HOW TO USE GRASEBY SYRINGE DRIVER

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 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the clinical implications of this situation and thus does not currently require existing devices to be recalled or withdrawn from clinical use when alternates are not available provided the manufacturer’s instructions are carefully observed. 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. 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. 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. 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. Medsafe does not undertake comparative evaluation of medical devices, nor is it appropriate for Medsafe to endorse any specific device.

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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. 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.

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.

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. Medsafe does not undertake comparative evaluation of medical devices, nor is it appropriate for Medsafe to endorse any specific device.

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. This document briefs you on the situation, the reasons for Medsafe’s action and the action that will need to be taken grassby users of these devices.

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These syringe drivers are commonly used in palliative care and other situations to provide continuous ambulatory infusion of medicines.

These guidelines reflect international minimum requirements for the safety and effectiveness of medical devices.

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. 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. Spare parts and service for existing devices continue to be available through Smiths Medical at this time.