Medical Devices and Equipment Maintenance and Support service

Sirona Care & Health are seeking a single provider to manage the maintenance of medical devices. The Provider will be the primary point for contact for service users from the purchaser and will subcontract for items that cannot be covered by the provider. The contract lifetime will be for a 2 +1 year term within a financial envelope of £1,080,000. The current contracts in place will cease on the 30/06/2026 any potential supplier must be able to mobilise by this date.

To provide a responsive maintenance service for the Clinical Equipment listed in the attached schedule in line with manufacturers guidance, including servicing periods. Servicing is designed to achieve safety in use, functional reliability and prolong the economic life of the equipment. Mains powered devices will require an electrical safety test against IEC 62353. Service date labels to be applied so the Purchaser is aware that items have been checked and when they are next due to be serviced.

The provider should comply with quality system standards including European Standard BS EN ISO 13485: (2016) [18] or BS EN ISO 9001:(2015) [19], and compliance with legal frameworks including Lifting Operations and Lifting Equipment Regulations 1998 , The Management of Health and Safety at Work Regulations 1999, Provision and Use of Work Equipment Regulations 1998.

To carry out acceptance (and/or commissioning) of agreed medical equipment in accordance with the Medicines & Healthcare products Regulatory Agency (MHRA) recommendations and Managing Medical Devices - see inserts at the bottom of this section.

For new models/manufacturers, the supplier will review manufacturer recommendations and support with identifying training needs prior to acceptance.

Additional equipment management services such as assistance with evaluation, contract monitoring, and advice on clinical user training where appropriate

To maintain a comprehensive medical equipment register on behalf of the purchaser. Specifically, so that multiple users from the purchasing organisation have direct access to update the areas they are responsible for, and to enable logging in and out of items to help track the whereabouts of items. The purchaser would also hope to add items to the register that may not be serviced by the provider to remove the need for a separate data base to be help by the purchaser.

Provide reports on the purchaser Equipment and/or the Services provided as reasonably required by the Purchaser.

Review of Department of Health and manufacturer safety information (MHRA and CAS alerts) providing interpretation for users, routed through the Purchasers Medical Devices Safety Officers unless recall of specific equipment is required when provider may approach clinical units directly.

To register any equipment issues directly via the MHRA yellow card reporting system as appropriate

To manage the disposal of medical portable equipment no longer required for use in line with the WEEE and the Hazardous Waste Regulations. .The provider would seek to recycle parts where possible, and work with the purchaser to review charitable options where equipment is still functional but no longer meets the purchasers requirements but no longer meets the purchasers requirements.

Items of Purchaser Equipment that are deemed unsuitable for patient use and/or beyond economical repair, will be removed from the Purchaser's service and will be disposed of by the Provider with the consent of the Purchaser - if the Purchaser wishes to continue using such items of equipment, against the Provider's advice, the risk and device management responsibility of the items will be handed over the Purchaser. The Provider will remove those items from the Schedule of Purchaser Equipment and Database.