Supply of Cochlear Implants

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        "title": "Supply of Cochlear Implants",
        "description": "This requirement is for the purchase, provision and support of Cochlear Implants, Sound Processors and associated accessories for NHSS.",
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                    "description": "Minimum level(s) of standards required: (1)All candidates will be required to provide a statement, covering the 3 previous financial years including the overall turnover of the candidate in respect of the activities which are similar type to the subject matter of the notice. (2)All candidates will be required to provide statement of accounts or extracts relating to their business. See contract/tender documentation which incorporates the requirements of the SPD(Scotland)and the financial period of reporting is the previous 3 financial years. Employer's (Compulsory) Liability Insurance of 2 million pounds sterling (This requirement relates to SPD 4B.5.1a) and - Public Liability Insurance of 5 million pounds sterling (This requirement relates to SPD 4B.5.1b)"
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                    "minimum": "1. Compliance with BS EN ISO 13485 or equivalent for Quality Management. 2. Compliance with BS EN ISO 14708 or equivalent for Implants for Surgery (active implantable medical devices). 3. Tendered products are CE marked 4. Declaration of implant or sound processor refused approval by any worldwide regulatory body. 5. Provision of technical specifications for the receiver stimulator package, including dimensions, weight and materials etc. 6. Provision of information on safety features as a minimum: biocompatibility, impact resistance, hermetic sealing, max. current density, DC leakage, controlled delivery of stimulation. 7. Provision of technical specifications for the electrode array, including as a minimum dimensions, number of physical contacts, description of contacts, spacing of contacts, markers, ground electrode. 8. Provision of technical specifications for electrical stimulation, including as a minimum modes of stimulation, current amplitude, pulse width, stimulation rates (overall and per channel), input dynamic range, telemetry. 9.Provision of technical specifications for the sound processor, including as a minimum dimensions, weight and materials together with a picture or diagram. Details must also include wearing options and accessories including remote controls, adapters and lapel microphones 10. Evidence a proven track record in worldwide clinical use in both adults and children. Candidates will be required to provide numbers of adults and children implanted with each version of the cochlear Implant both in the UK and worldwide (annually). 11. Declaration to support cochlear implant users throughout their lifetime. This should include plans for the ongoing support of existing patients using older technology (implants and processors), backwards compatibility of new sound processors with previous generations of cochlear implants, worldwide support (should the patient move overseas) and details of contingency plans in the case of the company ceasing to trade. 12. Reliability data must be provided for each cochlear implant device that is currently commercially available, providing definitions for any terms used e.g. device failure, survival time, clinical benefit, reduced clinical benefit etc. 13. Provision of at least two (2) Demonstration Kits free of charge \"FOC\" when a new device is launched. 14. Provision of appropriate written information, online resources and inhouse training for staff at the Scottish Cochlear Implant programme to ensure that they are adequately informed and knowledgable in the management of all implants and sound processors that they provide. In particular when new products become available (including software). 15. Information for counselling patients pre-implant and instruction manuals for Adults and young cochlear implant recipients on the use of sound processor and its accessories must be user friendly and provided in an accessible format (e.g. quick refrence guides, booklet, DVD, online resources, helplines etc.) Provision in other languages is also desirable. 16. Rehabilitation tools / resources should be available for implant centre staff CI recipients or for recipients to use themsleves in their own homes (including online resources). 17. Confirm adherence to UK GDPR guidelines and provide any applicable documentation relating to this standard 18. Evidence of measures taken to ensure IT systems cyber security conforms to UK GDPR on a rolling basis."
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