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- CAP Advocacy Win: FDA issues Guidance on Updating Breakpoints in AST Device Labeling
On September 29, the Food and Drug Administration (FDA) issued guidance to provide recommendations to update susceptibility test interpretive criteria (STIC) (also referred to as “breakpoints”) in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint updates posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website. Previously, the CAP and 4 other health care organizations advocated to the FDA for regulatory oversight of breakpoints for the protection of public health. Through the combined efforts of industry, government, standards development organizations, and clinical laboratories following this new FDA guidance, patients safely will be safeguarded going forward. A breakpoint represents a defined antibiotic concentration or zone of inhibition diameter that serves as a gatekeeper for antimicrobial use. A breakpoint enables interpretation and reporting of an AST result as “susceptible,” “intermediate,” or “resistant,” which guides clinical therapeutic decision-making. The CAP and other groups had argued to the FDA for a clear path forward not only for breakpoint updates, but also for “bug/drug” combinations that are routinely tested and reported using Clinical and Laboratory Standards Institute (CLSI) breakpoints. Manufacturers have not been updating breakpoints and many labs do not know that the breakpoints are obsolete. This causes widespread struggle of clinical laboratories to stay up to date with current breakpoints. The use of obsolete breakpoints limits the global public health response to antimicrobial resistance, as pathogens of serious or urgent concern can go undetected, spread to additional patients and across healthcare centers and communities. Without receiving official acknowledgment of these life-saving breakpoints from the FDA, the CAP added breakpoint updates to all new laboratory accreditations to help mitigate the problem and protect patients.
On September 29, the Food and Drug Administration (FDA) issued guidance to provide recommendations to update susceptibility test interpretive criteria (STIC) (also referred to as “breakpoints”) in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint updates posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website. Previously, the CAP and 4 other health care organizations advocated to the FDA for regulatory oversight of breakpoints for the protection of public health. Through the combined efforts of industry, government, standards development organizations, and clinical laboratories following this new FDA guidance, patients safely will be safeguarded going forward.
A breakpoint represents a defined antibiotic concentration or zone of inhibition diameter that serves as a gatekeeper for antimicrobial use. A breakpoint enables interpretation and reporting of an AST result as “susceptible,” “intermediate,” or “resistant,” which guides clinical therapeutic decision-making.
The CAP and other groups had argued to the FDA for a clear path forward not only for breakpoint updates, but also for “bug/drug” combinations that are routinely tested and reported using Clinical and Laboratory Standards Institute (CLSI) breakpoints. Manufacturers have not been updating breakpoints and many labs do not know that the breakpoints are obsolete.
This causes widespread struggle of clinical laboratories to stay up to date with current breakpoints. The use of obsolete breakpoints limits the global public health response to antimicrobial resistance, as pathogens of serious or urgent concern can go undetected, spread to additional patients and across healthcare centers and communities.
Without receiving official acknowledgment of these life-saving breakpoints from the FDA, the CAP added breakpoint updates to all new laboratory accreditations to help mitigate the problem and protect patients.