Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

Concerns have been raised over the quality of evidence on the performance of medicalartificial intelligence devices, including devices that are already on the market in theUSA and Europe. Recently, the Medical Device Regulation, which aims to set high standardsof safety and quality, has become applicable in the European Union. The aim of thisarticle is to discuss whether, and how, the Medical Device Regulation will help improvethe safety and performance of medical artificial intelligence devices entering the market.The Medical Device Regulation introduces new rules for risk classification of the devices,which will result in more devices subjected to a higher degree of scrutiny before enteringthe market; more stringent requirements on clinical evaluation, including the requirementfor appraisal of clinical data; new requirements for post-market surveillance, which mayhelp spot early on any new, unexpected side effects and risks of the devices; andrequirements for notified bodies, including for expertise of the personnel andconsideration of relevant best practice documents. The guidance of the Medical DeviceCoordination Group on clinical evaluation of medical device software and the MEDDEV2.7guideline on clinical evaluation also attend to some of the problems identified in studieson medical artificial intelligence devices. The Medical Device Regulation will likely helpimprove the safety and performance of the medical artificial intelligence devices on theEuropean market. The impact of the Regulation, however, is also dependent on its adequateenforcement by the European Union member states.

IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (hereinafter referred to as "EP"), which further promoted the unification of medical device safety and effectiveness internationally. In order to strengthen the scientific review of medical device and deepen the understanding of EP, we introduce EP, focus on the role of EP and the connection with the construction of quality management systems, risk and benefit determination, and registration, analyze the problems and reasons in the process of medical device registration, and give suggestions to promote the application of EP.

BackgroundAfter 25 years of implementing the Medical Devices Directive (MDD), in 2017, the new Medical Devices Regulation (MDR) came into force, establishing stricter requirements for post-market surveillance of the safety and performance of medical devices (MD). For electrocardiogram (ECG) devices, which are crucial for monitoring cardiac activities, these requirements are essential to ensure the reliability and accuracy of diagnosing cardiac conditions and timely treatment.ObjectiveThis study aims to enhance post-market surveillance of ECG devices by leveraging Machine Learning (ML) algorithms to predict the operational status of these devices. Specifically, the research focuses on classifying the success or failure of ECG device operations based on performance and safety parameters. The ultimate goal is to improve the management strategies of ECG devices in healthcare institutions, ensuring optimal functionality and increasing the reliability of diagnostic procedures.MethodDuring the inspection process of ECG devices conducted by an accredited laboratory in accordance with ISO 17020 standard in numerous healthcare institutions in Bosnia and Herzegovina, a total of 5577 samples were collected. Various machine learning algorithms, including Decision Tree (DT), Logistic Regression (LR), Random Forest (RF), Gaussian Naive Bayes (NB), and Support Vector Machine (SVM), were employed for result comparison and selection of the most accurate algorithm.ResultsAll algorithms demonstrated good performance, but the Random Forest (RF) algorithm stood out, achieving 100% accuracy in predicting the success/unsuccess status of the device. While the results of this research are specific to the collected data from EKG devices, the developed algorithms can be applied to other similar datasets, offering opportunities for broader use in the medical environment.ConclusionImplementing machine learning algorithms for automated systems in healthcare institutions can significantly enhance the quality of patient diagnosis and treatment. Additionally, these systems can optimize costs associated with managing medical devices. Improved post-market surveillance using ML can address challenges related to ensuring device reliability and safety.

The development and introduction of new medical devices have radically changed the practice of medicine. No area of medicine has been affected more than cardiology, with new devices facilitating the effective treatment of coronary artery disease (percutaneous coronary interventions [PCIs]/stents), valvular heart disease (mechanical and bioprosthetic valves), and electrophysiological disorders (pacemakers and automatic implantable cardiodefibrillators). In addition to fueling the growth of the medical device industry, this explosion of technology has driven the development of new medical subspecialties, eg, interventional cardiology and electrophysiology. Other areas of medicine, including orthopedics and general surgery, have witnessed similar transformations. The current regulatory pathway for a significant-risk first-in-class medical device is typically a long, expensive, and risky process, culminating in a pivotal trial designed to demonstrate safety and efficacy. The pivotal trial phase is typically the most time-consuming and costly phase of the process. In the United States, medical devices are regulated by the Center for Devices and Radiological Health at the Food and Drug Administration (FDA), which has been charged by Congress to seek the “least burdensome means” when determining the scope of data required to evaluate the safety and efficacy necessary for device approval.1 Thus, pivotal trials by intention are designed to select patient cohorts most likely to demonstrate procedural benefit while limiting patient/study subject risk within the shortest time frame that can provide meaningful data. The realities of logistics, time, and resources limit the size and duration of most new device trials to 800 to 1500 patients, limiting the power of these trials to detect events with an occurrence rate of <1%. Furthermore, pivotal trials are conducted by the most experienced physician operators at medical centers with sufficient patient volume and research infrastructure to recruit and conduct clinical studies. Some have questioned whether results obtained under these settings from such …

The new Medical Device Regulations (MDR) in Europe represent unprecedented challenges for researchers in academic environments. Adherence to regulatory frameworks, like the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization. However, the MDR now extends its reach into the preliminary phases of pre-clinical research, imposing new challenges and necessitating compliance for any clinical investigation involving medical device safety or performance. We have systematically engineered and implemented a Quality Management System (QMS) tailored to meet the distinct needs of academic institutions. Our objective was to establish a comprehensive framework that enable our research group to comply with MDR without hindering innovation and discovery. Specifically, we engineered a traditional commercial QMS aligned with ISO13485 to fulfill academic needs. We ensured the QMS focused on requirements relevant to pre-market clinical investigations and considered appropriate roles for an academic setting. We present an optimized QMS implementation to satisfy the urgent need for research institutions to align with the MDR. Notably, our efforts yielded demonstrable results, culminating in the successful approval of research projects by the Swedish Medical Product Agency (MPA). This achievement stands as a testament to the impact of our work within the regulatory landscape. Here, we share the insights and challenges we encountered during the implementation of an appropriate and efficient QMS for academic research, which we believe can serve as a guiding example for other academic research groups. By presenting our QMS implementation validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal importance of MDR compliance among researchers in Europe. Our contribution seeks to provide a roadmap for fellow research groups in navigating the evolving regulatory landscape while sustaining their focus on groundbreaking research and innovation in the field of biomedical engineering.

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

Measurement Does Not Take Place in a Legal Vacuum

Introduction: Medical devices are boon to the healthcare system and are available in the market since long ago. More than 500,000 different types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and safety of these medical devices is essential.&#x0D; Objectives: This review article discusses the classification and regulation of medical devices in India and the world with framework of adverse event reporting system for medical devices in India.&#x0D; Methods: To address the aforesaid issue International Medical Device Regulators Forum (IMDF) was established in 2011 was established at international Level. In India, 4 years later in 2015, Materiovoigilance Program of india (MvPI) was introduced with the prime aim of improving the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood of reoccurrence of an adverse event associated with the use of medical devices.&#x0D; Results: At present, there are 50 Medical Device Adverse Event Monitoring Centres (MDMCs) in India. Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices eg: USFDA in USA, TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc.&#x0D; Conclusions: In India, the provisions of regulation of safety, quality and performance of medical devices are laid down in the Drugs and Cosmetics Act, 1940 and rules 1945.

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. Medline (1980-2021), EBSCO (1991-2021), and PubMed (1980-2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as the European Commission and the Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices and relevant national and international legislation, standards and guidelines concerning the topic were included in the review. The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.

Medical device use is expanding with the emergence of sophisticated applications to gather, store, process and communicate patient-centric data. Diversity, fast-paced technological advances and complex interfaces between users and technology complicate challenges associated with promoting medical device safety. The purpose of this conceptual paper is to evaluate strategies for improving medical device safety and performance through collaborative evidence generation and innovative analytics. Developing public–private partnerships and the infrastructure for active surveillance, evidence generation and data analytics requires engaged and enlightened institutional leadership who share a common vision and values. Integration of interprofessional initiatives may remediate the silo mentality pandemic in the healthcare community, harness the digital revolution for surveillance and promote improvements in medical device safety and performance.

Medical devices and In Vitro Diagnostics (IVDs) are vital for public health and accessible healthcare. Still, there is an imbalance in high-quality products in Low and Middle-Income Countries (LMICs). Zimbabwe's regulatory framework for medical devices and IVDs is unclear, leading to ineffective compliance and surveillance. As a result, there are knowledge gaps regarding pre-market and post-market regulatory elements to ensure the safety, quality and performance of medical devices and IVDs used in Zimbabwe. Our study aimed to explore the current status of medical devices and IVD regulations in Zimbabwe. Semi-structured interviews were conducted with 12 regulators from the Medicines Control Authority of Zimbabwe (MCAZ) National Microbiology Reference Laboratory (NMRL), Medical Laboratory and Clinical Scientists Council (MLCScCZ) to understand the current status of medical devices and IVD regulations in Zimbabwe. Three participants completed a questionnaire to understand the regulatory landscape in Zimbabwe. Three key informant interviews were conducted with three regulators from the South African Health Products Regulatory Authority (SAHPRA), Tanzanian Medicines and Medical Devices Authority (TMDA), and World Health Organization Regulatory Systems Strengthening (WHO RSS) to learn best practices to create a roadmap for Zimbabwe. We analyzed qualitative data using a thematic analysis. The findings reveal significant deficiencies and gaps in the legal framework for regulating medical devices and IVDs, highlighting the need for a legal framework and the absence of more comprehensive regulations. Regulatory entities face capacity limitations, especially in regulating medical devices and IVDs. Conformity assessment processes, medical devices, IVD classification criteria, and post-market surveillance also represent challenges, highlighting the need for a well-defined framework and regulatory procedures. The Zimbabwean regulatory system pathway is reactive, prompting several regulatory initiatives to address needs. Despite facing challenges, there is recognition of the importance of collaboration among regulatory authorities, emphasizing a shared commitment to improving and strengthening medical devices and IVD regulations for improved patient safety. By advocating for a proactive, comprehensive, and legally sound approach, indicating the potential for collaboration and synergy, this study provides a foundation for well-informed policy recommendations to guide enhancements and build a framework for a resilient, efficient, and transparent regulatory environment in the Zimbabwe and African regions as a whole.

The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.