Stevenson, Todd 

From: 

Sent: 

To: 

Rachel Weintraub < rweintraub@consumerfed.org > 

Thursday, April 25, 2013 9:32 AM 

Stevenson, Todd 

Subject: Adult Bed Rail Petition from CFA, Consumer Voice, Gloria Black and 60 other 

organizations 

Attachments: Bed Rail petion April 25 final.pdf 

Todd, 

Attached please find a petition that Consumer Federation of America, the National Consumer Voice for Quality LongTerm Care (Consumer Voice), bed rail activist Gloria Black, and 60 other organizations are submitting to CPSC to ban 

adult portable bed rails and to take other actions to protect consumers. 

If you need any further information, please do not hesitate to contact me. 

Sincerely, 

-Rachel Weintraub 

Rachel Weintraub 1 Legislative Director and Senior Counsel 

Consumer Federation of America 

1620 Eye Street, NW Suite 200 1 Washington, DC 20006 

T 202/939-1 012 I I M 202/904-4953 

consumerfed.org 1 rweintraub@consumerfed.org 

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C.Jl 
In the United States of America 

Before the U.S. Consumer Product Safety Commission 

In the Matter of the Petition of 

Gloria Black, The National Consumer 

Voice for Quality Long-Term Care 

(Consumer Voice), Consumer 

Federation of America and 60 

Other organizations, To Ban Adult 

Portable Bed Rails, To Issue Mandatory 

Standards for Adult Portable 

Bed Rails, To Require Warning 

Labels and to Recall Potentially 

Hazardous Products 

Pursuant to the Administrative Procedures Act, 5 U.S.C. 

section 553 (e) and regulations of the Consumer Product 

Safety Commission (CPSC), 16 C.F.R. Part 1051 , Gloria Black, 

The National Consumer Voice for Long-Term Care (Consumer 

Voice), Consumer Federation of America and 60 other 

organizations hereby petition CPSC to determine, under 

section 8 of the Consumer Product Safety Act (CPSA), 15 

U.S.C. section 2057, that all currently marketed adult portable 

bed rails pose an unreasonable risk of injury, that no feasible 

consumer product safety standard under the CPSA would 

adequately protect the public from the unreasonable risk of 

injury associated with adult bed rails, that the Commission 

shall, in accordance with section 9 of the CPSA, 15 U.S.C. § 

2058, promulgate a rule declaring all currently marketed adult 

bed rails to be a banned hazardous product, and that a 

mandatory standard, promulgated under section 9 of the CPSA, 

15 U.S.C. §2058, should be issued to adequately address the 

asphyxiation and entrapment hazard caused by the use of adult 

bed rails; that a mandatory standard should also require an 

adequate label to warn of the hazard. The groups further urge 

the CPSC, under section 27(e) of the CPSA, 15 U.S.C. § 

2076(e) to promulgate a rule requiring any manufacturer of an 

adult bed rail to provide performance and technical data related 

to performance and safety of such products to the Commission. 

The Groups also petition CPSC to exercise its authority under 

section 15 of the CPSA, 15 U.S.C. section 2064 to require adult 

bed rail manufacturers to issue a public recall notice and offer a 

refund for all adult portable bed rails. 

1 
I. Interest of Petitioners 

This petition is brought by Gloria Black, as an individual, and by 

Consumer Federation of America, Consumer Voice, and 60 other 

organizations on behalf of their members and their families affected by 

adult portable bed rails. 

Consumer Federation of America is an association of nearly 300 

nonprofit consumer organizations that was established in 1968 to 

advance the consumer interest through research, advocacy, and 

education. 

The National Consumer Voice for Quality Long-Term Care (Consumer 

Voice) is a national non-profit organization that advocates for quality 

care on behalf of long-term care consumers across all care settings. 

The membership of Consumer Voice consists primarily of consumers 

of long-term services and supports, their families, long-term care 

ombudsmen, individual advocates, and citizen advocacy groups. 

Consumer Voice has over 37 years' experience advocating for quality 

care. 

The Georgia Office of the State Long-Term Care Ombudsman seeks to 

improve the quality of life for residents of long-term care facilities 

(nursing homes, intermediate care facilities for the mentally retarded, 

personal care homes, and community living arrangements). The State 

Office certifies and trains community ombudsmen who work to resolve 

concerns of long-term care facility residents statewide and emphasize 

residents' wishes in assisting to resolve problems. 1 

The Resident Councils of Washington (RCW) is a partnership of 

residents living in long term care facilities, family members and friends, 

healthcare professionals and educators who recognize that disability 

and/or chronic illness does not mean inability, but rather to focus on 

the strengths of individuals to live their lives as fully as possible. RCW 

is the only independent consumer-based statewide organization in the 

USA which is governed for and by residents (citizens) living in LTC 

residential settings.

2 

Since 1983, California Advocates for Nursing Home Reform (CANHR), 

a statewide nonprofit 501 (c)(3) advocacy organization, has been 

dedicated to improving the choices, care and quality of life for 

California's long term care consumers. Through direct advocacy, 

community education, legislation and litigation it has been CANHR's 

1 http:/ /www.georgiaombudsman.org/ 2 http:/ /volunteer. truist.com/uwkc/org/10333804619.html 

2 
goal to educate and support long term care consumers and advocates 

regarding the rights and remedies under the law, and to create a united 

voice for long term care reform and humane alternatives to 

institution a I izatio n. 

3 

Ombudsman Services of San Mateo County in California is a non-profit 

organization that investigates complaints and brings resolution to those 

complaints on behalf of residents in long-term care facilities and their 

family members. 4 

The Delaware Office of the State Long-Term Care Ombudsman 

advocates for residents who live in long-term care facilities, and those 

who live in the community and receive home and community-based 

services from providers. The Ombudsman program investigates and 

resolves complaints on behalf of these residents . 

5 

Centralina Area Agency on Aging in North Carolina strives to support 

and enhance the capacity of service and advocacy systems to promote 

independence, preserve dignity and advocate for the rights of older 

and disabled adults and their families. 6 

Senior Care Cooperative in Pennsylvania is a Naturally Occurring 

Retirement Community, which is a community that naturally evolves 

over time to include a relatively large concentration of senior residents. 

The Regional Long-Term Care Ombudsman Program housed within 

the Area Agency on Aging, PSA 3 in Ohio provides a voice for 

consumers of long-term care services in nursing homes, assisted living 

facilities, adult care facilities, adult foster homes, county homes and in 

private residences. Ombudsman staff seeks to identify, verify and 

resolve concerns regarding quality of life and quality of care in the 

above settings. 7 

The Barren River Long-Term Care Ombudsman Program in Kentucky 

accepts complaints from anyone regarding a problem affecting 

someone residing in a long term care facility. The goal of the program 

is to resolve problems on behalf of individual residents and groups of 

residents. 8 

3 http:/ /www.canhr.org/about/index.html 4 http:/ /www.ossmc.org/html/ossmchome.htm 

5 http:/ /dhss.delaware.gov/dhss/main/ltcop.html 6 http://www .centra lin a .org/ centra li na-area-agency-on-aging-home/ about-us/ 7 http:/ /www.aaa3.org/longtermcareombudsmanprogram.aspx 8 http:/ /www.klaid.org/ombudsman/default.aspx 

3 
The Council on Aging-Orange County in California promotes the 

independence, health and dignity of older adults through compassion, 

education and advocacy. It was founded in 1973 by a group of skilled 

professionals, civic leaders, and committed citizens who recognized a 

need to define and address community concerns regarding aging. 

Originally named the Orange County Council on Aging, COA-OC was 

the first agency in Orange County formed to address the needs of 

older adults. 9 

The District 9 Long-Term Care Ombudsman program in Tennessee 

advocates for residents of long-term care facilities, including nursing 

homes, assisted-living facilities, and residential care homes. Through 

regular visits to facilities by staff and specially trained volunteers, the 

program investigates and mediates complaints, monitors residents' 

care and quality of life, and provides public education for clients and 

families. 10 

The San Francisco Long-Term Care Ombudsman Program in 

California works to improve the quality of life and quality of care of 

people living in nursing homes, residential care homes and assisted 

living facilities. The Ombudsman Program receives, responds to and 

investigates complaints made by residents, family members and 

anybody else concerned about the well being of a resident. In addition, 

the Ombudsman Program provides consultation and education to the 

residents and the public regarding resident rights and good care 

practices. 11 

The Alliance for Better Long Term Care in Rhode Island promotes the 

quality of life and care of residents of nursing homes and other longterm care institutions. The Alliance provides information and support to 

family members and residents. In addition, this grassroots agency 

works to support a more caring industry and to educate healthcare 

providers and staff as well as society to be more sensitive and 

compassionate to nursing home residents. The Alliance is the 

designated office of the Rhode Island State Ombudsman for Long 

Term Care. 12 

The Maryland Office of the State Long-Term Care Ombudsman seeks 

to improve the quality of life for residents of long-term care facilities 

(nursing homes, and assisted living). The State Office certifies and 

trains community ombudsmen who work to resolve concerns of long9 http://www .coaoc.org/about-us/ mission-an d-h istory.aspx 10 http://www.mifa.org/ombudsman 11 http://www .sanfranciscoltcombudsman.org/about.html 12 http:/ /alliancebltc.com/ 

4 
term care facility residents statewide. We emphasize residents' wishes 

in assisting to resolve problems. 13 

The Center for Advocacy for the Rights and Interests of the Elderly 

(CARIE) in Pennsylvania is a non-profit organization, based in 

Philadelphia, dedicated to improving the quality of life for vulnerable 

older people. 14 

The Rainbow Connection Community ("RCC") in Virginia is a 501 (c)3 

tax-exempt not-for-profit organization created to meet the needs of 

America's senior citizens with a truly innovative approach to elder 

care. RCC is not a medical model. RCC is a model of 

empowerment. 15 

The Michigan Campaign for Quality Care is a non-partisan, grassroots 

group seeking better care, better quality of life, and better choices for 

Michigan's long term care consumers. The campaign is a non-profit 

organization. 16 

The King George Department of Social Services in Virginia promotes 

and enhances the quality of life for the residents of the County through 

locally administered State/Federal/Local/Private programs designed to 

support the economic and social self-sufficiency of families and to 

safeguard vulnerable children, the disabled and our elderly residents. 17 

The Catherine Hunt Foundation in South Carolina is a non-profit 

transportation company that provides nursing home residents with 

convenient, low or no cost transportation to allow them to maintain 

their ties to their communities. 

The Advocates for Basic Legal Equality's (ABLE) Ombudsman 

Program provides services to more than 9,000 individuals who reside 

in 1,000 nursing homes, located in the program's 10 county service 

area in northwest, Ohio. 

Kansas Advocates for Better Care (KABC) works to promote quality 

long-term care for residents of licensed adult care homes. KABC is a 

501 (c) (3) non-profit organization, funded by members, contributors 

and grants for special purposes. 18 

13 http:/ /www.aging.maryland .gov/Ombudsman .html 14 http:/ /www.carie.org/about/ 15 http:/ /www.ra inbow-cc.org/ 16 http://www.michigancampaignforqualitycare.org/ 17 http://www .king-george. va. us/ county-offices/ department -of -social-services/socialservices.php 

18 http://www.kabc.org/h istory.html 

5 
The Family Council of Ellicott City Health and Rehabilitation Center is 

an independent group of families and friends of nursing home 

residents at the Ellicott City Health & Rehabilitation Center, a largersized nursing home facility in Ellicott City, Maryland. 19 

NICHE (Nurses Improving Care for Healthsystem Elders) in 

Pennsylvania is the leading nurse driven program designed to help 

hospitals improve the care of older adults. The vision of NICHE is for 

all patients 65-and-over to be given sensitive and exemplary care. The 

mission of NICHE is to provide principles and tools to stimulate a 

change in the culture of healthcare facilities to achieve patientcentered care for older adults. 

20 

The Detroit Area Agency on Aging in Michigan has the mission to 

educate, advocate and promote health aging to enable people to make 

choices about home and community-based services and long term 

care that will improve their quality of life. 21 

The Indiana Association o.f Adult Day Services (IAADS) is the leading 

voice of the adult day service (ADS) industry in Indiana, and the state 

focal point for adult day service providers. IAADS is committed to 

providing its members with effective advocacy, educational and 

networking opportunities, technical assistance, research and 

communication services. 22 

The Massachusetts Advocates for Nursing Home Reform ("MANHR") 

is a network of long-term care consumers, their family and friends, and 

citizen advocates. MANHR's mission is to improve the quality of care 

and ensure the dignity and quality of life for Massachusetts long-term 

care residents. 23 

Our Mother's Voice in South Carolina provides information to families 

of nursing home residents to empower and equip them to advocate for 

quality of life and quality of care which goes beyond traditional 

custodial care to encompass the achievement of maximum physical, 

spiritual, social, mental, and emotional health for each resident. 24 

19 

http://www .nu rsinghomesite.com/ELLICOTI _CITY _HEAL TH_%26_REHABILITATION_ CENTER 

_ELLICOTI _CITY _MD 20 http:/ /www.nicheprogram.org/ 21 http:/ /www.daaala.org/DAAA/ 22 http:/ /iaads.net/ 23 http:/ /www.manhr.org/ 24 http://www.ourmothersvoice.org/about.html#mission 

6 
The New York City Ombudsman Program housed within the New York 

Foundation for Senior Citizens enhances the lives of residents of New 

York City's nursing homes, adult homes and assisted living facilities. 

Ombudsmen actively visit the facilities to talk with residents and help 

resolve challenging situations they face. Using non-confrontational 

approaches to problem solving, Ombudsmen monitor and protect 

residents' rights related to their health, safety and general welfare25 

Kentuckians for Nursing Home Reform is a non-profit organization in 

Kentucky dedicated to making a positive difference in the lives of the 

23,000 "Forgotten Kentuckians" in nursing homes by educating the 

public about the critical need to improve the care of residents in 

nursing homes and advocating for laws and regulations that will ensure 

that nursing home residents will be safe and comfortable.

26 

The Areawide Aging Agency in Oklahoma works to improve the lives of 

older adults in the community. They work with partners in the 

community to develop and maintain programs serving the community 

which keep older adults active and independent. 27 

The Ohio Office of the State Long-term Care Ombudsman advocates 

for people receiving home care, assisted living and nursing home care. 

Paid and volunteer staff work to resolve complaints about services, 

help people select a provider and offer information about benefits and 

consumer rights. 28 

The Ombudsman Program housed within the Alamo Area Agency on 

Aging in Texas is an oversight agency for elder rights in long-term care 

certified by the Texas Department of Aging and Disability Services. 

The program uses specially trained and certified individuals 

(ombudsmen) to provide advocacy services to residents of long-term 

care facilities. 29 

The California Office of the State Long-Term Care Ombudsman 

investigates and endeavors to resolve complaints made by, or on 

behalf of, individual residents in long-term care facilities. These 

facilities include nursing homes, residential care facilities for the 

elderly, and assisted living facilities. 30 

25 http://www .nyfsc.org/services/ombuds.html 26 http ://www. kynu rsinghomereform. org/mission .htm I 27 http://www .areawideaging.org/home.html 28 http:/ /aging.oh io.gov/services/ombudsman/ 29 http ://www .aacog.com/index.aspx?nid=65 30 http://www .aging.ca.gov/programs/LTCOP I 

7 
The Terence Cardinal Cooke Health Care Center in New York is a long 

term care facility sponsored by the Roman Catholic Archdiocese of 

New York and conducted in accord with the medical, moral and ethical 

teachings of the Catholic Church as promulgated by the Archbishop of 

New York. 31 

The Long-Term Care Community Coalition in New York works to 

improve care for the elderly and disabled in all settings. It encourages 

and helps people to speak out on their own , and provide a voice for 

those who are too frail to advocate for themselves. 32 

The Nursing Home Victim Coalition in Texas is a non-profit 

organization that helps victims of elder abuse in nursing homes. 33 

The Pennsylvania Office of the State Long-Term Care Ombudsman 

Program oversees ombudsmen in the state, who are federally 

mandated, legally-based and state certified via standardized training to 

actively advocate and give voice to older consumers of long-term care 

services, whether delivered in the community or a facility-based 

setting. 

34 

The New York State Office of Long Term Care Ombudsman protects 

the health, safety, welfare, and rights of people living in New York's 

nursing homes and adult care facilities . Hundreds of certified 

Ombudsmen work in concert with government agencies to fulfill this 

duty. 35 

The New Hampshire Office of the Long Term Care Ombudsman 

receives services, investigates and resolves complaints or problems 

concerning residents of long-term health care facilities. The program 

also provides advocacy services to long-term care facility residents, 

and comments on existing and proposed le~islation , regulations and 

policies affecting long-term care residents. 

3 

Levin & Perconti, located in Chicago, Illinois, is a nationally renowned 

law firm concentrating in all types of serious injury, medical 

malpractice, nursing home, and wrongful death litigation. Our Chicago 

31 http://www .archca re.org/tcc-mission.html 32 http://www .ltccc.org/ 33 Did not have a website. Used what I could find from other website, however, no mission 

was located. 34 

http://www. agi ng.state. pa. us/porta !/server. pt/ community /advocacy _%28ombudsman%29/ 

19389 

3

s http://www.ltcombudsman.ny.gov/ 36 http:/ /www.dhhs.state.nh .us/oltco/index.htm 

8 
personal injury attorneys are committed to protecting and vindicating 

the rights of people who are seriously injured by the negligence of 

others.

37 

Bethany Village Senior Action in Indiana is a senior care community 

that provides a variety of services including rehabilitation, memory 

care, skilled nursing, hospice, and respite care. 38 

The Snohomish County Long Term Care Ombudsman Program in 

Washington promotes the interests, well-being and rights of vulnerable 

adults living in long term care facilities. It is part of the Washington 

State Long Term Care Ombudsman program, a federally mandated 

program created by the Older Americans Act. 39 

The DC Coalition on Long Term Care in Washington, DC was formed 

in 1995 by consumers, advocates and health care providers whose 

goal was to expand the quality choices of District adults with chronic 

care needs.

40 . 

The Legal Assistance Foundation in Illinois works to provide highquality civil legal services to low- income and disadvantaged people 

and communities. Through advocacy, education, collaboration and 

litigation the LAF empowers individuals, protects fundamental rights, 

strengthens communities, creates opportunities and achieves 

justice. 41 _ 

Friends of Residents in Long-Term Care is a nonprofit charitable 

organization in North Carolina committed to advancing the quality of 

life for individuals who receive long-term care services and 

supports. They advocate for changes in public policy, support families 

and help build public awareness in North Carolina about issues 

impacting the long-term care services system. 

42 

Our Mother's Voice in North Carolina provides information to families 

of nursing home residents to empower and equip them to advocate for 

quality of life and quality of care which goes beyond traditional 

37 http://www.levinperconti.com/ 38 http://www .ascseniorcare.com/bethany-village/ 39 

http://www 1. co. snohomish. w a. us/De p a rtme n ts/H u man_ Se rvi ces/Divi si on s/Lo ng Term Ca reA 

ging/Ombudsman/ 

40 http:/ /iona.org/ advocacy I dc-coa I ition -on-long-term-care 41 http:/ /www.lafchicago.org/content/view/1/40/ 42 http://www .forltc.org/cms/ 

9 
custodial care to encompass the achievement of maximum physical, 

spiritual, social, mental, and emotional health for each resident. 43 

Advocacy, Inc. (formerly Ombudsman/Advocate, Inc.) is an 

independent non-profit agency serving Santa Cruz and San Benito 

counties in California, which is comprised of the Long-Term Care 

Ombudsman Program and the Patients' Rights Advocate Program. 44 

The California Long-Term Care Ombudsman Association (CL TCOA) is 

a membership organization dedicated to providing leadership and 

advocacy to the local long-term care ombudsman programs. Since 

1979, CLTCOA has been the voice of local Long-Term Care 

Ombudsman programs in California. It is the mission of CL TCOA to 

improve the quality and availability of Ombudsman services to elders 

and vulnerable adults living in long-term care facilities.

45 

The Montgomery County Long Term Care Ombudsman Program in 

Maryland serves over 7,700 people living in 34 Nursing Homes and 

183 Licensed Assisted Living Facilities in its jurisdiction. The program 

is designated by the Maryland Department on Aging to operate within 

the Department of Health and Human Services, Aging & Disability 

Services. The program supports a cadre of volunteer ombudsman 

representatives which has received national recognition . As advocates 

for long term care residents, the staff and volunteers seek to resolve 

problems, replicate best practices, research current issues and trends, 

and convey relevant information about topics that promote the highest 

degree of quality of life and care.

46 

The Long-Term Care Ombudsman Program housed within the Central 

Ohio Area Agency on Aging is an advocacy program for the rights of 

consumers of long term care. The Long-Term Care Ombudsman works 

on behalf of individuals receiving services or care from in-home 

services, nursing homes, adult care facilities, or residential care such 

as assisted living facilities. 47 

OWL- The Voice of Older and Mid life Women is a national 

membership organization that addresses social, economic and political 

concerns of mid life and older women through advocacy, education and 

empowerment. OWL values older women's independence, self43 http://www.ourmothersvoice.org/about.html#mission 44 http://www .advocacy-i nc.org/about.htm 45 http ://www .cltcoa.org/about.html 46 

http:/ /www6. montgomerycou ntymd.gov /h hstm pl.asp ?u rl =/ content/hhs/ads/Ombudsm an .a 

sp 

47 http:/ /www.coaaa .org/programs-long-term.php#ltc 

10 
determination, security, respect, dignity and diversity, and the social 

contracts to achieve them. 48 

PHI- Quality Care through Quality Jobs is a national organization that 

works to improve the lives of people who need home or residential 

care-by improving the lives of the workers who provide that care. 

PHI's goal is to ensure caring, stable relationships between consumers 

and workers, so that both may live with dignity, respect and 

independence: Quality care through quality jobs.

49 

The National Association of States United for Aging and Disabilities 

(NASUAD) was founded in 1964 under the name National Association 

of State Units on Aging (NASUA). In 2010, the organization changed 

its name to NASUAD in an effort to formally recognize the work that 

the state agencies were undertaking in the field of disability policy and 

advocacy. Today, NASUAD represents the nation's 56 state and 

territorial agencies on aging and disabilities and supports visionary 

state leadership, the advancement of state systems innovation and the 

articulation of national policies that support home and communi~ 

based services for older adults and individuals with disabilities. 5 

The National Association of State Long-Term Care Ombudsman 

Programs was formed in 1985. The non-profit organization is 

composed of state long-term care ombudsmen representing their state 

programs. 51 

The National Senior Citizens Law Center's principal mission is to 

protect the rights of low-income older adults. Through advocacy, 

litigation, and the education and counseling of local advocates, the 

center seeks to ensure the health and economic security of older 

adults with limited income and resources. Since 1972, the National 

Senior Citizens Law Center has worked to promote the independence 

and well-being of low-income elderly and persons with disabilities, 

especially women, people of color, and other disadvantaged 

minorities. 52 

The Service Employees International Union (SEIU) is a national 

organization of 2.1 million members united by the belief in the dignity 

and worth of workers and the services they provide and dedicated to 

48 http:/ /www.owl-national.org/pages/mission 49 http :/ /phi national. org/q u ality-care-th rough-quality-jobs 50 http ://www .nasuad.org/about_nasuad/nasuad.html 51 http:/ /www.nasop.org/about.htm 52 http:/ /www.nsclc.org/index.ph p/about/who-we-are/ 

11 
improving the lives of workers and their families and creating a more 

just and humane society. 53 

The Direct Care Alliance (DCA) is a nationwide and state-based 

alliance of direct care workers, employers and people of all ages and 

disabilities who use long-term services, care and supports. DCA is 

united to build an empowered and valued professional direct care 

workforce essential to ensuring high-quality services and a life of 

dignity, respect, autonomy and opportunity for all to participate in 

community life. 54 

United Spinal Association is a national organization whose mission is 

to improve the quality of life of all people living with a spinal cord injury 

or disease (SCI/D). United Spinal Association believes that despite 

living with a spinal cord injury or disease, a full, productive, and 

rewarding life is within the reach of an~one with the strength to believe 

it and the courage to make it happen. 5 

The Center for Medicare Advocacy, Inc., established in 1986, is a 

national nonprofit, nonpartisan organization that provides education, 

advocacy and legal assistance to help older people and people with 

disabilities obtain fair access to Medicare and necessary health care. 

The Center is headquartered in Connecticut and Washington, DC with 

offices throughout the country. 56 

The National Research Center for Women & Families promotes the 

health and safety of women, children, and families, by using objective, 

research-based information to encourage new, more effective 

programs and policies. The Center achieves its mission by gathering 

and analyzing information and translating that information into clearly 

presented facts and policy implications that are made widely available 

to the public, the media and policy makers. 5

7 

53 http://www.5eiu.org/our-union/ 54 http://www.directcarealliance.org/index.cfm ?pageld=495 

55 http:/ /www.unitedspinal.org/ 56 http:/ /www.medicareadvocacy.org/about/ 

57http://www.womensorganizations.org/index.php?option=com_content&view=article&id= 

223:national-research-center-nrc-for-women-a-families&catid=l3:memberprofiles<emid=69 

12 
II. The Product 

For the purpose of this Petition, portable bed rails shall be considered 

to be those that are sold and marketed directly to the public, and 

intended to be used with a home-style bed. This would include those 

portable bed rails marketed on the Internet, in department stores and 

other retail outlets, and directly by manufacturers. The scope of this 

definition also includes bed rails sold in medical supply stores, since no 

special requirement or prescription is currently needed for the sale or 

purchase there, 58 even though such a shop may advertise that it 

specializes in medical supplies. Portable bed rails sold without 

reference to a particular bed of a manufacturer would be included in 

the scope. The exclusion of other bed rail products from the scope in 

this petition does not mean that such rails are necessarily safe; rather, 

they are being excluded for jurisdictional reasons. The term "bed 

rails," as referenced in this petition, includes, but is not limited to, side 

rails, split rails, half rails, bed handles, full length rails, and bed 

canes. If a manufacturer develops another term to define their 

company's bed rails, such new terminology should not create an 

exemption from oversight and regulation as proposed in this petition. 

Ill. Hazards Presented by Portable Bed Rails 

Portable bed rails currently on the market are responsible for too many 

injuries and deaths among users, particularly the elderly and frail. 

Many of these deaths result from asphyxiation caused by entrapment 

within openings of the rail or between the rail and the mattress or bed 

frame. Individuals attempting to climb over bed rails placed on their 

beds are also victims: research has shown that a fall resulting from an 

individual attempting to climb over a rail- which can have the effect of 

increasing the height from which that person may fall -may be at 

greater risk for injury or death than if no rail were used at all. 

To cite one such example, in 2004, on Christmas morning, a 75 year 

old man was found with his neck entrapped between the mattress or 

bed frame and a bed rail. 5

9 The New York Times blog in which this 

story was identified includes an important common, but flawed 

perception of these devices: 

58 Of major importance for CPSC to note in addressing this Petition is that requirements for 

prescriptions from doctors to purchase bed rails will not address the fundamental problem of fiawed 

designs in bed rails. Many deaths are documented where doctors recommended purchase of a bed rail, 

in the misguided belief the bed rail would make the individual "safer," only to find a person dies instead 

allegedly from use of the bed rail. 

59 The New Old Age blog, written by reporter Paula Span on March 10, 2010, in which she described the 

Christmas morning death. 

13 
Like a lot of people, I supposed that bed rails were a safety 

device, analogous to a seat belt in a car, meant to keep, 

sick, drugged, confused or restless people from falling or 

climbing out of beds in hospitals and nursing homes. 

Dr. Steven Miles of the University of Minnesota found that bed rails 

are not safety devices, after spending years reviewing bed rail death 

and injury incidents of elderly people. In the same New York Times 

blog, he states that, "Rails decrease your risk of falling by 10 to 15 

percent, but they increase the risk of injury by about 20 percent 

because they change the geometry of the fall." 60 The incidents take 

place when "confused or demented patients who try to climb over the 

rails, instead of falling from a lower level and landing on their knees or 

legs, are apt to fall father and strike their heads. But the greater danger 

is entrapment- patients getting stuck within the rails or between the 

rail and the mattress." 

Portable bed rails are purchased as consumer products by wellmeaning family members and then not infrequently are brought into 

various care facilities where their loved ones are living. Even when 

their use in said facilities is in violation of state or federal regulations, 

the facilities, either through ignorance or indifference, allow the 

portable bed rails to remain on their clients' beds. 

In one example of a Department of Health and Human Services 

Departmental Appeals Board Case,

61 (which was denied}, the following 

statements by an administrative law judge reveal the documented 

hazards posed by bed rails: 

No one disputes that side rails can represent an accident 

hazard. (P. 4) 

Facility policies did not reflect the standard of care, which 

mandates that: a) side rails be used only where an 

individualized resident assessment establishes that their 

potential benefit outweighs safety risks; and b) the facility 

takes steps to minimize the risk of entrapment whenever 

side rails are used. (P. 4) 

Side rails present an inherent safety risk, particularly 

when the patient is elderly or disoriented. Even when a 

side rail is not intentionally used as a restraint, patients 

may become trapped between the mattress or bed frame 

and the side rail. (P. 4) 

60The New Old Age blog, written by Paula Span, March 10, 2010. 61 May 30, 2008; Docket No. C-07-222; Decision No. CR1796; Laurelwood Care Center, (CCN: 39-

5812), Petitioner v. Centers for Medicare & Medicaid Services. 

14 
Facilities should begin with the presumption that side 

rails not be used, and should place the burden on the 

side rail proponent to demonstrate that their use is 

appropriate. (P. 5) 

Any time a bed rail is purchased for an adult by a consumer, for private 

use at home or for use while traveling or while in a facility, it is because 

the consumer has a concern which in all likelihood is related to 

cognition or a physical weakness of the adult for whom the rail is being 

purchased. An average consumer is not likely qualified or likely to 

make the necessary evaluation at the time the bed rail is purchased. 

Such evaluations should include assessing the actual needs of the 

intended user of the bed rail, and taking measurements the consumer 

may ultimately be called upon to make by a manufacturer such as the 

size of a mattress used at home. Further, most consumers are 

probably unaware that adult portable bed rails are not required to meet 

mandatory safety standards, that there is no independent verification of 

manufacturer claims made for that product, and that use of bed rails 

has resulted in injuries and deaths. 

IV. Bed Rail Deaths and Injuries: Statistics Available 

A. CPSC Memo to Gloria Black 

In a CPSC memo dated December 7, 2010, in which an answer was 

provided to Gloria Black's question addressed to the CPSC regarding 

a breakdown of the CPSC known statistics on bed rail deaths and 

injuries, the following data were provided: 62 

CPSC staff is aware of 203 incidents between 1985 and 2009 

that involved entrapments, entanglements, or strangulations in 

bed rails. The sources of these incident reports include 

consumers reporting via the Internet or hotline, death 

certificates provided by states, newspaper clippings, medical 

examiner reports, and reports from a probability sample of 

hospitals with emergency departments. 

Of the 203 reported incidents, 155 resulted in fatalities; 18 

resulted in non-fatal injuries; and 30 reports did not mention any 

injury. The number of incidents and fatalities of which CPSC 

staff is aware does not likely represent all incidents that 

occurred in the time period because not all incidents are 

reported and the reports are not projected nationally. It is also 

62 It is acknowledged that responses provided in said letter were prepared by CPSC staff, and do not 

necessarily constitute an official position taken by the CPSC. 

15 
possible that some of these incidents may be, or should be, 

reported directly to the FDA. 

Of the 203 incidents reported to the CPSC, 4 mentioned a 

hospital bed, 13 mentioned a bed in a nursing home, and 37 

mentioned twin/full/queen/king size bed. The remaining 149 

reports did not mention either the bed rail type or the bed. Of the 

203 incidents reported to the CPSC between 1985 and 2009, 

123 incidents involved individuals older than 60 years of age; 40 

incidents involved children younger than 5 years of age; and 31 

involved individuals between the ages of 5 and 60. Victim age 

was not mentioned in 9 of the incidents reported to the CPSC. 

B. CPSC Bed Rail Data 

In the summer of 2012, the CPSC researched the issue of bed rail 

injuries and deaths for adults. The resulting findings were reported in 

the CPSC's October 11, 2012, memo, "Adult Portable Bed RailRelated Deaths, Injuries, and Potential Injuries: January 2003 to 

September 2012." People aged 13 years and older were included in 

the analysis. The number of fatalities CPSC uncovered for that 

approximately nine year period totaled 155. Of the 155 fatalities, 129 

were aged 60 years and over. The CPSC found that 94 of the total 

number of fatalities took place at home, 25 in a nursing home, 15 in an 

assisted living facility, and 3 in hospice. 63 The study further provided 

that: 

• There were 145 incidents related to rail entrapment. This 

category included incidents in which the victim was caught, 

stuck, wedged, or trapped between the mattress/bed and the 

bed rail, between bed rail bars, between a commode and rail, 

between the floor and rail, or between the headboard and rail. 

Based on the narrative, the most frequently injured body parts 

were the neck and head. Most of these incidents (143 out of 

145) resulted in fatalities. 

• There were an estimated 36,900 adult portable bed rail-related 

injuries ... that were treated in U.S. hospital emergency 

departments from January 2003 to December 2011. 

• The data included an age range from 13 to 101 years old. The 

injuries were fairly evenly distributed among age groups. Thirtynine percent were 60 years and over; 34 percent were between 

30 and 60 years old; and 27 percent were younger than 30 

years old. Most of the injuries (92%) were treated and released. 

The following injury characteristics occurred more frequently: 

63 Page 4 of report. 

16 
o *Injured body part- head (14%), lower leg (12%), 

foot (12%) 

o *Injury type- laceration (30%), 

contusions/abrasions (30%), fracture (14%). 

On November 26, 2012, the New York Times ran a front page article 

on bed rails: "After Dozens of Deaths, an Inquiry into Bed Rails."

64 It 

made public for the first time CPSC's findings on the nearly 37,000 

hospital emergency ward visits due to bed rail related injuries that had 

taken place over the nine year period. 

V. Existing Voluntary Standards are Inadequate to 

Address the Risks Caused by Portable Bed Rails 

a. ASTM Standard 

An ASTM standard for bed rails exists but its scope is limited to 

children's bed rails . ASTM F 2085, Standard Consumer Safety 

Specification for Portable Bed Rails defines a "portable bed rail" as a 

device intended to be installed on an adult bed to prevent children from 

falling out of bed. 65 CPSC, as required by the CPSIA, has issued a 

mandatory standard for these products. Given the limited scope of the 

voluntary standard, it is clear that the voluntary standard is failing to 

address the hazards posed by adult portable bed rails. Further, given 

that the hazards posed by adult portable bed rails have persisted and 

are well documented and that ASTM has failed to write a voluntary 

standard that adequately addresses these products, reliance upon 

such a nonexistent voluntary standard would not reduce the product 

risk. 

VI. CPSC Actions Taken to Address Children's Bed Rails 

In 2011 , as a result of the passage of the Consumer Product Safety 

Improvement Act in 2008, which required CPSC to promulgate 

mandatory standards for infant and toddler durable products, including 

bed rails, CPSC proposed a rule on children's portable bed rails. 66 By 

2012, the mandatory standard was finalized, requiring a standard 

addressing the suffocation hazard of bed rails and a labeling 

requirement warning of potential hazards posed by children's portable 

64 NY Times, front page article, "After Dozens of Deaths, Inquiry into Bed Rails," Ron Nixon, Nov. 26, 

2012, http://www.nytimes.com/2012/11/26/health/after-dozens-of-deaths-inquiry-into-bed-rails.html 65 http://www.cpsc.gov/PaqeFiles/1 33466/adultbedrail.pdf at 1. 66 CPSC Docket No. CPSC-2011-0019; Safety Standard for Portable Bed Rails. 

17 
bed rails. Unfortunately, the CPSC has not taken similar actions to 

address adult portable bed rails. 

The CPSC has also recalled children's bed rails due to suffocation and 

strangulation hazards. For example, on December 6, 2012,

67 CPSC 

conducted a recall of Dream On Me Children's Bed Rails. The hazards 

identified in their press release announcing the recall are that "the bed 

rail can separate from the mattress allowing a child's body to become 

entrapped if it slips between the rail and the mattress. This poses 

suffocation and strangulation hazards to children." This is the identical 

hazard posed by portable adult bed rails to adults. The CPSC should 

similarly recall bed rails when the bed rail poses the risk of 

strangulation to adults, especially when reports indicate that there have 

been multiple deaths for the same model bed rail. Regrettably, 

currently such adult bed rails remain on the market- not recalled, 

unlabeled and without warning. 68 

VII. Misleading Advertising of Bed Rails and Hazard 

Warning Labeling 

The fact that misleading advertising has been allowed to flourish, 

allowing consumers to believe that the use of bed rails makes a person 

"safer," when evidence suggests otherwise, and the fact that we have 

a growing, aging population make it all the more urgent that this issue 

be addressed. Appendix A (p. 24) cites research conducted on safety 

of bed rails. Appendix B, which cites excerpts from adverse event 

reports of alleged death events involving bed rail use, is found on page 

27. A description of death by asphyxiation is included there. 

An article published in Biomedical Safety & Standards in November of 

2012, "Safe Portable Bed Rails- There's no Such Thing (Re~uest to 

Stop False Advertising Goes to Federal Trade Commission)," 9 

reported on alleged unsubstantiated advertising of bed rails. The article 

also mentions a letter sent jointly by Public Citizen and the National 

Consumer Voice for Quality Long-Term Care in September 2012 to the 

Federal Trade Commission (FTC)(See Appendix F, p. 35). 70 The two 

consumer organizations argued that a bed rail for which there allegedly 

67 http://www.cpsc.gov/cpscpub/prerel/prhtml13/13060.html 

68 Public Citizen Petition to FDA; FDA-2011-P-0438. Also, "Safe, Portable Bed Rails: There's No Such 

Thing (Request to Stop False Advertising Goes to Federal Trade Commission)," Lisa Marshall, 

Biomedical Safety & Standards, Nov. 15, 2011 . 

ss Safe, Portable Bed Rails: There's No Such Thing (Request to Stop False Advertising Goes to Federal 

Trade Commission)," Lisa Marshall, Biomedical Safety & Standards, Nov. 15, 2011. 

70 A link to the Public Citizen/National Consumer Voice for Quality Long Term Care letter sent to the 

FTC in September 2012 is available here: .http://www.citizen .org/hrg2069, and also appears in 

Appendix F on page 36 of this petition. 

18 

------------------
are multiple reports of death in government files does not, as is 

claimed in its advertising, "make any bed safer," and hence should not 

be allowed to continue to make such claims. The FTC's response to 

date has been a form letter acknowledging receipt of the letter by the 

groups. 

1. Unsubstantiated and False Advertising of Adult Portable 

Bed Rails 

Numerous claims made in the marketing of portable bed rails are 

easily found through an Internet search. Many of the promises made 

include increased safety, and use words to promote the sense that to 

buy a bed rail for a loved one is to show that you care for their safety. 

Examples of this advertising are found in Appendix C, page 30, of this 

petition. 

It is important to contrast the advertising of bed rails to what is found in 

some of the text written in the CMS (Centers for Medicare and 

Medicaid Services) State Operations Manual Appendix PP- Guidance 

to Surveyors for Long Term Care Facilities. Excerpts from that 

document appear in Appendix 0, page 32, of this petition. That 

information underscores a dual standard in bed rail oversight within our 

government agencies. When an individual purchases a portable bed 

rail as a consumer product, he may then bring it into a care facility and 

request it be used by that facility for a loved one. While federal and 

some state regulations attempt to regulate bed rail use in facilities, 

those regulations are too frequently not enforced, and caregivers are 

themselves frequently unaware of the dangers of bed rail use. Hence, 

if there is a death or injury involved and the rail was used in a facility 

which receives federal funding, the portable bed rail, most likely initially 

purchased as a consumer product, may be treated as if it were a 

medical device, and, the facility that allowed the bed rail use now 

stands to be fined by the federal government. 

2. Hazard Warning Labeling for Adult Bed Rails 

Information in advertisements is misleading consumers into thinking 

that bed rails increase safety, and at the same time, useful information 

on bed rails warning of documented hazards fails to be visible on bed 

rails. (See Appendix A, page 24, and Appendix C, page 30.) At a 

minimum, consumers should have been warned of potential 

entrapment, strangulation and asphyxiation risks especially for 

particular populations such as those who may experience confusion. 

While redesigning the product to eliminate the hazard is the most 

effective solution, warning labels should be required to be permanently 

affixed to the packaging as well as the product, visible to caregivers 

19 
and those using the bed, and should be readable for the life of the 

product. 

Warnings alone are not the solution to the problem. Without 

mandatory safety standards that effectively reduce the hazards, 

warnings are a band-aid approach. William Hyman, Professor 

Emeritus of the Bio-Medical Engineering Department at the Texas A & 

M University, author of 'Bed Rail Entrapments- Still a Serious 

Problem, McKnights, July 24, 2008, stated that 

"Warnings are not an appropriate way to 'fix' dangerous designs, 

unless perhaps the warning says 'Do Not Use This Product.' 

Furthermore, effective warnings must not only identify a hazard but 

instruct on how to avoid it, and in a way that users will be able to 

understand and implement. The proper use of warnings is for 

residual risk, i.e., risk that cannot be reasonably eliminated by 

design, or replacement. Since most entrapment hazards can be 

eliminated by design (or by not using bed rails at all), there is no 

acceptable residual risk." 

VI. Action Requested 

For the reasons enumerated above, the Petitioners request that 

the Consumer Product Safety Commission, pursuant to the 

Administrative Procedures Act, 5 U.S.C. section 553 (e) and 

regulations of the Consumer Product Safety Commission 

(CPSC), 16 C.F.R. Part 1051, determine under section 8 of the 

Consumer Product Safety Act (CPSA), 15 U.S.C. section 2057, 

that all currently marketed adult portable bed rails pose an 

unreasonable risk of injury, that no feasible consumer product 

safety standard under the CPSA would adequately protect the 

public from the unreasonable risk of injury associated with adult 

bed rails , that the Commission shall, in accordance with section 

9 of the CPSA, 15 U.S.C. § 2058, promulgate a rule declaring 

all currently marketed adult bed rails to be a banned hazardous 

product, and that a mandatory standard, promulgated under 

section 9 of the CPSA, 15 U.S.C. §2058, should be issued to 

adequately address the asphyxiation and entrapment hazard 

caused by the use of adult bed rails; that a mandatory standard 

should also require an adequate label to warn of the hazard. 

The Petitioners further urge the CPSC, under section 27(e) of 

the CPSA, 15 U.S.C. § 2076(e) to promulgate a rule requiring 

any manufacturer of an adult bed rail to provide performance 

and technical data related to performance and safety of such 

products to the Commission. The Petitioners also petition 

20 
CPSC to exercise its authority under section 15 of the CPSA, 

15 U.S.C. section 2064 to require adult bed rail manufacturers 

to issue a public recall notice and offer a refund for all adult 

portable bed ra ils. 

Specifically, the Petitioners request that CPSC initiate a rulemaking for 

a rule that states: 

Under the authority of section 8 of the Consumer Product Safety 

Act the Commission has determined that adult portable bed rails 

present an unreasonable risk of injury and no feasible consumer 

product safety standard under this chapter would adequately 

protect the public from the unreasonable risk of injury 

associated with these products. Therefore such products are 

banned hazardous products under section 8 of the Act. 

If the CPSC determines, in spite of the evidence provided, not to 

pursue a ban, the petitioners request that CPSC initiate a rulemaking 

to promulgate mandatory standards under section 9 of the CPSA, as 

such mandatory standards for adult portable bed rails would be 

necessary to reduce the unreasonable risk of asphyxiation and 

entrapment hazard posed by these bed rails. 

Further, we request that under the authority of section 15 of the 

Consumer Product Safety Act, the Commission require manufacturers 

to issue a public recall notice and offer a refund for portable adult bed 

rails, as these products pose a substantial product hazard to 

consumers in that they contain product defects that create a 

substantial risk of asphyxiation and entrapment hazard to the public. 

This Petition requests that, the U.S. Consumer Product Safety 

Commission: 

1. Ban the sale of adult portable bed rails that are sold directly to 

the public and that are intended to be used with a range of 

typical home style beds, which would include those beds that, 

for example, might be found in nursing care and assisted living 

facilities, as well as beds found in homes. 

2. Exercise recall authority and require notices and refunds to 

consumers for portable bed rails presently on the market that 

present risk of entrapment, asphyxiation , or other failure that 

can lead to injury. 

21 
APPENDIX E 

Gathering of Signatures on a Petition Created by The National Consumer Voice for 

Quality Long-Term Care to be submitted to the CPSC and FDA jointly. 

In December 2012, The National Consumer Voice for Quality Long-Term Care 

(referred to here as Consumer Voice) began seeking signatures on a national petition 

http://wfc2. wiredforchange. com/o/8641 /p/dia/action/public/?action KEY=8970 which 

they presently are planning to send to both the FDA and the CPSC, asking the two 

agencies to: 

Please protect vulnerable elderly consumers by establishing minimum safety 

standards for all adult bed rails and prohibiting the use of dangerous bed rails 

currently in use. 

Consumer Voice goes on to say, "The statistics are appalling." 

While the delivery of the signatures for the Consumer Voice document has not yet 

taken place, the following details emerge from an analysis of the current signatories: 

of the more than 500 signatories who have signed the petition and submitted 

comments to date (April 23, 2013), roughly an astounding 77 come forward and 

acknowledge that they have first-hand knowledge of injuries or deaths-and in 

several instances multiple deaths-among people using bed rails. Many of those 

approximately 77 signatories are health care providers who work with the elderly, 

some are family members whose loved one died in a bed rail, some are witnesses to 

the results, and one was a clergy person. Every geographic part of the United States 

is represented among those signing the petition. One person signing anonymously 

writes, "I don't understand why anyone would not care about this issue." Given that it 

is a fact that, on average, with each passing month a minimum of one to two people 

die in a bed rail-related incident, it does seem to beg the question: why do we seem 

to not care about this issue? Is it because most of the victims are elderly? Let us be 

reminded, there are children being documented as dying in these adult bed rails as 

well. 

Additional comments on the petition include the following: 

"This is a scandalous practice of restraining the elderly that might kill them. 

Every single individual deserves the opportunity to be safe." 

"As an Ombudsman and RN, there must be safer ways to protect older adults 

than with the use of bed rails. It is clear that this has been an on-going issue 

for many years." 

"Our senior citizens deserve the same focus and protections as our youngest 

citizens." 

With the inclusion of reference to the Consumer Voice gathering of signatures, no 

assumption is made that signatories on that particular document would support or not 

support this present Petition made to CPSC. The document is included in this 

Appendix E only because of the relevance to the issue of bed rails and safety. 

34 
APPENDIX F 

Joint Letter from Public Citizen and Consumer Voice to the Federal Trade 

Commission 

September 6, 2012 

Jon Leibowitz, Chairman 

J. Thomas Rosch, Edith Ramirez, Julie Brill, and Maureen Ohlhausen 

Commissioners 

Federal Trade Commission 

600 Pennsylvania A venue NW 

Washington, DC 20580 

Dear Commissioners, 

Public Citizen, a consumer advocacy group representing more than 300,000 

members and supporters nationwide, and the National Consumer Voice for 

Quality Long-Term Care hereby request that the Federal Trade Commission 

(FTC), pursuant to the Federal Trade Commission Act, 15 U.S.C. §§ 45 and 

52-55, order Bed Handles, Inc., to stop its deceptive advertising of Bedside 

Assistant bed handles. In particular, the website for Bed Handles promotes 

Bedside Assistant bed handles as "[making] any bed a safer bed,"i whereas 

this consumer product, in fact, poses an unreasonable risk of injury and has 

resulted in the deaths of at least four adults. 

I. BACKGROUND 

A. Manufacturer of Bedside Assistant bed handles 

Bedside Assistant bed handles are manufactured by Bed Handles, Inc., located 

at 2905 S W 19th Street, Blue Springs, MO 64015. 11 

B. Advertisement for the Bedside Assistant bed handles 

Bedside Assistant bed handles are devices intended to assist patients in getting 

in and out of bed, sitting up in bed, and rolling over in bed. They are used by 

patients in private homes, assisted living facilities, and nursing homes. 

Bedside Assistant bed handles typically are sold by home-health-care medical 

supply stores, which do not require a doctor's prescription. 

The manufacturer's we.bsite provides the following description of the Bedside 

Assistant bed handles: 111 

35 
Makes any bed a safer bed [emphasis in original] ... Especially for 

anyone who is mobility impaired and simply needs something to hold 

on to as they get in and out of bed. 

Designed by an engineer for his wife who had [multiple sclerosis], the 

Bedside Assistant has been used by many that need a little extra help 

to be more independent. 

The Bedside Assistant is stable in all directions and can be firmly 

pulled, pushed, lifted and leaned on. 

The Bedside Assistant is easy to install on any bed you use: at home, 

visiting friends and family, even at hotels. 

Continue to use an existing bed with the added help of a stable pair of 

handles to hold while standing, sitting, rising and rolling over. 

The device is installed by sliding the long horizontal bar of the bed handle 

between the mattress and box spring of a bed and securing it with a strap. 'v 

C. Public Citizen's petition to the Food and Drug Administration (FDA) 

On May 4, 2011 , Public Citizen petitioned the FDA, pursuant to the Medical 

Device Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 

§§ 360fand 360h, and 21 C.F.R. §§ 10.30, 810, and 895, to immediately: 

(1) ban the marketing of Bedside Assistant bed handles, model 

numbers BA 1 OW and BA 1 OW -6, manufactured by Bed Handles, Inc., 

because these devices have directly caused the deaths of at least four 

adult patients through entrapment and subsequent strangulation or 

positional asphyxia and therefore present "an unreasonable and 

substantial risk of illness or injury" ... 

(2) order Bed Handles, Inc. to recall all Bedside Assistant bed handles, 

model number BA 1 OW and BA 1 OW -6, that have been sold or 

distributed; and 

(3) investigate thoroughly the association between (a) the design and 

use of all similar bed handle or bed rail devices manufactured by Bed 

Handles, Inc. or any other manufacturer and (b) the risk of lifethreatening injury or death due to entrapment and subsequent 

strangulation or positional asphyxia, and as appropriate, based on the 

result of this investigation, take action to ban the marketing of, and to 

recall, those devices that pose similar risks of death and injury as seen 

with Bedside Assistant bed handles. 

Public Citizen has not received a decision from the FDA on its petition 

(enclosed). 

36 
II. EVIDENCE THAT BEDSIDE ASSISTANT BED HANDLES POSE 

LIFE-THREATENING RISKS 

Contrary to the manufacturer's claim that its bed handles improve the safety 

of any bed, data provided to the FDA demonstrate that these devices can turn 

a bed into a death trap for individuals who are physically weak and have 

physical or mental impairments- the type of individuals for whom this 

device is intended. Our review of the FDA's Manufacturer and User Facility 

Device Experience (MAUDE) database reveals that since 1999, the FDA has 

received reports of four deaths secondary to entrapment by Bedside Assistant 

bed handles.v,vi,vii,viii In three of these cases, the description clearly is 

consistent with death being caused by asphyxiation or strangulation. A fifth 

report describes another life-threatening incident in which this device 

entrapped a hospital patient. ix 

The deaths and injuries caused by Bedside Assistant bed handles that have 

been reported to the FDA's MAUDE database likely represent a minority of 

actual cases. Major reasons for such underreporting include the following: 

• Many - perhaps most - healthcare providers and consumers are 

unaware that Bedside Assistant bed handles are classified as medical 

devices and, as a result, would not even think about reporting adverse 

events related to these devices to the FDA. 

• These devices are commonly used in the home setting without any 

involvement of a health care provider, and family members of people 

injured or killed by these devices likely are not aware of the 

procedures for reporting adverse events to the FDA. 

The mechanism by which the Bedside Assistant bed handles and similar 

devices can cause death is straightforward and well-known. x Given their 

design and installation, the bed handles can slip out of place, creating a gap 

between the edge of the mattress and the vertical bars. A person in the bed can 

then slip into this gap, becoming entrapped. Even a small gap, particularly 

resulting from use of these devices with soft or worn mattresses, can lead to 

entrapment. Death may ensue either through compression of the trachea 

against the horizontal support bars and subsequent strangulation, or through 

positional asphyxia. xi Enclosed with Public Citizen's petition to the FDA are 

pictures in which a caregiver, who found the body of a deceased person 

entrapped by a Bedside Assistant bed handle, demonstrates the position of the 

patient at the time of death (the death of this patient was reported to the 

FDAxii). 

The manufacturer's inclusion of a security strap with the Bedside Assistant 

bed handles does not sufficiently mitigate the risk of entrapment and death. 

Many people may not use the strap or may fail to install the strap properly. 

37 
Even with proper installation of the strap in accordance with the 

manufacturer's directions, entrapment and subsequent asphyxiation or 

strangulation still may occur, depending on a variety of factors, including the 

condition of the mattress and the size of the person using this product. 

III. CONCLUSION 

In conclusion, given the risk of serious injury and death by entrapment and 

subsequent strangulation or positional asphyxia that may occur when using 

Bedside Assistant bed handles, the manufacturer's advertising of this 

consumer product as making any bed a safer bed is deceptive. Therefore, the 

FTC should sanction Bed Handles, Inc., for deceptive advertising and require 

the company to pull its advertisement immediately and publish corrective 

advertising that discloses the risk of entrapment and death. 

Thank you for your prompt attention to this important consumer protection 

issue. 

Sincerely, 

Michael A. Carome, M.D. 

Deputy Director 

Public Citizen's Health Research Group 

Sidney M. Wolfe, M.D. 

Director 

Public Citizen's Health Research Group 

Sarah F. Wells 

Executive Director 

National Consumer Voice for Quality Long-Term Care 

Robyn Grant 

Director of Public Policy and Advocacy 

National Consumer Voice for Quality Long-Term Care 

cc: David Vladeck, Director, Bureau of Consumer Protection, FTC 

Enclosure: Public Citizen's May 4, 2011, petition to the FDA to ban Bedside 

Assistant bed handles 

; Bed Handles, Inc., website. Available at http://www.bedhandles.com/page4.htm#page4.htm. 

Accessed August 22, 20 12. 

;; Bed Handles, Inc., website. Available at http://www.bedhandles.com/. Accessed August 22, 

2012. 

38 
iii Bed Handles, Inc., website. Available at 

http ://www.bedhandles.com/page4.htm#page4.htm. Accessed August 22, 2012. 

'v Bed Handles, Inc., website. Available at 

http ://bedhandles.com/SecurityStraplnstallationPictorial.pdf. Accessed August 22, 2012. 

v Food and Drug Administration. Manufacturer and User Facility Device Experience 

database: report of patient death on March 27, 1999, associated with Bedside Assistant bed 

handles. Available at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI ID=2 

18072. Accessed August 22. 

vi Food and Drug Administration. Manufacturer and User Facility Device Experience 

database: report of patient death on February 4, 2002, associated with Bedside Assistant bed 

handles. Available at 

http://www .accessdata. fda.gov/scripts/cdrh/cfdocs/cfMA UDE/Detai l.C FM?MD RFO I fD= I 

366564. Accessed August 22 . 

vii Food and Drug Administration. Manufacturer and User Facility Device Experience 

database : report of patient death on January 10, 2004, associated with Bedside Assistant bed 

handles. Available at 

http://www.accessdata.fda .gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI 10=50 

7241 . Accessed August 22. 

vi ii Food and Drug Administration. Manufacturer and User Facility Device Experience 

database: report of patient death on March 9, 2007 associated with Bedside Assistant® bed 

handles. Available at 

http://www .accessdata. fda. gov/scripts/cdrh/cfdocs/cfMA UDE/Detai l.CFM?MDRFOI I D= I 

366563. Accessed August 22,2012. 

ix Food and Drug Administration. Manufacturer and User Facility Device Experience 

database: report of an entrapment incident in 2006 associated with Bedside Assistant bed 

handles. Available at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI ID=8 

36669. Accessed August 22,2012. 

' Food and Drug Administration. Guidance for industry and FDA staff: hospital bed system 

dimensional and assessment guidance to reduce entrapment. March 10, 2006. Available at 

http://www. fda. gov I download s/Med icalDevi ces/Devi ceRegu lationan d G uidance/G uidanceDoc 

uments/ucm072729.pdf. Accessed August 22,2012. Available at 

xi Hyman W A. Bed-rail entrapments still a serious problem. McKnight's Long-Term Care 

News and Assisted Living. July 24, 2008 . http://www.mcknights.com/bed-rail-entrapmentssti 11-a-serious-problem/article/ 112809/. Accessed August 22, 2012. 

" i Food and Drug Administration. Manufacturer and User Facility Device Experience 

database: report of patient death on March 9, 2007, associated with Bedside Assistant bed 

handles. Available at 

http://www .accessdata. fda. gov/scripts/cdrh/cfdocs/cfMA UD E/Detail.CFM?MDRFOI ID= I 

366563. Accessed August 22,2012. 

39 
BIBLIOGRAPHY 

"After Dozens of Deaths, Inquiry Into Bed Rails," Ron Nixon, New York Times, 

November 26, 2012, p. 1. 

"Autopsy Findings in Asphyxia in Medical Bed Rails," Steven H. Miles, MD, American 

Journal of Forensic Medicine and Pathology, Vol. 30, No. 3, Sept. 2009. 

"Bed-rail entrapments still a serious problem," W.A. Hyman, (2008) McKnight's, 

http://www.mcknights.com/bed-rail-entrapments-still-a-seriousproblem/article/112809/ 

"Consumer Agency Finds Most Adult Bed rail Deaths Are Among Those 60 and 

Older," Ron Nixon, The New York Times, November 30, 2012, p. 17. 

"Dangerous Bed Rails Live On," W.A. Hyman, Patient Safety & Quality Health Care, 

April, 2010, 

http :1 lwww. psgh. com/online-articles/461-dangerous-bed-rails-live-on. htm I 

"Deaths caused by bedrails." Parker, K., Miles SH., JAm Geriatr Soc. 1997; 45; 797-

802. 

"Do split-side rails present an increased risk to patient safety?" S. Hignett and P. 

Griffiths, Qual Saf Health Care, 2005, Apr. 14(2): 113-6. 

FDA MAUDE Database, search using the words 'bed rail death.' 

http://www. accessdata. fda. gov/scripts/cd rh/cfdocs/cfmaude/sea rch. cfm 

FDA, Hospital Bed Safety Workgroup, Hospital Bed System Dimensional and 

Assessment Guidance to Reduce Entrapment- Guidance for Industry and FDA Staff, 

dated March 10, 2006. http://www.fda.gov/cdrh/beds/guidance/1537.html. 

FDA Safety Alert, Entrapment Hazards with Hospital Bed Side Rails, dated August 

23, 1995. http//www.fda.gov/cdrh/bedrails.html. 

Felcher, E. Marla, "Understanding Government Report: The U.S. Consumer Product 

Safety Commission, The Paper Tiger of American Product Safety," 31 pp 

. http:/ /understandi nggov. org/reports/felcher. html. 

"Held Back, Unfinished Consumer Product Safety Commission Rules, Class of 2007," 

Public Citizen, March 2008, 'Bed Rail Strangulation,' pp.1 0-11 . 

"Home Medical Equipment Rentals and Instructions for Use," W. Hyman, Patient 

Safety & Quality Healthcare, 12- 13, May/June, 2009. 

http :1 lwww. psg h. com/mayju ne-2009/134-h uman-factors-home-med ical-eg uipmentrentals-

"Hospital Alarms Fail to Prevent Injury," Paula Span, The New York Times, The New 

Old Age blog, December 14, 2012, http://nvti.ms/TRWSAQ 

"The Myth of Benign Bed Rails: A Consumer Protection Issue, NCCNHR Policy 

Paper," Omoniyi Adekanmbi, April 2010. 

40 
"Myths and Facts about Side Rails", Karen A. Talerico, PhD, RN, CS, and Elizabeth 

Capezuti, PhD, RN, FAAN, (2001 ), American Journal of Nursing, 101 (7), 43-48. 

'Nursing home prosecutions rare - no single agency has role of bringing abuse, 

neglect cases to court,' Beth Musgrave and Valarie Honeycutt Spears, posted July 

11, 2010, Lexington, KY, Herald-Leader. 

"Portable Bed Rails Aren't Safe, Research Shows: FTC Asked to Ban False 

Advertising,'' Science News Daily, November 19, 2012, 

http://www.sciencedaily.com/releases/2012/11/121119132104.htm. 

"Portable Youth Bed Rail Entrapments and Hangings," dated June 7, 2000. U.S. 

Consumer Product Safety Commission, Memo, CPSC Data Files 1/1/90 to 3/14/00. 

Public Citizen, Docket FDA-2011-P-0438; Petition to the FDA. 

"A Reminder from Canada on Bed Side Rail Entrapments," W. Hyman, Biomedical 

Safety & Standards, 39(21), 161-163, 2009. 

"Safe in Bed?" Paula Span, The New York Times, March 10, 2010. 

http :1/newoldage. blogs. nvtimes. com/20 1 0/03/1 0/safe-in-bed/ 

"Safe Portable Bed Rails- There's No Such Thing," Lisa Marshall, Biomedical Safety 

& Standards, Feature article, November 15, 2012. 

U.S. Consumer Product Safety Commission, Memo, Dated October 11 , 2012, "Adult 

Portable Bed Rail-Related Deaths, Injuries, and Potential Injuries, January 2003 to 

September 2012." 

"When Bed Rails Kill Confused Patients, Facilities Do Not Tell the Family!" David 

Zeman and Patricia Montemurri, Hospice Patients Alliance, 

http://www. hospicepatients. org/bedraildangers. htm I. 

41 
If CPSC will not ban adult portable bed rails , we request that the 

Commission proceed with the following: 

3. Promulgate a mandatory safety standard that establishes 

requirements for the design of adult portable bed rails. Such 

mandatory standards must include, at a minimum: 

a. Design standards that substantially reduce the entrapment, 

strangulation and asphyxiation hazard posed by portable bed 

rails. 

b. Set requirements for the verification by an independent third 

party that new, mandatory safety standards have been met by 

the manufacturer in question prior to allowing said product to 

be introduced to the market. 

c. Set requirements for warning labels alerting users to the risk of 

asphyxiation and entrapment in large print. Such warnings 

must remain visible to all users and caregivers for the life of 

the product. 

d. Set requirements for permanently affixed manufacturer and 

model number on the product. Information affixed permanently 

to the bed rail stating that such product complies with the new, 

mandatory guidelines that CPSC would establish . 

4. Take all necessary action, including coordinating with the 

Federal Trade Commission (FTC) to prohibit advertising that 

states or implies that the use of bed rails increases safety. 

Dated: April 25, 2013 

22 

Respectfully submitted, 

Rachel M. Weintraub 

Attorney for Petitioners 

Consumer Federation of America 

1620 Eye St., NW 

Suite 200 

Washington, DC 20006 

(202) 387-6121 

direct dial: (202) 939-1012 
Appendices 

The following pages contain: 

Appendix A: Research on Bed Rail Safety. Excerpts from two 

different sources which discuss research on safety and bed rail use. 

P. 24. 

Appendix B: Excerpts from adverse event reports describing alleged 

death events involving bed rails. Followed by a description of 

asphyxia. P. 27 

Appendix C: Samples of Adult Portable Bed Rail Advertising Found on 

the Internet P. 30 

Appendix 0: Excerpts from Centers for Medicare and Medicaid 

Services (CMS) on restraints and bed rail use. P. 32 

Appendix E: Consumer Voice Petition and Gathering of Signatures to 

CPSC and FDA. P. 34 

Appendix F: Consumer Voice and Public Citizen letter to the Federal 

Trade Commission about misleading advertising. P. 35 

Bibliography P. 40 

23 
APPENDIX A: 

Following are excerpts from two different sources which discuss research on safety 

and bed rail use. 

1. The Myth of Benign Bed Rails: A Consumer Protection Issue; NCCNHR (now 

renamed National Consumer Voice for Quality Long-Term Care) Policy Paper, 

Omoniyi Adekanmbi, April 2010 . 

... One evaluation of patients on a rehabilitation ward found that all 

patients with dementia, Parkinson's, bone or rheumatologic 

abnormalities, and epilepsy were restrained. However, there was no 

relationship between actual history of falling and application of 

restraints (Gallinagh et al., 2002). It appears that the use of restraints 

is based more on the staff's belief that they are necessary to protect 

individuals who might fall, based on criteria such as age, 

functionality, and cognition, than to prevent future falls in those who 

have already fallen . .. . 

A large body of research has focused on the effectiveness of bed 

rails as a method of fall prevention as they are the most commonly 

used and there is a prevailing belief that rails are benign and 

effectual. This research has found that use of restraints did not lower 

fall rates, recurrent fall rates, or injurious fall risk among residents , 

even residents with impaired cognitive function . Si, Neufeld, & 

Dunbar (1999) found there were no serious injuries associated with 

removal of the bed rails and for most residents raised bed rails did 

not enhance safety. Furthermore, reducing the use of restraints may 

actually significantly decrease the incidence of minor injuries due to 

falls from bed and the incidence of falls among residents. Many 

studies have actually suggested that the fall rate among restrained 

residents is equivalent to or in fact greater than the fall rate among 

unrestrained residents (Capezuti, 2004; Capezuti, Evans, Strumpf, & 

Maislin, 1996; Capezuti, Maislin, Strumpf, & Evans, 2002; Capezuti, 

Strumpf, Evans, Grisso, & Maislin, 1998; Capezuti, Wagner, Brush, 

Boltz, Renz, & Talerico, 2007). One investigation of fall rates in 

nursing homes across six states found that a resident's likelihood of 

sustaining a serious injury decreased significantly after restraints 

were removed (Neufeld, Libow, Foley, Dunbar, Cohen , & Breuer, 

1999). (P. 2) 

In addition, rather than mitigating injury, bed rails heighten the risk 

and dangers associated with a fall. The purpose of the bed rail is to 

signal to residents to get assistance when they want to leave the 

bed. However, cognitively impaired residents, who are among the 

most frequently restrained, view the rail as a hindrance to try to 

squeeze through or climb over or around (Capezuti et al., 

2007). Raised bed rails aggravate the risk of injury from the fall 

because they add up to an additional two feet to the fall height 

24 
(Capezuti, 2004}, van Leeuwen, Bennett, & West (2001) found that 

of 92 falls with bed rail position recorded over a seven year span at 

an acute care hospital, 60 residents fell while bedrails were raised. 

Over half of these residents had been climbing over the rail when 

they fell; four had climbed through them, three squeezed between 

end of bedrails and bed end and two patients jumped over rails. 

Residents who fell when rails were raised were more likely to be 

non-rational at the time than those who fell when rails were lowered. 

Residents are also more likely to strike their heads if (they) fall while 

trying to climb over the rails. While bed rails may decrease the risk of 

a fall by 10-15% they actually increase the risk of injury from a bed 

fall by 20% (Span, 2010). In addition to the risk of aggravated injury 

from a fall, residents are at risk of entrapment in bed rails resulting in 

serious injury or death by asphyxiation. Entrapment occurs when 

patients slip through the side rail bars and the space between the 

rails, between the rails and the mattress or between the head or 

footboard, side rail, and mattress (Capezuti, 2004, see Figure 1 ). 

The head or neck is the most frequently trapped body part 

(Todd,Ruhl & Gross, 1997). Asphyxiation occurs when the resident is 

caught between mattress and bed rail, between the headboard and 

rail, head stuck in rail, or strangulated by vest restraint between the 

rails (JC, 2002). A person will roll into the slot next to the rail, the 

mattress slides to the other side, doubling the side of the gap, and 

the patient drops into the gap - mattress presses against his chest 

and he suffocates (Span, 2010). Miles (2002) suggests that air 

mattresses pose a particular danger to residents. From 1994 and 

2000, 35 deaths due to entrapment between bedrails and air 

mattresses were reported to the FDA. (P. 2) 

2. Myths and Facts about Side Rails, by Karen A. Talerico and Elizabeth Capezuti, 

AJN, July 2001, Vol. 101, Issue 7, 43-48. 

Myth: Side rails serve as a safe and effective means of preventing 

patients from falling out of bed. Facts: No research study has 

demonstrated the efficacy of side rails in the prevention of injuries 

resulting from falling out of bed. In fact, several studies have shown 

that raised side rails do not deter older patients from getting out of 

bed unassisted, and may even lead to more serious falls and 

injuries(8-1 0). Si and colleagues studied the effects of a program to 

reduce side rail use among older residents (mean age, 83 years) on 

a short-term rehabilitation unit. (1 0) They found there were 15 falls in 

the control group and 15 falls in the study group of residents (N=246) 

and that serious injuries rarely occurred. Similarly, Hanger and 

colleagues, studying the effects of a significant reduction in side rail 

use on an Australian rehabilitation unit, found that there was no 

significant change in rates of falling; they also found that significantly 

fewer serious injuries occurred.(9) (P. 44) 

25 
(8) Capezuti, E., eta/. The effects of a low-height bed intervention on 

nightfalls among frail nursing home residents (abstract); 

Gerontologist 1999, 39, Special issue 1): 196. 

(9) Hanger, HC, eta/. An analysis of falls in the hospital; can we do 

without bedrails? JAm Geriatr Soc 1999;(5) 47; 529-31. 

(10) Si, M, eta/. Removal of bedrails on a short-term nursing home 

rehabilitation unit. Gerontologist 1999;39(5);611-4. 

26 
APPENDIX B 

MAUDEADVERSEEVENTREPORTS 

(Followed by a Description of Asphyxia) 

The following report is excerpted from the FDA MAUDE database, found at 

http://www. accessdata. fda. gov/scripts/cd rh/cfdocs/cfmaude/Detail. C FM ?MDRFO 1_1 

D=2281458. Filing of reports with the FDA or CPSC is not of itself conclusive proof 

of a given event or of guilt. The sample provided here is done so strictly for 

academic purposes. It is to provide the CPSC with just one example of an alleged 

situation for which, had the consumer had prior knowledge of the risks of portable 

bed rail use, she may have been able to avoid the tragedy she describes surrounding 

her mother's death. 

There are numerous other examples to be found; this particular entry is unique in that 

most family members of loved ones who have allegedly been killed through bed rail 

use do not know that they should report these incidents, either to the FDA or to the 

CPSC. Nor do they know that it is worthwhile to look at websites such as the CPSC 

saferproducts.gov site or the FDA Maude database prior to making their portable bed 

rail purchase. Because the product is on the market, the assumption is, it is 'safe' to 

use. Indeed, bed rails are manufactured as 'safety' products. In the case of reports 

made to the FDA, most descriptions of death events lack reference to the role of the 

portable bed rail consumer, the one who initially makes the fatal purchase. 

DRIVE MEDICAL DESIGN AND MANUFACTURING DRIVE 

BED ASSIST RAIL 

Model Number 15064 

Event Date 02/05/2011 

Event Type Death Patient Outcome Death 

Event Description 

Back to Search 

Results 

About 2 years ago, i bought a "drive" bedrail (model15064) at (b)(6) in (b)(6) to 

assist my elderly mother, (b)(6), in getting in and out of bed. The bedrail is shaped 

like an "I" with the bottom part of the "I" sliding under the mattress. It is secured to 

the mattress by a one inch wide strap that goes around the mattress. On (b)(6) of 

this year, my mother was reaching for the telephone on the bedside table and 

started to fall out of bed. Instead of keeping her from falling out of the bed, the strap 

slipped, causing her to fall between the bed and the bedrail. Her neck got caught on 

the bedrail, strangling her, and she suffocated to death. After her death, i contacted 

(b)(6), and they immediately removed that model from their shelves, but a bedrail 

with that kind of strap should not be sold anywhere. 

Attention should be brought to the following YouTube video of the product referred to 

above: https://www.youtube.com/watch?v=QuG 1 pHYUQ. 

The following additional excerpts are taken directly from the FDA Manufacturing and 

User Facility Device Experience (MAUDE) reports on bed rail deaths, from the Event 

Description. 

27 
* " ... with his head between the vertical uprights of a bed side rail. ... and the 

administrator stated that there was no malfunction of the side rail." 

*"No imminent hazard to public health claimed ... " 

*"Kneeling like they were praying, that was how their body was." 

*"Pt contributed to the event." 71 

*" ... pupils were fixed and dilated and resident was blue around the mouth ... " 

*" ... found with her neck caught between the bed frame and side rail." 

*" ... found on floor with head between bed rail and mattress." 

*"Resident was alert and responding, 'please help me'." 

*"Resident found laying on left side on floor with head and left arm wedged in mobility 

bar." 

*"The resident got their head caught in a side rail and fell out of bed. Death by 

asphyxiation." 

Description of Asphyxia in Bed Rails, provided by Dr. Steven Miles, responding to a 

request for a description of death by bed rail type products. 

"The most common manner of death caused by beds equipped with bed rails is by 

positional asphyxia. Asphyxia refers to death by suffocation. Positional asphyxia 

means that the suffocation is caused by the position of the body. In this case, the 

person slides against the rail and partly into a groove between the rail and the 

mattress. As the person wedges in that groove, the mattress slides toward the 

opposite side of the bed thereby widening the space between the mattress and 

the bed rail. The edge of the mattress, bearing the concentrated pressure of the 

upper body of the patient, compresses and the person's chest or abdomen drops 

into the space between the rail and the mattress. The person's downward motion 

is stopped by a variety of means (sometimes the head or an arm caught in the rail, 

sometimes the rib cage is too large to slide through the space between the rail 

and the bed frame. The total sequence from starting to move off ttie bed to 

entrapment takes a couple of minutes. 

Once held and stopped between the rail and the mattress, the person cannot 

inhale and so they are squeezed to death. Unable to inhale, they are unable to 

exhale or call for help. They die of suffocation- a painful death; the pain is 

compounded by the mechanical pressure on the abdomen, chest, or neck. 

Bruising however is usually minimal. Occasionally and uncommonly, the person 

will die of a crush injury to the upper throat or even a fracture of the vertebrae in 

the neck. 

Patients who are at a high risk tend to be somewhat small in size, are impulsive 

and active in bed, and have impaired thinking. The majority of patients have been 

71 This statement was used multiple times by one company for 

their manufacturer's narrative in multiple FDA reports filed on alleged deaths in their bed 

rails. 

28 
rescued from a nearly lethal entrapment in rails shortly before they did however in 

such cases, there was no change to the bed environment." 

29 
APPENDIX C 

ADVERTISING 

Below is a random selection of what was found on the Internet using a search for 

portable adult bed rails on January 21 , 2012. Note the consistent promise of safety 

through use of portable bed rails in most of the ads. 

Adult Bed Rails, Safety Bed Rails for Elderly & Seniors 

www.parentgiving. com/shop/adult-bed-rails-79/c/ 

Home and hospital bed rails keep adults with mobility issues safe! Great selection of 

safety bedrails fit any standard sized bed .... Portable Bed Rails. Great for ... 

Bed Rails for Seniors and the Elderly Adult 

www. bedrailsforseniors. com/ 

Bed Rails for Seniors, a specialty store for bed rails for the elderly adult. We have a 

wide selection of safety bed rails, side bed rails and guard bed rails. 

Bed Safety Rails 

Bed Safety Rails offered at great prices. Many styles to choose from to suit different 

needs and preferences. Our bed rails for elderly help with fall prevention in the 

elderly. We have name brands and several styles including a travel bed rail. Sizes 

include queen size bed rails, full size and other. Take a look at our selection for the 

right bed rail to suit your need. 

D Adult Bed Railsl Walgreens 

www. walgreens. comlqladult-bed-rails 

Adult bed rails come in a range of sizes and shapes with multiple features to choose 

from. Some home bed rails work on either side of the bed and are portable ... 

D Portable Side Rails For Adult Beds from Sears.com 

www.sears.com/search=portable%20side%20rails%20for%20adult%2 ... 

Items 1 - 21 of 21 -FREE SHIPPING AND 2X REWARDS POINTS WITH SHOP 

YOUR WAY MAX. Search results "portable side rails for adult beds" ... 

D Bed Rails- Vitality Medical 

www. vitalitymedical. com/bed-rails. html 

Items 1 - 28 of 42- Bed Railing DISCOUNT Bed Rail, Safety Bed Rails, Bed Guard 

Rails, Bed Side Rails, Adult Bed Rail, Kids Bed Rails, Bed Rails for Elderly & More. 

WHOLESALE Bed ... Regalo Portable Kids Bed Rails. $22.81 . Regalo ... 

D Bed Rails & Handles 11800Wheelchair.com 

www. 1800wheelchair. com/asp/view-category-products. asp? ... id. .. 

30 
Bed rails and assist handles for children and adults. Shop from 24 different models . 

... Stander Children's Portable Bed Rail and Sports Pouch ... 

Tall and High Bed Rails for Adults- Bed Time Elder Care Safety 

www.parentgiving.com >Bedding> Bed Rails 

Tall (high) adult bed rails provide extra security against roll accidents or unsafe 

climbing. Safety and assist rails reach the extra mile of bed safety! 

0 Standers Portable Bed Rail with Pocket Organizer- Walmart.com 

www. walmart. com!ip!Standers-Portable-Bed-Rail-with. . .16372783 

$49.88- In stock 

Find the Standers Portable Bed Rail with Pocket Organizer at Every Day Low Prices. 

Save money, live better. Walmart. 

Item Description - Product Warranty and Service ... - Specifications - Gifting Plans 

0 Regalo Easy Hide-Away Bed Rail- Walmart.com 

www. walmart. com/ip/Regalo-Easy-Hide-Away-Bed-Rail/4433184 

$28.00 - In stock 

Get the Regalo Easy Hide-Away Bed Rail from Walmart.com . ... provides security 

and will accommodate pillow-top mattresses; Easy-to-assemble and portable ... 

31 
APPENDIX D 

CMS (Centers for Medicare and Medicaid Services) State Operations Manual 

Appendix PP- Guidance to Surveyors for Long Term Care Facilities 

Excerpts from CMS §483.13(a) Restraints 

Physical Restraints are defined as any manual method or physical or mechanical 

device, material, or equipment attached or adjacent to the resident's body that the 

individual cannot remove easily which restricts freedom of movement or normal 

access to one's body. 

'Physical restraints' include, but are not limited to, leg restraints, arm restraints, hand 

mitts, soft ties or vests, lap cushions, and lap trays the resident cannot remove easily. 

Also included as restraints are facility practices that meet the definition of a restraint, 

such as: 

• Using side rails that keep a resident from voluntarily getting out of bed . . . 

The use of side rails as restraints is prohibited unless they are necessary to treat a 

resident's medical symptoms. Residents who attempt to exit a bed through, 

between, over or around side rails are at risk of injury or death. The potential for 

serious injury is more likely from a fall from a bed with raised side rails than from a 

fall from a bed where side rails are not used. They also potentially increase the 

likelihood that the resident will spend more time in bed and fall when attempting to 

transfer from the bed. 

As with other restraints, for residents who are restrained by side rails, it is expected 

that the process facilities employ to reduce the use of side rails as restraints is 

systematic and gradual to ensure the resident's safety while treating the resident's 

medical symptom. The same device may have the effect of restraining one individual 

but not another, depending on the individual resident's condition and 

circumstances. For example, partial rails may assist one resident to enter and exit 

the bed independently while acting as a restraint for another. 

Devices Associated with Entrapment Risks - Devices can be therapeutic and 

beneficial; however, devices are not necessarily risk free so it is important to weigh 

the relative risks and benefits of using certain devices. For example, while physical 

restraints may be used to treat a resident's medical symptom, the devices may create 

a risk for entrapment. 

Physical restraints are defined in the SOM at F221 as any manual method, physical 

or mechanical device, material, or equipment attached or adjacent to the resident's 

body that the individual cannot remove easily and that restricts freedom of movement 

or normal access to one's body. In 1992, the Food and Drug Administration (FDA) 

issued a Safety Alert entitled 'Potential Hazards with Restraint Devices'. 

Serious injuries, as well as death, have been reported as a result of using physical 

restraints. Some physical restraints carry a risk of severe injury, strangulation, and 

asphyxiation. Restrained residents may be injured or die when they try to remove 

restraints, to ambulate while restrained, or due to an improperly fitted or used device. 

32 
Regardless of the purpose for use, bed rails (also referred to as "side rails," "bed side 

rails," and "safety rails") and other bed accessories (e.g. , transfer bar, bed 

enclosures), while assisting with transfer and positioning, can increase resident 

safety risk. Bed rails include rails of various sizes (e.g., full length rails, half rails, 

quarter rails) that may be positioned in various locations on the bed. 

In 1995, the FDA issued a Safety Alert entitled "Entrapment Hazards with Hospital 

Bed Side Rails." Residents most at risk for entrapment are those who are frail or 

elderly or those who have conditions such as agitation, delirium, confusion, pain, 

uncontrolled body movement, hypoxia, fecal impaction, acute urinary retention, etc. 

that may cause them to move about the bed or try to exit from the bed. The 

timeliness of toileting, appropriateness of positioning, and other care-related activities 

can contribute to the risk of entrapment. 

Entrapment may occur when a resident is caught between the mattress and bed rail 

or in the bed rail itself. Technical issues, such as the proper sizing of mattresses, fit 

and integrity of bed rails or other design elements (e.g., wide spaces between bars in 

the bed rails) can also affect the risk of resident entrapment. ... " 

33