Cyto-Set®

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I.V. administration set for the application of cytostatics

Cyto-Set® is a single-use, sterile infusion system for administration of different cytotoxic drugs via one single closed line-system by gravity or pressure. The Cyto-Set® system reduces the risk of contamination of person and environment when preparing and applying cytotoxic drugs provided by its technical components forming a closed system and the resulting workflow.

The variety of Cyto-Set® products is widespread and offers a convenient solution for the application and preparation of cytostatic drugs in several situations. When used together, Cyto-Set® Mix and Cyto-Set® provide a closed system from preparation in the pharmacy to the application on the ward, all the way to the disposal after treatment.

Advantages

Chemical Contamination

  • Needle-free valve: Helps to reduce the risk of chemical contamination as the valves are designed for preventing spillage / drug exposure.1

Microbiological Contamination

  • Finger stopper and finger grip: Reduction of microbial contamination due to the finger stopper and finger grip.2
  • PrimeStop: Improved safety against microbial contamination due to the hydrophobic, bacteria retentive PrimeStop cap on the patient connector which provides a closed system until connection to the patient.3,4
  • Needle-free valve: Provides easy access, while helping to reduce the chance of accidental touch contamination.5
  • Air vent filter in the spike: The bacteria tight air vent filter in the spike reduces the contamination risk of the infusion solution.6

Drug Incompatibility

  • Grip plate with integrated back check valves: Integrated back check valves enable an improved safety standard and less risk of unmeant mixture of drugs due to the prevention of reflux.7

Particulate Contamination

  • 15 µm filter in the drip chamber: A particle filter in the drip chamber with a pore size of 15 µm prevents the infusion of particles from the infusion container.8
  • 0.2 µm Sterifix® filter: The 0.2 µm Sterifix® filter retains bacteria, fungi, particles and air.

Sharps Injury

  • Needle-free valve: Provides needle-free access, while eliminating the risk of needlestick injuries.9, 10

Medication Error

  • Structure of the regime: Due 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 drugs within the therapy.

Air Embolism

  • AirStop: AirStop function in the drip chamber reduces the risk of air embolism.11

DEHP Exposure

  • PVC / DEHP free tubing: All lines are PVC-free, there is no risk of DEHP exposure.
  • Tightness of valves: Test on stress cracking corrosion with drug solution
  • Evaluation of microbial barrier performance of Cyto-Set® and Cyto-Set® Mix
  • Investigation of the adsorption and desorption behavior of Cyto-Set® AirStop
  • Tightness of tubing connection with clamp (Cyto-Set® Mix)
  • 1 Abstract - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J. Brunke Quality Labs BT GmbH Nuremberg, Report 1816.3, 01.09.2015
  • 2 Abstract - Evaluation of the microbial barrier performance of Cyto-Set® and Cyto-Set R Mix (NEW) signed by Prof. Dr. med.M.Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-195, 23.02.2015
  • 3 Test Report - Closed system test by means of Sodium Fluorescein signed by Dr. rer. nat. J. Brunke Quality Labs BT GmbH Nuremberg, Report 1678.3, 28.05.2013
  • 4 Confirmation PrimeStop Cap - Bacteria tightness of PrimeStop Cap. Confirmation available.
  • 5 Abstract - Evaluation of the microbial barrier performance of Cyto-Set® and Cyto-Set R Mix (NEW) signed by Prof. Dr. med.M.Exner and Dr. rer. nat. J. Gebel, Report DMT 2014-195, 23.02.2015
  • 6 Confirmation Air vent filter –Filter prevents the escape of any contamination into the adjacent environment signed by Andreas Katerkamp and Dr. Stefan Seidel, 01.11.2016
  • 7 Non-return valves do not prevent backflow and bacterial contamination of intravenous infusions 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 Infection
  • 8 Confirmation ISO Standard - ISO 8536-4 signed by Gudrun Henke and Caroline Fuhr, 01.02.2017
  • 9 American Nurses Association –Independent Study Module: Needlestick Safety and Prevention written by Mary Foley, MS, RN and Annemarie T. Leyden, EdD, RN
  • 10 Review Article - Review on Needle Free Drug Delivery Systems, International Journal of Pharma Research & Review, written by Bhagyashri Chavan, Abha Doshi, Yashwant Malode, Balu Misal, Sept 2013; 2(9):30-36
  • 11 Pheriphervenose Schwerkraftinfusionen –Intrafix® SafeSet mit Vorteilen gegenuber herkommlichen Infusionssystemen written by lic. rer. pol. Andreas Frei, Die Schwester Der Pfleger 43. Jahrg. 5/04