Radiation-Emitting Products

Inspection News Updates

Hologic Combines Quality Control (QC) for Two Full-Field Digital Mammography (FFDM) Models in One Manual

Until June 2009, there had been two Hologic Selenia FFDM QC Manuals for the Selenia FFDM units – one for Selenia models with the molybdenum tube and one for Selenia models with the tungsten tube. Hologic recently updated its Selenia QC Manual in a version that combines the two manuals into one and has QC tests for both tungsten and molybdenum models, along with some updates. The new manual (MAN-01476, Revision 001) now includes a revision summary in Section 6 of the Preface which describes the changes.

Additionally, Hologic has revised its statement telling mammography facilities under what conditions they can use prior Selenia QC Manuals when performing MQSA required QC procedures. This latest manual applies to Selenia FFDM and Selenia-S FFDM units but does not apply for use with the Selenia Dimensions 2-D FFDM unit.

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Clarification of General Electric FFDM Phantom QC Testing Requirements

FDA received a question from a facility about following General Electric’s (GE) phantom quality control (QC) testing procedures for the Senographe DS and Essential units. GE’s manuals for these units have procedures for performing the test on both the Acquisition Workstation (AWS) monitor and the printer on a weekly basis. Because the facility only does softcopy interpretation of its clinical images, the facility asked us to allow it to forgo phantom testing on the printer and only perform that test when it needed to produce hardcopy images of final interpretation quality, such as for the transfer of examinations.

Because our full field digital mammography (FFDM) QC regulatory requirements are tied to the specific FFDM manufacturer’s QC manual, we asked GE to clarify its intent regarding applicability of phantom QC testing procedures in a facility that only does softcopy final interpretation. GE responded that it did not intend for the facility to perform routine weekly phantom QC testing on devices that are not used for image interpretation. If the facility does its final interpretations using softcopy only, it does not have to perform routine weekly phantom test evaluation using the printer. Please note that the facility must still perform a phantom QC test on the printer prior to printing final interpretation quality images.

We are clarifying this issue so that inspectors do not cite facilities that have GE 2000D, DS, or Essential FFDM systems and only perform softcopy interpretation, for not performing the weekly phantom image QC test on the printer. However, we do require these facilities to perform this test prior to printing hardcopy final interpretation quality images, and inspectors should cite these facilities if they fail to do so. Facilities that do their final interpretations using hardcopy only are still required to perform the weekly phantom image QC test on the printer and the AWS.

Reminder to Follow the FFDM Manufacturer’s QC Manual

Recently FDA learned that there may be confusion when a review workstation’s (RWS) or printer’s quality control (QC) manual has instructions that are different from the FFDM unit’s QC manual (as with the Selenia system). In the case of the Selenia unit, the manual specifically instructs the facility to perform the (DICOM) printer QC testing on a weekly basis. Therefore, for the Selenia unit and all other units with specific procedures regarding a component’s QC testing, the FFDM QC manual’s instructions are the regulatory requirement, even when the QC manual for the component at the facility calls for daily QC testing. However, FDA recommends that the facility perform the daily QC testing initially and when there has been a major repair performed, moving to a weekly schedule when it determines that the component’s operating levels have reached an adequate level of stability.

In addition, for facilities with laser printers that use wet processing where the printer’s
QC manual calls for daily QC testing, we recommend that the facility regularly perform the daily printer QC.

If the FFDM unit’s QC manual simply refers the facility to the component’s QC manual for all the component-related tests, the facility must then follow the component manual for all QC testing on the component.

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 MEE Scope for Newly Installed FFDM Systems

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Communication of Mammography Results to Referring Healthcare Providers and Patients

The Division of Mammography Quality and Radiation Programs has been made aware that sometimes there are issues with the methods some facilities use to track that mammography results are provided to referring healthcare providers and patients. Some MQSA facilities may not be consistently tracking or monitoring that medical reports and/or lay summaries are being provided on time or at all. As a result, some referring healthcare providers and patients are not receiving their exam results or are not receiving them in a timely manner. In most instances, facilities have established written procedures in place to issue the reports, however, in practice, the tracking of reports is sometimes not adequate to ensure timely issuance of the mammography results.

MQSA allows facilities to develop or use a procedure and tracking system that works best for them. Facilities need to monitor their systems to ensure that their policy and procedures are actually and correctly being followed. FDA supports the use of computer tracking and paper or patient log systems to assist in tracking timely issuance of medical reports and lay summaries. Some radiology computer reporting systems can track individual reports and generate summary reports indicating when a mammography report or lay summary has been issued. By routinely checking these summary reports, facilities can ensure that all mammography results have been issued in a timely manner. Facilities are encouraged to check with their computer support vendors to see if their software can generate such summary reports. FDA encourages all facilities to reassess their current systems, whether they are computerized or paper logs to ensure that they communicate mammography results to all patients and their referring healthcare providers.

Another sometimes overlooked problem deals with facilities that fax or email medical reports and/or lay summaries. Policies and procedures to deal with faxes and emails that are reported as “failed” are important to ensure that reports and lay summaries are resent in a timely manner.

Facilities may obtain additional information about medical records and mammography reports from the MQSA Policy Guidance Help System located on this website (Search on keywords: Medical Records, Mammography Reports, Mammographic Assessments, Written Report, Recordkeeping, and Communication of Mammography Results.)

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Quality Control Testing for Printers and Monitors

1. Printer and/or Monitors without QC Manuals

Under the Mammography Quality Standards Act (MQSA) final regulation 900.12(e)(6), facilities using a mammographic modality other than screen-film must follow a quality control program that is “substantially the same as the quality assurance program recommended by the image receptor manufacturer…”. While all full field digital mammography (FFDM) manufacturers have quality control (QC) manuals, in some cases, the QC manual instructs the facility to test monitors and printers according to the component’s QC manual. In these cases, it is the responsibility of each facility to ensure that it obtains and follows the component’s QC manual for its monitors and printers.

2. Facilities Using the Same Printer or Monitor with FFDM Units from Different Manufacturers

For facilities that are using FFDM units from different manufacturers, each with its own QC requirements for printers and monitors, there may be uncertainty regarding the QC tests to perform on these components. The following three examples should help facilities decide.
a. Each FFDM manufacturer QC manual requires that the same or equivalent test be done, but at different time frequencies. In this case facilities need to perform the test at the more stringent frequency.
b. Each FFDM manufacturer QC manual requires that different but equivalent tests be done. In this case facilities may perform only one of the tests at the more stringent frequency. The medical physicist should provide a written statement for the facility’s quality control records, indicating that in his or her opinion, the two tests are equivalent.
c. Each FFDM manufacturer QC manual requires that different tests (not equivalent) be done. In this case facilities need to perform each test at the frequency required in the respective FFDM manufacturer QC manual.

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Medical Physicist Responsibilities Regarding Laser Printer Mammography Equipment Evaluation (MEE)

We recently learned that some medical physicists are not including appropriate testing of the laser printer in their survey /MEE report to the facility. There seems to be confusion between the required MEE testing of a laser printer: (1) before it is first put into clinical use; (2) following reassembly; or (3) after major repairs vs. the routine Quality Control (QC) testing of the laser printer after it is placed into clinical use. In some cases, the medical physicists did not test the laser printer at all. In other cases, they did inappropriate testing and, in a few cases, they did appropriate testing but did not include documentation of the tests in the facility survey / MEE report. Therefore, we want to clarify the MQSA requirements regarding this issue.

The final regulations require that all test procedures be conducted as specified in the QC manual of the FFDM system manufacturer. Some of these QC manuals specify both periodic QC (daily, weekly, or annual) and MEE testing for the laser printer. Other manuals do not address the subject and refer the user to the laser printer manufacturer’s QC manual. For easy reference, the following table summarizes laser printer test procedures in current QC manuals:

FFDM System QC Manual Weekly/Daily Annual MEE QC Procedures - Comments
GE- All systems All Yes* No No *Per printer mfr. QC manual
Fischer Rev.10-10/07 Daily check No No Follow printer mfr. QC manual
Selenia Rev. 7–8/07, **Sec. 2.1 Yes No Yes** Follow the Selenia QC manual
Siemens Rev. 5–4/07 Before clinical use No Yes Follow printer mfr. QC manual
Fuji 3rd Edit.–4/07 Yes Yes Yes Follow applicable printer QC manual

As the above table shows, some of the FFDM QC manuals do not specifically address the laser printer MEE testing requirements when first installed, reassembled, or after having undergone a major repair. Hence, the facility or medical physicist has to obtain this information from the laser printer manufacturer. In some cases, the QC manuals only address the interface between the FFDM unit and the laser printer. They do not address the basic requirement that the laser printer, before it is used clinically for mammography, has to be operating as designed by the laser printer manufacturer. Since the MEE requires that both these areas be checked, the medical physicist may have to consult both the FFDM manufacturer’s QC manual and the laser printer QC or operator’s manual to determine which tests are required to assure that the laser printer is functioning properly.

Some medical physicists incorrectly assume that simply scoring a laser printed phantom image satisfies all the requirements of the laser printer MEE. However, in most cases, this practice would not be acceptable. To avoid unnecessary follow-ups by MQSA inspectors, we urge all medical physicists to review the FFDM manufacturer’s QC manual and, where necessary, the laser printer QC or operator’s manual to determine the appropriate testing. They then need to clearly document the testing of the laser printer in their reports.

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 Attention Mammography Community - Pending Inspection Software Citations will be Activated on January 1, 2008

On January 1, 2008, FDA will modify the current inspection software (FISS Version 6.03) to allow citations for failures in the following areas:

  • Failing phantom score(s) in full field digital mammography (FFDM) systems – As you know, MQSA inspectors have been scoring phantom images in FFDM systems since 2006, but we have withheld issuing citations for failing these image scores to give the inspectors adequate time to become comfortable with the FFDM scoring procedure and to give the facilities a “heads-up” view of our intent in this area. Effective January 1, 2008, failing phantom image scores in FFDM systems will have the same observation levels as screen-film (S-F) systems.
  • Failing to take corrective action before resuming clinical use if the dose reported by the medical physicist exceeds 3 mGy (300 mrad). Specifically, we added the following data entries in early 2006:
    • Dose value (mrad) reported -------, and if the inspector entered a value over 300 mrad, the software prompts the inspector to answer the following question:
    • C/A taken before resuming clinical use? (yes/no)

Thus, effective January 1, 2008, if the inspector answers “no” to the above question, the software program will issue a level 2 observation, which will be applicable to both S-F and FFDM systems.

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