The FDA is responsible for ensuring the safety of biomedical devices that are available in the United States. Precision and accuracy are both factors that affect how doctors and patients will react to results from a medical instrument, and so both are vital to ensuring safety standards. Accuracy is how close an instrument’s result is to that of a reliable “gold standard.” It is incredibly vital because an inaccurate measurement can lead to an inaccurate diagnosis. Misdiagnoses can result in wrong treatments, which can result in poor patient outcomes.

Precision is concerned with the differences in results for a set of measurements, regardless of the accuracy. According to the FDA, precision is related to uncertainty meaning that the instrument in question needs to be able to repeat results consistently in order to reduce the uncertainty of future results independent from its accuracy. This is important because an instrument that provides different results each time it is used is not very useful. Analytical validation must be conducted on all medical instruments to check for Precision, including repeatability and reproducibility.

Over time, both precision and accuracy for instruments “drift,” causing instruments to become both less accurate and less precise. For this reason, the FDA also has safety standards related to equipment calibration, so that original instrument performance is maintained. Based on standards for all of these things, FDA often engages in product recalls. Do any of you know of any FDA recalls specifically for poor accuracy or precision for a medical device?