Bedrail entrapment: is your facility safe? A comprehensive look at strategies to reduce these often fatal mistakes

Nursing Homes, Nov, 2004 by Julie A. Braun, Elizabeth A. Capezuti

More than 2.5 million hospital beds are in use in the United States. (1) The U.S. Food and Drug Administration (FDA) received approximately 575 entrapment reports from January 1, 1985, to January 1, 2004. (2,3) During this 19-year period, 358 people died, 111 were injured, and 106 were near-miss events with no injury. One limitation of the report data is that many adverse events may not be reported to the FDA; thus, the true number of bedrail entrapments may be unknown. Entrapments happen in all care settings--nursing homes, hospitals, and home healthcare. (4) Entrapment occurs when a resident/patient is caught, trapped, or entangled in the space in or about the bedrail, mattress, or hospital bed frame. (5) Sadly, entrapments can result in serious injury or death. Clearly, risk management strategies aimed at reducing or eliminating entrapment occurrence best serve resident/patient interests and an institution's legal interests.

The Hospital Bed Safety Workgroup

In response to continued reports of entrapment, the Hospital Bed Safety Workgroup (HBSW) was born in 1999 with membership consisting of, but not limited to:

* the FDA;

* other U.S. governmentagencies such as the Centers for Medicare & Medicaid Services, Consumer Product Safety Commission, and Department of Veterans Affairs;

* the Medical Devices Bureau of Health Canada;

* national healthcare organizations and provider groups;

* resident/patient advocacy groups (e.g., Untie the Elderly and National Citizens' Coalition for Nursing Home Reform);

* ECRI, a nonprofit health services research organization;

* attorneys;

* nurses;

* doctors; and

* hospital bed and equipment manufacturers.

The HBSW creates educational materials seeking to raise awareness of entrapment hazards and educate caregivers along with family members about the risks and benefits associated with bedrail use. The HBSW developed clinical guidance to reduce the occurrence of resident/patient entrapment, and it is creating procedures for measuring and assessing hospital bed systems with plans to make this information available shortly.

Draft Dimensional Guidelines for Hospital Beds

A recent effort to reduce life-threatening entrapment events involves evidence-based dimensional guidelines for hospital beds, now available for public review. The FDA released Draft Guidance for Industry and FDA Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment on August 30, 2004, with a 90-day comment period ending November 29. (6) The draft:

* reviews historical entrapment data;

* presents a retrospective study of entrapment reports to the FDA to verify proposed dimensional limits;

* characterizes body parts at risk for entrapment (such as the head, neck, and chest);

* shares line drawings of potential entrapment events (figure 1);

* identifies locations of hospital bed openings that can serve as potential entrapment areas;

* recommends maximum and minimum dimensional limits for gaps or openings in hospital bed systems;

* provides a scientific basis for the dimensional limits derived from a review of international anthropometric data;

* relates dimensional limits for the identified entrapment zones (figure 2);

* offers additional resources concerning hospital bed entrapment; and

* conveys information for healthcare providers and healthcare facilities, including suggestions about what information to relay when reporting entrapment events.

Products excluded from dimensional criteria. The dimensional criteria described do not apply to a number of products. Draft dimensional guidance lists the products totally or partially excluded. For example, air-fluidized therapy beds are totally excluded from the guidance's scope because the nature of the therapy does not allow the resident/patient to exit the bed easily. When these products are used, the therapeutic benefit is expected to outweigh the risk of entrapment.

Seven entrapment zones. Healthcare facilities can use the FDA draft guidance as part of a bed safety program to help identify entrapment risks that may exist with current hospital bed systems. The guidance considers seven potential entrapment zones (figure 2). Descriptions of these zones appear in the guidance accompanied by illustrations. International anthropometric data references were used to determine the relative sizes of key body parts--head, neck, and chest--for the vulnerable, at-risk population and provide a guide for the dimensional limits that would reduce their entrapment. For example, to reduce the risk of head entrapment, openings in the bed system should be small enough to prevent passage of the widest part of the head (i.e., head breadth measured across the face from ear to ear). The FDA is recommending fewer than 4 3/4" (120 mm) for the head breadth dimension.

Reporting Entrapment Events to the FDA

The Safe Medical Devices Act of 1990 requires hospitals, long-term care facilities, and others to report to the FDA any deaths, serious illnesses, and injuries associated with the use of medical devices, including bedrails. The FDA MedWatch reporting program receives reports of entrapment hazards. Manufacturers and users, however, often fail to report the events to regulatory agencies such as the FDA or fail to note event details. To improve the quality of entrapment event reports, the FDA recommends reporting the following important and helpful details: