Revised: 23 November 2007
Safety Information
Medical Device Safety Issues
Discontinuation of supply of Graseby MS16A and MS26 syringe drivers
Wellington
23 November 2007
Ref - TT05-16-2-6
Earlier this year Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, raised concerns with Smiths Medical about the safety of the Graseby MS-Series Syringe Driver. These syringe drivers are commonly used in palliative care and other situations to provide continuous ambulatory infusion of medicines. As a consequence of Medsafe's action Smiths Medical decided to cease supply of the Graseby MS-Series Syringe Driver to the market with effect from 4 October 2007.
This document briefs you on the situation, the reasons for Medsafe's action and the action that will need to be taken by users of these devices.
Background
Regulators in several countries, including Australia and the UK, have previously issued safety alerts in relation to the Graseby MS-Series Syringe Driver and these have related to possibilities of over-infusion, tampering with the device and confusion between the different models of Graseby device.
Among the specific points noted by regulators were;
- The visually similar MS16A and MS26 models have a 24-fold difference in infusion rate. Confusing the two has resulted in multiple serious adverse events
- The device does not use standard measuring units requiring a calculation to set the flow rate, thus introducing the risk of error.
- The pump lacks a stop button.
- The rate can be changed while the pump is in operation.
- There is no protection against misloading of the syringe, air entrainment, tampering or siphoning.
- The occlusion response characteristics of this pump are very poor.
- The pump does not retain a record of operation
- Some models feature a "prime" button which provides maximum infusion rate when depressed. There is no limitation on the number of times this may be activated nor a record of activation. Serious adverse outcomes have resulted from inappropriate use.
Although available for some time it has become apparent that the safety features of the Graseby MS-Series devices have not been upgraded to comply with current minimum standards as recommended by internationally respected regulators.
In particular the Graseby MS-Series devices do not meet the Global Harmonisation Task Force for medical devices (GHTF) "Essential Principles of Safety and Performance of Medical Devices" guidelines. These guidelines reflect international minimum requirements for the safety and effectiveness of medical devices.
The "Essential Principles" may be downloaded from the GHTF website at;
http://www.ghtf.org/documents/sg1/sg1n41r92005.pdf
Smiths Medical and Medsafe agreed that the Graseby MS-Series devices did not meet these requirements and thus Smiths Medical decided to cease supply of the devices in New Zealand from 4 October 2007.
Current Situation
Supply of Graseby MS-Series devices in New Zealand ceased on 4 October 2007. Spare parts and service for existing devices continue to be available through Smiths Medical at this time.
Medsafe recognises the clinical implications of this situation and thus does not currently require existing devices to be recalled or withdrawn from clinical use when alternates are not available provided the manufacturer's instructions are carefully observed.
Medsafe also recognises the on-going risks associated with these devices and therefore advises users to give immediate consideration to sourcing alternative equipment which meets the "Essential Principles" for safety and efficacy.
The Next Steps
Medsafe has commenced consultation with healthcare professionals and stakeholder groups to determine a process and timeline for the removal of all existing Graseby MS-series devices from clinical use.
Users should consider how best to phase the use of these devices out and consider which device or devices may be used as a satisfactory replacement.
Medsafe does not undertake comparative evaluation of medical devices, nor is it appropriate for Medsafe to endorse any specific device. However Medsafe can assist users by providing information about the notification status of alternative devices on the Web Assisted Notification of Devices (WAND) database and by facilitating end-user group discussions.
Rob Allman
Acting Interim Manager
Medsafe
