faq

Q: Do you need to use a spatula or other collection device in addition to the Gynemed device?

A: If the transformation zone is in the normal position within the cervical os, the Gynemed device will adequately sample the squamous and glandular cellular components. If cervical eversion or erosion is present, and additional device such as cervical spatula or cervix broom should be considered to ensure optimal sampling of the transformation zone.

Q: Is the Gynemed collection device FDA cleared?

A: Yes, the device is FDA approved for cellular sample collection for conventional and liquid based Pap test technologies.

Q: Can the Gynemed device be used when the cervix is stenotic?

A: If the cannula cannot be inserted into the correct position within the cervical canal, obtaining an adequate trans os sample is unlikely.

Note: A smaller diameter device is currently in production and will be available soon to address this problem.

Q: Can the Gynemed device be used to collect ECC samples?

A: The device is FDA cleared for Pap sample collection only at this time.

Q: Your instructions indicate that the device should be discarded after the process is completed. Isn't it better to leave the device in the collection fixative fluid to insure that all the material is captured?

A: If a collection device is carefully and thoroughly manipulated in the fixative fluid prior to placing the device into the fluid, most of the cellular sample will be in suspension and available to the slide preparation process. However, if cellular material remains in the device and is placed into the fixative solution, the mucinous sample will congeal on the device and becomes very difficult to remove. Vortexing is the only procedure available in the laboratory to attempt to breakup the clumped material so that it will become available to the prep technique...Often, this is not done at all, and even when attempted, it is seldom successful. Some studies show that 60-70% of the original cellular sample remain on the devices, and never make it to the prepared slide for examination. (see photos, click to enlarge)
 

     These photos are taken of other devices after the Pap slide has been made and sent to the lab. The remaining material is routinely discarded, with it's diagnostic value unobserved.
 

The plunging action of the Gynemed device successfully removes the cellular material from the device and is completely availableto the preparation process and microscopic examination.



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