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 the Department of Justice (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

The Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act are civil rights laws that prohibit discrimination on the basis of disability. Title II of the ADA (42 U.S.C. 12131 to 12165) applies to state and local governments, and Title III of the ADA (42 U.S.C. 12189 to 12189) applies to private entities that are public accommodations such as health care providers. Section 504 of the Rehabilitation Act (29 U.S.C. 792) applies to recipients of federal financial assistance such as Medicaid and federally conducted programs.

Pursuant to the ADA and Section 504 of the Rehabilitation Act, health care providers must provide individuals with disabilities full and equal access to their health care services and facilities. DOJ has 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 advance notice of proposed rulemaking (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 NPRM 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;
  • Questions 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.[9] 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.

          

  

Table Type

  
  

Products

  
  

Products in Sample

  
  

Lower Cost Products MSRP

  
  

Higher Cost Products MSRP

  

Treatment

74

20

$400   – $850

$850   – $1,450

Manual

15

9

$1,250

$2,250

Power

30

25

$1,650   – $2,900

$3,650   – $16,800

Treatment tables typically have a flat top. Some products 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 stand-on scales and wheelchair scales made by the manufacturers, the number of scales included in the sample, and range of lower cost and higher cost products are summarized below.

          

  

Stand-On Scales

  
  

Products

  
  

Products in Sample

  
  

Lower Cost Products MSRP

  
  

Higher Cost Products MSRP

  

Mechanical without Handrails

22

3

$250

$550

Mechanical with Handrails

1

1

$700

$700

Digital without Handrails

50

15

$300   – $600

$700   – $1,200

Digital with Handrails

21

9

$600   – $1,050

$1,750   – $2,600

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.

          

  

Wheelchair Scales

  
  

Products[10]

  
  

Products in Sample

  
  

Lower Cost Products MSRP

  
  

Higher Cost Products MSRP

  

Mechanical with Ramped Platform

2

2

$1,200

$2,900

Digital with Ramped Platform

32

15

$800   – $1,700

$2,100   – $4,950

Digital with Flush Platform in Floor

8

5

$3,300

$6,500

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.