scholarly journals Effectiveness of Closed System Drug Transfer Devices in Reducing Leakage during Antineoplastic Drugs Compounding

2021 ◽  
Vol 18 (15) ◽  
pp. 7957
Author(s):  
Maria Teresa Piccardo ◽  
Alessandra Forlani ◽  
Alberto Izzotti
Keyword(s):  
Closed System ◽  
Surveillance Program ◽  
Drug Preparation ◽  
Antineoplastic Drugs ◽  
Intravenous Therapy ◽  
Access Port ◽  
Drug Transfer ◽  
Access Device ◽  
Surveillance Programs ◽  
Port System

This study, conducted in a centralized cytotoxic drug preparation unit, analyzes the effectiveness of two closed system drug transfer devices (CSTDs) in reducing leakage during antineoplastic drug compounding. Wipe/pad samplings inside and outside the preparation area were taken during surveillance programs from 2016 to 2021. All samples were analyzed for gemcitabine (GEM) contamination. In 2016, the presence of GEM in some samples and the contamination of the operators’ gloves in the absence of apparent drug spilling suggested unsealed preparation systems. In subsequent monitoring, GEM was also evaluated in the vial access device and in the access port system to the intravenous therapy bag of TexiumTM/SmartSiteTM and Equashield® II devices after the reconstitution and preparation steps of the drug. The next checks highlighted GEM dispersion after compounding using TexiumTM/SmartSiteTM, with positive samples ranging from 9 to 23%. In contrast, gemcitabine was not present at detectable levels in the Equashield® II system in all of the evaluated samples. The Equashield® II closed system seems effectively able to eliminate spills and leakage during gemcitabine compounding. Since drugs with different viscosities can have different effects on CSTDs, Equashield® II needs to be considered with other antineoplastic drugs during a structured surveillance program.

Determining Sources of Workplace Contamination with Antineoplastic Drugs and Comparing Conventional IV Drug Preparation with a Closed System

2003 ◽  
Vol 38 (2) ◽  
pp. 135-139 ◽  
Author(s):  
Susan Spivey ◽  
Thomas H. Connor
Keyword(s):  
Work Environment ◽  
Health Care Workers ◽  
Closed System ◽  
Uv Light ◽  
Drug Preparation ◽  
Antineoplastic Drugs ◽  
Dry Powder ◽  
Care Workers ◽  
Risk Of Exposure ◽  
Hazardous Drugs

Many procedures involved in the preparation and administration of hazardous drugs put health care workers at risk of exposure to these agents through leakage or accidental spills. The first objective of this study was to determine if the conventional needle/syringe technique has the potential to allow drugs to escape into the environment. The second objective was to evaluate if a closed system, PhaSeal, prevents inadvertent release of hazardous drugs. Fluorescein, a fluorescent indicator, was prepared as a dry powder and a 0.05% solution in empty drug vials. Each phase of the manipulation was photographed using UV light to visualize fluorescein leaks and spills. The procedures included reconstitution of a dry powder, drug transfer from the vial to an IV bag, simulated drug administration, and IV push administrations through an IV port. With the conventional needle/syringe technique, each phase of the manipulations resulted in visible fluorescein leakage into the environment. Fluorescein leakage ranged in size from less than 1 to 50 mm in diameter. The syringes, work surfaces, gloves, manifold ports, and IV bag ports exhibited fluorescein contamination. With PhaSeal, no leakage was observed during any phase of the manipulations. Using the conventional needle/syringe technique during preparation of a hazardous drug may lead to release of the agent into the work environment, posing a health risk to the worker. A closed system such as PhaSeal has the ability to confine hazardous drugs, substantially reducing or possibly eliminating drug exposures.

scholarly journals Validation of chemotherapy drug vapor containment of an air cleaning closed-system drug transfer device

2021 ◽  
pp. 107815522110306
Author(s):  
Galit Levin ◽  
Paul JM Sessink
Keyword(s):  
Activated Carbon ◽  
Closed System ◽  
Membrane Filter ◽  
Drug Transfer ◽  
Glass Vessel ◽  
Air Cleaning ◽  
No Release ◽  
Activated Carbon Filter ◽  
Carbon Filter ◽  
Transfer Device

Purpose The purpose of this study was to test the efficacy of ChemfortTM, an air filtration closed-system drug transfer device to prevent release of chemotherapy drug vapors and aerosols under extreme conditions. The air cleaning system is based on the adsorption of drug vapors by an activated carbon filter in the Vial Adaptor before the air is released out of the drug vial. The functionality of the carbon filter was also tested at the end of device’s shelf life, and after a contact period with drug vapors for 7 days. Cyclophosphamide and 5-fluorouracil were the chemotherapy drugs tested. Methods The Vial Adaptor was attached to a drug vial and both were placed in a glass vessel. A needle was punctured through the vessel stopper and the Vial Adaptor septum to allow nitrogen gas to flow into the vial and to exit the vial via the air filter into the glass vessel which was connected to a cold trap. Potential contaminated surfaces in the trap system were wiped or rinsed to collect the escaped drug. Samples were analyzed using liquid chromatography tandem mass spectrometry. Results Cyclophosphamide and 5-fluorouracil were detected on most surfaces inside the trap system for all Vial Adaptors without an activated carbon filter. Contamination did not differ between the Vial Adaptors with and without membrane filter indicating no effect of the membrane filter. The results show no release of either drug for the Vial Adaptors with an activated carbon filter even after 3 years of simulated aging and 7 days of exposure to drug vapors. Conclusions Validation of air cleaning CSTDs is important to secure vapor and aerosol containment of chemotherapy and other hazardous drugs. The presented test method has proven to be appropriate for the validation of ChemfortTM Vial Adaptors. No release of cyclophosphamide and 5- fluorouracil was found even for Vial Adaptors after 3 years of simulated aging and 7 days of exposure to drug vapors.

Hip surgery and radiology reporting for children with cerebral palsy prior to initiation of a hip surveillance program

2021 ◽  
pp. 1-7
Author(s):  
Kyra Kane ◽  
Marshall Siemens ◽  
Shane Wunder ◽  
Jacqueline Kraushaar ◽  
J. Alexandra Mortimer ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Retrospective Chart Review ◽  
Surveillance Program ◽  
Radiology Reporting ◽  
Reporting Practices ◽  
Hip Displacement ◽  
Primary Surgery ◽  
Radiology Reports ◽  
Children With Cerebral Palsy ◽  
Surveillance Programs

PURPOSE: Hip displacement impacts quality of life for many children with cerebral palsy (CP). While early detection can help avoid dislocation and late-stage surgery, formalized surveillance programs are not ubiquitous. This study aimed to examine: 1) surgical practices around pediatric hip displacement for children with CP in a region without formalized hip surveillance; and 2) utility of MP compared to traditional radiology reporting for quantifying displacement. METHODS: A retrospective chart review examined hip displacement surgeries performed on children with CP between 2007–2016. Surgeries were classified as preventative, reconstructive, or salvage. Pre- and post-operative migration percentage (MP) was calculated for available radiographs using a mobile application and compared using Wilcoxon Signed Ranks test. MPs were also compared with descriptions in the corresponding radiology reports using directed and conventional content analyses. RESULTS: Data from 67 children (115 surgical hips) was included. Primary surgery types included preventative (63.5% hips), reconstructive (36.5%), or salvage (0%). For the 92 hips with both radiology reports and radiographs available, reports contained a range of descriptors that inconsistently reflected the retrospectively-calculated MPs. CONCLUSION: Current radiology reporting practices do not appear to effectively describe hip displacement for children with CP. Therefore, standardized reporting of MP is recommended.

scholarly journals Epidemiologic Measures for Quantifying the Incidence of Concussion in National Collegiate Athletic Association Sports

2017 ◽  
Vol 52 (3) ◽  
pp. 167-174 ◽  
Author(s):  
Zachary Y. Kerr ◽  
Karen G. Roos ◽  
Aristarque Djoko ◽  
Sara L. Dalton ◽  
Steven P. Broglio ◽  
...  
Keyword(s):  
Student Athletes ◽  
National Collegiate Athletic Association ◽  
Injury Surveillance ◽  
Ice Hockey ◽  
Surveillance Program ◽  
Injury Rates ◽  
Policy Makers ◽  
Sports Concussion ◽  
Women's Basketball ◽  
Surveillance Programs

Context: Injury rates compare the relative frequency of sport-related concussions across groups. However, they may not be intuitive to policy makers, parents, or coaches in understanding the likelihood of concussion. Objective: To describe 4 measures of incidence (athlete-based rate, athlete-based risk, team-based rate, and team-based risk) during the 2011–2012 through 2014–2015 academic years. Design:  Descriptive epidemiology study. Setting: Aggregate injury and exposure data collected from the National Collegiate Athletic Association Injury Surveillance Program in 13 sports (men's baseball, basketball, football, ice hockey, lacrosse, soccer, and wrestling and women's basketball, ice hockey, lacrosse, soccer, softball, and volleyball). Patients or Other Participants: Collegiate student-athletes. Main Outcome Measure(s): Sport-related concussion data from the National Collegiate Athletic Association Injury Surveillance Program during the 2011–2012 through 2014–2015 academic years were analyzed. We calculated concussion rates per 1000 athlete-exposures (AEs), concussion risk, average number of concussions per team, and percentage of teams with at least 1 concussion. Results: During the 2011–2012 through 2014–2015 academic years, 1485 concussions were sustained by 1410 student-athletes across 13 sports. Concussion rates ranged from 0.09/1000 AEs in men's baseball to 0.89/1000 AEs in men's wrestling. Concussion risk ranged from 0.74% in men's baseball to 7.92% in men's wrestling. The average ± SD number of concussions per team ranged from 0.25 ± 0.43 in men's baseball to 5.63 ± 5.36 in men's football. The percentage of teams with a concussion ranged from 24.5% in men's baseball to 80.6% in men's football. Conclusions Although men's wrestling had a higher concussion rate and risk, men's football had the largest average number of concussions per team and the largest percentage of teams with at least 1 concussion. The risk of concussion, average number of concussions per team, and percentage of teams with concussions may be more intuitive measures of incidence for decision makers. Calculating these additional measures is feasible within existing injury surveillance programs, and this method can be applied to other injury types.

scholarly journals Pressure Compatibility Test of Closed System Drug Transfer Devices for 71 Anticancer Drugs

2021 ◽  
Vol 141 (1) ◽  
pp. 143-150
Author(s):  
Hiromasa Ishimaru ◽  
Yasumasa Tsuda ◽  
Hidenori Kage ◽  
Tomoaki Kawano ◽  
Shinji Takayama ◽  
...  
Keyword(s):  
Anticancer Drugs ◽  
Closed System ◽  
Drug Transfer ◽  
Compatibility Test
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