
4. PAREXEL International To Present At Robert Baird Healthcare Conference And Raymond James North American Equities Conference
5. Parents and Harm Reduction Advocates from Southern California Gather in Los Angeles for the 13th Annual International Overdose Awareness Day on August 31
6. National coordinated health care and health IT transformation event will be hosted by OCHIN, Inc., the Oregon Medical Association, and Oregon Health Network: The cHealth Innovation Symposium
7. BioLineRx to Present at 15th International Celiac Disease Symposium
8. Digirad Signs Exclusive International Distribution Agreement with Dilon Diagnostics
9. CVS Caremark Uses Data to Combat National Prescription Drug Abuse Epidemic; Program Details Published in New England Journal of Medicine Online
10. Larkin Community Hospital Hosts International Dental Teaching Symposium
11. ResMed Patent Infringement Case Against BMC Advances: International Trade Commission Agrees to Investigate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... WOONSOCKET, R.I. , April 20, 2017 /PRNewswire/ ... (NYSE: CVS), today unveiled a new store design ... new assortment of healthier food, health-focused products and ... the store to help customers discover new offerings. ... represent the next evolution of the customer experience ...
(Date:4/20/2017)... April 20, 2017 NeuroVive Pharmaceutical AB ... announced positive preclinical results demonstrating anti-fibrotic effects ... non-alcoholic steatohepatitis (NASH), in an additional well-validated ... NV556 has previously shown similar anti-fibrotic effects ... NeuroVive,s scientists present novel data demonstrating anti-fibrotic ...
(Date:4/19/2017)... , April 19, 2017  IRIDEX Corporation (Nasdaq: ... financial results for the first quarter 2017 after the ... Company,s management team will host a corresponding conference call ... Investors interested in listening to the conference ... domestic callers or (703) 326-3030 for international callers, using ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... 2017 , ... Ushio America proudly introduces the new ... solution for F32T8 fluorescent lamps on most instant-start and programmed-start electronic ballasts so ... lamps utilize the existing electronic ballast, saving labor and maintenance costs. It’s easy ...
(Date:4/28/2017)... Md. (PRWEB) , ... April 28, 2017 , ... ... Association of America (UCAOA) and College of Urgent Care Medicine will host industry ... workshops, sessions and speakers will help those in the industry adapt to the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Researchers at ... ActiGraph’s CentrePoint Data Hub in a sample of participants enrolled in ... activity and sleep monitoring solutions for the global scientific community. The company’s new ...
(Date:4/28/2017)... ... 28, 2017 , ... Rob Lowe is a popular actor that has been ... to an educational purpose as the host of the “Informed” series. The program focuses ... recent episode, the series focuses on thyroid cancer. , Although thyroid cancer is an ...
(Date:4/27/2017)... ... April 27, 2017 , ... Healthcare companies are trying ... will rapidly reject an outdated healthcare executive resume. , “If you’re a healthcare executive ... executive resume and wondering if it’s as ready as you are for a new ...
Breaking Medicine News(10 mins):