Alerta De Seguridad O Notificaciones De Seguridad para Medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar/20,000 kPa)

Safety alert / Field Safety Notice

MDA/2013/002

CON224427

2013-01-14

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON224427?tabName=allTabs

Risk of serious injury to staff and patients. currently 137 bar cylinders are widely used in the uk. connection to significantly higher pressure 200 bar cylinders may cause damage to devices such as anaesthetic machines, ventilators, incubators, respiratory support and resuscitation equipment. a hospital trust is undertaking a pilot scheme to introduce 200 bar cylinders into clinical use. while the trust involved has ensured the safety of these cylinders within their organisation, there are concerns that these cylinders could be moved out of the trust during patient discharge, or patient transfer in ambulances for use with transport incubators and transport ventilators.

Be aware that 200 bar medical oxygen and medical air cylinders will be entering clinical use in a pilot scheme.  If this pilot is successful, the use of 200 bar cylinders is expected to become widespread across the UK. Before connecting these 200 bar cylinders to medical devices staff must confirm that it is safe to operate at this higher pressure by checking the instructions for use, or contacting the manufacturer. All users should check the cylinder label before use to ensure the cylinder gas and pressure are appropriate and that the expiry date has not been exceeded. Staff must seek permission to remove cylinders for use outside the hospital and ensure the above checks are carried out prior to use.