Earlier this year the Food and Drug Administration issued long overdue guidance to the healthcare industry to reduce the risk of hospital bed entrapment. The FDA has identified over 400 deaths from this serious problem since 1985, although there is reason to believe this figure underestimates the true number of deaths. View the FDA press release here.
While these numbers appear small, we believe they are signals about significant adverse events. Often, adverse events such as these go unreported to the FDA making it likely our counts of these tragic adverse incidents is lower than the number that actually occurs. – Larry Kessler, Sc.D., Director, Office of Science and Engineering Laboratories, FDA’s Center for Devices and Radiological Health
Those especially at risk include the critically ill and elderly in hospitals and nursing homes. Once a patient’s head, neck or chest becomes trapped they can suffocate, leading to hypoxia, brain injury and death. The FDA’s final guidance for industry, along with other documents to help patients and their families can be found on the FDA website.