The EQUIP initiative is in its third year, with 2017 being an educational year, and 2018 marking the first year citations were issued for violations. This year, the FDA will start issuing repeat Level 2 Citations for sites that fail to meet the criteria outlined by the program.
According to the FDA, inspectors have identified some of the following common issues related to the periodic clinical image quality review:
- • Failing to include the IPs or lead IP in the review
- • Using IP peer reviews that do not include a review of image quality
- • Mistakenly believing that individual IPs reviewing images daily obviates the need for the periodic clinical image quality review
- • Inadequately explaining the facility’s periodic clinical image quality review process to the inspector and/or failing to produce the required documentation of the periodic review at the time of inspection
MagView has a solution in the EQUIP module, which was made available shortly after this initiative was announced. In addition to providing a worklist for IPs and technologists to review images and feedback respectively, it includes compliance reports for both your team and your inspector.
To find out how MagView provides a solution for EQUIP compliance, check out our Solutions page.
For more information from the FDA, read the recent article posted here.