36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

6. Regulatory Analyses

Executive Order 13563 (Improving Regulation and Regulatory Review) and Executive Order 12866 (Regulatory Planning and Review): Preliminary Regulatory Assessment

The Office of Management and Budget has reviewed this proposed rule in accordance with Executive Orders 13563 and 12866. Among other things, Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.

The Access Board has prepared a preliminary regulatory assessment for the proposed standards. The preliminary regulatory assessment is available on the Access Board’s web site at: http://www.accessboard.gov/medical-equipment.htm. The preliminary regulatory assessment is summarized below.

Need for and Benefits of the Proposed Standards

The U.S. Census Bureau reports that 54.4 million Americans, about one in five U.S. residents, reported some level of disability in 2005.¹¹ The number of individuals with disabilities is almost equal to the combined total population of California and Florida. The U.S. Census Bureau provides this breakdown of the population of people aged 15 and older:

• 27.4 million (11.9 percent) had difficulty with ambulatory activities of the lower body;

• 22.6 million (9.8 percent) had difficulty walking a quarter of a mile;

• 21.8 million (9.4 percent) had difficulty climbing a flight of stairs;

• 10.2 million (4.4 percent) used a cane, crutches, or walker to assist with mobility;

• 3.3 million (1.4 percent) used a wheelchair or other wheeled mobility device;

• 7.8 million (3 percent) had difficulty seeing words or letters in ordinary newspaper print, including 1.8 million who are completely unable to see; and

• 7.8 million (3 percent) had difficulty hearing conversations, including 1 million who are unable to hear conversations at all.

The prevalence of disability increases with age. The Administration on Aging reports that there were 39.6 million persons age 65 or older in the United States in 2009, and that this population is expected to increase to 55 million in 2020.¹² Among this population, 37 percent reported some type of disability in 2005.¹³

A national survey collected information on the types of medical equipment that is most difficult for individuals with disabilities to access and use.¹⁴ The survey was completed by a diverse sample of individuals with a wide range of disabilities, including mobility disabilities and sensory disabilities. Survey respondents who had experience with specific medical equipment rated their degree of difficulty when attempting to access or use the equipment as follows:

• 75 percent rated examination tables as moderately difficult to impossible to use;

• 68 percent rated radiology equipment as moderately difficult to impossible to use;

• 53 percent rated weight scales as moderately difficult to impossible to use; and

• 50 percent rated examination chairs as moderately difficult to impossible to use.

Survey respondents reported difficulties with getting on and off the equipment, positioning their bodies on the equipment, physical comfort and safety, and communication issues. Focus group sessions of individuals with disabilities reported that participants find examination tables, imaging equipment, and other diagnostic equipment not only difficult but unsafe to use, and that these negative health care experiences can result in their not scheduling regular medical examinations and diagnostic procedures.¹⁵ A report on the “The Current State of Health Care for People with Disabilities” issued by the National Council on Disability found that individuals with disabilities experienced significant health disparities and barriers to health care, as compared to individuals without disabilities.¹⁶ Among the key barriers cited in the report is the lack of accessible examination equipment. A report on the “Importance of Accessible Examination Tables, Chairs and Weight Scales” issued by the Center for Disability Issues and the Health Professions discusses how the lack of accessible equipment reduces the likelihood that individuals with disabilities will receive timely and appropriate health care.¹⁷ Health care providers may not perform some diagnostic procedures for patients with disabilities because they lack accessible equipment. This can result in suboptimal examinations, missed or delayed diagnoses, and worsening conditions that require more expensive and extensive treatments.

The proposed standards address many of the barriers that have been identified as affecting the accessibility and usability of diagnostic equipment by individuals with disabilities. The standards will improve the quality of health care for individuals with disabilities and ensure that they receive examinations, diagnostic procedures, and other health care services equal to those received by individuals without disabilities. The standards will facilitate independent transfers by individuals with disabilities onto and off of diagnostic equipment, and enable them to maintain their independence, confidence, and dignity. The standards will lessen the need for health care personnel to assist individuals with disabilities when transferring on and off of diagnostic equipment. Where assisted transfers are necessary, the proposed standards will also facilitate such transfers. The proposed standards will reduce the risk of injury during transfers to both health care personnel and patients.¹⁸ The proposed standards will result in more positive health care experiences for individuals with disabilities and health care providers.

Entities Potentially Affected by Proposed Standards

The proposed standards do not impose any mandatory requirements on health care providers or medical device manufacturers. Thus, there are no compliance costs that can be attributed to the proposed standards. As discussed below, if an enforcing authority such as DOJ adopts the standards as mandatory requirements for entities subject to its jurisdiction, health care providers may experience some compliance costs. Medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment.

Health Care Providers

As discussed under Department of Justice Activities Related to Health Care Providers and Medical Equipment, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities to comply with the ADA and Section 504 of the Rehabilitation Act. Both the federal government through DOJ and private parties, including individuals with disabilities, have entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act. In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. See Access to Medical Care for Individuals with Mobility Disabilities available at: http://www.ada.gov/medcare_ta.htm. The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel. In July 2010, DOJ also issued an ANPRM announcing that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment and will prepare a regulatory assessment in accordance with Executive Orders 13563 and 12866.

Medical Device Manufacturers

If DOJ amends its ADA regulations as announced in the ANPRM, medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. The size of the economic incentive will depend on the amount of accessible medical diagnostic equipment health care providers need to acquire and the manufacturers’ incremental costs to design or redesign and manufacture accessible products that conform to the standards.

Many medical device manufacturers currently incorporate accessible features in some of their products such as patient support surfaces that are height adjustable, transfer and positioning supports, and scales designed for use by patients seated in a wheelchair. The incremental costs for manufacturers to conform these products to the standards are expected to be small because the features may already meet or closely meet the standards. The incremental costs may be greater for manufacturers that do not currently incorporate accessible features in their products but plan to do so in future designs or redesigns of their products. The incremental costs to design or redesign and manufacture accessible products that conform to the standards will be incurred voluntarily by manufacturers that choose to produce them for health care providers who need to acquire accessible medical diagnostic equipment. Some manufacturers may choose not to design or redesign and manufacture accessible products that conform to the standards, or may produce accessible products with less market appeal than that of their competitors, thereby losing market share and incurring losses. These economic impacts are not regulatory costs and are not generally social costs because for the most part, one manufacturer’s loss is another manufacturer’s gain.

The following questions in the preamble request comments on the incremental costs to design or redesign and manufacture accessible products that conform to the technical criteria in the proposed standards, as well as alternative and additional technical criteria that the Access Board is considering:

• Questions 9 and 10 on the technical criteria in Chapter M3;

• Questions 14 (a) and (b) on height adjustable patient support surfaces;

• Question 15 (b) on width of patient support surfaces on equipment used by patients in a supine, prone, or side-lying position;

• Question 18 (a) on structural strength of repositionable transfer supports;

• Question 19 (c) on location and size of transfer supports;

• Question 23 (a) on stirrups;

• Question 24 (b) on positioning supports;

• Question 29 (a) on alternative dimension for minimum depth of wheelchair spaces;

• Question 30 on edge protection for wheelchair spaces on raised platforms;

• Question 33 on dimensions for wheelchair spaces on raised platforms;

• Question 34 (a) on alternative dimensions for toe clearance and knee clearance at wheelchair spaces;

• Question 35 (b) on handrails on diagnostic equipment ramps;

• Question 37 (c) on a folding or removable seat on weight scale platforms or other types of diagnostic equipment used by patients in a standing position;

• Question 41 (b) on audible, visible, and tactile communications; and

• Question 42 (a) on operating force for operable parts.

The Access Board will consider the information provided in the comments when preparing the final standards, and will provide an analysis of the incremental costs with the final standards.

Product Data and Unit Costs

The Access Board and its contractor, Eastern Research Group, collected product data and unit costs for a broad sample of examination tables and weight scales, including products with accessible features. The Access Board and Eastern Research Group did not evaluate the products for conformance with the proposed standards and do not endorse any of the products included in the sample. The Access Board and Eastern Research Group used the Internet to collect the product data and unit costs. Medical equipment suppliers typically list the manufacturer suggested retail price (MSRP) for the products on their web sites and sell the products at discounted prices. The discounted prices for the same product can vary widely among medical equipment suppliers. Health care providers typically purchase the products for less than the MSRP (i.e., actual price paid is less than MRSP). The unit costs in the tables below are the MSRP, and are shown as a range of lower cost and higher cost products rounded to the nearest $50. The data shows that there are a wide variety of examination tables and weight scales available to meet almost every budget.

Product data and unit costs for examination chairs and imaging equipment will be provided when the final standards are issued.

Examination Tables

Product data and unit costs were collected for examination tables produced by five manufacturers. The manufacturer’s web sites typically grouped the tables by the following types: treatment tables, manual tables, and power tables. The number of each type of table made by the manufacturers, the number of tables included in the sample, and range of lower cost and higher cost products are summarized below.

Question 44. Does the above sample fairly reflect the range of costs for examination tables?

Treatment tables typically have a flat top. Some models have adjustable backrests, but the backrests typically cannot support patients in a sitting position. Treatment tables typically have a fixed height of 31 inches measured from the floor to the top of the table. The lower cost products have an open base with an H-brace or shelf. The higher cost products have cabinets, drawers, or shelves. Adjustable height treatment tables are available, but are not included in the sample. The MSRP for adjustable height treatment tables ranged from $1,500 to $2,400.

Manual tables typically have a fully articulated, pneumatic backrest. The backrests typically can support patients in a seated position and recline to a lying position. Manual tables typically have a fixed height of 32 inches measured from the floor to the top of the table. Manual tables typically have cabinets, drawers, or shelves.

Power tables have an electric motor that can adjust the table height to as low as 18 inches and as high as 40 inches above the floor on some products. The higher cost products have a fully articulated, pneumatic or powered, backrest that can support patients in a seated position and recline to a lying position. Some power tables have armrests, grab rails, side rails, and cabinets or drawers.

Weight Scales

Product data and unit costs were collected for weight scales produced by eight manufacturers. The scales are grouped by the following types: stand-on scales and wheelchair scales. Within each group, there are mechanical and digital scales. Unit costs are presented for stand-on scales with and without handrails. Unit costs are presented for wheelchair scales with raised platforms and with flush platforms in the floor. The number of each type of scale made by the manufacturers, the number of scales included in the sample, and range of lower cost and higher cost products are summarized below.

Question 45. Does the above sample fairly reflect the range of costs for stand-on scales?

Stand-on mechanical scales typically have a weight capacity ranging from 400 to 500 pounds. Stand-on digital scales without handrails typically have a weight capacity ranging from 400 to 750 pounds, and the higher cost products typically have larger platforms. Stand-on digital scales with handrails typically have a weight capacity ranging from 500 to 1,000 pounds, and the higher cost products typically are bariatric scales.

Question 46. Does the above sample fairly reflect the range of costs for wheelchair scales?

Wheelchair mechanical scales with a ramped platform typically have a weight capacity ranging from 350 to 500 pounds. Wheelchair digital scales with a ramped platform typically have a weight capacity ranging from 800 to 1,000 pounds. Wheelchair digital scales with a flush platform in the floor typically have a weight capacity of 1,000 pounds. Some wheelchair digital scales have standard or optional handrails for use as a stand-on bariatric scale.

The Access Board has made a preliminary determination based on the preliminary regulatory assessment that the benefits of the proposed standards will justify the costs; that the proposed standards will impose the least burden on society, consistent with obtaining the regulatory objectives; and that the regulatory approach selected will maximize net benefits.

Regulatory Flexibility Act: Initial Regulatory Flexibility Analysis

The Regulatory Flexibility Act requires agencies to consider the impacts of their regulatory proposals on small entities, analyze alternatives that minimize the impacts on small entities, and make the analysis available for public comment. The proposed standards do not impose any mandatory requirements on any entity, including small entities. Nonetheless, in keeping with the Regulatory Flexibility Act, the Access Board has prepared this initial regulatory flexibility analysis.

Reason the Access Board is issuing the proposed standards

Section 510 of the Rehabilitation Act (29 USC 794f) requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain minimum technical criteria to ensure that medical diagnostic equipment used in or in conjunction with medical settings such as physicians’ offices, clinics, emergency rooms, and hospitals is accessible to and usable by individuals with disabilities.

Objective of, and legal basis for, the proposed standards

The objective of the proposed standards is to ensure that medical diagnostic equipment is accessible to and usable by individuals with disabilities. The proposed standards address barriers that affect the accessibility and usability of medical diagnostic equipment by individuals with disabilities. The legal basis for the proposed standards is Section 510 of the Rehabilitation Act.

Small entities potentially affected by proposed standards

The proposed standards do not impose any mandatory requirements on health care providers or medical device manufacturers. As discussed below, if an enforcing authority such as DOJ adopts the standards as mandatory requirements for entities subject to its jurisdiction, small health care providers may experience some compliance costs. Small medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment.

Health Care Providers

As discussed under Department of Justice Activities Related to Health Care Providers and Medical Equipment, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities to comply with the ADA and Section 504 of the Rehabilitation Act. Both the federal government through DOJ and private parties, including individuals with disabilities, have entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act. In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. See Access to Medical Care for Individuals with Mobility Disabilities available at: http://www.ada.gov/medcare_ta.htm. The guidance document includes information on accessible examination rooms and the clear floor space needed adjacent to medical equipment for individuals who use mobility devices to approach the equipment for transfer; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training health care personnel. In July 2010, DOJ also issued an ANPRM announcing that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, it was considering amending its regulations implementing Titles II and III of the ADA to include specific standards for the design and use of accessible equipment and furniture that is not fixed or built into a facility in order to ensure that programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities. If DOJ proposes to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking (NPRM) requesting public comment and will prepare an initial and final regulatory flexibility analyses in accordance with the Regulatory Flexibility Act.

Medical Device Manufacturers

If DOJ amends its ADA regulations as announced in the ANPRM, small medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. The size of the economic incentive will depend on the amount of accessible medical diagnostic equipment health care providers need to acquire and the manufacturers’ incremental costs to design or redesign and manufacture accessible products that conform to the standards.

Many medical device manufacturers currently incorporate accessible features in some of their products such as patient support surfaces that are height adjustable, transfer and positioning supports, and scales designed for use by patients seated in a wheelchair. The incremental costs for manufacturers to conform these products to the standards are expected to be small because the features may already meet or closely meet the standards. The incremental costs may be greater for manufacturers that do not currently incorporate accessible features in their products but plan to do so in future designs or redesigns of their products. The incremental costs to design or redesign and manufacture accessible products that conform to the standards will be incurred voluntarily by manufacturers that choose to produce them for health care providers who need to acquire accessible medical diagnostic equipment. Some manufacturers may choose not to design or redesign and manufacture accessible products that conform to the standards, or may produce accessible products with less market appeal than that of their competitors, thereby losing market share and incurring losses. These economic impacts are not regulatory costs and are not generally social costs because for the most part, one manufacturer’s loss is another manufacturer’s gain.

The preamble requests comments on the incremental costs to design or redesign and manufacture products that conform to the technical criteria in the proposed standards, as well as alternative and additional technical criteria that the Access Board is considering. The Access Board will consider the information provided in the comments when preparing the final standards, and will provide an analysis of the incremental costs with the final standards.

Compliance requirements in proposed standards

The proposed standards contain technical criteria for accessible medical diagnostic equipment. The proposed standards do not impose any mandatory requirements on medical device manufacturers or health care providers.

Other relevant federal rules and guidance documents

As discussed above, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. DOJ also issued an ANPRM announcing that it was considering amending its regulations implementing Titles II and III of the ADA to ensure that equipment and furniture used in programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities.

The Access Board worked closely with the FDA-CDRH in developing the proposed standards. The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access Board’s standards. If the FDA-CDRH develops such a guidance document, it will provide the public notice and opportunity to comment on a draft of the guidance document in accordance with its procedures for issuing guidance documents. See 21 CFR 10.115.

Significant alternatives

Questions are included in the preamble requesting comments on the economic and technical impacts of the technical criteria in the proposed standards, and whether alternative technical criteria would be appropriate. The Access Board plans to convene an advisory committee when the comment period on the rulemaking closes to assist the Board in reviewing the comments and make recommendations on issues addressed in the rulemaking. The Access Board will analyze the comments submitted in response to the questions and the advisory committee’s recommendations, including alternatives that achieve the statutory objectives of ensuring that medical diagnostic equipment is accessible to and usable by individuals with disabilities and minimize any significant impacts of the standards on small entities. The Access Board will prepare a final regulatory flexibility analysis when the final standards are issued that discusses any significant alternatives considered.

Executive Order 13132 (Federalism)

The proposed standards do not impose any mandatory requirements on state and local governments. The proposed standards do not have any direct effects on the state governments, the relationship between the national government and state governments, or the distribution of power and responsibilities among the various levels of government. The proposed standards do not preempt state law. Therefore, the consultation and other requirements of Executive Order 13132 (Federalism) do not apply.

Unfunded Mandates Reform Act

The proposed standards do not impose any mandatory requirements on state, local, or tribal governments or the private sector. Therefore, the Unfunded Mandates Reform Act does not apply.

List of Subjects in 36 CFR Part 1195

Health care, Individuals with disabilities, Medical devices.

Nancy Starnes,

Chair.

For the reasons stated in the preamble, the Access Board proposes to add part 1195 to title 36 of the Code of Federal Regulations to read as follows:

PART 1195 –STANDARDS FOR ACCESSIBILE MEDICAL DIAGNOSTIC EQUIPMENT

Sec. 1195.1 Standards.

Appendix to part 1195 – Standards for Accessible Medical Diagnostic Equipment

Authority: 29 U.S.C. 794f.

§ 1195.1 Standards.

The standards for accessible medical diagnostic equipment are set forth in the appendix to this part. Other agencies, referred to as an enforcing authority in the standards, may adopt the standards as mandatory requirements for entities subject to their jurisdiction.

Appendix to Part 1195 –Standards for Accessible Medical Diagnostic Equipment