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. MI TA knows that without accessible medical equipment, individuals with disabilities may

not have equal access to quality medical care . Ihave a Biomedical Electri cal 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 ye ars. 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 MI TA represents. We appreciate the work that the Access Board has done and shortly you will hear from my

colleagu es on a more in depth technical analy sis 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 earl y 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 ye ars for my mother after she had had a stoke that left her paral yz ed on the right side, I personally helped her with access to the MR scanner when she required MRIexams. With my

support and the clinicians’ guidance, we ensured that she was placed properl y on the table to ensure the shortest possible exam time with the most effective image qualit y results. Itis important to realize the importance of the role that the Phy sician and the technologists play in proper patient positioning. Hospitals are under legal con straints with respect to radiological equipment and are extensively involved in internally

training their emplo ye es as well. Second, while the Access Board has pointed out that it does not have enforceability authority for the proposed standards, MI TA me mbers 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 American s with Disabilities Act (ADA). We respectfull y 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 us ers . 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 sy stem requirements. The quality s ys tem 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 ev idence. Th e imaging equipment offer man y features to ensure accessibility

for all patient s 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 equ ipment. L ikewise, 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 du e 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 alway s a trained technologist guiding the patient into proper po sitioning 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
 Phy sical ability

to enter/move through opening in device
 Image Qualit y impactAccess Board

– May 8, 2012 (Elisabeth George) Page 3  Reliable, stable/ performance impact Activities that manufactures would need to take include: Implement a complete design chang e program to ensure compliance with the FDA Code of Federal Regulations, specificall y, 21 CFR 820.30 which requires for identification, documentation, verification and validation, review and approval of change prior to implementation. Itshould 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 effectivel y 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 analy sis 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 MRI s

– table modifications, coil changes e tc

.... Lastl y, 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, w e want to emphasize that our goal has long been and continues to be to ensure acce ss 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

t o c ontinue to use their equipment for its full useful life due to the ext ensive capital investment. We urge you to continue to consider the capital investment by providers as you finalize these standards.
We again thank you f

or yo ur time and consideration and look forward to working with yo u going forward. Now, we would like to tran sit i on into our modality s pecific presentations. We will start with the Ultrasound devices. These devices are completely p ortable and not patient operated therefore, this is a device that already enables unrestricted access and enables access per the proposed rule making. The variet y of tables that could be utilized with the equipment are standalone and not a part of the ultrasound device. Now we will move onto mammograph y devices.