Medical Device System Research Articles

Rotation insensitive implantable wireless power transfer system for medical devices using metamaterial-polarization converter

This article introduces an innovative approach for creating a circular polarization (CP) antenna-based rotation-insensitive implantable wireless power transfer (WPT) system for medical devices. The system is constructed to work in the industrial, scientific, and medical (ISM) frequency band of 902–928 MHz. Initially, a flexible, wide-band, and bio-compatible open-ended CP slot antenna is designed within a single-layer human skin tissue model to serve as the receiving (Rx) element. To form the implantable WPT link, a circular patch antenna is also constructed in the free-space to use as a transmitting (Tx) source. Further, a new metamaterial-polarization converter (MTM-PC) structure is developed and incorporated into the proposed system to enhance the power transfer efficiency (PTE). Furthermore, the rotational phenomenon of the Rx implant has been studied to show how the rotation affects the system’s performance. Moreover, a numerical analysis of the specific absorption rate (SAR) is conducted to confirm compliance with safety regulations and prioritize human safety from electromagnetic exposure. Finally, to validate the introduced concept, prototypes of the different elements of the proposed WPT system were fabricated and tested using skin-mimicking gel and porcine tissue. The measured results confirm the feasibility of the introduced approach, exhibiting improved efficiency due to use of the MTM-PC. The amplitude of the transmission coefficient (|S21|\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$|S_{21}|$$\\end{document}) has improved by 6.94 dB in the simulation, whereas the enhancement of 7.04 dB and 6.76 dB is obtained from the experimental study due to the integration of MTM-PC. As a result, the PTE of the proposed MTM-PC integrated implantable WPT system is increased significantly compared to the system without MTM-PC.

Design and implementation of a hybrid piezoelectric, radio frequency, solar, and thermal energy‐harvesting system for portable medical devices

AbstractToday, energy harvesting has developed into a technique from which various aspects are still hidden. By extracting energies from the environment and even the human body, and converting them into electrical energy, we can supply power to low‐consumption electronic devices. Energy harvesting works by inhibiting small amounts of ambient energies; otherwise, it is wasted in other forms such as heat, vibration, and light. In this paper, we aim to eliminate or minimize the dependence of portable electronic devices to the batteries, which have limited life times, service costs, handling, and environmental problems. This is accomplished via incorporating the hybrid energy‐harvesting techniques and designed to power (bio)medical devices in order to measure vital signs. In this circuit, by simultaneously harvesting RF, light, thermal, and solar (natural and artificial) energies, we were able to increase the reliability of continuous supply of electrical energy in energy‐harvesting systems by generating and storing maximum power from the environment. Supercapacitors are used as the energy storage elements so that there is no energy waste, and each system is constantly storing the electrical energy with the aid of a diode block. In addition, with the help of supercapacitors, this device is able to transmit a maximum of 420 mW to the load and the total efficiency is equal to 74%.

Blockchain-Enabled Security Solutions for Medical Device Integrity and Provenance in Cloud Environments

The current period of medicine using digital technology for patient care presents a new level of integration of monitoring devices with the cloud computing environment that enables the collection, storage and access to data in ways that were never possible earlier. As the obvious part of this development, it is worth noting that the objective of such innovation is mostly on the integrity of data, provenance and security. Data integrity from as well as security of the Internet connected healthcare devices should be assured in the first place to keep patient safety and protect data privacy along with improve data-based decision-making. The centralized system and crowded nature of the current equipment are susceptible to single point of failure, data breach and potential manipulations of data, which raise questions and create doubts with regards data management processes pertaining to medical device systems. This work is addressed to the analysis of a novel security system based on blockchain that guarantees the implementation of a high performance with the solution of two medical device integrity and provenance safety issues in the cloud ecosystem. Fundamentally differentiating from the centralized systems that exist today, blockchain technology that is based on distributed database architectures, immutable logs, and consensus mechanisms provides for a new way to bring reliability and traceability to the entire medical device data chain. The suggested procedure is based on properties of blockchain technology. Such a solution can help to provide a clear and secure audit trail for medical devices. Storing, securing and accessing the device data can be carried out credibly, maintaining these data’s integrity and provenance. Ultimately, the solution, rely on the implementation of smart contracts, cryptocurrency processes, and the confidentiality and privacy of data, can be the answer which make up the practice of secure data sharing, data accessing and complying with regulations. The journal creates a modular system combining Medical devices, a cloud platform, and Blockchain solution. The architecture is intended to display the blockchain network's essential components, data validation and access control, and secure data storage mechanisms. Furthermore, the recommended solution implies state-of-the-art security tools, such as data encryption, access control, and abidance by regulatory systems, including HIPAA and GDPR. Implementation of an actual scenario of the proof-of-concept and performance evaluation are done to show the efficiency and performance of the blockchain-based solution provided. The results suggest that the proposed solution can establish the data reliability level, record all the various versions of modifications, and strengthen the security and transparency of medical device data processing in cloud computing. Through the exploration of the applications of blockchain for medical data management that this study proposes, we are laying the foundations of a future healthcare environment, which is expected to be more secure and trustworthy, where the sensor data of medical devices can be reliably controlled and accessed without jeopardizing the patient's safety or data privacy. To a great extent, the suggested solution can contribute to building trust in the digital tools utilized in health care, leading to more well-informed clinical decisions and ultimately improving the patients' results.

Blockchain-Enabled Security Solutions for Medical Device Integrity and Provenance in Cloud Environments

The current period of medicine using digital technology for patient care presents a new level of integration of monitoring devices with the cloud computing environment that enables the collection, storage and access to data in ways that were never possible earlier. As the obvious part of this development, it is worth noting that the objective of such innovation is mostly on the integrity of data, provenance and security. Data integrity from as well as security of the Internet connected healthcare devices should be assured in the first place to keep patient safety and protect data privacy along with improve data-based decision-making. The centralized system and crowded nature of the current equipment are susceptible to single point of failure, data breach and potential manipulations of data, which raise questions and create doubts with regards data management processes pertaining to medical device systems. This work is addressed to the analysis of a novel security system based on blockchain that guarantees the implementation of a high performance with the solution of two medical device integrity and provenance safety issues in the cloud ecosystem. Fundamentally differentiating from the centralized systems that exist today, blockchain technology that is based on distributed database architectures, immutable logs, and consensus mechanisms provides for a new way to bring reliability and traceability to the entire medical device data chain. The suggested procedure is based on properties of blockchain technology. Such a solution can help to provide a clear and secure audit trail for medical devices. Storing, securing and accessing the device data can be carried out credibly, maintaining these data’s integrity and provenance. Ultimately, the solution, rely on the implementation of smart contracts, cryptocurrency processes, and the confidentiality and privacy of data, can be the answer which make up the practice of secure data sharing, data accessing and complying with regulations. The journal creates a modular system combining Medical devices, a cloud platform, and Blockchain solution. The architecture is intended to display the blockchain network's essential components, data validation and access control, and secure data storage mechanisms. Furthermore, the recommended solution implies state-of- the-art security tools, such as data encryption, access control, and abidance by regulatory systems, including HIPAA and GDPR. Implementation of an actual scenario of the proof-of-concept and performance evaluation are done to show the efficiency and performance of the blockchain-based solution provided. The results suggest that the proposed solution can establish the data reliability level, record all the various versions of modifications, and strengthen the security and transparency of medical device data processing in cloud computing. Through the exploration of the applications of blockchain for medical data management that this study proposes, we are laying the foundations of a future healthcare environment, which is expected to be more secure and trustworthy, where the sensor data of medical devices can be reliably controlled and accessed without jeopardizing the patient's safety or data privacy. To a great extent, the suggested solution can contribute to building trust in the digital tools utilized in health care, leading to more well-informed clinical decisions and ultimately improving the patients' results.

Healthcare Providers’ Readiness to Address Medical Device Cybersecurity within the Irish Healthcare System

Medical devices that can diagnose and treat critically ill patients have become sophisticated and complex. Device manufacturers have been developing these systems to meet market requirements as technology evolves. Combining medical devices and ICT into a distributed medical device IT system can be a solution to incorporating continuous monitoring from the patient bedside to interoperability with a clinical information system. These technology innovations aim to manage patient data and configure medical devices into networked systems that can provide functionality and safety. The implementation of a medical device network solution allows a healthcare provider to take advantage of managing the flow of information to improve clinical work practices and implement a system that can be interoperable with other clinical information systems. International Electrotechnical Commission (IEC) 80001-1 was developed to assist healthcare providers in identifying and managing the risks associated with medical devices sharing the same IT network with other systems and software. This standard defines roles, responsibilities, and activities in relation to the management of risk with medical devices on an IT network. This study aims to determine if the standard International Electrotechnical Commission (IEC) 80001-1 is being implemented and determine familiarity with regulations and appropriate standards and guidance for an effective medical device security risk-management program with Irish healthcare providers. A literature review highlighted the restrictions healthcare providers face in adopting and implementing IEC 80001-1 and the security threats and risks present when integrating medical devices and IT networks. The study research was conducted with clinical engineering members of the Biomedical and Clinical Engineering Association of Ireland (BEAI). This survey targeted BEAI members due to their wealth of experience, knowledge, and skill level in supporting complex medical device systems. An online anonymous survey was created to determine knowledge, awareness, and familiarity with IEC 80001-1 and other medical device security risk-management guidelines. The study research results revealed low knowledge, awareness, and familiarity among research participants with IEC 80001-1 and guidelines on medical device security risk management. These results were consistent with the literature review that a key to the success of standard adoption is collaboration between stakeholders and a multidisciplinary approach to compliance.

Magnetorheological Damper Force Prediction using Particle Swarm Optimization and Long Short-Term Memory Model

Smart materials, like magnetorheological (MR) fluid, are gaining attention for their ability to rapidly change properties under magnetic influence, making them useful in vibration control systems for vehicles, medical devices, and civil engineering structures. Common parametric models, such as Bouc-Wen and Bingham, are traditionally employed to model MR damper dynamics behavior. However, the manual tuning of numerous parameters in these models increases complexity and hinders the identification of inverse models, potentially leading to unpredictable optimum target forces. In response to these challenges, this study suggested a non-parametric approach using Long Short-Term Memory (LSTM) models to predict the optimum target force of MR dampers. Unlike parametric models, LSTM models capture dynamic behavior without the need for extensive manual tuning. To optimize the LSTM model, Particle Swarm Optimization (PSO) is employed to fine-tune hyperparameter values, ensuring robust performance. The proposed non-parametric method, specifically the PSO-LSTM model, demonstrates faster processing times compared to traditional parametric approaches. The proposed model produced an accurate damping force prediction with a root mean square error of less than 5%, This novel approach simplifies the modeling process and offers an efficient and precise alternative to traditional parametric methods.

Polyelectrolyte Platforms with Copper Nanoparticles as a Multifunctional System Aimed at Healing Process Support

(1) Purpose: The aim of the study was to develop a nanocomposite with copper nanoparticles constituting a bacteriostatic surface to maintain human lung cell function. (2) Methods: A polyelectrolyte layer coating that incorporated copper nanoparticles was designed. As a bacteriostatic factor, copper nanoparticles were applied as a colloidal solution of copper nanoparticles (ColloidCuNPs) and a solution of copper nanoparticles (CuNPs). The influence of the polyelectrolytes on selected Gram (+) and Gram (−) strains was examined. The function and morphology of the human adenocarcinoma A549 cell line, comprising human epithelial lung cells cultured in the presence of nanocomposite layer coatings, were evaluated. We applied fluorescence and scanning electron microscopies, as well as flow cytometry, for these studies. Furthermore, the layer coating material was characterized by atomic force microscopy (AFM) and energy dispersive X-ray analysis (EDX). (3) Results: It was observed that the polyelectrolytes polyethyleneimine (PEI) and poly-L-lysine (PLL) did not induce proliferation of the E. coli strain. However, they did induce the proliferation of the S. aureus strain. Due to the effectiveness of the CuNPs against the E. coli strain, CuNPs were selected for further research. The designed coatings of proper NPs shared the sustained function of human lung cells within 10 days of culture. The AFM and EDX characterization confirmed the presence of copper in the layer coating nanomaterial. The presence of CuNPs in polyethyleneimine-based nanocomposite deepened the bacteriostatic effect on E. coli compared with PEI alone. Meanwhile, incorporating CuNPs in PLL allowed A549 cell maintenance but did not exert a bacteriostatic influence on the examined strain. (4) Conclusions: The platform based on polyelectrolytes, incorporated with copper nanoparticles, that ensures the growth and appropriate morphology of the human lung epithelial cells, might be considered an element of a system for medical devices used to maintain the function of human lung cells.

Ionized jet deposition of silver nanostructured coatings: Assessment of chemico-physical and biological behavior for application in orthopedics

Infection is one of the main issues connected to implantation of biomedical devices and represents a very difficult issue to tackle, for clinicians and for patients. This study aimed at tackling infection through antibacterial nanostructured silver coatings manufactured by Ionized Jet Deposition (IJD) for application as new and advanced coating systems for medical devices. Films composition and morphology depending on deposition parameters were investigated and their performances evaluated by correlating these properties with the antibacterial and antibiofilm efficacy of the coatings, against Escherichia coli and Staphylococcus aureus strains and with their cytotoxicity towards human cell line fibroblasts. The biocompatibility of the coatings, the nanotoxicity, and the safety of the proposed approach were evaluated, for the first time, in vitro and in vivo by rat subcutaneous implant models. Different deposition times, corresponding to different thicknesses, were selected and compared. All silver coatings exhibited a highly homogeneous surface composed of nanosized spherical aggregates. All coatings having a thickness of 50 nm and above showed high antibacterial efficacy, while none of the tested options caused cytotoxicity when tested in vitro. Indeed, silver films impacted on bacterial strains viability and capability to adhere to the substrate, in a thickness-dependent manner. The nanostructure obtained by IJD permitted to mitigate the toxicity of silver, conferring strong antibacterial and anti-adhesive features, without affecting the coatings biocompatibility. At the explant, the coatings were still present although they showed signs of progressive dissolution, compatible with the release of silver, but no cracking, delamination or in vivo toxicity was observed.

High-Performance Wireless Power and Data Transmission System for Medical Implant Devices Using ASK Modulation

Wireless power and data transmission (WPDT) solutions for medical implants are highly desired. However, achieving a high-power transmission efficiency and data rate simultaneously over an inductive link remains a significant challenge. This paper presents an innovative WPDT circuit that incorporates additional MOSFETs with an inductor in a Class-E power amplifier (PA), achieving amplitude-shift keying (ASK) modulation to address this issue. Firstly, the efficiency of the inductive power transmission link and Class-E PA was analyzed, providing design insights. Then, leveraging the insights, the proposed circuit was designed in such a way that it could effectively switch between two load networks to maintain high transfer efficiency for ASK modulation. Based on the load networks, the relationship between introducing the inductor’s value and the data modulation index (MI) was derived to help achieve the desired high-power transmission efficiency. Additionally, the design and calculation of the proposed circuit are also presented. Finally, the proposed circuit was validated through simulations and experiments, demonstrating a power delivery to a load of 84.1 mW with a power transmission efficiency of 70.8% at a data rate and carrier frequency of 3 Mbps and 16 MHz, respectively. Furthermore, the bit error rate (BER) is less than 10−6 with an MI of 10%.

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America.

Metrology plays a crucial role in small healthcare service businesses to ensure the quality of products and services. While legal metrology in healthcare exists in some regions, it lacks harmonization. In other countries, there is limited presence of metrology in medical and biomedical engineering. We aimed to evaluate the implementation of metrological assurance systems for medical devices in Latin America. A systematic review was conducted following PRISMA 2020 guidelines and registered with PROSPERO (CRD42022359284). Searches were performed across 13 databases from October 30th to November 3rd, 2022. The search equation was "(((quality assurance) AND (metrology)) AND (medical devices))." A total of 7,789 documents were identified, of which only 16 met the inclusion criteria. The majority of studies (75%) were conducted in Colombia, with a significant portion being undergraduate theses. The primary normative references used in the analyzed studies were ISO 10012 and ISO 17025, with the majority (68.75%) relying on national legislation for their approach. One study in Colombia referenced eight standards, and one in Brazil analyzed user involvement in medical device management. Among the included studies, 56.25% were conducted in healthcare institutions, mainly clinics. Most studies provided implementation guidelines, with ISO 10012 being prominent, alongside ISO 17025, which implicitly addresses ISO 9001 elements. Global bias was low across all studies. Our results underscore the importance of metrological assurance in managing medical devices in Latin America. The utilization of international standards and national legislation illustrates the diverse approaches adopted by different institutions. Future research should focus on optimizing metrological practices to enhance quality and safety in healthcare.

Blockchain-Enabled Hyperledger Fabric to Secure Data Transfer Mechanism for Medical Cyber-Physical System: Overview, Issues, and Challenges

This paper proposes a model to address the challenges faced by medical cyber-physical systems (MCPS) by implementing a permissioned blockchain platform. The platform incorporates the unique properties of blockchain into the network of affected systems, including decentralization, transparency, and immutability. The platform also includes a novel technique to secure MCPS through an automated access-control manager. This manager allows users to control who has access to their data, and can be configured to trust a third party if desired. The paper also extends into networked medical device systems, and discusses how the platform can be used to address critical is-sues specific to this field, such as network design. Finally, the paper discusses how various security features can be integrated into ultra-small devices, enhancing the protection of embedded systems. The overall objective of this research is to develop a secure and efficient data transfer mechanism for MCPS. The proposed platform addresses the challenges faced by MCPS by incorporating the unique properties of blockchain.

Metamaterial integrated highly efficient wireless power transfer system for implantable medical devices

In this article, a novel and highly efficient metamaterial (MTM) integrated approach is presented for the development of a wireless power transfer system (WPT) specifically tailored for implantable medical devices. The system is designed by using a biocompatible implantable ring slot antenna constructed on a flexible dielectric, functioning as a receiving (Rx) antenna. Additionally, a conventional patch antenna is modelled for the use in free space, serving as an external transmitting (Tx) element. By exploiting the unique characteristics of MTMs, the power transfer efficiency (PTE) of the introduced system is effectively improved. To ensure the system’s performance stability in real-time application scenario, the effects of misalignment (lateral and angular) and the flexibility of the implantable antenna are meticulously performed. The prototypes of the Tx, Rx, and MTM structures are fabricated, and comprehensive measurements are performed in human-equivalent tissue models, such as skin-mimicking gel and minced pork. Both the simulated and measured results established the proposed methodology, showcasing marked improvements in PTE due to the use of MTMs. The efficiency of the pioneering MTM-integrated WPT system increases from 0.19% to 3.07% in skin-mimicking gel and from 0.24% to 3.26% in minced pork, respectively. This study highlights the potential of MTM-integrated WPT systems in advancing the field of implantable medical devices and expanding their practical applicability.

A Novel Method of Wireless Micro Energy Transmission Based on MEMS Micro Coil.

Based on current implantable devices, a battery's rigidity and large size makes it prone to immune rejection and wound incisions. Additionally, it is limited by its finite lifespan, which hinders long-term usage. These limitations greatly restrict the development of implantable medical device systems towards miniaturization and minimally invasive approaches. Consequently, obtaining high-fidelity and stable biological signals from the target tissue area of the organism remains challenging. Therefore, there is a need to develop wireless power transmission technology. In this paper, we propose a wireless micro energy transfer method based on MEMS micro coils for charging implantable devices. Through simulation calculations, we first investigate the influence of coaxial distance, horizontal displacement, and rotation angle between the MEMS micro coil and the transmitting coil on power transmission. Subsequently, we utilize micro nanofabrication technology to create a MEMS micro spiral copper coil with a line width, thickness, and spacing of 50 µm and a total of five turns. Finally, we conduct wireless power transmission tests on the coil. The results show that, when the transmitting coil and the receiving coil are 10 mm apart and the operating frequency is 100 kHz, the power of the wireless power transmission system reaches 45 µW. This power level is sufficient to meet the power supply requirements of implantable pacemakers. Therefore, this technology holds great potential for applications in the field of wireless power transmission for implantable medical devices, including pacemakers and brain neurostimulators.

Quality management system: A tool for the development of the organization or an additional burden?

A quality management system constitutes one of the organizations management systems that provides for the selection of a set of processes in the organizations activities designed to ensure the stable quality of products and services provided.
 The growth of global industrial production has underscored the need for the creation of such production and management systems. These systems are designed to ensure that enterprises remains prepared to meet the constantly changing consumer value of manufactured products in accordance with consumer requirements, as well as the satisfaction of consumers themselves. As a result, attention began to focus on the production processes implemented within the organization when creating products. Regarding the production of medical devices, a quality management system can be defined as an organizational structure encompassing its functions, procedures, processes, and resources necessary for the coordinated direction and management of a manufacturing organization with respect to the quality of medical products.
 The article reflects the principles of the quality management system and management processes. Noteworthy emphasis is placed on the features of quality management systems for medical devices, including the features of the quality management system for software that is a medical device. Furthermore, the conditions under which the quality management system becomes a tool for ensuring the sustainable development of the organization are noted.

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices

The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

HPR133 Introduction of an Integrated Review and Assessment System for Artificial Intelligence and Digital Innovative Medical Devices in Korea

The purpose of the study is to share an effective policy to ensure innovative medical devices(IMD) to be used swiftly at the medical field.

An early screening model of pulse detection technology for hepatic steatosis

BackgroundThe increasing prevalence of hepatic steatosis presents a considerable challenge to public health. There is a critical need for the development of novel preventive and screening strategies for this condition. This study evaluated the potential applications of wrist pulse detection technology for the early detection of liver diseases. The pulse time-domain features of a medical exam population with and without hepatic steatosis were assessed to develop a screening model for this disease. MethodsParticipants were consecutively recruited from March 2021 to March 2022 in the medical examination centers of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine and the Shanghai Municipal Hospital of Traditional Chinese Medicine. Clinical data from 255 participants, including general information (sex, age, and body mass index), and data related to glucose and blood lipids (fasting plasma glucose, triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein levels) were collected. Wrist pulse signals were acquired using a pulse detection device, and the pulse time-domain features, including t1, t4, t5, T, w1, w2, h2/h1, h3/h1, and h5/h1 were extracted. Participants were assigned to hepatic steatosis and non-hepatic steatosis groups according to their abdominal ultrasound examination results. Their clinical data and pulse time-domain features were compared using chi-square and parametric or non-parametric statistical methods. Three datasets were used to construct screening models for hepatic steatosis based on the random forest algorithm. The datasets for modeling were defined as Dataset 1, containing blood glucose and lipid data and general information; Dataset 2, containing time-domain features and general information; Dataset 3, containing time-domain features, blood glucose and lipid data, and general information. The evaluation metrics, accuracy, precision, recall, F1-score, and areas under the receiver operating characteristic curve (AUC) were compared for each model. ResultsThe time-domain features of the two groups differed significantly. The t1, t4, t5, T, h2/h1, h3/h1, w1, and w2 features were higher in the hepatic steatosis group than in the non-hepatic steatosis group (P < 0.05), while the h5/h1 features were lower in the hepatic steatosis group than in the non-hepatic steatosis group (P < 0.05). The screening models for hepatic steatosis based on both time-domain features and blood glucose and lipid data outperformed those based on time-domain features or blood markers alone. The accuracy, precision, recall, F1-score, and AUC of the combined model were 81.18%, 80.56%, 76.32%, 79%, and 87.79%, respectively. These proportions were 1.57%, 1.86%, 1.76%, 2%, and 3.54% higher, respectively, than those of the model based on time-domain features alone and 3.14%, 4.2%, 2.64%, 4%, and 6.47% higher, respectively, than those of the model based on blood glucose and lipid alone. ConclusionThe early screening model for hepatic steatosis using datasets that included pulse time-domain features achieved better performance. The findings suggest that pulse detection technology could be used to inform the development of a mobile medical device or remote home monitoring system to test for hepatitis steatosis.

Medical Device Recalls for Electronic Components

Through the advancement of technology, an ever-increasing number of medical devices contain electronic components and sensors. As a result of these technological advances, smaller devices need more memory, sensors, processing power, and increased energy requirements. Ultimately, the performance of many medical devices is directly dependent on the functionality of these interconnected electronic components. In this article, medical device recalls are examined for malfunctions of electronic systems and components with respect to what system or component specifically did not perform as intended. From this examination, recalls related to electronic medical device systems and components are identified and grouped into common themes. By alerting the Food and Drug Administration to medical device failures, clinical engineering staff can help make manufacturers aware of issues that can be used to make future design changes or mitigations that can ultimately improve the performance and reliability of electronic medical devices.

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system

ObjectivesThis study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences...

Identification of Known Use-Related Problems in Artificial Intelligence Medical Imaging Devices

As Artificial Intelligence (AI) advances, it is included into more and more medical device systems to carry out these systems’ intended functions. Given AI’s ability to learn from real-world use and its capability to continuously improve performance, manufacturers of medical devices are utilizing AI to innovate their products to better assist health care providers. However, like application of other types of medical devices, the application of AI in medical care might pose different types of potential risks to the patients, the users themselves, and to the use environment. For manufactures to successfully ensure the safety of AI medical devices, it is crucial to identify known problems by investigating use-related, user interface, and user interaction in-cidents that have occurred in comparable medical devices. The objective of this study is to identify potential use-related problems of DeepView® Wound Imaging System that assesses the healing potential of thermal burn wounds by analyzing multispectral images with an ML algorithm. We use a variety of sources of information on reports and recalls of medical devices that are associated with deaths, serious injuries and mal-functions. After examining relevant reports and recalls, 19 use-related problems were identified. An in-depth analysis was then conducted, considering each identified use-related problem and determining how it relates to the specific features and functionality of DeepView® Wound Imaging System as well as identifying patterns and commonalities among them. The information gained from this analysis can be beneficial in enhancing the safety of AI medical devices by providing a deeper understanding of the reasons for failure, to avoid similar issues in the future, and ultimately to improve patient safety and public health.