The Canadian government agency Health Canada issued a reminder to hospitals last fall on the risk of entrapment of patients in hospital beds. This notice raises again what should by now be a well known hazard. Some side rail-mattress-bed frame combinations present a risk of the patient becoming injured and possibly killed if part of their body gets stuck within a side rail, between parts of a split rail, or between the side rail and the mattress or bed frame. While the Health Canada notice cites in particular an older model Stryker bed (FL14E1), this is not the only older product still in use that can present such a risk. Nor is there adequate assurance that even newer beds are safe. Furthermore, it is not just hospitals where the problem exists since nursing home, long term care, and home hospital type beds also continue to be the cause of patient deaths.
Side rail entrapment is an issue for everyone involved in the design, distribution, selection, and use of hospital-style beds. The U.S. FDA has addressed this issue since at least 1995, and many other reports, notices and documents have followed including material from the Hospital Bed Safety Working Group (HBSWG). The HBSWG has produced a variety of publications and a dimensional guidance document, but a guidance document and its recommendations are not mandatory. A similar guidance document was issued by Health Canada in 2008. Unfortunately there does not appear to have ever been a recall or other market withdrawal of side rails or bed systems that are not in compliance with the newer guidelines, and even new products do not necessarily meet the guidance since not all side rails are subject to before-market scrutiny.
The entrapment issue is also complicated by not all patients necessarily being equally vulnerable. In general big people are at lower risk for at least some kinds of entrapment because their body parts may be less likely to fit into or through the dangerous spaces. However achieving safety by patient selection is at best a challenging endeavor because it requires one-on-one assessment by a knowledgeable person using explicit patient size criteria—which are not available. In any case, eliminating the inherent risks of a product is a far better safety measure than relying on determining who is vulnerable to those risks.
The “bed system” concept includes the interchangeability of many side rail products among various beds, and the role of the size and stiffness of the mattress in creating gap openings. Easy interchangeability also may be related to frequent changes, thereby increasing the risks associated with inappropriate combinations or improper assembly. Furthermore, the difference between a bad side rail and a better side rail may be relatively subtle and therefore not easily recognized by an untrained or superficially trained eye.
The best way to address the entrapment risk includes the following:
Be sure appropriate personnel are well trained with respect to bed entrapment risks.
Determine if the patient really needs side rails. If not, this gives you the opportunity to exercise what is always the first choice in hazard mitigation — eliminate it.
If you own bed systems, determine yourself if they are in compliance, ask the manufacturer, or as a last resort, hire someone who knows how to do the necessary measurements. If you ask the manufacturer, insist on a clear and explicit answer, preferably in writing. If the manufacturer doesn’t know, that isn’t a good sign. If your beds are not compliant, consider replacement. Remember that someone might die in a bed that you knew or should have known was not compliant.
If you buy bed systems, insist on written compliance certification from the manufacturer. If the manufacturer balks, keep shopping. As you replace beds, determine what to do with older non-compliant ones.
If you have seemingly interchangeable components, or when buying replacement mattresses, be sure that a combination that is a compliant does not become non-compliant if configured differently. Create a system to control interchangeability if necessary.
If you rent beds, ask the rental supplier if their beds are in compliance, and if they have older non-compliant products still in their inventory. If they do have older, find out how they segregate and select, and train their workers. Get the answer in writing, and if you can’t get a straight answer, or they don’t understand the question, go elsewhere for your rentals.
When rental beds are delivered and set up, have an individual who is knowledgeable about entrapment at least visually check the bed for compliance and correct assembly. For home care, also insist that the original instructions are provided.
If you are involved in ordering beds for patients, insist on a comprehensive prescription. Too many such orders say simply “hospital bed” without specifying with or without side rails, or full, half or split rails. With these brief orders there is often little direct evidence of assessment of the patient for entrapment risk. When this is the case, it is the equipment supplier who is making the decision on what kind of rails, if any, to supply. Subject to (6) above, the rental supplier may have a mix of old and new products, and lack the knowledge or processes necessary to control who gets what.
Be leery of add-on gap fillers. They may only work if designed for particular gaps in particular products, and they often rely on continuous placement and replacement by busy caregivers. Moreover, there is good reason not to take on the responsibility of fixing what is an inherent danger in a product.
The goal is clear. Hospital and home patients should not be killed by their beds. Do your part to make sure that it doesn’t happen.
William Hyman is a professor of biomedical engineering at Texas A&M University, College Station, Texas. His primary areas of professional activity are in medical device design, system safety and human factors. He is an executive board member and secretary of the ACCE Healthcare Technology Foundation and he is an editor of the Journal of Clinical Engineering. Dr. Hyman may be contacted at firstname.lastname@example.org