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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Correction Period When Components of the Senographe(TM) 2000D Full Field Digital Mammography FFDM System Fail Quality Control Tests

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This alternative standard was approved on June 27, 2002. It allows a 30 day period for corrective actions following the failure of specified quality control tests by the SenographeTM 2000D FFDM system. The specified tests are equivalent to quality control tests for screen-film systems for which a 30 day correction period is already allowed. The alternative standard also divides into two groups the quality control tests whose failure requires corrective action before the failing component is used again during patient examinations. This division makes it clear that when the test failure is related to the acquisition of images only, the review of already acquired images can continue and when the test failure is related to the image review components only, images can continue to be acquired. The alternative was approved for an indefinite period.

The original standard is 21 CFR 900.12(e)(8)(ii), which states:

21 CFR 900.12(e)(8): Use of test results

(ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further examinations are performed or any films are processed using the component of the mammography system that failed any of the tests, described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;

The approved alternative is:

21 CFR 900.12(e)(8): Use of test results.

(ii) If the test results for the SenographeTM 2000D FFDM fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) Before any further mammographic images are acquired using the SenographeTM 2000D FFDM system that failed any of the following tests:

(1) Monitor cleaning for the Acquisition Work Station (AWS)

(2) Flat Field Test

(3) CNR Test

(4) Phantom Image Quality Test for the AWS

(5) MTF Measurement

(6) AOP Mode and SNR Check

(7) Visual Check List

(8) Compression Force Test

(9) Average Glandular Dose

(10) Post-move, Pre-examination Tests for Mobile SenographeTM 2000D FFDM

(B) Before any further mammographic images are reviewed or interpreted or any films are printed or processed using the component of the SenographeTM 2000D FFDM system that failed any of the following tests:

(1) Monitor cleaning for the Review Work Station (RWS)

(2) Viewing Conditions for the RWS (Radiologic Technologist’s test)

(3) Viewing Conditions Check and Setting (Medical Physicist’s test for the RWS)

(4) Phantom Image Quality Test for the RWS

(5) Phantom Image Quality Test for the Printer

(6) Viewbox and Viewing Conditions Test

(7) Monitor Calibration Check (Radiologic Technologist’s test for the RWS)

(8) Image Quality—SMPTE Pattern (Medical Physicist’s test for the RWS)

(9) Printer QC

(C) Within 30 days of the test date for the following tests:

(1) Repeat Analysis

(2) Collimation Assessment

(3) Evaluation of Focal Spot Performance

(4) Exposure and mAs Reproducibility

(5) Artifact Evaluation; Flat Field Uniformity

(6)  Monitor Calibration (Medical Physicist’s test for the RWS)

(7) Analysis of the RWS Screen Uniformity

(8) kVp Accuracy and Reproducibility

(9) Beam Quality Assessment (Half-Value Layer Measurement)

(10) Radiation Output

(11) Mammographic Unit Assembly Evaluation

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