Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight
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:
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.
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
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|
|July 2006||Senographe 2000 D AWS v17.4.5 Upgrade.||
1. FMI # 12063
2. No FMI is needed
|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||
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. 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. 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:
Upgrades applicable to both DS and Essential. These upgrades: