Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

Philips Healthcare

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: ----------------------------

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 programs^1,2. E.g. Baldelli et al.¹ showed 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 thicker^4. 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.

Image:

Philips MicroDose Mammography System

For additional pictures and brochures on device:
http://www.healthcare.philips.com/us_en/clinicalspecialities/WomensHealthCare/imaging/digital-mammography/