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

OBJECTIVE: To investigate the clinical efficacy of needle-guided percutaneous cannulated compression screw fixation in the treatment of acute non-displaced scaphoid fracture of wrist. METHODS: The clinic data of twenty-eight patients with acute non-displaced scaphoid fracture from January 2014 to January 2019 were analyzed retrospectively. According to the intraoperative method of placement of cannulated screw, they were divided into Guide group(16 patients)and Conventional group(12 patients). There were 13 males and 3 females in Guide group, aged from 20 to 60 years old with an average of(31.42±9.71)years old;5 patients were classified as type A2, 3 patients were classified as type B1 and 8 patients were classified as type B2 according to Herbert classification;they were treated with percutaneous cannulated compression screw fixation under the guidance of needle. There were 11 males and 1 female in Conventional group, aged from 23 to 61 years old with an average of(30.51±7.52)years old;5 patients were classified as type A2, 2 patients were classified as type B1 and 5 patients were classified as type B2 according to Herbert classification;they were treated with conventional percutaneous cannulated compression screw fixation. The operation time, screw angle relative to the longitudinal axis of the scaphoid and wrist function score were assessed and compared between the two groups. RESULTS: A total of 28 patients were followed up from 20 to 45 months with an average of (33.00±8.72) months. None of patients had intraoperative complication and incision infection. These patients returned to work gradually 2 weeks after operation, and all fractures healed within 12 weeks. The operation time in the Guide group was significantly less than that in the Conventinal group(P<0.05). Screw angle relative to the longitudinal axis of the scaphoid in the Guide group was significantly smaller than that in the Conventional group(P<0.05). There was no significant difference in Mayo wrist function scores at the last follow-up between the two groups(P>0.05). During the follow-up period, none of the 28 patients showed internal fixation displacement, arthritis, scaphoid necrosis and other complications. CONCLUSION In the treatment of acute non-displaced scaphoid fractures, the operation time of needle-guided percutaneous cannulated headless compression screw fixation is significantly shorter than that of conventional percutaneous screw fixation, and the screw axis is easier to be parallel to the longitudinal axis of the scaphoid.
Male ; Humans ; Female ; Young Adult ; Adult ; Middle Aged ; Fractures, Bone/surgery* ; Scaphoid Bone/surgery* ; Wrist ; Retrospective Studies ; Syringes ; Wrist Injuries/surgery* ; Fracture Fixation, Internal/methods* ; Bone Screws ; Treatment Outcome

Until now, automatic contrast agent injector syringes licensed for consecutive one-time use have been employed with a number of patients. In 2016, regulation of automatic injector syringes ensured their single use, and reuse was strictly limited by law. However, this regulation creates the social problems of rising medical costs and resource waste. Many doctors are not significantly concerned about infection from contrast agent injection because the needle and connection lines on the patient side are set up for single use, the connections between syringes and contrast agents are reusable, and there are no reports of excessive infection. However, infection can nevertheless occur with injection of contrast agents. We should therefore implement the correct and safe use of contrast agents and take precautions against infection. To prevent infection due to contrast agents, syringes and connection lines for injection of such agents should be used once per patient, or multi-use licensed products should be used. In the latter case, reverse flow prevention filters must be used on the patient's side.
Contrast Media ; Humans ; Injections, Intravenous ; Jurisprudence ; Needles ; Social Problems ; Syringes

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.
Disposable Equipment/standards* ; Equipment Safety ; Injections, Intradermal/instrumentation* ; Syringes

BACKGROUND: Carrying epinephrine can save lives in patients with anaphylaxis. The feature of epinephrine in prefilled syringe that commonly prescribed in Thailand may influence the willingness to carry. However, the rates of carrying prefilled syringe epinephrine are unknown in children with history of food-induced anaphylaxis. OBJECTIVE: To determine the rate of epinephrine carrying in children with history of food-induced anaphylaxis and factors influencing the decision to use the devices. METHODS: A cross-sectional study was conducted by performing the structured interview in the parent(s) who were the main caregiver of the children with history of food-induced anaphylaxis. RESULTS: The parents of 99 children (male, 50.5%) were interviewed. The median age of the child was 11 years old (range, 9 months to 18 years). Rate of carrying epinephrine was 84.7% (always 57.6%, some occasions 27.2%). The most common reason for not carrying was the thoughts that the children could avoid the food allergens. The first-aid facility at school was available in 48.3%. Rate of carrying epinephrine tended to be lesser in children attend the schools without first aid facility (p = 0.053). Forty-one patients had relapsing episodes, 34 (82.9%) had epinephrine carried, and 20 (58.8%) injected the epinephrine. The most common reason for not using epinephrine despite carrying was that they were afraid of getting injection (28.5%). CONCLUSION: Most children with history of food-induced anaphylaxis carried epinephrine, but only half used it at the episodes. Interventions to promote epinephrine-carrying and injection training are needed in our setting.
Allergens ; Anaphylaxis ; Caregivers ; Child ; Cross-Sectional Studies ; Epinephrine ; First Aid ; Food Hypersensitivity ; Humans ; Parents ; Syringes ; Thailand

Objective of this study was to compare the color stability, mechanical and chemical properties of three different types of temporary crown resins. Commercially available powder-liquid (Group PL), light-cured (Group LC) and auto-mix syringe (Group AM) types' temporary crown resins were used as experimental groups for each of the evaluation. All the test groups were evaluated after 1 day and 7 days of immersion in various staining solutions. The colors of all groups before and after storage in the staining solutions were measured by a spectrophotometer based on CIE Lab system, and the color differences (ΔE(*)) thereby calculated. Micro hardness test was performed before water storage and aging after 7 days at 37 ℃. In addition, flexural strength, water sorption and solubility tests were performed according to international standard, ISO 10477. All experimental groups showed significant color change in staining solutions when compared to those stored in the control solution (distilled water) (p<0.05). Group PL showed the least color change among the three groups followed by Group AM (p<0.05). This tendency was observed after 7 days of immersion. In terms of the micro hardness test, Group PL showed the highest value among the three groups followed by Group AM (p<0.05). Additionally, the flexural strength decreased in the following order: AM > PL > LC (p<0.05). Water sorption and solubility increased in the following order: AM < PL < LC (p<0.05). The results of this study would provide useful information when choosing temporary crown resin types in various clinical situations.
Aging ; Crowns ; Hardness Tests ; Immersion ; Solubility ; Syringes ; Water

Arm ; Information Services ; Infusion Pumps ; Medication Errors ; Methods ; Patient Harm ; Prospective Studies ; Syringes

BACKGROUND: Inaccuracies associated with target-controlled infusion (TCI) delivery systems are attributable to both software and hardware issues, as well as pharmacokinetic variability. However, little is known about the inaccuracy of the syringe pump operating in TCI mode. This study aimed to evaluate the accuracy of the TCI pump based on international standards.METHODS: A test apparatus for accuracy evaluation of a syringe pump (PION TCI®, Bionet Co. Ltd.) was designed to apply the gravimetric method. Pump accuracy was evaluated in terms of deviation defined by the following equation: infusion rate deviation (%) = (Rate(mea) − Rate(est)) / Rate(est) × 100, where Rate(mea) is the infusion rate (ml/h) as measured by the gravimetric system, and Rate(est) is the infusion rate (ml/h) as estimated by the pump. An infusion rate representing TCI mode was determined from previous clinical trial data which evaluated the predictive performance of the pharmacokinetic model. The PION TCI pump used in that clinical trial was used to evaluate accuracy of the syringe pump. The distribution of infusion rates obtained from the clinical trial was calculated, and the median value of the distribution was determined as the representative value.RESULTS: The representative infusion rate representing TCI mode was 31 ml/h, at which the infusion rate deviation was 4.5 ± 1.6%.CONCLUSIONS: The inaccuracy of the syringe pump contributing to TCI system inaccuracy is insignificant.
Mesons ; Methods ; Syringes

PURPOSE: The most common risk factor for fecal incontinence (FI) is obstetric injury. FI affects 1.4%–18% of adults. Most patients are unaware when they are young, when symptoms appear suddenly and worsen with aging. Autologous fat graft is widely used in cosmetic surgical field and may substitute for injectable bulky agents in treating FI. Authors have done fat graft for past several years. This article reports the effectiveness of the fat graft in treating FI and discusses satisfaction with the procedure. METHODS: Fat was harvested from both lateral thighs using 10-mL Luer-loc syringe. Pure fat was extracted from harvests and mixed with fat, oil, and tumescent through refinement. Fats were injected into upper border of posterior ano-rectal ring, submucosa of anal canal and intersphincteric space. Thirty-five patients with FI were treated with this method from July 2016 to February 2017 in Busan Hangun Hospital. They were 13 male (mean age, 60.8 years) and 22 female patients (mean age, 63.3 years). The Wexner score was checked before procedure. We evaluated outcome in outpatients by asking the patients. For 19 patients we checked the Wexner score after procedure. RESULTS: Symptom improved in 29 (82.9%), and not improved in 6 (17.1%). In 2 of 6 patients, they felt better than before procedure, although not satisfied. No improvement in 4. Mean Wexner score was 9.7 before procedure. There were no serious complications such as inflammation or fat embolism. CONCLUSION: Autologous fat graft can be an effective alternative treatment for FI. It is safe and easy to perform, and cost effective.
Adult ; Aging ; Anal Canal ; Busan ; Embolism, Fat ; Fats ; Fecal Incontinence ; Female ; Humans ; Inflammation ; Male ; Methods ; Outpatients ; Risk Factors ; Syringes ; Thigh ; Transplants

STUDY DESIGN: Retrospective cohort study. PURPOSE: To investigate the correlation between the syrinx morphology and neuropathic pain caused by syringomyelia associated with Chiari I malformation. OVERVIEW OF LITERATURE: Neuropathic pain caused by syringomyelia is refractory and markedly impairs the patient. METHODS: We examined 24 patients with neuropathic pain caused by syringomyelia associated with Chiari I malformation. We statistically analyzed the illness duration and age at surgery between patients with and without neuropathic pain. Additionally, we classified the morphology of the syringes into deviated (D), enlarged (E), central (C), and bulkhead (B) types using T2-weighted axial imaging. Moreover, we investigated the correlation between syrinx morphology and neuropathic pain. A Mann–Whitney U-test was performed to compare between the presence or absence of neuropathic pain and the presence or absence of type D syringes. RESULTS: The median age at surgery was 27.5 years, and the median illness duration was 24 months. Among the 24 patients, 11 had preoperative neuropathic pain, one of which was free of neuropathic pain during the final follow-up period. Among patients with neuropathic pain, the syringes’ preoperative morphology was type D in nine patients and types E and C in one patient each. No patient exhibited type B morphology. Among patients without neuropathic pain, the preoperative morphology of the syringes was type D in three patients, type E in seven patients, and types C and B in two patients each. For types D and E, a correlation between neuropathic pain and syrinx morphology was observed. Moreover, type D was associated with significant neuropathic pain in both preoperative and postoperative states. CONCLUSIONS: This study showed a correlation between the morphological features of the syringes and the occurrence of neuropathic pain in patients with syringomyelia associated with Chiari I malformation.
Cohort Studies ; Follow-Up Studies ; Humans ; Magnetic Resonance Imaging ; Neuralgia ; Retrospective Studies ; Syringes ; Syringomyelia