Market Engagement for Third-Party Contingency Support for Decontamination Services in Scotland

Background: The main objectives of NHSScotland’s decontamination services are: -Clean, disinfect and sterilise Reusable Medical Devices (RMDs) to strict standards, set in national policy and guidance; -deliver the correct set of products at the correct time and places, in accordance with agreement with service users e.g. theatre, clinics etc. CDUs are required to comply with a range of legal and technical requirements, guidance, and documentation systems to process RMDs that are fit for purpose and reduce risks to patient safety. CDUs are registered with the Medicines and Healthcare Products Regulatory Agency (if applicable) and compliant with Medical Devices Regulations. They must operate their quality management system to BS 13485: 2021 and regulatory requirements. They are audited at least annually by an Approved body. Scotland’s CDUs are facing increasing pressure to provide sufficient capacity during unplanned outages. Recent unplanned outages have disrupted service delivery and impacted patient care. There is currently not enough internal contingency processing capacity available to support Boards during such outages. Purpose of this PIN: This PIN is issued as part of a preliminary market consultation. It does not signify the start of a formal procurement process but aims to: -Assess market capability to provide reserved capacity for processing approximately 1.5m re-usable medical devices per year. -Identify suitably accredited suppliers with the reprocessing capabilities to support the range of services supplied by decontamination services -Understand indicative costs for providing such contingency capacity. -Invite innovative solutions and ideas to enhance the resilience of Scotland’s decontamination services through additional processing capacity. Key Considerations: -Frequency of contingency support requirement is variable and can’t be predicted. The number of un-planned outages tend to impact services for a period of 7 days up to 8 weeks. -Capacity may also be used for increased workload, not just during planned and un-planned outages. -The feedback will inform future strategy and potential procurement options. Next Steps: Interested suppliers are invited to express interest and provide relevant information, including: -Capability statements -Indicative cost information for such services -Suggestions for service resilience and contingency planning