Why would someone become a patient advocate?

See also Patient Advocates on this site

I have a friend whose doctorate is in chemistry. One of his gifts to humanity is earning his living by working for NIOSH analyzing toxins in the workplace to protect workers. Another is teaching science to children on weekends. One time he was telling the children about the importance of developing the tools necessary for sharing with other people what you learn. For instance, he said, what if you found the cure for cancer but didn’t tell anyone? What good would that do? One boy rejoined, “I could cure myself.”

Somewhere in the world there are witch doctors. Elsewhere are people who, when they figure out that the care they are isn’t what it could be, feel a duty to share what they have learned with other people to protect them.

"The important thing . . . is what you do with what they have done to you." - Jean-Paul Satre

What they did to Gloria Black’s mother lead her to discover that every year about 4,000 older adults are injured by bed rails. She discovered that the figure is probably an underestimate because, as everyone should know by now, caregivers rarely make a record of adverse events, and the ones they do record usually are recorded inaccurately (see Medical Reporting), even when the problem only is one of poorly designed equipment. In the case of bed rails it is emergency room doctors not making a note of the cause of injury, and nursing homes writing something like “infarction” as the cause of death rather than describing the ghastly sight of the older person who, on their watch, was entangled in the bed rails long enough finally to have succumbed to it before being discovered.

Imagine how useful accurate notes or photographs could be to people whose first priority really was the well-being of patients – people like Gloria Black who wanted to know, for one thing:

Who Is In Charge of This?

Are bed rails medical devices under the purview of the F.D.A., or are they consumer products regulated by the federal consumer safety commission? No one is sure.

None of the bed rails in use at this time would comply with the suggested design standards detailed in the voluntary guidelines that were adopted in 2006. Requiring that all bed rails be updated could cost hundreds of millions of dollars. So no one moves on this.

Then Gloria Black’s Mother Died

Because of bed rails. And Ms. Black wondered how common this is. This is how some problems in medicine are addressed. Patients get injured or die and then they or their loved ones take it upon themselves to try to protect future patients from the specific problems they themselves encountered. So it is piecemeal work by amateurs.

We Need An Agency Without a Conflict of Interest to Address such Issues

And we need one with the motivation to tackle problems no matter whose turf it might be. This might not fall strictly under the aegis of state patients boards (if we had those), but if their charters were written correctly, finding someone or creating someone to work on it could be something they could take on.

Certainly people have complained about this before. If nothing else a state patients board might have been able to put concerned amateurs in touch with each other to try to figure out what to do to protect patients while we are waiting for medicine and the government to figure out whose jurisdiction it is. At least they could have tried. The agencies currently involved managed to come up only with the idea of attaching warning labels.

We need the warning labels, but

No one is suggesting disallowing the use of bed rails. There probably would be more injuries without them. But of what value is a warning label to a confused older person in the middle of the night? Children as young as two years old have been injured by them, but the typical injury is to an older adult who is confused and/or lacking in muscle control – like a two-year-old.

Might there be a chance that a design student or a professional designer could create a solution that can be retrofitted? Concerned amateurs and design students might be able to coax enough information out of the caregivers who have discovered people entangled in bed rails to develop a real-world understanding of the problems.

Imagine knowledgeable volunteers monitoring relatives of their own who are sleeping between newly designed solutions in order to test the solutions as well as protect their loved ones. The energy that injured patients and the people close to them have for working on these things can be hard to overestimate. Some of them spend many years creating websites, writing letters, contributing to online discussions, and in other ways spinning their wheels vainly struggling to make a difference. Why not plug them into something that can?

FDA Knowledge

As food for thought, the FDA says that reported entrapments occurred in one of the following ways:FDA Bed Rail Diagram

  1. through the bars of an individual side rail;
  2. through the space between split side rails;
  3. between the side rail and mattress; or
  4. between the headboard or footboard, side rail, and mattress.

Their full report is at this link.

It’s not as though nothing is known

Perhaps the industry cannot afford a complete rebuild of bed rails, but perhaps concerned amateurs could figure out a $20 add-on that could cut the number of deaths caused by bed rails down to 1,000 per year. Would bolsters secured to fill the gaps between rails help? If amateurs demonstrated that something they came up with helped (one can imagine siblings keeping a 24 hour a day watch on an elderly parent to see), perhaps when taking your older parent to a facility that has bed rails you could order the solution online and then leave it for the next patient – patients helping patients while waiting and hoping for medicine to become inclined to file accurate reports and do something.

Where could we report it ourselves?

If you are aware of a specific problem or incident to report, you can report it yourself at MedWatch, the FDA’s voluntary reporting program at this link by pressing the BEGIN button on that page to access the correct form, which is form 3500A. Don’t be put off by notes that say it is to be used to meet Mandatory Reporting requirements. Other instructions direct consumers to use it too. By the way, the instructions for filling out form 3500A are at this link and are 18 pages long when printed out. Perhaps another reason for why so little gets reported in medicine. And also perhaps another reason for why having government run medicine may not be the best idea.

You also can report through snail mail at the address below:
Medical Product Reporting Program
MedWatch, HF-2
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

If you fill out, or attempt to fill out, that form, let me know what the experience is like for you so that others can benefit from yours.

And Yet

Advocates focusing on the specific problem that affected them might not always be better than nothing. They have a tendancy to believe that the answer is more regulation, which often makes things worse. Isn’t the real problem the fact that medicine doesn’t care enough to them to fix these things themselves? If it mattered to their own well-being, wouldn’t they? Instead their well-being often is better served by not fixing the problems that harm patients. What we could do about that is the main focus of this site (for instance, see Community Patient Agencies, a page on this site), but historically regulation has not proved to be it.