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

BACKGROUND: Previous studies have shown that sequential intrathecal injection of fentanyl and hyperbaric bupivacaine for cesarean section (CS) anesthesia provides a superior anesthetic effect than use of bupivacaine alone, and prolongs postoperative analgesia. Herein, we investigated whether rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine affects the duration of postoperative analgesia, the effectiveness of anesthesia, and hemodynamic status. METHODS: Fifty-six parturients with American Society of Anesthesiologists physical status I or II, aged 18–40 years, and scheduled to undergo elective CS were randomly assigned to 2 groups of 28 patients each. The normal sequential group received sequential intrathecal injections of fentanyl and hyperbaric bupivacaine at the same rate, each with a 5 ml syringe. The rapid sequential group received a rapid intrathecal injection of fentanyl with an insulin syringe, followed by a slow injection of hyperbaric bupivacaine with a 5 ml syringe. The onset of sensory block, the timing of the first rescue analgesia, the doses of rescue analgesics, the degree of postoperative pain, the onset and duration of motor block, the incidence and duration of hypotension, and spinal anesthesia-related complications were recorded. RESULTS: While both approaches had comparable spinal anesthesia-related complications, incidence and duration of hypotension, and doses of ephedrine, the rapid sequential group exhibited a more rapid onset of sensory block, a higher sensory level, and more prolonged postoperative analgesia. CONCLUSIONS: Rapid sequential injection of fentanyl and hyperbaric bupivacaine produced superior anesthesia and more prolonged postoperative analgesia than sequential injections of both at the same rate.
Analgesia ; Analgesics ; Anesthesia ; Anesthesia, Spinal ; Anesthetics ; Bupivacaine ; Cesarean Section ; Ephedrine ; Female ; Fentanyl ; Hemodynamics ; Humans ; Hypotension ; Incidence ; Injections, Spinal ; Insulin ; Pain, Postoperative ; Pregnancy ; Syringes

PURPOSE: Fine-needle aspiration biopsy (FNAB) can be used to diagnose thyroid cancer and other tumors. Although FNAB without negative pressure (FNAB−P) reduces the risk of blood contamination, FNAB with negative pressure (FNAB+P) increases the sensitivity of the biopsy results. Therefore, we performed a randomized study of FNAB with or without negative pressure to identify the better diagnostic method. METHODS: Between March 2016 and February 2017, 172 consecutive patients were enrolled to investigate >0.5 cm nodules with indeterminate or suspicious malignant features. Patients were randomly assigned to the FNAB+P group (a 50 mL syringe was used to provide negative pressure) or to the FNAB−P group (passive collection of blood in the needle's hub). The 2 methods' diagnostic adequacy and quality were evaluated using an objective scoring system. The study's protocol was registered with the World Health Organization Clinical Research Information Service (http://cris.nih.go.kr/cris, KCT0001857). RESULTS: The patients were randomly assigned to the FNAB+P group (n = 86) or the FNAB−P group (n = 86). There were no significant intergroup differences in nodule position, size, age, consistency, calcification, BRAF mutation, or pathology. Evaluation of diagnostic adequacy parameters revealed no significant differences in background blood/clot (P = 0.728), amount of cellular material (P = 0.052), degree of cellular degeneration (P = 0.622), degree of cellular trauma (P = 0.979), or retention of appropriate architecture (P = 0.487). Furthermore, there was no significant intergroup difference in the diagnostic quality (P = 0.634). CONCLUSION: This prospective randomized study failed to detect significant differences in the diagnostic adequacy and quality of FNAB with or without negative pressure. Therefore, the examiner may select whichever FNAB method they prefer.
Biopsy ; Biopsy, Fine-Needle ; Cytological Techniques ; Humans ; Information Services ; Methods ; Pathology ; Prospective Studies ; Syringes ; Thyroid Gland ; Thyroid Neoplasms ; Thyroid Nodule ; World Health Organization

BACKGROUND AND OBJECTIVES: To determine the efficacy of filling the external auditory meatus with 1% clotrimazole at a single visit for the treatment of otomycosis. SUBJECTS AND METHODS: This prospective study included 40 patients who were referred to our clinic with complaints of ear itching, pain, and fullness, and were diagnosed with unilateral otomycosis. After cleaning the mycotic hyphae from the external auditory meatus, the ear canal was filled with 1% clotrimazole, using an intravenous catheter and syringe. The patients received follow-up examinations on post-treatment days 7, 15, and 45. RESULTS: The follow-up otomicroscopic examinations revealed that 95% of the ear canals were entirely clean and that all symptoms had resolved. The post-treatment scores of pain, aural fullness and itching were significantly lower than the pre-treatment scores (p < 0.01). CONCLUSIONS: Filling the external auditory meatus with 1% clotrimazole at a single visit is an easy, efficient, and cost-effective treatment for otomycosis. Additionally, high patient compliance makes this treatment superior to long-term topical therapy.
Catheters ; Clotrimazole ; Ear ; Ear Canal ; Follow-Up Studies ; Humans ; Hyphae ; Otomycosis ; Patient Compliance ; Prospective Studies ; Pruritus ; 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