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

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

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

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

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

PURPOSE: Complete removal of air bubbles from balloons for neurovascular angioplasty is cumbersome. We compared the preparation difficulty, air removal efficiency, and air collection pattern of six different balloon catheter preparation methods to propose a better preparation method for both initial and second balloon uses, especially for small-profile angioplasty balloon catheters. MATERIALS AND METHODS: A total of 18 neurovascular angioplasty balloon catheters with nominal diameters of 2 mm were prepared to test six different preparation methods: the instruction for use method (method A), simplified method using a syringe (method B) and four newly devised preparation methods using inflating devices (methods C–F). Serial radiographs were obtained while the balloons were gradually inflated. We measured the time for each preparation and the bubble number, analyzed their distribution in the balloon, and calculated the contrast filling ratio (contrast filling area/total balloon area) for initial and second ballooning. The whole process was repeated three times. RESULTS: The preparation time varied widely (11.5 seconds [method D] to 73.3 seconds [method A]). On initial inflation, the contrast filling ratio at 8 atm was the highest (100%) with methods A and F. On second inflation, the ratio was again highest with method A (99.5%), followed by method F (99.2%). Initial ballooning tended to show a uniform pattern of single bubble in the distal segment of the balloon; in contrast, second ballooning showed varying patterns in which the bubbles were multiple and randomly distributed. CONCLUSION: None of the six methods were able to completely exclude air bubbles from the balloon catheters including the second ballooning; however, the method of repeating aspiration with high-volume inflating device (method F) could be a practical option considering the simplicity and efficiency of preparation.
Angioplasty ; Angioplasty, Balloon ; Catheters ; Clothing ; Embolism, Air ; Equipment Failure ; Inflation, Economic ; Intracranial Arteriosclerosis ; 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

Barium sulfate is commonly used to prepare contrast media for videofluorograpy. The flow characteristics of thickened liquids formulated for oropharyngeal imaging are known to be greatly affected by the addition of barium. In this study, thickened barium liquids were prepared by mixing a commercial xanthan gum (XG)-based thickener (Visco-up®) at different concentrations (0.1%–3.0%) with barium powder (Baritop HD®), and differences in the viscosity between thickened non-barium and thickened barium liquids were investigated. In addition, the thickness levels of thickened barium liquids, which are based on the National Dysphagia Diet (NDD) and International Dysphagia Diet Standardization Initiative (IDDSI) guidelines, were classified by measuring the viscosity (NDD) and gravity flow through a syringe (IDDSI) with 0.1%–3.0% thickener concentrations. The apparent viscosity (η(a),₅₀) values of thickened barium liquids were much higher than those of thickened non-barium liquids, indicating that the addition of barium to the XG-based thickener resulted in further thickening. Standard recipes for preparing thickened barium liquids with desirable thickness levels were also established, showing the different thickener concentrations corresponding to the different NDD and IDDSI levels.
Aphasia ; Barium Sulfate ; Barium ; Contrast Media ; Deglutition Disorders ; Diagnosis ; Diet ; Gingiva ; Gravitation ; Syringes ; Viscosity