The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents detailing the agency's recommendations for manufacturers to improve both over-the-counter (OTC) and point-of-care (POC) blood glucose meters. This marks the first time that the FDA has issued separate documents for the two types of meters, stemming from the need to address the different ways that patients and professionals use the meters.
Glucose meters measure the level of glucose (sugar) in the blood from a small finger-prick blood sample taken using a disposable test strip. OTC meters are intended for use by an individual diabetic patient at home to self-monitor glucose levels, determine insulin adjustments, and understand how diet and exercise affect blood glucose. POC meters are used in a healthcare setting and may be used to monitor the glucose levels of more than one person. These meters are used by professionals in hospitals and healthcare institutions to monitor patients and help guide treatment.
Although the FDA guidance documents will likely create little noticeable change for home self-monitoring consumers, it is important for patients to understand why the FDA has proposed two different sets of standards and how the standards could impact patient care in the future. The FDA stated that having separate guidance documents will address the "unique characteristics and device design requirements" of OTC and POC meters and will make the two device types "better designed to meet the needs of their intended use populations, thereby ensuring greater safety and efficacy."
In an effort to improve meter accuracy and performance, the FDA's guidance documents propose new recommendations for the labeling, performance evaluation, manufacturing controls, and cleaning and disinfection of meters. For example, it is recommended that OTC meters be designed and labeled for ease of use by a lay person and must also be made to be used by an individual patient to prevent the risk of spreading infections, as might occur if devices were shared. The FDA also proposes that meters be more precise by tightening the acceptable range of repeatability from plus or minus 20% to plus or minus 15%. The Endocrine Society supports this effort to improve glucose meter precision. [For more on accuracy and precision in laboratory testing, see the article How Reliable is Laboratory Testing?]
While manufacturing guidelines will tighten for both home use and those used in healthcare setting, POC meters in particular will be held to even higher standards. These increased POC standards address two important needs unique to the hospital setting: greater measurement accuracy necessary for emergency treatment situations and easier ways to disinfect devices to avoid the spread of infections among the many patients tested using a single meter. For very ill or medically fragile patients, incorrect glucose measurements could lead to delays in insulin dosing and could possibly cause more low blood glucose (hypoglycemic) episodes or other detrimental complications. In such instances, POC meter accuracy becomes critical.
What the FDA's recommendations mean for diabetic patients is that they will likely see improvements to at-home glucose meters in the future. The larger impact will be seen with professional, institution-use meters. The two guidance documents, released in January, are the proposed requirements the FDA will look for when evaluating manufacturers' meters and test strips for FDA clearance. The FDA is inviting public comments about the recommendations during a 90-day feedback period before the documents are finalized.
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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used. To access online sources, copy and paste the URL into your browser.
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Draft Guidance for Industry and Food and Drug Administration Staff (Jan. 7, 2014.). The U.S. Food and Drug Administration. Available online through http://www.fda.gov. Accessed February 2014.
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Draft Guidance for Industry and Food and Drug Administration Staff (Jan. 7, 2014.). The U.S. Food and Drug Administration. Available online through http://www.fda.gov. Accessed February 2014.
Fiore, Kristina. (Jan. 9, 2014.) FDA Rules Differ for OTC vs. POC Glucose Monitors. MedPage Today. Available online at http://www.medpagetoday.com/Endocrinology/Diabetes/43720 through http://www.medpagetoday.com. Accessed February 2014.
Blood Glucose Monitoring Devices. (Updated Jan. 10, 2014.) The U.S. Food and Drug Administration. Available online at http://blogs.fda.gov/fdavoice/index.php/2014/01/setting-the-bar-for-blood-glucose-meter-performance/ through http://blogs.fda.gov. Accessed February 2014.
Price, Catherine. (Jan. 23, 2014.) FDA's New Draft Guidance on Blood Glucose Test Strips. A Sweet Life Magazine. Diabetes Media Foundation. Available online through http://asweetlife.org. Accesssed February 2014.