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NEW WITH AIRSTOPCyto-Set Advanced preparation and application of hazardous drugs
Challenges in ChemotherapyThe treatment of chemotherapy is one of the most challenging processes within the infusion therapy. Starting with the preparationof the drug by way of transportation, administration to the patient and disposal after the treatment, healthcare workers, physicians,pharmacists and also the patients are permanently at the risk of endanger their health. International guidelines dictates the specialhandling of cytostatic drugs to reduce risks during the process. In line with the regulatory requirements Cyto-Set is supporting theuser to prevent the following risks:ContaminationMedication ErrorRisk Prevention in Infusion TherapyInfusion TherapyChemical ContaminationUnintended exposure of a healthcare professional to hazardous drugs.··Possible consequencesToxic contamination can lead both to acute symptoms (nausea, diarrhea, throat irritation, skin rashes, hairloss, even mutagenicity) or chronic symptoms (carcinogenicity, secondary malignant neoplasia due to theSharps Injuryexposure to high doses of cytotoxic medication, reproductive effects). 1, 2·tibilityion TherapyPossible consequences 10Errors in IV drug preparation can have a broad range of consequences ranging from harmless to serious.·Risk Prevention in Infusion TherapyDrug IncompatibilityUndesirable reaction that occurs between the drug and a) the IV solution b) the container or c) another apywww.safeinfuPossible consequencesDamage from toxic drugs (e. g. dermatitis, antibiotics hypersensitivity)Particulate emboli from crystallization and separation (thrombophlebitis up to multi-organ failure)Tissue irritation due to major pH changesTherapeutic failure due to the reduction or elimination of the active drug3, 4, 5····siontherapy.comEffects of plasticizers on Health and Environment140218 Medication Error 6069096.indd 1Microbiological ContaminationInfection which a patient incurs in a healthcare facility and which was not present at the time of admission.(incl. infections acquired in the hospital but appearing after discharge, and also occupational infectionsamong the staff of the facility.)Infections are caused by microbiological pathogens like bacteria, viruses, prions or fungi, as well as by toxinsand by-products that these pathogens release.siontherapy.com·e Contaminationwww.sPossible consequencesLocal infection consequences: surgical wound infections, skin irritations and catheter entry site infectionsSystemical inflammation consequences (pathogens reaching the systemic circulation): septicemia, sepsisand septic shock 6, 7··Possible consequencesThe main concern regarding a needle stick injury (NSI) is not characterized by the trauma itself, but by thepercutaneous exposure to a patient s blood and body fluids (BBF) which may carry infectious diseases. 11The likelihood of developing a disease after a NSI depends on various independent factors: pathogenconcentration in the blood and body fluids, depth of the wound, blood volume, amount of pathogenstransmitted and the infection phase of the pathogen carrier.DEHP-ExposurePolyvinyl chloride (PVC) plastic is used to manufacture a huge number of articles for daily life, e. g. toys,building material such as flooring, cables, as well as medical products. Unplasticized PVC is hard and brittleat room temperature. As a result, plasticizers are necessary to impart flexibility to the polymer.·www.safeinfusiontherapy.comPossible consequencesHealth concerns about phthalate plasticizers are currently the subject of considerable media, legislativeand scientific debate. The exposure of human beings and especially developing children to DEHP can havesignificant health consequences.12·18.02.14 13:18140218 Sharps Injury 6069095.indd 1·18.02.14 13:15·www.safeinfuSharp InjuriesSkin penetrating stab wounds caused by sharp instruments and accidents in a medical setting.These instruments include needles, lancets, scalpels and broken glass.·DEHP Exposure23.10.13 09:30in Infusion Therapy1.indd 1Medication ErrorAn error in prescribing, dispensing or administering of a drug, irrespective of whether such errors lead toadverse consequences or not.Air Embolism18.02.14 13:11Risk Prevention in Infusion TherapyParticulate ContaminationUnintended presence of extraneous, mobile and undissolved particles in a parenteral herapy.comPossible consequencesUnfavorable effects (phlebitis, damage lungs 8, kidneys, nodular fibrosis of the liver and spleen, granulomatouslung disease, myocarditis, occult pulmonary granulomas to local tissue infarction and pulmonary infarction)9·ontherapy.com··www.safe20.02.14 08:35Air Embolism 6069093 CS6.indd 118.02.14 13:13·Possible consequencesThe symptons and clonical signs of air embolism are related to the degree of air entry into the circulationsystem. They usually develop immediately after embolization. 13Air embolism can have a broad range of consequences ranging from harmless to serious.131002 DEHP Exposure 6069089 CS6.indd 1www.safeinfusiAir EmbolismVascular air embolism is the entrainment of air (or exogenously delivered gas) from the operative field or othercommunications with the environment into the venous or arterial vasculature, producing systemic effects.02.10.13 16:16cominfusiontherapy.23.10.13 09:32
Risk Reduction with Cyto-Set The new and improved Cyto-Set design is in line with our SafeInfusion Therapy concept to protect users and patients. In thefield of drug preparation the wide spread portfolio of Cyto-Set offers a high safety standard of each component. During theapplication on the ward the new Cyto-Set portfolio not onlyimproves handling but also increases the safety standard.The variety of Cyto-Set products is widespread and offersa convenient solution for the application of cytostatic drugsin several situations. When used together Cyto-Set Mix,Cyto-Set Infusion and Cyto-Set Infusomat Space providea closed system from preparation in the pharmacy to theapplication on the ward, all the way to the disposal afterthe treatment.RiskSafety NCOMPATIBILITYSafety BenefitsChemicalContaminationNeedle-free valveHelps to reduce the risk of chemical contamination as the valves aredesigned for preventing spillage / drug exposure.14MicrobiologicalContaminationFinger stopper andfinger gripReduction of microbial contamination due to the finger stopperand finger grip.15PrimeStopImproved safety against microbial contamination due to the hydrophobic,bacteria retentive PrimeStop cap on the patient connector which providesa closed system until connection to the patient.16, 17Needle-free valveProvides easy access, while helping to reduce the chance of accidentaltouch contamination.18Air vent filter inthe spikeThe bacteria tight air vent filter in the spike reduces the contamination riskof the infusion solution.19DrugIncompatibilityGrip plate with integratedback check valvesIntegrated back check valves enables an improved safety standard andless risk of unmeant mixture of drugs due to the prevention of reflux.20ParticulateContamination15 µm filter in thedrip chamberA particle filter in the drip chamber with pore size of 15 µm preventsthe infusion of particles from the infusion container.210.2 µm Sterifix filterThe 0.2 µm Sterifix filter retains bacteria, fungi, particles and air.Sharps InjuryNeedle-free valveProvides needle-free access, while eliminating the risk of needlestick injuries. 22, 23Medication ErrorStructure of the regimeDue to the 90 angle of the valves in the grip plate, the whole Cyto-Set regime is structured well, which reduces the risk of mistaking the drugswithin the therapy.Air EmbolismAirStopAirStop function in drip chamber reduces the risk of air embolism.24DEHP ExposurePVC / DEHP free tubingAll lines are PVC-free, there is no risk of DEHP exposure.
A Proven Closed System*INNOVATION IN DESIGN AND TECHNOLOGYImproved design of Cyto-Set offers a higher level of patientand user safety due to it‘s new features. In addition to this,the features are supporting to increase the usability of thenew portfolio due to the intuitive handling of the IV-Set.Cyto-Set products detailsPrimeStop Cap**Proven bacteria tightnessduring storage and transportation.Vented Spike ***High filter performance! Thebacterial and viral filter efficiencyis higher than 99.99 %! 19Needle-free valveWith finger stopper and fingergrip helps to reduce the risk ofmicrobial contamination.As the precursor the new Cyto-Set is a closed system*, andthe new portfolio has been tested according to NIOSH guidelines.* No disconnection during the treatment or afterwardsare necessary to dispose of the system.YOUR BENEFITSCytostatic resistant material “Tritan ” is used for theneedle-free valve to avoid the risk of chemical contaminationcaused by stress-cracking.Systematic arrangement of the needle-free valves supportingthe user during application. This helps to reduce the risk ofmedication errors.Integrated back check valves to avoid drug incompatibilitiesand medication errors caused by unmeant reflux.Ergonmic design of grip plate and Y-site needle-free valvesupports safe handling and helps to reduce risk of microbialcontamination.Improved fluid flow leads to a reduced dead space volumeof Y-site needle-free valve which is decreasing the risk ofdrug in compatibilities and air embolism.AirStop function in drip chamber prevents air entrainmentinto the infusion tubing and helps to reduce the risk of airembolism.··· Improved fluid flow forreduced dead space volume.· Finger plate & finger stopper··are helping to reduce risk oftouch contamination.·Design Assisted LoadingPump segment for long term accuracyduring usage with infusion pumpsAnti-freeflow clamp for automatedfreeflow protection when removingthe line from the pump.··· New designed grip plate with·valves made of Tritan andintegrated back check valvesin all needle-free valves.Only the combination ofautomatic closing valve andback check valves enablesthe closed system*.·AirStopIs available in Cyto-Set Infusomat Space andCyto-Set Infusion protecting against air infusion bypreventing the infusion linerunning dry.* Cyto-Set is tested according to NIOSH guidelines as a closed system. Confirmation available.** Bacteria tightness of PrimeStop Cap. Confirmation available.*** Filter prevents the escape of any contamination into the adjacent environment. Confirmation available.Easy re-fill of drip-chamber due to short tubingabove and low priming volume of grip-plate.The systemicarrangement issupporting theclear identification of which lineis connected towhich drug.
Drug Preparation in the Pharmacy11Handling StepClose venting cap.Safety FeatureAir vent filter in spike withintegrated B.C.V. helps to avoidcontamination during venting.2Safety FeatureHelps to avoid chemical contamination as only salin will remainat the connection site.Handling StepSpike the container.2Safety FeatureContainer stability of Ecoflac plusallows easy and convenient spikingwhile helping to reduce risks ofsharps injuries.213Safety Feature0.2 μm Sterifix filters everyparticals larger than 0.2 μm toavoid particular contamination.344Priming of Cyto-Set Mix in the pharmacyProtect yourself and your enviroment during the preparation of cytostatic drugs in thepharmacy by priming Cyto-Set Mix first. As it is a matter of common knowledge cytostatic drugs can pose serious health harzards, Cyto-Set Mix is supporting the pharmacists reducing the risk of contamination and helps to increase the process efficiency ofadmixing drugs.Handling StepPrime the filter.Handling StepClose white clamp close to theneedle-free valve.1Handling StepConnect prepared syringe withdiluted drug to the needle-freevalve by using the finger plate.Safety FeatureHelping to reduce risk ofmicrobiological contaminationsince no direct contact to theneedle-free valve is needed. Theneedle-free valve is preventingneedle-stick injuries.23Handling StepPrime the line completely.3Handling StepInject drug into container and mixthe high concentrated drug well byaspirating once or twice.Safety FeatureDrug is administered in accordancewith the prescripted concentration.Safety FeatureHydrophobic, bacteria retentivecap maintaining a closed systemuntil connection to the main linewithout spillages of fluid.Drug preparation in the pharmacy with Cyto-Set MixDuring the admixture process not only Cyto-Set Mix but also a lot of supporting productsof the widespread B. Braun portfolio is used. Besides proctective equipment (e. g. gloves)and disinfectiants, the closed male connector PureSite, the semi-rigid container Ecoflac plus and the luer-lock syringe Omnifix is used during the preparation process.
Application on the Ward11Handling StepClose venting cap.Safety FeatureAir vent filter in spike withintegrated B.C.V. to avoidcontamination during venting.242313Safety FeatureClosed clamp prevents acontamination of flushingsolution to reduce the riskof drug incompatibilites.Handling StepSpike the container.Safety FeatureTight connection. Once insertedthe spike stays firmly connectedto reduce the chance of beingdisconnected accidentaly.212Handling StepWhile allowing system to fill, holdthe drip chamber upside down.Safety FeatureFluid filter in the drip chamber toavoid particular contamination.4Handling StepPrime the line completely.Safety FeatureHydrophobic, bacteria retentivecap maintaining a closed systemuntil connection to the main linewithout spillages of fluid.Priming of Cyto-Set main line on the wardCyto-Set main line is designed for a safe drug application on the ward while supporting the idea of a safe procedure of handling before, during and after the treatment.Cyto-Set is supporting the process with features dedicated to the enviroment of anoncology ward.Handling StepClose white clamp of main line.Drug application on the ward with Cyto-Set & Cyto-Set MixThe fact that the numbers of cytostatic drugs available on the market increase and theprices for most of the drugs are stable on a high level any residual volume in the IV-Setas well as drug incompatibilities increases the risk of an uneffective treatment or of anunefficient process. The concept of Cyto-Set is supporting the process by helping toincrease: efficiency, effectiveness and safety!Handling StepConnect Cyto-Set Mix to mainline, open white clamp and starttreatment.Safety FeatureA tactile “click” will let the userknow that the sets are connected.
Application on the Ward and Disposal1Safety FeatureThe full amount of drug is given tothe patient which helps to reducethe risk of medication errors.11Handling StepAfter each drug flush the linecompletely with flushing solution.1Thanks to AirStop function the fluidlevel remains in the drip chamberafter drug application. The line is notrunning dry which helps to preventair embolism.22Handling StepOpen clamp of next Cyto-Set Mixto start the next treatment.Safety FeatureFlushing plus integrated backcheck valves helps to reduce therisk of drug incompatibilities.Drug application on the ward with Cyto-Set & Cyto-Set MixIn order to support the cancer treatment Cyto-Set is enabling the user to flush theIV-Set after the treatment completely for the application of the whole medication inaccordance with the prescription.Disposal as a complete systemEven after the treatment the IV-Set and the contaminated containers need theundivided attention to protect the user and the environment. The whole Cyto-Set portoflio is also supporting the healthcare worker afterwards to dispose the systemin a convenient way.Handling StepDispose as a closed system.Safety FeatureHelps to avoid the risk of chemicalcontamination because no disconnection is necessary.
Product PortfolioCyto-Set ProductTypeProduct Portfolio & LiteratureLightprotectionAirStopUnitsper boxCode no.(REF)Cyto-Set PreparationCyto-Set Mix––A2900Nwith 3 needle-free valves–with 1 needle-free valve,with 0.2 µm filter––A2903Nwith 3 needle-free valves–with 5 needle-free valves–with 5 needle-free valves––20A2906Nwithout needle-free valve––A2581NFwithout needle-free valve,with 0.2 µm filter––A2582NFwith 3 needle-free valves--with 5 needle-free valves--with 3 needle-free valves-with 5 needle-free valves-with 3 needle-free valves–with 3 needle-free valves–with 5 needle-free valves–with 5 needle-free valves–Cyto-Set Infusomat -8250817SP835817SP-with 3 needle-free valves8250920SP835920SPwith 3 needle-free valves-with 5 needle-free valves208250820SP835820SPwith 5 needle-free valvesCyto-Set Pump AdapterAirStop–Application (Pump) Infusomat SpaceCyto-Set Infusomat SpaceLightprotectionwith 1 needle-free valveApplication (Gravity)Cyto-Set InfusionTypeUnitsper boxCode no.(REF)Application (Pump) Infusomat compactpluswith 1 needle-free valveCyto-Set LineProductwith 5 needle-free valves,with 0.2 µm filter–with 5 needle-free valves,with 0.2 µm filter–4 needle-free ��87004908700430with 3 needle-free valves2087004408700450with 5 needle-free valveswith 5 needle-free valves,with 0.2 µm filter–with 5 needle-free valves,with 0.2 µm filter––87004708700460Literature1. McDiarmid MA, Egan T. Acute occupational exposure to antineoplastic agents. J Occup Med1988; 30(12): 984-9872. Valanis GB, Vollmer WM, Labuhn KT, Glass AG. Association of antineoplastic drug handlingwith acute adverse effects in pharmacy personnel. Am J Hosp Pharm 1993b; 50; 455-4623. Fahimi F, Sefidani Forough A, Taghikhani S, Saliminejad L. (2015) The rate of PhysicochemicalIncompatibilities, Administration Errors. Factors correlating with Nurses’ errors. Iran J PharmRes; 14(suppl); 87-934. Vijayakumar A, Sharon EV, Teena J, Nobil S, Nazeer I. (2014) A clinical study on drug-relatedproblems associated with intravenous drug administration. J Basic Clin Pharm; 5(2): 49-5313. Mirski et al. 2007 Wittenberg 2006, Josephson 2006, Perdue 200114. Abstract - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J. BrünkeQuality Labs BT GmbH Nuremberg, Report 1816.3, 01.09.201515. Abstract - Evaluation of the microbial barrier performance of Cyto-Set and Cyto-Set Mix(NEW) signed by Prof. Dr. med. M.Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-195,23.02.201516. Test Report - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J.Brünke Quality Labs BT GmbH Nuremberg, Report 1678.3, 28.05.201317. Confirmation PrimeStop Cap - Bacteria tightness of PrimeStop Cap. Confirmation available.5. Höpner JH, Schulte A, Thiessen J, Knuf M, Huth RG. (2007) Preparation of a compatibilitychart for intravenous drug therapy in neonatal and pediatric intensive care units. Klin Padiatr;219(1): 37-4318. Abstract - Evaluation of the microbial barrier performance of Cyto-Set and Cyto-Set Mix(NEW) signed by Prof. Dr. med. M.Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-195,23.02.20156. Uslusoy E., Mete S.: Predisposing factors to phlebitis in patients with peripheral intravenouscatheters: a descriptive study. J Am Acad Nurse Pract. 2008; 20(4): 172-8019. Confirmation Air vent filter – Filter prevents the escape of any contamination into theadjacent environment signed by Andreas Katerkamp and Dr. Stefan Seidel, 01.11.20167. Bouchoucha et al. Deep venous thrombosis associated with acute hematogenous osteomyelitisin children. Orthop Traumatol Surg Res. 2010 Dec; 96(8): 890-3., Boucher 201020. Non-return valves do not prevent backflow and bacterial contamination of intravenousinfusions written by B. Ellger, D. Kiski, E. Diem, I. van den Heuvel, H. Freise, H. Van Aken,F. Hinder, A. W. Friedrich, 11.03.2011, Journal of Hospital Infection8. Dewan et al. 1995b; publications ex Dewan et al. 2002; Ewan PA, Stefanek W, Byard RW.Long-term response to intravenously injected Teflon and Silicone in a rat model. PediatricSurgery Interantional 1995b; 10(2,3): 129-13321. Confirmation ISO Standard - ISO 8536-4 signed by Gudrun Henke and Caroline Führ,01.02.20179. Roth 2007, Lehr et al. 2002; Roth JV. How to enter a medication vial without coring. AnesthAnalg 2007; 104(6): 161522. American Nurses Association – Independent Study Module: Needlestick Safety and Preventionwritten by Mary Foley, MS, RN and Annemarie T. Leyden, EdD, RN10. Cousins DH, Sabatier B, Begue D, Schmitt C, Hoppe-Tichy T (2005) Medication errors inintravenous drug preparation and administration: a multicentre audit in the UK, Germanyand France. QSHC 14: 190-19523. Review Article - Review on Needle Free Drug Delivery Systems, International Journal ofPharma Research & Review, written by Bhagyashri Chavan, Abha Doshi, Yashwant Malode,Balu Misal, Sept 2013; 2(9):30-3611. Canadian Center for Occupational Health and Safety (CCOHS); Needlestick injuries. 2000.(www.ccohs.ca/oshanswers/diseases/needlestick injuries.html)24. Pheriphervenöse Schwerkraftinfusionen - Intrafix SafeSet mit Vorteilen gegenüberherkömmlichen Infusionssystemen written by lic. rer. pol. Andreas Frei, Die Schwester DerPfleger 43. Jahrg. 5/0412. National toxicology programm, the US department of health and human services(11/2006) HYPERLINK “http://www.ncbi.nlm.nih.gov/pubmed/?term NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl)”Center for the evaluation of risks to human reproduction: NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl)Phthalate (DEHP). NIH Publication No. 06 – 4476.
DEHP ExposureMedication ErrorParticuEffects of plasticizersRisk Prevention in Infusion Therapyinationlate ContamDrug Incomon Health and Environmenton in Infusionwww.safeinfusiontww ntiomical Contaminaw.safeCheRisk PreventionpatibilityRisk Preventision Therapyon in InfuRisk iontherapy.comMicrobiological ContaminationSharps InjuryRisk Prevention in Infusion TherapyRisk Prevention inpyin Infusion TheraB. Braun On131002 DEHP Exposure18.02.14 13:156069089 CS6.inddwww.safeinfusiontherapy.comcology PortfInfusion TherapyThe system140218 Medication Error 6069096.indd 113:1318.02.14Therapysolution forenhancedoliosafety through each process step114021802.10.1316:16Drug Incompatibility 6069092.inn 6069091.inddte Contaminatio140218 Particuladd onm140220 MicrobiologicalContamination 6069094.indd 123.10.13 .02.14ps Injury 60608:35140218 Shar9095.indd 118.02.14 13:11d 1tion 6069097 CC.indChemical ContaminaFor further information about Risk Prevention in InfusionTherapy, please refer to the Risk Prevention brochures orscan the QR-code and visit:WWW.SAFEINFUSIONTHERAPY.COMB. Braun Melsungen AG Hospital Care 34209 Melsungen GermanyTel. 49 5661 71-0 www.bbraun.comDate of last revision: 04.2018
Risk Reduction with Cyto-Set The new and improved Cyto-Set design is in line with our Safe Infusion Therapy concept to protect users and patients. In the field of drug preparation the wide spread portfolio of Cyto-Set offers a high safety standard of each component. During the application onthe ward the new Cyto-Set portfolio not only
