1.Review of Leachable Substances in Prefilled Syringes.
Shuhan WANG ; Senju MA ; Jun PENG ; Linnan KE ; Yuanli HUANG
Chinese Journal of Medical Instrumentation 2025;49(3):280-286
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
2.Treatment of acute non-displaced scaphoid fracture of wrist with syringe needle-guided percutaneous cannulated headless hollow compression screw internal fixation.
China Journal of Orthopaedics and Traumatology 2023;36(2):161-164
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
3.Study on Testing Methods of Pen-injector's Dosing Accuracy.
Chinese Journal of Medical Instrumentation 2020;44(6):549-552
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
4.Prevention of infection from contrast agents
Journal of the Korean Medical Association 2020;63(3):141-144
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
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Humans
;
Injections, Intravenous
;
Jurisprudence
;
Needles
;
Social Problems
;
Syringes
6.The survey on the infection control of noncritical instruments used in dental treatment
Journal of Dental Rehabilitation and Applied Science 2019;35(1):27-36
PURPOSE: The aims of this study were to evaluate the dentist's awareness and the actual status of infection control of noncritical dental instruments. MATERIALS AND METHODS: 40 dental clinics in Daejeon, South Chungcheong, North Chungcheong and North Jeolla provinces were surveyed. The questionnaire was delivered to the dentists belonging to those clinics, and the awareness and the practice of infection control were examined. The microbial contamination on the surface of five noncritical instruments (impression gun, light curing unit, 3-way syringe, shade guide, and dental floss dispenser) used by them was measured with an ATP luminometer. Correlation analysis between the awareness and the actual state of infection control was conducted. RESULTS: Awareness and frequency of infection control was highest in the 3-way syringe. Surface disinfection using disinfectant was most frequent in all instruments. 3-way syringes and shade guides were less contaminated than impression guns, light curing units, and dental floss dispensers. CONCLUSION: 3-way syringes had a significant correlation between user awareness of infection control and surface contamination, and the higher awareness, the lower the contamination measurement was shown.
Adenosine Triphosphate
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Dental Clinics
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Dental Devices, Home Care
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Dental Instruments
;
Dentists
;
Disinfection
;
Firearms
;
Humans
;
Infection Control
;
Syringes
7.Single Dose Topical Application of Clotrimazole for the Treatment of Otomycosis: Is This Enough?
Journal of Audiology & Otology 2019;23(1):15-19
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
8.Carrying rates of epinephrine devices in children with food-induced anaphylaxis
Chanonart RATANAPRUG ; Witchaya SRISUWATCHARI ; Orathai JIRAPONGSANANURUK ; Nualanong VISITSUNTHORN ; Punchama PACHARN
Asia Pacific Allergy 2019;9(2):e12-
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
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Anaphylaxis
;
Caregivers
;
Child
;
Cross-Sectional Studies
;
Epinephrine
;
First Aid
;
Food Hypersensitivity
;
Humans
;
Parents
;
Syringes
;
Thailand
9.Comparison of color stability, mechanical and chemical properties according to temporary crown resin type
Song Yi YANG ; Ji Yeon KWON ; Ji Su NO ; So Yeon PARK ; Ha Eun PARK ; Eun Ji BAEK ; Su Yeon IM ; Jae Sung KWON
Korean Journal of Dental Materials 2019;46(1):11-20
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
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Crowns
;
Hardness Tests
;
Immersion
;
Solubility
;
Syringes
;
Water
10.Efficiency of Air Bubble Removal in Preparation of Low-Profile Angioplasty Balloon Catheter: Bench-Top Comparison of Six Methods
Joon Ho CHOI ; Seon Moon HWANG ; Deok Hee LEE
Neurointervention 2019;14(1):27-34
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
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Angioplasty, Balloon
;
Catheters
;
Clothing
;
Embolism, Air
;
Equipment Failure
;
Inflation, Economic
;
Intracranial Arteriosclerosis
;
Methods
;
Syringes

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