Bed Entrapment, the FDA, and the affects within Long Term/Hospital Care.

The FDA explains entrapment as referring to the user becoming caught by their head, neck, limb, or chest in the tight spaces around the bed rail. From 1985 to 2009, the FDA received approximately 803 entrapment reports – 480 of which resulted in death. Reports have also identified the most vulnerable population to be the elderly, especially those who are frail, confused, restless and those who do not have full control over their body movements. (1) Most of these reported show a pattern of, entrapment happening when an attempt to move within or exit the bed is done without assistance.

In 2006 the FDA took action to reduce the risk of hospital bed entrapment by issuing guidance to the healthcare industry. The Hospital Bed Safety Workgroup (HBSW) (a partnership among FDA, the medical bed industry, national health care organizations, patient advocacy groups, and other federal agencies) published three sets of guidelines related to clinical, dimensional and mitigation concerns in addition to identifying “Entrapment Zones”. (2)

• Zone 1: any open space within the perimeter of the rail. Openings in the rail should be small enough to prevent the head from entering.
• Zone 2: the gap under the rail between a mattress compressed by the weight of a patient’s head and the bottom edge of the rail at a location between the rail supports, or next to a single rail support.
• Zone 3: the space between the inside surface of the rail and the mattress compressed by the weight of a patient’s head.
• Zone 4: the space is the gap that forms between the mattress compressed by the patient, and the lowermost portion of the rail, at the end of the rail.
• Zone 5: the space between the split rails may present a risk of either neck entrapment or chest entrapment between the rails if a patient attempts to, or accidentally, exits the bed at this location.
• Zone 6: the space between the end of the rail and the side edge of the headboard or footboard.
• Zone 7: the space between the inside surface of the head board or foot board and the end of the mattress.

The FDA guidelines generally refer to all “entire, existing bed systems (frame, mattress, and accessories that attach to the bed)” but, there are exceptions such as bariatric bed and powered mattress which are partially excluded. (2)

Even with the new FDA guidelines, it still falls to the healthcare facility to determine who should measure beds and mitigate indentified risks (3) adding to the responsibilities of the support staff and leaving it to the family to advocate on behalf of their loved ones.

MOXI Enterprises, in St Louis Missouri, manufactures a non-restraint option; a universal bolster cover called the Protect You 2. It is the safest non-restraint, universal mattress cover for rail free facilities. This is a full enclosure cover designed to fit most standard size mattresses with a voluntary ingress/egress bolster sections to address rolling concerns. The cover is fluid resistant, anti-microbial, easy to wipe down, and meets CAL 117/CFR 16 Part 1632 flame retardant standards.

Death or injury by bed rail entrapment is an unacceptable outcome from a product whose intent is to increase safety. The Protect You 2 gives a non bed rail option which eliminates entrapment in the tight spaces.

Credits:
(1) https://www.directsupply.com/resources/products-services/bed-entrapment-guide.pdf
(2) https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072729.pdf (page 15-19)
(3) https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/ucm123467.htm#5 (Question 5)