The FDA recently acknowledged that there are more than 510,000 blood glucose meters and test strips that do not meet the current accuracy standards for which they were approved, reports the website Stripsafely.com. What this means for those with diabetes is inaccurate readings, which could potentially cause patients on insulin to take too little or too much — resulting in dangerous diabetes-related complications.
Diabetic Connect first covered this topic last year in How Accurate Are Your Glucose Test Strips? Since then, the lack of oversight by the FDA has begun to gain momentum. The FDA has now proposed new accuracy standards for meters and test strips before they clear them for purchase. However, these new guidelines won’t affect current products on the market — unless you want them too. Yes, the FDA is asking for your input on what these new standards should be.
FDA expert Courtney Lias met with diabetes advocate Bennet Dunlap for a live chat to discuss how the FDA is approaching the new standards. Lias brought up a critical point telling viewers that since the arrival of glucose monitors for home use, the sample size needed has decreased and the result time has gotten shorter, but unfortunately accuracy has not improved. “Many people thought their meters were more accurate than they really were,” she says.
Dunlap asked viewers to speak up and inform the FDA on what new standards those in the diabetic community want to see enforced. Ideas include continual testing after a product goes to market, which is important for maintaining the safety and security of those who rely on glucose monitors and test strips for accurate readings. They also brought up proposed guidelines for external markers on test strip packages that will help ensure the patients that test strips have been stored and handled properly prior to use.
Have Your Voice Heard
The FDA is asking the diabetic community to reach out and share their concerns. They want to know what guidelines you think should be implemented when it comes to glucose monitoring test systems.
If you want to take action and share your concerns with the FDA, you have until May 7, 2014 before the two draft guidance documents close. Act now by visiting:
Comments for: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
Comments for: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
For more information and ways to get involved visit www.stripsafely.com. The diabetic community must speak up! Let the FDA know what concerns you have and what guidelines you would like to see in the future.