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Bed Rail Injuries and Gaps in Governmental Agency Regulations

by Leah Greene, JD, LLM on December 4th, 2012

Bed rails are often implicated in the injuries of elderly patients, many times because elderly patients and Alzheimer’s patients become confused and get caught in the bed rails.  From 2003 to May 2012, 150 adults, mostly elderly, died after becoming trapped in bed rails. During nearly the same time period, nearly 4,000 elderly adults per year were treated in emergency departments for injuries related to bed rails.

Governmental oversight of bed rails falls into a regulatory gap. The Food and Drug Administration (“FDA”) regulates medical devices, but for bed rails to be considered medical devices, the manufacturer must make specific claims, such as whether the bed rails will prevent a dementia or Alzheimer’s patient from falling out of bed. Otherwise, the bed rails are considered a consumer safety product and fall under the purview of the Consumer Product Safety Commission (“CPSC”).

The FDA attempted to put bed rail regulations in place beginning in 1995, but it decided against it after manufacturers resisted, citing costs and difficulties in getting the regulations through layers of governmental approval. Instead, in 2006, the FDA issued voluntary guidelines, with recommendations for size limits for the gaps between the bed rails and the bed and identified the body parts that were most likely to get stuck.

Currently, industry officials maintain that bed rails are an effective way of keeping older patients safe, but preventing injuries is problematic when the different bed parts, such as the mattress, rails and frame, come from different manufacturers.

Elder safety is becoming an increasingly higher priority with the aging of the American population, so the FDA and CPSC have recently begun closing the regulatory gap regarding bed rails.  No required regulations are in place, but we will update you on any changes in that area.

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