Elisabeth	George	– Philips	Healthcare	 Page	1 of	3

U.S. Access Board Federal

Medical Diagnostic Equipment

Accessibility Standards Advisory Committee

BALLOT ON COMMITTEE REPORT

This Ballot is due to the Access Board by October 11th, 2013

I, __Elisabeth George______,

(Print Name)

AGREE (with exceptions) that the recommendations included in the Advisory Committee 

Report dated September 13th, 2013 represent the consensus of the committee

With the following exceptions: 

1) NPRM M303.2.4 Knee and Toe Clearance: Specifically regarding Mammography - 

Section 5.8.2 of the report. 

 Refer to Pages 2 & 3 of this ballot. 

2) NPRM M301.2.1 and M302.2.1 : Table Height:– Section 5.1

 Refer to separate document from four medical diagnostic imaging equipment 

industry members. 

DO NOT AGREE that the recommendations included in the Advisory Committee Report dated 

September 13th, 2013 represent the consensus of the committee

PLEASE NOTE: If you disagree with any of the recommendations included in the report, you are 

encouraged to submit a Minority Report describing your position on the specific recommendation with 

which you disagree. 

Signed: ____________________________________________

(Signature required)

Representing: __Philips Healthcare ______

__3000 Minuteman Road Andover, MA 01810-1099____ Date: ______________

Please return this ballot by e-mail or fax to:

Rex Pace

U.S. Access Board

pace@access-board.gov

(202) 272-0080 (FAX)

Initials & Date: ----------------------------

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Elisabeth	George	– Philips	Healthcare	 Page	2 of	3

EXCEPTION #2: NPRM M303.2.4 Knee and Toe Clearance

Specifically regarding Mammography - Section 5.8.2 of the report

The proposed recommendations focus on standard conventional and flat panel technology. However, 

there are also new emerging detector technologies, which are applied in state-of-the art mammography 

systems.

This mainly affects the breast support, because the breast support houses the detector, thus determining 

the dimensions of the breast support. This affects knee clearance.

Emerging technologies strive to improve mammography performance while increasing the safety of the 

devices by reducing women’s exposure to X-ray radiation.

Photon-counting technology has shown to deliver good mammography image quality while enhancing the 

safety of the procedure by applying a significantly lower dose of 40% or less, compared to other digital 

technologies. 

The effectiveness of photon-counting technology in early cancer detection has been shown in European 

screening programs1,2. E.g. Baldelli et al.1showed in the context of the Irish breast screening program, that 

despite recording the largest average compressed breast thickness (64.7 mm), the photon-counting 

system resulted in the lowest average examination mean glandular dose (1.86 mGy) compared with two 

other standard digital systems (3.03 and 2.91 mGy, respectively). The same radiologists’ performance at a 

dose reduced by 40% was also shown by Pisano et al.3

Photon counting systems imply a more voluminous breast support, as the detector itself is thicker4. 

However, by designing the lower detector housing smoothly sloped and curved, safe access is also given 

for women in wheel chairs.

References:

1. P. Baldelli et al: Comprehensive Dose Survey of Breast Screening in Ireland, Protection Dosimetry 

(2011), 145 (1), 52–60

2. B. Hemdal et al.: Average Glandular Dose in Mammography Screening using a Sectra MicroDose 

Mammography Unit, Protection Dosimetry (2005), 114 (3), 436-443.

3. E. Pisano et. al.: Comparison of Radiologist Performance with Photon-Counting Full-Field Digital 

Mammography to Conventional Full-Field Digital Mammography, Acad. Radiol. (2012): 19 (8) ,916-922.

4. M. Aslund et al.: Physical characterization of a scanning photon counting digital mammography system 

based on Si-strip detectors, Med Phys. (2007), 34(6):1918-25.

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Elisabeth	George	– Philips	Healthcare	 Page	3 of	3

 Philips MicroDose Mammography System 

For additional pictures and brochures on device: 

http://www.healthcare.philips.com/us_en/clinicalspecialities/WomensHealthCare/imaging/digital-mammography/