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In recent years, many efforts have been made to promote a healthcare paradigm shift from the traditional reactive hospital-centered healthcare approach towards a proactive, patient-oriented, and self-managed approach that could improve service quality and help reduce costs while contributing to sustainability. Managing and caring for patients with chronic diseases accounts over 75% of healthcare costs in developed countries. One of the most resource demanding diseases is chronic kidney disease (CKD), which often leads to a gradual and irreparable loss of renal function, with up to 12% of the population showing signs of different stages of this disease. Peritoneal dialysis and home haemodialysis are life-saving home-based renal replacement treatments that, compared to conventional in-center hemodialysis, provide similar long-term patient survival, less restrictions of life-style, such as a more flexible diet, and better flexibility in terms of treatment options and locations. Bioimpedance has been largely used clinically for decades in nutrition for assessing body fluid distributions. Moreover, bioimpedance methods are used to assess the overhydratation state of CKD patients, allowing clinicians to estimate the amount of fluid that should be removed by ultrafiltration. In this work, the initial validation of a handheld bioimpedance system for the assessment of body fluid status that could be used to assist the patient in home-based CKD treatments is presented. The body fluid monitoring system comprises a custom-made handheld tetrapolar bioimpedance spectrometer and a textile-based electrode garment for total body fluid assessment. The system performance was evaluated against the same measurements acquired using a commercial bioimpedance spectrometer for medical use on several voluntary subjects. The analysis of the measurement results and the comparison of the fluid estimations indicated that both devices are equivalent from a measurement performance perspective, allowing for its use on ubiquitous e-healthcare dialysis solutions.
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In March 2021, several cold chain breaches were reported in Australia8. Moreover, a 2019 report found that thousands of patients of a Sydney clinic were asked to be re-vaccinated due to incorrect or out-of-date storage of vaccines since 20109. A cold chain breach during transportation in Finland, left staff only an hour to prepare the doses and 6 h to find people to receive them10. A similar incident was reported by the staff of an East Sydney clinic which received 100 batches of AstraZeneca vaccines with the temperature device attached to the parcel showing that the vaccines were exposed to a higher temperature during transmission11. Therefore, every temperature violation event must be recorded and reported immediately to ensure the safety of vaccines.
Two other factors demonstrate the importance of the safe storage of vaccines in health premises. First, a growing number of cyberattacks have targeted critical infrastructures like hospitals and health clinics during the past few years12. For example, in December 2020, hackers compromised a European Medicines Agency (EMA) server and leaked Pfizer/BioNTech Covid-19 data onto the Internet13. Another cyberattack forced health clinics in the US and Italy to shut down their Covid-19 vaccination programs during the pandemic14. Second, the pandemic has accelerated the necessity of transparency and traceability in the vaccine supply chain15. People now want to know the full history of the vaccines that they are consuming. Although numerous Internet of Things (IoT) and blockchain-based solutions are proposed by researchers, these generic solutions mainly focus on the distribution and delivery of vaccines, not their storage.
To overcome these limitations, this paper proposes a smart contract enabled vaccine storage and monitoring system that records detailed information about every individual vaccine in an immutable and incorruptible decentralized database. Any deviation from the required standards (e.g., exposure to higher temperatures) will be immediately identified, reported and recorded in the blockchain. Thus, the system would allow patients to check whether the vaccine is safe before taking the shot. The contributions of this research are two-fold:
Vaccines are categorized into four different groups based on several factors such as stability, liveliness, heat, and freeze-sensitivity. Live vaccines use weakened, attenuated versions of the germ that can replicate16. These vaccines require careful maintenance of the vaccine cold chain. On the other hand, inactivated vaccines contain the killed versions of the germ and thus they are non-replicating. Similarly, subunit vaccines are non-replicating vaccines that use only specific pieces of the germ such as protein, sugar or capsid. Both these two latter categories of vaccines are typically available in liquid form and are generally more stable. However, these vaccines can be freeze-sensitive and must be stored and distributed within the recommended range of temperature. Unlike these, toxoid vaccines contain a toxin that creates immunity to the parts of the germ that causes a disease. This type of vaccine remains stable at elevated temperatures, even for long periods of storage. However, for any kind of vaccine, it is crucial to have a reliable system that will maintain the recommended temperatures from the manufacturer to the point of use.
Although the World Health Organisation (WHO) urges the need for an end-to-end temperature monitoring system in the cold chain, there is a long history of breaches in temperature during vaccine storage and distribution. Dipika et al. found that 14% to 35% of refrigerators or transport shipments exposed vaccines to freezing temperatures17. Since more expensive, freeze-sensitive vaccines are being introduced into immunization schedules, freeze prevention is very critical to ensure that people are receiving fully potent vaccines.
Fatima et al. propose a model for cold chain monitoring using a Colored Petri Net (CPN) which focuses mainly on the vaccine warehouse storage process18. Although the authors claim that their proposed model can reduce the risks of cold chain breach and monitor temperatures in real-time, the paper does not indicate how a breach will be detected and notified to the corresponding authority.
A data-centric and Internet of Things (IoT) based cold chain monitoring system is proposed in19 by Hasnat et al. The system focuses on real-time data acquisition and monitoring of the temperature and humidity of the carrier during vaccine distribution and transportation processes. This mobile app-based supervision system ensures transparency and efficiency in the whole process. However, the integrity and security of critical information are not addressed in this paper.
In20, the authors proposed a methodology for cold storage monitoring and tracking using a LoRaWAN (LoRa Wide Area Network) gateway, a LORIOT network server, a user application and an end node to monitor the temperature, pressure, and humidity data collected by the built-in sensors. Although the system provides security against the unauthorized removal of sensors, it fails to ensure data provenance and transparency.
In addition to the above mechanisms, there are numerous IoT based solutions designed and developed by the industry to monitor and track vaccines in real-time21,22,23,24,25. However, these solutions have several limitations such as a single point of failure (centralized system), limited communication range, integrity and scalability issues, and lack of transparency. Table 2 presents a comparison between our proposed system with several industry solutions.
Unlike IoT based solutions, Yong et al. proposed an in- telligent vaccine supply and supervision system based on blockchain and machine learning technologies to overcome the problems of vaccine expiration and record fraud26. The proposed system deploys a smart contract to detect expiry dates and retrieve query information about vaccines. However, the authors have not considered the security aspects or the need for an appropriate access control mechanism. Moreover, it does not include all stakeholders involved in the vaccine delivery and distribution processes.
Musamih et al.27 presented an Ethereum blockchain-based solution to automate the traceability of Covid-19 vaccines to ensure data provenance, transparency, security, and accountability of the vaccine supply chain. They also analyzed the resilience of the proposed system against Man-in-the-middle (MITM) attacks. However, the solution focuses on manufacturing and distribution processes, not storage and real-time monitoring in a health clinic.
Another blockchain-based generic scheme, VaCoChain, pro- posed by Verma et al. fuses blockchain, unmanned aerial vehicles (UAVs) and fifth-generation (5G) communication services for timely vaccine distribution during pandemics28. However, its primary focus is the timely delivery of the vaccine using UAVs, not the traceability of the stored information.
As above, most of the blockchain-based solutions are proposed to ensure transparency and traceability in the vaccine supply chain29,30,31,32. However, there is an urgent need to develop a distributed and secure vaccine storage and tracking system for health facilities since they are more vulnerable to security attacks nowadays. Therefore, this research (based on our initial work33) proposes such a system. 152ee80cbc
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