How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices
MedSun: Newsletter #53, October 2010

FDA Medical Device Safety

Clarification for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices. This 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. 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.

Additional Information:

FDA Medical Device Safety. How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices. July 27, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm220292.htm


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