Infusion systems and pumps

MHRA has tackled this issue in several ways:

• We have issued a Device Bulletin on infusion systems, describing best practice with respect to the purchase, management and use of infusion systems DB2003(02)
• A One Liner was issued based on a variety of adverse incident investigations - Issue 16, August 2002
• Infusion systems are increasingly used in the home. We have issued a checklist of points to consider when patients and/or their carers are provided with a medical device, either from a clinic or on discharge from hospital
• We also issue safety information (Medical Device Alerts) covering a range of aspects. Please see list below for alerts issued since 2001

To support these publications, we are able to visit healthcare establishments and provide demonstrations of best practice and common errors (please use contact details below if you are interested). In addition, we run infusion pump study days, which are advertised on the 'Conferences and learning centre' part of our website. At these events, we use several posters to illustrate some common failures. A pdf file of the posters which you can print and display is attached. If you need to print larger versions, please contact us by e-mailing info@mhra.gsi.gov.uk and we can send you a high resolution file.

MHRA collaborated in the development of the National Infusion Device Training Programme (161Kb) which was launched jointly by the NHS Core Learning Unit in partnership with the NPSA in May 2006. The programme is free to the NHS and available now from www.clu.nhs.uk (external link).

Completion of the programme will:

• Ensure that staff understand how to use Infusion Devices properly
• Build competence and confidence amongst practitioners
• Promote patient confidence
• Reduce HAI
• Support organisations to deliver Risk Management and HCC standards (The programme is mapped to both HCC standards and to the KSF)

The programme is linked to a City and Guilds qualification accredited to FE level 3. Not all staff will wish to go for the accreditation but it is recommended. The unit has negotiated a significantly reduced price of £22.90 for the accreditation from City and Guilds.

If you would like any more information on the programme please contact the Core Learning Unit at: clpu@sysha.nhs.uk

The NHS Purchasing and Supply Agency's Centre for Evidence-based Purchasing (formerly the MHRA Device Evaluation Service) also evaluates a selection of infusion systems. 

Recent Medical Device Alerts relating to infusion systems

MDA/2006/058 - Volumetric infusion pump: Alaris SE pump - all models

MDA/2006/048 - Elastomeric infusion pump: Baxter Intermate and Infusor large volume (LV) infusion pumps

MDA/2006/042 - Syringe pump: IVAC P4000 manufactured by Cardinal Health (formerly known as ALARIS)

MDA/2006/011 - Baxter Ipump pain management system, APII infusion pump, PCAII syringe infusion pump

MDA/2006/010 - Baxter Colleague volumetric infusion pumps: all models

MDA/2005/071 - Baxter Colleague volumetric infusion pumps: all models

MDA/2005/050 - Baxter Healthcare Colleague volumetric infusion pumps product code 2M8151K, FKM8151 and 2M8153K - Recall

MDA/2004/059 - Baxter 6060 solution sets and Sabraset administration sets for use with Baxter 6060 multi-therapy ambulatory infusion pump

MDA/2004/053 - Administration sets for use with Graseby 500, 505 and AVI volumetric infusion pump systems

MDA/2003/035 - Medtronic SynchroMed® Implantable Drug Pump

SN 2000(25) - ALARIS (IVAC) 597 and 598 Pumps: Risk of over Infusion

Contacts

Jim Lefever: jim.lefever@mhra.gsi.gov.uk or 020 7084 3262

Catriona McNie: catriona.mcnie@mhra.gsi.gov.uk or 020 7084 3219