The FDA has proposed new industry guidelines that the agency hopes will make blood glucose meters safer and more durable for everyday use.
On January 7, the FDA issued two sets of proposed blood glucose meter guidelines; one set for over-the-counter meters (PDF) and another for meters used at healthcare facilities (PDF). The agency hopes the guidelines will cut the risk of infections and make the meters more durable and reliable for public use.
Blood glucose meters, often used in combination with blood glucose test strips, are used by diabetics to monitor blood sugar levels. They help tell the user when they may need to eat or take insulin to regulate their blood sugar levels. If they fail or provide inaccurate information it can lead to misdiagnosis and severe injury or even death to patients.
Courtney Lias, director of the FDA’s Division of Chemistry and Toxicology Devices, wrote an FDA blog on January 9, explaining the agency’s recent move. She said that the last decade has seen the meters get smaller, require less blood and produce faster results. However, she notes that “their accuracy has improved little.”
“FDA recognize the need to optimize the safe use of blood glucose meters in two distinct settings: self-monitoring using devices purchased over-the-counter, and use in a clinical setting by health care professionals,” she wrote. “Historically, devices used in these two settings have been studied using the same methods and standards. However, it has become increasingly clear that meters used in these different settings have unique characteristics and different design specifications.”
Lias notes that these differences can affect the accuracy, particularly among over-the-counter devices that are used at home by patients who vary greatly in age, knowledge of blood glucose meters and other critical factors. The new guidance focuses on reducing the risk of bloodborne pathogens, and performance and precision evaluation testing techniques.
The draft guidance put forward by the FDA, if finalized, would not represent legally enforceable responsibilities for medical device manufacturers. However, the guidance would represent the Agency’s current thinking and recommendations. In product liability cases, such guidelines are often seen as benchmarks for what effort a manufacturer should put into products to make them safe and effective.
The guidance came as the result of a March 2010 public meeting, Lias says. However, they also come on the heels of a number of blood glucose meter and testing strip recalls.
Just this year has already seen two major recalls. On January 2, the FDA announced a TRUEbalance and TRUEtrack glucose meter recall due to an incorrect factory setting that could lead to monitors showing results in mmol?L (millimoles/liter) instead of the industry standard mg/dl (milligrams/decileter) which the agency fears could cause a diabetic to take the wrong course of action and suffer severe injuries or death.
That was followed by a January 6 FreeStyle and FreeStyle Lite Blood Glucose Test Strip recall which was announced after it was determined that the strips could give erroneously low blood glucose results. While the initial recall was issued in November via a letter sent by Abbott to its customers, the FDA declared last week that the recall should be considered Class I; the most serious classification of medical device recall.