November 27, 2012

Bed Rails: The Fine Line Between Medical Devices and Consumer Products

by Levin & Perconti

Our attorneys often explain the difference between medical malpractice (professional negligence) issues and ordinary negligence. While professional negligence refers to mistakes made in specialized medical care, ordinary negligence refers to general safety lapses. For example, while giving a patient an overdose of a medication is professional negligence, failing to properly monitor a wandering patient is ordinary negligence. The difference has legal ramifications, often with different procedural and evidentiary rules.

One similar split exists between products and regulation of those products. There are medical products and regular consumer goods. While all products need to be safe, the rules for use of these devices and the governmental entity that is charged with ensuring their safety differs between them. In many cases, it is easy to differentiate between the two. A Tiffany lamp is obviously a consumer good, while a DePuy hip implant is a medical device. However, at times the line between whether a device is a medical product or an ordinary consumer item is not clear.

Where Do Bed Rails Fit In?
For example, take bed rails. These are usually metal bars that attach to the side of beds to help patients sit up and to prevent someone sleeping from rolling out of the bed. Most have seen different versions of these rails on beds in hosptials and nursing homes. However, the rails are also used on occasion in individual homes, sometimes for seniors or even children.

Are bed rails medical devices or regular consumer goods? Unlike hip implants, they are not obviously used exclusively for actual medical care. In theory they can help anyone who is sick or well, inside or outside the hospital.

This issue was disussed tangentially in a recent New York Times article that delved into the dangers of bed rails. Many patient safety advocates have been calling for years for improvements to limit harm caused by these rails. Hundreds of medical patients and nursing home residents have died and tens of thosuands have been injured in the last decade or so as a result of getting stuck in the metal rails or smothered between the rail and the bed. Seniors with cognitive issues like dementia and Alzhemiers are the most likely to be affected.

Safety advocate urge the ban of these devices in many settings or at least the use of tougher safety protocols and warnings. However, even though the dangers have been known for many years, little has been done to keep those at risk safe. Part of the problem, say those involved, is confusion over which federal agency is responsible for ensuring the safety of the devices. The U.S. Food and Drug Administation (FDA) is charged with monitoring medical devices. Alternatively, the Consumer Product Safety Commission (CPSC) regulates traditional, non-medical consumer goods.
So where do bed rails fit? One one hand, they may include specific instructions from manufacturers on medical uses, such as helping to ensure the safety of patients with dementia and Alzheimers. When unique benefit for those with specific ailments is used, then it tends to be viewed as a medical device. However, if the manufacturer does not make those claims, then it may be a regular consumer good just like other products on a bed--the pillow, sheets, or mattress. According to the NYT story, the CPSC has long-maintainted that bed rails are medical devices outside of their purview, however, FDA officials have noted that the line is not so clear.

See Our Related Blog Posts:
Reminder: Bed Rail Dangers are Real

Consumer Voice on the Dangers of Bed Rails