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INTRANASAL MUCOSAL ATOMIZATION DEVICE, without syringe

https://unicat.msf.org/cat/product/88295
STD SDDCMADW1--

Valid Article

Single patient multiple use A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
Article is intended to be used with children (<12 years) ONLY.
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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INTRANASAL MUCOSAL ATOMIZATION DEVICE, without syringe

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Definition

An easy-to-use and effective device for administering nasal medication to children.

It creates a seal with the nostril, allowing for the delivery of atomised drug particles to the nasal mucosa. The particles are then absorbed through the mucosa and directly into the bloodstream, avoiding first pass metabolism.

Single patient multiple use device

Synonym

MAD Nasal 300 (Teleflex), DART 300 (Pulmodyne)

Specifications

A foam applicator equipped with a plastic aerosoliser designed to attach to a syringe containing medication. When the syringe plunger is pressed, the medication is sprayed through the aerosoliser and converted into a mist.

Luer-lock tip for connecting a pre-filled Luer-lock syringe.

Technical specifications

  • A conical plastic plug covered with a foam envelope that forms a seal within the nostril, preventing the expulsion of fluid during administration
  • Flexible stylet allows positioning of the nasal plug at a180º angle
  • Atomiser disperses the medication as a fine mist of 30-100 µ particles
  • System dead space: 0.06 ml or 0.16 ml, depending on the model
  • Tip diameter: 4.3 mm
  • Applicator length: approx 4 cm
  • Luer-lock tip
  • Non sterile, for single-use

Packaging & Labelling

Box of 25 or 50 pieces (depending on the manufacturer)

To be Ordered Separately

Luer-lock syringes

Instructions for use

Procedure for intranasal administration

  • Prepare the syringe:
    • Fill a single-use Luer-lock syringe with the required volume of medication, adding an extra 0.1 ml to compensate for the dead space volume of the device.
    • Ensure all air is removed from the syringe.
  • Attach the atomisation device:
    • Remove the needle from the syringe
    • Connect the atomization device to the syringe using the Luer-lock connector, twisting it securely into place.
  • Position the patient:
    • Place the child on their back or in a seated position.
    • Hold the top of the child's head steady.
  • Administer the medication:
    • Insert the tip of the device into one nostril, angling it slightly upward and toward the ear on the same side.
    • Press the syringe plunger firmly to administer half the dose into the first nostril
    • Repeat the process in the other nostril to deliver the remaining dose.

Repeating a dose

If a dose must be repeated, the remaining 0.1 ml of medication in the device should be expelled before re-use:

  • Disconnect the atomisation device from the syringe.
  • Fill the syringe with 1 ml of air and reconnect the device.
  • Press the plunger firmly, repeating the process until all medication is expelled.

Refer to the manufacturer's instructions for use.

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Precautions for Use

Do not exceed 0.5 to 1 ml of medication per nostril. The ideal volume is 0.2 to 0.3 ml per nostril. If a higher total volume is required, divide the dosage into two separate administrations, allowing time for absorption between each.

Always divide the dose equally between both nostrils. This method increases the surface area, enhances absorption, and improves onset speed.

For small volumes, consider the device's dead space when calculating the total volume of medication to be administered.

In case of excessive nasal secretions or nasal trauma, aspirate the nasal cavity before administration, or consider using an alternative route of administration.

Mucous, blood, and vasoconstrictors may reduce drug absorption.

The same device may be reused for multiple doses in the same patient, provided the medication remains the same. Do not reuse the device if the medication has been changed.

Storage

Keep in the original packaging protected from dust, heat and light.

MSF requirements

This device is recommended by MSF anaesthetists and critical care referents for use in children with medical complexity, who often require multiple medications, including some prescribed as an intranasal mist (e.g. midazolam, fentanyl).

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