Are healthcare providers required to comply with the HBSW documents?
As stated in the FDA Hospital Bed System Dimensional Guidance and Assessment Guidance to Reduce Entrapment, “The FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” Similarly, the other HBSW documents are guidances not requirements. However, some states and authorities having jurisdiction (e.g., state Departments of Health) have adopted or might choose to adopt the HBSW documents into their requirements for healthcare providers, and thus the documents may be required to be followed in certain localities.
