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
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
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
This paper presents a design of new type of multi-parameter wearable medical devices signal processing platform. The signal processing algorithm has a QRS-wave detection algorithm based on LADT, wavelet transformation...This paper presents a design of new type of multi-parameter wearable medical devices signal processing platform. The signal processing algorithm has a QRS-wave detection algorithm based on LADT, wavelet transformation and threshold detection with TMS320VC5509 DSP system. The DSP can greatly increase the speed of QRS-wave detection, and the results can be practical used for multi-parameter wearable device detection of abnormal ECG.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
Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within t...Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within the past few years,resulting in the notification of approximately 20 000 patients.These medical errors,the specific infection-control standards they breached,and assessments of the risk of infection associated with each are discussed.Other topics discussed include the Food and Drug Administration’s(FDA)regulation of medical devices and infection-control products;the use of adulterated,misbranded,and investigational devices;consent decrees and associated Certificates of Medical Necessity;and informed patient consent.Focus is placed on liquid chemical sterilization,its history,and the FDA’s recent censure and discontinuation of a medical device labeled with this claim,namely,the STERIS System 1 processor.Recommendations are provided for healthcare facilities,regulatory agencies,manufacturers of reusable medical devices,and professional healthcare organizations and administrations to improve public health and prevent healthcareassociated infections.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 w...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
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
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
The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which re...The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.展开更多
Background: Medical Equipments are designed to aid in the diagnosis;monitoring or treatment of medical conditions. Upgrades in technology also help continuously educate healthcare professionals. Where previously the u...Background: Medical Equipments are designed to aid in the diagnosis;monitoring or treatment of medical conditions. Upgrades in technology also help continuously educate healthcare professionals. Where previously the use of devices like “mercury sphygmomanometers” is common place, they are now being replaced by either aneroid or “mercury-free” devices. It indicates the development of technology in this area. However, trends show that healthcare professionals still seem to trust “old school” equipment a lot more. Thus, it would be motivating to see why healthcare professionals have such engraved perceptions regarding medical equipment and to be able to investigate their knowledge about current medical devices and what their thoughts are on new technology available in this area. Objectives: This research is designed with an aim to gauge perception and knowledge of targeted HCPs on the risks, benefits, issues, usage and perception on the difference between older medical equipment and the newer ones with state of the art technology available in the market. Methods: A cross-sectional study using a 34 item questionnaire was used to survey a convenient sample of nurses, pharmacists and doctors across community practices in Ajman and Sharjah, UAE. Conclusion: Discouraging HCP’s from a long standing bias towards certain brands may lead towards better therapeutic outcomes for patients. Also, comments from HCP’s prove that HCP’s in these Emirates really do care for their patients and overall improvement of the health care industry.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
Heart diseases are common life-threatening acute diseases.They are leading causes of mortality worldwide,especially significant in developed countries.Other than medications for therapies and prophylaxis,special treat...Heart diseases are common life-threatening acute diseases.They are leading causes of mortality worldwide,especially significant in developed countries.Other than medications for therapies and prophylaxis,special treatment considerations with implantable cardiac devices are important to reduce mortality and medical disability.This paper aims to review indications,contraindications,efficacy,complications,and generic considerations of several commonly implanted cardiac devices including pacemakers,cardiac resynchronization devices,implantable cardiac defibrillators,left atrial appendage occlusion watchman devices,and ventricular assist devices.As various implantable therapeutic cardiac devices are sometimes carried in the bodies of patients with cardiac disease,practitioners of various specialties should be familiar with different cardiac devices on the management of different cardiac conditions while providing holistic care.展开更多
As cardiac implantable electronic devices(CIED)become more prevalent,it is important to acknowledge potential electromagnetic interference(EMI)from other sources,such as internal and external electronic devices and pr...As cardiac implantable electronic devices(CIED)become more prevalent,it is important to acknowledge potential electromagnetic interference(EMI)from other sources,such as internal and external electronic devices and procedures and its effect on these devices.EMI from other sources can potentially inhibit pacing and trigger shocks in permanent pacemakers(PPM)and implantable cardioverter defibrillators(ICD),respectively.This review analyzes potential EMI amongst CIED and left ventricular assist device,deep brain stimulators,spinal cord stimulators,transcutaneous electrical nerve stimulators,and throughout an array of procedures,such as endoscopy,bronchoscopy,and procedures involving electrocautery.Although there is evidence to support EMI from internal and external devices and during procedures,there is a lack of large multicenter studies,and,as a result,current management guidelines are based primarily on expert opinion and anecdotal experience.We aim to provide a general overview of PPM/ICD function,review documented EMI effect on these devices,and acknowledge current management of CIED interference.展开更多
Three-dimensional(3D)printing technology belongs to a new manufacturing science and has been widely used in various fields of industry.This article will apply 3D printing technology as its main research topic,with emp...Three-dimensional(3D)printing technology belongs to a new manufacturing science and has been widely used in various fields of industry.This article will apply 3D printing technology as its main research topic,with emphasis on its application in the field of medical devices and prospects for contribution.展开更多
Background A medical content-based image retrieval(CBIR)system is designed to retrieve images from large imaging repositories that are visually similar to a user′s query image.CBIR is widely used in evidence-based di...Background A medical content-based image retrieval(CBIR)system is designed to retrieve images from large imaging repositories that are visually similar to a user′s query image.CBIR is widely used in evidence-based diagnosis,teaching,and research.Although the retrieval accuracy has largely improved,there has been limited development toward visualizing important image features that indicate the similarity of retrieved images.Despite the prevalence of 3D volumetric data in medical imaging such as computed tomography(CT),current CBIR systems still rely on 2D cross-sectional views for the visualization of retrieved images.Such 2D visualization requires users to browse through the image stacks to confirm the similarity of the retrieved images and often involves mental reconstruction of 3D information,including the size,shape,and spatial relations of multiple structures.This process is time-consuming and reliant on users'experience.Methods In this study,we proposed an importance-aware 3D volume visualization method.The rendering parameters were automatically optimized to maximize the visibility of important structures that were detected and prioritized in the retrieval process.We then integrated the proposed visualization into a CBIR system,thereby complementing the 2D cross-sectional views for relevance feedback and further analyses.Results Our preliminary results demonstrate that 3D visualization can provide additional information using multimodal positron emission tomography and computed tomography(PETCT)images of a non-small cell lung cancer dataset.展开更多
The high rates of depression,burnout,and increased risk of suicide among medical students,residents,and physicians in comparison with other careers signal a mental health crisis within our profession.We contend that t...The high rates of depression,burnout,and increased risk of suicide among medical students,residents,and physicians in comparison with other careers signal a mental health crisis within our profession.We contend that this crisis coupled with the inadequate acquisition of interpersonal skills during medical education results from the interaction between a challenging environment and the mental capital of individuals.Additionally,we posit that mindfulness-based practices are instrumental for the development of major components of mental capital,such as resilience,flexibility of mind,and learning skills,while also serving as a pathway to enhance empathy,compassion,self-awareness,conflict resolution,and relational abilities.Importantly,the evidence base supporting the effectiveness of mindfulness-based interventions has been increasing over the years,and a growing number of medical schools have already integrated mindfulness into their curricula.While we acknowledge that mindfulness is not a panacea for all educational and mental health problems in this field,we argue that there is currently an unprecedented opportunity to gather momentum,spread and study mindfulness-based programs in medical schools around the world as a way to address some longstanding shortcomings of the medical profession and the health and educational systems upon which it is rooted.展开更多
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.
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.
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.
文摘This paper presents a design of new type of multi-parameter wearable medical devices signal processing platform. The signal processing algorithm has a QRS-wave detection algorithm based on LADT, wavelet transformation and threshold detection with TMS320VC5509 DSP system. The DSP can greatly increase the speed of QRS-wave detection, and the results can be practical used for multi-parameter wearable device detection of abnormal ECG.
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Several well-publicized cases of improper cleaning,disinfection or sterilization of contaminated reusable medical equipment that posed an increased risk of patientto-patient disease transmission were reported within the past few years,resulting in the notification of approximately 20 000 patients.These medical errors,the specific infection-control standards they breached,and assessments of the risk of infection associated with each are discussed.Other topics discussed include the Food and Drug Administration’s(FDA)regulation of medical devices and infection-control products;the use of adulterated,misbranded,and investigational devices;consent decrees and associated Certificates of Medical Necessity;and informed patient consent.Focus is placed on liquid chemical sterilization,its history,and the FDA’s recent censure and discontinuation of a medical device labeled with this claim,namely,the STERIS System 1 processor.Recommendations are provided for healthcare facilities,regulatory agencies,manufacturers of reusable medical devices,and professional healthcare organizations and administrations to improve public health and prevent healthcareassociated infections.
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.
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.
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The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.
文摘Background: Medical Equipments are designed to aid in the diagnosis;monitoring or treatment of medical conditions. Upgrades in technology also help continuously educate healthcare professionals. Where previously the use of devices like “mercury sphygmomanometers” is common place, they are now being replaced by either aneroid or “mercury-free” devices. It indicates the development of technology in this area. However, trends show that healthcare professionals still seem to trust “old school” equipment a lot more. Thus, it would be motivating to see why healthcare professionals have such engraved perceptions regarding medical equipment and to be able to investigate their knowledge about current medical devices and what their thoughts are on new technology available in this area. Objectives: This research is designed with an aim to gauge perception and knowledge of targeted HCPs on the risks, benefits, issues, usage and perception on the difference between older medical equipment and the newer ones with state of the art technology available in the market. Methods: A cross-sectional study using a 34 item questionnaire was used to survey a convenient sample of nurses, pharmacists and doctors across community practices in Ajman and Sharjah, UAE. Conclusion: Discouraging HCP’s from a long standing bias towards certain brands may lead towards better therapeutic outcomes for patients. Also, comments from HCP’s prove that HCP’s in these Emirates really do care for their patients and overall improvement of the health care industry.
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.
文摘Heart diseases are common life-threatening acute diseases.They are leading causes of mortality worldwide,especially significant in developed countries.Other than medications for therapies and prophylaxis,special treatment considerations with implantable cardiac devices are important to reduce mortality and medical disability.This paper aims to review indications,contraindications,efficacy,complications,and generic considerations of several commonly implanted cardiac devices including pacemakers,cardiac resynchronization devices,implantable cardiac defibrillators,left atrial appendage occlusion watchman devices,and ventricular assist devices.As various implantable therapeutic cardiac devices are sometimes carried in the bodies of patients with cardiac disease,practitioners of various specialties should be familiar with different cardiac devices on the management of different cardiac conditions while providing holistic care.
文摘As cardiac implantable electronic devices(CIED)become more prevalent,it is important to acknowledge potential electromagnetic interference(EMI)from other sources,such as internal and external electronic devices and procedures and its effect on these devices.EMI from other sources can potentially inhibit pacing and trigger shocks in permanent pacemakers(PPM)and implantable cardioverter defibrillators(ICD),respectively.This review analyzes potential EMI amongst CIED and left ventricular assist device,deep brain stimulators,spinal cord stimulators,transcutaneous electrical nerve stimulators,and throughout an array of procedures,such as endoscopy,bronchoscopy,and procedures involving electrocautery.Although there is evidence to support EMI from internal and external devices and during procedures,there is a lack of large multicenter studies,and,as a result,current management guidelines are based primarily on expert opinion and anecdotal experience.We aim to provide a general overview of PPM/ICD function,review documented EMI effect on these devices,and acknowledge current management of CIED interference.
文摘Three-dimensional(3D)printing technology belongs to a new manufacturing science and has been widely used in various fields of industry.This article will apply 3D printing technology as its main research topic,with emphasis on its application in the field of medical devices and prospects for contribution.
文摘Background A medical content-based image retrieval(CBIR)system is designed to retrieve images from large imaging repositories that are visually similar to a user′s query image.CBIR is widely used in evidence-based diagnosis,teaching,and research.Although the retrieval accuracy has largely improved,there has been limited development toward visualizing important image features that indicate the similarity of retrieved images.Despite the prevalence of 3D volumetric data in medical imaging such as computed tomography(CT),current CBIR systems still rely on 2D cross-sectional views for the visualization of retrieved images.Such 2D visualization requires users to browse through the image stacks to confirm the similarity of the retrieved images and often involves mental reconstruction of 3D information,including the size,shape,and spatial relations of multiple structures.This process is time-consuming and reliant on users'experience.Methods In this study,we proposed an importance-aware 3D volume visualization method.The rendering parameters were automatically optimized to maximize the visibility of important structures that were detected and prioritized in the retrieval process.We then integrated the proposed visualization into a CBIR system,thereby complementing the 2D cross-sectional views for relevance feedback and further analyses.Results Our preliminary results demonstrate that 3D visualization can provide additional information using multimodal positron emission tomography and computed tomography(PETCT)images of a non-small cell lung cancer dataset.
基金Supported by the Brazilian National Council for Scientific and Technological Development(CNPq),No.312499/2022-1São Paulo Research Foundation(FAPESP),No.2023/00823-9,and No.2023/01251-9.
文摘The high rates of depression,burnout,and increased risk of suicide among medical students,residents,and physicians in comparison with other careers signal a mental health crisis within our profession.We contend that this crisis coupled with the inadequate acquisition of interpersonal skills during medical education results from the interaction between a challenging environment and the mental capital of individuals.Additionally,we posit that mindfulness-based practices are instrumental for the development of major components of mental capital,such as resilience,flexibility of mind,and learning skills,while also serving as a pathway to enhance empathy,compassion,self-awareness,conflict resolution,and relational abilities.Importantly,the evidence base supporting the effectiveness of mindfulness-based interventions has been increasing over the years,and a growing number of medical schools have already integrated mindfulness into their curricula.While we acknowledge that mindfulness is not a panacea for all educational and mental health problems in this field,we argue that there is currently an unprecedented opportunity to gather momentum,spread and study mindfulness-based programs in medical schools around the world as a way to address some longstanding shortcomings of the medical profession and the health and educational systems upon which it is rooted.
