Bed rails under new scrutiny

Q&A with Invacare’s Phil Cunningham
Friday, January 11, 2013

YARMOUTH, Maine – A recent New York Times article shone a bright light on the dangers associated with bed rails: the injuries and deaths (36,000 and 150, respectively, from 2003 through May of 2012), and the lack of oversight on manufacturers. On the heels of that article, Rep. Edward Markey, D-Mass., called on several government agencies to form a national task force dedicated to better addressing the regulation and oversight of bed systems and bed rails. Here’s what Phil Cunningham, business manager of HME and LTC Beds for Invacare, had to say about where the manufacturer stands on bed safety.

HME News: So there are guidelines for manufacturers, but no requirements?

Phil Cunningham: Right. There are guidelines that the FDA has published (UL60601-2-38), and if you look at the big picture, we fully support those guidelines. Every one of our bed systems is tested to meet the guidelines.

HME: How do you feel about the possibility of increased regulation?

Cunningham: I hope a couple of things happen, and we’re already seeing movement in other countries on this. Europe has already adopted a standard that takes the FDA guidelines to a new level (IEC 60601-2-52). It’s much more stringent—the gap limits are much narrower. Then Health Canada this summer sent out letters basically urging all the hospitals and nursing homes to start upgrading their facilities and getting rid of equipment prior to 2002. They were manufactured before any guidelines.

HME: The Times article also talked about the dangers associated with having bed systems that are pieced together from various manufacturers. Why is this a problem?

Cunningham: There are a couple of things. The size of a deck may vary and that extra 1/2 inch to 1 inch causes a lot of problems. Seventeen percent of deaths and injuries occur between the side of the mattress and the bed rail. A mattress may have 5-inch foam instead of 6-inch foam and 1.6 pounds of density instead of 2.3 pounds, meaning it collapses more easily and creates a gap.

HME: What’s the role of HME providers in promoting safety?

Cunningham: Providers need to educate the consumer and caregiver about entrapment—if the person is getting restless or they’re trying to get out of bed or they don’t have a lot of cognitive ability, there’s a big risk for entrapment.