What is Health Canada’s position on the HBSW documents?
Health Canada, through the Medical Devices Bureau of the Therapeutic Products Directorate, has participated in the development of the HBSW documents. As an active partner in the development of the documents, Health Canada has used HBSW work to produce its own guidance documents. The public comment period ended July 3, 2007, after which the guidance will be finalized. For the current draft, please see the Health Canada Web site at http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index_e.html#guidance_devices. The main differences from the FDA Guidance are (1) the addition of recommendations for side rail latch reliability, (2) the addition of data on other types of bed issues reported to Health Canada, and (3) the inclusion of a form to report bed entrapment incidents to help in the investigation of these incidents and to better assess the effectiveness of the guidance. Manufacturers that sell beds in Canada and Canadian user facilities are also encouraged to consult other H
