Objective: To identify the principal factors associated with the occurrence and development of medical device-related pressure injuries (MDRPI) in adults admitted to hospitals. MDRPI, a peculiar subtype of pressure in...Objective: To identify the principal factors associated with the occurrence and development of medical device-related pressure injuries (MDRPI) in adults admitted to hospitals. MDRPI, a peculiar subtype of pressure injuries (PI), result from the pression exerted by devices (or their fixation systems) applied for diagnostic and therapeutic purposes. MDRPI represent a serious problem for patients and healthcare systems. Understanding potential risk factors is an important step in implementing effective interventions. Methods: In this study, we will perform a systematic review;if possible, also a meta-analysis will be performed. The review will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) reporting guidelines for systematic reviews. A rigorous literature search will be conducted both in electronic databases (Medline/PubMed, Embase, CINAHL, Web of Science, Scopus, Cochrane Library) to identify studies published since 2000 and in gray literature for unpublished studies. Pairs of researchers will identify relevant evidence, extract data, and assess risk of bias independently in each eligible study. Factors associated with the occurrence of MDRPI are considered the primary outcome. Secondary outcomes are prevalence and incidence of MDRPI, length of hospital stay, infections, and death. The evidence will be synthesized using the GRADE methodology. Results: Results are not currently available as this is a protocol for a systematic review. Conclusions: This systematic review will identify evidence on risk factors for developing MDRPI. We are confident that the results of this review will help to improve clinical practice and guide future research.展开更多
Biodegradable magnesium(Mg)-based medical devices have revolutionized medical implants by uniquely combining biocompatibility and mechanical strength.Fully degradable Mg-based implants have been developed to provide t...Biodegradable magnesium(Mg)-based medical devices have revolutionized medical implants by uniquely combining biocompatibility and mechanical strength.Fully degradable Mg-based implants have been developed to provide temporary structural support and serve as a dynamic scaffold for tissue repair and restructuring.Additionally,Mg-based devices can respond to physiological signals,and their integration with electrical currents or pulses has been explored to enhance tissue healing and functional recovery.This review provides a comprehensive overview of the development and application of Mg-based medical devices,highlighting their evolution from traditional orthopedic,vascular,and dental uses to advanced systems that actively modulate physiological processes—a shift from passive support to active modulation.The application range of Mg-based devices has expanded from early vascular sutures,bone screws,and stents to multiple clinical fields including porous bone repair scaffolds,anastomotic staples,bioactive devices,and electro-active systems.Bioactive Mg devices demonstrate therapeutic properties including antibacterial,anti-inflammatory,anti-tumor,and osteogenic functions through their degradation products,while electro-active devices utilize the electrical properties of Mg for sensing,monitoring,and therapeutic stimulation.Finally,this review highlights current challenges,including maintaining mechanical support performance,optimizing control of biochemical reactions,and balancing electroregulatory functions,and identifies future research directions aimed at enhancing the clinical application of biodegradable Mg-based implants,thereby contributing to the significant advancement in the biomedical field.展开更多
In China,the regulatory framework for medical device procurement and sales,particularly concerning anti commercial bribery,relies heavily on punitive mechanisms applied after violations occur.Consequently,there is an ...In China,the regulatory framework for medical device procurement and sales,particularly concerning anti commercial bribery,relies heavily on punitive mechanisms applied after violations occur.Consequently,there is an urgent need to establish a scientific risk regulation framework as a complementary approach.Effective risk-oriented regulatory models require precise identification of risk areas in commercial bribery.Focusing on several major procurement scenarios such as centralized bulk-buying,tendering and bidding processes,in-hospital procurement,and online purchasing,this article analyzes the structural factors contributing to these risks,represented by the absence of certification mechanisms,lack of transparency in information disclosure,and inadequate checks and balances.Based on official risk assessment results,this study applies the theory of power and responsibility to propose a preventive regulatory framework that combines industry self-discipline and administrative oversight.By combining these approaches,the framework aims to develop regulatory measures that can effectively reduce commercial bribery risks and prevent illegal and non-compliant conduct.展开更多
This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their supp...This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their support for all stages,and their use in risk and change management.It also covers document template creation,review record association,information management,adverse event traceability,and the reconciliation of differences in international declarations.展开更多
The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history,impacting nearly 93000 patients worldwide.In response to alarming failure rates and a global reca...The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history,impacting nearly 93000 patients worldwide.In response to alarming failure rates and a global recall in August 2010,countries such as Australia,the United States,and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety.In stark contrast,India's response was alarmingly delayed;defective implants continued to be sold even after the global recall.By the time the import license was revoked,and the Central Drugs Standard Control Organization issued a recall notice,these implants had already been involved in 4700 surgeries across India.This paper explores the systemic weaknesses in India’s medical device regulatory framework that contributed to this delayed action,resulting in many patients suffering from serious health complications.It highlights deficiencies in monitoring and reporting mechanisms,inadequate regulatory oversight,and insufficient approval processes.Furthermore,the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation.Although subsequent legislative reforms were introduced,this paper argues that substantial loopholes remain,posing risks for future incidents.Thus,urgent,comprehensive,and enforceable regulatory measures are needed to increase patient safety.展开更多
Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personaliz...Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods.The emerging manufacturing technology of three-dimensional(3D)printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures.However,the application of this new technology has also brought new risks to medical devices,making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry.This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China,and provide ideas to address these challenges.We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices,highlighting the quality system of such devices,and discuss the guidelines that manufacturers should follow,as well as the current limitations and the feasible path of regulation and standardization work based on this perspective.The key points of the whole process quality control,performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized.Furthermore,the significance of regulation and standardization is pointed out.Finally,aspects worthy of attention and future perspectives in this field are discussed.展开更多
Three-dimensional(3D)printing is a highly automated platform that facilitates material deposition in a layer-by-layer approach to fabricate pre-defined 3D complex structures on demand.It is a highly promising techniqu...Three-dimensional(3D)printing is a highly automated platform that facilitates material deposition in a layer-by-layer approach to fabricate pre-defined 3D complex structures on demand.It is a highly promising technique for the fabrication of personalized medical devices or even patient-specific tissue constructs.Each type of 3D printing technique has its unique advantages and limitations,and the selection of a suitable 3D printing technique is highly dependent on its intended application.In this review paper,we present and highlight some of the critical processes(printing parameters,build orientation,build location,and support structures),material(batch-to-batch consistency,recycling,protein adsorption,biocompatibility,and degradation properties),and regulatory considerations(sterility and mechanical properties)for 3D printing of personalized medical devices.The goal of this review paper is to provide the readers with a good understanding of the various key considerations(process,material,and regulatory)in 3D printing,which are critical for the fabrication of improved patient-specific 3D printed medical devices and tissue constructs.展开更多
The present study examines the various techniques being used to maintain the integrity of the medical devices,and develops a quantitative framework to list these in the sequence of priority.To achieve the intended obj...The present study examines the various techniques being used to maintain the integrity of the medical devices,and develops a quantitative framework to list these in the sequence of priority.To achieve the intended objective,the study employs the combined procedure of Fuzzy Analytic Network Process(ANP)and Fuzzy Technical for Order Preference by Similarities to Ideal Solution(TOPSIS).We selected fuzzy based decision making techniques for assessing the integrity of medical devices.The suggested methodology was then used for classifying the suitable techniques used to evaluate the integrity of medical devices.Different techniques or the procedures of integrity assessment were ranked according to their satisfaction weights.The rating of the options determined the order of priority for the procedures.As per the findings of the study,among all the options,A1 was assessed to be the most likely option.This means that the integrity of medical devices of A2 is the highest amongst all the chosen alternatives.This analysis will be a corroborative guideline for manufacturers and developers to quantitatively test the integrity of medical devices in order to engineer efficacious devices.The evaluations undertaken with the assistance of the planned procedure are accurate and conclusive.Hence instead of conducting a manual valuation,this experimental study is a better and reliable option for assessing the integrity of the medical devices.展开更多
Medical devices are a major component of precision medicine and play a key role in medical treatment,particularly with the rapid development of minimally invasive surgery and wearable devices.Their tissue contact prop...Medical devices are a major component of precision medicine and play a key role in medical treatment,particularly with the rapid development of minimally invasive surgery and wearable devices.Their tissue contact properties strongly affect device performance and patient health(e.g.,heat coagulation and slipperiness on surgical graspers).However,the design and optimization of these device surfaces are still indistinct and have no supporting principles.Under such conditions,natural surfaces with various unique functions can provide solutions.This review summarizes the current progress in natural functional surfaces for medical devices,including ultra-slipperiness and strong wet attachment.The underlying mechanisms of these surfaces are attributed to their coupling effects and featured micronano structures.Depending on various medical requirements,adaptable designs and fabrication methods have been developed.Additionally,various medical device surfaces have been validated to achieve enhanced contact properties.Based on these studies,a more promising future for medical devices can be achieved for enhanced precision medicine and human health.展开更多
A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators.Apart from clinical studies,register and routine data wil...A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators.Apart from clinical studies,register and routine data will play an essential role in this context.To ensure adequate use of these data,adapted methodologies are required as register data in fact represent a new scientific entity.For the interpretation of register and routine data several limitations of published data should be taken into account.In many cases essential parameters of study cohorts-such as age,comorbidities,the patients'risk profiles or the hospital profile-are not presented.Required data and evaluation procedures differ significantly,for example,between hip and spine implants.A"one fits for all"methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future.The new legislation will affect all high-risk products,besides joint implants also contact lenses,cardiac pacemakers or stents,for example,the new regulations can markedly enhance product quality monitoring.Register data and clinical studies should not be considered as competitors,they complement each other when used responsibly.In the future follow-up studies should increasingly focus on specific questions,while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.展开更多
Aiming at localizing the telemetric capsule for detecting gastrointestinal physiological parameters in vivo accurately,a portable alternating current(AC)electromagnetic localization system is designed.To verify the fe...Aiming at localizing the telemetric capsule for detecting gastrointestinal physiological parameters in vivo accurately,a portable alternating current(AC)electromagnetic localization system is designed.To verify the feasibility of the method,the model and construction of the localization system are detailed.And static and dynamic accuracy of the localization system are tested by experiments.Next,we compare the simulating results of the electromagnetic radiation aroused by the localization system with the electromagnetic safety standards of human(ICNIRP guidelines and IEEE standard C95.1-1991).Finally,in terms of the results of the static and dynamic experiments,conclusions are drawn that the accuracy of portable positioning system is high(less than 10 mm)enough to satisfy the localization need of the micro invasive medical devices in vivo,and there is no harm of electromagnetic radiation to human.展开更多
Exosomes(exos), nanoscale extracellular vesicles, play a critical role in tissue development and function. Stem cell-derived exos, containing various tissue repair components, show promise as natural therapeutic agent...Exosomes(exos), nanoscale extracellular vesicles, play a critical role in tissue development and function. Stem cell-derived exos, containing various tissue repair components, show promise as natural therapeutic agents in disease treatment and regenerative medicine. However, challenges persist in their application, particularly in targeted delivery and controlled release, which are crucial for enhancing their biological efficacy. The integration of medical devices may provide a superior platform for improving drug bioavailability. Consequently, the combination products of stem cell-derived exos and medical devices present novel opportunities for expanding the therapeutic potential of exosomes. This review offers a comprehensive overview of the current research frontier in stem cell-derived exos combined with medical devices and discusses the prospective challenges and future prospects in this field.展开更多
Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical ...Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.展开更多
Advances in medical devices have revolutionized the treatment of human diseases,such as stents in occluded coronary artery,left ventricular assist devices in heart failure,pacemakers in arrhythmias,etc.Despite their s...Advances in medical devices have revolutionized the treatment of human diseases,such as stents in occluded coronary artery,left ventricular assist devices in heart failure,pacemakers in arrhythmias,etc.Despite their significance,the development of devices for reducing and avoiding the thrombosis formation,obtaining excellent mechanical performance,and achieving stable electronic physiology remains challenging and unresolved.Fortunately,nature serves as a good resource of inspirations,and brings us endless bioinspired physicochemical ideas to better the development of novel artificial materials and devices that enable us to potentially overcome the unresolved obstacles.Bioinspired approaches,in particularly,owe much of their current development in biology,chemistry,materials science,medicine and engineering to the design and fabrication of advanced devices.The application of bioinspired devices is a burgeoning area in these fields of research.In this perspective,we would take the cardiovascular device as one example to show how these bioinspired approaches could be used to build novel,advanced biomedical devices with precisely controlled functions.Here,bioinspired approaches are utilized to solve issues like thrombogenic,mechanical and electronic physiology problems in medical devices.Moreover,there is an outlook for future challenges in the development of bioinspired medical devices.展开更多
The Technical Services and the Medical Administration of the Hospitals of Trieste have been working for years to ensure the optimal functioning of the Surgery, Intensive Care, Diagnostics and Research Services offered...The Technical Services and the Medical Administration of the Hospitals of Trieste have been working for years to ensure the optimal functioning of the Surgery, Intensive Care, Diagnostics and Research Services offered to the Patients and to the University in an 800-bed hospital complex, transforming and innovating the buildings and support installations. We have dedicated special attention to the technologies necessary to guarantee the continuity of the power supply to the electromedical devices, increasingly numerous in highly specialized hospitals. We report the power of the generator sets and the UPS and our opinion that their power must be related to the overall consumption of the hospital, with a reserve margin.展开更多
Long-term, body-adhered medical devices rely on an adhesive interface to maintain contact with the patient. The greatest threat to on-body adhesion is mechanical stress imparted on the medical device. Several factors ...Long-term, body-adhered medical devices rely on an adhesive interface to maintain contact with the patient. The greatest threat to on-body adhesion is mechanical stress imparted on the medical device. Several factors contribute to the ability of the device to withstand such stresses, such as the mechanical design, shape, and size of the device. This analysis investigates the impact that design changes to the device have on the stress and strain experienced by the system when acted on by a stressor. The analysis also identifies the design changes that are most effective at reducing the stress and strain. An explicit dynamic finite element analysis method was used to simulate several design iterations and a regression analysis was performed to quantify the relationship between design and resultant stress and strain. The shape, height, size, and taper of the medical device were modified, and the results indicate that, to reduce stress and strain in the system, the device should resemble a square in shape, be short in height, and small in size with a large taper. The square shape experienced 17.5% less stress compared to the next best performing shape. A 10% reduction in device height resulted in a 21% reduction in stress and 24% reduction in strain. A 20% reduction in device size caused a 7% reduction in stress and 2% reduction in strain. A 20% increase in device taper size led to a negligible reduction in stress and a 6% reduction in strain. The height of the device had the greatest impact on the resultant stress and strain.展开更多
With the aim of creating biodegradable materials for medical devices clinical appointments with high hemocompatibility we have developed a new polymer product.The basis of this product is plasticized by polyethylene g...With the aim of creating biodegradable materials for medical devices clinical appointments with high hemocompatibility we have developed a new polymer product.The basis of this product is plasticized by polyethylene glycol bacterial copolymer of hydroxybutyrate and oxovalerate. A well-known antitbrombotic supplement--acetylsalicylic acid has been added to improve hemocompatibility in the polymer. The results of our studies showed a controlled prolonged separation of acetylsalicylic acid from polymeric material in the blood. We studied in vitro the dynamics of liberation of acetylsalicylic acid from polymeric coatings. It was shown that the concentration of polyethylene glycol and the thickness of the polymer layer can affect the rate of diffusion of acetylsalicylic acid from polymer films.展开更多
Objective To study the patent situation of medical device industry in China based on patent data.Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two pe...Objective To study the patent situation of medical device industry in China based on patent data.Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives:The overall situation and the technical level.Results and Conclusion At present,China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation,but only 16%of patents are authorized.In addition,the technology distribution of medical device industry is mainly related to diagnostic,surgical and identification medical devices and implantable devices,accounting for 59%of the main technology distribution,and their technical effects are mainly related to improving convenience,reducing complexity,and improving safety.The quality of patents related to medical device industry in China is low,the technology distribution is not rich enough,and the level of technical efficacy is low.展开更多
ICU is a major ward rescue of critically ill patients, for ward medical apparatus and instruments of its variety, which can be timely and effective treatment according to the patient, because the patients in the ICU f...ICU is a major ward rescue of critically ill patients, for ward medical apparatus and instruments of its variety, which can be timely and effective treatment according to the patient, because the patients in the ICU for coma patients or need to stay in bed for all the patients, patients' action is reduced, medical apparatus and instruments of placement will lead to damage in patients with pressure. It not only affects the recovery of patients, but also causes other serious complications, which affects the prognosis of patients and prolongs the length of hospital stay, causing serious troubles to the quality of life and the quality of life of children during and after hospital discharge. This paper analyzes how nursing staff should improve the recovery and reduce the occurrence of stress injury when stress injury occurs in ICU ward.展开更多
Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasi...Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasing year by year, so it is particularly important to improve the clinical research level of medical devices. Medical statistics is one of the effective means to ensure scientific and reasonable clinical trial design and reliable test results. SAS software is important software for statistical analysis of clinical trials of medical equipment. Starting from the specific application of SAS software, this paper focuses on correctly understanding and selecting various results of SAS statistics, and provides some practical experience for those who learn to apply SAS, so as to make the clinical statistics of medical devices possible. The trial is more accurate and scientific.展开更多
文摘Objective: To identify the principal factors associated with the occurrence and development of medical device-related pressure injuries (MDRPI) in adults admitted to hospitals. MDRPI, a peculiar subtype of pressure injuries (PI), result from the pression exerted by devices (or their fixation systems) applied for diagnostic and therapeutic purposes. MDRPI represent a serious problem for patients and healthcare systems. Understanding potential risk factors is an important step in implementing effective interventions. Methods: In this study, we will perform a systematic review;if possible, also a meta-analysis will be performed. The review will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) reporting guidelines for systematic reviews. A rigorous literature search will be conducted both in electronic databases (Medline/PubMed, Embase, CINAHL, Web of Science, Scopus, Cochrane Library) to identify studies published since 2000 and in gray literature for unpublished studies. Pairs of researchers will identify relevant evidence, extract data, and assess risk of bias independently in each eligible study. Factors associated with the occurrence of MDRPI are considered the primary outcome. Secondary outcomes are prevalence and incidence of MDRPI, length of hospital stay, infections, and death. The evidence will be synthesized using the GRADE methodology. Results: Results are not currently available as this is a protocol for a systematic review. Conclusions: This systematic review will identify evidence on risk factors for developing MDRPI. We are confident that the results of this review will help to improve clinical practice and guide future research.
文摘Biodegradable magnesium(Mg)-based medical devices have revolutionized medical implants by uniquely combining biocompatibility and mechanical strength.Fully degradable Mg-based implants have been developed to provide temporary structural support and serve as a dynamic scaffold for tissue repair and restructuring.Additionally,Mg-based devices can respond to physiological signals,and their integration with electrical currents or pulses has been explored to enhance tissue healing and functional recovery.This review provides a comprehensive overview of the development and application of Mg-based medical devices,highlighting their evolution from traditional orthopedic,vascular,and dental uses to advanced systems that actively modulate physiological processes—a shift from passive support to active modulation.The application range of Mg-based devices has expanded from early vascular sutures,bone screws,and stents to multiple clinical fields including porous bone repair scaffolds,anastomotic staples,bioactive devices,and electro-active systems.Bioactive Mg devices demonstrate therapeutic properties including antibacterial,anti-inflammatory,anti-tumor,and osteogenic functions through their degradation products,while electro-active devices utilize the electrical properties of Mg for sensing,monitoring,and therapeutic stimulation.Finally,this review highlights current challenges,including maintaining mechanical support performance,optimizing control of biochemical reactions,and balancing electroregulatory functions,and identifies future research directions aimed at enhancing the clinical application of biodegradable Mg-based implants,thereby contributing to the significant advancement in the biomedical field.
文摘In China,the regulatory framework for medical device procurement and sales,particularly concerning anti commercial bribery,relies heavily on punitive mechanisms applied after violations occur.Consequently,there is an urgent need to establish a scientific risk regulation framework as a complementary approach.Effective risk-oriented regulatory models require precise identification of risk areas in commercial bribery.Focusing on several major procurement scenarios such as centralized bulk-buying,tendering and bidding processes,in-hospital procurement,and online purchasing,this article analyzes the structural factors contributing to these risks,represented by the absence of certification mechanisms,lack of transparency in information disclosure,and inadequate checks and balances.Based on official risk assessment results,this study applies the theory of power and responsibility to propose a preventive regulatory framework that combines industry self-discipline and administrative oversight.By combining these approaches,the framework aims to develop regulatory measures that can effectively reduce commercial bribery risks and prevent illegal and non-compliant conduct.
文摘This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their support for all stages,and their use in risk and change management.It also covers document template creation,review record association,information management,adverse event traceability,and the reconciliation of differences in international declarations.
文摘The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history,impacting nearly 93000 patients worldwide.In response to alarming failure rates and a global recall in August 2010,countries such as Australia,the United States,and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety.In stark contrast,India's response was alarmingly delayed;defective implants continued to be sold even after the global recall.By the time the import license was revoked,and the Central Drugs Standard Control Organization issued a recall notice,these implants had already been involved in 4700 surgeries across India.This paper explores the systemic weaknesses in India’s medical device regulatory framework that contributed to this delayed action,resulting in many patients suffering from serious health complications.It highlights deficiencies in monitoring and reporting mechanisms,inadequate regulatory oversight,and insufficient approval processes.Furthermore,the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation.Although subsequent legislative reforms were introduced,this paper argues that substantial loopholes remain,posing risks for future incidents.Thus,urgent,comprehensive,and enforceable regulatory measures are needed to increase patient safety.
基金the National Natural Science Foundation of China(No.81827804,U1909218)the Science Fund for Creative Research Groups of the National Natural Science Foundation of China(No.T2121004).
文摘Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods.The emerging manufacturing technology of three-dimensional(3D)printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures.However,the application of this new technology has also brought new risks to medical devices,making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry.This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China,and provide ideas to address these challenges.We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices,highlighting the quality system of such devices,and discuss the guidelines that manufacturers should follow,as well as the current limitations and the feasible path of regulation and standardization work based on this perspective.The key points of the whole process quality control,performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized.Furthermore,the significance of regulation and standardization is pointed out.Finally,aspects worthy of attention and future perspectives in this field are discussed.
文摘Three-dimensional(3D)printing is a highly automated platform that facilitates material deposition in a layer-by-layer approach to fabricate pre-defined 3D complex structures on demand.It is a highly promising technique for the fabrication of personalized medical devices or even patient-specific tissue constructs.Each type of 3D printing technique has its unique advantages and limitations,and the selection of a suitable 3D printing technique is highly dependent on its intended application.In this review paper,we present and highlight some of the critical processes(printing parameters,build orientation,build location,and support structures),material(batch-to-batch consistency,recycling,protein adsorption,biocompatibility,and degradation properties),and regulatory considerations(sterility and mechanical properties)for 3D printing of personalized medical devices.The goal of this review paper is to provide the readers with a good understanding of the various key considerations(process,material,and regulatory)in 3D printing,which are critical for the fabrication of improved patient-specific 3D printed medical devices and tissue constructs.
基金Funding for this study was granted by the King Abdul-Aziz City for Science and Technology(KACST),Kingdom of Saudi Arabia under the Grant Number:12-INF2970-10.
文摘The present study examines the various techniques being used to maintain the integrity of the medical devices,and develops a quantitative framework to list these in the sequence of priority.To achieve the intended objective,the study employs the combined procedure of Fuzzy Analytic Network Process(ANP)and Fuzzy Technical for Order Preference by Similarities to Ideal Solution(TOPSIS).We selected fuzzy based decision making techniques for assessing the integrity of medical devices.The suggested methodology was then used for classifying the suitable techniques used to evaluate the integrity of medical devices.Different techniques or the procedures of integrity assessment were ranked according to their satisfaction weights.The rating of the options determined the order of priority for the procedures.As per the findings of the study,among all the options,A1 was assessed to be the most likely option.This means that the integrity of medical devices of A2 is the highest amongst all the chosen alternatives.This analysis will be a corroborative guideline for manufacturers and developers to quantitatively test the integrity of medical devices in order to engineer efficacious devices.The evaluations undertaken with the assistance of the planned procedure are accurate and conclusive.Hence instead of conducting a manual valuation,this experimental study is a better and reliable option for assessing the integrity of the medical devices.
基金National Natural Science Foundation of China(Grant Nos.T2121003,51935001,51725501,and 51905022)National Key R&D Program of China(Grant No.2019YFB1309702).
文摘Medical devices are a major component of precision medicine and play a key role in medical treatment,particularly with the rapid development of minimally invasive surgery and wearable devices.Their tissue contact properties strongly affect device performance and patient health(e.g.,heat coagulation and slipperiness on surgical graspers).However,the design and optimization of these device surfaces are still indistinct and have no supporting principles.Under such conditions,natural surfaces with various unique functions can provide solutions.This review summarizes the current progress in natural functional surfaces for medical devices,including ultra-slipperiness and strong wet attachment.The underlying mechanisms of these surfaces are attributed to their coupling effects and featured micronano structures.Depending on various medical requirements,adaptable designs and fabrication methods have been developed.Additionally,various medical device surfaces have been validated to achieve enhanced contact properties.Based on these studies,a more promising future for medical devices can be achieved for enhanced precision medicine and human health.
文摘A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators.Apart from clinical studies,register and routine data will play an essential role in this context.To ensure adequate use of these data,adapted methodologies are required as register data in fact represent a new scientific entity.For the interpretation of register and routine data several limitations of published data should be taken into account.In many cases essential parameters of study cohorts-such as age,comorbidities,the patients'risk profiles or the hospital profile-are not presented.Required data and evaluation procedures differ significantly,for example,between hip and spine implants.A"one fits for all"methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future.The new legislation will affect all high-risk products,besides joint implants also contact lenses,cardiac pacemakers or stents,for example,the new regulations can markedly enhance product quality monitoring.Register data and clinical studies should not be considered as competitors,they complement each other when used responsibly.In the future follow-up studies should increasingly focus on specific questions,while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.
基金National Natural Science Foundation of China(NSFC)(No.30570485)National High Technology Research and Development Program of China(863)(No.2006AA04Z368)Natural Science Foundation of Shanghai,China(No.06ER1406)
文摘Aiming at localizing the telemetric capsule for detecting gastrointestinal physiological parameters in vivo accurately,a portable alternating current(AC)electromagnetic localization system is designed.To verify the feasibility of the method,the model and construction of the localization system are detailed.And static and dynamic accuracy of the localization system are tested by experiments.Next,we compare the simulating results of the electromagnetic radiation aroused by the localization system with the electromagnetic safety standards of human(ICNIRP guidelines and IEEE standard C95.1-1991).Finally,in terms of the results of the static and dynamic experiments,conclusions are drawn that the accuracy of portable positioning system is high(less than 10 mm)enough to satisfy the localization need of the micro invasive medical devices in vivo,and there is no harm of electromagnetic radiation to human.
文摘Exosomes(exos), nanoscale extracellular vesicles, play a critical role in tissue development and function. Stem cell-derived exos, containing various tissue repair components, show promise as natural therapeutic agents in disease treatment and regenerative medicine. However, challenges persist in their application, particularly in targeted delivery and controlled release, which are crucial for enhancing their biological efficacy. The integration of medical devices may provide a superior platform for improving drug bioavailability. Consequently, the combination products of stem cell-derived exos and medical devices present novel opportunities for expanding the therapeutic potential of exosomes. This review offers a comprehensive overview of the current research frontier in stem cell-derived exos combined with medical devices and discusses the prospective challenges and future prospects in this field.
文摘Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.
基金supported by the National Natural Science Foundation of China(Nos.21673197,31570947)Young Overseas High-level Talents Introduction Plan,the 111 Project(No.B16029)the Fundamental Research Funds for the Central Universities of China(No.20720170050)
文摘Advances in medical devices have revolutionized the treatment of human diseases,such as stents in occluded coronary artery,left ventricular assist devices in heart failure,pacemakers in arrhythmias,etc.Despite their significance,the development of devices for reducing and avoiding the thrombosis formation,obtaining excellent mechanical performance,and achieving stable electronic physiology remains challenging and unresolved.Fortunately,nature serves as a good resource of inspirations,and brings us endless bioinspired physicochemical ideas to better the development of novel artificial materials and devices that enable us to potentially overcome the unresolved obstacles.Bioinspired approaches,in particularly,owe much of their current development in biology,chemistry,materials science,medicine and engineering to the design and fabrication of advanced devices.The application of bioinspired devices is a burgeoning area in these fields of research.In this perspective,we would take the cardiovascular device as one example to show how these bioinspired approaches could be used to build novel,advanced biomedical devices with precisely controlled functions.Here,bioinspired approaches are utilized to solve issues like thrombogenic,mechanical and electronic physiology problems in medical devices.Moreover,there is an outlook for future challenges in the development of bioinspired medical devices.
文摘The Technical Services and the Medical Administration of the Hospitals of Trieste have been working for years to ensure the optimal functioning of the Surgery, Intensive Care, Diagnostics and Research Services offered to the Patients and to the University in an 800-bed hospital complex, transforming and innovating the buildings and support installations. We have dedicated special attention to the technologies necessary to guarantee the continuity of the power supply to the electromedical devices, increasingly numerous in highly specialized hospitals. We report the power of the generator sets and the UPS and our opinion that their power must be related to the overall consumption of the hospital, with a reserve margin.
文摘Long-term, body-adhered medical devices rely on an adhesive interface to maintain contact with the patient. The greatest threat to on-body adhesion is mechanical stress imparted on the medical device. Several factors contribute to the ability of the device to withstand such stresses, such as the mechanical design, shape, and size of the device. This analysis investigates the impact that design changes to the device have on the stress and strain experienced by the system when acted on by a stressor. The analysis also identifies the design changes that are most effective at reducing the stress and strain. An explicit dynamic finite element analysis method was used to simulate several design iterations and a regression analysis was performed to quantify the relationship between design and resultant stress and strain. The shape, height, size, and taper of the medical device were modified, and the results indicate that, to reduce stress and strain in the system, the device should resemble a square in shape, be short in height, and small in size with a large taper. The square shape experienced 17.5% less stress compared to the next best performing shape. A 10% reduction in device height resulted in a 21% reduction in stress and 24% reduction in strain. A 20% reduction in device size caused a 7% reduction in stress and 2% reduction in strain. A 20% increase in device taper size led to a negligible reduction in stress and a 6% reduction in strain. The height of the device had the greatest impact on the resultant stress and strain.
文摘With the aim of creating biodegradable materials for medical devices clinical appointments with high hemocompatibility we have developed a new polymer product.The basis of this product is plasticized by polyethylene glycol bacterial copolymer of hydroxybutyrate and oxovalerate. A well-known antitbrombotic supplement--acetylsalicylic acid has been added to improve hemocompatibility in the polymer. The results of our studies showed a controlled prolonged separation of acetylsalicylic acid from polymeric material in the blood. We studied in vitro the dynamics of liberation of acetylsalicylic acid from polymeric coatings. It was shown that the concentration of polyethylene glycol and the thickness of the polymer layer can affect the rate of diffusion of acetylsalicylic acid from polymer films.
文摘Objective To study the patent situation of medical device industry in China based on patent data.Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives:The overall situation and the technical level.Results and Conclusion At present,China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation,but only 16%of patents are authorized.In addition,the technology distribution of medical device industry is mainly related to diagnostic,surgical and identification medical devices and implantable devices,accounting for 59%of the main technology distribution,and their technical effects are mainly related to improving convenience,reducing complexity,and improving safety.The quality of patents related to medical device industry in China is low,the technology distribution is not rich enough,and the level of technical efficacy is low.
文摘ICU is a major ward rescue of critically ill patients, for ward medical apparatus and instruments of its variety, which can be timely and effective treatment according to the patient, because the patients in the ICU for coma patients or need to stay in bed for all the patients, patients' action is reduced, medical apparatus and instruments of placement will lead to damage in patients with pressure. It not only affects the recovery of patients, but also causes other serious complications, which affects the prognosis of patients and prolongs the length of hospital stay, causing serious troubles to the quality of life and the quality of life of children during and after hospital discharge. This paper analyzes how nursing staff should improve the recovery and reduce the occurrence of stress injury when stress injury occurs in ICU ward.
文摘Medical device clinical trial is a preliminary clinical human safety and effectiveness evaluation test. With the rapid development of science and technology, the research and development of medical devices is increasing year by year, so it is particularly important to improve the clinical research level of medical devices. Medical statistics is one of the effective means to ensure scientific and reasonable clinical trial design and reliable test results. SAS software is important software for statistical analysis of clinical trials of medical equipment. Starting from the specific application of SAS software, this paper focuses on correctly understanding and selecting various results of SAS statistics, and provides some practical experience for those who learn to apply SAS, so as to make the clinical statistics of medical devices possible. The trial is more accurate and scientific.
