MDD Compliant Decontamination Services and Sterilisation of Medical Instruments

Lancashire Teaching Hospitals NHS Foundation Trust (LTHTR) is inviting suitably experienced Providers to submit tenders for the provision of MDD Compliant Decontamination Services and Sterilisation of Medical Instruments. At LTHTR, the delivery of the Sterile Services function (largely related to the cleaning and sterilising of re-useable surgical instruments) is currently provided in-house.

It delivers a good service in terms of turnaround times and performance. A recent review regarding the provision of the service has presented opportunities for achieving significant efficiencies by out-sourcing to an external provider.

The overall objective of the Trust is to secure the provision of a safe, modern and efficient decontamination and sterilisation service which meets the national policy for compliance (and future quality and legislative standards) and maintains (if not improves) existing service levels at a competitive and cost effective price. These efficiencies will enable the Trust to service their current and future growth requirements in an effective and timely manner and offer the flexibility to meet changing requirements in terms of demand and advances in surgical methodology (e.g. use of robotic equipment).

The proposed outsourcing of sterile services will include the following: the comprehensive provision of sterile services including the cleaning of surgical instruments operating to Medical Devices Directive (93/42/EEC, as amended by Directive 2007/47/EEC) (MDD) and ISO 13485/2003 standards, the delivery and collection of surgical instruments and the provision of associated support services and supplies to the Trust. All activity currently dealt with by LTHTR - approximately 89% of the total activity.

This includes not only sterilisation trays of surgical instruments, but various other services relating to implants (eyelid, breast, cranial etc.), tray changes, loan kits and arrangement of repairs to equipment. Activity currently directed to, and managed, under SLA by ELTH - approximately 11% of the total activity including that generated by Orthodontics, ENT and Gynaecology.

Cleaning of theatre clogs at Chorley site which are currently processed with Sterile Services equipment. Approx 45% of sets are packed in autoclave able containers (B Braun) which impacts on washer disinfector capacity - this is expected to rise in the future.

The use of tray liners and tip protectors - these form part of the existing processing and will be required as part of the service. LTHTR have worked closely with the Physical Risk team to ensure that needle stick injuries in the Trust are minimised and as such the protection given by these two items is crucial. The dismantling of instruments as per manufactures instructions - all instructions within instrumentation specification sheets reference this and this practice must continue Management of returned sharps - again current practice of removal of sharps and completion of an Indent report must continue