After 21 years – and reports of 413 deaths – the FDA last week unveiled its final guidance on hospital bed design intended to reduce the occurrence of hospital bed entrapments.

In announcing the guidance, the agency said that over those 21 years – from Jan. 1, 1985, to Jan. 1, 2006 – it had received reports of 691 entrapments in hospital beds. Of these 691 incidents, there were 413 deaths, 120 injuries and 158 “near-miss events.“ The near-misses resulted in no serious injuries because there had been some intervention to prevent them.

Most of the entrapments involved strangulation, the result of the neck being caught under, in or between bed rails, the neck or chest being caught between the bed rails and mattresses, under bed rails, between split rails, or between the bed rails and the head or foot boards. Some appeared to be the result of being smothered by being trapped in these openings.

It said that the entrapments occurred in various settings: hospitals, nursing homes and private homes, and that most of the entrapments occurred in long-term care facilities.

Larry Kessler, director of the Office of Science and Engineering Laboratories in the FDA's Center for Devices and Radiological Health, characterized the total number of deaths, injuries and near-misses as appearing “small,“ but said the agency “believe[s] they are signals about significant adverse events.“

He also suggested there has been significant under-reporting of such events.

“Often adverse events such as these go unreported to the FDA, making it likely our counts of these tragic adverse incidents is lower than the number that actually occurs,“ Kessler said.

The guidance says that those at greatest risk are elderly patients, “especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment.“

This guidance, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment,“ was developed, the FDA said, with the use of input from both government and private-sector groups.

It identifies special issues associated with hospital bed systems and provides design recommendations for manufacturers of new hospital beds and suggestions for healthcare facilities on ways to determine any risks of entrapment for existing beds.

The terms “recommendations“ and “suggestions“ are key, since the guidelines are not mandatory. And it specifies various limitations. The “dimensional limits,“ it says, “may not reduce entrapments in all populations,“ such as pediatrics and the developmentally disabled.

The bed systems that are covered include manual patient transfer devices, manual adjustable hospital beds, hydraulic adjustable hospital beds, AC-powered adjustable hospital beds, wheeled stretchers labeled for extended-stay use, power patient rotation beds, power patient transport systems labeled for extended-stay use, powered wheeled stretchers labeled for extended-stay use, manual patient rotation beds and powered flotation therapy beds.

The guidance characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, recommends dimensional criteria for new hospital bed systems, provides information about reporting entrapment adverse events, and includes a description of recommended test methods for assessing gaps in hospital bed systems.

In this latter category, it describes what for many of us is a test device that we probably have never heard of before: a “cone and cylinder tool.“ This is a combination tool for taking various measures of the “zones“ of a hospital bed where entrapment might occur. The cone and cylinder can either be used together, or the two parts can be separated, according to the guidance.

The diameter of the large end of the cone represents the width of a small adult head, about 4 inches; the diameter of the cylinder represents the size of a small adult neck, about 2 3/8 inches. Used together, the tool weighs 15 pounds, representing the combined weight of the adult head and neck. An area of the cylinder defines angles in which the neck could become wedged (60 degrees or narrower).

The tool can then be used to assess seven “zones“ of the bed, as defined by the guidance: within the rail; under the rail, between the rail supports or next to a single rail support; between the rail and the mattress; between the rail, at the ends of the rail; between split bed rails; between the end of the rail and the side edge of the head or foot board, and between the head or foot board and the mattress end.

Kessler said that the guidance is intended to “assist individuals, families and healthcare facilities in making better informed decisions to ensure a safe sleeping environment for people who need these beds. While not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment, this new guidance will help ensure that new hospital beds are designed to reduce the potential for entrapment“ and entrapment risks identified. He said it could also be used “as part of a manufacturer's or facility's comprehensive bed safety program.“

This guidance document is the result of a years-long partnership between the FDA and the Department of Veterans Affairs, Health Canada's Medical Devices Bureau, representatives from national healthcare organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers, who formed a working group in 1999 known as the Hospital Bed Safety Workgroup (HBSW).

The HBSW also worked in cooperation with the Joint Commission on Accreditation of Healthcare Organizations (Oakbrook Terrace, Illinois), the Center for Medicare & Medicaid Services and the Consumer Product Safety Commission to improve patient safety associated with the use of hospital beds.

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