### ST **ANDARDS FOR**  **ACCESSIBLE MEDICAL** **DIAGNOSTIC EQUIPMENT** 

## Background
• **Section 4203 of Patient Protection and**  **Affordable Care**  **Act**

– **(Public Law 1 11**  **- 148, 124 Stat. L. 1**  **19)** • **Added Section 510 to the Rehabilitation**  **Act of 1973 on March 23, 2010**  • **Ti tle: “EST** 

**ABLISHMENT OF ST** 

**ANDARDS FOR**  **ACCESSIBLE MEDICAL** **D IAGNOSTIC**  **EQUIPMENT ”** 

## Background

• **ANSI/AAMI HE75**  **– 2009**  **Human Factors Engineering**  **– Design**  **of Medical Devices**  • **Chapter 16**  **– Accessibility**  **Considerations**

## Background **ADA and**  **ABA Accessibility**  **Guidelines**

## Organization
• **Preamble** • **Te xt of the Proposed Rule**  • **Example Applications** 

## Organization
• **Chapter M1:**  **A pplication and**  **Administration** • **Chapter M2:**  **Scoping** • **Chapter M3:**  **T**

**echnical Criteria**

### Te **chnical Criteria**  **Equipment used by patients:**  • **in a supine, prone, or side**  **- lying**  **position -**  **M301** • **in a seated**  **position -**  **M302** • **seated in a**  **wheelchair -**  **M303** • **in a standing**  **position -**  **M304**

### Te **chnical Criteria** 

• **Supports -**  **M305**

### Te **chnical Criteria** 

**Across equipment types:**

• **Communication M306**  • **Operable Parts**  **M307**

### Data from **Wheeled Mobility**  **Anthropometry Project** 

### Example **Applications Document**

## Steps • **Comment Period** • **Public Hearing** • **Advisory Committee**

## Responses **to NPRM** 
• **46 questions were posed in the preamble**  • **51 commenters** • **Range of comments**

## Initial **Review**

• **Nature of responses to questions**  • **Issues affecting multiple interest** 

## Recommended **Issues**

**Issues Areas**  • **Tr ansfer**  **surface height and size**  • **Permitted obstructions to the transfer**  **surface** • **Tr ansfer support location and**  **configuration** • **Depth of wheelchair spaces**

## Recommended **Issues**

**Tr ansfer**  **Surface Height**  **and Size** 

## Tr**ansfer Surface Height** 

M301.2.1 Height. The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm ) maximum measured from the floor to the top of the transfer surface.

## Tr**ansfer Surface Height** 

M302.2.1 Height. The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm ) maximum measured from the floor to the top of the transfer surface.

## Tr**ansfer Surface**  **Height NPRM Question 14**  **Adjustability -**  **17 inches min.**  **and 25 inches max.**  **range Minimum Height** 

### Patients • **Height is a major concern**  • **Range of users accommodated** 

## Tr**ansfer Surface**  **Height**

### Manufacturers • **Seat profile** • **Components beneath transfer surface**  • **Span between the lowest transfer**  **height and optimal**  **caregiver height** • **Cost and redesign** 

## Tr**ansfer Surface**  **Height**

### Equipment Design Concerns 

## Tr**ansfer Surface**  **Height M301.2.2**  **Size.** The transfer surface shall be 30 inches (760 mm) wide minimum and 15 inches (381mm) deep minimum . 

## Tr**ansfer Surface Size** 

## Tr**ansfer Surface Size** 

**M302.2.2 Size.**  The transfer surface shall be 21 inches (610 mm) wide minimum and 15 inches (381 mm) deep minimum.

## Tr**ansfer Surface**  **Size NPRM Questions 15 and 16**  **Sufficiency of proposed requirement**  **Minimum width Alternative dimensions** 

## Tr**ansfer Surface**  **Size**

**Patients** • **Space for transfer** • **Repositioning after transfers**  • **Range of body sizes –**  **large and obese**  • **Ergonomics**

### Manufacturers

• **Use of supports** • **Corner shape on transfer sides**  • **Relationship to base design**  • **E quipment**  **proportions** • **Redesign and costs**  • **Impact on exam room lay** **outs** 

## Tr**ansfer Surface**  **Size**

### Equipment Design Concerns 

## Tr**ansfer Surface**  **Size M301 Diagnostic Equipment Used by** 

**Patients in Supine, Prone, or**  **Side -**  **Ly ing**  **Position** • **Width: increase to 35 to 36 inches** 

**decrease to 25 to 28 inches**  • **Same requirement for Equipment**  **Used by Patients in**  **Seated Position** 

## Tr**ansfer Surface**  **Size M302**  **Diagnostic Equipment Used by**

**Patients in in Seated Position** • **Alternate dimensions –**  **17 inches min. depth**  • **Relationship to size requirement for M301**  

## Tr**ansfer Surface**  **Size**

# Questions?