As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.
Syringes ; Drug Packaging ; Quality Control

The improvement of food labeling can improve consumers' health awareness, reduce the burden of chronic diseases on the health and economy, and promote the development of the healthy food industry. Disease Risk Reduction Claim has been developed in European Union and the U.S. for over 20 years, with mature management methods and experience, but it is still lacking in China. Learning and drawing on the international management experience of food disease risk reduction claims can assist China to establish food disease risk reduction claims and improve the food health claims and labeling system.
Humans ; United States ; European Union ; Food Labeling ; Food Industry ; China/epidemiology*

The improvement of food labeling can improve consumers' health awareness, reduce the burden of chronic diseases on the health and economy, and promote the development of the healthy food industry. Disease Risk Reduction Claim has been developed in European Union and the U.S. for over 20 years, with mature management methods and experience, but it is still lacking in China. Learning and drawing on the international management experience of food disease risk reduction claims can assist China to establish food disease risk reduction claims and improve the food health claims and labeling system.
Humans ; United States ; European Union ; Food Labeling ; Food Industry ; China/epidemiology*

Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.
Humans ; Hematopoietic Stem Cell Transplantation ; Drug Packaging

Objective: This study identified the prevalence of Nutrition Facts Panel (NFP) use. It determined the factors associated with NFP use among young adults aged 19-30 years old in the National Capital Region (NCR). Methods: This analytical cross-sectional study collected data using a developed survey questionnaire. It was pretested to 32 respondents and administered online among young adults aged 19 to 30 years old residing in NCR at the time of the study, with a target sample size of 384. Convenience sampling was used to gather study participants. Nominal, ordinal, and interval data were summarized as frequencies and proportions. Mean and standard deviation were computed for ratio and interval data. Multiple logistic regression was used to test for the association to NFP use, reported as odds ratios. Results: Study findings showed that the prevalence of NFP use among the respondents was 50.49% (95% CI: 44.64 – 54.81%). The factors found to be associated to NFP use were: 1) being a primary household food shopper (p-value= 0.029; OR: 1.67; 95% CI: 1.05–2.63), 2) having a special diet (p-value= 0.001; OR: 3.40; 95% CI: 1.62–7.14), 3) using nutritional supplements (p-value= 0.041; OR: 1.51; 95% CI: 1.02–2.25), 4) preparing food at home (p-value= 0.019; OR: 1.64; 95% CI: 1.08–2.49), and 5) engaging in physical activity (p-value< 0.001; OR: 2.05; 95% CI: 1.37–3.06) regularly. Conclusion The findings show the need for improved nutrition education and promotion, especially in the NFP. The study recommended improvement in the study methodology and nutrition education programs. It suggested several research areas and topics to be explored.
Food Labeling ; Diet ; Young Adult

OBJECTIVES: The advanced non-small cell lung cancer (NSCLC) patients with pleural effusion have no opportunity for surgery treatment. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the first-line drugs for these patients with EGFR-sensitive mutation. However, the disease progression and drug update during or after treatment of EGFR-TKIs bring more challenges and puzzles to clinical diagnosis and treatment, which inevitably requires archived pleural cell samples for EGFR re-examination or comparative study. Understanding the DNA quality of archived pleural fluid samples and effectively using archival data of pleural fluid cells are of great significance for tracing the origin of cases and basic medical research. This study aims to evaluate the consistency of EGFR mutant gene expression between the 2 methods, and to explore a reliable way for preserving cytological data and making full use of cytological archival data via cell HE staining smear and cell paraffin section. METHODS: A total of 57 pleural fluid cytology cases in the Department of Pathology of China Aerospace Center Hospital from October 2014 to April 2021 were selected. Tumor cells were detected by cell HE staining smears and immunohistochemical staining for TTF-1 and Napsin A in the paired cell paraffin sections. There were more than 200 tumor cells in cell HE staining smear and the proportion of tumor cells were ≥70% in matched cell paraffin sections. Patients with 2 cell smears (one for cell data retention and the other for DNA extraction) were selected as the research subjects, and 57 pleural fluid samples were enrolled. EGFR gene mutation was detected by amplification refractory mutation system-polymerase chain reaction in 57 paired cell HE staining smears and cell paraffin sections. DNA concentration was 2 ng/μL. Cell HE smear was amplified side-by-side with DNA samples from paired cell paraffin sections. Result determination was according to the requirements of the reagent instructions. The external control cycle threshold (Ct) value of the No. 8 well of the samples to be tested was between 13 and 21, which was considered as successful and reliable samples. When the Ct value of EGFR gene mutation was <26, it was considered as positive; when the Ct value was between 26 and 29, it was critical positive; when the Ct value was equal or more than 29, it was negative. ΔCt value was the difference between mutant Ct value and externally controlled Ct value. The smaller the ΔCt value was, the better the quality of DNA of the detected sample was. RESULTS: Among the 57 pleural effusion samples, 42 patients were hospitalized with pleural effusion as the first symptom, accounting for 73.7% (42/57). EGFR mutation was detected in 37 samples [64.9% (37/57)]. The mutation rate for 19del was 37.8% (14/37) while for L858R was 48.6% (18/37). Females were 56.7% (21/37) of mutation cases. The mutation consistency rate of cell HE staining smear and matched cell paraffin sections was 100%. The ΔCt values of cell HE staining smears were less than those of matched cell paraffin sections. The mutation Ct values of 37 cytological samples were statistically analyzed according to the preservation periods of the years of 2014-2015, 2016-2017, 2018-2019, and 2020-2021. There were significant differences in cell paraffin section in the years of 2014-2015 and 2016-2017 compared with the years of 2018-2019 and 2020-2021, while no significant differences were found in cell HE staining smear. Statistical analysis of externally controlled Ct values of 57 cytological samples showed that there were significant differences between cell HE staining smears and cell paraffin section in the years of 2014-2015 and 2016-2017, compared with the years of 2018-2019 and 2020-2021. The mutational Ct values of 37 paired cell blocks and smears were all <26, and the externally controlled Ct values of 57 paired cell paraffin sections and HE staining smears were all between 13 and 21. CONCLUSIONS The DNA quality of cell HE smears and matched cell paraffin section met the qualified requirements. Two methods possess show an excellent consistency in detecting EGFR mutation in NSCLC pleural fluid samples. The DNA quality of cell HE staining smear is better than that of cell paraffin sections, so cell HE staining smear can be used as important supplement of the gene test source. It should be noted that the limitation of cell HE staining smears is non-reproducibility, so multiple smears of pleural fluid are recommended to be prepared for multiple tests.
Carcinoma, Non-Small-Cell Lung/drug therapy* ; DNA Mutational Analysis/methods* ; ErbB Receptors/genetics* ; Female ; Humans ; Lung Neoplasms/drug therapy* ; Male ; Mutation ; Paraffin/therapeutic use* ; Pleural Effusion/genetics* ; Protein Kinase Inhibitors/therapeutic use* ; Staining and Labeling

Objective: To explore the association between the cognition of Nutrition Facts Panel and prepackaged food purchase behavior among residents in six provinces in China. Methods: Using a multi-stage sampling method, 3 002 adults aged 18-70 were selected from the western region (Sichuan), eastern region (Guangdong, Jiangsu, Beijing), central region (Henan), and northeastern region (Heilongjiang) of China from July 2020 to March 2021. Socio-demographic characteristics of participants and their cognition of Nutrition Facts Panel and prepackaged food purchase behavior were collected through questionnaire. A multivariate binary logistic regression model was used to analyze the association between cognition of Nutrition Facts Panel and prepackaged food purchase behavior. Results: The age of 3 002 subjects was (42.3±13.4) years, among which 63.8% (1 914) were female, 66.7% knew the Nutrition Facts Panel, 49.8% would read it when purchasing, 30.7% could understand it, and 56.6% (1 699) bought prepackaged food more than once a week. The results of multivariate analysis showed that after adjusting for relevant confounding factors, compared with the participants knowing but not reading the Nutrition Facts Panel, the group knowing and reading was more likely to buy 11 types of prepackaged food at least once a week (all P<0.05). Compared with the participants reading but not understanding the Nutrition Facts Panel, the group reading and understanding was less likely to buy 11 types of prepackaged food at least once a week (all P<0.05). Conclusion: There was a correlation between cognition of Nutrition Facts Panel and prepackaged food purchase behavior among residents.
Adult ; Female ; Humans ; Male ; Food Labeling/methods* ; Food ; Nutritional Status ; Surveys and Questionnaires ; China ; Health Knowledge, Attitudes, Practice

To analyze the usage and loss of the COVID-19 vaccine in ten districts of Suzhou city from December 18, 2020 to April 30, 2021.The results showed the loss rate was 0.222‰ in Suzhou city. The loss rate of pre-filled packaging COVID-19 vaccine was higher than that of vial packaging. The loss rate of 40 packaging was the lowest in vial packaging. The loss rate of all kinds of COVID-19 vaccine in stable inoculation unit was the lowest. It is recommended to distribute 40 vial packaging COVID-19 vaccine for centralized vaccination to reduce the loss of COVID-19 vaccine.
Humans ; COVID-19 Vaccines ; COVID-19/prevention & control* ; Vaccination ; Cities ; Drug Packaging

OBJECTIVE: To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU). METHODS: Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices. RESULTS: The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain. CONCLUSIONS According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.
Product Labeling

Objective: This study has been conducted to determine the prevalence of nutrition label use and the factors associated with it among adults in selected communities in Los Baños, Laguna. Methods: This is an analytical cross-sectional study, which conducted face-to-face interview using a developed questionnaire, among 440 adults in the top four barangays with highest population in Los Baños, Laguna using twostage sampling design. In the first stage, three puroks were randomly selected in each barangay, while households were selected using systematic sampling in the second stage. An eligible adult in each selected household was invited to participate in the study. Results: Study findings revealed that nutrition label use among adults in the selected communities was 87.73%. Factors found to be associated with nutrition label use were: 1) intention to use nutrition label (OR: 4.37; 95% CI: 1.77–10.82), 2) enough perceived time-spent on shopping (OR: 2.16; 95% CI: 1.17–4.01), and 3) searching for specific information (OR: 4.77; 95% CI: 2.55–8.93). Conclusion These study findings can be used in promoting and increasing nutrition label use in the country and serve as basis for improvement of nutrition labeling policies. Moreover, this study can serve as a reference in the development and strategy-planning of interventions and programs especially in promoting healthy diets.
Prevalence ; Food Labeling