Management Of Medical Devices Research Articles

Polyethylene glycol/melamine foam composite phase change materials modified by CdS/Ag exhibits high photothermal conversion performance

CdS has been shown to be an excellent photon trap with strong absorption of light at visible and near-infrared wavelengths. The use of CdS for phase change material (PCM) modification can significantly improve its photothermal conversion performance. However, due to the unique energy band structure of CdS, the difficulty in electron conduction leads to poor thermal conductivity. This problem can be improved by introducing high thermal conductivity nanometals for modification, however, the effective combination of CdS and nanometals has been challenging. In this study, a new preparation strategy is demonstrated, in which Ag nanoparticles (NPs) with similar lattice parameters and crystalline coordination to CdS is first introduced on the surface of carbonized melamine foam (CMF), followed by the introduction of CdS NPs. This similar structure helps to form a better interfacial bond between CdS and Ag. The resulting stabilized structure enables the composite phase change material (CPCM) to achieve 96.1 % PEG loading with an ultra-high photothermal conversion efficiency of 94.6 %, thermal conductivity of 0.61 W/m∙K, and excellent antimicrobial activity. This study provides valuable guidance for the engineering design of CPCM with high photothermal conversion performance and suggests its practical application value in seawater evaporation and thermal management of medical devices.

Thực trạng và một số yếu tố ảnh hưởng đến công tác quản lý trang thiết bị y tế tại khoa hồi sức tích cực – chống độc của bệnh viện đa khoa tỉnh Trà Vinh năm 2020

Objectives: This study has two objectives, as follows: to describe the management situation. Medical devices and some factors affecting medical devices management in hospitals in Tra Vinh province, 2020. Methods: This is a cross-sectional descriptive study, combining quantitative and qualitative methods. Quantitative data was collected via a self-administered questionnaire among 25 staffs directly managing medical devices and 124 medical devices records. Qualitative data was collected from four in-depth interviews and two focus group discussions. Main findings: Medical devices invested by the hospital (59.7%), low frequency of use of medical devices accounted for 0%, and unused equipment accounted for 0%. Dossiers of incomplete equipment, mainly lack of operational logs and documents for maintenances and repairs; medical devices with qualified certificates accounted for 100%; all equipments are built using procedures and operating procedures; but inspections and verifications are only carried out periodically and incompletely; post-repair inspections have not been carried out, equipment maintenance costs still remains low. However, maintenance budget constraints were observed, and the information system and maintenance work did not fully meet requirements due to various reasons, primarily financial issues. Hospital chairmans identified financial concerns as a key issue and planned to solve them in the near future to utilize the quality of medical devices according to regulations. Key words: Medical devices, influenced factor, Tra Vinh province hospital.

MediLog: A Pilot Study of Online Management System for Medical Device Status and Loan

Malaysia's medical device industry is experiencing significant growth, with 309,829 devices procured at a cost of RM 7.78 billion and actively utilized in public hospitals nationwide. This surge highlights the need for an advanced medical device management system to efficiently handle the life cycle of these devices to ensure optimal utilization and streamline operations. Other proposed technological solutions like RFID, RTLS, and infrared tags aim to address these challenges, but their high installation costs pose barriers, especially for government hospitals. To overcome these obstacles, this pilot study advocates for a mobile application as a cost-effective alternative for comprehensive medical data management. The proposed application, developed using MIT Apps, capitalizes on portability, ease of management, and the multifunctionality of mobile platforms. A key feature of the application is the barcode scanner, widely employed across industries for enhanced data capture efficiency. The Real-time Database is integrated into the project, facilitating the swift and accurate storage of medical device information. In essence, the mobile application prototype provides a practical solution to the limitations of manual data management in the biomedical department. Leveraging MIT Apps and incorporating features like the barcode scanner and Real-time Database, the application streamlines the updating of machine details, ensuring users access precise and current information. This approach promotes efficiency, accuracy, and effectiveness in medical device management within the healthcare system.

Critical Control Points and Case Studies in the Production of Metal Additive Manufacturing Medical Device

The critical control points in the production quality management of metal additive manufacturing medical devices, including personnel, hardware, design and development, procurement control, production management and quality control are summarized from the perspective of supervision. The typical cases are analyzed to provide reference for medical device regulatory authorities and enterprises.

Evaluation of the Impact of Refined Quality Control Management Model on the Qualified Rate of Disinfection and Sterilization of Surgical Instruments in the Sterilization Supply Center

Objective: To evaluate the application value of a refined quality control management model for a sterilization supply center. Methods: A retrospective analysis was conducted on the work situation of the sterilization supply center from January 2021 to January 2023. The work situation before January 31, 2022, was classified as the control group; a routine quality control management model was implemented, and the work situation after January 31, 2022, was classified as the observation group. The quality of medical device management and department satisfaction between the two groups were compared. Results: The timely recovery and supply rate, classification and cleaning pass rate, disinfection pass rate, packaging pass rate, sterilization pass rate, and department satisfaction score in the observation group were all higher than those of the control group (P < 0.05). Conclusion: Implementing a refined quality control management model in the sterilization supply center can improve the quality management level of medical devices and department satisfaction and is worthy of promotion.

A hybrid Bayesian network for medical device risk assessment and management

A hybrid Bayesian network for medical device risk assessment and management

Applying a human factors approach to proning pillows in the ICU: Opportunities for redesign

AbstractProning, or turning a patient face down, is a technique used to manage patients with acute respiratory distress in intensive care units (ICUs). Research suggests that the type of pillow used in proning may have a significant impact on patient outcomes and increase the risk of disfiguring pressure injuries to the face. However, there is little evidence surrounding the usability of these pillows in the ICU. The aim of this study was to identify redesign opportunities by understanding how the tools, tasks, people, environment, and organization all interact during proning in the ICU. Thirty‐six ICU clinicians from two Australian public metropolitan hospitals completed an online questionnaire regarding their opinions and experiences with proned patients and the prevention of pressure injuries. Seven ICU clinicians then completed journey mapping activities to document the key workflows, critical incidents, considerations, and personnel involved in managing proned patients in the ICU. Several barriers and facilitators to pressure injury prevention were identified, including interactions between the various tools (e.g., proning pillows with one opening limits the management of several medical devices), the tasks (e.g., high frequency of repositioning), the people (e.g., clinical inexperience, patient features), the environment (e.g., limited availability of tools), and the organization (e.g., limited number of staff to support tasks). This holistic approach revealed several opportunities for the redesign of proning pillows and associated systems. Key takeaways include the limitations of a one‐size‐fits‐all approach to proning in the ICU context, and the need for flexibility and customization to improve proning pillows, associated medical devices, prophylactic dressings, aids, and processes.

Decision tool of medical endoscope maintenance service in Chinese hospitals: a conjoint analysis

BackgroundMedical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other articles that are intended for use in the treatment or diagnosis of disease or injury in humans. Concerning medical endoscope devices, which enable doctors to observe and manipulate the area under examination through a puncture hole in the body cavity or organ, hospitals predominantly consider the quality and cost of maintenance services when making their selection. The effective and efficient provision of maintenance services plays a crucial role in ensuring cost-effective and high-quality management of medical devices. In this study, we have developed an innovative decision tool that analyzed key factors impacting the choice of medical devices’ maintenance service. This tool assists hospitals in evaluating and selecting appropriate maintenance services for medical device, specifically endoscopy devices. Moreover, it also serves as a valuable resource for manufacturers and suppliers to enhance their after-sales service offerings.MethodsA cross-sectional survey was undertaken in 50 Chinese hospitals, including primary and tertiary hospitals. Moreover, 56 medical staff and 65 medical engineers were recruited from 50 Chinese hospitals to participate the survey. A comprehensive set of factors were defined and investigated. Conjoint analysis and orthogonal design were used for survey design and statistical analysis.ResultsFactors importance and utility values of decision-making factors were analyzed at the aggregate, occupation, and medical institution levels. (1) At the aggregate level, the most critical factor is “maintenance response” and the least important one is “maintenance efficiency”. (2) At the occupation level, medical staff paid more attention to “maintenance response” while medical engineers paid more attention to “maintenance quality”. (3) At the medical institution level, Primary hospitals paid more attention to “maintenance price”, while tertiary hospitals paid more attention to “maintenance quality”.ConclusionsIn general, this study provides a more scientific decision-making tool to both hospitals in choosing maintenance service for medical device such as endoscopy, and it also helps manufacturers and suppliers improve the after-sales service.

Hospital Pharmacy: Comprehensive management of medical devices during SARS-CoV-2

Medical devices have become essential to the prevention and control of the COVID-19 pandemic, being crucial for health professionals and patients in particular, and the population in general.It is important to be aware of the laws that regulate the management, distribution, and control of medical devices. Article 82 of the Spanish Law 29/2006 on Guarantees and Rational Use of Medicines and Medical Devices establishes that it is the responsibility of Hospital Pharmacy Services “to participate and coordinate management of purchase of medicines and medical devices in the hospital to ensure an efficient acquisition and rational use of medical devices”. For this reason, working groups of the Spanish Society of Hospital Pharmacy and other scientific societies have issued technical guidelines and consensus statements to provide technical support and updated information on the use of masks, individual protection equipments and other medical devices.In addition, the shortage of medical devices caused by the high demand has resulted in the uncontrolled production and distribution of medical devices. This phenomenon, added to the fraudulent selling of medical devices, highlights the need for a closer surveillance of the market to guarantee the efficacy and safety of available medical devices.A rational use of medical devices is necessary to ensure the availability and safety of these products, which requires the involvement of different stakeholders, including hospital pharmacists. Thus, it is essential that hospital pharmacists receive specific training in technical aspects concerning the possession and use of medical devices. This will help guarantee an effective and safe use of medical products. The acquisition and use of medical devices requires a keen understanding of the technical and legal aspects concerning these products, which makes hospital pharmacists essential for the integral management of medical devices.

Outsourcing the Management of Reusable Medical Devices in a Chain-Wide Care Setting: Mixed Methods Feasibility Study.

Managing reusable medical devices incurs substantial health care costs and complexity, particularly in integrated care settings. This complexity hampers care quality, safety, and costs. Studying logistical innovations within integrated care can provide insights to medical devices use among staff effectively. This study aimed to establish the feasibility of a logistical intervention through outsourcing and a web portal. The goal was to provide insights into users' acceptability of the intervention, on whether the intervention was successfully implemented, and on the intervention's preliminary efficacy, thus benefiting practitioners and researchers. This paper presents a mixed methods feasibility study at a large chain-wide health care provider in the Netherlands. The intervention entailed outsourcing noncritical reusable medical devices and introducing a web portal for device management. A questionnaire gauged perceived ordering and delivery times, satisfaction with the ordering and delivery process, compliance with safety and hygiene certification, and effects on the care delivery process. Qualitative data in the form of observations, documentation, and interviews were used to identify implementing challenges. Using on-site stocktaking and data from information systems, we analyzed the utilization, costs, and rental time of medical devices before and after the intervention for wheelchairs and anti-pressure ulcer mattresses. Looking at the acceptability of the intervention, a high user satisfaction with the ordering and delivery process was reported (rated on a 5-point Likert scale). With respect to preliminary efficacy, we noted a reduction in the utilization of wheelchairs (on average, 1106, SD 106 fewer utilization d/mo), and a halted increase in the utilization of anti-pressure ulcer mattresses. In addition, nurses who used the web portal reported shorter ordering times for wheelchairs (-2.7 min) and anti-pressure ulcer mattresses (-3.1 min), as well as shorter delivery times for wheelchairs (-0.5 d). Moreover, an increase in device certification was reported (average score of 1.9, SD 1.0), indicating higher levels of safety and hygiene standards. In theory, these improvements should translate into better outcomes in terms of costs and the quality of care. However, we were unable to establish a reduction in total care costs or a reduced rental time per device. Furthermore, respondents did not identify improvements in safety or the quality of care. Although implementation challenges related to the diverse supply base and complexities with different care financers were observed, the overall implementation of the intervention was considered successful. This study confirms the feasibility of our intervention, in terms of acceptability, implementation success, and preliminary efficacy. The integrated management of medical devices should enable a reduction in costs, required devices, and material waste, as well as higher quality care. However, several challenges remain related to the implementation of such interventions.

EVALUATION OF IMPLEMENTATION OF PHARMACY SERVICES STANDARDS AT TK II. HOSPITAL R.W. MONGISIDI MANADO

Pharmaceutical services focus on responsible services for patients related to the management of pharmaceutical preparations, medical devices, consumable medical materials and clinical pharmacy services with the aim of increasing the quality of life of patients. The aim of the study was to evaluate the application of pharmaceutical services from the management of pharmaceutical preparations, medical devices and consumable medical materials at the TK II. hospital R.W. Mongisidi Manado based on the pharmaceutical service standards of the Republic of Indonesia Minister of Health no 72 of 2016. This research is descriptive qualitative using the observation method (checklist) supplemented by interviews, the results are processed descriptively, analyzed by grouping each part and presented in the form of a percent score. The results showed that the average total score was 82.18%. This study concludes that pharmaceutical services are from the management of pharmaceutical preparations, medical devices and consumable medical materials at the TK II. hospital R.W. Mongisidi Manado is in accordance with the standards of the Minister of Health of the Republic of Indonesia no 72 of 2016 with a total score of more than 75%, which is in the good category.

Analisis Pengadaan Logistik Alat Kesehatan di Rumah Sakit : Meningkatkan Kualitas Pelayanan Pasien

The hospital is an important organization and is engaged in providing health services that focus not only on medical service issues but also on non-medical service issues. The hospital guarantees the availability of medical devices to the availability of equipment that can affect the quality of health services provided, including patient satisfaction. Therefore the purpose of this study is to determine the analysis of the procurement of medical equipment logistics in hospitals. The method used in this research is literature review from seven national journals obtained using online database facilities via Google pages scholar and researchgate. The selected journal is based on its publication published from 2018-2023. The research results show that the analysis of logistics planning and procurement activities of medical devices in several hospitals in Indonesia have various differences. The difference consists of hospitals that already have a plan logistics is good and some are not running perfectly. Procurement of medical devices that have not been good due to several factors, one of which is an inadequate budget. So that management or logistics management of medical devices is needed in hospitals so that medical devices are always available in accordance with quality standards hospital health.

Dilemmas Encountered by Small and Medium-sized Orthopedic Medical Device Manufacturing Companies in Healthcare Reform Based on a Supply Chain Perspective: Taking a Manufacturer in Jiangsu Province as an Example

As China’s healthcare reform progresses, the medical device industry is receiving significant attention as an essential part of the healthcare delivery system. Current research on the supply and management of medical devices in the context of healthcare reform mainly focuses on the downstream of the supply chain to innovate the management model of orthopedic consumables in hospitals and realize competent healthcare. However, only a few studies have focused on medical device manufacturers upstream of the supply chain and proposed measures to improve supply chain performance. This paper takes a medium-sized customer medical device manufacturer in China as a case study. This study analyzes the problems revealed in its supply chain operation through literature research, case study analysis, and fieldwork. It proposes countermeasures for the continuous improvement of the industry against the background of healthcare reform. The study found that small and medium-sized medical device manufacturers were not using management information systems adequately and were suffering from the impact of healthcare reform by sticking to their old distribution models. For long-term growth, these small and medium-sized medical companies should focus on research and development, cater to market needs, integrate downstream distributors, and work with hospitals to establish a more transparent and efficient healthcare supply chain.

EFOMP policy statement 17: The role and competences of medical physicists and medical physics experts in the different stages of a medical device life cycle

MPPs are trained in the branches of physics associated with the practice of medicine. Possessing a solid scientific background and technical skills, MPPs are well suited to play a leading role within each stage of a medical device life cycle. The various stages of the life cycle of a medical device include establishment of requirements with use-case assessment, investment planning, procurement of medical devices, acceptance testing especially regarding safety and performance, quality management, effective and safe use and maintenance, user training, interfacing with IT systems, and safe decommissioning and removal of the medical devices. Acting as an expert within the clinical staff of a healthcare organisation, the MPP can play an important role to achieve a balanced life cycle management of medical devices. Given that the functioning of medical devices and their clinical application in routine clinical practice and research is heavily physics and engineering based, the MPP is strongly associated with the hard science aspects and advanced clinical applications of medical devices and associated physical agents. Indeed, this is reflected in the mission statement of MPP professionals [1]. PurposeThe life cycle management of medical devices is described as well as the procedures involved. These procedures are performed by multi-disciplinary teams within a healthcare environment. The task of this workgroup was focused on clarifying and elaborating the role of the Medical Physicist and Medical Physics Expert - here collectively referred to as the Medical Physics Professional (MPP) - within these multi-disciplinary teams. This policy statement describes the role and competences of MPPs in every stage of a medical device life cycle. If MPPs are an integral part of these multi-disciplinary teams, the effective use, safety, and sustainability of the investment is likely to improve as well as the overall service quality delivered by the medical device during its life cycle. It leads to better health care quality and reduced costs. Furthermore, it gives MPPs a stronger position in health care organisations throughout Europe.

Economic Time Impacts on HTMA

There are many stages in the medical device management lifecycle to consider, and from the planning stage to commissioning, dismantling and decommissioning, replaceing an equipment is a critical decision. This phase includes several information that help replacement decisions intelligent. Technical, monetary and safety principles are taken into account when replacing medical equipment. One of the most frequently criterion is service life. In recent times, the delivery of a sustainable competitive advantage through the optimization of the management of non-essence activities is considered more relevant. A non-essence example is the Lifespan management of capital goods which are required in supporting the processes involved in healthcare operations ranging from acquiring assets to maximizing the operation, sustaining the performance and conclude the right time to get rid of it properly. The objective: is to identify if Total Cost Ownership (TCO) will give recommendations for decision-making even though it is capable of helping us identify the optimal economic life of the medical device. Overall, 40% of our specimens showed that monitoring TCO is essential to the continuous mapping of the cost of these devices on service.

Quantification of Benefits for Medical Devices

One of the most prominent challenges in safety risk management of medical devices is the Benefit-Risk Analysis. This paper proposes a methodology to quantify benefits, thereby creating more consistency, and explainability in the evaluation of benefits and the benefit/risk ratio.
 Leveraging the guidance from the FDA, we define four Dimensions for appraising benefits. The product of the rankings of a benefit in all four Dimensions is used as a quantitative measure of a benefit.
 The quantitative score for the overall benefit of a medical device would be the sum of the scores of the individual benefits.

Analysis and Research on Intelligent Management and Control System of Reusable Medical Devices

Focusing on the influencing factors of the operation and processing process of reusable medical devices, the management problems of reusable medical devices are analyzed from the processing processes of device assembly, packaging, handover, inventory and information recording. In the specific practice of designing the intelligent management and control system of reusable medical devices, the medical processes in different periods from device addition, packaging, disinfection, transfer, transportation, distribution, recycling to scrapping are integrated into the intelligent service system. Through the changes of medical device treatment, this study comprehensively explores the innovative ideas and specific problems in the construction of intelligent process system of hospital disinfection supply center.

Research on Quality Effect Evaluation of Medical Device Management in Shanghai Based on Radar Chart Method

Under the new pattern of high-quality development, the 2021 Briefing Report on Quality Control of Medical Devices in Shanghai Hospitals at All Levels will be subjected to secondary data processing, and the radar map analysis method will be used to visually evaluate the quality control effects and differences of medical devices in different types of hospitals in Shanghai. Analyze the quality level of medical device management in hospitals at all levels in Shanghai, study the key parts that affect the quality effect, and provide more theoretical basis for the effective control of medical device management quality. From the radar chart, the overall medical device level of tertiary hospitals is higher than that of secondary hospitals, and the overall coverage area is also larger. The overall quality balance of tertiary specialized hospitals needs to be improved urgently, mainly focusing on medical consumables and on-site inspection. There is a big gap in the quality control level of medical devices in other second-level hospitals, but the preparations for quality control training are more comprehensive. Hospital medical device management should pay more attention to specialized hospitals, low-level hospitals and socially run hospitals, and continuously improve the quality control system. At the same time, strengthen the standardization of medical device management and standardization of quality control, and promote the healthy and stable development of medical devices.

Avantages cliniques de l’hémodialyse à domicile et les obstacles à son développement: Clinical benefits of home hemodialysis and barriers to its development

In 2023, home hemodialysis (HHD) is a dialysis modality used safely and performed independently at home by patients with chronic kidney disease (CKD). HHD requires adequate training and appropriate installation which includes the management of medical devices and consumables in the environment of each patient. According to each patient, HHD can be performed daily, every other day or overnight (nocturnal). The duration of the session varies from a few hours (less than three) during the day to several hours (six to ten) during the night. Over the past 10 years, we have been part of a revival in HHD with the availability of small machines better suited to homes and patients. Few controlled interventional studies and extensive registry data support the hypothesis that increase of frequency and duration of dialysis is associated with improved patient survival, cardiovascular risk profile, and quality of life. In addition to the physiological benefits of HDD, there are clear quality of life, social and economic benefits. There are, however, some disadvantages of HHD, including the application and time required for training, the risk of burnout, and the reluctance to "hospitalize" at home. Overall, these limits can be anticipated and overcome by appropriate training, multidisciplinary monitoring, and a dedicated organization. This review recalls the main clinical advantages of HDD related to both physiology and lifestyle as well as the main obstacles and proposes perspectives to guarantee its development. © 2022 Société francophone de néphrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.

Predictive Maintenance in Healthcare System: A Survey

Medical devices are a vital component of healthcare systems, the advantages they may give continue to grow as they are crucial for the safe and effective prevention, diagnosis, treatment, and rehabilitation of illnesses and diseases. Therefore, it is critical to maintain them in good operating order to ensure optimum availability, minimal failures, and guarantee patients’ and users’ safety. The stages involved in medical devices regulation and management are complex, but they are necessary to ensure their quality, safety, and compatibility with the settings in which they are used. Medical equipment complexity has increased due to technological advancement and the traditional maintenance strategies do not meet the needs of today’s healthcare organizations. Therefore, integrating information technology, social networking technologies, digitization and management of medical devices, and the use of big data technologies and Machine Learning (ML) techniques has the potential to significantly improve healthcare services. Integrating autonomous and intelligent systems where data and sophisticated data analytics may be employed led to enhanced equipment data collecting via the deployment of information and communication technologies, notably intelligent devices. With this advancement came an increase in Predictive Maintenance (PdM) solutions. PdM has become a commonly used approach, described as a set of procedures used to evaluate the condition of equipment and predict future failures. These estimations are then utilized to schedule maintenance activities through smart scheduling of maintenance procedures, which aids in preventing or at least minimizing the impacts of unanticipated failures. The purpose of this article is to present a Systematic Literature Review (SLR) exploring and reviewing prior research on the subject of PdM and the developments of this method, particularly in the medical field. In addition to supporting new research projects in the PdM sector, this paper offers a good foundation for understanding PdM approaches, their key findings, problems, and potential. This review focuses on two scientific databases from which a substantial number of articles dedicated solely to PdM in the medical field have been retrieved for analysis. Our research led us to conclude that, despite the many potential benefits of predictive maintenance in the medical field, the concept is still being under-exploited and faces many obstacles.