Evaluation Of Medical Devices Research Articles

Knowledge attitude and practice of materiovigilance among healthcare professionals in tertiary care hospitals

Background: Materiovigilance (Mv) refers to the systematic monitoring and evaluation of medical devices in order to assess their performance and safety during all stages of their life. The purpose of Mv is to identify and avoid any potential hazards or issues linked with medical equipment. In brief, Mv plays an important role in ensuring the performance and safety of medical equipment. It consists of the systematic observation, the collection, and analysis of data on occurrences and adverse events related to medical equipment. The study was conducted to assess knowledge, attitude, and practice regarding Mv among healthcare professionals in tertiary care hospitals. Methods: Self-prepared and validated questionnaires were distributed among healthcare Professionals in India through online forms from December 2022 to July 2023, a cross-sectional questionnaire-based survey was used, with convenience sampling utilized. Responses from 220 subjects were analyzed. Results: The primary objective of this study was to assess the demographic details of the Healthcare Professionals as well as the distribution of knowledge, Attitude, Practice on Mv, in a list of 220 responses, 40% of them know about the Mv. Remaining 60% of them they don’t know about the Mv. Total 220 responses, 76.8% of the Healthcare professionals suggested to thought about the Mv, remaining 23.1% were disagreed. 75 out of 220 healthcare professionals acknowledged to seeing the reporting form and experiencing AE in their patients, while the remaining 145 denied it. Conclusions: This study determined the knowledge, attitude and practice of Mv among healthcare professionals in tertiary care hospitals. According to the current study, the majority of healthcare professionals were knowledgeable and supportive of Mv, however they are not as effective in practice.

Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey

BackgroundStakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders’ views, needs, and values. Methods for these engagements have however not been compared to analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, interaction, and time-investment.MethodsWe compared focus groups, interviews, and an online survey in a case-study on minimally invasive endoscopy-guided surgery for patients with intracerebral haemorrhage. The focus groups and interviews featured two rounds, one explorative focussing on individual perspectives, and one interactive focussing on the exchange of perspectives between participants. The comparison between methods was made in terms of number and content of themes, how participants interact, and hours invested by all researchers.ResultsThe focus groups generated 34 themes, the interviews 58, and the survey 42. Various improvements for the assessment of the surgical procedure were only discussed in the interviews. In focus groups, participants were inclined to emphasise agreement and support, whereas the interviews consisted of questions and answers. The total time investment for researchers of focus groups was 95 h, of interviews 315 h, and survey 81 h.ConclusionsWithin the context of medical device evaluation, interviews appeared to be the most appropriate method for understanding stakeholder views since they provide a scope and depth of information that is not generated by other methods. Focus groups were useful to rapidly bring views together. Surveys enabled a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.

An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 2: Implementation Considerations and Harms.

The introduction of artificial intelligence (AI) in interventional radiology (IR) will bring about new challenges and opportunities for patients and clinicians. AI may comprise software as a medical device or AI-integrated hardware and will require a rigorous evaluation that should be guided based on the level of risk of the implementation. A hierarchy of risk of harm and possible harms are described herein. A checklist to guide deployment of an AI in a clinical IR environment is provided. As AI continues to evolve, regulation and evaluation of the AI medical devices will need to continue to evolve to keep pace and ensure patient safety.

Validation of a new kit for preeclampsia screening: A comprehensive analysis

ObjectivesPreeclampsia is a common pregnancy complication that significantly contributes to maternal mortality, perinatal mortality, and preterm delivery. The sFlt-1/PlGF (fms-like tyrosine kinase-1/placental growth factor) ratio has demonstrated robust diagnostic value for preeclampsia. This study assessed the analytical performance and diagnostic accuracy of a novel quantitative determination kit for sFlt-1 and PlGF for the diagnosis of preeclampsia. MethodsThe detection performance of the test kit was validated using the Center for Medical Device Evaluation (CMDE) and Clinical and Laboratory Standards Institute (CLSI) documents. The test results were compared to those of the Elecsys immunoassay (Roche Diagnostics). Independent discovery and validation sets were used to analyze the diagnostic efficacy of the preeclampsia kit. The area under the curve (AUC) for preeclampsia at different gestational ages was calculated. ResultsCorrelation analysis between the test and Roche kits revealed a strong concordance (sFlt-1: r = 0.9966, P < 0.0001; PlGF: r = 0.9935, P < 0.0001). The AUCs for sFlt-1, PlGF, and the sFlt-1/PlGF ratio in diagnosing preeclampsia were 0.749, 0.795, and 0.834, respectively, in the discovery set and 0.729, 0.811, and 0.831, respectively, in the validation set. The corresponding results from the Roche kit were 0.741, 0.795, and 0.829, respectively, and 0.761, 0.864, and 0.844, respectively. ConclusionsQuantitative sFlt-1 and PlGF kits exhibited high levels of consistency with the Roche kits in terms of quantitative outcomes and diagnostic performance for preeclampsia.

Current status and future development of digital therapeutics

Background: Digital therapeutics, evidence-based software applications, offer preventive measures for various diseases and enhance healthcare accessibility and change. This article explores the current status and future trajectory of these devices.Current Concepts: Digital therapeutics prioritize a patient-centered approach. Historically, healthcare relied heavily on prescribed treatments during hospital visits. However, these devices provide objective data on patient symptoms through real-time digital monitoring. They also foster advancements in biotechnology and information technology, leading to improved patient care through technologies like artificial intelligence and virtual reality apps. Rigorous clinical trials are crucial for these devices, and integrating digital technology is proving increasingly efficient, particularly for decentralized clinical trials. Despite initial promise, challenges abound. While an international leader in this sector gained U.S. Food and Drug Administration approval, it recently filed for bankruptcy. Similarly, companies employing gaming techniques for attention deficit hyperactivity disorder treatment experienced lackluster performance. In Korea, the domestic digital therapeutics ecosystem stagnates with limited new approvals. High dropout rates and low user engagement remain major hurdles. Addressing these issues requires a design focused on user experience and motivation.Discussion and Conclusion: Digital therapeutic devices, coupled with digital monitoring, are poised to revolutionize healthcare into a patient-centered ecosystem. Establishing this ecosystem demands collaboration among patients, medical professionals, developers, and regulatory agencies. Continuous regulatory innovation, such as shortening the medical device evaluation process from 390 days to 80 days, is vital for progress.

Radiopacity Enhancements in Polymeric Implant Biomaterials: A Comprehensive Literature Review.

Polymers as biomaterials possess favorable properties, which include corrosion resistance, light weight, biocompatibility, ease of processing, low cost, and an ability to be easily tailored to meet specific applications. However, their inherent low X-ray attenuation, resulting from the low atomic numbers of their constituent elements, i.e., hydrogen (1), carbon (6), nitrogen (7), and oxygen (8), makes them difficult to visualize radiographically. Imparting radiopacity to radiolucent polymeric implants is necessary to enable noninvasive evaluation of implantable medical devices using conventional imaging methods. Numerous studies have undertaken this by blending various polymers with contrast agents consisting of heavy elements. The selection of an appropriate contrast agent is important, primarily to ensure that it does not cause detrimental effects to the relevant mechanical and physical properties of the polymer depending upon the intended application. Furthermore, its biocompatibility with adjacent tissues and its excretion from the body require thorough evaluation. We aimed to summarize the current knowledge on contrast agents incorporated into synthetic polymers in the context of implantable medical devices. While a single review was found that discussed radiopacity in polymeric biomaterials, the publication is outdated and does not address contemporary polymers employed in implant applications. Our review provides an up-to-date overview of contrast agents incorporated into synthetic medical polymers, encompassing both temporary and permanent implants. We expect that our results will significantly inform and guide the strategic selection of contrast agents, considering the specific requirements of implantable polymeric medical devices.

Novel Meta-Fractal Wearable Sensors and Antennas for Medical, Communication, 5G, and IoT Applications

Future communication, 5G, medical, and IoT systems need compact, green, efficient wideband sensors, and antennas. Novel linear and dual-polarized antennas for 5G, 6G, medical devices, Internet of Things (IoT) systems, and healthcare monitoring sensors are presented in this paper. One of the major goals in the evaluation of medical, 5G, and smart wireless communication devices is the development of efficient, compact, low-cost antennas and sensors. Moreover, passive and active sensors may be self-powered by connecting an energy-harvesting unit to the antenna to collect electromagnetic radiation and charge the wearable sensor battery. Wearable sensors and antennas can be employed in smart grid applications that provide communication between neighbors, localized management, bidirectional power transfer, and effective demand response. A low-cost wearable antenna may be developed by etching the printed feed and matching the network on the same substrate in the printed antenna. Active modules may be placed on the same dielectric board. The antenna design parameters and a comparison between the computation and measured electrical performance of the antennas are presented in this paper. The electrical characteristics of the new compact antennas in the vicinity of the patient’s body were simulated by using electromagnetic simulation techniques. Fractal and metamaterial efficient antennas and sensors were evaluated to maximize the electrical characteristics of smart communication and medical devices. The dual- and circularly polarized antennas developed in this paper are crucial to the evaluation of wideband and multiband compact 5G, 6G, and IoT advanced systems. The new efficient sensors and antennas maximize the system’s dynamic range and electrical characteristics. The new efficient wearable antennas and sensors are compact, wideband, and low-cost. The operating resonant frequency of the metamaterial antennas with circular split-ring resonators (CSRRs) may be 5% to 9% lower than the resonant frequency of the sensor without CSRRs. The directivity and gain of the metamaterial fractal antennas with CSRRs may be up to 3 dB higher than the antennas without CSRRs. The directivity and gain of the metamaterial fractal passive sensors with CSRRs may be up to 8.5 dBi. This study presents new wideband active meta-fractal antennas and sensors. The bandwidth of the new sensors is around 9% to 20%. At 2.83 GHz, the receiving active sensor gain is 13.5 dB and drops to 8 dB at 3.2 GHz. The receiving module noise figure with TAV541 LNA is around 1dB.

Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation

In recent years, China has made great progress in basic nanomedicine, nanotoxicology and nanobiology research. Nanotechnology has been continuously applied in biomaterial and medical device, more and more medical devices applying nanomaterials are developed and manufactured. In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices, this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad, and discussed the current challenges in biological evaluation of nanomaterial medical devices, with a view to providing ideas for the safety evaluation and research of related products.

Streamlining Randomized Clinical Trials for Device Therapies in Heart Failure: Bayesian Borrowing of External Data.

The Breakthrough Devices Program of the US Food and Drug Administration has accelerated the development and evaluation of medical devices for patients with heart failure. One such device is the Optimizer Smart System, which the US Food and Drug Administration approved in 2019. The Optimizer device was evaluated in a pivotal randomized clinical trial (FIX-HF-5C [Confirmatory Randomized Trial Evaluating the Optimizer System]) that leveraged Bayesian borrowing of external data to reduce the sample size and determine therapeutic device benefit versus continued medical therapy. Bayesian borrowing is explained in the context of the FIX-HF-5C trial, including an overview of the statistical methodologies, regulatory considerations, and interpretations of trial results. The US Food and Drug Administration Breakthrough Devices Program and novel Bayesian statistical methodology accelerated the path to regulatory approval and patient access to a potentially lifesaving device and may serve as a model for future clinical trials.

Preparation and Performance Study of a Novel Antibacterial Hemostatic Chitosan Sponge

To create a novel chitosan antibacterial hemostatic sponge (NCAHS) and to evaluate its material and biological properties. Chitosan, a polysaccharide, was used as the sponge substrate and different proportions of sodium tripolyphosphate (STPP), glycerol, and phenol sulfonyl ethylamine were added to prepare the sponges through the freeze-drying method. The whole-blood coagulation index (BCI) was used as the screening criterion to determine the optimal concentrations of chitosan and the other additives and the hemostatic sponges were prepared accordingly. Zein/calcium carbonate (Zein/CaCO3) composite microspheres loaded with ciprofloxacin hydrochloride were prepared and added to the hemostatic sponges to obtain NCAHS. Scanning electron microscope was used to observe the microscopic morphology and porosity of the NCAHS. The water absorption rate, in vitro antibacterial susceptibility rate against Staphylococcus aureus (S. aureus) and Escherichia coli (E. coli), in vitro coagulation performance, and hemocompatibility of NCAHS were examined. The coagulation performance of NCAHS was evaluated by using rabbit liver injury and rabbit auricular artery hemorrhageear models and commercial hemostatic sponge (CHS) was used as a control. The in vivo biocompatibility, including such aspects as cytotoxicity, skin irritation in animals, and acute in vivo toxicity, of the NCAHS extracts was examined by using as a reference the national standards for biological evaluation of medical devices. The NCAHS prepared with 1.5% chitosan (W/V), 0.01% STPP (W/V), 0% glycerol (V/V), 0.15% phenol-sulfonyl-ethylamine (V/V), Zein and CaCO3 at the mixing ratio of 5∶1 (W/W), Zein at the final mass concentration of 2.5 g/L, and ethanol at the final concentration of 17.5% (V/V) were fine and homogeneous, possessing a honeycomb-like porous structure with a pore size of about 200 μm. The NCAHS thus prepared had the lowest BCI value. The water absorption ([2362.16±201.15] % vs. [1102.56±91.79]%) and in vitro coagulation performance (31.338% vs. 1.591%) of NCAHS were significantly better than those of CHS (P<0.01). Tests with the in vivo auricular artery hemorrhage model ([36.00±13.42] s vs. [80.00±17.32] s) and rabbit liver bleeding model ([30.00±0] s vs. [70.00±17.32] s) showed that the hemostasis time of NCAHS was significantly shorter than that of CHS (P<0.01). NCAHS had significant inhibitory ability against S. aureus and E. coli. In addition, NCAHS showed good in vitro and in vivo biocompatibility. NCAHS is a composite sponge that shows excellent antimicrobial properties, hemostatic effect, and biocompatibility. Therefore, its extensive application in clinical settings is warranted.

Evaluation of digital medical devices: How to take into account the specificities of these solutions?

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability. In France and Europe, the construction of evidence, the assessment process and evaluation methodologies with a view to purchase or reimbursement must adjust to these changes, given the specific features of these technologies. This digital leap has opened up new perspectives for healthcare, along with economic, ethical and regulatory issues. The challenge is to assess the clinical and organisational impact, reliability, safety, interoperability, efficiency and budgetary impact of DMDs in line with the requirements of new standards, guidelines and regulations. This should result in a coherent, pragmatic and proportionate evaluation, so that public decision-makers and buyers can take advantage of the potential opportunities that these digital devices offer to improve healthcare delivery. Thus, a fair and informed evaluation of DMDs would emerge, providing a solid basis to steer their inclusion into contemporary medical practices. This fundamental issue of evaluation, linked to the digital nature of these MDs, is what the round table, comprising experts from academia and/or hospitals, institutions and industry, sought to resolve. Discussions led to proposals on how DMDs should be evaluated, bearing in mind their complexity. The round table set out to identify the bottlenecks in the entire evaluation process, from the CE marking phase, compliance with French safety and interoperability requirements, through to national or local evaluation, in order to inform a purchasing policy and draw up proposals covering the entire spectrum. Ten concrete recommendations were put forward by the round table, aimed at improving the evaluation process by making it clearer and more adaptable, thus offering greater flexibility in the evaluation and decision-making stages. This well-thought-out approach is designed to facilitate a comprehensive and flexible evaluation of DMDs given the constantly evolving technological context.

Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.

Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of "lifecycle" and "lifecycle evaluation" as embodied within evaluation models/frameworks used for medical devices. Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives. Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The "lifecycle" may represent a single stage, a series of stages, a cycle of innovation, or a system. "Lifecycle evaluation" focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase. Using a "lifecycle evaluation" approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.

MSR86 Use of Data Linkage for the Evaluation of Medical Devices: A Systematic Literature Review

MSR86 Use of Data Linkage for the Evaluation of Medical Devices: A Systematic Literature Review

HTA65 Economic Evaluation of Medical Devices By the French National Authority (2014-2022): Where Do We Stand?

HTA65 Economic Evaluation of Medical Devices By the French National Authority (2014-2022): Where Do We Stand?

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

How to objectively evaluate the impact of image-guided surgery technologies.

This manuscript aims to provide a better understanding of methods and techniques with which one can better quantify the impact of image-guided surgical technologies. A literature review was conducted with regard to economic and technical methods of medical device evaluation in various countries. Attention was focused on applications related to image-guided interventions that have enabled procedures to be performed in a minimally invasive manner, produced superior clinical outcomes, or have become standard of care. The review provides examples of successful implementations and adoption of image-guided surgical techniques, mostly in the field of neurosurgery. Failures as well as newly developed technologies still undergoing cost-efficacy analysis are discussed. The field of image-guided surgery has evolved from solely using preoperative images to utilizing highly specific tools and software to provide more information to the interventionalist in real time. While deformations in soft tissue often preclude the use of such instruments outside of neurosurgery, recent developments in optical and radioactive guidance have enabled surgeons to better account for organ motion and provide feedback to the surgeon as tissue is cut. These technologies are currently undergoing value assessments in many countries and hold promise to improve outcomes for patients, surgeons, care teams, payors, and society in general.

Intangible assets innovation through Health Technology Assessment. The case of the Italian Healthcare Organisations

The use of Health Technology Assessment (HTA) for the evaluation of medical devices in healthcare organisations implies the creation of new knowledge to be combined with that stored in the human, relational, and structural dimensions of their Intellectual Capital (IC).Therefore, HTA can represent a trigger for innovating the IC and this process can be influenced by external factors that can be reconducted to the Institutional Theory (IT). However, to the best of our knowledge, there are no studies in the literature analysing these aspects. By using the case study methodology, this work explores how the innovation of the IC dimensions is triggered by the use of the HTA tools, considering also the moderating role of the IT pillars.

Réducteur de sinus coronaire : revue de littérature et enjeux autour du registre France Reducer

Coronary sinus Reducer implantation is a percutaneous technique used to treat patients suffering from refractory angina pectoris. The device narrows the coronary sinus, increases the back pressure in the myocardial venous system and forces redistribution of coronary blood flow from less ischemic subepicardium to the more ischemic subendocardium. Multiple clinical studies had proven its efficacy to alleviate myocardial ischemia and related symptoms, and to improve the quality of life of patients with refractory symptomatic chronic coronary artery disease for whom coronary revascularization is deemed unsuitable. This literature review aims to expose the device design, its mechanisms of action, and the clinical data supporting its use.Since November 2021 Reducer's reimbursement has been granted in France by the national health authority. It is the first device to be approved under a newly established reimbursement approval process. A transitional coverage is provided with opportunities for renewal before applying for full-time reimbursement. To fulfill the requirements of the National Commission for Evaluation of Medical Devices and Health Technologies, the French Society of Cardiology has been creating the France Reducer registry. This clinical registry has been collecting data from patients undergoing coronary sinus Reducer implantation regarding their clinical situation, periprocedural information, and one-year follow-up. It is crucial for the future of this emerging therapeutic option in France. To date, 215 patients from 28 centers have been included between June 2022 and September 2023.

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers

Safety Evaluation of paclitaxel-eluting medical devices in the management of peripheral arterial disease - The national DETECT “Drug Eluting Devices French Safety Survey” study

Safety Evaluation of paclitaxel-eluting medical devices in the management of peripheral arterial disease - The national DETECT “Drug Eluting Devices French Safety Survey” study