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Atirix Guideline:
The FDA EQUIP Process and QC-Track
FDA EQUIP means MQSA inspectors are asking three new questions.
Questions 1 and 2 relate to image quality, and Question 3 relates to device QC and LIP Sign Off.
Per the FDA, facilities are responsible for having adequate processes in place to meet the information gathering and review needs,
but the FDA has not provided a process to follow.
To learn more about FDA EQUIP guidelines and requirements, review the links to the FDA EQUIP website below:
The
Atirix process
for FDA EQUIP uses a combination of QC-Track workflows and spreadsheets adapted from the
ACR 2016 Digital Quality Control Manual,
as follows:
-
QA - Clinical Image Corrective Action -
Does the facility have procedures for corrective action when clinical images are of poor quality?
-
See the
Credentials
module - Tracking for FDA EQUIP, which logs image feedback and corrective actions and sends email notices.
-
Optional: Log in to the
Client Center
to download the EQUIP for Radiologist Image Quality Feedback Form.
Your IP can use this paper logging form to record feedback and corrective action data,
which can then be entered into the image feedback tracking page.
-
Clinical Image Quality -
Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality
standards established by the facility’s accreditation body?
-
See the
Credentials
module - Tracking for FDA EQUIP, which logs reviews and corrective actions. Also see the
QC Event Tracking
module for scheduling review events with email reminders.
-
Optional: Log in to the
Client Center
to download the RT and IP Image Review Form.
Your IP can use this paper logging form to record feedback and corrective actions for data entry into the
image feedback tracking page.
-
Quality Control -
Does the facility have a procedure for LIP oversight of QA/QC records and corrective actions?
-
See the
Mammography
module for device QC,
Reports
to learn about the Report Package module, and
Sign Off
for the LIP desktop.
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Atirix products are covered by issued and pending patents, including US 8,478,610 “Medical Imaging Device Quality Control
System and Method” and US 8,428,969 “System and Method for Tracking Imaging Quality”
©
2023
Atirix Medical Systems, Inc. All Rights Reserved.
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