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

8. Additional and Unaddressed Issues

Throughout the MDE Advisory Committee’s meetings, members raised issues that went beyond the scope of the Committee’s statutory authority but were nonetheless viewed as critical to ensuring access of persons with disabilities to medical equipment and thus to comprehensive, equitable medical care. Other topics fell within the MDE Advisory Committee’s statutory authority but involved specific considerations that were not feasible to address adequately given the limited time, information, and resources available to the Committee. Because MDE Advisory Committee members attached great significance to these issues, they instituted a list of so-called “parking lot topics” – considerations either beyond the statutory authority or resources of the Committee that nevertheless require enumeration to guide future efforts for improving the accessibility of medical equipment to individuals with disabilities.

Section 8 reviews these “parking lot topics,” listed in an order that makes conceptual sense rather than by priority. MDE Advisory Committee members did not attempt to assign priority ratings to these issues, nor did the Committee formally determine whether all members endorsed a topic. Furthermore, the Advisory Committee did not seek external evidence to support the importance of a proposed topic, but instead relied on the expertise of Committee members for this assessment.

8.1 Excluded Populations Needing Future Attention

The statutory authority of the MDE Advisory Committee applied only to adults with disabilities not to pediatric populations. Significant advances in medical care now allow individuals born with formerly life-threatening, disabling conditions – and those who acquire such conditions in childhood – to live into early adulthood, middle-age, and sometimes old age. The numbers of children and youth under age 18 living with disabilities is growing and will continue rising in coming decades. Some of these children and youth require intensive diagnostic testing and therapeutic interventions to maintain and promote their health. These individuals and other children and youth with disabilities will also need the same routine care (e.g. annual visits), preventive services, and episodic care (e.g., diagnosis and treatment of accidental injuries) as do other persons younger than 18 years old. Therefore, future efforts must consider standards to ensure that medical diagnostic equipment is accessible to children and youth with disabilities.

Because of time, information, and feasibility constraints, the MDE Advisory Committee decided early in its deliberations not to address specific standards for ensuring that medical diagnostic equipment is accessible to individuals disabled by extreme obesity.^PP Committee members across the various stakeholder groups endorsed the urgency of addressing this topic. In support, various Committee members cited reports from the Centers for Disease Control and Prevention (CDC), which tabulates data on obesity among individuals within states and nationwide. CDC figures document significantly increasing rates of obesity over the last 20 years among Americans of all ages. More than one-third (35.7%) of U.S. adults are obese (http://www.cdc.gov/obesity/data/facts.html). Especially worrisome, 16.9% of American children and adolescents are obese, portending another generation of obese adults. Of special note, rates of extreme obesity have also risen. Largely because of the critical importance of this growing population, Committee members felt that addressing this topic thoughtfully and comprehensively was infeasible, requiring more time, information, and resources than were available.

The MDE Advisory Committee recognized that certain individuals at the extreme end of the weight continuum may have difficulty accessing medical diagnostic equipment without specific accommodations to address their weight-related needs. Committee members spent some time trying to define this population using standard metrics, such as the body-mass-index (BMI), and seeking guidance from information available from the CDC and the World Health Organization. However, the MDE Advisory Committee did not reach consensus on a specific BMI level or levels for defining disability among individuals who are obese, especially for extreme or severe obesity. Notably, no anthropometric data are available for obese individuals.

Given the large numbers of persons who are obese, specific medical services have emerged that address needs specific to the evaluation and treatment of obesity. These services, often grouped under the broad title of “bariatric services,” have generated equipment designs specifically for their diagnostic and therapeutic care settings. However, persons disabled by extreme obesity also require the same range of clinical services as do other individuals. Without special accessibility features, equipment outside non-bariatric care settings may not accommodate these individuals, perhaps delaying the diagnoses and treatment of other health conditions. Without anthropometric information, the Committee would have found it difficult to make meaningful recommendations to improve MDE accessibility for these individuals. As noted, future initiatives will need to address this topic.

Notes

^PP The Advisory Committee spent considerable time trying to: (1) choose appropriate language for describing this population subgroup; and (2) find explicit parameters for what constitutes extreme or severe obesity. Many Committee members, including the Editorial Committee, rejected the word “bariatric” to describe these individuals because “bariatric” is typically used specifically to indicate particular types of services or service settings. Not all persons with severe obesity will chose bariatric services. The word “morbid,” often used before obesity (“morbid obesity”), carries connotations of the consequences of obesity that made some Committee members uncomfortable. The Editorial Committee settled on using the common adjectives “severe” or “extreme” that are employed in many contexts to identify values at the high end of a continuum of values. As noted in the text, although Committee members searched for definitions of extreme obesity among prominent public health organizations (e.g., Centers for Disease Control and Prevention, World Health Organization), we could not find a consensus definition of extreme obesity. The Committee intends for the phrase “extreme obesity” to represent individuals at the highest end of the weight continuum, who often have a body habitus or physique that necessitates diagnostic medical equipment designed specifically to accommodate their needs.

8.2 Expanding Medical Equipment Covered

Its statutory authority limited the MDE Advisory Committee to addressing medical diagnostic equipment. However, some Committee members raised concerns that the Committee had not addressed every possible type of diagnostic equipment. Other Committee members noted that equipment used specifically for treatments was explicitly excluded. Committee members stated strongly that future standard setting initiatives must aim to encompass all equipment used within health care settings, both diagnostic and therapeutic equipment. The U.S. Access Board’s MDE initiative will work hand-in-hand with the existing requirements under the Americans with Disabilities Act and the Rehabilitation Act of 1973, which already require health care providers to provide accessible health care to their patients (see Section 2.7).

At their first meeting, MDE Advisory Committee members conducted an exercise aimed at eliciting a comprehensive listing of medical diagnostic equipment types. Table 3.1 lists the equipment types mentioned during this exercise. Although this list seemed to encompass a wide range of diagnostic equipment types, it is possible that the Committee did not sufficiently consider specific diagnostic equipment with sufficiently different features to have merited special attention. Clearly outside the statutory authority of the committee is medical equipment with solely therapeutic (treatment) intent. Examples of these types of equipment include:

• Infusion chairs: chairs used for seating of patients receiving infusions, such as intravenous chemotherapy;

• Dialysis chairs: chairs occupied by individuals undergoing hemodialysis or peritoneal dialysis;

• Radiation therapy equipment: treatments involving various types of radiation for persons with cancers, in which patients typically are positioned carefully on a table and then strapped down so they cannot move; this focuses the beam of radiation on the tumor and minimizes damage of nearby tissues; and

• Other tables and chairs specifically designed for highly specialized procedures.

Persons with disabilities obviously need these services just as do others. Without necessary accommodations they confront barriers to obtaining these services. This could lead to worse health and perpetuate inequities in health and well-being experienced by individuals with disabilities. Future efforts to develop accessibility standards must include the full range of medical equipment used for treating patients. Exceptions might include equipment used in settings where all patients are sedated, anesthetized, or transferred by medical personnel, such as operating room tables.

8.3 Alternate Means of Access

As noted throughout this report, MDE Advisory Committee members aimed explicitly to encourage research and innovation to ensure that the next generation of MDE is more accessible than equipment is now. Although current technical requirements may prevent compliance with recommended access standards (see Section 7 for examples), Committee members aimed to encourage manufacturers and developers to consider new and creative solutions to the barriers posed by today’s technologies. As in other areas of technological innovation, the hope is that future MDE developers will aspire to follow universal design principles and enable access for all users.

Nonetheless, MDE Advisory Committee members recognized that certain types of technologies cannot today meet recommended accessibility standards. As discussed in Section 7, this is especially true for some categories of imaging equipment, where specific technological requirements and even laws of physics pose barriers to access with current equipment designs. As noted there, some Committee members recommended “imaging system accessibility configurations” as a relatively expedient way to accommodate persons with disabilities in gaining access to today’s imaging equipment. However, precisely specifying these configurations was beyond the Committee’s statutory authority.

Future rulemaking or standards-setting will need to consider the types of situations where alternate means of access might be allowed and specific provisions for these alternate means. Again, however, the ultimate goal is to encourage innovation to eliminate the access barriers embedded in current technologies. Thus, these future deliberations must also avoid discouraging the pace of innovation.

8.4 Improving Data Sources and Research

As described in Section 3, to inform their deliberations, MDE Advisory Committee members sought as much information as possible, including anthropometric data, information about wheelchair and scooter dimensions, standards from previous rulemaking, and findings about how users approach transfers and other movements relevant to medical diagnostic equipment. Although Committee members did find helpful data, many gaps remained leaving Committee members to make recommendations based on experience and judgments of experienced clinicians and technical personnel. These experienced practitioners offer valuable perspectives, but they may not produce results that generalize broadly to the entire population of persons with disabilities.

MDE Advisory Committee members struggled in particular with applying the anthropometric data that were available for wheelchair and scooter users. The sample sizes for these data were small and not always representative of all wheelchair and scooter users. Another critical shortcoming was the lack of “functional” anthropometric data. For example, the Committee was making recommendations about standards for transfer surfaces of certain sizes. It is not clear what size surface is truly needed for individuals to transfer comfortably. To inform this standard, one would need to observe individuals transferring and then measure the size of the surface that they used to perform this task. A recent review of the literature confirms the Committee’s concern about inadequate information about wheelchair transfers:

... There is scarce evidence related to the impact of setup on the performance of independent transfers. The results of this expert review of the literature highlight the need for future studies particularly as it relates to how environmental factors such as height and gap distances, use of handholds, surface softness, number of transfers needed to go from the initial location to the final destination, use of assist devices, space available for transfer and obstacles or barriers impact the ability to perform independent transfers.¹

Likewise, the Committee had difficulty considering the optimal placement of hand supports due to the lack of data on functional placement of hands for individuals using wheelchairs and scooters. When considering mammography access standards, critical information was missing pertaining to breast anthropometrics, such as breast height while seated, standing, and in a wheelchair. These data are critical for determining optimal height ranges for an adjustable breast platform.

One particular gap in research is information on the costs and benefits or effectiveness of recommended accessibility standards. Committee members agreed that generating information about the potential costs of changing technologies to meet accessibility requirements would be more straightforward than tallying the benefits of these changes. Manufacturer representatives on the Committee described some of the costs to healthcare providers that might be incurred; in particular, manufacturers of medical examination tables estimated the costs of adapting the currently-available adjustable-height tables to comply with the range of standards discussed by the Committee. Additional costs include those of research and development of new product designs to improve accessibility.

In contrast, quantifying the benefits is challenging. Potential benefits include:

• Improving diagnostic efficiency for persons with disabilities, perhaps resulting in earlier diagnosis of conditions at more treatable stages than with previous equipment and thus improving patients’ outcome;

• Decreasing the risks of falls, injuries, and discomfort to patients during diagnostic procedures;

• Increasing the likelihood that persons with disabilities will choose to undergo diagnostic testing because they no longer anticipate discomfort and difficulties during testing (e.g., as with mammography screening); and

• For clinical personnel, reducing their risks of injuries from transferring patients onto and off of MDE.^QQ

Therefore, going forward, research on the costs and benefits of improving MDE access requires additional attention.

Notes

^QQ Clinical personnel and their supervisors also share responsibility for ensuring their safety during transfers, for example by explicit training in transfer ergonomics. Nonetheless, having accessible equipment should help minimize risks to patients and clinical staff.

Section 8 References

^1. Koontz A, Toro M, Kankipati P, Naber M, Cooper R. An expert review of the scientific literature on independent wheelchair transfers. Disability and Rehabilitation: Assistive Technology, January 2012; 7(1): 20–29, p. 28

8.5 Updating Standards in the Future

Finally, two forces underscore the need for future vigilance concerning accessibility standards: (1) potential changes in the needs of the population of persons with disabilities; and (2) the emergence of new technologies with different accessibility considerations than existing technologies.

First, attributes of the population of individuals with disabilities might change in the future, perhaps altering in some way their accessibility needs. As noted above, the general population is increasingly overweight and obese; if population heights and weights change significantly, this might alter dimensions required for equipment accessibility. Wheelchair technologies might also change, lowering or raising seat heights or altering width or depth dimensions. Other types of mobility modalities might emerge (such as new limb prostheses, nerve stimulation, or exoskeleton technologies) that might alter how people approach accessing medical equipment. Policies and procedures are therefore required to monitor these anthropometric and technological trends and consider their implications for the accessibility of medical equipment to individuals with disabilities.

Second, basic science research will result in significant advances in both diagnostic and therapeutic modalities in coming years. As this foundational research proceeds into the development and production of new medical technologies – for both diagnoses and treatments – it will be essential to ensure that these advances extend equitably to persons with disabilities. It is difficult to imagine today the technological specifications of medical scientific advances that will emerge over coming decades. Nonetheless, having policies and procedures in place to address the accessibility of new technologies will be critical so that individuals with disabilities can benefit equally from these advances as will other patients. As new technologies emerge, manufacturers will likely turn – as they have done in the past – to scientists, engineers, and various health care professionals for recommendations to ensure the effectiveness and safety of their products. Equipment designers should seek advice from individuals with disabilities about accommodation features to ensure that new technologies are maximally accessible to all patients.

Notes

^PP The Advisory Committee spent considerable time trying to: (1) choose appropriate language for describing this population subgroup; and (2) find explicit parameters for what constitutes extreme or severe obesity. Many Committee members, including the Editorial Committee, rejected the word “bariatric” to describe these individuals because “bariatric” is typically used specifically to indicate particular types of services or service settings. Not all persons with severe obesity will chose bariatric services. The word “morbid,” often used before obesity (“morbid obesity”), carries connotations of the consequences of obesity that made some Committee members uncomfortable. The Editorial Committee settled on using the common adjectives “severe” or “extreme” that are employed in many contexts to identify values at the high end of a continuum of values. As noted in the text, although Committee members searched for definitions of extreme obesity among prominent public health organizations (e.g., Centers for Disease Control and Prevention, World Health Organization), we could not find a consensus definition of extreme obesity. The Committee intends for the phrase “extreme obesity” to represent individuals at the highest end of the weight continuum, who often have a body habitus or physique that necessitates diagnostic medical equipment designed specifically to accommodate their needs.

^QQ Clinical personnel and their supervisors also share responsibility for ensuring their safety during transfers, for example by explicit training in transfer ergonomics. Nonetheless, having accessible equipment should help minimize risks to patients and clinical staff.

Section 8 References

^1. Koontz A, Toro M, Kankipati P, Naber M, Cooper R. An expert review of the scientific literature on independent wheelchair transfers. Disability and Rehabilitation: Assistive Technology, January 2012; 7(1): 20–29, p. 28