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Blockchain-Based Infrastructure for Product Traceability in the Medical Supply Chain
Abstract
This chapter introduces a blockchain-based infrastructure to support the traceability of medical products and implementation of unique device identification. Therefore, in the next pages, the characteristics of blockchain technology as well as benefits and challenges in supply chain management are described. After that, regulations for medical supply chains are gathered with a focus on American and European regulations and interlinked with the current concepts of the labling medical products. Finally, a technical blockchain-based solution is conceptualized with regard to full and light node system in medical supply chains before the chapter is concluded with an outlook and further scientific and technical research possibilities.
... Ethereum has a client application named Mist Browser, a user-friendly wallet also known as a Light Node. This Light Node connects to a blockchain to perform only basic functions of a full node, such as sending and receiving cryptocurrencies which only requires a wallet application on the IoT device [38,39]. A light node is thus able to sign and broadcast transactions on its own. ...
While the number of blockchain ecosystems is growing, enterprises are confronted with the decision on how data can be securely and reliably transferred to blockchains. Even though current blockchain solutions proof to be a secure way for cross-enterprise data exchange, the data entries and respective devices might still be tampered and therefore build the focal point of this paper. To give an introduction to blockchain devices, current definitions and relevant device configurations, network connections and communication opportunities are gathered through a systematic literature research. The findings are then clustered and discussed with blockchain experts in a semi-structured interview series. Finally, the paper presents a characterization scheme for blockchain devices in form of a multi-dimensional taxonomy and concludes with further research needs. The outcome of the paper also contributes to practice as the taxonomy may also be used as a basis for management decisions.
Auf der Blockchain-Technologie basierende IT-Lösungen werden in verschiedenen Branchen konzeptioniert und erprobt, um auf Basis nachvollziehbarer Produkt-, Informations- und Finanzflüsse, Transparenz sowie vertrauensvolle Beziehungen zwischen Supply-Chain-Akteuren herzustellen. Unternehmen erkennen diese und weitere Potenziale der Technologie, die sich je nach Anwendungsbereich und Nutzungslevel ausweiten können, doch werden in ihrem Vorhaben, konzeptionierte Lösungen in unternehmensübergreifende Geschäftsprozesse zu integrieren und in den Realbetrieb zu überführen, gehemmt. In diesem Zusammenhang sind schwer messbare wirtschaftliche Auswirkungen von Blockchain-Lösungen als eine zentrale Herausforderung und Ursache für Investitionshemmnisse aufzuführen. Insbesondere bzgl. strategischer Nutzenfaktoren sind die wirtschaftlichen Auswirkungen oft unbekannt und werden bei der Bewertung von Pilotprojekten nicht berücksichtigt.
Das Ziel der Arbeit besteht deshalb darin, Blockchain-Anwenderunternehmen bei der Integration von Blockchain-Lösungen im Supply Chain Management sowie der Berücksichtigung wirtschaftlicher Auswirkungen zu unterstützen, indem der Ablauf des Integrationsprozesses, die Klassifikation des Anwendungsbereichs und Nutzungslevels sowie die Identifikation und Bewertung von Wirtschaftlichkeitsfaktoren untersucht werden. Zu diesem Zweck wird ein anwendungsorientierter Forschungsprozess konzipiert, der aufbauend auf systematischen Literaturrecherchen zur Fundierung der Arbeit, begleitende empirische Erhebungen in Form von Fokusgruppen- sowie Einzelinterviews mit ausgewählten Blockchainexperten vorsieht.
Auf diese Weise wird die Entwicklung eines umfassenden Gestaltungsmodells zur profitablen Integration von Blockchain-Lösungen im Supply Chain Management unter Einfluss praktisch relevanter Anforderungen ermöglicht. Das Gestaltungsmodell führt dabei insbesondere drei konkrete Lösungsartefakte zusammen: (1) Ein Integrationsmodell, welches notwendige Schritte und Methoden, übergeordnete Managementfunktionen und Meilensteine sowie Bewertungsphasen zur profitablen Integration vorsieht; (2) eine multidimensionale Taxonomie, welche die Klassifikation des Blockchain-Projekts hinsichtlich Anwendungsbereich, Nutzungslevel und Wirtschaftlichkeitssituation ermöglicht; sowie (3) ein Bewertungsmodell, welches zur Identifikation von Einflussfaktoren auf die Wirtschaftlichkeit und deren Messbarmachung genutzt wird. Abschließend werden die Erkenntnisse der Arbeit unter Berücksichtigung der Netzwerk- sowie der Dynamic-Capabilities-Theorie reflektiert und zukünftige Forschungsbedarfe aufgezeigt.
The early development of blockchain technology (BCT) has already demonstrated the technology's potential to serve the needs of different industries. BCT has also become established as a popular research topic in different scientific disciplines. This paper aims at introducing how several relevant scientific disciplines-supply chain management; management, economics and finance; computer science; security engineering-see the research and education perspectives for BCT. A field review is conducted to present challenges and opportunities of BCT, as well as suggestions for future research and education on the topic as seen from the selected different perspectives. The paper also presents methods for combining relevant disciplines in a modular online course to address the stated challenges and promote interdisciplinary blockchain education.
Purpose: Supply chain networks face an increasing demand to integrate globally distributed customers and suppliers. As supply chain processes are deemed to lack sufficient transparency and security, blockchain solutions are piloted to offer an IT infrastructure covering these needs. This paper aims to bring current projects one step further and evolves a model for integrating blockchain solutions into supply chain processes. Methodology: In order to get an overview of existing models for technology integration , an exploratory research study is conducted. In addition, requirements for the specific integration of blockchain solutions are gathered and categorized in a systematic content analysis. Based on these requirements, the models are evaluated, compared and utilized for the development of a new model. Findings: Since none of the presented models fully meet the specific blockchain-based requirements, the existing models must be further developed. Specifically, increases in the number of supply chain partners and external stakeholders involved in blockchain-based systems are not supported by current models, and need to be integrated systematically. Originality: In this paper, an integration model is developed that is particularly suitable for blockchain integration into supply chain processes. In order to give starting points for a validation of the model, a case study is conducted in the field of blockchain-based payment gateway solutions.
In the course of the digital transformation, organizations are not only facing increasing volatility of the markets, but also increasing customer requirements and thus an increasing complexity in production and logistics systems. Therefore, production plants need to become more flexible by transforming conventional production systems to Cyber-physical Production Systems (CPPS). CPPS allow organizations to dynamically react to fluctuations in demand and markets and to introduce new product lines quickly and effectively. The challenge in implementing CPPS is to handle and store relevant data streams between Cyber-physical objects in a secure but transparent way. As CPPS involve a high level of decentralization, the data storage can either be combined with centralized IT-solutions like a Cloud or utilize decentralized IT-technologies like Edge Computing or Distributed Ledger Technologies (DLT) like Blockchains. The paper addresses the suitability of centralized and decentralized technologies in terms of dealing with data streams in the fields of CPPS. For this purpose, based on a paper exploration, appropriate evaluation criteria are derived, followed by a comparison of exemplary centralized and decentralized technologies. The outcome is a qualitative evaluation of the supplement of each technology regarding its suitability of dealing with data streams.
The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.
Kurzfassung
Die Blockchain-Technologie wird aktuell in Unternehmensnetzwerken unterschiedlicher Branchen insbesondere zur Erhöhung der Transparenz erprobt. Pilotprojekte zeigen, dass eine interdisziplinäre Zusammenarbeit das Schlüsselkonzept für eine erfolgreiche und ganzheitliche Integration der Technologie darstellt. Im Rahmen der akademischen Ausbildung müssen Studierende auf die fachübergreifende Zusammenarbeit in heterogenen Teams vorbereitet werden. In diesem Beitrag wird aufgezeigt, wie dieser Bedarf durch die Entwicklung eines europäischen, interdisziplinären Blockchain-Kursprogramms adressiert wird.*)
The Internet of Things (IoT) is poised to transform human life and unleash enormous economic benefit. However, inadequate data security and trust of current IoT are seriously limiting its adoption. Blockchain, a distributed and tamper-resistant ledger, maintains consistent records of data at different locations, and has the potential to address the data security concern in IoT networks. While providing data security to the IoT, Blockchain also encounters a number of critical challenges inherent in the IoT, such as a huge number of IoT devices, non-homogeneous network structure, limited computing power, low communication bandwidth, and error-prone radio links. This paper presents a comprehensive survey on existing Blockchain technologies with an emphasis on the IoT applications. The Blockchain technologies which can potentially address the critical challenges arising from the IoT and hence suit the IoT applications are identified with potential adaptations and enhancements elaborated on the Blockchain consensus protocols and data structures. Future research directions are collated for effective integration of Blockchain into the IoT networks.
While Radio Frequency Identification (or RFId) technology has gained significant traction in the downstream operations and industries like retail, adoption upstream of the value-chain has been much slower. Few reported cases of implementations in job-shops exists today for several reasons, key among which is the relative cost of the technology and uncertainties regarding the expected results. In this paper, we present the insights from the evaluation and pre-implementation stage of a project to implement RFId technology in the customized products’ department of a large process manufacturing company in Europe. The case company is an innovation leader in the European pipe and drainage systems’ manufacturing industry. Preliminary findings indicate the need to align RFId implementation with strategic goals to minimize the risk associated with the implementation and increase the chance of success.
STRUCTURED ABSTRACT
Purpose-This paper strives to close the current research gap pertaining to potential implications of the Blockchain for SCM by presenting a framework built on four established economic theories (principal agent theory, transaction cost analysis, resource-based view, network theory). These theories can be used to derive research questions that are theory-based as well as relevant for the industry. This paper is intended to initiate and stimulate an academic discussion on the potential impact of the Blockchain and introduces a framework for middle-range theorizing together with several research questions.
Design/methodology/approach-This paper builds on previous theories that are frequently used in SCM research and shows how they can be adapted to Blockchain-related questions. Findings-This paper introduces a framework for middle-range theorizing together with several research questions. Research limitations/implications-The paper presents Blockchain-related research questions derived from four frequently used theories: namely principal agent theory (PAT), transaction cost theory (TCA), resource-based view (RBV) and network theory (NT). These questions will guide future research pertaining to structural (PAT, TCA) and managerial issues (RBV, NT) and will foster middle-range theory development in SCM research. Practical implications-Blockchain technology has the potential to significantly change SCM. Given the huge investments by industry, academic research is needed that investigates potential implications and supports companies. In this paper various research questions are introduced that illustrate how the implications of Blockchain on SCM can be investigated from different perspectives. Originality/value-To the best of our knowledge, no academic papers are published in leading academic journals that investigate the relationship between SCM and Blockchain from a theory-based perspective.
In the Internet of Things (IoT) vision, conventional devices become smart and autonomous. This vision is turning into a reality thanks to advances in technology, but there are still challenges to address, particularly in the security domain e.g., data reliability. Taking into account the predicted evolution of the IoT in the coming years, it is necessary to provide confidence in this huge incoming information source. Blockchain has emerged as a key technology that will transform the way in which we share information. Building trust in distributed environments without the need for authorities is a technological advance that has the potential to change many industries, the IoT among them. Disruptive technologies such as big data and cloud computing have been leveraged by IoT to overcome its limitations since its conception, and we think blockchain will be one of the next ones. This paper focuses on this relationship, investigates challenges in blockchain IoT applications, and surveys the most relevant work in order to analyze how blockchain could potentially improve the IoT.
Die digitale Transformation wird zu tiefgreifenden Veränderungen von Geschäftsmodellen, Organisationen und Arbeitsgestaltung führen. Entsprechend werden auch gänzlich neue Anforderungen an Führungskräfte gestellt. Um diese veränderten Anforderungen greifbar zu machen haben wir eine großangelegte Befragung von ExpertInnen aus Wirtschaft, Wissenschaft, Verbänden und Politik durchgeführt, deren Ergebnisse wir in diesem Kapitel vorstellen. Dabei betonten die befragten ExpertInnen, dass durch die digitale Transformation die Abgabe von Macht von Führungskräften an Mitarbeitende zunehmen, die Wichtigkeit von beziehungsförderndem und coachenden Verhalten von Führungskräften gegenüber Mitarbeitenden steigen und Führungskompetenzen wie Agilität, Veränderungsmanagement und Führung auf Distanz eine stärkere Rolle einnehmen werden. Mitarbeiterleistungen werden transparenter und sollten von Führungskräften daher entsprechend ergebnisorientiert bewertet werden. Darüber hinaus wird durch die Digitalisierung auch mehr Druck auf Mitarbeitende entstehen, welchen Führungskräfte durch gesundheitsbewusste Führung abfedern sollten. Führung selbst wird insgesamt stärker technologisiert, d.h., durch digitale Tools unterstützt, werden. Diese Veränderungen von Führung werden am Beispiel von Organisationen verschiedener Größen und Branchen illustriert.
The benefits of information sharing along supply chains are well known for improving productivity and reducing costs. However, with the shift toward more dynamic and flexible supply chains, privacy concerns severely challenge the required information retrieval. A lack of trust between the different involved stakeholders inhibits advanced, multi-hop information flows, as valuable information for tracking and tracing products and parts is either unavailable or only retained locally. Our extensive literature review of previous approaches shows that these needs for cross-company information retrieval are widely acknowledged, but related work currently only addresses them insufficiently. To overcome these concerns, we present PrivAccIChain, a secure, privacy-preserving architecture for improving the multi-hop information retrieval with stakeholder accountability along supply chains. To address use case-specific needs, we particularly introduce an adaptable configuration of transparency and data privacy within our design. Hence, we enable the benefits of information sharing as well as multi-hop tracking and tracing even in supply chains that include mutually distrusting stakeholders. We evaluate the performance of PrivAccIChain and demonstrate its real-world feasibility based on the information of a purchasable automobile, the e.GO Life. We further conduct an in-depth security analysis and propose tunable mitigations against common attacks. As such, we attest PrivAccIChain’s practicability for information management even in complex supply chains with flexible and dynamic business relationships.
Blockchain technology gets more attention and adoptions in various countries and companies all over the world. Blockchain is currently bringing a revolution in many enterprises like finance, healthcare, supply chain, insurance, registry, and the internet of things. Many enterprises integrate blockchain with their systems for the benefits of the blockchain. Despite its strength, blockchain has some challenges in security, privacy, scalability, and other few. This paper surveys the breakthrough in blockchain technology, its applications, and challenges. As many blockchain papers focus on cryptocurrencies, IoT, and security, this paper focuses on the overall state of the art of blockchain technology, its recent developments, and adoptions, especially in areas besides cryptocurrencies. We give a comprehensive review of the cryptography behind the blockchain for a better understanding of the technology. We also review quantitative surveys and analysis on both the public and the enterprise blockchains. Finally, we review the future research opportunities and directions on the blockchain technology.
Seit der Einführung des Bitcoin hat die zugrunde liegende Blockchain steigende Aufmerksamkeit erfahren, begründet durch das hohe Maß an Manipulationssicherheit dieser Technologie. Als wichtiges Anwendungsfeld für Blockchain wird dabei häufig die Lieferkette von Unternehmen genannt. Johannes Hinckeldeyn gibt in diesem essential eine Einführung in die Blockchain-Technologie mit besonderem Fokus auf Logistik und Lieferkette. Er stellt verschiedene Blockchains und System-Architekturen vor, diskutiert – basierend auf realen Projekten – generische Anwendungsfälle und leitet Empfehlungen ab.
Der Inhalt
• Stand der Technik
• Ausgewählte Projekte und Start-ups
• Prototypische Anwendungsfälle
• Kritische Einordnung der Blockchain-Technologie
• Potenzielle Anwendungsbereiche der Blockchain-Technologie in der Supply Chain
• Entwicklungstrajektorien der Blockchain-Technologie
Die Zielgruppen
• Dozierende und Studierende der Fächer Logistik, Wirtschaftsingenieurwesen und Wirtschaftsinformatik
• Fachkräfte im Supply Chain Management
Der AutorDr. Johannes Hinckeldeyn ist Oberingenieur am Institut für Technische Logistik (TUHH) der Technischen Universität Hamburg.
Real-time tracking and tracing are important in providing a unified view of global supply chains consisting of several parties. This paper illustrates the needs and requirements for managing supply chains in multi-company project environments by adopting various tracking and tracing technologies. This kind of tracking and tracing is especially needed within distributed architectures engaged in project-based businesses, where several vendors are involved in a single project. Such tracking and tracing data can be used extensively to generate key performance indicators, which can be used to measure and control supply chain processes. This paper also proposes a pilot system of a cloud-based portal for real-time tracking and tracing of logistics and supply chains. This portal is formed by the combination of RFID, IoT and blockchain technology into an integrated real-time view. RFID (Radio Frequency Identification) and IoT (Internet of Things) provides real-time information or data, while blockchain technology is used to provide a chain of immutable transactions. The architecture of the proposed portal system is connected to transport companies, tracking devices, consolidation points and suppliers. The pilot study also illustrates the benefits and advantages of such a portal system.
Blockchains sind eine Art verteiltes elektronisches Register um Informationen dauerhaft, transparent und vertrauenswürdig zu speichern und zugänglich zu machen, ohne dass auf eine zentrale Instanz zurückgegriffen werden muss. Im folgenden Kapitel wird die grundsätzliche Funktionsweise von Blockchains erläutert. Dazu werden zuerst grundlegende Technologien wie kryptografische Hash-Funktionen, kryptografische Puzzles, Merkle-Bäume und digitale Signaturen vorgestellt. Anschließend werden Datenstrukturen von Blockchains und das Vorgehen zum Hinzufügen von neuen Blöcken erläutert. Ebenso wird auf Smart Contracts eingegangen, die der Hinterlegung und verteilten Ausführung von Algorithmen in Blockchains dienen und die Grundlage für dezentrale Anwendungen (DApps) bilden. Als Ausblick werden Limitationen und aktuell in Entwicklung befindliche Ansätze im Bereich Blockchains vorgestellt, um eine Einschätzung der auf diesem Gebiet zu erwartenden Fortschritte zu geben.
Purpose
The purpose of this paper is to review the existing literature on blockchain technology, present some trends and consider its potential value in supply chain management (SCM).
Design/methodology/approach
Papers that contained the word “blockchain” in their titles, keywords or abstracts were selected for conducting trend analyses.
Findings
The blockchain technology is rapidly making inroads in many industries and there is tremendous potential to eliminate intermediaries and to make SCM more efficient.
Research limitations/implications
This analysis is limited to 299 papers from the EBSCO database through December 2018.
Practical implications
This paper highlights the imperative role of blockchain technology that has created a discourse in the world of innovation and technology. This work will help academics to further the understanding of blockchain technology.
Social implications
Blockchain technology will provide transparency to consumers.
Originality/value
This paper presents the first review of blockchain technology and delves into its value in SCM. This work will help researchers in identifying the areas where blockchain is the most desirable and can be implemented.
Blockchain technology back in 2009 was mainly used for finance use cases due to the cryptocurrency support of the Bitcoin and the Ethereum networks. Nowadays with the emergence of business oriented distributed ledger frameworks we can find blockchain (BC) in almost every aspect of our everyday real-life transactions. Starting with supply chain, BC has been used to support and secure education, e-government, real estate, insurance, healthcare and other business cases. Regarding blockchain in supply chain, examples as the Walmart and IBM partnership shows that smart contracts (SC) and cryptocurrencies can disrupt the way suppliers, shippers, retailers and customers trust each other and interact. This paper describes how we applied BC technology in two real-life supply chain scenarios. The first one is for logging and tracing products, showing how we can use SCs to identify the ingredients of food products and how to uniquely identify the food product throughout its shipment from the factory to the customer who purchase it. Important aspects of this route is the transparency of the process as well as the verification of transport. The second one deals with how authentication works for users holding BC identities. The identity of a user is important in order to secure the network, allowing only permissioned parties to access it and perform actions on the data. As long as the network is private and immutable, authenticating and authorizing users is crucial for enforcing the end-to-end security to increase users' trust and protect the confidentiality of data. While exploring these two scenarios we define the actors, the transactions these actors can perform on the systems and we propose the SCs that have to be implemented for these use cases to take advantage of BC's unique characteristics, as immutability and non-repudiation. In addition, we provide sample template SCs for both scenarios.
Background and objectives:
Similarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the European Regulations for medical devices MDR (EU) 2017/745 and in-vitro diagnostic medical devices IVDR (EU) 2017/746 and it is on the way to become a worldwide standard. The aim of this work was to provide a possible approach for the implementation of UDI and traceability in Europe for standalone software medical devices according to lifecycle and quality system standards.
Methods:
The key points of the UDI regulation were determined and analyzed in order to identify the main issues related to the manufacturing of software medical devices and, in particular, labeling, privacy aspects, UDI assignment criteria, and international standards compliance.
Results:
An approach for the management of each key point was suggested, resulting in different levels of implementation for UDI and traceability.
Conclusions:
Among the various types of medical devices, software is an increasingly large reality with very specific characteristics that must be taken into consideration. All the relevant aspects for the implementation of the UDI should be taken into consideration to combine safety and feasibility in order to effectively pursue the traceability of these medical devices.
Blockchain and the Internet of Things (IoT) are key technologies that will have a huge impact in the next 10 years for companies in the industrial market. This article describes how these two technologies will improve efficiencies, provide new business opportunities, address regulatory requirements, and improve transparency and visibility.
Modern supply chain is a complex system and plays an important role for different sectors under the globalization economic integration background. Supply chain management system is proposed to handle the increasing complexity and improve the efficiency of flows of goods. It is also useful to prevent potential frauds and guarantee trade compliance. Currently, most companies maintain their own IT systems for supply chain management. However, it is hard for these isolated systems to work together and provide a global view of the status of the highly distributed supply chain system. Using emerging decentralized ledger/blockchain technology, which is a special type of distributed system in essence, to build supply chain management system is a promising direction to go. Decentralized ledger usually suffers from low performance and lack of capability to protect information stored on the ledger. To overcome these challenges, we propose CoC (supply chain on blockchain), a novel supply chain management system based on a hybrid decentralized ledger with a novel two-step block construction mechanism. We also design an efficient storage scheme and information protection method that satisfy requirements of supply chain management. These techniques can also be applied to other decentralized ledger based applications with requirements similar to supply chain management.
Background: Most countries have different registration and tracking system, but unique device identification based approach was recently introduced in the USA. In 2013, FDA and EU released regulations about unique device identification system. In literature, there is not any study that compares the UDI legislations on the basis of the requirements. In addition to the legal requirements, establishing a UDI system in digital environment is very challenging. Methods: This is a theory based study that includes information from healthcare industries and key points from UDI related legislations which are discussed. To visualize the design of the proposed system, the Dia program that contains the Unified Modeling Language (UML) components was used. Results: Implementation of the UDI based tracking system is very difficult due to two reasons. First, the relevant legislations do not give detailed information on how UDI system will be implemented. Second, each type of medical device has difficulties due to UDI labeling. We have observed that the stakeholders in the medical devices sector in Turkey, especially the manufacturers, are not yet ready for UDI-based tracking. The current registry system is not effective to track medical devices and share data. Conclusions: To overcome compliance problems, UDI requirements should be perfectly determined and subsequently related legislation should be established. Regarding these requirements, every country should introduce an action plan and include all sector stakeholders in that action plan. We suggest a model for medical device tracking to be able to use instead of the current registry system in Turkey.
Medizinprodukte Die Rückverfolgung von Aufbereitungsprozessen ist ein wichtiger Baustein der Medizinprodukte-Sicherheit. Allerdings hat die Rückverfolgung ihre Grenzen und Lücken – bedingt durch die Vielfalt der Produkte und Schwierigkeiten bei der Kennzeichnung. Ohne eindeutige Kennzeichnung ist es praktisch nicht möglich, zurückzuverfolgen, welche Instrumente bei welchem Patienten zum Einsatz kamen. Eine mögliche Verbesserung wird in Zukunft ein universeller, maschinenlesbarer Code bringen, die sogenannte „Unique Device Identification“ (UDI). Darüber hinaus birgt die RFID-Technologie (Radio-Frequence-Identified-Device) großes Potenzial in der automatischen Erkennung und Lokalisation von Instrumenten.
Background:
Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration.
Methods:
An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data.
Results:
Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management.
Conclusions:
This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information.
In recent years, firms in high-technology supply chains have established internet-based electronic linkages with their trading partners. As a result, they have improved their ability to coordinate and synchronize shared business processes by using more complete, accurate, and timely information. These electronic linkages are based on open-standard interorganizational information systems (OSIOS), which are fundamentally different from traditional electronic data interchanges. OSIOS capture not only the technical specifications for data interchange but also the sequential steps for the execution of shared business processes. Because OSIOS are still at an early diffusion stage, it remains unclear why firms would assimilate such an innovation and whether assimilation provides firms any benefits. In this research, we develop a framework grounded on the economics of standards, institutional theory, and strategic interorganizational information systems literatures to investigate the drivers and outcomes of OSIOS assimilation in a focused context. In order to test our hypotheses based on this framework, we used data from a high-technology supply chain and employed econometrics techniques. We found that both competition asymmetry across supply chain echelons and OSIOS assimilation within supply chain echelons predict individual firms’ OSIOS assimilation. The results also suggest that firms’ supply chain dominance is both a driver and an outcome of OSIOS assimilation, highlighting a mutually reinforcing process. In addition, our study reveals boundary conditions of the hypothesized relationships. The use of multiple theoretical perspectives, a unique dataset, and innovative statistical techniques to investigate OSIOS assimilation in high-technology supply chains contributes to the body of knowledge in both the supply chain management and management of information systems disciplines.
The FDA’s plan is a big ask but will be well worth the effort
In September 2012, the US Food and Drug Administration (FDA) released its vision for a postmarket surveillance system for medical devices,1 describing four key strategies to protect public health. But why this initiative now? Firstly, several concerns about the safety of specific devices, such as the Medtronic Fidelis defibrillator lead and the DePuy ASR hip implant, have garnered substantial press coverage.2 3 4 Secondly, the Institute of Medicine recently called for a substantial overhaul of processes for the approval and postmarket safety surveillance of medical devices.5 Thirdly, the FDA has undertaken several premarket initiatives to improve the efficiency of the regulatory review for innovative devices.6 With the number and complexity of medical devices growing rapidly, it is timely to complement the new premarket initiatives with a strong postmarket surveillance program.
Regulation of the entry into use of medical devices in the United States was introduced after that for drugs (table⇓), and it quickly became apparent that the public health assessment of devices would need to be different from that of drugs. Unlike drugs, medical devices are assembled from many components, may affect patients long after the initial exposure, and have rapid product development cycles, which lead to frequent incremental improvements. Medical devices also pose unique challenges to studying …
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Blockchain und smart contracts: Effiziente und sichere wertschöpfungsnetzwerke
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Exploring the Attack Surface of Blockchain: A Systematic Overview
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Blockchain not understood by almost 70% of firms in asiapacific
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