Access Board – May 8, 2012 (Elisabeth George) Page 1

Presentation of Elisabeth George

Vice President of Global Government Affairs, Regulations & Standards for Philips 

Healthcare and Chair of Medical Imaging and Technology Alliance (MITA) 

Technical and Regulatory Affairs Committee

U.S. Access Board

May 8, 2012

I would like to thank you for your invitation to present today on behalf of medical 

imaging device manufacturers, which are represented by the Medical Imaging & 

Technology Alliance (MITA). It is an honor to be here to speak about the important issue 

of ensuring appropriate access to medical diagnostic equipment for persons with 

disabilities. MITA knows that without accessible medical equipment, individuals with 

disabilities may not have equal access to quality medical care. I have a Biomedical 

Electrical Engineering Bachelors of Science and an Engineering Management Masters in 

Science. I have worked in the medical device arena for more than 30 years and in 

medical device regulations for more than 20 years. 

First, we want to point out that the issue of accessibility, both for patients and operators 

of the equipment, has long been and continues to be a primary concern of the companies 

that MITA represents. We appreciate the work that the Access Board has done and 

shortly you will hear from my colleagues on a more in depth technical analysis of the 

impact of the Access Board’s proposed standards on the various medical imaging 

modalities we represent including X-ray imaging, computed tomography (CT), diagnostic 

ultrasound, nuclear medicine imaging, and magnetic resonance (MR) which are primarily

use for diagnostic purposes, as well as mammography and dual-energy X-ray

absorptiometry (DXA) which are primarily used in screening for common diseases, 

which relies on early detection to ensure the most beneficial outcomes. 

I also want to share with you that from a personal standpoint, having been a care provider 

for a number of years for my mother after she had had a stoke that left her paralyzed on 

the right side, I personally helped her with access to the MR scanner when she required 

MRI exams. With my support and the clinicians’ guidance, we ensured that she was 

placed properly on the table to ensure the shortest possible exam time with the most 

effective image quality results. It is important to realize the importance of the role that 

the Physician and the technologists play in proper patient positioning. Hospitals are 

under legal constraints with respect to radiological equipment and are extensively

involved in internally training their employees as well. 

Second, while the Access Board has pointed out that it does not have enforceability

authority for the proposed standards, MITA members take them very seriously. Further, 

we are aware that the Department of Justice (DoJ) is closely monitoring the development 

of these proposed standards, and is poised to move forward as an enforcement 

mechanism using their authority under the Americans with Disabilities Act (ADA). We 

respectfully request that coordination on all levels with all stakeholders (manufacturers, 
Access Board – May 8, 2012 (Elisabeth George) Page 2

users, patient advocates, FDA and hospital administrators) will occur so that we can 

ensure access to imaging equipment for all users. 

Third, it is important to note that all of the diagnostic imaging equipment that our 

member companies manufacture are subject to the US FDA Code of Federal 

Regulations. These devices are developed,, manufactured and distributed subject to 

quality system requirements. The quality system defines the requirements for design, 

verification and validation of the design, material and process records as well as 

traceability. An important requirement of the design process is the requirement that 

manufacturer’s have an FDA 510(k) clearance to market their devices. This process 

requires a manufacturer to assess the need for device modification to undergo FDA 

direct review of the safety and effectiveness of the changes and the adequacy of a 

manufacturer’s evidence. The imaging equipment offer many features to ensure 

accessibility for all patients and those offerings vary by modality, design, and 

purpose. Manufacturers utilize many recognized standards in the development of the 

products including the ANSI/AAMI HE75:2009 – Human factores engineering – Design of 

medical devices, ISO 14971:2007 - Medical devices -- Application of risk management to 

medical devices as well as may many device specific global standards. 

Fourth, our manufacturers have sought to improve the picture clarity, application, dose 

management and overall simplification to support human factors of these life-saving 

devices, while at the same time ensuring that the equipment is accessible for the full 

range of patients in need of this equipment. Likewise, they have also made great strides 

in ensuring that the equipment accommodates the needs of the healthcare workers who 

position patients and guide testing so as to reduce their risk of workplace injury. It is also 

important to note that due to the nature of radiological equipment, all exams require a 

technologist to be present to position the patient for proper alignment to produce 

acceptable image quality. Therefore, there is always a trained technologist guiding the 

patient into proper positioning for safe and effective screening and diagnostic imaging 

procedures. This is the case for all patients at all times, regardless of their degree of 

mobility. 

As previously stated, my colleagues will discuss current accessibility features of the

screening and diagnostic services as well as potential opportunities for modifications. 

I would like to share with you an example of a change for a particular diagnostic 

piece of equipment and what action(s) a registered medical device manufacturer 

would need to do to ensure that the devices’ safety and efficacy are maintained. 

For example, to modify the material or structure or performance (e.g.; height) of a table 

used for MRI the following potential issues must be understood: 

 Impact on installation/ technical feasibility and costs

 Physical ability to enter/move through opening in device 

 Image Quality impact
Access Board – May 8, 2012 (Elisabeth George) Page 3

 Reliable, stable/ performance impact 

Activities that manufactures would need to take include: 

Implement a complete design change program to ensure compliance with the FDA Code 

of Federal Regulations, specifically, 21 CFR 820.30 which requires for identification, 

documentation, verification and validation, review and approval of change prior to 

implementation. It should be noted that a standard design history file (the record where 

all information is documented) can be quite large (many file cabinets) for even a simple 

modification. Design History File must adequately and effectively document that the 

intended use, indications for use, claims and the safety and efficacy of the device has or 

has not changed. This assessment supports a manufacturers analysis on whether a 510(k) 

is required. 

Additional activities that are key design inputs to the design process: 

 Customer Input – Suggestions, Complaints and Compliments. 

 New Standards, Regulations or Rules – Global

 Cost Reduction efforts 

 New Applications, availability of intra-operative MRIs – table modifications, 

coil changes etc.... 

Lastly, in the Access Board Notice of Proposed Rulemaking (NPRM), you note that there 

may be an economic benefit to some manufacturers in the finalization of these standards. 

As stated at the outset, we want to emphasize that our goal has long been and continues to 

be to ensure access to screening and diagnostic equipment for all patients. Concurrently, 

our member companies want to ensure that those customers who purchase their products 

are ensured the ability to continue to use their equipment for its full useful life due to the 

extensive capital investment. We urge you to continue to consider the capital investment 

by providers as you finalize these standards.

We again thank you for your time and consideration and look forward to working with 

you going forward. 

Now, we would like to transition into our modality specific presentations. We will start 

with the Ultrasound devices. These devices are completely portable and not patient 

operated therefore, this is a device that already enables unrestricted access and enables 

access per the proposed rule making. The variety of tables that could be utilized with the 

equipment are standalone and not a part of the ultrasound device. Now we will move 

onto mammography devices.