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FDA Bed Safety Guidance: Mitigating Risk

May 1, 2006
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Julie A. Braun, JD, LLM, talks to the FDA's Larry Kessler, ScD, and ECRI's Mark Bruley about the new federal guidance on bed entrapment risks
FDA bed safety guidance: Mitigating risk
Julie A. Braun, JD, LLM, interviews Larry Kessler, ScD, Director of Science and Engineering Laboratories, FDA Center for Devices and Radiological Health; and Mark Bruley, Vice-President for Accident and Forensic Investigation, ECRI

Beds are one of the few medical devices used by virtually every acute care patient and resident of a long-term care facility. A safe bed environment has long been the concern of nursing home residents and their families, healthcare practitioners, healthcare administrators, risk managers, clinical and facilities engineers, consumer advocacy groups, hospital bed and mattress manufacturers, and regulators, among others. A risk-management strategy to address entrapment risks involves developing and implementing an entrapment prevention protocol. The many components involved in creating such a protocol have been brought together in the Food and Drug Administration's (FDA) Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment (Available at: www.fda.gov/cdrh/beds/guidance/1537.pdf) released March 10, 2006.

In 1999, the FDA, in partnership with the U.S. Department of Veterans Affairs (VA), Health Canada's Medical Devices Bureau and representatives from national healthcare organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers, formed the Hospital Bed Safety Workgroup (HBSW) to examine real and potential causes of entrapment and make recommendations for design improvements in bed frames, bedrails, mattresses, and head/footboards. The guidance is the culmination of the HBSW's seven-year effort to reduce potentially life-threatening entrapment.

The FDA received 691 entrapment reports over 21 years from January 1, 1985, to January 1, 2006, in which a person was caught, trapped, or entangled in the spaces in or about the bedrail, mattress, or bed frame. Most vulnerable are a person's head, neck, and chest which, if entrapped, can cause strangulation and death. Elderly individuals in nursing homes and hospitals, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most at risk. Since 1985, 413 people have died, 120 were injured, and 158 experienced near-miss events without injury. The FDA shares that long-term care facilities report the majority of entrapments and the number of tragic adverse events likely is higher because many cases go unreported.

This nonbinding guidance, produced in collaboration with the HBSW, addresses the components to consider when developing a protocol and includes assessing a patient's need for bedrails, caregiver ratios and training, equipment age and condition, and the variety of bed systems in the institution. Evaluating the dimensional limits of the gaps in hospital beds is another component of an overall assessment and mitigation strategy to reduce entrapment. Related methods for performing such evaluations are included in the guidance, along with references to relevant HBSW documents.

"This guidance assists individuals, families, nursing homes, hospitals, and other healthcare facilities in making informed decisions to ensure a safe bed environment," says Larry Kessler, ScD, Director, Office of Science and Engineering Laboratories, FDA Center for Devices and Radiological Health. Kessler further reminds that "not all persons are at risk for an entrapment, and not all bed systems pose a risk of entrapment." The new guidance, according to Kessler, "will help ensure that all new hospital beds are designed to reduce the potential for entrapment and that risks that may exist with current bed systems are identified and alleviated where possible and reasonable. The dimensional assessment may be incorporated as part of a manufacturer's or facility's comprehensive bed safety program."

Nursing Homes/Long Term Care Management contributor Julie A. Braun, JD, LLM, chair of HBSW's legal subcommittee, spoke with Larry Kessler, ScD, about the guidance. In a separate interview, Braun spoke to Mark Bruley, ECRI vice-president for Accident and Forensic Investigation on implementing bed safety protocols and testing.

In September 2002, Larry Kessler, ScD, was appointed Director of the Office of Science and Technology at the FDA's Center for Devices and Radiological Health (CDRH). In this position, he directs the efforts of the laboratories of CDRH and the Standards Coordination Program. From 1995 to 2001, he served as Director of the Office of Surveillance and Biometrics, CDRH, and prior to that served as Chief, Applied Research Branch, National Cancer Institute.

Braun: Why did the FDA begin looking into bed entrapment?

Dr. Kessler: In 1995, we noticed a pattern of deaths and injuries in hospital beds. Further investigation into our adverse event reports suggested these were largely preventable deaths and injuries. Our August 23, 1995, safety alert (Available at: www.fda.gov/cdrh/bedrails.html) generated considerable interest from the healthcare community. In fact, reports of this type of injury increased following the alert. That suggested we had tapped into an important health issue.

Braun: Why did the FDA choose to undertake a voluntary consortium for the development of the Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment?