The U.S. Food and Drug Administration has drafted more stringent guidelines for blood glucose monitoring test systems used in nursing homes, hospitals and other healthcare settings.
In the past, FDA regulations have not distinguished between glucose meters used in clinical settings and those used by individuals for self-monitoring, the draft guidance notes. However, the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention have raised concerns that some meters are not robust enough to withstand the rigors of use in professional settings, and could pose infection control risks. This is because meters can become contaminated with blood, and have been associated with the spread of diseases such as hepatitis.
In response, the FDA is proposing separate specifications for glucose meters that would be used by clinicians. The 41-page draft guidance lays out the design elements that these meters would have to meet, and the information that device makers would have to provide in premarket submissions to the FDA.
All parts of the meters used by healthcare professionals should be able to be easily and completely cleaned and disinfected, including seams and the test strip port, the guidance states. It describes potential labeling requirements, such as a warning that lancing devices are never to be used on multiple patients, and discusses effective cleaning agents.
Device makers also should consider potential sources of error, including operator errors, software errors and errors caused by environmental factors, according to the guidance. It includes a table listing many of these sources of error.
The draft guidance was published Tuesday in the Federal Register. Comments are being accepted for 90 days.
