Life Cycle Of Medical Devices Research Articles

Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis.

The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation. Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher' or Mann Whitney' test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain). We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III-IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05). The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.

HYALURONIC ACID BEYOND SKIN REJUVENATION: THE INTERSECTION BETWEEN BEAUTY AND SAFETY IN COMPLIANCE WITH THE NEW EU MEDICAL DEVICES REGULATION

Hyaluronic acid-based mesotherapy has become a highly popular and valuable option for facial rejuvenation, with a renowned efficacy and safety profile.The new European Regulation (EU) 2017/745 on medical devices remarks the need for post-market clinical follow-up to guarantee safety and efficacy during the entire life cycle of medical devices. In line with the new regulation, we aimed to further evaluate the clinical performance and safety of hyaluronic acid-based mesotherapy within routine practice in a period of 9 weeks. The present work is anobservational, prospective, open and non-controlled study in a cohort of patients treated with hyaluronic acid-based mesotherapy for facial aging. Patients between 30 and 75 years old, treated with hyaluronic acid 1% injections for facial rejuvenation, were included. Point-by-point and epidermal administration techniques were usedin three visits (initial, 3 weeks and 6 weeks). The outcomes were measured using GAIS for efficacy and VAS for patient satisfaction. A total of 25 patients underwent hyaluronic acid mesotherapy in the face or neck, and were followed up for 9 weeks. Throughout the study, a significant improvement (p &lt; 0.05) in skin appearance and hydration was observed in both groups between first and last visit. No significant differences were observed between the two groups. All participants showed increased skin hydration and/or reduced fine lines. In conclusion, hyaluronic acid-based mesotherapy is effective for facial and neck skin boosting, with an excellent safety profile, highlighting the potential of linear hyaluronic acid as a non-surgical solution for skin rejuvenation.

Sustainability across the Medical Device Lifecycle: A Scoping Review

Medical devices are instrumental in servicing the healthcare sector and promoting well-being in modern societies. However, their production and use contribute significantly to greenhouse gas emissions, thus causing indirect harm to global health. With a share of approximately 4.4% of global emissions, the healthcare sector exhales CO2 throughout its value chain; sources of this range from direct electricity consumption and water heating in healthcare facilities to the supply chains delivering healthcare services and products. Within this context, the environmental impact of medical devices is present across their production, distribution, usage, and eventual disposal. Each step in the lifecycle of medical devices consumes energy and natural resources, and the end product, after its often single use, is discarded, generating plastic or electronic waste. This study aims to present the key findings from a scoping review of academic research on the topic, which focuses on reducing the environmental impact of medical devices and equipment. The review, conducted according to the PRISMA checklist for scoping reviews, examined 41 studies and categorised them based on the lifecycle stages of medical devices (design and development, manufacturing, usage, and end of life) and the sustainability aspects (economic, environmental, and social) discussed by the authors. The findings suggest that while efforts have been made to enhance economic and environmental sustainability throughout the design, development, and usage of medical devices, there is still room for improvement in mitigating their ecological impact at the end of their lifecycle and maximising their social impact by design.

Development of an AI-based IT tool to support medical device nomenclature standardization for post-market surveillance by automated mapping from GMDN to EMDN standards

Abstract Introduction The EU Medical Device Regulation 2017/745 has defined new rules for medical device (MD) certification and post-market surveillance (PMS). In particular, a centralized database (Eudamed) has been established to collect and share information about the lifecycle of MD in EU market. To become effective for PMS, the European MD Nomenclature (EMDN), a 7-levels hierarchical system, has been adopted as a free standard among EU to describe MDs to this aim. However, Global MD Nomenclature (GMDN), a poly-hierarchical not-for-free system, was previously used in several EU Member States, and it is still adopted in other countries (i.e., UK, Australia, Brazil). A complete mapping between these nomenclatures is still missing, or not publicly and freely available, and this multiplicity of nomenclatures is going to affect the traceability of MD in PMS, ultimately generating an adverse impact on the patient. Purpose 1) To develop an IT tool to automatically map a given GMDN description to the most appropriate EMDN code, to facilitate and accelerate the uptake of EMDN and the mapping process between nomenclatures. 2) To introduce a user-science approach towards a continuous improvement of the tool, allowing user interaction to highlight potentially incorrect mapping and suggest the most appropriate one, to be further included in the database after manual verification. Methods By text analytics methods, the freely available list of MD on the Italian market, described by EMDN code, was compared with the same MD on the USA market, described by GMDN. As a result, 379317 devices were found present in both the Italian and USA markets, and 9683 different mappings between GMDN and EMDN are used to define an initial mapping from GMDN to EMDN. Then, given in input a GMDN description, semantic similarity was searched in the vocabulary for the proper GMDN with the corresponding EMDN, as well as for all EMDN descriptions, using a pre-trained AI transformer model (all-mpnet-base-v2). As a result, two possible EMDN codes with the respective reliability were given as output. The mapping performance at different EMDN levels was tested using a leave-one-out approach only on 2863 unique GMDN descriptions. Results From the GMDN descriptions, the correct EMDN code at level 1 (22 categories available) was given in 2343 cases (81.84%), at level 2 in 2088 cases (72.93%) and at level 3 in 1605 cases (56.06%). In Figure 1, an example of the developed user interface with the resulting two possible EMDN codes and their reliability, given a GMDN description of interest, is shown. The ability to select the most appropriate mapping, or to suggest a different one is given to the user, thus indirectly giving information for improving the tool. Conclusions The proposed approach provides with good accuracy the automatic mapping between GMDN and EMDN, thus potentially accelerating the nomenclature standardization process and improving effectiveness of MD PMS in EU and beyond.Figure 1

Biomedical/clinical engineering education and certification: fifty years of actions.

Health care is today technology driven and biomedical engineering is behind the impressive developments that reshaped medicine during the last 50 years. Biomedical Engineers (BMEs) as professionals are playing a vital role during the whole life cycle of Medical Devices (MDs), from the innovative idea to their final use and decommissioning. This rapid evolution creates a constant pressure for new knowledge and skills for the BMEs and therefore for continuous curriculum updates of education in BME, to meet current trends and market demands. Biomedical Engineering is relatively new when compared with other engineering disciplines. The earliest programs during the 1970s, most of which were at Doctoral and M.Sc. levels. B.Sc. programs were developed in most European Universities from the 1990s. Today there is an impressive trend to create new programs and the number of higher education institutions offering a BME degree is almost two hundred, just in Europe. Although biomedical engineering is playing a vital role in innovation, development, maintenance, and safe use of medical technology, BMEs are not yet recognized as a distinct professional entity and do not appear in the International Labour Organisation (ILO) lists. This is partly because biomedical engineering covers a very broad domain and includes professionals with very heterogeneous areas of specialization. Unlike in other engineering fields, where certification is a prerequisite for being a licensed professional, even for the clinical engineering, certification is not widely applied. This is mainly due to the lack of motivation since certification is not mandatory. In contrast with other health care professionals, that cannot practice their profession if they are not officially registered, such requirement does not exist for clinical engineers. In the present paper a review of the developments in BME educational programs in Europe, fifty years long, is attempted, focusing on some important initiatives and actions well known to the author. Additionally, some aspects of Clinical Engineering certification are addressed.

Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Special Risk of Using Portable Emergency Ventilator Based on Clinical Application

Risk management of medical devices covers the whole life cycle of medical devices, which is of great significance to the life safety and health condition of patients. The existing risk management of medical devices, especially the risk analysis in the research and development stage, often becomes a mere formality. The special risks faced by the research and development products in the clinical application scenarios are not well addressed. This study proves the necessity and importance of the combination of risk analysis and clinical application in the research and development stage of medical devices by the analysis of several special hazard sources in the process of clinical application of portable emergency ventilator.

Risk Management to Shanghai Medical Device Registrants

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.

Analysis of Similarities and Differences between Guidance of Magnetic Resonance Diagnostic Devices Clinical Evaluation and Guidance of Medical Device Clinical Evaluation

Clinical evaluation of medical devices plays an important role in the life cycle of medical devices. This paper introduces guidance of magnetic resonance diagnostic devices clinical evaluation and guidance of medical device clinical evaluation issued by CFDA. Their similarities and differences of the framework and content are analyzed, especially the definition, clinical evaluation methods and support data. By comparison, the clinical evaluation work of registration applicants can be more scientific and reasonable. At the same time, it can also be used for reference by the food and drug administration departments in evaluating the clinical evaluation of other products.

How can cardiothoracic and vascular medical devices stay in the market?

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety.

Recent Patents on Risk Management During Medical Device Lifecycle "Managing the Transition From Bench to Market"

Recent Patents on Risk Management During Medical Device Lifecycle "Managing the Transition From Bench to Market"