General Guidance 1.2: Universal Design
Overview
These guidelines are based on the universal design principles and inclusive design strategies, as applied to the design of medical devices.
The term “universal design” was originally coined by the late Ronald L. Mace to describe the process of designing all products and environments to be usable by people of all ages and abilities, to the greatest extent possible (Mace, 1991). Related terms that are popular in the U.S. are transgenerationaldesign (Pirkl 1988, Pirkl 1994) or lifespan design (National Aging in Place Council, 2005) to emphasize the multi-age applicability of the design approach. The term inclusive design is sometimes used to emphasize concern for the needs of all members of society, some of whom may have been excluded or marginalized by mainstream design practices (Royal Society for the encouragement of Arts ).In Japan, the term “kyoho-hin,” which means “shared design,” is preferred by some, and has been defined as “designed to be used by as many people as possible, including the elderly and those with disabilities” (Kyoyo-Hin Foundation, 2001). In Europe the term design for all is most popular. The motto of the European Design for All Declaration, also called the Stockholm Declaration, is “Good design enables, bad design disables” (European Institute for Design and Disability, 2004) .
Universal or inclusive design differs from assistive technology and accessible design, and can be viewed as a key strategy (but not the only one) for enhancing the direct accessibility of medical products. Unlike assistive technologies, inclusive design seeks to design products to suit concurrently the needs of people of all ages, sizes, and shapes, and with a wide range of abilities and disabilities, and accessible features are integrated into universal designs so that they look like they belong there. While inclusive design may be difficult or impossible to achieve, it is often more efficient and economically advantageous to approach it as closely as practicable when designing for diverse user populations. Often, however, rather than try to achieve a one-size-fits-all product, additional strategies are needed to provide broader access. The two major strategies are to offer different versions of a device or a device that has optional components, or to provide support for or compatibility with a variety of auxiliary equipment or assistive technologies that may be used in conjunction with the device. These strategies are especially appropriate for prescription devices, which can be customized.
One resource for this guidance is a set of seven principles that were the output of a consensus process involving ten experts in the universal design field, which were disseminated in 1997 as the Principles of Universal Design by The Center for Universal Design at North Carolina State University; for each of these seven principles, four or five guidelines were articulated. Note that the following section provides design process guidance, as no validated metrics have yet been developed for evaluating the degree of the universal or inclusive design of a product.
For a text version of the Principles of Universal Design, including names, definitions, and guidelines, see http://www.design.ncsu.edu/cud/newweb/about_ud/udprinciples_text.htm. For more information and a table on the application of these principles to performance measures for product design, see http://www.rerc-ami.org/ami/projects/d/2/udg/index.aspx#tableudppm.
1.2.1 Provide the same means of use for all users: identical whenever possible, equivalent when not.
An example is a weight scale with a large platform that is recessed into the floor (see Fig. 3.1). This helps eliminate a trip hazard and all patients can use the same scale, whether they walk or use a wheelchair or a scooter. The scale may also have side railings to enhance standing stability, and audio output, which is particularly advantageous for people with visual impairments (but if audio output is provided, for privacy reasons there should be headphones, a volume control, or the scale should be located in a private area).
Motivated by: the Principles of Universal Design, Principle 1: Equitable Use, Guideline 1a.
Figure 3.1. Weight scale recessed into floor of medical facility (add citation).
1.2.2 Segregation or stigmatization of any users should be avoided.
An example is using leg supports (e.g., knee crutches) instead of stirrups on a gynecology table so that patients are more comfortable and only one healthcare provider is needed to conduct a pelvic examination on a woman with paralysis.
Motivated by: the Principles of Universal Design, Principle 1: Equitable Use, Guideline 1b.
1.2.3 Provisions for privacy, security, and safety should be equally available to all potential users.
An example is side railings on examination tables to help stabilize and improve the safety and security of patients on the table.
Motivated by: the Principles of Universal Design, Principle 1: Equitable Use, Guideline 1c.
1.2.4 The design of the device should be appealing to all potential users.
An example is examination tables for pediatric clinics that are designed to resemble animals (see Fig. 3.2).
Motivated by: the Principles of Universal Design, Principle 1: Equitable Use, Guideline 1d.
Figure 3.2. An examination table intended for pediatric patients can look like an animal (QuickMedical 2006).
1.2.5 The device should offer choice in methods of use.
An example is a dental chair with adjustable angles at the hip and knee that can accommodate patients of atypical sizes or with limited joint ranges of motion or individual position preferences. If the chair adjusts in height, it can be lowered so that it is easier for the patient to get onto and off; it can also be raised so that it is easier for the dental professional to examine and treat the patient at a level that is most effective and comfortable for him or her as well as for the specific procedure (see Fig. 3.3).
Motivated by: the Principles of Universal Design, Principle 2: Flexibility in Use, Guideline 2a.
Figure 3.3. Medical chair that articulates at the lower leg and adjusts in height (add citation).
1.2.6 The device should accommodate right- or left-handed access and use.
An example is an ultrasound machine that can be operated with either the left or right hand on the transducer and the other hand on the control panel. This option suits people with one-side dominance or preference, and allows the operator to switch hands during periods of heavy workload to reduce hand, arm and neck fatigue and injury.
Motivated by: the Principles of Universal Design, Principle 2: Flexibility in Use, Guideline 2b.
1.2.7 The device should facilitate the user's accuracy and precision.
An example is cable and cord connectors that have varied specific shapes to facilitate correct connections. This allows users with visual limitations to tactilely distinguish between different connectors.
Motivated by: the Principles of Universal Design, Principle 2: Flexibility in Use, Guideline 2c.
1.2.8 The device should adapt to the user's pace.
An example is a blood glucose monitor that does not “time out” and shut down if an individual takes a long time between steps. This allows users with vision, movement, or reading limitations to operate the device successfully.
Motivated by: the Principles of Universal Design, Principle 2: Flexibility in Use, Guideline 2d.
1.2.9 The device should have no unnecessary complexity.
An example is an infusion pump that is used in the home. The controls should be simple enough to enable the healthcare provider to set the parameters of the device easily and accurately, and the patient to operate the device successfully and correctly. The device may operate in different modes for different users, to limit the number of options offered to each.
Motivated by: the Principles of Universal Design, Principle 3: Simple and Intuitive Use, Guideline 3a.
1.2.10 Device operation should be consistent with user expectations and intuition.
An example is an anesthesia workstation with a labeled control that increases systematically (e.g., in a clockwise direction around a dial), which is operated to change the dosage of an anesthesia agent.
Motivated by: the Principles of Universal Design, Principle 3: Simple and Intuitive Use, Guideline 3b.
1.2.11 The device should accommodate a wide range of literacy and language skills.
An example is a personal blood pressure cuff that uses icons to communicate more effectively (and quickly) than text for users who have limited literacy or language skills, and to reinforce the content of text for those who read it.
Motivated by: the Principles of Universal Design, Principle 3: Simple and Intuitive Use, Guideline 3c.
1.2.12 Information on the device should be arranged in a manner consistent with its importance.
An example is an EMG, EEG, or ECG monitor whose most important and frequently used buttons are easy to recognize visually (perhaps are larger in size) and to reach. Another example is prompts for a task sequence displayed on a monitor, when the next planned operation in the ordered default sequence is presented in a larger, bolded font.
Motivated by: the Principles of Universal Design, Principle 3: Simple and Intuitive Use, Guideline 3d.
1.2.13 The device should provide effective prompting and feedback during and after task completion.
An example is a defibrillator designed for use in a public place (such as an airport) that guides non-expert users, both visually and audibly, through the entire process of use, from set up through shut down.
Motivated by: the Principles of Universal Design, Principle 3: Simple and Intuitive Use, Guideline 3e.
1.2.14 The device should use different modes (visual, verbal, tactile) for redundant presentation of essential information.
An example is a transparent surgical mask that enables a deaf person who reads lips to understand the speech of a healthcare professional who is wearing one.
Motivated by: the Principles of Universal Design, Principle 4: Perceptible Information, Guideline 4a.
1.2.15 The "legibility" of essential device information should be maximized.
An example is a vital sign monitor’s visual display with visual contrast between the text and the background and auditory contrast between the alert or alarm and the ambient noise level. The visual display may offer a choice of font type and size, and the auditory output should have a volume control.
Motivated by: the Principles of Universal Design, Principle 4: Perceptible Information, Guideline 4c.
1.2.16 Elements of the device should be differentiated in ways that can be described (i.e., make it easy to give instructions or directions).
An example is a home healthcare device, such as an oxygen administration system, whose components are sufficiently different from each other so that verbal descriptions are easier to write in instruction manuals or provide over the telephone.
Motivated by: the Principles of Universal Design, Principle 4: Perceptible Information, Guideline 4d.
1.2.17 The device should be compatible with a variety of techniques or devices used by potential users who have sensory limitations.
An example is an x-ray machine that indicates to the operator both visually and audibly when the image has been taken; ideally it would have a volume control and an audio jack to support use of headphones.
Motivated by: the Principles of Universal Design, Principle 4: Perceptible Information, Guideline 4e.
1.2.18 Elements of the device should be arranged to minimize hazards and errors: the most used elements should be most accessible; hazardous elements should be eliminated, isolated, or shielded.
An example is a hospital bed control unit that securely encloses all wiring connections and terminations. (These units should be inspected regularly to ensure they have not become cracked or damaged.)
Motivated by: the Principles of Universal Design, Principle 5: Tolerance for Error, Guideline 5a.
1.2.19 The device should provide warnings of hazards and errors.
An example is hazard warning labeling on medical sharps containers that imply danger.
Motivated by: the Principles of Universal Design, Principle 5: Tolerance for Error, Guideline 5b.
1.2.20 The device should have fail-safe features.
An example is protected lead wires and patient cables used with devices such as arrhythmia detectors and alarms that, for example, cannot be inadvertently inserted into electrical outlets and thus pose an electrocution hazard to patients.
Motivated by: the Principles of Universal Design, Principle 5: Tolerance for Error, Guideline 5c.
1.2.21 The device should discourage unconscious action in tasks that require vigilance.
An example is bar coding of medications, which can help reduce errors by ensuring that there is a match between medication and patient.
Motivated by: the Principles of Universal Design, Principle 5: Tolerance for Error, Guideline 5d.
1.2.22 Allow user to maintain a neutral body position
An example is a supply cart handle that is oriented vertically rather than horizontally to prevent sustained forearm pronation. The handles should be long enough to allow people of varying heights to grasp them at the vertical location that is most comfortable for them.
Motivated by: the Principles of Universal Design, Principle 6: Low Physical Effort, Guideline 6a.
1.2.23 The forces required to operate the device should be reasonable.
An example is the force required to move the plunger of a syringe. The force should be neither so high as to cause hand fatigue and pain, nor so low as to hinder control.
Motivated by: the Principles of Universal Design, Principle 6: Low Physical Effort, Guideline 6b.
1.2.24 Repetitive actions should be minimized.
An example is a multi-channel pipette, which enables the user to empty or fill more than one test tube in a single operation.
Motivated by: the Principles of Universal Design, Principle 6: Low Physical Effort, Guideline 6c.
1.2.25 Sustained physical effort should be minimized.
An example is a backrest or armrests on a chair, which can improve healthcare practitioner comfort and reduce fatigue during long procedures. A chair that provides chest support can reduce load on the lower back during sustained forward reaching tasks, such as performing surgery.
Motivated by: the Principles of Universal Design, Principle 6: Low Physical Effort, Guideline 6d.
1.2.26 The device should offer a clear line of sight to important elements for any seated or standing potential user.
An example is video monitors in surgical suites, which need to be easily visible for all healthcare personnel involved. This often requires use of multiple monitors.
Motivated by: the Principles of Universal Design, Principle 7: Size and Space for Approach and Use, Guideline 7a.
1.2.27 The reach to all critical components of the device should be comfortable for any seated or standing potential user.
An example is a height-adjustable surgical platform to suit surgeons of varying heights and who may stand or sit during use, including wheelchair users.
Motivated by: the Principles of Universal Design, Principle 7: Size and Space for Approach and Use, Guideline 7b.
1.2.28 The device should accommodate variations in hand and grip size.
An example is protective gloves, which should come in various sizes to suit professionals whose hands vary in size. Gloves must fit well in order to maximize physical protection and optimize manual dexterity. (See also Section on Anthropometry/Biomechanics, part 3.1 on Hand Data.)
Motivated by: the Principles of Universal Design, Principle 7: Size and Space for Approach and Use, Guideline 7c.
1.2.29 Adequate space should be provided for the use of assistive devices or personal assistance.
An example is an x-ray platform that has space underneath or along one or both sides to accommodate the horizontal support legs of lift equipment that may be used to transfer patients who cannot walk.
Motivated by: the Principles of Universal Design, Principle 7: Size and Space for Approach and Use, Guideline 7d.