Elisabeth	George – Philips	Healthcare Page 1 of	3 

## U.S. **Ac cess Board Federal**  **Medical Diagnostic Equipment Ac**  **cessibility Standards Ad**  **vi sory Committee**  **BA LLOT ON COMMITTEE**  **REPORT This Ballot is due**  **to the A ccess Board**  **by October 11**  **th** 

### , 2013 I, __ Elisabeth George

___ ___ , (Print Name) **AG REE**  **(with exceptions)**  that the recommendations included in the Advisory Committee Report dated September 13 th , 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 Page s 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 A GREE**  that the recommendations included in the Advisory Committee Report dated September 13 th , 2013 represent the consensus of the committee **PLEA SE**  **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: ----------------------------**  XElisabeth	George – Philips	Healthcare Page 2 of	3 

### EXCEPTION #2: **NPRM M 303.2.4 Knee and Toe Clearance**  Specifically regarding Mammography - Section 5.8.2 of t he report The proposed recommendations focus on standard conventional and flat panel technology. However, there are also new emerging detector techn ologies, 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 techn ologies 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 d espite 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 wi th 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.

**Initials & Date: ----------------------------** Elisabeth	George – Philips	Healthcare Page 3 of	3 

### Philips MicroDose Mammography **Sy stem**  For additional pictures and brochures on device: **http://www.healthcare.philips.com/us_en/clinicalspecialities/WomensHealthCare/imaging/digital -**  **mammography/**