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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight

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This alternative standard was approved on May 31, 2002. It defines the conditions under which the mammography equipment evaluations performed after some computer software upgrades may be performed either by a medical physicist on site or under the conditions of Medical Physicist Oversight. If these conditions are not met the mammography equipment evaluation after the upgrade must be performed by a medical physicist on site.

The original standard is contained within 21 CFR 900.12(e)(10).

(10) Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a unit or processor is installed, a unit or processor is dissembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.

The approved alternative and the conditions for its use are:

Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade. The mammography equipment evaluation must be performed and all failures to meet the applicable standards must be corrected before the affected equipment is used for patient examinations. The tests to be included in the mammography equipment evaluation must be specified by the manufacturer. The specified tests must be adequate for determining whether all of the standards of 21 CFR 900.12(b) and (e) that are applicable to the upgrade are met. If the tests included in the mammography equipment evaluation are all tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer, then the mammography equipment evaluation may be conducted either during an onsite visit by a medical physicist or under Medical Physicist Oversight. If any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.

Additional conditions for using this alternative requirement in association with a software upgrade are that:

  1. The manufacturer must notify FDA of its intention to install the upgrade. The notification must include a brief description of the upgrade, the model(s) of the units that will be upgraded, and a copy of the information to be provided to each facility describing the upgrade and the facility’s post installation responsibilities. The manufacturer must receive confirmation from FDA that the upgrade is covered by the alternative requirement before beginning installation.

  2. By the completion of each individual upgrade, the manufacturer must inform the facility in writing of its post installation responsibilities under the alternative requirement, which are that the facility must:

  • conduct a mammography equipment evaluation after installation of the upgrade, either during a medical physicist onsite visit or under Medical Physicist Oversight,

  • include in its mammography equipment evaluation the tests specified by the manufacturer,

  • perform the mammography equipment evaluation and correct all test failures before the affected equipment is used for patient examinations, and

  • keep records of the test results and follow-up actions in accordance with 21 CFR 900.12(d)(2).

Since the subject alternative standard was approved in 2002, General Electric (GE) has applied to the FDA and, as of August 14, 2007, has obtained approval to conduct the MEE under Medical Physicist Oversight for the software upgrades and to the GE units shown in the Table below:

 

Table in Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight

 

 

Date Application Name/Description GE FMI # Comments
April 2003 Field Modification Instruction (FMI) No. 11497, "ADS & RWS software upgrade." 11497 - ADS & RWS software upgrade Upgrade applied to facilities with RWS V9.1 software on their review workstation.
May 2003 Service Note (SN) "IDC DIONE 3 INTRODUCTION" combining FMI No. 11496 and FMI No. 11497 11496 and 11497 Combined software upgrade V 10.2 (#11497) with hardware (#11496)
December 2004 Field Modification Instruction (FMI) "ADS software upgrade to V31.3" for the Senographe DS, full-field digital mammography system 12027 Operation of the system to perform stereotactic procedures, (outside MQSA), and to address an issue relating to image labeling (MQSA)
November 2005 Field Modification Instruction (FMI) No. 12026, "Seno Advantage Upgrade to Version 1.2" 12026 Applied to the SenoAdvantage Workstation- final interpretation of clinical mammograms
March 2006 Two software upgrades for the Seno Advantage (SA) diagnostic workstation: 1. The "SA1 to SA2" upgrade 2.The "M3 to M4" upgrade 1. No FMI. Only a "Read Me First" note. 2. FMI # 12061 1. Ensures that the view and laterality labeling is always displayed near the axilla, allows the use of Premium View for final interpretation, and enables a display at full resolution by means of a single button push. 2. Fixes software "bugs" and enables the "full resolution" button.
July 2006 Senographe 2000 D AWS v17.4.5 Upgrade. 1. FMI # 12063 2. No FMI is needed 1. Distributes new documentation and asks the facility to verify it. It also installs "Premium View" (PV) software without enabling it. 2. If facility buys and enables the PV software upgrade, testing under the approved alternative standard applies.
January 2007 LUT Printing Correction. Seno Advantage Software Upgrade FMI # 12078 Corrects errors in printing hard copies from the SenoAdvantage 1.2 and 2.0 Workstations.
May 2007 Senographe DS Stereotaxy Upgrade 12083 1. Corrects a previous AWS software issue so that the “view name” appears in the axillary position when printing any FFDM image from the AWS. In addition, while not an MQSA issue, this software upgrade corrects a “bug” that caused an error message when the system was used in the stereotaxy mode. 2. A new label is to be placed on the unit’s radiation shield indicating that the position of the “view name” label may not be near the axilla when images are viewed at the AWS.
May 2007 Seno Advantage RWS Software Upgrades as follows: 1. Upgrade 1.2 or 2.0 to 2.1 M4 Release 2. Upgrade 2.1 M3 to 2.1 M4 Release 3. Upgrade 2.0 to 2.0_05 Release

1. No FMI is needed 

2. 12086 3. 12086

1. Converts a Seno Advantage 1.2 or 2.0 system to a Seno Advantage 2.1 system (SA 21_03.1.3), e.g., it implements the following: a. For a 1.2 system; 1. view name annotation for magnification cleavage view (MCV) 2. printing annotation relating size of the printed image to original size 3. view & laterality labeling always near the axilla 4. enables Premium View for final interpretation 5. full resolution zoom display by pushing a single button 6. customizable protocol manager b. For a 2.0 system; it implements 1.a.1 & 1.a.2. 2. Converts a Seno Advantage 2.1 M3 system to a Seno Advantage 2.1 M4 (SA 21_03.1.3) system, e.g., it implements items 1.a.1 and 1.a.2 above. 3. Upgrades a Seno Advantage 2.0 system to a Seno Advantage 2.0_05 release system, e.g., it adds items 1.a.1 & 1.a.2 above to a 2.0 software system capability.
August 2007 Field Modification Instruction (FMI) No. 12075, “Senographe DS and Senographe Essential IS4-3 upgrade” as follows: 1. Extends the software upgrade provided in FMI 12083 regarding image printing from the AWS to both DS and Essential systems. 2. Fixes some software “bugs” and improve system reliability. 3. Provides a new set of system technical publications including QC manuals. 12075 1. Upgrades applicable to both DS and Essential. These upgrades: A) Ensure that the “view name” appears in the axillary position when printing any FFDM image from the AWS in both DS and Essential systems. B) Affix a new label on the unit’s radiation shield indicating that, except for the “from below” view, most images viewed on the AWS do not comply with MQSA vis-à-vis the position of the “view name,” which is acceptable for the AWS. C) Improve the automatic operation of the acquisition system gantry, correct an internet protocol bug, and improve error management. D) Reduce the occurrence of “white images.” E) Reduce the occurrence of an artifact caused by the operation of positioning motors during readout of the image from the digital detector. 2. Upgrades applicable to the DS only. While not an MQSA issue, these upgrades: A) Remove a “bug” that occasionally displayed an error message in the stereotaxy mode when the operator attempted window level adjustment during image display. B) Allow the use of the biopsy compression paddle in the magnification configuration. C) Ensure constancy of the position of markers used during stereotactic procedures. 3. Upgrades applicable to the Essential only. These upgrades: A) Make possible the use of the full-size magnification paddle when performing the AOP calibration in the magnification configuration. B) Apply reliability updates to the generator software. C) Improve the Bucky movement by using new firmware, e.g., a programmable read-only memory (PROM) chip to improve the consistency of the acceleration and return-to-start-position phases of the grid motion. After the upgrade, the Field Service Engineer will perform the Grid Line Index (GLI) test, to make an objective assessment of the presence of grid lines. D) Ensure that both the old and new AWS computers produce identical images for printing (by performing a pixel-by pixel comparison of the images).