On March 10, 2006, the FDA (U.S. Food and Drug Administration) released long-awaited guidelines for reducing the risk of bed entrapment: “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment”. The new Guidance identifies potential entrapment areas and those body parts most at risk for entrap- ment; provides design criteria for manufacturers of new hospital/convalescent beds; recommends particular test methods to assess the conformance of existing hospital/convalescent bed systems; and answers frequently-asked questions about entrapment issues.
The new Guidance was a result of a long-standing collaboration between the FDA and the Hospital Bed Safety Workgroup (HBSW), formed in 1999. Graham-Field’s Long-Term Care Bed division: Basic American Medical Products, is an HBSW charter member. As a result of Graham-Field’s commitment to product safety, all of Graham-Field current long-term care beds have been strictly tested and conform to the new FDA Guidance.
The guidelines set forth by the FDA Guidance layout specific dimensional limitations on potentially injury-threatening gaps and spaces that can occur between bed system components, such as rails, when not properly installed. Graham-Field and Basic American Medical Products have conformed to these guidelines from a manufacturing aspect. However, entrapment issues can often arise when a healthcare provider/facility has not correctly assembled the components on a bed. It is essential that the provider/ facility fully understand their responsibility in complying to the guidelines set forth by the FDA in order to avoid injury. To that end, we have provided the links below as a resource for understanding and following these guidelines for the safety of the patient/resident.
Graham-Field encourages all hospital bed owners to read the FDA guidance.
◗Please visit the FDA’s Hospital Bed Safety page at "http://www.fda.gov/cdrh/beds/"
◗To find many resources, including a link to the new Guidance page go to "http://www.fda.gov/cdrh/beds/guidance/1537.pdf"
◗Ordering instructions for a Testing Kit which you can use to determine whether your beds are in conformance with the guidance can be found at "http://www.fda.gov/cdrh/beds/entrapmentkit.html"("http://www.fda.gov/cdrh/beds/entrapmentkit.html" http://www.fda.gov/cdrh/beds/entrapmentkit.html) ;
◗A discussion of Clinical Guidance protocol which you can use to assess an individual patient’s needs when using a side rail can be found at "http://www.ute.kendal.org/learning/documents/clinicalguidance_SideRails.pdf"
These resources will supply you with the knowledge to evaluate the safety of the hospital beds you currently own.
It is also essential to have the correct bed components/accessories that correspond with the needs of your patient/resident and the particular bed you have purchased. Matching the correct bed component that correlates with the regulatory guidelines can be a daunting task. Our Graham-Field Sales team and the friendly Customer Service Representatives at Basic American Medical Products can help you sift through the wide array of compliance and bed options. We will help you determine which bed/bed part is best for your patient’s/resident’s particular needs and help you with your compliance issues.
