URGENT WARNING Regarding the use of 200 bar oxygen Medical Gas Cylinders with Inhalation Sedation Equipment
On the 14th January 2013 the MHRA issued a Medical Device Alert Ref: MDA/2013/002 warning about the use of medical oxygen and medical air cylinders filled to 200 atmospheres (200 bar). The alert was aimed at all medical, technical and nursing staff responsible for handling or attaching medical oxygen cylinders to medical devices and warned of risk of serious injury to staff and patients. The MHRA Device Alert instructs all users to check the cylinder label before use to ensure the cylinder gas and pressure are appropriate. They also state that 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.
In February 2013 R A Medical Services had suspicion to believe a faulty inhalation sedation machine, last serviced in January 2013, but reported as malfunctioning, had been connected to one of these cylinders. This equipment comprised a Quantiflex Analogue MDM R A Head mounted on a Mobile 4 Cylinder Stand.
Currently, Inhalation Sedation equipment is not designed to be used with cylinders filled to more than 137 bar and indeed, regulators fitted to mobile 4 cylinder stands are not designed to withstand inlet pressures of more than 138 bar. This also applies to pipework and gauges. Use of 200 bar oxygen cylinders is likely to cause significant damage. Therefore we are issuing a warning against use of these 200 bar cylinders with Inhalation Sedation equipment as it will immediately negate any equipment warranty in place and has the potential to be a causative factor in a more serious occurrence involving dental personnel.
This warning applies to, but not exclusively, inhalation sedation flowmeter types such as:
Quantiflex Mark I, Mark II, Digital and Analogue MDM, Accutron Ultra and Newport flowmeters and associated equipment such as mobile four cylinder stands.
Any user in doubt or requiring further clarification is urged to contact their supplier without delay and should put amended procedures for cylinder handling and awareness into place as a matter of some urgency.
Issued 6th March 2013
Mrs J E Pickles – R A Medical Services Ltd