Is the Bedsore Rescue Cushion a Medical Device ?

Many people have asked me if it is ‘legal’ to ask the hospital/skilled nursing facility/care home where my loved one is staying to use the Bedsore Rescue Backbone Positioning Cushion?

First of all, YES! Actually its more than legal, it’s a requirement. Especially if that person has a wound on their behind.

Most facilities and caregivers who see the cushion absolutely love it, and use it, and ask to carry it for all their patients. But I’m alarmed to hear from some of you that you have been told by a facility that they are “not allowed” to use it under your person. That is not true.

The belief stems from a simple mis-understanding. They think The Bedsore Rescue Bedsore Rescue positioning cushion is a medical device. There are laws around medical devices; FDA approval is required, and in most cases the facility has to “clear” it too before a medical device can be used on their patients, regardless of who paid for it.
I know its more sophisticated than most :) but The Bedsore Rescue Backbone Positioning Cushion is NOT a medical device.

Cushions and pillows have been around since the beginning of time and in some way, shape or form are used every day, everywhere, by everyone. There is no way the FDA could regulate something so ubiquitous.

That being said, it is confusing because actually medical facilities are required to do everything they can to minimize the risk of pressure injury. And that includes turning to lift and support the at risk patients near a 30 degree angle. If they can’t prove they’ve done that and their patients get bedsores, they get rationed and even cut off from Medicare reimbursement.

They also can easily lose lawsuits when then cannot prove they did this one care intervention correctly. So its no wonder they think The Bedsore Rescue Cushion^® is a medical device.
If the facility tells you they cant use this cushion, the best thing to do is to tell them any cushion and pillow you wish to use to support people is perfectly legal.

Point out that this cushion will help to relieve the pressure and contribute to creating an environment where healing may take place. Again, once they realize The Bedsore Rescue Cushion^® will actually help them do their job better, you will be amazed at how much better the care becomes. But if not, feel free to call me if you need more help.