Description of the procurement
Pursuant to the original open tender competition concluded in 2013, the HSE has successfully implemented the Fingerprint Track and Trace system across all of its hospitals. The Track and Trace Systems provide evidence that RIMD, Endoscopes and Accessories used have been decontaminated prior to and after use. The systems enable timely identification of clinical RIMD, Endoscopes and Accessories used on patients thus facilitating recall / withdrawal of potential faulty or contaminated RIMD, Endoscopes and Accessories from use. A comprehensive traceability system must also facilitate timely identification of patients exposed to specific RIMD, Endoscopes and Accessories, which is required for patient follow-up. The National Traceability system presently includes the tracking of RIMD’s, Endoscopes and accessories through the decontamination/sterilisation processes to the patient record at point of use.
The Track and Trace work programme includes:
• Electronic tracking of RIMDs / Endoscopes and accessories through each stage of the decontamination process and allow retrospective demonstration that surgical sets and endoscopes, including accessories have been decontaminated in accordance with recommended practices
• Electronic tracing of RIMDs / Endoscopes and accessories to the service user (patients) thus ensuring an effective and comprehensive audit functionality
• Provide the optimum foundation for fully digital records of all decontamination processes in the HSE’s Central Decontamination; Endoscopy Decontamination Units; Theatres and any service area where reusable devices are used. (HSSU)
Article 32.3(b) of the Directive provides for direct negotiation with an incumbent supplier to replace or extend supplies where changing supplier would lead to incompatibility or disproportionate technical difficulties in operation and maintenance. It is necessary to extend the current contract and extend its scope to include Electronic tracking of Class III implantable medical devices in compliance with the new Medical Devices Regulation (MDR) (EU) 2017/745 to allow for continuity of safe delivery of public health services and provide a value for money return on the significant capital investment to date across 52 hospital sites in the placement and support of the following:
• 4,754 active users of the system
• Tracker Traceability Software on 550 workstations across 52 sites
• Patient Association Software in 363 Theatres across 52 sites
• Endoscopy Traceability Software on 280 workstations across 44 sites
• To include Electronic tracking of Class III implantable medical devices in compliance with the new Medical Devices Regulation (MDR) (EU) 2017/745.
• Machine interfacing software support for automatic parametric product release
• MS1 interfacing software provision for loan set traceability and business continuity
• HL7 interfacing at a large number of sites for accessing patient demographic data
• Interfacing to the existing EndoRaad and Unisoft clinical endoscopy systems
• Software and technical support for the HSE’s National data centre.
The extension of the current contract and inclusion of the additional track and trace functionality for medical devices are necessary as a change of contractor cannot be made for both economic and technical reasons including requirements of interchangeability and interoperability with existing equipment, services and installations already procured under the initial procurement, and such a change would cause significant inconvenience, additional risk and substantial duplication of costs for the contracting authority.