Graseby Syringe Drivers MS26 and MS16a Withdrawal from the Australian Market Aug 2007

th

24 August 2007

To: Australian & New Zealand Market (All palliative care organisations) Re: “Graseby Syringe Drivers” (Codes MS26 & MS16a) In May this year Smiths Medical Australasia (SMA) began informing the Australian market of a planned withdrawal of these products from the Australian market. The changes in the Medical Device registration process in Australia (DEAL) which becomes fully th legislative on the 4 October 2007, requires all companies to resubmit documentation to prove their products meet all appropriate standards. Smiths Medical International does not believe the Graseby Syringe Drivers will meet the Australian Standards appropriate for these devices. Therefore the company cannot in good faith offer the products for registration knowing they would no longer meet the necessary criteria that has been set. Whilst a date for the withdrawal of the Syringe Drivers was proposed by SMA, the Australian Therapeutic Goods Administration (TGA) have since been in communication with SMA and are aware, of and agreed to, our company’s intention to cease supply of these products. It is incorrect to suggest that the TGA have independently deregistered the devices or have given a deadline for their current registration to be cancelled. In July, Medsafe New Zealand also contacted Smiths Medical Australasia, to discuss the ability of the MS Syringe Drivers to meet the appropriate standards. SMA has advised Medsafe that the company had th already devised a strategy to cease supply in New Zealand on the 4 October 2007. Smiths Medical is able to recommend a replacement product – the Deltec CADD Legacy PCA. This alternative product can be discussed with your SMA Product Specialist who can assess its suitability for your application and provide all necessary training. Due to increased demand for Graseby Syringe Drivers, SMA may not satisfy the current orders in the th system and delivery cannot be guaranteed prior to 4 October 2007. rd

Supply of the MS16a and MS26 will continue up until the close of business on the 3 October. Syringe th Drivers currently in use and those sold prior to October 4 are not affected by this change. Only the ongoing promotion and sale of these items will cease. SMA will continue to service and support these devices for a minimum of 5 years. Yours faithfully

Tony Yong Managing Director Smiths Medical Australasia