The EU Artificial Intelligence Act (2024): Implications for healthcare.

In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world's first extensive legal framework on AI, it aims to boost innovation while protecting individuals against the harms of AI. Since healthcare is one of the top sectors for AI deployment, the new rules will significantly reform national policies and practices on health technology. In this article, we highlight the implications of the AI Act for the healthcare sector. We give a comprehensive overview of the new legal obligations for various healthcare stakeholders (tech developers; healthcare professionals; public health authorities). We conclude that, due to its horizontal approach, it is necessary to adopt further guidelines to address the unique needs of the healthcare sector. To this end, we make recommendations for the upcoming implementation and standardization phase.

Advantages of online supercritical fluid extraction and chromatography hyphenated to mass spectrometry to analyse plastic additives in laboratory gloves.

Plastic additives are introduced in plastic material formulations, along with organic polymers, to offer different properties such as stability, plasticity or color. However, plastic additives may migrate from the plastic material to the content (in case of plastic containers) or to the material in contact with the plastic, like human skin. In the case of plastic medical devices, this migration is of particular interest, as plastic additives may be deleterious to health. In the present paper, we examined the interest of combining supercritical fluid extraction (SFE) to supercritical fluid chromatography (SFC) hyphenated to mass spectrometry (MS) in an online system to characterize plastic additives in laboratory gloves, taken as samples of medical devices. A set of target compounds comprising 18 plasticizers, 4 antioxidants and 2 lubricants was defined and their detectability with MS was examined, where it appeared that electrospray ionization (ESI) provided better detectability than atmospheric pressure chemical ionization (APCI). After examining possible stationary phases with the help of Derringer desirability function, an isocratic chromatographic method (CO2:methanol 95:5) was developed on Shim-pack UC Phenyl column. The extraction method was examined with a 3-level full factorial design of experiments to optimize the extraction temperature (40 °C) and pressure (200 bar). The online SFE-SFC-MS method was compared to offline methods where the samples were extracted with liquid solvents at atmospheric pressure or high pressure then analysed with SFC-MS. In all cases, offline methods showed significant contaminants (like the oleamide lubricant) issuing from laboratory plastic materials as nitrogen drying station, syringes and filters, while the online method allowed a complete elimination of laboratory contaminations. Furthermore, the online method saved time, solvents and laboratory consumables. It will also show that transferring a compressible fluid from a loading loop is favourable to high efficiency, as the resulting chromatographic peaks are much thinner than when transferring a liquid. Compared to injecting liquid heptane, the efficiency increase was 3.4-fold, while compared to injecting liquid methanol (a common practice in SFC), the efficiency increase was 13-fold. Finally, the additive composition of different laboratory gloves was compared.

Trustworthy and ethical AI-enabled cardiovascular care: a rapid review.

BACKGROUND: Artificial intelligence (AI) is increasingly used for prevention, diagnosis, monitoring, and treatment of cardiovascular diseases. Despite the potential for AI to improve care, ethical concerns and mistrust in AI-enabled healthcare exist among the public and medical community. Given the rapid and transformative recent growth of AI in cardiovascular care, to inform practice guidelines and regulatory policies that facilitate ethical and trustworthy use of AI in medicine, we conducted a literature review to identify key ethical and trust barriers and facilitators from patients' and healthcare providers' perspectives when using AI in cardiovascular care. METHODS: In this rapid literature review, we searched six bibliographic databases to identify publications discussing transparency, trust, or ethical concerns (outcomes of interest) associated with AI-based medical devices (interventions of interest) in the context of cardiovascular care from patients', caregivers', or healthcare providers' perspectives. The search was completed on May 24, 2022 and was not limited by date or study design. RESULTS: After reviewing 7,925 papers from six databases and 3,603 papers identified through citation chasing, 145 articles were included. Key ethical concerns included privacy, security, or confidentiality issues (n = 59, 40.7%); risk of healthcare inequity or disparity (n = 36, 24.8%); risk of patient harm (n = 24, 16.6%); accountability and responsibility concerns (n = 19, 13.1%); problematic informed consent and potential loss of patient autonomy (n = 17, 11.7%); and issues related to data ownership (n = 11, 7.6%). Major trust barriers included data privacy and security concerns, potential risk of patient harm, perceived lack of transparency about AI-enabled medical devices, concerns about AI replacing human aspects of care, concerns about prioritizing profits over patients' interests, and lack of robust evidence related to the accuracy and limitations of AI-based medical devices. Ethical and trust facilitators included ensuring data privacy and data validation, conducting clinical trials in diverse cohorts, providing appropriate training and resources to patients and healthcare providers and improving their engagement in different phases of AI implementation, and establishing further regulatory oversights. CONCLUSION: This review revealed key ethical concerns and barriers and facilitators of trust in AI-enabled medical devices from patients' and healthcare providers' perspectives. Successful integration of AI into cardiovascular care necessitates implementation of mitigation strategies. These strategies should focus on enhanced regulatory oversight on the use of patient data and promoting transparency around the use of AI in patient care.

Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.

INTRODUCTION: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety. AREAS COVERED: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks. EXPERT OPINION: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.

INSAFEDARE Project: Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support.

Digital health solutions hold promise for enhancing healthcare delivery and patient outcomes, primarily driven by advancements such as machine learning, artificial intelligence, and data science, which enable the development of integrated care systems. Techniques for generating synthetic data from real datasets are highly advanced and continually evolving. This paper aims to present the INSAFEDARE project's ambition regarding medical devices' regulation and how real and synthetic data can be used to check if devices are safe and effective. The project will consist of three pillars: a) assurance of new state-of-the-art technologies and approaches (such as synthetic data), which will support the validation methods as part of regulatory decision-making; b) technical and scientific, focusing on data-based safety assurance, as well as discovery, integration and use of datasets, and use of machine learning approaches; and c) delivery to practice, through co-production involving relevant stakeholders, dissemination and sustainability of the project's outputs. Finally, INSAFEDARE will develop an open syllabus and training certification for health professionals focused on quality assurance.

Enhancing Medical Device Management with IoT Powerstrip.

Managing medical devices efficiently was a challenge, especially with manual methods proving error-prone amid staff shortages. To overcome these issues, we developed a novel IoT powerstrip device for tracking usage and location. This helps monitor devices in real-time, empowering more efficient management and utilization. We introduced it in four hospitals, connecting 192 medical devices to the strips and quantitatively confirmed its effectiveness.

The rise of bioelectronic medicine.

Bioelectronic Medicine (BEM), which uses implantable electronic medical devices to interface with electrically active tissues, aspires to revolutionize the way we understand and fight disease. By leveraging knowledge from microelectronics, materials science, information technology, neuroscience and medicine, BEM promises to offer novel solutions that address unmet clinical needs and change the concept of therapeutics. This perspective communicates our vision for the future of BEM and presents the necessary steps that need to be taken and the challenges that need to be faced before this new technology can flourish.

3D-printing inherently MRI-visible accessories in aiding MRI-guided biopsies.

BACKGROUND: 3D printers have gained prominence in rapid prototyping and viable in creating dimensionally accurate objects that are both safe within a Magnetic Resonance Imaging (MRI) environment and visible in MRI scans. A challenge when making MRI-visible objects using 3D printing is that hard plastics are invisible in standard MRI scans, while fluids are not. So typically, a hollow object will be printed and filled with a liquid that will be visible in MRI scans. This poses an engineering challenge however since objects created using traditional Fused Deposition Modeling (FDM) 3D-printing techniques are prone to leakage. Digital Light Processing (DLP) is a relatively modern and affordable 3D-printing technique using UV-hardened resin, capable of creating objects that are inherently liquid-tight. When printing hollow parts using DLP printers, one typically requires adding drainage holes for uncured liquid resin to escape during the printing process. If this is not done liquid resin will remain inside the object, which in our application is the desired outcome. PURPOSE: We devised a method to produce an inherently MRI-visible accessory using DLP technology with low dimensional tolerance to facilitate MRI-guided breast biopsies. METHODS: By hollowing out the object without adding drainage holes and tuning printing parameters such as z-lift distance to retain as much uncured liquid resin inside as possible through surface tension, objects that are inherently visible in MRI scans can be created without further post-processing treatment. RESULTS: Objects created through our method are simple and inexpensive to recreate, have minimal manufacturing steps, and are shown to be dimensionally exact and inherently MRI visible to be directly used in various applications without further treatment. CONCLUSION: Our proposed method of manufacturing objects that are inherently both MRI safe, and MRI visible. The proposed process is simple and does not require additional materials and tools beyond a DLP 3D-printer. With only an inexpensive DLP 3D-printer kit and basic cleaning and sanitation materials found in the hospital, we have demonstrated the viability of our process by successfully creating an object containing fine structures with low spatial tolerances used for MRI-guided breast biopsies.

Can mechanical heart valves perform similarly to tissue valves? An in vitro study.

Current surgical aortic valve (AV) replacement options include bioprosthetic and mechanical heart valves (MHVs), each with inherent limitations. Bioprosthetic valves offer superior hemodynamics but suffer from durability issues, typically initiating deterioration within 7-8 years. MHVs, while durable, necessitate lifelong anticoagulation therapy, presenting risks such as severe bleeding and thromboembolic events. The need for anticoagulants is caused by non-physiological flow through the hinge area during the closed phase and large spikes of regional backflow velocity (RBV) during the closing phase that produces high shear events. This study introduces the iValve, a novel MHV designed to combine the hemodynamic benefits of bioprosthetic valves with the durability of MHVs without requiring anticoagulation. The iValve features eye-like leaflets, a saddle-shaped housing, and an optimized hinge design to enhance blood flow and minimize thrombotic risk. Fabricated using 6061-T6 aluminum and polyether ether ketone (PEEK), twelve iValve iterations were evaluated for their opening and closing dynamics. The reported top-performing prototypes demonstrated competitive performance against industry standards. The proposed iValve prototype exhibited a mean RBV of -4.34 m/s with no spikes in RBV, performing similarly to bioprosthetic valves and significantly outperforming existing MHVs. The iValve's optimized design showed a 7-10% reduction in closing time and a substantial decrease in RBV spikes, potentially reducing the need for anticoagulation therapy. This study highlights the iValve's potential to revolutionize prosthetic heart valve technology by offering a durable, hemodynamically superior solution that mitigates the drawbacks of current MHVs.

More than red tape: exploring complexity in medical device regulatory affairs.

Introduction: This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Methods: Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using a mix of qualitative coding and natural language processing (NLP) techniques. Results: The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (1) regulatory language complexity, (2) intricacies within the regulatory process, (3) global-level complexities, (4) database-related considerations, and (5) product-level issues. Discussion: The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.

[Dispensing Service: An Essential Service Provided by Community Pharmacy to Enhance Patient Safety. A Case Study]. / Servicio de Dispensación: un servicio esencial brindado desde la Farmacia Comunitaria que permite reforzar la Seguridad del Paciente. A propósito de un caso.

A 38-year-old patient diagnosed with asthma and anxiety, who takes two medications (salbutamol 100 mcg inhaler (2 puffs every 6 hours), and diazepam 5 mg (0-0-1), visited the Community Pharmacy to pick up a treatment prescribed by the Primary Care Physician (PCP) following a diagnosis of anxious-depressive symptoms.During the Dispensing Service, a potential Drug-Related Problem (DRP) of prescription error is detected, which could be related with a Negative Outcomes Releated to Medicines (NOM) due to the concurrent use of desvenlafaxine and mirtazapine. Additionally, a Health Problem (HP)-related DRP was detected, as the proposal to discontinue the use of diazepam could result in an Insufficiently Treated HP, potentially leading to a NOM of Treatment Necessity due to the risk of worsening anxiety episodes.From de Community Pharmacy, a report was prepared with recommendations that were accepted by the PCP. Subsequent case monitoring revealed an improved management of the patient's health problems, as well as the resolution of the identified DRP and NOM. This ensured a rational, safe, and effective use of the medication.

Load shift keying communication techniques in implantable devices.

Inductive links represent a highly promising avenue for both powering and communicating medical implants. Yet they encounter challenges such as constrained communication distance and limited data rate. In Load Shift Keying (LSK), a switch in the secondary side of the inductive link can be placed in parallel with the load (Short-Circuit Technique - SCT), in series with the load (Open-Circuit Technique - OCT), or both (Dual Technique - DLT), to vary the impedance of the secondary. Hence, the impedance reflected to the primary side changes and is used to transmit information externally from the implant. Among these, DLT is a novel LSK technique proposed in this work, which becomes independent from the load on the implant side. This study compares these three methods, confronting measurements to simulations. The evaluation focused on variations in coil distance and load. The proposal is illustrated in the case of an implantable gastric stimulator, with specific constraints in secondary coil size and power requirements. The newly developed DLT consistently outshone SCT and OCT in extending the operational range of communication, registering a maximum modulation index of 0.797 and a bit error rate below 10- 7 at an operating distance of 95 mm through the air. Its load-independent characteristic allowed DLT to surpass the performance of SCT and OCT, which were each advantageous under high and low loads, respectively. All these results are confirmed by a LTSpice simulation. Consequently, the communication techniques put forward in this work mark a significant progression in medical implant communications, enhancing coil-to-coil operational distance while adhering to a low carrier frequency.

Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.

Objectives: Identify, through a systematic review, the main domains and methods to support health technology assessment of Medical Devices (MD) from the perspective of technological incorporation into healthcare systems. Methods: Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer. Results: A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations. Conclusion: Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible.

Screening of Lithium Substituted Ag-TiO2 Nanoparticle Coating for Antibiofilm Application.

Bacterial infections and biofilm growth are common mishaps associated with medical devices, and they contribute significantly to ill health and mortality. Removal of bacterial deposition from these devices is a major challenge, resulting in an immediate necessity for developing antibacterial coatings on the surfaces of medical implants. In this context, we developed an innovative coating strategy that can operate at low temperatures (80 °C) and preserve the devices' integrity and functionality. An innovative Ag-TiO2 based coating was developed by ion exchange between silver nitrate (AgNO3) and lithium titanate (Li4Ti5O12) on glass substrates for different periods, ranging from 10 to 60 min. The differently coated samples were tested for their antibacterial and antibiofilm efficacy.

Comparisons between In-Check DIAL® and PF810® in evaluation and training inspiratory capacity for using dry powder inhalers.

BACKGROUND: Dry powder inhalers (DPIs) rely on both internal resistance and patients' inspiratory capacity for effective operation. Optimal inspiratory technique is crucial for DPI users. This study assessed the accuracy and repeatability of two available devices, PF810® and In-Check DIAL®, and analyzed their measurement errors and consistency in detecting inspiratory capacity. METHODS: The accuracy and repeatability of peak inspiratory flow (PIF) and forced inspiratory vital capacity (FIVC) against various internal resistances of the two devices were assessed using standard waveforms generated by a breathing simulator. The agreement of PIF measurements between the two devices in healthy volunteers and chronic obstructive pulmonary disease (COPD) patients was analyzed with the intraclass correlation coefficient and Bland-Altman graphical analysis. RESULTS: PF810® showed great accuracy and repeatability in measuring PIF, except for square waveforms at the lowest flow rate (20 L/min). In-Check DIAL® exhibited poor accuracy against high resistance levels. In scenarios with no resistance, In-Check DIAL® had significantly smaller measurement errors than PF810®, but larger errors against high resistance levels. The two devices showed excellent agreement (ICC > 0.80, P < 0.05), except for healthy volunteers against medium to high resistance (R3-R5) where the ICC was insignificant. Bland-Altman plots indicated small disagreements between the two devices for both healthy volunteers and COPD patients. CONCLUSIONS: In-Check DIAL® exhibited poor accuracy and larger measurement errors than PF810® when detecting PIFs against higher internal resistances. However, its good performance against lower internal resistances, along with its cost-effectiveness and convenience made it appropriate for primary care. PF810® showed good accuracy and repeatability and could detect additional parameters of inspiratory capacity beyond PIF, though required further studies to confirm its clinical benefits.

Hospital process performance and the adoption of medical devices: An organization-based view.

Over the past two decades, there has been a growing scholarly interest in the adoption of technology in healthcare. While numerous studies have delved into the effects of specific technologies on the performance of different organizational units and medical specialties, the findings have often been divergent. Unlike the established literature, our approach focuses on the organization's perspective to analyze how technology impacts process performance in hospital settings. More precisely, we compiled a tailored dataset from 56 healthcare organizations in Italy and conducted a comprehensive analysis of panel data from 2016 to 2019, utilizing Ordinary Least Squares (OLS) regression as our main analytical tool. The data shows a clear relationship between an organization's use of medical devices and its overall process performance. Our research highlights the importance of achieving substantial improvements in process performance by strategically integrating new technologies and devices. Policymakers are encouraged to consider introducing incentives to drive hospitals to invest in innovative technologies. Furthermore, monitoring expenditures on new devices could serve as a valuable metric for assessing the extent of technology adoption within clinical practices.

Characterizing thrombus adhesion strength on common cardiovascular device materials.

Thrombus formation in blood-contacting medical devices is a major concern in the medical device industry, limiting the clinical efficacy of these devices. Further, a locally formed clot within the device has the potential to detach from the surface, posing a risk of embolization. Clot embolization from blood-contacting cardiovascular devices can result in serious complications like acute ischemic stroke and myocardial infarction. Therefore, clot embolization associated with device-induced thrombosis can be life-threatening and requires an enhanced fundamental understanding of embolization characteristics to come up with advanced intervention strategies. Therefore, this work aims to investigate the adhesive characteristics of blood clots on common biocompatible materials used in various cardiovascular devices. This study focuses on characterizing the adhesion strength of blood clots on materials such as polytetrafluoroethylene (PTFE), polyurethane (PU), polyether ether ketone (PEEK), nitinol, and titanium, frequently used in medical devices. In addition, the effect of incubation time on clot adhesion is explored. Results from this work demonstrated strongest clot adhesion to titanium with 3 h of incubation resulting in 1.06 ± 0.20 kPa detachment stresses. The clot adhesion strength on titanium was 51.5% higher than PEEK, 35.9% higher than PTFE, 63.1% higher than PU, and 35.4% higher than nitinol. Further, adhesion strength increases with incubation time for all materials. The percentage increase in detachment stress over incubation time (ranging from 30 min to 3 h) for polymers ranged from at least 108.75% (PEEK), 140.74% (PU), to 151.61% (PTFE). Whereas, for metallic surfaces, the percentage rise ranged from 70.21% (nitinol) to 89.28% (titanium). Confocal fluorescence imaging of clot remnants on the material surfaces revealed a well-bounded platelet-fibrin network at the residual region, representing a comparatively higher adhesive region than the non-residual zone of the surface.

IVDCheckR - simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool.

OBJECTIVES: A recent challenge for clinical laboratories is the lack of clear guidelines for handling significant modifications of CE-marked assays. The modifications may involve, for example, extending measurement intervals, changing dilution procedures or using non-validated sample materials. The challenge arises due to the amended Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which is now poised for implementation, despite the extended transition periods. The IVDR application imposes challenges not only for diagnostic companies but also for clinical laboratories when using laboratory developed tests (LDTs), often referred to as in-house assays. In this context, a coherent and meticulously structured LDT documentation is highly beneficial. While laboratories are obliged to meet the IVDR requirements, the absence of a streamlined framework or guideline hampers the ability to gain a comprehensive overview on the requirements and possible options for their fulfilment. METHODS: To address this issue, we introduce a web based digital tool powered by an R Shiny web application. This tool facilitates a seamless implementation of IVDR requirements for LDTs across diverse laboratory environments in terms of their transparency and validity. Our approach focuses on adequate handling of significant modifications of CE-marked in vitro diagnostic medical devices (IVD). RESULTS: IVDRCheckR is an open-source tool that is easily accessible and free from system dependencies. The tool promotes a seamless process and a guide to enhance transparency, reliability, and validity of laboratory examination results based on LDTs. Additionally, the tool further provides modules for evaluating quality control data and quantitative method comparison data. CONCLUSIONS: Our Shiny web application-based platform is a digitised, user-friendly tool that simplifies the documentation for LDTs according to IVDR requirements with special emphasis on solutions for handling modifications to CE-marked assays.

Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment.

The study is designed to advocate for a harmonized medical device regulatory framework throughout the BRICS countries with a view to facilitating trade, attracting investments and safeguarding patients' health. The development of the medical devices industry in BRICS countries is impeded by a lack of standardized regulation. A harmonized framework would facilitate the approval process, promotion of innovation and wider access for patients to modern medical technologies. The paper analyses existing regulatory frameworks for medical devices in BRICS countries and identifies their strengths and weaknesses. Specific measures to harmonize such as standardization of technology, interoperability and the implementation of transparent licensing procedures are also proposed. The study indicates that a joint committee should be set up to supervise legal harmonization, standardization of classification and development of specific technical specifications. It also provides information about the regulatory framework in different countries, such as Brazil, Russia, India, China and South Africa, on classification of medical devices. Report emphasizes the need for a harmonized regulatory framework to rapidly introduce new healthcare technologies. It suggests that the BRICS countries can create a more conducive environment for the medical device industry, ultimately benefiting patients, manufacturers and the overall healthcare system by aligning their legislation.

Risk analysis applied to the process of managing medical single use devices in a hospital pharmacy department.

INTRODUCTION: During the COVID-19 pandemic, single use medical devices' supply (SUMD) was marked by repetitive and unforeseen interruptions. The present study aimed to determine the risks related to the processes of management of medical devices in our CHU according to a method of failure mode, effect and criticality analysis (FMECA). METHODS: Qualified healthcare professionals were recruited to form a multidisciplinary consensus committee. By analyzing the process map, all failure modes, causes and consequences were identified through brainstorming meetings. They were then classified taking into account the criticality index (CI) calculated according to three parameters: frequency, severity, and detectability. The prioritization was carried out by considering the mean and the median values of the CI as limits. Corrective and preventive actions were then proposed. RESULTS: A total of 49 failure modes were identified, accumulating 4466 criticality points. The most critical step is that relating to the inter-depot order with a CI equal to 783 points. An action plan was developed, allows us to control 64% of the overall criticality of the risks linked to the process. Three main lines of action have been proposed: continuous training, especially for managerial and administrative tasks, logistical improvement (architectural reorganization and implementation of systems for securing the circuit of SUMDs) and support for the digitization of hospital pharmacy. CONCLUSION: The FMECA is a consensual method, which makes it possible to propose actions in order to reduce the risks linked to the process of managing medical devices. Optimizing the estimation of needs, strengthening communication with stakeholders and securing the circuit are essential to guarantee the availability of SUMDs for the benefit of the patient.