Standards Development

Scope

This document provides guidance for the development of design of devices and systems intended for administration of medicinal products to paediatric patients who are performing some or all use steps required for its intended use.

Use steps may include but are not limited to transport, storage, preparation, operation, maintenance and disposal.

NOTE 1 Delivery systems developed by applying the guidance in this document might also be intended to be used for administration to paediatric patients by caregivers.

The scope is limited to the following devices and systems:

- Needle-based injection systems for medical use;

- Aerosol drug delivery devices;

- Needle-free injectors for medical use;

- Non-prefilled sterile hypodermic syringes for single use;

- Sterile hypodermic needles for single use.

NOTE 2 Although specifically intended for medication delivery devices and systems as given above, this document could be useful in the development of the design of other devices and systems if they are intended for use by the paediatric population.

Catheters, infusion pump systems and devices for basal delivery are outside the scope of this document.

Purpose

The proposed document is intended to address the unique requirements of medication delivery systems for paediatric use which are not addressed in other documents or standards. Key elements in the proposal include the following:

- special considerations for paediatric patients, including design considerations related to the developmental stage, age and aptitude of the user;

- the importance of risk assessment appropriate to the intended use population (paediatric patients, caregivers, and healthcare providers (HCPs));

- specific considerations with respect to Human Factors.

Medication deliver systems are normally designed to be intended for adult use as this will be the main population for the development and design of most delivery devices and systems. Often, these devices and systems are also marketed to younger populations or slightly changed to fit those. However, there is a trend towards development of new devices and systems that are designed from scrats of to fit the paediatric population – or a sub of the paediatric population. And there is a trend to re-develop and redesign delivery devices systems and systems intended for adults to fully fit the purpose for younger populations.

There exists no common international practice for how to develop and design delivery devices and systems that are intended to be used by paediatric patients themselves or partly assisted. A guidance on development and design of such devices and systems are therefore requested by both manufacturers and national and regional health authorities in order to assist in better development and design and also in easier approval mechanisms for marketing of the devices and systems. And most importantly, a guidance will lead to safer and better performing delivery devices and systems for the paediatric patients. This group of patients is a vulnerable group which needs to be addressed. A guidance can improve their livelihood by getting better access to delivery devices and systems which they can use by themselves or assisted by care persons, family members or other people with the needed competences to assist them in getting their correct medication