Special Note; Patient Safety - Invacare 1171780 Guía De Notificación

2 Appendix

SPECIAL NOTE

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For your convenience, the April 2010 version of the FDA's bed safety guidelines are provided in this section. The
information from the FDA's brochure, published by Hospital Bed Safety Workgroup, is reproduced verbatim, the latest
revision of which is available at http://www.fda.gov.
2.1 A Guide to Bed Safety Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts
Bed Rail Entrapment Statistics
Today there are about 2.5 million hospital and nursing home beds in use in the United States. Between 1985 and 2009, 803 incidents of patients*
caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. Food and Drug Administration. Of these reports, 480 people
died, 138 had a nonfatal injury, and 185 were not injured because staff intervened. Most patients were frail, elderly or confused.
* In this brochure, the term patient refers to a resident of a nursing home, any individual receiving services in a homecare
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setting, or patients in hospitals.

Patient Safety

Patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without
assistance, MUST be carefully assessed for the best ways to keep them from harm, such as falling. Assessment by the patient's health care team will
help to determine how best to keep the patient safe. Historically, physical restraints (such as vests, ankle or wrist restraints) were used to try to keep
patients safe in health care facilities. In recent years, the health care community has recognized that physically restraining patients can be dangerous.
Although not indicated for this use, bed rails are sometimes used as restraints**. Regulatory agencies, health care organizations, product manufacturers
and advocacy groups encourage hospitals, nursing homes and homecare providers to assess patients' needs and to provide safe care without restraints.
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** Invacare bed rails MUST NEVER be used as a means of restraints.
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2 APPENDIX
The FDA's Brochure