FDA Provides Guidance for Calculating Workload for FDA-Approved Gynecologic Cytology Screening Devices
Published: Jul 30, 2010
The Food and Drug Administration has issued a communication to clarify for laboratories how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices. According to the FDA, the current product labeling regarding workload recording for these devices has been difficult to interpret, resulting in variability and lack of standardization in counting methods. Exceeding the designated maximum workload jeopardizes the ability of device users to detect precancerous and cancerous lesions of the cervix and is a public health risk.
The communication is intended for cytotechnologists, technical supervisors, and laboratory managers using these systems and addresses how to count fields of view (FOV) and full manual slide reviews (FMR), as well as establishing maximum workload limits.
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