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

Notes

A As for persons without disabilities, individual patients with disabilities have their own set of health conditions, including coexisting diseases and health risk factors that might affect the cost-benefit equation of obtaining various health care services. For example, although the U.S. Preventive Services Task Force gives colonoscopy screening to detect colorectal cancers a Grade A (service recommended: high certainty that the net benefit of the service is substantial), individual patients might determine in consultation with their physicians that the clinical risks of the bowel cleansing process required before colonoscopy outweigh the potential benefit of the test in their particular case. This decision should be based on clinical considerations and informed patients’ preferences, not on the inability to accommodate the needs of persons with disabilities during the bowel preparation.

B Secondary disabilities are conditions or complications that are related to a person’s primary disability and are also potentially disabling. Examples include injuries from falls, pressure ulcers, urinary tract complications, and depression.

C Each year, the National Healthcare Disparities Reports look at different measures of disparities, such as different types of service use or different measures of patients’ experiences with care.

D The National Health Interview Survey is a continuous federal survey overseen by the National Center for Health Statistics within the Centers for Disease Control and Prevention (CDC). Over the years, NHIS has been a major source of information about health care disparities for persons with disabilities among other vulnerable populations.

E Although the U.S. Preventive Services Task Force recommends mammography screening (for women ages 50-74 years old) and Pap smears (for women < age 65 who have been sexually active and have a cervix) with Grade B and Grade A evidence, respectively, these recommendations relate to broad populations of women. For each specific woman, the choices about whether to receive these screening services must be assessed based on her individual circumstances. For instance, women with severe, coexisting health conditions and high health risks may decide, in consultation with their physicians, that they will not benefit from this screening and choose not to have the tests.

F The clinical breast exam requires clinicians to palpate the entire breast, its perimeter, and immediately adjacent areas including the axilla (e.g., checking for lymph nodes). The breast tissue must be spread evenly over the chest wall, which requires women to be supine. With the woman lying flat on her back on an examination table, positioning her arm toward her head and rotating her hip and torso can assist in spreading the breast tissue.

G (1) “Are you limited in any way in any activities because of a physical, mental, or emotional problem?” (2) “Do you now have any health problems that require you to use special equipment such as a cane, a wheelchair, a special bed, or a special telephone?” and (3) “Do you consider yourself a person with a disability?”²³ Those classified as having a disability were then asked about whether their disability was physical, sensory, mental, or learning (they could report more than one type) and whether their disability was slight, moderate, or severe (based on their own perceptions).

H (1) Experiencing restricted social activity. (2) Not knowing where to obtain disability resource information. (3) Needing home modifications but not having them. (4) Having difficulty accessing a health care provider’s office because of its physical layout or location. (5) being treated unfairly at a health care provider’s office^.23

I The methods for measuring “low heights” for current height adjustable products vary among manufacturers and product designs. No official measurement method currently exists. Sections 4.1.2 and 5.1.4 describe the new standardized measurement method proposed by the Advisory Committee. Heights referenced in this report utilize this proposed new measurement method.

J As noted in Sections 1 and 8, this report does not address accessibility standards for children or for individuals with extreme obesity.

K Association for the Advancement of Medical Instrumentation. ANSI/AAMI ES60601-1:2005 (R) 2012. Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance. Approved 9 February 2006 by American National Standards Institute, Inc. Revised 2012.

L Tilley, Alvin R. The Measure of Man and Woman: Human Factors in Design. New York: Wiley, 2002.

M U.S. Department of Labor. OSHA Technical Manual, Section VII, Chapter 1, Back Disorders and Injuries. OSHA website: http://www.osha.gov/dts/osta/otm/otm_vii/otm_vii_1.html (visited May 17, 2012).

N U.S. Department of Labor. Hospital eTool: Healthcare Wide Hazards – Ergonomics. OSHA website: http://www.osha.gov/SLTC/etools/hospital/hazards/ergo/ergo.html (visited May 17, 2012).

O Examples of settlements include Metzler v. Kaiser Permanente, Olson v. Sutter Health, University of California San Francisco Medical Center. Full settlement agreements are available online: http://thebarrierfreehealthcareinitiative.org/?page_id=16

P This list of consensus standards recognized by the FDA is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

Q Information about the human factors design principles for medical devices is available at: http://www.aami.org/he75

R Western University of Health Sciences, University of California - San Francisco/Berkeley, University of Connecticut, University of Wisconsin-Milwaukee

Section 2: References

^23. Centers for Disease Control and Prevention. Environmental barriers to health care among persons with disabilities, Los Angeles county, California, 2002-2003. Morbidity and Mortality Weekly Report. 2006;55(48):1300-1303.