The American Association of Diabetes Educators has filed a comment letter with the US Food and Drug Administration (FDA), supportive of the agency’s goal of increasing the accuracy and dependability of over-the-counter diabetes testing supplies and equipment.
“We are focused on ensuring the maximum level of accuracy in blood glucose monitoring devices to ensure that persons with diabetes are comfortable and confident that they are self monitoring appropriately,” said Martha Rinker, AADE’s Chief Advocacy Officer. “At the same time, we support FDA efforts that will foster innovation in blood glucose monitoring.
In its comment letter, AADE suggested several strategies toward improving accuracy and ease of use by patients:
Adopt the international recognized standard for blood glucose monitoring systems (ISO 15197).
ISO 15197:2013 was updated through a consensus group of multiple stakeholders including clinicians, industry, engineers and regulators. It is what most of the rest of the world follows; therefore FDA using different criteria for decision-making could disadvantage patients in the United States because companies may not improve old models to avoid filing regulatory submissions for changes in the United States while products in the rest of the world continue to improve and incorporate innovations.
Force manufacturers to provide the FDA with a summary description of the lot release criteria they will use and maintain the underlying data in the design history file.
FDA needs to do all it can to ensure the reliability of SMBG test systems that people with diabetes rely on for daily management of their disease. Part of this is having established lot release criteria as a part of the manufacturer’s quality system.
Develop a representation of accuracy that is easily understood by people with diabetes
Providing technical performance information on the labeling and box may seem helpful, but we are concerned it will be confusing and hinder a user from selecting a product,” Rinker said.
“Accuracy of meters is a significant threat to the public health, and we appreciate the FDA’s work toward solving this problem,” Rinker said.
About AADE:
AADE is a multi-disciplinary professional membership organization dedicated to improving diabetes care through education. With more than 14,000 professional members including nurses, dietitians, pharmacists, and others, AADE has a vast network of practitioners involved in the daily treatment of diabetes patients.