After completing the construction of the device, it will be taken to Monmouth Medical Center and attached to a hospital bed. Five different sized volunteers will get into the bed and try to fit into the 7 problem zones. While the volunteers are attempting to fit into the zones, they will be photographed. Once all of the volunteers have tried to fit through the 7 zones on the bed, the device will be evaluated based on its performance.

1.Attach device to the bed.
2.Label each of the 7 zones with Post Its so that the volunteers will know which zone is which.
3.Have volunteer #1 move around, be restless, and attempt to be entrapped in each zone one by one.
4.Using a digital camera capture photos of each person attempting to fit their bodies into each of the 7 danger zones.
5.Once volunteer #1 has finished being restless move on to volunteer #2, then volunteer #3, and so on...
6.Once all 5 volunteers have attempted to be entrapped in the bed, detach the device from the bed railing.
7.After photo capturing is finished, look at the images to determine if the device was successful in preventing entrapment in all 7 of the zones for each volunteer.

In Solution Number One the vinyl or mesh material covers the whole hospital mattress and is connected to the pieces that slide over the side bed rails. The pieces that slide over the side bed rails are attached on the bottom by a combination of elastic and snaps. The vinyl would make the covers easy to keep clean and sterilize. Between the bed rail and the actual mattress, foam pieces would slide into place to avoid the risk of patients getting trapped between the mattress and the side rail.

Pros

• The foam between the sides would aid in preventing getting caught between mattress and rails
• Sheet underneath the mattress would be used to prevent patient from falling through or getting caught between the bed frame and the bed rails
• Appropriate height to cover the rails entirely and not loom over the patients while they are in the bed

Cons

• Lack of foam between the ends of the mattress and the head or foot board may make it possible for the patients to become wedged in those two zones.
• Snaps or straps may be difficult to use for fast removal of the device in case of an emergency where the patients airway may need to be accessed, CPR may need to be performed, advanced life saving may need to be performed, or intubation of airways need to be accessed.

In general this solution would prevent entrapment in all 7 zones as intended. The lack of foam between the head and foot boards doesn't solve the problem of becoming stuck in those two zones.

Solution Number Two:

In Solution Number Two, 4 foam pieces surround the bed and are covered with a vinyl/mesh material to slip over the side bed rails and between the head and foot board and the mattress. The 4 pieces can be attached or removed with Velcro for easy removal. This also allows patients to remove one section if they feel uncomfortable, or to allow heath care providers gain access to a part of the body without having to remove the whole device. The foam is only 1” thicker than the bed rail so it won’t be too bulky for the patient.

Pros

• Velcro is good to use to connect the pieces because it is very easy to take it apart in case of an emergency where the rails need to be removed quickly
• Foam surrounds the entire bed so that patient can't fall through any of the spaces between the mattress and the rail or the mattress and the head or footboard
• Appropriate height to cover the rails entirely and not loom over the patients while they are in the bed

Cons

• Having foam on all 4 sides of the bed may feel like a crib for a patient and may be uncomfortable.
• There isn't a snap or strap that would attach the device to the actual bed rail
• The foam would have to be skinny enough to fit between the mattress and the rail, which means that the piece of foam as a whole may not be thick enough to prevent the patients from getting wedged between the mattress, rail, and bed frame.

In this solution, the foam would prevent entrapment in the 7 zones, but the foam may be a little thin. The velcro in this solution makes it easy for nurses, doctors, and hospital staff to get to the patients. The covers for the rails don't have a section that patients can see through. It might be uncomfortable and feel too much like a crib for a patient.

Solution Number Three:

In Solution Number Three, 4 foam pieces are attached by Velcro once again, but this time the foam is 3” thick as opposed to 1” thick in Solution Number Two. Also in this Solution the foam is in a wedge shape so that it can easily slide into the space between the mattress and the bed rail. The foam is covered in vinyl or a mesh material to be attached to the bed rail. This solution also allows for the removal of one section of the device and not the whole device if need be.

Pros

• The wedged shaped foam allows the top of the device to be thicker than the bottom part of the device which would slide between the rail and the mattress. This would allow more protection for the patient
• Velcro is a good way to attach pieces together because it is easy to remove in case of an emergency where the patients airways etc... need to be accessed
• Foam on all four sides prevents entrapment between mattress and head or foot board and the mattress and the rails of the bed
• Appropriate height to cover the rails entirely and not loom over the patients while they are in the bed

Cons

• No straps to attach the device to the bed rails
• May feel like a crib just like solution number two
• Thickness may be too bulky on the top. May want to decrease the thickness a little bit on the top but keep it the same on the bottom.

In this solution the foam is a wedge so that it can slide into the narrow spaces between the bed frame and the mattress. The foam is thicker on the top so it prevents the risk of a patient slipping into that gap between the mattress and the bed frame. The patients once again might be uncomfortable and feel like they are in a crib.

For my final solution I plan on adapting solutions two and three. I plan to add some kind of a mesh material to the centers of each of the 4 sides so that patients can see out. I would also like the mesh sections to be removable in case of an emergency. I also plan on developing some kind of snap or velcro system to the bottom of the device so that it can be attached directly to the rails and the head and foot boards.

1. Within the rail
2. Under the rail
3. Between the rail and the mattress
4. Between rails, at the end of the rail
5. Between split bed rails
6. Between the end of the rail and the side edge of the head or foot board
7. Between the head and footboard and the mattress

Entrapments have occurred in a variety of patient care settings, including hospitals, nursing homes, and private homes. Long-term care facilities reported the majority of the entrapments mentioned above. (“FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment”)

The risk of entrapment increases when the bed moves up and down and when a gap is present between the mattress and headboard or footboard. In addition, many facilities use older beds, called “legacy” beds, with new mattresses. This may present an entrapment hazard by increasing or creating spaces or gaps between various components of the bed system. (“Reducing Risk of Bed Entrapment”)

Since this problem was discovered in 1985 many hospitals and healthcare providers have developed different cushions and covers to try to prevent entrapment in hospital beds. However, none of these devices block entrapment in all 7 zones.