U.S. Agencies to Develop Standards for Bed Rails

“Considering the number of deaths and injuries, we strongly believe all reasonable and timely efforts should be undertaken to address this hazard and protect the safety of the public,” the agencies wrote.

The standards were developed by ASTM International, which is an organization that develops and publishes voluntary technical standards for a wide range of products and which will oversee the committee.

A spokesman for Representative Edward J. Markey, Democrat of Massachusetts, who had called on the agencies to address bed rail deaths, said the congressman was disappointed.

“It’s a really tepid response,” said the spokesman, Eben Burnham-Snyder. “They issued voluntary standards for bed-rail manufacturers the last time and people still died. We’re not sure how this is going to be different.”

Gloria Black, who has campaigned for safer bed rails after her mother was killed in a 2006 accident, said the agencies’ action was a positive first step. “But they are still not addressing the serious problem of deaths and injuries that occur in hospital beds, only portable rails,” she said.

Bed rails are metal or plastic bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They can also prevent people from rolling out of bed. But sometimes patients, particularly those with Alzheimer’s, can get confused and trapped between a bed rail and a mattress, which can lead to serious injury or even death.

After first being warned of the deaths in 1995, the F.D.A. in 1999 formed a working group made up of medical device makers, researchers and patient advocates. The agency considered requiring bed rail makers to add warning labels, but decided against it after they resisted. The agency said the added cost to small manufacturers and the difficulties of getting regulations through layers of government approval worked against tougher standards.

In 2006, the F.D.A. issued voluntary guidelines, instructing hospitals and nursing homes on the use of bed rails.

Last year, The New York Times reported that about 550 bed-rail-related deaths had occurred since 1995. In a review, the safety commission found 155 such deaths from January 2003 to last September. Most of those who died were 60 or older. Almost 37,000 people were injured in bed rail accidents and treated at hospital emergency rooms from 2003 to 2011, the agency said.