§ Mr. Gordon MarsdenTo ask the Secretary of State for Health what recent discussions(a) his Department and (b) the Medical Devices Agency has held with (i) residential and nursing homes, (ii) NHS trusts and (iii) patients' groups on guidelines for the use of bed rails; and what plans there are to issue further guidelines. [113038]
§ Jacqui SmithThere have been no recent direct discussions with these bodies by either the Department of Health or the Medical Devices Agency, now the Medicines and Healthcare Products Regulatory Agency. There are no current plans to issue further guidelines, as we have recently issued 41,500 wall posters on this subject to care homes, the independent healthcare sector and the national health service, together with our guidance document, DB2001(04), "Advice on the safe use of bed rails". We are embarking upon a programme of countrywide training events for users of bed safety equipment in conjunction with the Disabled Living Centres Council. This will provide useful hands-on experience with a variety of current equipment to care assistants, nurses and occupational therapists.
§ Mr. Gordon MarsdenTo ask the Secretary of State for Health what guidelines are in place on the use of bed rails for people with osteoporosis and similar brittle bone conditions. [113039]
§ Jacqui SmithThe Medical Devices Agency, now the Medicines and Healthcare Products Regulatory Agency (MHRA), published a guidance document in 2001, DB2001(04), "Advice on the safe use of bed rails", which highlighted the importance of individual risk assessment for every bed occupant, rather than focussing on particular patient groups. No specific guidelines have been published by the MHRA, or any other body that we are aware of, in relation to bed rail use by people with osteoporosis.
§ Mr. Gordon MarsdenTo ask the Secretary of State for Health how many(a) fatalities and (b) serious injuries from incidents involving bed rails have been reported to the Medical Devices Agency in each year since 1994. [113041]
§ Jacqui SmithThe available information is shown in the table.
Fatalities Serious injuries 1994 0 0 1995 0 0 1996 1 0 1997 4 3 1998 2 0 1999 3 0 2000 7 1 2001 4 3 2002 7 1 2003 1 1 These data should be interpreted with caution.
The existence of a report does not imply established causality, and there has been a significant increase in reporting levels for all devices following initiatives by the Medicines and Healthcare Products Regulatory 737W Agency to address under-reporting, together with the introduction of mandatory vigilance reporting under the Medical Devices Directive.