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ICCI Bed Rails and Accessories

8

Part No 1143214

APPENDIX

SPECIAL NOTE

For your convenience, the January 2008 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 verba-
tim, the latest revision of which is available at http://www.fda.gov.

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 2005, 
691 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, 413 people died, 120 had a nonfatal injury, and 158 were not injured because 
staff intervened. Most patients were frail, elderly or confused.

*NOTE: In this brochure, the term patient refers to a resident of a nursing home, any individual receiving services in a home care 
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 home care 
providers to assess patients’ needs and to provide safe care without restraints.

The Benefits and Risks of Bed Rails

Potential benefits of bed rails include:

Aiding in turning and repositioning within the bed. 

Providing a hand-hold for getting into or out of bed. 

Providing a feeling of comfort and security. 

Reducing the risk of patients falling out of bed when being transported. 

Providing easy access to bed controls and personal care items. 

Potential risks of bed rails may include:

Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or 
between the bed rails and mattress. 

More serious injuries from falls when patients climb over rails. 

Skin bruising, cuts, and scrapes. 

Inducing agitated behavior when bed rails are used as a restraint. 

Feeling isolated or unnecessarily restricted. 

Preventing patients, who are able to get out of bed, from performing routine activities such as going to the 
bathroom or retrieving something from a closet. 

Meeting Patients' Needs for Safety

Most patients can be in bed safely without bed rails. Consider the following:

Use beds that can be raised and lowered close to the floor to accommodate both patient and health care worker 
needs. 

Keep the bed in the lowest position with wheels locked. 

When the patient is at risk of falling out of bed, place mats next to the bed, as long as this does not create a greater 
risk of accident. 

Use transfer or mobility aids. 

Monitor patients frequently. 

Anticipate the reasons patients get out of bed such as hunger, thirst, going to the bathroom, restlessness and pain; 
meet these needs by offering food and fluids, scheduling ample toileting, and providing calming interventions and 
pain relief. 

Summary of Contents for ICCG 1143214

Page 1: ...Invacare products are specifically designed and manufactured for use in conjunction with Invacare accessories Accessories designed by other manufacturers have not been tested by Invacare and are not recommended for use with Invacare products ENTRAPMENT WARNING Proper patient assessment and monitoring and proper maintenance and use of equipment is required to reduce the risk of entrapment Variation...

Page 2: ... 3 Locate the proper mounting holes on the bed to install the bed rails Refer to Detail B of FIGURE 2 4 Position the mounting bracket on the mattress deck Refer to Detail B of FIGURE 2 5 Secure the mounting bracket to the mattress deck with the two hex bolts and locknuts 6 Install the bed rail to the mounting bracket by sliding the mounting pin of the bed rail through the pivot tube NOTE Ensure th...

Page 3: ...ks into place Lowering Pull up on the release lever and push down on the bed rail while rotating towards the foot end of the bed until the bed rail lowers into place FIGURE 3 Using the Epoxy Bed Rails Head End Release Lever Towards the foot end of the bed Bed Rail Socket Screw Mounting Bracket Hex Bolt Locknut Mattress Deck Attach Head End Crossmember Here Bed Rail Mattress Deck Mounting Bracket S...

Page 4: ...g hole in the bed frame Detail B 4 Loosely install the hex nut on the bolt to secure the latch arm to the bed frame Detail B 5 Loosen and remove the hex nut from the bar closest to the latch arm Detail A 6 Carefully push the bolt through the corresponding mounting hole in the bed frame Detail A 7 Loosely install the hex nut on the bolt to secure the bar to the bed frame Detail A 8 Repeat STEPS 5 7...

Page 5: ...xerted on this device Installing the IHRAILTS DLX Positioning Device NOTE For this procedure refer to FIGURE 6 and FIGURE 7 1 When installing the positioning device IHRAILTS DLX on a bed used with an 80 inch mattress the head board mounting brackets and mattress keepers MUST be adjusted Refer to Changing the Head Board Mounting Position and Changing the Mounting Position of the Mattress Keepers on...

Page 6: ...NOTE When using bed rails 6815A 6816A 6803A or IHRAILTS DLX in conjunction with an 80 inch mattress the head board mounting brackets MUST be adjusted 1 Remove the two mounting screws that secure head board mounting bracket to the bed frame See Detail A 2 Secure the head board mounting bracket to the bed frame as shown in Detail B using two mounting screws and locknuts Securely tighten NOTE Ensure ...

Page 7: ...ead end of the mattress deck FIGURE 10 Changing the Mounting Position of the Mattress Keepers Head Board Mounting Bracket Bed Frame Mounting Screws and Locknuts DETAIL A NOTE Mounting position of head board mounting bracket for use with 80 inch mattress without side rails DETAIL B NOTE Mounting position of head board mounting bracket for use with 80 inch mattress using side rails 6815A 6816A 6803A...

Page 8: ...e bed rails are sometimes used as restraints Regulatory agencies health care organizations product manufacturers and advocacy groups encourage hospitals nursing homes and home care providers to assess patients needs and to provide safe care without restraints The Benefits and Risks of Bed Rails Potential benefits of bed rails include Aiding in turning and repositioning within the bed Providing a h...

Page 9: ... adverse event or medical device problem please call FDA s MedWatch Reporting Program at 1 800 FDA 1088 For additional copies of the brochure see the FDA s website at http www fda gov cdrh beds For more information about this brochure contact Beryl Goldman at 610 335 1280 or by e mail at bgoldman kendaloutreach org She has volunteered to answer questions For information regarding a specific hospit...

Page 10: ...ICCI Bed Rails and Accessories 10 Part No 1143214 NOTES ...

Page 11: ...er provide dealer s name address and the date of purchase indicate nature of the defect and if the product is serialized indicate the serial number Do not return products to our factory without our prior consent LIMITATIONS AND EXCLUSIONS THE FOREGOING WARRANTY SHALL NOT APPLY TO SERIAL NUMBERED PRODUCTS IF THE SERIAL NUMBER HAS BEEN REMOVED OR DEFACED PRODUCTS SUBJECTED TO NEGLIGENCE ACCIDENT IMP...

Page 12: ...re Continuing Care Inc A subsidiary of Invacare Corporation Manufacturing Location 2101 E Lake Mary Blvd Sanford Florida USA 32773 All rights reserved Trademarks are identified by the symbols and All trademarks are owned by or licensed to Invacare Corporation or its subsidiaries unless otherwise noted 2009 Invacare Corporation Part No 1143214 Rev E 3 09 ...

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