Public Citizen, the consumer advocacy group, has filed a petition with the U.S. Food and Drug Administration (FDA), urging the agency to order a Missouri company to recall all Bedside Assistant bed handles, also known as bed rail devices, because they pose a danger to weak and frail elderly who can be injured by the medical device. The rails are supposed to offer support for those who are bedridden, but they can strangle and suffocate those who are caught between the rails and the mattress, says the petition pointing out that bed rails are used in patients’ and nursing homes.
The Public Citizen Health Research Group found that since 1999, four patients have been trapped by Bedside Assistant, however the true number may not be known because a nursing home may not think to contact the FDA not understanding that this is a medical device overseen by the FDA. Deaths sometimes occurred when the patient’s trachea or chest wall pressed against the support bars and the frail person could not extract themselves.
The Public Citizen petition compares the defective medical device to the defective drop-side cribs, 7 million of which are currently being recalled by the Consumer Product Safety Commission. Both have trapped people too weak to protect themselves, i.e. infants and elderly.
In its defense, the manufacturer says the Public Citizen petition is incomplete and inaccurate. A spokesman says that after a second injury, the company added buckles and straps to securely affix the bed handles to the bed, therefore fixing the defective design. He says there have been no additional problems since the straps were added. A defective design will impact the entire lot of product manufactured and a retrofit is not exactly a sound alternative to recalling the entire lot and fixing the design defect.
Farah & Farah’s product liability attorneys in Jacksonville understand that a manufacturer may have made a mistake in manufacturing, which may affect a number of products, or there may be a defective design, which likely will affect the entire product. With the deaths of at least four individuals whose families relied on the promises of Bedside Assistant, adding a security strap may not be the best way to fix a defective product, though it may be the most cost-effective fix. Don’t our seniors deserve better?
Sources: http://www.citizen.org/hrg1947 and http://thechart.blogs.cnn.com/2011/05/04/bed-handles-dangerous-for-elderly-public-citizen-says/
