Multiple Medical Devices Research Articles

Leveraging blockchain and federated learning in Edge-Fog-Cloud computing environments for intelligent decision-making with ECG data in IoT

Blockchain technology combined with Federated Learning (FL) offers a promising solution for enhancing privacy, security, and efficiency in medical IoT applications across edge, fog, and cloud computing environments. This approach enables multiple medical IoT devices at the network edge to collaboratively train a global machine learning model without sharing raw data, addressing privacy concerns associated with centralized data storage. This paper presents a blockchain and FL-based Smart Decision Making framework for ECG data in microservice-based IoT medical applications. Leveraging edge/fog computing for real-time critical applications, the framework implements a FL model across edge, fog, and cloud layers. Evaluation criteria including energy consumption, latency, execution time, cost, and network usage show that edge-based deployment outperforms fog and cloud, with significant advantages in energy consumption (0.1% vs. Fog, 0.9% vs. Cloud), network usage (1.1% vs. Fog, 31% vs. Cloud), cost (3% vs. Fog, 20% vs. Cloud), execution time (16% vs. Fog, 28% vs. Cloud), and latency (1% vs. Fog, 79% vs. Cloud).

The Effect of Mitral Valve Prostheses Design and Orientation on Left Ventricular Flow during Left Ventricular Assist Device Support

The mitral valve affects the shape and timing of incoming flow to the left ventricle of the heart, establishing a strong central jet that generates a vortex ring that conserves momentum during the cardiac cycle. When the vortex is disrupted, regions of stasis are introduced that increase blood residence time and the risk of thrombus formation. This risk is increased when multiple medical devices are combined, as occurs in the fraction of patients with mitral valve prostheses that experience heart failure and receive treatment with a left ventricular assist device (LVAD). LVADs are attached directly to the apex of the left ventricle, continuously pumping blood from the heart into the ascending aorta. While LVADs ameliorate the symptoms of heart failure, they are associated with thromboembolic events that result from disrupted blood flow. In this study, six different mitral prosthesis designs/orientations were studied in combination with LVAD support in a mock circulatory loop. Hemodynamics and the intraventricular velocity field were measured and the vortex characteristics determined. The bioprosthetic valve produced the standard flow pattern with a dominant clockwise vortex that circulated within the left ventricle before exiting through the LVAD. The tilting disk valve exhibited skewed inflow that produced a reverse vortex pattern when oriented towards the septum, which greatly increased stasis and residence time. The bileaflet valves split the incoming flow into two streams directed towards the apex but produced weaker vortices than the bioprosthesis. The results inform the surgical planning for LVAD patients with preexisting mitral prostheses, enabling concomitant repair procedures that would decrease the risk of thromboembolic events.

SEPRES: Intensive Care Unit Clinical Data Integration System to Predict Sepsis.

The lack of information interoperability between different devices and systems in the intensive care unit (ICU) hinders further utilization of data, especially for early warning of specific diseases in the ICU. We aimed to establish a data integration system. Based on this system, the sepsis prediction module was added to compose the Sepsis PREdiction System (SEPRES), where real-time early warning of sepsis can be implemented at the bedside in the ICU. Data are collected from bedside devices through the integration hub and uploaded to the integration system through the local area network. The data integration system was designed to integrate vital signs data, laboratory data, ventilator data, demographic data, pharmacy data, nursing data, etc. from multiple medical devices and systems. It integrates, standardizes, and stores information, making the real-time inference of the early warning module possible. The built-in sepsis early warning module can detect the onset of sepsis within 5 hours preceding at most. Our data integration system has already been deployed in Ruijin Hospital, confirming the feasibility of our system. We highlight that SEPRES has the potential to improve ICU management by helping medical practitioners identify at-sepsis-risk patients and prepare for timely diagnosis and intervention.

Learning from pediatric CAR-T development: insights from manufacturing unique patient doses

Chris Brown is the Director of GMP Manufacturing within the Therapeutic Cell Production Core, Seattle Children’s Therapeutics’ GMP cell manufacturing facility. He leads the facility’s manufacturing/process development team and played a key role in initial design, stand-up, and ongoing development of the TCPC facilities, team, and manufacturing methodologies. He has more than 20 years’ experience in the manufacturing of cellular products for Phase 1 and 2 clinical trials, with a focus in translating cutting-edge research into first-in-human cellular therapeutics. He joined Seattle Children’s Research Institute from the Fred Hutchinson Cancer Research Center in 2010, where he led the manufacturing team within the Cellular Production Facility cleanroom. He holds a BA in Biology from Carleton College in Northfield, Minnesota.Sean Werner is the Chief Technology Officer – Cell Processing at BioLife Solutions, a leading provider of bioproduction tools and services to the cell and gene therapy and broader biopharma markets. BioLife acquired Sexton Biotechnologies in 2021 where Sean was President of the company known for providing processing and handling solutions for the CGT industry. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Sean has previous experience filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.

CLABSI Reduction Strategy: Utilizing Weekly Rounds with an Interdisciplinary Team.

Introduction: Central line-associated bloodstream infections (CLABSIs) in pediatric ICU patients lead to a wide variety of adverse outcomes, including increased mortality and morbidity, longer length of stay in the hospital, and greater healthcare costs.1 Pediatric cardiac ICU patients are at a significantly higher risk for these healthcare-associated infections because of an increase in risk factors, such as congenital anomalies, presence of surgical wounds, compromised immune function post cardiopulmonary bypass, and the presence of multiple invasive medical devices.2 After noting an increase in the pediatric cardiac ICU CLABSI rate, an interdisciplinary team was formed to approach the problem. Objectives: The primary aim was to decrease the pediatric cardiac ICU’s CLABSI rate by 25% in 8 months by engaging an interdisciplinary team with identifying and addressing CLABSI maintenance bundle concerns in real time on the unit. Methods: An interdisciplinary team with representatives from nursing, unit leadership, intensive care physicians, infection prevention, nurse practitioners, vascular access team, and quality improvement utilized initial Plan-Do-Study-Act (PDSA) cycles to develop a rounding tool that identified threats to the CLABSI prevention bundle with patient-specific interventions to consider implementing. Weekly interdisciplinary rounds were then conducted on all central lines. Additional PDSA cycles focused on addressing unit-specific gaps in education and increasing awareness of best practices for central line care and maintenance. These included addition and delineation of space to separate clean and dirty supplies, hygiene supplementations to the care bundle, eRecord handoff updates, and both in-person and online educational offerings. Results: Preliminary data suggested a decrease in CLABSI rate during the initial 4-month intervention period (Fig. 1). The focus on central line care has also led to more consistent and robust observations for bundle compliance. In 2021, zero CLABSIs were noted for the initial 4 months after intervention contributing to a unit record of 243 days CLABSI-free. We would like to call attention to 2 points in Figure 1. Point two represents the initiation of weekly interdisciplinary CLABSI rounds. Point three represents 2 premature infants, atypical for unit census, on extracorporeal membrane oxygenation with hemodialysis catheters that required off-label use of Prismaflex. Conclusions: Engagement of a microsystem’s interdisciplinary team to focus efforts on identifying and addressing real-time concerns to central lines has led to a short-term decrease in CLABSI rate. Sustaining this decrease in CLABSIs will require continual reassessment of the effectiveness of strategies utilized. Additional PDSA interventions as a result of the weekly rounds are being investigated, including the use of antimicrobial sheets for high-risk patients, the creation of unit-specific prepackaged sterile central line dressing kits, and transitioning from alcohol to chlorohexidine scrubs for hub accessing.Fig

Determining Incidence and Risk Factors of Pressure Injury After Orthopaedic Surgery in Children and Adolescents With Neuromuscular Complex Chronic Conditions.

Pressure injuries are serious yet often preventable alterations in skin integrity prevalent in orthopaedics, especially in pediatric patients with neuromuscular complex chronic conditions (NCCC). The aims of this study were to (1) estimate incidence of pressure injury in children with NCCC after orthopaedic surgery; (2) determine risk factors for pressure injury development; and (3) describe severity and location of pressure injuries. Children and adolescents (<22y old) with NCCC who underwent orthopaedic surgery at a single tertiary-care children's hospital between 2016 and 2020 were retrospectively identified. A matched case-control design was used to match patients who developed a pressure injury within 1.5 months after surgery to subjects who did not develop a pressure injury using a 1:1 matching based on neuromuscular diagnosis, age, sex, and type of surgery. Patient characteristics, comorbidities, pressure injury characteristics, and a pressure injury risk assessment score utilizing the Braden QD scale were compared across pressure injury groups. Of 564 children with NCCC who underwent orthopaedic surgery, 43 (7.6%) developed a postoperative pressure injury. Pressure injuries were primarily located on the heel, followed by sacral/groin/buttocks, then knee. The most common diagnosis was cerebral palsy with associated neuromuscular scoliosis, and hip reconstruction was the most common surgical procedure. The pressure injury cohort had significantly more patients who were non-ambulatory (GMFCS IV/V), with a seizure disorder, g-tube, nonverbal status, wheelchair usage, and had additional medical devices. Median Braden QD risk score was higher in the injury cohort and a cutoff ≥12 was optimal for predicting pressure injury development. Pressure injuries after orthopaedic surgery are not uncommon in children with NCCC. The entire care team should be aware of additional risk factors associated with pressure injury development, including the diagnosis of cerebral palsy with neuromuscular scoliosis, seizure disorder, nonverbal status, g-tube, and the presence of multiple medical devices. Implementation of evidence-based pressure injury prevention guidelines on identified high-risk children with NCCC may reduce pressure injury risk and improve the postoperative course. Level III.

VitalDB, a high-fidelity multi-parameter vital signs database in surgical patients

In modern anesthesia, multiple medical devices are used simultaneously to comprehensively monitor real-time vital signs to optimize patient care and improve surgical outcomes. However, interpreting the dynamic changes of time-series biosignals and their correlations is a difficult task even for experienced anesthesiologists. Recent advanced machine learning technologies have shown promising results in biosignal analysis, however, research and development in this area is relatively slow due to the lack of biosignal datasets for machine learning. The VitalDB (Vital Signs DataBase) is an open dataset created specifically to facilitate machine learning studies related to monitoring vital signs in surgical patients. This dataset contains high-resolution multi-parameter data from 6,388 cases, including 486,451 waveform and numeric data tracks of 196 intraoperative monitoring parameters, 73 perioperative clinical parameters, and 34 time-series laboratory result parameters. All data is stored in the public cloud after anonymization. The dataset can be freely accessed and analysed using application programming interfaces and Python library. The VitalDB public dataset is expected to be a valuable resource for biosignal research and development.

Privacy-preserving aware data aggregation for IoT-based healthcare with green computing technologies

Despite the rapid development of the Internet of Things technologies where more and more medical sensors and gadgets are connected to the Internet, limited energy resources due to transmission, and security are still main challenges. Most cases, patients wear multiple medical devices that transmit sensed medical data wirelessly to servers, which might cause big traffic on the communication networks, which in turn cause high energy consumption. Therefore, using the data aggregation, we can considerably reduce the energy consumption by eliminating redundant data; yet collected data must be fully protected. Secure data collection and transfer to centralized servers in healthcare applications employing IoT is quite challenging to protect against several attacks for illegal data access. For this reason, massive security measures should be taken to ensure that patients’ data can only be accessed by legitimate users. This paper proposes EPPADA: Efficient Privacy‑Preserving Authentication and Data Aggregation scheme in conjunction with Homomorphic Encryption concepts to meet requirements of healthcare using IoT with green computing technologies. The main objective of this proposed scheme is to decrease the communication overhead and energy consumption while maintaining safe and secure aggregation of the healthcare data between medical sensors and cloud servers. The proposed system is experimentally developed using E-health sensor shield V2.0 platform. Based on security analysis that has the most extensive set of security features, our multi-objective approach enhances the End-to-End Delay, Computational Cost, Communication Overhead, besides maintaining security features.

Device-related pressure ulcers: SECURE prevention. Second edition.

Device-related pressure ulcers: SECURE prevention. Second edition.

Impact of informal care with multiple medical devices on caregiver burden: A cross-sectional national survey in Japan.

Family caregivers provide long-term, home-based, informal medical care to patients with special healthcare needs. We examined whether informal care involving medical device use is associated with caregiver burden, considering potential risk variables as moderators. Data were collected from March to May 2019 through a Japanese public visiting care system. This system is offered to patients with severe chronic or intractable disease or impairment. After contacting government-certified offices that provide visiting care systems, the offices that agreed to participate invited dyads of patients and caregivers to complete our questionnaire. To focus on new parameters other than the caregiver factor that had been clarified previously, we aimed to analyse the data from patient-caregiver dyads. Using a questionnaire-based cross-sectional design, we asked participants about caregiver and patient characteristics, care types, and caregiver burden using the Zarit Caregiver Burden Interview. Logistic regression analyses were conducted to test the association between caregiver burden and informal medical care. Data from 371 complete patient-caregiver dyads were analysed; 49.3% showed high caregiver burden, and 40.4% were administering at least one informal medical care procedure. Univariate analyses indicated a relationship between high caregiver burden among caregivers who slept less, provided care for longer periods daily, performed medical care procedures and cohabited with patients. Importantly, logistic regression analyses indicated a significant relationship between high caregiver burden and care involving multiple medical procedures (i.e. 4-6 procedures with medical devices; adjusted odds ratio (AOR)=2.03, 95% confidence intervals (95% CI)=[1.01, 4.09]). In propensity-matched participants (n=314), results continued to show that multiple medical care procedures were significantly related to high caregiver burden (AOR=2.19, 95% CI [1.14-4.22]). The effects of non-medical informal care on caregiver burden were moderate. This result suggests that more intensive interventions are required for patients with multiple medical care needs to reduce caregiver burden.

Ex vivo evaluation of retinal cytotoxicity after the use of multiple medical devices in pars plana vitrectomy in porcine eyes

This study aimed to evaluate viability of retinal cells after the use of multiple intraoperative devices, namely a vitreal dye (triamcinolone acetonide,TA), a ERM/ILM dye (solution of trypan blue 0.15% and brilliant blue 0.025%), and two intraocular tamponades, namely perfluoro-n-octane, (PFO) and silicone oil (SO 1000 cSt), with minimal and maximal removal of their residues, during a simulated pars plana vitrectomy (PPV) in porcine eyes ex-vivo. The in vitro cytotoxicity of each of these compounds was verified on ARPE-19 cells by direct tests according to the ISO 10993-5 (2009). Pars plana vitrectomy was performed on 25 enucleated porcine eyes divided in five groups according to the following conditions: Group A) No surgery control: eye bulbs were kept at room temperature for 40 min; Group B) Sham surgery: PPV with the sole use of BSS for 40 min; Group C) Cytotoxic control: PPV with BSS infusion (20 min) followed by intravitreal injection of 1H-PFO (contact time: 20 min); Group D) Surgery with residues: PPV with BSS infusion and sequential intravitreal injection of TA, ERM/ILM dye, PFO and SO, with minimal removal of each compound after a specified contact-time (overall duration: 40 min); Group E) Surgery with minimal residues: PPV performed as in group D, but with maximal removal of each compound (overall duration: 40 min). All the experimental procedures were performed at room temperature. Immediately after surgery, the retina was extracted from each eye bulb and samples of 3-mm diameter were prepared. Retinal viability was determined for each sample by 3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyltetrazolium bromide assay. A cell viability <70% was considered the cytotoxicity threshold. Kruskal-Wallis test was used to evaluate the differences in retinal viability between groups. No cytotoxicity was detected in retinal samples in groups A, B and E. Samples from eye bulbs that had undergone surgery with minimal removal of residues (group D) and cytotoxic controls (group C) showed high retinal cytotoxicity. The tested conditions indicated that the combined use of TA, ERM/ILM dye, PFO and SO during PPV does not affect retinal cells viability if all the devices are properly removed, whereas the cytotoxicity detected in group D may suggest that the presence and accumulation of the residues of the compounds used intraoperatively could negatively impact retinal viability due to a cumulative and/or synergistic cytotoxic effect between them, supporting the crucial role of an optimal removal of the intraoperative medical devices to ensure a safe vitrectomy to the patient.

Cell and gene manufacturing: a case study approach to overcoming challenges – understanding the value of an expert supplier

Watch the video or read the poster to learn: What are the biggest hurdles for cell and gene therapies?What are the challenges with current technologies and manufacturing methods?What are the biggest payoffs of solving these problems?Sean Werner President, Sexton Biotechnologies. A manufacturer of processing and handling tools and reagents for the development and manufacture of cell and gene therapies. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Prior to his current role he spent 11 years with Cook Medical and Cook Regentec filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.

EHealthChain-a blockchain-based personal health information management system.

Medical IoT devices that use miniature sensors to collect patient’s bio-signals and connected medical applications are playing a crucial role in providing pervasive and personalized healthcare. This technological improvement has also created opportunities for the better management of personal health information. The Personal Health Information Management System (PHIMS) supports activities such as acquisition, storage, organization, integration, and privacy-sensitive retrieval of consumer’s health information. For usability and wide acceptance, the PHIMS should follow the design principles that guarantee privacy-aware health information sharing, individual information control, integration of information obtained from multiple medical IoT devices, health information security, and flexibility. Recently, blockchain technology has emerged as a lucrative option for the management of personal health information. In this paper, we propose eHealthChain—a blockchain-based PHIMS for managing health data originating from medical IoT devices and connected applications. The eHealthChain architecture consists of four layers, which are a blockchain layer for hosting a blockchain database, an IoT device layer for obtaining personal health data, an application layer for facilitating health data sharing, and an adapter layer, which interfaces the blockchain layer with an application layer. Compared to existing systems, eHealthChain provides complete control to the user in terms of personal health data acquisition, sharing, and self-management. We also present a detailed implementation of a Proof of Concept (PoC) prototype of eHealthChain system built using Hyperledger Fabric platform.

A Description of Children Dependent on Long Term Ventilation via Tracheostomy and Their Hospital Resource Use

PurposeTo describe the proportion of children with an index hospitalization in 2014 who had established long-term invasive ventilator dependence (LTVD), and determine regional variation in hospital length of stay, charges, and readmissions. Design and methodsMulticenter, longitudinal, retrospective cohort study using a recently established algorithm to identify children with LTVD from the Pediatric Health Information System database with an index hospitalization at least once during 2014, excluding normal newborn care or chemotherapy, and the subset with established LTVD. Hospitals were grouped by geographic regions. Analysis included descriptive statistics and multi-variable mixed modeling for length of stay, charges, and readmissions. ResultsOf the 615,883 unique children discharged from 45 children's hospitals in 2014, 2235 (0.4%) had established LTVD. Of these, 342 (15%) were hospitalized in the Northeast, 677 (30%) Midwest, 733 (32%) South and 481 (22%) West. Most had at least two complex chronic conditions (97%) and used a medical device for at least two body systems (71%). No statistically significant regional variation was found for length of stay, charges, or readmissions after adjustment for child demographics, admission type, disposition, primary diagnosis, ICU stay, and number of chronic conditions. ConclusionsThis study characterized the population of children with LTVD hospitalized in 2014. No regional variation was found for length of stay, charges, or readmissions. Practice implicationsChildren with established LTVD make up a small subset of all children admitted to children's hospitals however, they require substantial, costly, multifaceted care as most have additional complex chronic conditions and require multiple medical devices.

11384 Medication Use Safety During Care Transitions for Children with Medical Complexity

ABSTRACT IMPACT: This study will generate preliminary data to address a critical, care transition-related patient safety gap involving medication use among children with medical complexity. OBJECTIVES/GOALS: The objectives of this study are: (1) to understand care transition-related medication safety risks for children with medical complexity (CMC), and (2) through a participatory, human centered design (PD) approach, to develop an early prototype intervention to address identified safety risks. METHODS/STUDY POPULATION: The study population includes children with medical complexity (CMC), a medically fragile pediatric population with intensive healthcare needs. CMC rely on multiple and complex medication regimens and/or medical devices for optimal functioning. Parents of CMC report multiple unmet healthcare needs. For Aim 1, we will conduct observations and interviews with ˜15 clinicians as well as semi-structured interviews with ˜30 family caregivers during three care transition experiences: from Cardiac ICU to home, Neonatal ICU to home, and those between primary care/specialty clinic to home. For Aim 2, we will conduct participatory design sessions with up to 5 participants (separately for clinicians and family caregivers) from each of the three care transition settings to co-design a prototype intervention. RESULTS/ANTICIPATED RESULTS: The study is currently recruiting family caregivers of CMC for aim 1 research activities, with interviews planned to be completed in February/March 2021. Transcribed interviews will be used to inform development of patient journey maps. A patient journey map helps to visually depict healthcare services through the patient and family lens, and highlights important ‘touch points’ along the patient journey (e.g., decisions, encounters, constraints, emotional states, etc.) that shape the patient and family experience. The journey map will distill findings from qualitative data and generate a concise visual story focused on the medication use experience of CMC as they transition between the hospital and their home. Individual journey maps will also be combined to generate a consolidated journey map. DISCUSSION/SIGNIFICANCE OF FINDINGS: An-in-depth understanding of medication safety risks unique to the context of CMC care would be essential to develop interventions that are useful, scalable, and sustainable. This is even more important because current interventions are primarily adopted from adult care settings with mixed outcomes.

Modelling, Simulation and Investigation of Wireless Power Transfer in Square-loop Chip at UHF Band for Medical/Biomedical Charging

Medical electronics (Implant) devices are important in daily lives of the sick patient with terminal infections. The recent discovery of wireless power transfer (WPT) technology provides a gateway for the noncontact electricity transmission for multiple gadgets and medical implantable devices such as (artificial heart, sphincter, defibrillator and electrical simulator) simultaneously. Wireless power transfer is the transfer of power between a transmitting module and a receiving module of different system. In this work, we designed, modelled and analyzed the effects of orientation, alignment as well as coupling losses of a transmitting and receiving antenna. We designed the antenna by determining the frequency of operation (f₁), dielectric constant of substrate (ε_r), the substrate height (h), loop length, width using the fundamental mode. Simulation of the wireless power transfer system was accomplished using the electromagnetic system COMSOL Multiphysics 5.5 model at a frequency domain of 1.8MHz. The model consists of two printed square loop antenna enclosed by an air domain with perfectly matched layer (PML). The etched layer is patterned on 2mm Polytetrafluoroethylene (PTFE) board, the thickness of the copper layer used varies geometrically, but much thicker than the copper skin depth, so that it is modelled as a perfect electric conductor (PEC). Results obtained from the simulation shows a strong coupling at 0, 22.5, 45, 67.5 degrees and a hot coupling around the receiving antenna at angle 90 degrees. These results indicate the device can only be used for direct charging.

MM-BiFPN: Multi-Modality Fusion Network With Bi-FPN for MRI Brain Tumor Segmentation

For medical imaging tasks, it is a prevalent practice to have a multi-modality image dataset, as experts prefer using multiple medical devices to diagnose a disease. Each device can show different aspects of segmentation, which in our case, is magnetic resonance imaging (MRI) brain tumor segmentation. For such medical imaging tasks, researchers tend to combine all modalities as an input into the network for feature extraction, and neglect the complexity between different modalities. It is no longer novel to use an encoder-decoder-based model and residual connections to transfer information from high-resolution maps to lower-resolution maps in medical segmentation tasks. In this work, we propose a multimodal fusion network with bi-directional feature pyramid network (MM-BiFPN) using an individual encoder to extract the features of each of the four modalities (FLAIR, T1-weighted, T1-c, and T2-weighted) to focus on the exploitation of the complex relationships among the modalities. In addition, by using the bi-directional feature pyramid network (Bi-FPN) layer, we focus on the aggregation of multiple modalities to study the cross-modality relationship and multi-scale features. Our experiment was conducted on the brain segmentation challenge datasets, the MICCAI BraTS2018 and MICCAI BraTS2020 datasets. We also implemented two ablation studies on our model with different cross-scale modalities fusion networks, as well as a study on different modality settings to see the effect each modality brings in detecting tumor content. With missing modalities, our method achieves a comparable result, demonstrating that our method is robust for brain tumor segmentation.

FDA Approves Multiple Medical Devices and Guidance

Corresponding author: Jay Geller, JD, MBA, 121000 Wilshire Blvd, Ste 1250, Los Angeles, CA 20025 ([email protected]). The author declares no conflicts of interest.

Ethical Assessment and Reflection in Research and Development of Non-Conformité Européene Marked Medical Devices

Today there are multiple implantable medical devices on the market. The type of implants that interface the body's tissues has been considered to have particular strong ethical implications. This article describes a development of a novel practice for ethical assessment and reflection within medical device research and development of non-CE marked medical devices, taking the perspective of both the ethicist and the researcher. The research case was an EU funded project where the aim was to develop and compare the efficiency of invasive and non-invasive technological medical devices to create meaningful sensations as a novel therapy for phantom limb pain. An Independent Ethical Advisor (IEA) with a regulatory and advisory role was assigned to the project, allowing us to investigate the projects deliberate incorporation of ethics. In the article we suggest and applied a novel framework based on action research for combining ethical assessment with building ethical reflection. The case analyse five different activities / elements: 1) the use of informed consent; 2) a survey amongst the research partners; 3) a workshop session; 4) observation of consortium meetings; and 5) an interview with a participating patient.

Therapeutische Aspekte zur Hilfsmittelversorgung von Patienten mit Multipler Sklerose

Therapeutic aspects with regard to the supply of medical devices to patients with multiple sclerosis Medical devices can make a significant contribution to the self-activity and participation of patients with multiple sclerosis (PwMS). They should be selected and adapted carefully and, if necessary, modified as the disease progresses. The article presents various medical devices and explains their prescription and use in everyday life.