Devices Claimed to Improve Safety Are Dangerous, Reports Biomedical Safety & Standards
Portable bed rails marketed to "make any bed safer" actually increase the risk of injury and death, according to an article in the November 15 issue of Biomedical Safety & Standards (BS&S). A newsletter for medical device safety professionals, BS&S is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
Two consumer watchdog groups have requested the Federal Trade Commission (FTC) to order one manufacturer to stop making false advertising claims regarding the safety of its portable bed rail. A front-page feature in BS&S reports on the request and provides background on the safety concerns related to the use of such products.
Bed Rails Linked to Deaths—Request to Stop False Advertising
In September, two groups sent a formal letter to the FTC requesting that one manufacturer be stopped from making false safety claims for its portable bedrails. Last year, one of the groups petitioned the U.S. Food and Drug Administration (FDA) to ban marketing and order a recall of specific bed rail models; to assess the design and use of similar bed handle or bed rail devices; and to investigate the risk of life-threatening injury or death from entrapment, strangulation, or positional asphyxia and ban other devices as appropriate.
The request cites more than 525 deaths associated with bed rail use that have been filed with the FDA, along with more than 155 deaths reported to the Consumer Product Safety Commission (CPSC). There are multiple "entrapment zones" with the use of a bed rail, each with a risk of causing death by asphyxiation. This entrapment risk can be a fundamental feature of the design of the rail openings or may arise from how the bed rail attaches to the bed.
Meanwhile, the manufacturer continues to make safety clams, such as that its product "makes any bed a safer bed." In the petitions, the FTC is asked to order the manufacturer to stop making these unproved safety claims. Other portable bed rails on the market present similar safety issues.
Previous CPSC standards addressing bed rails for children and toddlers have led to sharp reductions in injuries and deaths in young children. However, the standards don't apply to products intended for adults—especially older adults, for whom falls are a common and potentially catastrophic event.
There's no evidence that side rails safely prevent falls, whereas other measures—such as lowering the bed and using anti-slip matting—are effective. "A fall with a bed rail in place is more dangerous than a fall without a rail, because of the change in trajectory of the fall”, according to the article in BS&S.
Although hundreds of deaths have been reported, it is likely that the true number of incidents is substantially higher. Home users and even some health care professionals may be unaware that such events should be reported to the FDA or CPSC. (Or if they are aware, they may not be motivated to report.) The BS&S feature article concludes, "Given portable bed rails are often sold directly to consumers and through medical supply stores, consumer groups think the CPSC and the FDA, both of which have been petitioned for rulemaking repeatedly in these matters, should be taking action to regulate, force recalls, and effectively ban marketing and sales of the dangerous devices.
About Biomedical Safety & Standards
Biomedical Safety & Standards has been a key resource for reliable information in the areas of medical safety and standards for more than three decades. The newsletter updates biomedical technicians and clinical engineers on the latest developments in patient safety, standards, regulations, incidents, device recalls, and professional issues. Bi-weekly issues cover everything needed to stay current on technology, safety and risk policies, new laws and standards, and equipment maintenance. Regular features include reports on safety, hazards, and risk management; updates on class I and II FDA recalls and field corrections; briefings on the latest requirements for medical equipment and/or facilities; legal issues surrounding medical device safety; the latest news from government agencies; and new educational resources.
About Lippincott Williams & Wilkins
Lippincott Williams & Wilkins (LWW) is a leading international publisher of trusted content delivered in innovative ways to practitioners, professionals and students to learn new skills, stay current on their practice, and make important decisions to improve patient care and clinical outcomes.
LWW is part of Wolters Kluwer Health, a leading global provider of information, business intelligence and point-of-care solutions for the healthcare industry. Wolters Kluwer Health is part of Wolters Kluwer, a market-leading global information services company with 2011 annual revenues of €3.4 billion ($4.7 billion).