2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC51
Submitter : Mr. James Gilmore Date & Time: 12/15/2004 11:12:29
Organization : Newport Hospital
Health Professional
Category :
Issue Areas/Comments
Newport Hospital understands & appreciates the intention of this document ... to minimize the potential of patient entrapment in a hospital bed. But, as written, this guidance will create an expectation of & focus attention on proactive testing of existing beds with little or no actual risk reduction. We do feel, however, the dimensional guidance has value to existing beds if it is clearly stated that the primary focus is to be of a 'Clinical Assessment' of the patient's physical condition to establish whether they are or not vulnerable to the risk of bed entrapment. At that point the clinical & support staff can use the assessment tool and/or guidance to meet the needs of the patient as appropriate ... not just arbitrarily going around wasting scarce resources testing/assessing beds. Besides 'Clinical Assessments' (patient assessment 1st on existing beds) this document should also direct its intention on establishing dimensional limits for NEW beds manufactured after the implementation of this document. Jim Gilmore, Director of Facilities Mgmt & Support Svc, Newport Hospital, Newport, RI.