Sentinel Event Alert

Sentinel Event Alert September 06, 2002 Issue 27 - September 6, 2002

Bed rail-related entrapment deaths

http://www.jointcommission.org/sentinelevents/sentineleventalert/sea_27.htm

On March 9, 2006, the Food & Drug Administration published final guidance designed to reduce the occurrence of hospital bed entrapments. The guidance, entitled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," identifies special issues associated with hospital bed systems and provides design recommendations for manufacturers of new hospital beds and suggestions for health care facilities on ways to assess existing beds. The guidelines and supporting materials are available on the FDA website at http://www.fda.gov/.

Since 1995, the Joint Commission has received reports of seven deaths or injuries related to bed rails; three of these reports were from hospitals, two were from long term care facilities, one was from a behavioral health care facility, and one involved a patient receiving home care services. JCAHO has root cause analysis information only for the five incidents that occurred in hospitals and long term care facilities, and this Alert will report information derived from those five cases.

All five cases involved patients/residents who were 65 years of age or older and all resulted in death by asphyxiation. Of the patients/residents, four were mentally or behaviorally impaired; three were at risk for falling; two had limited mobility in bed; one was on psychoactive or sedative medications; and one had a physical deformity. Asphyxiation was caused by one of the following: being caught between the mattress and the bed rail; being caught between the headboard and the bed rail; getting his or her head stuck in the bed rail; or being strangulated by a vest restraint between the rails. No particular bed rail configuration was implicated in these cases, which included upper rails only, upper and lower rails, both upper rails and one lower rail, or continuous full- length rails. None of the cases involved the use of only lower rails. Root causes and risk reduction strategies

Recognizing the limitations of the small sample of cases, certain findings were recurrent in the root cause analyses. All five organizations cited a breakdown in communication, most often among staff (two cases) or with or between physicians (two cases), as well as with administration (one case). Four of the five organizations cited equipment factors, including side rail protector pads not being used (four cases) and problems with the bed/mattress/side rail configuration (one case). Other problems cited were patient/resident assessment (three cases), including adequacy of assessment, scope and timing of reassessment, and patient/resident observation; human factors (three cases), including staff orientation and use of an agency nurse; and leadership (one case).

The risk reduction strategies implemented at these health care organizations included:

 Orientation and retraining of staff.  Equipment redesign, including the use of bed rail protector pads, re-evaluation of beds for entrapment potential, replacing beds, replacing or modifying side rails with gaps greater than five inches, removing side rails from the bed, installing a positioning bar, or using "low" beds.  Process redesign, including patient assessment for risk of entrapment (e.g. confusion, sedation, restlessness, lack of muscle control, size), patient observation, resident/family education about bed rails, and improving communication policies. Expert advice on bed rail safety

Elizabeth Capezuti, Ph.D., R.N., F.A.A.N., associate director for nursing science at the Center for Health in Aging at Emory University, is an expert on restraints and bed rail safety. "Health care organizations need to look at these devices like any restraint and evaluate the rationale for using them," says Capezuti. "Don't pull up the siderail and walk away. Both split and full rails have the potential to cause fall-related injuries as well as entrapment. Health care organizations need to look at bed rails as potentially restrictive devices, or "Health care organizations restraints, and ask themselves what kind of surveillance need to look at these devices like any restraint and needs to be in place to assure safety." evaluate the rationale for using them. Don't pull up The Safe Medical Devices Act of 1990 requires hospitals the siderail and walk away. and other facilities to report to the Food and Drug Both split and full rails have Administration (FDA) any deaths, serious illnesses and the potential to cause fall- related injuries as well as injuries associated with the use of medical devices, entrapment. Health care including bed rails. In 1995, the FDA issued its FDA organizations need to look Safety Alert: Entrapment Hazards with Hospital Bed Side on bed rails as potentially Rails (1), a report that includes actions to prevent deaths restrictive devices, or and injuries from entrapment, including evaluating the restraints, and ask themselves what kind of bed, mattress and bed rails and taking additional safety surveillance needs to be in measures for patients at risk for entrapment. From 1995 place to assure safety." through 2001, the FDA received 381 entrapment reports of deaths, injuries or near misses involving bed rails; of -- Elizabeth Capezuti, these reports, 237 were of deaths, 73 were of injuries, and Ph.D., R.N., F.A.A.N., 71 were of near misses. More than half—53 percent—of associate director for nursing science at the the reports to the FDA occurred in nursing homes, and 20 Center for Health in Aging percent occurred in hospitals. at Emory University Of the 381 reports to the FDA, 35 of the deaths involved air pressure mattresses (either overlay air mattresses placed on top of a regular mattress or beds with built-in air mattresses.) A recent Journal of the American Geriatrics Society (2) article reports that "the high compressibility of air pressure mattresses distinguishes these deaths from similar events involving conventional mattresses. As a person moves to one side of an air mattress, that side compresses. This raises the center of the mattress and lowers the side, making a ramp that 'pours' the patient off the bed or against the bed rail. Mattress compression also widens the space between the mattress and the rail." The article states that while foam blocks can be used to occlude the space between the bed rail and a conventional mattress, highly compressible air mattresses make this option less feasible. The article concludes that "healthcare providers should manage this risk rather than abandoning the beneficial use of pressurized mattresses for treating or preventing decubitus ulcers."

In July 2001, the Department of Veterans Affairs' (VA) National Center for Patient Safety issued guidance addressing bed rail entrapment and requiring that beds used for patients at risk for entrapment be assessed for excessive gaps and openings. Guidance was provided to use bed rail retrofit kits, bed rail netting, clear padding or other suitable materials that would not obstruct staff's visibility of the patient to fill gaps and openings. The VA suggested positioning the mattress on the bed frame with Velcro or anti-skid mats to prevent the mattress from being pushed to one side creating a large gap on one side of the bed.

Currently, the FDA, in partnership with the VA, Health Canada, representatives from the hospital bed industry, national health care organizations and patient advocacy groups, formed the Hospital Bed Safety Workgroup. This group is specifically concerned with preventing patient entrapment in hospital beds. In early 2003, this group is scheduled to issue clinical guidance to assist caregivers in their assessment and implementation of bed rail use. Dimensional guidance that includes entrapment zones measurements and a tool for caregivers to measure openings in a bed will follow. (While devices to measure entrapment zones may be helpful in identifying risk to patient safety, Joint Commission standards do not require the measurement of entrapment zones.) Joint Commission standards require that organizations have a patient safety program that encompasses performance improvement, environmental safety and risk management; however, the standards do not prescribe how these activities should be structured. Joint Commission recommendations

To help prevent entrapment deaths associated with bed rails, Joint Commission recommends that health care organizations take these precautions:

1. Provide orientation and training to staff about entrapment dangers with bed rails and assessment of patients/residents for entrapment risk, as appropriate to the patient population and the care environment. 2. Assess patients/residents for risk of entrapment, including physical, mental, behavioral or medication impairment. 3. Re-evaluate beds for entrapment potential, including "gap" measurement and appropriate sizing of mattresses for bed frames. 4. For individual patients/residents at risk for entrapment, implement appropriate changes to beds (for example, the use of retrofit kits, bed rail netting, clear padding, Velcro or anti-skid mats) to reduce the risk of entrapment. 5. When possible, keep patients/residents with risk factors for entrapment under more frequent observation. 6. Educate the patient/resident and/or his or her family about the purpose and potential dangers of bed rails. Resources

1. FDA Safety Alert: Entrapment Hazards is available at the United States Food and Drug Administration website, http://www.fda.gov/. A Guide to Bed Safety brochure is also available at www.fda.gov/. 2. "Deaths Between Bedrails and Air Pressure Mattresses," by Steven H. Miles, Journal of the American Geriatrics Society, June 2002, p. 1124-5.

Please route this issue to appropriate staff within your organization. Sentinel Event Alert may only be reproduced in its entirety and credited to The Joint Commission. Sentinel Event Alert