Objective To establish a safe disposal management program for home used sharps waste of insulin injection so as to provide a reference for the standardised management of sharps waste after insulin.injection.Methods Based on the model of information-motivation-behavioural skills,the safe disposal management program for insulin needles used at home was developed by literature reviews and semi-structured interviews to investigate the perceptions and requirements of patients.The program was then modified and refined by two rounds of expert consultation with Delphi method.Results The effective retrieval rates of questionnaire for two rounds of expert consultations were 88.89%and 93.75%,with an expert authority coefficient at 0.93.In the second round,the mean importance scores of the items were 4.40 to 5.00,with a coefficient of variation ranged from 0 to 0.168.The established program consisted of three primary items,six secondary items,and 20 tertiary items.Conclusion The safe disposal management program for home used sharps waste of insulin injection established from the perspectives of information,motivation and behavioural skills was scientific and practical,which offered a guidance to healthcare professionals in the clinical practices.

Objectives:Analyze the clinical characteristics of patients with primary antiphospholipid syndrome (PAPS) progressing to systemic lupus erythematosus (SLE).Explore the risk factors for the progression from PAPS to SLE.Methods:The clinical data of 262 patients with PAPS enrolled in Peking Union Medical College Hospital from February 2005 to September 2021 were evaluated. Assessments included demographic data, clinical manifestations, laboratory tests (serum levels of complement, anti-nuclear antibodies, anti-double-stranded DNA antibodies), treatment, and outcomes. Kaplan-Meier analysis was used to calculate the prevalence of SLE in patients with PAPS. Univariate Cox regression analysis was employed to identify the risk factors for PAPS progressing to SLE.Results:Among 262 patients with PAPS, 249 had PAPS (PAPS group) and 13 progressed to SLE (5.0%) (PAPS-SLE group). Univariate Cox regression analysis indicated that cardiac valve disease ( HR=6.360), positive anti-double-stranded DNA antibodies ( HR=7.203), low level of complement C3 ( HR=25.715), and low level of complement C4 ( HR=10.466) were risk factors for the progression of PAPS to SLE, whereas arterial thrombotic events ( HR=0.109) were protective factors ( P<0.05 for all). Kaplan-Meier analysis showed that the prevalence of SLE in patients suffering from PAPS with a disease course>10 years was 9%-15%. Hydroxychloroquine treatment had no effect on the occurrence of SLE in patients with PAPS ( HR=0.753, 95% CI 0.231-2.450, P=0.638). Patients with≥2 risk factors had a significantly higher prevalence of SLE compared with those with no or one risk factor (13-year cumulative prevalence of SLE 48.7% vs. 0 vs. 6.2%, P<0.001 for both). Conclusions:PAPS may progress to SLE in some patients. Early onset, cardiac-valve disease, positive anti-dsDNA antibody, and low levels of complement are risk factors for the progression of PAPS to SLE (especially in patients with≥2 risk factors). Whether application of hydroxychloroquine can delay this transition has yet to be demonstrated.

Objective:To retrieve and summarize the best evidence related to the management of insulin injection-related sharps waste disposal in diabetic patients at home and abroad, so as to provide reference for clinical healthcare professionals.Methods:This was a evidence-based research. Evidence on insulin injection-related sharps waste management in patients with diabetes, including guidelines, expert consensus, evidence summaries, best practice information sheet, recommended practices, clinical decisions and systematic reviews was systematically searched from domestic and international databases and professional websites, and the search time frame was from the establishment of the database to December 2021. Evidence was extracted and summarized following a quality evaluation of the literature that met the criteria.Results:A total of 15 papers were included, summarizing 25 pieces of best evidence on four areas including risk assessment and management of sharps waste associated with insulin injections, education and training, and the use of safe devices and sharps containers.Conclusions:Best evidence on the management of insulin injection-related sharps waste disposal provides evidence to support clinical practice for healthcare professionals to standardized sharps waste disposal practices in patients with diabetes.

Objective:To develop Insulin Pen Waste Needles Disposal Behavior Scale for Diabetic Patients and test its reliability and validity.Methods:Using the model of information, motivation and behavior skills as the theoretical framework, the item pool was constructed by literature review, semi-structured interview and expert consultation, and the test scale was formed after a small sample pre-survey. In July 2022, 158 and 204 diabetes patients who self-injected insulin in Endocrinology Outpatient Department of a general hospital in Shanghai were selected by the convenient sampling method. Two questionnaires were conducted to test the reliability and validity of the scale.Results:Insulin Pen Waste Needles Disposal Behavior Scale for Diabetic Patients included four dimensions, such as disposal behavior cognition, disposal behavior motivation, disposal behavior skills, and safe disposal behavior, with a total of 16 items. Four common factors were extracted from exploratory factor analysis, and the cumulative variance contribution rate was 73.80%. Content validity index was 0.98 at the average scale level, 0.88 at the level of unanimity scale, and 0.83-1.00 at the level of each item. The results of confirmatory factor analysis showed that the scale structure was stable. The Cronbach's α coefficient of the scale was 0.908, the Cronbach's α coefficient of the four factors was 0.858-0.901, the split half reliability coefficient was 0.941, and the retest reliability coefficient was 0.819.Conclusions:The scale constructed in this study has good reliability and validity, which can provide a scientific and effective assessment tool for medical staff to evaluate the disposal behavior of discarded needles used for insulin pens in diabetic patients.

Objective:To understand the causes of improper disposal of discarded insulin pen needles at home in diabetic patients.Methods:Using descriptive phenomenological research method, semi-structured interviews were conducted in November 2021 with 18 patients with diabetes from the outpatient department of Shanghai University of Medicine & Health Sciences Affiliated Sixth Peoples Hospital South Campus (Shanghai Fengxian District Central Hospital), and Colaizzi seven-step analysis method was used to extract the themes.Results:The reasons for improper disposal of discarded insulin pen needles at home by diabetic patients included misconceptions about methods for safe disposal of needles, low awareness of safe disposal of needles, fear of needle stick injuries, lack of social support, time and distance conflict and economic burden.Conclusions:Medical staff should pay attention to health education to increase patients′ knowledge about safe disposal of needles. The collection program was optimized to alleviate patients′ fear of safe disposal of needle. At the same time, multiple support should be given to improve patients′ compliance with safe disposal of needle.

ObjectiveTo investigate the prevenance rate and related factors of anxiety among the public before and after outbreak of COVID-19， and to provide scientific guidance for public health emergency response in psychological intervention field. MethodsBy using the convenient sampling method， residents in Chinese mainland participated in predesigned questionnaire survey from February 7^th to February 14^th， 2020， meantime， all the selected individuals were assessed using Self-rating Anxiety Scale （SAS）. The anxiety status was also retrospectively evaluated before January 20^th， prior to the outbreak. Thereafter， a before-and-after comparison was conducted on the anxiety status， and the related influencing factors were discussed. ResultsA total of 1 222 valid questionnaires were collected， with a valid rate of 93.8%. After the outbreak， the number of people with anxiety symptoms increased from 90 （7.4%） to 172 （14.1%）， with statistical difference （P<0.01）. The SAS score increased from （40.65±10.43） to （36.32±8.46）， with statistical difference （P<0.01）. For overall sample， the independent risk factors of anxiety aggravation included serious disruptions of daily life （P<0.01）， older age （P<0.01）， female （P<0.01）， poor education background （P=0.005）， occupied in medical staff （P=0.031） and lack of medical education （P=0.039）. For medical staff， the independent risk factors of anxiety aggravation included sense of being-alienated （P<0.01）， older age （P<0.01）， female （P=0.002） and serious disruptions of daily life （P=0.044）. ConclusionThe prevalence rate of anxiety is increased after the outbreak of COVID-19， especially among the general public with serious disruptions of daily life， older age， females， poor education background， and the lack of medical education， and among medical staff with sense of being-alienated， older age， females， and serious disruptions of daily life.

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.
China ; Equipment Safety ; Equipment and Supplies ; United States ; United States Food and Drug Administration

ObjectiveTo evaluate the application effect of phased intensive medication education (PIME) on patients after percutaneous coronary intervention(PCI). MethodsBy convenience sampling method, 60 patients who underwent PCI for the first time in Department of Cardiology, Second Affiliated Hospital of Shantou University Medical College from October 2017 to February 2018 were selected and randomly divided into experimental group (n=30) and control group (n=30). The experimental group was educated by PIME, while the control group received conventional medication education. The patients were followed up after discharge. Seven indicators, including medication literacy, medication compliance and exercise tolerance and so on were collected and compared. ResultsThere was no significant difference in the scores of medication literacy between the two groups before intervention (P＞ 0.05). On the day of discharge, 1 month and 3 months after discharge, the scores of the experimental group were higher than those of the control group, and the differences were statistically significant (P＜0.01). There was no significant difference in the scores of compliance between the two groups before intervention (P＞0.05). At 2 weeks, 1 month and 3 months after discharge, the scores in the experimental group were higher than those in the control group with statistical differences (P＜0.01). There was no significant difference in exercise tolerance between the two groups before intervention, at discharge and 1 month after discharge (P＞0.05). The experimental group was higher than the control group at 3 months after discharge with a statistical difference (P＜0.01). The decrease of heart rate and systolic blood pressure in the experimental group was greater than that in the control group (P＜ 0.05). One month after discharge, the incidence of adverse medication reactions in the experimental group was lower than that in the control group and the difference was statistically significant (P＜ 0.05). Conclusions PIME can effectively improve patients' medication literacy, medication adherence, safety and effectiveness, which is worthy of promotion.

The new version of Medical Device Classification Directory(revised Draft has opened to the public comments. This paper briefly introduces the classification of medical device in China and the historical development of the directory, and focuses on the analysis of the main changes in the new version of the directory to help the supervision department, manufactures, and related organizations better understand and use the new directory.

Objective To study the relationship between Clonorchis sinensis infestation and different types of gallbladder stones.Methods From May 2011 to September 2014, 1 052 cases of gallbladder stones were collected from the Department of General Surgery at The Sixth People's Hospital of Nansha, Guangzhou.These stones were first grinded for microscopic examination and divided into two groups based on the results of detection of Clonorchis sinensis eggs.They were then analyzed by FTIR spectroscopy to identify the type of gallbladder stones.Some stones were also chosen randomly for observation under scanning electron microscope (SEM).Results Clonorchis sinensis eggs were found in 300 stones and among these, the number and proportion of cholesterol, bile pigment, calcium carbonate, mixed and other types of stones were 28 (9.3％), 102 (34.0％), 102 (34.0％), 50 (16.7％), and 18 (6.0％), respectively.In the 752 egg-negative stones, the number and proportion of the above five types of stones were 414 (55.1％), 132 (17.6％), 66 (8.8％), 94 (12.5％), and 46 (6.1％), respectively.Observation under SEM showed a lot of tiny particles were absorbed on the mesh of the superficial texture of the Clonorchis sinensis eggs, which were also adherent to the bilirubin particles, calcium stearate crystals, phosphate, calcium stearate and protein particles.Conclusions The main types of egg-positive stones were bile pigment and calcium carbonate stones, while cholesterol stone was the main type of egg-negative stones.Clonorchis sinensis infestation was associated mainly with bile pigment and calcium carbonate stones.