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E008: Single-use Injection Devices

E008: Single-use Injection Devices

The products listed in this section are auto-disable (AD) syringes used to administer vaccines. WHO strongly recommends the systematic and exclusive use of auto-disable (AD) syringes only (and not disposable and reusable syringes) for either the administration or reconstitution of vaccines.

The correct use of injection devices for immunization is described in the WHO's Immunization in practice: A practical guide for health staff.

Currently, auto-disable syringes are the only equipment that WHO strongly recommends for the administration of injectable vaccines. Performance standards for AD syringes are defined in ISO 7886-3.

Details regarding the products included in each sub-category of E008, as well as guidelines, performance specifications and verification protocols for this category, can be accessed through the drop-down sections below.

E008 PRODUCT DATA SHEETS: Category E008 product data sheets are available for view, download and comparison here.

WHO-prequalified syringes must comply with ISO 7886-3 ‒ Sterile hypodermic syringes for single use ‒ Part 3: Auto-disable syringes for fixed-dose immunization.

The auto-disable syringe is the only type of single-use equipment that may be used for the administration of vaccines in all settings; it carries the lowest risk of person-to-person transmission of blood-borne pathogens because it cannot be reused. Refer to the Safety of injections : WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunization services, 2nd rev-.

Compliance with the IMD-PQS Product Specification and Verification Protocol is required (refer to "Category Documentation" below).

WHO strongly recommends the systematic and exclusive use of auto-disable (AD) syringes only (and not disposable and reusable syringes) for either the administration or reconstitution of vaccines in the context of immunization. Refer to the Joint Policy Statement: Promoting the exclusive use of injection safety devices for all immunization activities.

WARNING: There is clear evidence that the reuse of disposable syringes is widespread globally. WHO warns governments and donor agencies that the reuse of standard disposable syringes and needles places the general public at high risk of disease and death. Refer to the WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care settings.

Needle-free jet injectors deliver a sterile, single dose of liquid medication by pressurizing the dose in a chamber from which it is ejected through a small orifice on an auto-disabling syringe with sufficient force to penetrate human tissues. It is intended for clinical use by medical personnel on humans. It may be used to deliver intra-dermal (ID) and/or subcutaneous (SC) and/or intra-muscular (IM) injections.

Single-use and auto-disabling refer to the needle-free syringe/cartridge, not the injector itself.

Compliance with the IMD-PQS Product Specification PQS performance specification E008/JI01: Single-use auto-disable needle-free syringe injectors and Verification Protocol PQS type-examination protocol E008/JI01-VP.1: Single-use auto-disable needle-free syringe injectors is required.

Additional equipment is necessary to ensure the safety of the contaminated waste stream.

Compliance with the IMD-PQS Product Specification E010/SB01.1: Safety boxes for the collection of used syringes, needles and sharps and Verification Protocol PQS independent type-testing protocol E010/SB01-VP.1: Safety box for the disposal of used sharps is required.