Funding: POR MARCHE FESR 2014-2020 – Action 126.96.36.199 Promote innovative solutions to address the challenges of local communities in the area of health and well-being
Status: in progress
Participants: IDEA soc. coop., SOL spa, MESIS srl, VITRIFRIGO srl, University Hospital of the United Hospitals of Ancona
""The BOSET project aims to create and develop services and products that aim to achieve a more efficient and safer supply chain for blood and blood components, optimized from an organizational and production point of view.""
Without prejudice to the operational scope of existing information systems in the health sector, the project aims to devise a standard (with specific syntax and semantics for the management of transfusion flows) that integrates and harmonizes the existing one without replacing and / or eliminating it. A framework that starts from the real clinical workflow and allows the usability of information in the format desired by the healthcare system operators when required. Today this product (which also carries with it characteristics of process innovation) does not have transfusion medicine as a field of application.
In the first instance, the result will be documentary: a shared language.
This gives rise to the possibility of remotely equipping system auditors (especially in areas with a high quality and safety level) with verifiers and simulators that guarantee the minimization of “human error” and, at the same time, allow verification of the real-time accuracy of information flows. In this first phase, the result of the project will lead to the development of a FIRST PRODUCT – the “Integrated Transfusion Medicine Network” (ITMN) framework – which is not currently applied to the transfusion medicine sector, within and beyond the national border: any actor in this area assistance will be able to benefit from a univocal information standard, which allows you to put your computer system in communication with other computer systems, only through the implementation of a connection software.
Secondly, the design of traceability devices for the storage parameters of blood components is envisaged. This phase of the project, conveying the information of the integrated information systems (thanks to the ITMN), will give rise to the creation and testing of a device equipped with temperature, humidity and PH sensors fully communicating – according to the profiles provided by ITMN – with any software.
For the first time, this product will allow tracing the path (including times) and storage parameters of the blood component validated from production to the recipient’s bed (in compliance with the regulatory constraints of Law 219/2005 and the ministerial decree of 2 November 2015). In addition, this device will provide the reporting of any product or process non-conformities. All this is substantiated in line with the indications of the European directives, opening the way to a market – in the health sector – that is no longer just national. Furthermore, appropriate socio-economic evaluations will be carried out in order to evaluate the reuse of these traceability devices or their disposal together with the blood bags.
Finally, considering the need for storage and refrigeration according to quality standards defined by current regulations, the ITMN framework will guide the definition of the functional and informative characteristics of the cold chain, including the design of innovative solutions.
Proper refrigeration and storage of blood and blood components is one of the fundamental requirements to ensure a high level of quality of performance. One of the main reasons for the elimination of the bags of blood components is precisely the poor conservation during one or more phases of the supply chain. The refrigeration and conservation phase is also among the most energy-intensive of the entire supply chain.
The THIRD PRODUCT therefore takes the form of the design and construction of temperature-controlled equipment – “smart” refrigerators – for the transport of blood components at every stage of their movement during the journey from the donor to the patient, also considering their use in dedicated vehicles emergency in the health sector. This further product will allow, in addition, the diagnosis – real time – of possible unwanted events in the cold chain.
In particular, three types of ITMN complaint handling, refrigeration and storage systems will be developed to communicate with other players in the supply chain:
1- Ultra-portable systems with a useful volume of between 3 and 5 liters for the transport of blood at a controlled temperature in the last step of the supply chain (bed side refrigerator).
2- Small systems of useful volume between 50 and 80 liters for installation and use on vehicles or in an ambulance.
3- Larger size systems (600-1000 liters) for use in the machining center.
The three types of implants, developed according to ergonomic characteristics and in order to facilitate portability, will allow for multiple data back-up and full circulation of information from the handled blood component. They will be developed according to new technologies that allow energy savings and optimization of consumption. Currently “smart” refrigerators have not been marketed on the national territory and are in wide demand especially for the transport of blood components on emergency vehicles.