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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

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Definition

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

It forms a seal with the nostril and delivers atomised drug particles to the nasal mucosa. The particles are then absorbed through the mucosa and into the bloodstream, avoiding first pass metabolism.

Single patient multiple use device

Synonym

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

Specifications

Foam applicator containing a plastic aerosoliser that attaches to the syringe containing the medication. When the plunger of the syringe is pressed, the medication is sprayed through the aerosoliser and turned into a mist.

Luer-lock tip to connect a pre-filled Luer-lock syringe.

Technical specifications

  • Conical plastic plug with foam envelope that forms a seal with the nostril, preventing the expulsion of fluid
  • Flexible stylet allows the nasal plug to be positioned 180º
  • Atomiser releases medication in 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:

  • Fill a single-use Luer-lock syringe with required volume of medicine (including an additional volume of 0.1 ml to compensate for the dead space volume of the device). Eliminate remaining air.
  • Remove the needle from the syringe.
  • Connect the atomization device to the syringe using the Luer-lock connector and twist to secure.
  • Position the child on his/her back or the child can sit up.
  • Hold the the top of the head stable and place the tip of the device into the patient nostril, pointing slightly up and laterally (towards the tip of the ear on the same side of the head).
  • Press the syringe plunger with a brisk pressure to maximise the atomisation and administer half the dose into the first nostril.
  • Repeat in other nostril to administer the remaining dose.

Repeating a dose:

If a dose is to be repeated, the remaining 0.1 ml of medication in the device should be expelled:

  • remove the device from the syringe, fill the syringe with 1 ml of air, and reattach the device to the syringe.
  • press the plunger of the syringe forcefully and repeat until all the medication is expelled.

Refer to the manufacturer's instructions for use.

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Precautions for Use

Do not administer more than 0.5 to 1 ml of medication per nostril (ideal volume = 0.2 to 0.3 ml per nostril). If a higher volume is required, administer in two separate doses by spacing them a few minutes apart to allow absorption between doses.

Administer half the dose into each nostril, thus doubling the surface area, speed and absorption of drug.

For low volume doses, allow for "dead space" when calculating the volume of medication to be administered.

In case of excessive secretion or nasal trauma, aspirate the nasal cavity or consider an alternate access route.

Mucous, blood, and vascoconstrictors may reduce absorption of medication.

The same device can be reused for repeated doses in the same patient. Do not reuse if medication is changed.

Storage

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

MSF requirements

Device recommended by MSF anaesthetists and critical care referents for children with medical complexity often requiring multiple medications, some prescribed as an intranasal mist (e.g. midazolam, fentanyl).

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