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Hologic and MagView to develop solution for FDA inspection compliance

by John R. Fischer, Senior Reporter | July 23, 2019
Women's Health
Hologic and MagView will develop
Unifi EQUIP to help mammography
facilities comply with the FDA
inspection process
Hologic is teaming up with mammography information solutions provider MagView to develop an automated solution to help users comply with the FDA’s Enhancing Quality Using the Inspection Program (EQUIP) guidance.

Named Unifi EQUIP, the system will provide users with fully integrated tools, from automated EQUIP worklist generation for managing, tracking and documenting quality reviews of clinical images, to corrective actions for technologists.

“Workflow advantages are unlocked through the automation of image selection, review scheduling, and reporting all put into place to reduce the resource burden within a facility associated [with] complying with EQUIP,” Darren Selsky, senior director and franchise leader of global marketing at Hologic, told HCB News.

The EQUIP FDA inspection process relies on three questions to assess site compliance regarding image quality and quality control within a facility.
The first revolves around corrective actions by technologists. Unifi EQUIP populates cases in need of correcting within the technologist’s list. Cases drop off once the review is complete, with the facility able to run a report later to view the documentation for each case and which corrective actions that were taken.

The system also automates the radiologist’s image review process according to a site’s preferences, with a site-level EQUIP report providing all EQUIP-related documentation as an audit trail to prove compliance.

The third feature is a platform for Lead Interpreting Physician (LIP) attestation to document oversight of a facility’s QA/QC records.

The EQUIP requirement is currently only focused on mammography.

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