Research on the Classification Management of Digital Therapeutics Software / 中国医疗器械杂志

According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.

Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States / 中国医疗器械杂志

OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.

Packaging Related Terms and Their Application in Unique Device Identification System / 中国医疗器械杂志

This article introduces the significance of packaging for the implementation of Unique Device Identification System (UDI system) and some key terms associated with it. It is further supported by analyzing the important role it plays in building a successful UDI system. This article provides a reference for the related stakeholders to meet the requirement and implement UDI system.

Application Practice to Determine Structure of UDI-PI in Implementation of UDI System / 中国医疗器械杂志

The purpose of UDI-PI and related international regulations/guidelines is analyzed. The application practice for the registrant/filing applicant to determine the composition of UDI is given. The article provides reference for the related stakeholders to implement UDI system.

Expression of ACE2, TMPRSS2, and CTSL in human airway epithelial cells under physiological and pathological conditions: Implications for SARS-CoV2 infection

SARS-CoV-2 enters into human airway epithelial cells via membrane fusion or endocytosis, and this process is dependent on ACE2, TMPRSS2, and cathepsin L. In this study, we examined the expression profiles of the three SARS-CoV-2 entry-related genes in primary human airway epithelial cells isolated from donors with different physiological and pathological backgrounds such as smoking, COPD, asthma, lung cancer, allergic rhinitis, cystic fibrosis, or viral infections. By reanalyzing 54 GEO datasets comprising transcriptomic data of 3428 samples, this study revealed that i) smoking is associated with an increased expression of ACE2 and TMPRSS2 and a decreased expression of cathepsin L; ii) infection of rhinovirus as well as poly(I:C) stimulation leads to high expression of all three SARS-CoV-2 entry-related genes; iii) expression of ACE2 and cathepsin L in nasal epithelial cells are decreased in patients with asthma and allergic rhinitis. In conclusion, this study implicates that infection of respiratory viruses, cigarette smoking and allergic respiratory diseases might affect the susceptibility to and the development of COVID-19.

Distinctive trajectories of COVID-19 epidemic by age and gender: a retrospective modeling of the epidemic in South Korea

ObjectivesElderly people had suffered disproportional burden of COVID-19. We hypothesized that males and females in different age groups might have different epidemic trajectories. MethodsUsing publicly available data from South Korea, daily new COVID-19 cases were fitted with generalized additive models, assuming Poisson and negative binomial distributions. Epidemic dynamics by age and gender groups were explored with interactions between smoothed time terms and age and gender. ResultsA negative binomial distribution fitted the daily case counts best. Interaction between the dynamic patterns of daily new cases and age groups was statistically significant (p<0.001), but not with gender group. People aged 20-39 years led the epidemic processes in the society with two peaks: one major peak around March 1 and a smaller peak around April 7, 2020. The epidemic process among people aged 60 or above was trailing behind that of younger people with smaller magnitude. After March 15, there was a consistent decline of daily new cases among elderly people, despite large fluctuations of case counts among young adults. ConclusionsAlthough young people drove the COVID-19 epidemic in the whole society with multiple rebounds, elderly people could still be protected from virus infection after the peak of epidemic.

Risk interactions of coronavirus infection across age groups after the peak of COVID-19 epidemic

Backgroundthe COVID-19 pandemic has incurred significant disease burden worldwide, particularly on elderly population. This study aims to explore how risks of infection interact across age groups using data from South Korea. MethodsDaily new COVID-19 cases from March 10 to April 30, 2020 were scraped from online open sources. A multivariate vector autoregressive model for time series count data was used to examine the risk interactions across age groups. Case counts from previous days were included as predictors to dynamically examine the change of risk patterns. ResultsIn South Korea, the risk of coronavirus infection among elderly people was significantly affected by other age groups. An increase of virus infection among people aged 20-39 was associated with a double risk of infection among elderly people. Meanwhile, an increase in virus infection among elderly people was also significantly associated with risks of infection among other age groups. The risks of infection among younger people were relatively unaffected by that of other age groups. ConclusionsProtecting elderly people from coronavirus infection could not only reduce the risk of infection among themselves but also ameliorate the risks of virus infection among other age groups. Such interventions should be effective and for long term.

Did elderly people living in small towns or rural areas suffer heavier disease burden during the COVID-19 epidemic?

ObjectivesHealth inequalities were often exacerbated during the emerging epidemic. This study examined urban and non-urban inequalities in health services among COVID-19 patients aged 65 or above in US Florida from March 2 to May 27, 2020. MethodsA retrospective time series analysis was conducted using individual patient records. Multivariable Poisson and logistic models were used to calculate adjusted incidence of COVID-19 and the associated rates of emergency department (ED) visits, hospitalizations and deaths. ResultsAs of May 27, 2020, there were 13,659 elderly COVID-19 patients (people aged 65 or above) in Florida and 14.9% of them died. Elderly people living in small metropolitan areas might be less likely to be confirmed with COVID-19 infection than those living in large metropolitan areas. The ED visit and hospitalization rates decreased significantly across metropolitan statuses for both men and women. Those patients living in small metropolitan or rural areas were less likely to be hospitalized than those living in large metropolitan areas (35% and 34% versus 41%). Elderly women aged 75 or above living in rural areas had 113% higher adjusted incidence of COVID-19 than those living in large metropolitan areas, and the rates of hospitalizations were lower compared with those counterparts living in large metropolitan areas (29% versus 46%; OR: 0.37 [0.25-0.54]; p <0.001). ConclusionsFor elderly people living in US Florida, those who living in small metropolitan or rural areas were less likely to receive adequate health care than those who living in large or medium metropolitan areas during the COVID-19 pandemic.

Modeling Return of the Epidemic: Impact of Population Structure, Asymptomatic Infection, Case Importation and Personal Contacts

BackgroundProactive interventions have halted the pandemic of coronavirus infected disease in some regions. However, without reaching herd immunity, the return of epidemic is possible. We investigate the impact of population structure, case importation, asymptomatic cases, and the number of contacts on a possible second wave of epidemic through mathematical modelling. Methodswe built a modified Susceptible-exposed-Infectious-Removed (SEIR) model with parameters mirroring those of the COVID-19 pandemic and reported simulated characteristics of epidemics for incidence, hospitalizations and deaths under different scenarios. ResultsA larger percent of elderly people leads to higher number of hospitalizations, while a large percent of prior infection will effectively curb the epidemic. The number of imported cases and the speed of importation have small impact on the epidemic progression. However, a higher percent of asymptomatic cases slows the epidemic down and reduces the number of hospitalizations and deaths at the epidemic peak. Finally, reducing the number of contacts among young people alone has moderate effects on themselves, but little effects on the elderly population. However, reducing the number of contacts among elderly people alone can mitigate the epidemic significantly in both age groups, even though young people remain active within themselves. ConclusionReducing the number of contacts among high risk populations alone can mitigate the burden of epidemic in the whole society. Interventions targeting high risk groups may be more effective in containing or mitigating the epidemic.

Impact of mitigating interventions and temperature on the instantaneous reproduction number in the COVID-19 epidemic among 30 US metropolitan areas

BackgroundAfter more than four months into the coronavirus disease (COVID-19) epidemic, over 347,500 people had died worldwide. The current study aims to evaluate how mitigating interventions affected the epidemic process in the 30 largest metropolitan areas in the US and whether temperature played a role in the epidemic process. MethodsPublicly available data for the time series of COVID-19 cases and deaths and weather were analyzed at the metropolitan level. The time-varying reproductive numbers (Rt) based on retrospective moving average were used to explore the trends. Student t tests were used to compare temperature and peak Rt cross-sectionally. ResultsWe found that virus transmissibility, measured by instantaneous reproduction number (Rt), had declined since the end of March for all areas and almost all of them reached a Rt of 1 or below after April 15, 2020. However, the Rts remained around 1 for most areas since then and some small and short rebounds were presented in some areas, suggesting a persistent epidemic in those areas. The timing of the main decline was concurrent with the implementation of mitigating interventions. Cities with warm temperature also tended to have a lower peak Rt than that of cities with cold temperature. However, large geographic variations existed. ConclusionsAggressive interventions might have mitigated the current epidemic of COVID-19, while temperature might have some weak effects on the virus transmission. We may need to prepare for a possible return of the coronavirus outbreak.

Discussion on Energy Consumption Management and Green Development of Medical Electrical Equipment / 中国医疗器械杂志

Facing the new situation of national green development, energy conservation and environmental protection, this study systematically expounds the energy consumption management of medical electrical equipment in USA, Europe and China, and puts forward suggestions on green development of medical electrical equipment in China.

Analysis on Re-classifcation Management Procedure of Medical Devices in the United States / 中国医疗器械杂志

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.

Discussion on Information-based Management of Medical Device Standard / 中国医疗器械杂志

The information-based management of medical device standards is of great significance for promoting the development of the medical device standardization. Here we analyzed the important role of the information-based management of medical device standards in the delicacy management of the whole process of establishing and modifying medical device standards, introduced its present situation and upgrade of information-based management system of medical device standards, and put forward work ideas and suggestions for it.

Researching on the Classification of Computer Aided Diagnosis/Detection Software / 中国医疗器械杂志

Based on the developing situation of Computer Aided Diagnosis/Detection (CAD) software, considering the domestic and international regulation of CAD software, according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration (CFDA), this paper investigated and analyzed the classification of CAD software, and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence (AI) or other advanced technology from medical device regulation scope, for the reference of regulatory and technical departments.

Observation on the therapeutic effect of kangfuxin liquid topical treatment on open wound of postoperative perianal abscess / 中国生化药物杂志

Objective To explore the effect of kangfuxin liquid topical treatment on open wound of postoperative perianal abscess.Methods200 cases of patients with open wound abscess surgery in our hospital from February 2014 to September 2016 were randomly divided into control group and experimental group,with 100 cases in each group.The control group was given conventional treatment, the experimental group were treated by kangfuxin liquid.The relevant therapeutic indicators and clinical healing time between two groups were compared.ResultsThe effective rate of the treatment group was 93.0%, which was significantly higher than that of the control group (85.0%), the difference was statistically significant(P<0.05).The granulation growth period of the experimental group was (5.14±1.41) days, and the average healing time was (15.21±2.49) days.Which were significantly shorter than those of the control group[(7.45±1.32) days, (21.16±2.69) days], and the differences were Statistical differences (P<0.05).ConclusionTo improve the treatment effect to a great extent open wound infection of kangfuxin liquid in treatment of perianal abscess after surgery, shorten the healing time, improve the patient's symptoms, with further clinical promotion and application significance.

Application value of low-dose CT in a short-term review of lung cancer after operation / 中国肿瘤临床

To explore the application value of low-dose CT in lung cancer after operation in a short-term review by comparing conventional and low-dose CT. Methods:In 83 cases of lung cancer during the immediate postoperative period review, 50 cases (group A) underwent conventional CT scanning, whereas 33 cases (group B) underwent low-dose CT scanning. All CT scans were scored on the basis of image quality and clinical needs. The radiation dose indexes CTDIvol and DLP were recorded for each case. A comparison of the score and radiation dose between the two groups helped determine the existence of significant differences. Results:The average image quality scores of the two groups were 3.705±0.314 and 3.311±0.442, those for clinical demand were 2.670±0.373 and 2.561±0.410, those for CTDIvol were (19.248±1.532) mGy and (10.138±1.113) mGy, and those for DLP were (170.180±19.259) mGy*cm and (99.061±14.504) mGy*cm. The two groups exhibited significant differences in image quality, CTDIvol, and DLP but revealed no significant dissimilarity in clinical demand. Conclusion:Low-dose CT completely meets the clinical requirements for short-term follow-up after resection of lung cancer and significant reduction in radiation dose.

Clinical efficacy observation of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis / 中国生化药物杂志

Objective To explore clinical efficacy of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis.Methods 190 cases were selected from January 2012 to October 2013 who diagnosised bronchial tuberculosis treated in minda hospital affiliated of Hubei institute for Nationalities,then the patiens were randomly divided into two groups(n=95 ),the control group underwent conventional spray treatment,the observation group row treatment on the basis of atomization,while giving sulfamethoxazole treatment,observation and comparison of two groups clinical outcomes and adverse reactions. Result After continuous treatment for 4~6 months in the observation group therapy effective rate of 70.5%,total effective rate was 89.5%in the control group significant efficiency and total efficiency of 48.4%and 76.8%,respectively,two groups of significant efficiency and total efficiency,there were significant differences(P<0.05 );bacterial turn negative time indicator on the observation group and the control group were respectively(2.6 ±0.9)months and(4.2 ±1.1)months,there was significant difference(P<0.05);adverse reactions in observation group and control group was 7.4% and 11.6%,respectively,which compared no significant difference.Conclusion Application of compound sulfamethoxazole combined with conventional atomization in treatment of bronchial tuberculosis,has quickly and significantly effect,and bacterial clearance time is short,with low adverse reactions,safety and reliable.

Comparative study of medical device classification between China and USA / 中国医疗器械杂志

This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.

Analysis on the main difference and impact between IEC 60601-1 in Ed. 3.1 and GB 9706.1-2007 / 中国医疗器械杂志

For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.

Preliminary discussion on the preparation of medical device standards adopting international standards / 中国医疗器械杂志

Conclude some specific problems in drafting the industry standards of medical devices which are adopted to international standards. Provide relevant suggestion and recommendation in accordance to GB/T 1.1-2009 and GB/T 20000.2-2009, some preliminary suggestions were accordingly proposed.