Complex Medical Devices Research Articles

Methods for Medical Device Design, Regulatory Compliance and Risk Management

Despite the evolution of design controls and compliance as critical elements in the medical device development process, as stipulated by both domestic and international regulations and standards, a comprehensive model describing the comprehensive approach to medical device design is needed. This gap exists because design controls and regulatory compliance have become integral to the medical device design process, mandated by regulations and standards at both national and international levels. The medical device sector prioritizes design controls and compliance with regulatory requirements in isolation. On the other hand, the integration of design controls and compliance, such as those associated with projects involving complex medical device designs, have not been considered nearly enough. This review focuses on the integration of design controls and compliance in the medical device sector. Initially, the definition of a medical device and the different phases of medical device development are introduced. Afterwards, medical device development using the basic safety and essential performance concepts outlined in the IEC 60601-1 standard is discussed. The role of risk management practices about medical devices is also elaborated upon.

Neural digital twins: reconstructing complex medical environments for spatial planning in virtual reality

PurposeSpecialized robotic and surgical tools are increasing the complexity of operating rooms (ORs), requiring elaborate preparation especially when techniques or devices are to be used for the first time. Spatial planning can improve efficiency and identify procedural obstacles ahead of time, but real ORs offer little availability to optimize space utilization. Methods for creating reconstructions of physical setups, i.e., digital twins, are needed to enable immersive spatial planning of such complex environments in virtual reality.MethodsWe present a neural rendering-based method to create immersive digital twins of complex medical environments and devices from casual video capture that enables spatial planning of surgical scenarios. To evaluate our approach we recreate two operating rooms and ten objects through neural reconstruction, then conduct a user study with 21 graduate students carrying out planning tasks in the resulting virtual environment. We analyze task load, presence, perceived utility, plus exploration and interaction behavior compared to low visual complexity versions of the same environments.ResultsResults show significantly increased perceived utility and presence using the neural reconstruction-based environments, combined with higher perceived workload and exploratory behavior. There’s no significant difference in interactivity.ConclusionWe explore the feasibility of using modern reconstruction techniques to create digital twins of complex medical environments and objects. Without requiring expert knowledge or specialized hardware, users can create, explore and interact with objects in virtual environments. Results indicate benefits like high perceived utility while being technically approachable, which may indicate promise of this approach for spatial planning and beyond.

ROLE OF ARTIFICIAL INTELLIGENCE (AI) IN ENHANCING OPERATIONAL EFFICIENCY IN MANUFACTURING MEDICAL DEVICES

Artificial Intelligence (AI) plays a crucial role in enhancing operational efficiency in manufacturing medical devices by revolutionizing various aspects of the production process. The integration of Artificial Intelligence (AI) technologies within the manufacturing processes of medical devices has significantly transformed operational efficiency. This abstract delves into the pivotal role of AI in optimizing various aspects of manufacturing medical devices, ranging from design and production to quality control and maintenance. AI-driven design methodologies enable the creation of complex medical devices with enhanced functionality and precision. Machine learning algorithms assist in analysing vast datasets related to materials, performance metrics, and user feedback, facilitating the development of innovative device prototypes. In manufacturing, AI optimizes production workflows by predicting demand, managing inventory, and automating assembly processes. Predictive maintenance powered by AI ensures the continuous functionality of manufacturing equipment, reducing downtime and operational costs. Quality control is strengthened through AI-enabled inspection systems that can detect microscopic defects and ensure compliance with stringent regulatory standards. Real-time monitoring of manufacturing processes using AI-driven analytics enhances product consistency and minimizes errors. Furthermore, AI enhances supply chain management by optimizing logistics, procurement, and supplier selection processes, ensuring timely delivery of components and materials essential for medical device manufacturing.AI-driven technologies revolutionize medical device manufacturing through enhanced quality control, predictive maintenance, process optimization, supply chain efficiency, regulatory compliance, customization, cost reduction, and data-driven decision support, optimizing reliability and efficiency while ensuring regulatory standards.

Healthcare Providers’ Readiness to Address Medical Device Cybersecurity within the Irish Healthcare System

Medical devices that can diagnose and treat critically ill patients have become sophisticated and complex. Device manufacturers have been developing these systems to meet market requirements as technology evolves. Combining medical devices and ICT into a distributed medical device IT system can be a solution to incorporating continuous monitoring from the patient bedside to interoperability with a clinical information system. These technology innovations aim to manage patient data and configure medical devices into networked systems that can provide functionality and safety. The implementation of a medical device network solution allows a healthcare provider to take advantage of managing the flow of information to improve clinical work practices and implement a system that can be interoperable with other clinical information systems. International Electrotechnical Commission (IEC) 80001-1 was developed to assist healthcare providers in identifying and managing the risks associated with medical devices sharing the same IT network with other systems and software. This standard defines roles, responsibilities, and activities in relation to the management of risk with medical devices on an IT network. This study aims to determine if the standard International Electrotechnical Commission (IEC) 80001-1 is being implemented and determine familiarity with regulations and appropriate standards and guidance for an effective medical device security risk-management program with Irish healthcare providers. A literature review highlighted the restrictions healthcare providers face in adopting and implementing IEC 80001-1 and the security threats and risks present when integrating medical devices and IT networks. The study research was conducted with clinical engineering members of the Biomedical and Clinical Engineering Association of Ireland (BEAI). This survey targeted BEAI members due to their wealth of experience, knowledge, and skill level in supporting complex medical device systems. An online anonymous survey was created to determine knowledge, awareness, and familiarity with IEC 80001-1 and other medical device security risk-management guidelines. The study research results revealed low knowledge, awareness, and familiarity among research participants with IEC 80001-1 and guidelines on medical device security risk management. These results were consistent with the literature review that a key to the success of standard adoption is collaboration between stakeholders and a multidisciplinary approach to compliance.

Characteristics and Key Features of Antimicrobial Materials and Associated Mechanisms for Diverse Applications.

Since the Fourth Industrial Revolution, three-dimensional (3D) printing has become a game changer in manufacturing, particularly in bioengineering, integrating complex medical devices and tools with high precision, short operation times, and low cost. Antimicrobial materials are a promising alternative for combating the emergence of unforeseen illnesses and device-related infections. Natural antimicrobial materials, surface-treated biomaterials, and biomaterials incorporated with antimicrobial materials are extensively used to develop 3D-printed products. This review discusses the antimicrobial mechanisms of different materials by providing examples of the most commonly used antimicrobial materials in bioengineering and brief descriptions of their properties and biomedical applications. This review will help researchers to choose suitable antimicrobial agents for developing high-efficiency biomaterials for potential applications in medical devices, packaging materials, biomedical applications, and many more.

Comparative life cycle assessment of single-use cardiopulmonary bypass devices

The purpose of this study is to evaluate the impacts of the common cardiopulmonary bypass device over its life cycle. This represents the first such assessment of a complex medical device, to the best of the authors’ knowledge. This study was motivated by practitioners’ concerns over cardiopulmonary bypass devices constructed mainly of single-use plastics, such as polyvinyl chloride and polycarbonate. The open-source software OpenLCA was used to perform each life cycle assessment with respect to ten common impact categories: global warming, eutrophication, acidification, smog, human health cancer, human health non-cancer, water intake, human health air pollutants, ecotoxicity, and natural resource depletion. The environmental impact was evaluated using the Building for Environmental and Economic Sustainability impact assessment method. To quantify the uncertainty in the results, Monte Carlo simulation was used using 5000 runs. A comparative assessment was conducted to determine the potential trade-offs in each impact category of using alternative construction materials. Incineration as a common disposal option could contribute up to 33 % of total CO2 equivalent emissions over the life cycle of the device. Another 33% of total CO2 equivalent emissions are attributed to polycarbonate used in the construction of devices. Polycarbonate was also implicated as the top contributor to the other impact categories considered, except for human health cancer, which is almost entirely affected by the use of polyvinyl chloride in the device, primarily in the tubes. The accuracy of these results is corroborated by the uncertainty analysis. Lastly, the results show that replacing polycarbonate with polyethylene terephthalate, polypropylene, or polyethylene would be no worse than polycarbonate and provide a significant decrease in almost every impact category. Cardiopulmonary bypass devices are constructed primarily of single-use plastics that have relatively significant impacts in the 10 common categories considered. Alternative disposal methods and replacement of polycarbonate with alternative plastics could dramatically reduce the effects in most impact categories.

Use of real-time immersive digital training and educational technologies to improve patient safety during the processing of reusable medical devices: Quo Vadis?

Hospital acquired infections stemming from contaminated reusable medical devices are of increasing concern. This issue is exaggerated with the introduction of complex medical devices like endoscopes and robotic instrumentation. Although medical device manufacturers validate their cleaning instructions for use, evidence in the literature demonstrates that effective device processing is not being performed consistently within sterile processing departments in clinical settings. The result is increased risks to patient safety. As a solution to this problem, focused one-on-one training increases compliance to the medical device manufacturer's processing instruction. However, often this is not a practical solution for the volume of healthcare staff responsible for device processing activities. This constitutes the first paper to address the blended use of educational and digital technologies to address these challenges and as a result inform safety and sustainability for the medical device sector. Cognitive learning theory is an evidence-based framework for learning. It supports the use of immersive educational experiences using emerging extended reality technologies (e.g., virtual or augmented reality) to increase learning comprehension. The delivery of educational content via these technologies provides an innovative option for repeatable leaning and training outcomes. The motivation is to decrease patient risk of contaminated reusable medical devices. The proposed approach while primary motivated by safety can also enhance sustainability and efficiency enabled by artificial intelligence and robotic instrumentation.

Strategic Budget Planning for Complex Medical Devices: A Case Study on Surgical Microscopes

Dramatic developments in medical device technologies significantly influence the cost of equipment acquisition and operating expenses. Sometimes the budget estimation needed for rudimentary medical equipment can be complicated, even more so for a complex device with several add-on features. In Canada, the budget allocated to capital equipment purchases is challenging because the budget comes from the provincial government to the hospitals. The capital equipment budget amount is challenging because of the public healthcare funding model, whereby fiscal budgets come from the provincial government to the hospitals. The capital equipment budget allocation is limited and restricted in hospital as “big ticket” items compete with other capital requests. Having a strategic budgeting plan, completed by a clinical engineer, ensures a sufficient budget for the capital request. A strategic budgeting plan was central to this study to estimate the required funding for replacing aged existing surgical microscopes at the Children's Hospital of Eastern Ontario. This study demonstrates the development of a methodology to guide budget planning and includes inventory assessment, market analysis, the identification of clinical requirements, cost analysis, and the utilization of the outputs of these steps for capital planning requests. A basic step-by-step approach can be followed by any clinical engineering department before submitting a capital planning request for complex medical devices.

Medical Additive Manufacturing: Challenges and Features

Over the past 20 years, Medical Additive Manufacturing has been immensely developed and become an essential part of Contemporary healthcare. In the past, additive manufacturing was only utilized to develop basic anatomical models, but as technology evolved, it became more straightforward for researchers to produce complex medical devices. Medical additive manufacturing is a promptly emerging field with the competence to print living tissues and organs for transplantation and produce personalized implants and prostheses with astounding precision and accuracy. The ability of 3D printing to produce products that precisely match a patient’s unique anatomy has significant benefits for medicine, including better patient outcomes. Additive manufacturing is often employed in the orthopedic and dentistry fields to design, build, or produce parts specifically for the patient’s exact and ideal fit. Additionally, it is extensively being utilized to produce surgical equipment and customized anatomical models for pre-surgical planning. This allows surgeons to practice complex procedures on a replica of the patient’s anatomy, improving surgical outcomes and reducing the risk of complications. Experts are exploring the possibility of utilizing 3D printing techniques for developing innovative methods to administer medication, which could improve treatment effectiveness and patient well-being. Additionally, these advancements have contributed immensely to creating human organs through bio-printing technology; a progress that has the potential to revolutionize organ transplants as they exist today by reducing dependence on donors. Another imminent advancement is surgical robotics using robots created through 3D printing procedures working side by side with medical experts thus improving patient outcomes and decreasing risks associated with traditional surgery techniques. Ongoing research and development promise even more groundbreaking applications in the future. This research article gives an attempt at medical additive manufacturing research now, then, and in the future.

Chitosan-based (Captomucil® complex) medical device nasal spray for relieving symptoms in patients with rhinitis: a primary care study

BACKGROUND: Rhinitis is a common disease characterized by typical symptoms, including itching, sneezing, rhinorrhea, and nasal obstruction. A medical device has been developed. This medical device is a nasal spray formulated and produced with a patented manufacturing process and contains a natural complex based on chitosan. Chitosan reduces mucus overproduction and improves its rheological characteristics. METHODS: The present study investigated the medical device’s efficacy and safety in patients with nasal symptoms due to rhinitis and visited in a primary care setting. Nasal symptoms were assessed by a four-point scale (0-3), and the sum of all symptom scores was also calculated (TNSS). Patients took two sprays/nostril once a day per two weeks. Patients were visited at baseline, after one and two weeks. Fifty-one patients (22 males and 29 females, mean age 44 years) completed the study. RESULTS: The medical device with chitosan significantly reduced each symptom and the TNSS (P<0.05 after one week and P<0.001 after two weeks). In addition, the treatment was safe and well tolerated. CONCLUSIONS: In conclusion, this study showed that a medical device with chitosan, intranasally administered per two weeks, reduced the perceived severity of nasal symptoms during rhinitis.

Using Video to Describe the Patient-Controlled Analgesia Pump Programming Process: A Qualitative Study.

Patient-controlled analgesia (PCA) pumps are complex medical devices frequently used for postoperative pain control. Differences in how nurses program PCA pumps can lead to preventable medication errors. To describe similarities and differences in how surgical nurses program PCA pumps. We conducted a qualitative study using video reflexive ethnography (VRE) to film nurses as they programmed a PCA pump. We spliced and collated videos into separate clips and showed to nursing leaders for their deliberation and action. We found nurses ignored or immediately silenced alarms, were uncertain about the correct programming sequence, and interpreted how to load a syringe in the pump in multiple ways; in addition, the PCA pump design did not align with nurses' workflow. VRE was effective in visualizing common challenges nurses experienced during PCA pump programming. Nursing leaders are planning several nursing process changes due to these findings.

BIOMEDICAL SMART HOME SYSTEMS

Biomedical engineering is a system that includes the design, manufacture and operation of various systems, devices and methods used in the diagnosis and treatment of problems that may occur in human health. In recent years, as in the whole world, some important innovations in this field apply in the research conducted in Azerbaijan. Over the past 30 years, biomedical engineering has been established as an independent field of science and engineering. Currently, biological medicine is not limited to the field of medicine, it has continued to develop as a potential field, making an important contribution to the dentistry, veterinary medicine, rehabilitation, physical education, and sports fields. The types of biomedical devices available in stationary health care institutions are expressed in hundreds, and the number is expressed in thousands. From implant to stethoscope, from complex imaging medical devices such as MRI (magnetic resonance imaging) and X-rays devices to patient beds, many products that could be considered simpler have been designed by engineers. In modern hospitals, sophisticated engineering devices are used by doctors to treat patients. Biomedical smart home system or health-based smart homes are designed for patients who feel the need to return home after an average time from a hospital or healthcare facility, or who need to receive care at home. The article presents information about innovations in the mentioned field. Keywords: Bioengineering, biomedical equipment, biomedical sensor, smart home

Developing and Evaluating a Novel Educational Intensive Care Unit Wall Map

Developing and Evaluating a Novel Educational Intensive Care Unit Wall Map

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

The US medical device market is the world's largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation. To estimate the mean expected capitalized cost of developing a novel therapeutic complex medical device. In this economic evaluation, an analytical model of novel therapeutic complex medical device development using data from public and proprietary sources with coverage from 2000 through 2018 was used to estimate the cost, duration, and phase transition success probability associated with each stage of development. Data analysis was completed in September 2021. Conduct of nonclinical and clinical studies; payment of FDA user fees for novel therapeutic complex medical devices. Mean development cost (in 2018 US dollars) incurred by developers for an FDA-approved novel therapeutic complex medical device, accounting for failures and cost of capital. In this economic analysis, the mean development cost for a novel therapeutic complex medical device was $54 million (95% CI, $25 million-$200 million) excluding any postapproval studies that might be required. After accounting for the cost of failed studies and cost of capital, the mean capitalized cost of bringing a novel therapeutic complex medical device to the US market was $522 million (95% CI, $205 million-$3382 million). The key factors associated with this cost were the phase transition probabilities: 46.9% for nonclinical to feasibility study, 48.0% for feasibility to pivotal study, 75.7% pivotal study to FDA premarket approval submission, and 80.5% for FDA premarket approval submission to approval. The nonclinical development stage constituted the largest portion of overall cost at 85.0% with the FDA review stage with the highest phase transition probability accounting for only a small fraction at 0.5%. In this economic evaluation study, the cost of therapeutic complex medical device development from proof of concept through postapproval stages was assessed accounting for the cost of failures and the cost of capital. Existing estimates did not account for all stages of development, capitalization, or failure costs, which this study suggests were substantial.

Application of Pulsating Vacuum Cleaning Technology to Medical Devices Cleaning

This study aims to solve existing problems in cleaning medical devices, such as the cumbersome loading of minimally invasive surgical instruments, the incomplete cleaning of instruments with complex structures, and the low cleaning efficiency of ordinary instruments. A pulsating vacuum cleaning machine was combined with ultrasonic cleaning and boiling cleaning technology to clean various complex medical devices through a pressure pulsating process (i.e., repetitive pump-out and pumpin until the cleaning results meet the cleaning standards for medical devices). The cleaning results of spay washing, ultrasound cleaning and pulsating vacuum cleaning were compared among four groups of medical devices, including silica gel hoses, chamber instruments, whole box of minimally invasive instruments and surgical instruments. The amount of protein residues was tested using the spectrophotometric method. The testing results revealed that the loading capacity of a pulsating vacuum cleaning machine is 3–4 times as much as that of an ordinary spray cleaning machine, without manual placement and connection operation required, which reduced the workload of pretreatment. The protein residue after cleaning meets the requirements of the YY/T0734 standard for the cleaning effect of medical devices. Pulsating vacuum cleaning technology has an overall better loading capacity, when compared to spay washing and ultrasound cleaning, and this can make up for the shortcomings of commonly used cleaning machines, such as the low cleaning efficiency and unsatisfactory cleaning results of medical devices with complex structures.

Computed tomography tissue equivalence of 3D printing materials

IntroductionAdditive production refers to the process of prototyping, which allows the production of highly complex medical devices and products. Interpretation of additive manufacturing (AM) material in Computed Tomography (CT) has not been widely investigated. The aim of this study was to determine the CT number values of commercially available fused deposition modelling (FDM) and stereolithography (SLA) AM materials. MethodsTotal of 15 AM materials, 7 FMD and 8 SLA, were selected and scanned on CT to determine the HU value and appearance on the images. All test object were designed as rectangular blocks and after their production physical description were calculated. AM materials were scanned on CT operating at 80, 100, 120 and 135 kV. ResultsAll materials correspond to a certain human tissue and they have uniformity when printed with 100% infill. CT number ranged from a minimum of −188.0 HU to a maximum of 189.1 HU, for FDM materials, and from −15.8 HU to 167.3 HU, for SLA materials. ConclusionKnowing the CT number of an AM materials can allow the design of medical or rehabilitation products with a specific appearance on CT images. Analysed and collected data can find application in the design and manufacture of immobilization devices that can be easily distinguished from other materials or human tissue. Implications for practiceThis study provides information that can be used in the design and fabrication of anthropomorphic diagnostic and therapeutic phantoms. There is significant potential for the use of AM material for sophisticated test objects when used in medical image modality testing. Knowing actual CT numbers of frequently used AM materials allows manufacturing anthropomorphic phantoms to investigate radiation doses in diagnostic radiology and radiotherapy.

A dual-layer context-based architecture for the detection of anomalous instructions sent to medical devices

Complex medical devices are controlled by instructions sent from a host personal computer (PC) to the device. Anomalous instructions can introduce many potentially harmful threats to patients (e.g., radiation overexposure), to physical device components (e.g., manipulation of device motors), or to functionality (e.g., manipulation of medical images). Threats can occur due to cyber-attacks, human error (e.g., using the wrong protocol, or misconfiguring the protocol's parameters by a technician), or host PC software bugs. Thus, anomalous instructions might represent an intentional threat to the patient or to the device, a human error, or simply a non-optimal operation of the device.To protect medical devices, we propose a new dual-layer architecture. The architecture analyzes the instructions sent from the host PC to the physical components of the device, to detect anomalous instructions using two detection layers: (1) an unsupervised context-free (CF) layer that detects anomalies based solely on the instruction's content and inter-correlations; and (2) a supervised context-sensitive (CS) layer that detects anomalies in both the clinical objective and patient contexts using a set of supervised classifiers pre-trained for each specific context.The proposed dual-layer architecture was evaluated in the computed tomography (CT) domain, using 4842 CT instructions that we recorded, including two types of CF anomalous instructions, four types of clinical objective context instructions and four types of patient context instructions. The CF layer was evaluated using 14 unsupervised anomaly detection algorithms. The CS layer was evaluated using six supervised classification algorithms applied to each context (i.e., clinical objective or patient).Adding the second CS supervised layer to the architecture improved the overall anomaly detection performance (by improving the detection of CS anomalous instructions [when they were not also CF anomalous]) from an F1 score baseline of 72.6%, to an improved F1 score of 79.1% to 99.5% (depending on the clinical objective or patient context used). Adding, the semantics-oriented CS layer enables the detection of CS anomalies using the semantics of the device's procedure, which is not possible when using just the purely syntactic CF layer. However, adding the CS layer also introduced a somewhat increased false positive rate (FPR), and thus reduced somewhat the specificity of the overall process.We conclude that by using both the CF and CS layers, a dual-layer architecture can better detect anomalous instructions to medical devices. The increased FPR might be reduced, in the future, through the use of stronger models, and by training them on more data. The improved accuracy, and the potential capability of adding explanations to both layers, might be useful for creating decision support systems for medical device technicians.

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

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

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges.

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

Integration of antimicrobial substances in 3-D printed plastics

Abstract The risk of healthcare associated infections (HAI) is rising with the utilization of more complex medical devices. Cleaning and disinfecting measures of such devices are often insufficient leading to an increased microbiological contamination on these devices. Recent studies imply that antimicrobial coatings could present a solution for this topic. In this work a novel approach for the introduction of an antimicrobial technology into plastic granulate was tested. After 3-D printing the antimicrobial activity of the test samples was analysed. Our results show that the integration of an antimicrobial substance to ABS plastic is feasible only with sophisticated plastic processing technologies. Simple heating or mixing of the substance did not allow integration of the antimicrobial substance into the 3-D printed sample, but it was possible to integrate the antimicrobial ingredient into the raw material by compounding. The printed test samples showed strong antimicrobial activity in the standardized test procedures.