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Disposable Closed System for Sterile Drug Preparation and administration

European Statement

Patient Safety and Quality Assurance

Why was it done?

Our proposed system comes from the idea of a large clean room with pressure regimes, and airlock, hoods and other ancillary equipment, Which we made from it a very small clean room that is our box, when there will be no need for us as operators to get into it, or very simply take only those parts that are supposed to be sterile, and only those parts that are the two ends of the infusion bag and the end of the medicine vial

What was done?

“Closed” and airtight system for preparation (reconstitution, measurement, dilution) and injection of IV drugs at the patient’s bedside, in the various clinics and further home treatment, Disposable system, All its parts come in one piece without the need for threading, or assembly and disassembly
Estimated dimensions: 10 cm length, 5 cm width and 3.5 cm depth or similar, its shape can be rectangular or any shape convenient for use operation storage and destruction at the end of the process
Intended for a wide range of types of drugs – such as intravenous antibiotics, cytotoxic drugs, biological drugs, etc.
Designed according to its different variations for different types of vials and different amounts of drugs that come as a dry powder for dissolution, and are also suitable for drugs that come in the dissolved liquid form.
It is also intended for use with glass ampoules and there is a wide range of drugs that still come in glass ampoules
Intended for administration of drugs that do not need to be diluted in an infusion bag given in IV PUSH

How was it done?

We designed the device with 3D software (solid wark). It consists of a number of functional parts,
The sterile closed system comprises an airtight enclosure, which is shaped so as to define an enclosure interior; and an infusion-bag receptacle. An infusion-bag seal is configured, when in a sealing state, to make an airtight seal with respective external surfaces of a medication port and an IV tubing port of a bottom region of the infusion bag, when the medication port and an IV tubing port are inserted into the infusion-bag receptacle.

What has been achieved?

The proposed solution and its advantage
– A single-use system built in one piece, without the need for assemblies, disassembles, etc.
It will be possible to perform the entire process in one place, such as at the patient’s bedside or in the clinic, starting with the powdered drug dissolving process, mixing a measured dose, mixing it in an infusion bag and injecting it into the patient’s vein safely and accurately.
Maintains the perfect process under sterile conditions without fear of contamination of the injected drug
– Preparation in a system that is safe for the immediate environment and safe for the caregiver himself from contamination of drugs such as cytotoxic drugs, antibiotics and more
Savings in building very expensive infrastructure of clean rooms
Saving on very expensive disposables, such as closed system transfered deviced, robes and more
Save valuable work time dedicated team of pharmacists, nurses work time, work time transportation, storage places and more
Minimize the chance of errors in administering medications and confusion between different medications
Working with non-exposed needles reduces the chance of needle prick injury

What next?

Applied research will be carried out by pharmacists and nurses, in order to test the efficacy and safety of the device (by using a basic prototype), these experiments will use different IV administration drugs, we will test the method of dilution from a drug vials and glass ampoules, measure the exact dose and transfer to the infusion bag, and remove through the IV line, the accuracy of the preparation, the sterility of the preparation, the quality in terms of leakage or drip, comfort, safety and more are measured.

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