Medical Device System Research Articles

Metasurface‐based radiative near‐field wireless power transfer system for implantable medical devices

This article presents a novel approach to improve the efficiency of a radiative near-field wireless power transfer (WPT) system by using metasurface. The WPT system is designed particularly for implantable applications, which operate at the industrial, scientific, and medical (ISM) 2.40-2.48 GHz band. To construct the WPT link, a patch antenna is used as the transmitting element whereas a small planar loop antenna is considered as the receiving element. The receiving antenna is implanted under the skin tissue model operating at 2.45 GHz. The metasurface with a high refractive index is placed above the surface of the skin layer to improve the power transfer efficiency. Regarding the motion of the human body, different misalignment tolerances between the transmitter and the implant receiver are discussed. Also, the effect in the change of the skin property and placement depth of the Rx antenna inside the skin tissue model is studied. Furthermore, the study of specific absorption rate for the proposed configuration is performed. Finally, the proposed WPT system is designed and experimentally verified with and without metasurface. The experimental result confirms a significant amount of improvement in power transfer efficiency due to the integration of metasurface.

Reference and Innovation: Research on the Construction of Medical Device Registrar System

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.

Reprocessing and reuse of single-use medical devices in China: a pilot survey

BackgroundIn China, reprocessing and reuse of single-use medical devices (SUDs) are banned. However, the actual situation has not been reported so far. The study aims to clarify the perceptions and concerns of various sectors of the community on the reuse of SUDs, and whether such practice exists. In addition, we are also wondering how acceptable the respondents are on this matter.MethodsA cross-sectional study based on a national survey which was conducted on the professional online questionnaire survey platform (www.wjx.cn) from July 26 to August 4, 2015. We analyzed the data according to the work fields, sex, age, education level, professional background and participants’ answers to 49 other questions.ResultsFive hundred forty-four nationwide respondents belong to nine different work fields. In general, participants had positive attitudes towards the reprocessing and reuse of SUDs. However, many respondents doubted the hygienic and functional safety of the reprocessed SUDs. They also tended to think that the reuse of SUDs should have lower prices and more technical training as well as patient advocacy. Further analysis demonstrated the work fields, education level and professional background of respondents were statistically associated with their responses to certain questions.ConclusionsThe research indicated that although the reuse of SUDs is prohibited legally in China, there were extensive reprocessing and reuse in hospitals. Most responses tended to accept reprocessed SUDs if safety and low prices were guaranteed. These existing contradictions and the lack of relevant research led to policy makers in China will confront numerous challenges in building and improving this use system of medical devices to meet escalating demands of social sectors.

Tracking systems for intracranial medical devices: A review

AbstractIn minimally invasive surgery, especially in neurosurgery, the ability to reach deep and functional structures without damage remains a major challenge. Recent breakthroughs in microtechnologies have enabled the downsizing of an increasing number of devices. In such a context, the possibility to navigate a micromedical device inside the human brain is a reachable ambition. One of the most expected applications is the identification and the treatment of early‐stage cancers which could strongly improve therapies efficiency. Despite these remarkable attainments, micromachines, to actually become revolutionary, require a tracking system at least as accurate as its size and working in an heterogeneous environment. The aim of the present paper was to provide an overview of the state of the art in medical device tracking systems for the brain. Firstly, the latest advances are categorized by technological family: magnetic field, electromagnetic waves, magnetic resonance, ultrasound waves and hybrid solutions. Secondly, in a comparative purpose, performance criteria are evaluated and displayed in radar diagrams and graphs to highlight the three dimensions challenge the systems should take up: performance, invasiveness and user experience. Finally, the present and future of each localization family are provided.

A New Externally Worn Proxy-Based Protector for Non-Secure Wireless Implantable Medical Devices: Security Jacket

Wireless transmission systems of implantable medical devices (IMDs) should be secure against eavesdroppers and adversaries because of patient rights and health. This paper focuses on full-duplex secure communication of wireless IMD systems, proposing a new protector that is compatible with existing unsecure systems. This new protector is an externally worn jacket and therefore called a security jacket. Because some advanced sensors are placed on the jacket to provide physical layer security. Randomly multi-jamming with a great number of sensors is applied when IMD transmission occurs with the jamming extraction and maximum ratio combining (MRC) reception simultaneously. When reception by IMD is performed, a randomized spoofing-based transmit beamforming technique is applied. This protector also supports higher power efficiency and longer battery life.

Proof of Concept for a Universal Identification System for Medical Devices.

Medical devices need a unified way of accessing information that uniquely identifies them. This can provide traceability to specifications, lot numbers, recalls, and the like. Such a system would have applications for devices both in and out of the body. Common barcodes, such as a UPC code, can only be read in plain sight, when nothing comes between the scanner and the code. UPC coding is not suitable for all medical devices because some are implanted in the body or are otherwise inaccessible without invasive techniques. This article demonstrates a proof of concept for XRF coding on devices. Material codes were made and read externally by an XRF reader. The reading showed trace amounts of the chemicals that compose the medical device in the background signal. The energy levels of the chemicals were assigned values to build a readable code correlated with information about the medical device it is attached to. Attachment can be made during material synthesis, part or product manufacture, or even after final assembly. The technique demonstrated here is a promising concept for the future of medical device detection.

Subjective health status of multimorbidity: verifying the mediating effects of medical and assistive devices

BackgroundThis study aimed to verify the mediating effect of using assistive devices as a factor that alleviates the relationship between multimorbidity and subjective health status.MethodsThis study used three-year data (2011–2013) from the Korea Health Panel (KHP). The data were jointly collected by the consortium of the National Health Insurance Service and Korea Institute for Health and Social Affairs.ResultsThe mediating effect of using assistive devices was verified, but the direction of the effect was deteriorated subjective health. In other words, in terms of the impact of multimorbidity on subjective health, using assistive devices had a negative impact (−) on subjective health.ConclusionsThe current assessment system for medical devices, narrow scope for choice of assistive devices, and limited scope of health insurance benefits must change to ultimately lead to a positive mediating effect on using medical devices and on subjective health satisfaction of patients with chronic diseases. A system that embraces all ages and generations must be developed. To this end, it is necessary to expand the scope of medical devices and insurance payment in long-term care insurance for elderly users, as well as the active meaning of medical devices in terms of health insurance.

A high‐reliability alumina‐platinum multilayer system for implantable medical devices

AbstractA new Pt‐Al2O3 multilayer composite system has been developed and validated with an Accelerated Life Test (ALT) to confirm its potential for long‐term use in implantable medical devices (IMD). Panels containing over 100 Pt vias were subjected to highly accelerated immersion testing in deionized water at temperatures ranging from 90 to 175°C. Deionized water was employed as it best represents the IMD use environment. Degradation of individual Pt vias was evaluated using fluorescent dye infiltration into the subsurface of the panels. ALT guided refinement of materials and processing to produce a Pt‐Al2O3 multilayer composite system with promising performance for possible use in implantable devices.

A Batteryless Energy Harvesting Storage System for Implantable Medical Devices Demonstrated In Situ

We report a wireless energy harvesting and telemetry storage system in 180 nm CMOS technology, demonstrated in situ in rat carcass. The implantable device has dimensions 13 mm × 15 mm and stores 87.5 mJ, providing a self-powering time of 8.5 s transmitting through tissue. We utilize an all-solid-state flexible supercapacitor of breakdown voltage 0.8 V and capacitance 400 mF to harvest incoming wireless power, followed by a boost converter CMOS that drives an active wireless transmitter at 1.5 V at 2.4 GHz in the industrial, scientific, and medical (ISM) band. The DC/DC converter component and switching frequency selection were guided by genetic algorithm analysis and use digital feedback to control the pulse width modulation (PWM), which slowly modifies the duty cycle to control output voltage fluctuations. This implantable medical device system presents the roadmap for batteryless energy harvesting in vivo and in clinical environments, exhibiting the highest operating storage density of 450 μJ/mm2 reported to date.

Consumer opinions on adverse events associated with medical devices.

Post-market surveillance of medical devices relies on compulsory and voluntary reports. Although direct consumer reporting of medical device-related adverse events (AEs) is available in Australia, the proportion of consumer reports has remained low. Limited qualitative research has previously explored consumer insights on AEs associated with medical devices and in particular, AE reporting. To explore consumer opinions on AEs related to medical devices, and their knowledge of, experiences with, and views on, the reporting of medical device-related AEs. Focus groups (n = 4; total of 29 participants) were conducted in metropolitan Sydney, Australia. Focus group discussions of approximately 1.5 h in length centred on consumers' understanding of AEs, opinions on AEs and their previous experiences, views on medical device benefits and harms, and actions taken (or potential actions) in response to AEs. With participant consent, discussions were audio-recorded, transcribed verbatim, and thematically analysed. Participants regarded medical device-related side effects to be unexpected AEs associated with their use. Where there was a clear need for the medical device itself, potential improvement in quality of life took precedence over potential harms. Most participants had not experienced negative issues with their medical device(s). There was poor awareness among participants of an existing direct consumer AE reporting system for medical devices. Despite this, the value of reporting was acknowledged. Severity of the AE was a key motivator for potential AE reporting. Further efforts are necessary to improve consumer awareness of available AE reporting systems to better support post-market surveillance and safe medical device use.

EVALUASI PENYIMPANAN OBAT DAN ALAT KESEHATAN DI APOTEK RESTU FARMA

Storage is one of important process in the management of drug and medical devices.This study aims to evaluate the storage system of drug and medical devices in the Restu Farma Pharmacy. This is a descriptive research which carried on by direct observation and interview. This research was evaluate arrangement of drugs and medical devices in Restu Farma Pharmacy. This research show that in Restu Pharma Pharmacy the drug and medical devices were arranged by type of drugs (tablets, syrups, intervereous liquid and injection). The Restu Pharma Pharamcy‟s warehouse was as the drug and medical devices in Restu Pharma Pharmacy ware house was arrange by type of drugs (tablets, syrups, intervereous liquid and injection).The storage in the warehouse at 75% and the service room at 85% is [compliance with Permenkes No. 73 of the years 2016 about standard of pharmaceutical care at pharmacy.]

Clinical Engineering/Health Technology Management 2015 Global Update

Medical device systems Clinical Engineering (CE)/Health Technology Management (HTM) strategies and best practices are now well established in most first world and many developing countries (DC).Progress is being made to address identified gaps in DC CE/HTM, such as appropriate equipment selection and lifecycle management. One contributor to this progress is the 25 years of CE/HTM Seminars provided by WHO-PAHO, ACCE, and more recently, IFMBE CED, to 80 countries. There is also a new emerging challenge; the requirement for medical device (clinical data) integration (MDI) into electronic health records (EHRs) to improve care quality and safety (aka CE-IT).This study will review CE/HTM progress, gaps, and new challenges since the last study in 2011. It will provide a framework to direct the global CE/HTM movement forward in collaborative fashion, alongside other initiatives in 2015, such as the 1st International CE-HTM Congress and the Global CE Summit held in Hanzhou, China, in October, 2015.

Medical cyber-physical systems: A survey.

Medical cyber-physical systems (MCPS) are healthcare critical integration of a network of medical devices. These systems are progressively used in hospitals to achieve a continuous high-quality healthcare. The MCPS design faces numerous challenges, including inoperability, security/privacy, and high assurance in the system software. In the current work, the infrastructure of the cyber-physical systems (CPS) are reviewed and discussed. This article enriched the researches of the networked Medical Device (MD) systems to increase the efficiency and safety of the healthcare. It also can assist the specialists of medical device to overcome crucial issues related to medical devices, and the challenges facing the design of the medical device's network. The concept of the social networking and its security along with the concept of the wireless sensor networks (WSNs) are addressed. Afterward, the CPS systems and platforms have been established, where more focus was directed toward CPS-based healthcare. The big data framework of CPSs is also included.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices.

The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Contactless power transfer system for low power medical devices

Currently, contactless power transfer system is being implemented to power up the medical devices. Those medical devices can either power by transcutaneous cable or batteries. However, the power driven for medical devices via transcutaneous cable might lead to infection due to breach on the skin. The battery replacement surgery for cardiovascular patients also can lead to infection. Therefore, a contactless power transfer system is effectively solving the problem by transmitting power in a safe and non-invasive manner and has mitigate effect to patient health, yet efficient in the power transmission process. Magnetic coupled resonant is being designed since magnetic field cannot be shielded by biological tissues. Resonant power transfer technique can minimize the power scattering on the non-resonant objects such as human body. Impedance matching technique is utilized to improve the overall power transmission efficiency. The system consists a pair of transmitter and receiver coil, transmitter and receiver circuit, and a pair of transformer as impedance matching purpose. The system is capable to achieved a transfer efficiency of over 60%. Contactless power transfer technology does offer the advantages of safety, non-invasive and no significant effect on patient health. Eventually, bacterial infection on the skin breach is prevented.

Impact de l’implantation d’armoires sécurisées dédiés aux dispositifs médicaux dans un service de chirurgie cardiaque

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users.

Review and approval of medical devices in China: Changes and reform.

The 4th US-China Joint Workshop on Regulation, Standards and Innovation of Biomaterials was held during the Annual Meeting of the Society for Biomaterials on April 5, 2017 at Minneapolis, MN. This series of joint workshops have become a unique platform for both the US and China to discuss and update what is new in the field of biomaterials and medical devices in terms of regulation, standards and innovation since 2013. China Food and Drug Administration and its affiliated agencies such as Center for Medical Device Evaluation presented at each of the workshop. With the implementation of Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the People's Republic of China, No. 650) since June 1, 2014, the regulatory changes and reform for medical devices in China have been hot topics in the workshops. This report captures the key information presented during the workshops, which includes major changes of the Chinese medical device regulation systems, reform of the review and approval system for medical devices in China, and the special procedures of review and approval for innovative medical devices. The market growth of medical devices along with demands for innovative technologies brings the ongoing regulatory changes and reform in China, which will certainly create positive impact on both the development of the Chinese healthcare system and the innovation of medical devices in China. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2093-2100, 2018.

Research on Standard System of Home Use Electronic Medical Devices

Medical device going home is an inevitable trend, however, using these devices has potential safety risks. Through introducing the home use electronic medical device products and related medical device standards, this paper provides recommendations on construction of standard system for home use electronic medical devices, to improve the advancement of existing medical device standard system and guide future medical standardization work, to fully utilize standars's guiding and security role in the scientific and technological innovation, industrial development.

Personalization of a compartmental physiological model for an artificial pancreas through integration of patient's state estimation.

Artificial Pancreas (AP) are developed for patients with Type 1 diabetes. This medical device system consists in the association of a subcutaneous continuous glucose monitor (CGM) providing a proxy of the patient's glycaemia and a control algorithm offering the real-time modification of the insulin delivery with an automatic command of the subcutaneous insulin pump. The most complex algorithms are based on a compartmental model of the glucoregulatory system of the patient coupled to an approach of MPC (Model-Predictive-Control) for the command. The automatic and unsupervised control of insulin regulation constitutes a major challenge in AP projects. A given model with its parameterization on the shelf will not directly represent the patient's data behavior and the personalization of the model is a prerequisite before using it in a MPC. The present paper focuses on the personalization of a compartmental showing a method where taking into account the estimation of the patient's state in addition to the parameter estimation improves the results in terms of mean quadratic error.

Methods for Compensation of Coil Misalignment in Systems for Inductive Transcutaneous Power Transfer to Implanted Medical Devices

The problem of variation of the output characteristics (voltage, current, power) of inductive powering systems for implantable medical devices is considered. The variation is primarily caused by relative misalignment of transmitting and receiving coils. A classification of misalignments is proposed. Main approaches to coil misalignment compensation are: mechanical fixation of the coils; evaluation of the relative position of the coils for elimination of misalignment or further tuning of the transmitting part of the system; optimization of the coil geometry providing stability within the given misalignment range; tuning the working frequency of the transmitting part of the system. It is shown that the compensation method should be selected with due regard to the implantable device parameters (first of all, the coil implantation site and the power consumption of the device).