The CPSC (Consumer Product Safety Commission) and the FDA (Food and Drug Administration) have received many death and serious injury reports related to portable adult bed rails and hospital bed rails. Most of the injuries and deaths were related to entrapment or falls. Bed rails are metal bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They are also used to prevent people from rolling out of bed.
In November of 2012, The New York Times published a report about an elderly patient suffering from dementia who was found dead in her room. She had apparently strangled when she got her head caught in the side rails of her bed. The rails were placed there to keep her from falling out of bed and to keep her safe. Unfortunately, they killed her.
The death which had occurred six years before the The New York Times reported on the incident, caused great concern for the victim’s daughter, Gloria Black. Ms. Black began writing letters to the FDA and the CPSC and began to see firsthand the need for regulations for this segment of the healthcare industry.
At first, the CPSC and the FDA had a difficult time determining which entity was responsible for investigating the 150 reported deaths and the 4,000 injuries a year reported to them. The question that stumped the agencies was this: Are bed rails medical devices investigated by the FDA or are they simply consumer products and therefore investigated by the CPSC?
The CPSC investigates if the product is simply a consumer product. The FDA is responsible if the device claims to ensure “safety” of a person with a specified medical condition, such as Alzheimer’s disease. Since industry claims vary, neither organization has stepped in to regulate the product.
Investigations have been performed to determine the causes of deaths or injuries associated with the use of bed rails. Industry officials have found that in many cases a bed rail was paired with a mattress or bed frame from different manufacturers. The bed rails did not fit properly and left large gaps between the mattress and the rail. It is believed that patients suffering from dementia rolled into the gaps, became confused and suffocated. Other patients were simply not strong enough to free themselves from the entrapment.
Whatever the cause of the death, it is the duty of any manufacturer to warn nursing homes and caregivers of the dangers of this potentially deadly device.
If you or someone you love has been injured or killed by a defective product, call The Thomson Law Firm for a FREE consultation today.
