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U.S. Department of Health and Human Services

Radiation-Emitting Products

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#23: Correction Period When Components of the Fuji Aspire HD, Aspire HD Plus and Aspire HD-s Full Field Digital Mammography imaging systems Full Field Digital Mammography imaging systems Fail Quality Control Tests

This alternative requirement was approved and became effective on February 28, 2013.  It has no time limit.  It allows a 30 day period for corrective actions following the failure of specified quality control tests by the Fuji Aspire HD, Aspire HD Plus and Aspire HD-s Full Field Digital Mammography imaging systems. 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 specifies the quality control tests whose failures require 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, image acquisition must cease until the problem is corrected but image interpretation can continue. Similarly if the test failure is related to devices used for image interpretation, image acquisition can continue but image interpretation with the failed component must cease until the problem is corrected.

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;
(B) Within 30 days of the test date for all other tests described in paragraph (e) of this section.

The approved alternative is:

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

(ii) If the test results for the Fuji Aspire HD, Aspire HD Plus and Aspire HD-s Full Field Digital Mammography imaging systems fall outside the action limits, the source of the problem shall be identified and corrective actions shall be taken:

(A) If any of the quality control tests that evaluate the performance of the image acquisition components of the Fujifilm Aspire HD, Aspire HD Plus or Aspire HD-s Mammography Systems produces results that fall outside the specified action limits, the source of the problem shall be identified and corrective action shall be taken before any further examinations are performed using that component.

(1) CNR test with 1Shot Phantom (4.5.3)
(2) Spatial resolution test with 1 Shot Phantom (4.5.3)
(3) Missed tissue at chest wall test with 1 Shot Phantom (4.5.3)
(4) Uniformity test with 1 Shot Phantom (4.5.3)
(5) Linearity/ beam quality Constancy test with 1 Shot Phantom (4.5.3)
(6) Test with Mammography Accreditation Phantom (4.6.3)
(7) Compression Device Confirmation – Technologist (6.5.3)
(8) Compression Device Confirmation – Physicist (7.5.1.3 [2])
(9) AGD Mode 1 (7.5.5.3 [2])
(10) AGD – mammography accreditation phantom (7.5.5.3 [13])
(11) Any of the one shot phantom tests performed by the Physicist during the annual survey.

B) If any of the following Fujifilm Aspire HD, Aspire HD Plus or Aspire HD-s quality control tests that evaluate the performance of display components fail, clinical imaging may be continued. The source of the problem shall be identified and corrective action shall be taken for the component of the imaging system that failed before that component can be used for mammographic image processing, interpretation, or printing. If available, an alternative approved diagnostic device may be used for mammographic image interpretation, providing it has passed the applicable quality control tests.

(1) Printer Quality Control Test – Technologist (4.7.1)
(2) Monitor Quality Control Test – Technologist (4.8.1)
(3) Printer Quality Control Test – Physicist (7.5.1)
(4) Monitor Quality Control Test – Physicist (7.5.1)

C) If any of the following quality control tests that evaluate the performance of the image acquisition components of the Fujifilm Aspire HD, Aspire HD Plus or Aspire HD-s  Mammography Systems produces results that fall outside the action limits as specified by the manufacturer, the source of the problem shall be identified and corrective action shall be taken within thirty days of the test date. Clinical imaging and mammographic image interpretation may be continued during this period.

(1) Tests with the 1 Shot Phantom (other than CNR, spatial resolution, missed tissue at chest wall, uniformity, and linearity/ beam quality constancy) (4.5.3)
(2) Image Basic Test (7.5.1.3 [1])
(3) Image Performance Test (7.5.2.3 [1], [2], [4])
(4) Repeat Analysis (5.3.3)
(5) Spatial Resolution (Magnification) (7.5.3.3)
(6) X-Ray Equipment Performance Test (7.5.4.3 [6], [7], [8] and[9])
(7) AEC Reproducibility (7.5.5.3 [10])
(8) CNR mode 1 (7.5.5.3 [11])