There is a disassociation between consumer products & medical devices may be more wide spread than the fda would even imagine.
I hope to shed some light into the potential size of the problem.
For this report it is bed safety & bed rails aka bed bars & transfer handles etc.
Companies are mfg medical devices & don't know it.
Internet web sites are promoting products & making up marketing that is not from the mfr.
The above including healthcare providers have no idea they are using, suggesting or selling a medical device.
One of the main questions the fda may ask is "why haven't we had any adverse event reports.
" below are examples of why you don't: healthcare providers have no idea these products are med devices & have no reason to report an adverse event.
The disassociation! you need to know what an adverse event is before you would report it, like entrapment.
If the user does not know what entrapment is when it happened then it won't get reported.
If you don't know you are using a medical device then why would you report it to the fda.
If you don't understand restraint then how do you avoid it? many of these issues have not been uncovered or explored in the home health setting.
They are not much better understood in the healthcare setting.
It is an epidemic waiting to happened.
We know there is a bed safety issue around the use of bed rails & bed rail type products mainly from the fda hosp bed safety workgroup (hbsw).
Assuming healthcare providers know the difference has caused the proliferation of products with new names & old hazards.
They also come with new hazards because of new pt needs.
Truthful marketing & actual product abilities must be transparent.
You will find these products in hosps, nursing homes, rehab facilities, in research reports, gov't funded websites, gov't guidelines and in homes.
Some serious questions must be asked as we move towards bed safety, fall prevention & providers & dme suppliers that know little if anything about these products.
Unless those recommending products know the products they recommened how, will the end user or the fda know if they have an adverse event? a healthcare provider can be standing in front of a pt that is entrapped & not know it.
The typical family/friend caregiver would have even less of an idea what they saw.
There was an entrapment incident at a hosp 2006 that never got reported because the state did not f/u with the person attempting to file the report.
At one point there were 5 hosp staff in room & head nurse didn't know what entrapment was.
How many others are out there? healthcare providers in general are not aware that entrapment is an issue & many don't know what it is.
Therefore, the lack of adverse event reporting for these products! according to cpsc falls from bed are the 2nd leading cause of fall deaths.
This shows the bed by itself is a risk factor before you add one of these bed rails that are called safety devices.
Example fire aid call event: a fireman responds to an aid call because a resident has fallen & can't get up.
The resident is offered a safety device for the bed as part of a "fall prevention" program in that city or co.
The resident is happy because they know they can trust the firemen & they now have a safety product on their bed.
The problem: the firemen know nothing about the product except maybe how to install it (slide it under the mattress).
The only thing the resident knows is that this is a safety product.
If the resident has an adverse event they will: think it is their fault.
Not tell anyone because the fireman or healthcare provider told them it was for their safety and think they did something wrong.
They may also worry about being institutionalized if they can't use a safety product without getting hurt.
It almost turns into a mind game.
The disassociation & lack of knowledge is throughout.
Across the co "aide" calls for falls is a growing part of emergency responses not fires.
This is only going to increase.
The marketing of these products is a safety issue itself.
Some make up benefits & uses not mentioned by the mfr.
Products are marketed in ways that conflict with actual intended uses & use limitations.
This is a safety issue.
The lack of knowledge by healthcare providers & suppliers is cause for concern because when a safe product is presented to them they compare it based on no actual knowledge.
Knowledge is based on the marketing, pictures & dme suppliers.
How are people going to get products for homecare that are safe and effective? like drugs people have a right to know what the benefits, risks & use limitations are.
As you will see bed rails & like products are far from this.
Some of the issues surrounding bed rails are: increased fall risks, restraint, entrapment & improper use.
And now maybe pressure ulcers, incontinence & permanent damage of an integrated bed system with the use of "under the mattress rails.
" real user considerations: the population using bed rails no matter what name they may be given (transfer handles, bed assists etc.
) typically: have a disability, balance issues, elderly or very old, vision problems, frail, chronic conditions - arthritis, back problems, osteoporosis etc, not familiar with bed rails risks, use limitations, hearing problems, limited mobility, adl limitation, obese & take multiple drugs.
We are talking about people already at risk of an adverse event.
It makes their product choice even more important at this point.
Transparency will be key for therapeutic value & safety.
The multi-factorial issues are: no fda registration, fda registration with inappropriate device class, misleading marketing on federal & state guidelines for entrapment, confusing & misleading marketing pictures & print, inconsistent info: mfr & internet sites, mfr knowledge of safety issues: changes product for "clinical" settings only.