Anaesthesia and ventilation

Publications
We have published several dedicated documents relating to these devices including:

• medical device alerts
• one liners
• leaflets/posters.

Alerts
Alerts (medical device alerts, safety notices, hazard notices and device alerts) issued prior to 2007 are available at our Safety warnings section. Those issued since 2007 are listed below, followed by generic alerts from the last 5 years.

Medical Device Alerts issued since the beginning of 2007

Laryngoscope blades: Falcon single-use paediatric Miller blades size 00, 0 & 1, supplied by Draeger Medical UK.
Poor illumination of the airway and heating of the blade due to manufacturing problems with the bulb. The manufacturer is recalling all potentially affected devices, see UK distributor and manufacturer recall letters in the Appendix (in pdf only).
› MDA/2007/062 - Laryngoscope blades: Falcon single-use paediatric Miller blades size 00, 0 &1, supplied by Draeger Medical UK

Oxygen humidifier: - Hudson RCI® large volume nebuliser, product code 41770, NHS Supply Chain Code FDE 069. Lot numbers consisting of 10 numbers beginning: 50069/….., 52069/….., 01079/….., 06079/….., 16079/….., 17079/….. 17079R/…., 18079/….. Manufactured by Teleflex Medical.
There is the potential for lower than required oxygen concentration to be delivered due to a manufacturing fault. The manufacturer has recalled the above devices.
› MDA/2007/061 - Oxygen humidifier: - Hudson RCI® large volume nebuliser, product code 41770, NHS Supply Chain Code FDE 069

Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Models: 3000.308.10 and 3000.308.10T.
Poor contact between Timesco stubby handles and Timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation.
› MDA/2007/045 - Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd

Primus anaesthetic workstation supplied by Draeger Medical UK Ltd.
Potential misconnection of the backup oxygen cylinder; the oxygen cylinder inlet is situated alongside an oxygen outlet and both are fitted with the same connector. A misconnection to the oxygen outlet would prevent backup oxygen supply in the event of oxygen pipeline failure.
› MDA/2007/040 - Primus anaesthetic workstation supplied by Draeger Medical UK Ltd

All paediatric ventilator breathing systems containing a water trap, manufactured by Viasys Healthcare.
The MHRA has received reports of Viasys auto drain water traps failing to drain accumulated fluid. The manufacturer is investigating these failures. At this time there is no information available as to the extent of this problem, therefore the affected water traps may be found in any Viasys paediatric breathing system. The MHRA is urging caution in the use of these Viasys breathing systems until further information is available.
› MDA/2007/037 - All paediatric ventilator breathing systems containing a water trap, manufactured by Viasys Healthcare

Reusable flexible laryngeal mask airway size 2.5 supplied by Intavent Orthofix Ltd.
Model codes: 7125R and 7125DR.
Risk of the tube kinking in the proximity of the connector, which could lead to the obstruction of airflow to the patient.
› MDA/2007/028 - Reusable flexible laryngeal mask airway size 2.5 supplied by Intavent Orthofix Ltd

Laryngoscope: Callisto Macintosh size 3 (adult) single-use laryngoscope blade, manufactured by Timesco of London Ltd.
The fibreoptic core may break and separate from the blade. The manufacturer has initiated a recall of all affected product.
› MDA/2007/021 - Laryngoscope: Callisto Macintosh size 3 (adult) single-use laryngoscope blade, manufactured by Timesco of London Ltd

Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea.
Plastic tabs incorporated into the re-usable CPAP mask connectors may break off when in use with the possibility of components entering the patient’s airways. The affected connectors are found in most Fisher and Paykel CPAP face, nasal and oral mask kits, and various tubing kits. Fisher and Paykel have now redesigned this connector (available since April 2006) and are recalling all face mask kits with the previous version.
› MDA/2007/014 - Fisher and Paykel Healthcare re-usable CPAP respiratory masks and connectors for obstructive sleep apnoea

BOC Ltd, AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units.
Following the issue of MDA/2007/007, regarding AZ aluminium medical oxygen cylinders, BOC have informed MHRA that a similar problem has been found in a small number of medical nitrous oxide AZ cylinders. These cylinders have been fitted with an obsolete pin index valve containing a ferromagnetic component that makes the cylinder potentially hazardous when used in an MRI environment.
› MDA/2007/011 - BOC Ltd, AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units

Neonatal radiant warmer: Draeger Resuscitaire, model RW82VHA-1C with variable height adjustment.
Screws that secure the column to the base of the Resuscitaire may loosen over time, allowing the support column to tilt, due to an incorrect fitting.
› MDA/2007/008 - Neonatal radiant warmer: Draeger Resuscitaire, model RW82VHA-1C with variable height adjustment

BOC Ltd, AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units.
BOC have informed MHRA that a problem has been found in a small number of medical oygen AZ cylinders. These cylinders have been fitted with an obsolete pin index valve containing a ferromagnetic component that makes the cylinder potentially hazardous when used in an MRI environment.
› MDA/2007/007 - BOC Ltd, AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units

Generic notices issued in the last five years

All anaesthetic breathing systems
Entrapment of anaesthetic breathing system between the operating table and patient transfer trolley.
› MDA/2005/062 - All anaesthetic breathing systems

Suction systems including suction tubing, collection jar/canister and suction controller
Misassembly of suction systems leading to failure during emergency use.
› MDA/2005/035 - Suction systems including suction tubing, collection jar/canister and suction controller

Heat and moisture exchanger (HME) and heat moisture exchanging filter (HMEF) incorporated into anaesthetic and respiratory therapy breathing systems
HME components have very occasionally entered anaesthetic breathing systems and caused blockages in the breathing system with potential to cause excessive resistance.
› MDA/2004/037 - Heat and moisture exchanger (HME) and heat and moisture exchanger filter (HMEF), incorporated into anaesthetic and respiratory therapy breathing systems (e.g. ventilator)

Reusable nebulisers
Potential risk of transmission of Legionella bacteria due to poor drying after cleaning.
› MDA/2004/020 - Reusable nebulisers

All breathing system filters and heat  moisture exchanging Filters (HMEFs)
Inconsistencies in the methods used for testing filter efficiency can lead to difficulty in comparing their effectiveness.
› MDA/2004/013 - All breathing system filters and heat and moisture exchanging filters (HMEFs)

Anaesthetic vaporizers (all manufacturers)
Risk of an overdose of anaesthetic agent due to overfilling of the vaporizer.
› MDA/2003/039 - Anaesthetic vaporizers (all manufacturers)

Medical gas regulators and flowmeters
Risk of rupture, ignition or inadequate therapy.
› MDA/2003/016 - Medical gas regulators and flowmeters

Medical Gas Hoses for Oxygen
Risk of fire form worn or damaged hoses.
› MDA/2003/007 - Medical Gas Hoses for Oxygen

Manual Resuscitators/Self-inflating Resuscitation Bag
Risk of Misassembly Following Cleaning.
› SN 2001(33) - Manual Resuscitators/Self-inflating Resuscitation Bag: Risk of Misassembly Following Cleaning

All respiratory therapy devices connected to endotracheal and tracheostomy tubes
Risk of serious injury due to incorrect assembly.
› HN 2002(07) - All respiratory therapy devices connected to endotracheal and tracheostomy tubes: risk of serious injury due to incorrect assembly

Nebulsation therapy
Risk of incorrect connections.
› SN 2002(03) - Nebulisation therapy: risk of incorrect connections

Pre-use checks
A series of publications relates to the occurrence of blockages in breathing systems. These included a Hazard Notice (HN 2001(05)) and a DH publication ‘Protecting the breathing circuit in anaesthesia - Report to the Chief Medical Officer of an Expert Group on blocked anaesthetic tubing’.

We highlighted the importance of pre-use checks in anaesthesia in MDA/2004/003, which promoted the use of the Association of Anaesthetists in Great Britain and Ireland’s checklist for anaesthetic equipment 2004.

Leaflets
Domiciliary ventilators for life support are increasingly being used in the home environment. Two leaflets have been published providing some usage tips; one for users/carers and one for healthcare professionals.

A top ten tips leaflet on transport ventilators has been published providing tips on how to prevent many of the common incidents.

One Liners
We have also received several reports related to use issue on tracheostomy tubes. Therefore, we issued a dedicated One Liner (issue 37) on this topic.

Contacts for further information
Doug McIvor: douglas.mcivor@mhra.gsi.gov.uk or 020 7084 3193
Louise Mulroy: louise.mulroy@mhra.gsi.gov.uk or  020 7084 3344

Device problems can be reported to MHRA online..