2.Analysis of Changes in Medical Device Classification Concept of the New EU Regulations.
Chunqing ZHANG ; Liangbin ZHOU ; Yue WANG ; Li YI ; Wanjuan YANG ; Shankui RONG ; Jingli LI
Chinese Journal of Medical Instrumentation 2018;42(3):202-205
By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
Equipment and Supplies
;
classification
;
European Union
;
Government Regulation
;
Industry
3.Characterization of predominant bacteria isolates from clean rooms in a pharmaceutical production unit.
Journal of Zhejiang University. Science. B 2007;8(9):666-672
AIMSTo screen for the predominant bacteria strains distributed in clean rooms and to analyze their phylogenetic relationships.
METHODS AND RESULTSThe bacteria distributed in air, surfaces and personnel in clean rooms were routinely monitored using agar plates. Five isolates frequently isolated from the clean rooms of an aseptic pharmaceutical production workshop were selected based on their colony and cell morphology characteristics. Their physiological and biochemical properties, as well as partial 16S rDNA sequences, were analyzed. Results showed that all the five isolates belong to Gram positive bacteria, of which three were Staphylococcus, one Microbacterium and one Bacillus species. Sensitivity tests for these bacteria isolates to 3 disinfectants showed that isolate F03 was obtuse, and had low susceptivity to UV irradiation, while isolates F02, F01 and F04 were not sensitive to phenol treatment. Isolates F04, F01 and F05 were resistant to chlorhexidine gluconate.
CONCLUSIONBacteria widely distributed in clean rooms are mainly a group of Gram positive strains, showing high resistance to selected disinfectants.
SIGNIFICANCE AND IMPACT OF THE STUDYClean rooms are essential in aseptic pharmaceutical and food production. Screening bacteria isolates and identifying them is part of good manufacturing practices, and will aid in finding a more effective disinfection method.
Bacteria ; classification ; genetics ; isolation & purification ; Drug Industry ; Environment, Controlled ; Industrial Microbiology
4.Exploring the Contributory Factors of Confined Space Accidents Using Accident Investigation Reports and Semistructured Interviews
Zahra NAGHAVI K ; Seyed B MORTAZAVI ; Hassan ASILIAN M ; Ebrahim HAJIZADEH
Safety and Health at Work 2019;10(3):305-313
BACKGROUND: The oil and gas industry is one of the riskiest industries for confined space injuries. This study aimed to understand an overall picture of the causal factors of confined space accidents through analyzing accident reports and the use of a qualitative approach. METHODS: Twenty-one fatal occupational accidents were analyzed according to the Human Factors Analysis and Classification System approach. Furthermore, thirty-three semistructured interviews were conducted with employees in different roles to capture their experiences regarding the contributory factors. The content analyses of the interview transcripts were conducted using MAXQDA software. RESULTS: Based on accident reports, the largest proportions of causal factors (77%) were attributed to the organizational and supervisory levels, with the predominant influence of the organizational process. We identified 25 contributory factors in confined space accidents that were causal factors outside of the original Human Factors Analysis and Classification System framework. Therefore, modifications were made to deal with factors outside the organization and newly explored causal factors at the organizational level. External Influences as the fifth level considered contributory factors beyond the organization including Laws, Regulations and Standards, Government Policies, Political Influences, and Economic Status categories. Moreover, Contracting/Contract Management and Emergency Management were two extra categories identified at the organizational level. CONCLUSIONS: Preventing confined space accidents requires addressing issues from the organizational to operator level and external influences beyond the organization. The recommended modifications provide a basis for accident investigation and risk analysis, which may be applicable across a broad range of industries and accident types.
Accidents, Occupational
;
Classification
;
Confined Spaces
;
Emergencies
;
Humans
;
Jurisprudence
;
Oil and Gas Industry
;
Social Control, Formal
5.Prevalence and antibiogram distribution of Salmonella isolated from broiler production and processing course in four provinces, China.
Wei-wei LI ; Li BAI ; Xiu-li ZHANG ; Xin QIAO ; Xiao-rong YANG ; Yu-zhen CHEN ; Xiao-yan PEI ; Yong-ning WU ; Yun-chang GUO
Chinese Journal of Preventive Medicine 2013;47(5):435-438
OBJECTIVETo determine the contamination condition of Salmonella in broiler breeding and slaughter processing in China and to investigate the distribution of antimicrobial resistance profiles.
METHODSFive large-scale broiler holdings and fourteen slaughterhouses were chosen to detect Salmonella in Henan, Jiangsu, Sichuan and Shandong provinces in 2010. A total of 835 anal swabs and 744 chicken carcasses were sampled to compare the difference of Salmonella contamination rate.Salmonella isolates were identified by serotyping according to Kauffmann-White scheme.The antimicrobial susceptibilities of Salmonella isolates were determined by broth microdilution method and sixteen antimicrobial agents were chosen and examined.
RESULTSIn total, Salmonella isolates were recovered in 56 (6.7%) specimens among 835 collected anal swabs and 122 (16.4%) specimens among 744 broiler carcasses. Positive rate of Salmonella in broiler carcasses was higher than anal swabs (χ(2) = 36.94, P < 0.05). The dominant Salmonella serovars isolated from broiler anal swabs were S.enterica serovar Indiana and S.enterica serovar Enteritidis, accounting for 58.9% (33/56) and 32.1% (18/56) respectively. The prevalent serovars in broiler carcasses were also the two serovars and occupied 29.8% (37/124), 32.2% (40/124) respectively. Nearly 95.0% (171/180) Salmonella isolates were resistant to at least one antimicrobial, 78.3% (141/180) Salmonella strains were multi-drug resistant isolates and 20 (11.1%) Salmonella isolates were resistant to 14 antimicrobials.
CONCLUSIONOur findings indicated that Salmonella contamination was common and serious in commercial broiler production and processing course in China. Salmonella contamination rate in broiler slaughter processing performance was higher than broiler flocks. Additionally, antibiotic resistance of Salmonella was in serious situation.
Animals ; Chickens ; microbiology ; China ; Drug Resistance, Multiple, Bacterial ; Food Contamination ; Meat-Packing Industry ; Salmonella ; classification ; drug effects ; isolation & purification ; Serotyping
6.Update on Advances in Research on Idiosyncratic Drug-Induced Liver Injury.
Seung Hyun KIM ; Dean J NAISBITT
Allergy, Asthma & Immunology Research 2016;8(1):3-11
Drug-induced liver injury (DILI) is a major concern for public health, as well as for drug development in the pharmaceutical industry, since it can cause liver failure and lead to drug withdrawal from the market and black box warnings. Thus, it is important to identify biomarkers for early prediction to increase our understanding of mechanisms underlying DILI that will ultimately aid in the exploration of novel therapeutic strategies to prevent or manage DILI. DILI can be subdivided into 'intrinsic' and 'idiosyncratic' categories, although the validity of this classification remains controversial. Idiosyncratic DILI occurs in a minority of susceptible individuals with a prolonged latency, while intrinsic DILI results from drug-induced direct hepatotoxicity over the course of a few days. The rare occurrence of idiosyncratic DILI requires multicenter collaborative investigations and phenotype standardization. Recent progress in research on idiosyncratic DILI is based on key developments in 3 areas: (1) newly developed high-throughput genotyping across the whole genome allowing for the identification of genetic susceptibility markers, (2) new mechanistic concepts on the pathogenesis of DILI revealing a key role of drug-responsive T lymphocytes in the immunological response, and (3) broad multidisciplinary approaches using different platform "-omics" technologies that have identified novel biomarkers for the prediction of DILI. An association of a specific human leukocyte antigen (HLA) allele with DILI has been reported for several drugs. HLA-restricted T-cell immune responses have also been investigated using lymphocytes and T-cell clones isolated from patients. A microRNA, miR-122, has been discovered as a promising biomarker for the early prediction of DILI. In this review, we summarize recent advances in research on idiosyncratic DILI with an understanding of the key role of adaptive immune systems.
Alleles
;
Biomarkers
;
Classification
;
Clone Cells
;
Drug Industry
;
Drug-Induced Liver Injury*
;
Genetic Predisposition to Disease
;
Genome
;
Humans
;
Immune System
;
Leukocytes
;
Liver Failure
;
Lymphocytes
;
MicroRNAs
;
Phenotype
;
Public Health
;
T-Lymphocytes
7.Association of derived patterns of musculoskeletal disorders with psychological problems: a latent class analysis.
Maryam YAZDI ; Sara KARIMI ZEVERDEGANI ; Amir Hossein MOLLAAGHABABAEE
Environmental Health and Preventive Medicine 2019;24(1):34-34
BACKGROUND:
Musculoskeletal symptoms often occur in more than one anatomical site. The present study aimed to define specific patterns of multisite musculoskeletal disorders and examine how these patterns are related to common psychological problems.
METHODS:
Using the data from an interview-based health survey of 358 samples of the industrial manufacturing male employees, we derived major patterns of musculoskeletal complaints using latent class analysis and investigated its association with psychological problems score extracted from depression, anxiety, and stress measured by Depression/Anxiety/Stress Scale (DASS-21). Musculoskeletal disorders were assessed by Nordic Musculoskeletal Questionnaire (NMQ). The statistical analysis was carried out by Mplus 8.
RESULTS:
Complaints in the lower back (42.1%) and neck (30.7%) had the highest prevalence, and in the hip (15.0%) and ankle (12.2%) the lowest. Three major patterns of musculoskeletal disorders were extracted using latent class analysis. Class 1 (12.9%) was characterized by a high rate of complaints in upper musculoskeletal sites, such as the neck, shoulder, and joints; class 2 (38.2%) was identified by a higher rate of complaints in the lower and upper back; and class 3 (48.9%) was marked by low rates of complaints in all musculoskeletal sites. After adjustment for confounding variables and specifying class 3 as the reference, it turned out that there was a statistically significant association between the psychological problems score and the chance of being in class 1 (OR = 2.47, 95% CI 1.66-3.68), but not a significant association with the chance of being in class 2 (OR = 1.51, 95% CI 0.83-2.72).
CONCLUSION
Musculoskeletal disorders can be summarized in the latent class-derived patterns in the adult study population and provide additional prognostics. Common psychological problems are significantly associated with the type of musculoskeletal disorder patterns. The findings in this study could be useful for dealing with prevention and treatment programs.
Adult
;
Anxiety
;
epidemiology
;
Cross-Sectional Studies
;
Depression
;
epidemiology
;
Health Surveys
;
Humans
;
Iran
;
epidemiology
;
Latent Class Analysis
;
Male
;
Manufacturing Industry
;
statistics & numerical data
;
Middle Aged
;
Musculoskeletal Diseases
;
classification
;
epidemiology
;
psychology
;
Occupational Diseases
;
classification
;
epidemiology
;
psychology
;
Prevalence
;
Stress, Psychological
;
epidemiology
8.Industry and workplace characteristics associated with the downloading of a COVID-19 contact tracing app in Japan: a nation-wide cross-sectional study.
Tomohiro ISHIMARU ; Koki IBAYASHI ; Masako NAGATA ; Ayako HINO ; Seiichiro TATEISHI ; Mayumi TSUJI ; Akira OGAMI ; Shinya MATSUDA ; Yoshihisa FUJINO
Environmental Health and Preventive Medicine 2021;26(1):94-94
BACKGROUND:
To combat coronavirus disease 2019 (COVID-19), many countries have used contact tracing apps, including Japan's voluntary-use contact-confirming application (COCOA). The current study aimed to identify industry and workplace characteristics associated with the downloading of this COVID-19 contact tracing app.
METHODS:
This cross-sectional study of full-time workers used an online survey. Multiple logistic regression analysis was used to evaluate the associations of industry and workplace characteristics with contact tracing app use.
RESULTS:
Of the 27,036 participants, 25.1% had downloaded the COCOA. Workers in the public service (adjusted odds ratio [aOR] = 1.29, 95% confidence interval [CI] 1.14-1.45) and information technology (aOR = 1.38, 95% CI 1.20-1.58) industries were more likely to use the app than were those in the manufacturing industry. In contrast, app usage was less common among workers in the retail and wholesale (aOR = 0.87, 95% CI 0.76-0.99) and food/beverage (aOR = 0.81, 95% CI 0.70-0.94) industries, but further adjustment for company size attenuated these associations. Workers at larger companies were more likely to use the app. Compared with permanent employees, the odds of using the app were higher for managers and civil servants but lower for those who were self-employed.
CONCLUSIONS
Downloading of COCOA among Japanese workers was insufficient; thus, the mitigating effect of COCOA on the COVID-19 pandemic is considered to be limited. One possible reason for the under-implementation of the contact tracing app in the retail and wholesale and food/beverage industries is small company size, as suggested by the fully adjusted model results. An awareness campaign should be conducted to promote the widespread use of the contact tracing app in these industries.
Adult
;
COVID-19/prevention & control*
;
Contact Tracing/methods*
;
Cross-Sectional Studies
;
Female
;
Humans
;
Industry/classification*
;
Japan/epidemiology*
;
Male
;
Middle Aged
;
Mobile Applications/statistics & numerical data*
;
SARS-CoV-2
;
Smartphone
;
Workplace/statistics & numerical data*