:: Prequalified devices and equipment

:: E01 Cold rooms/freezer rooms and related equipment performance specifications and verification protocols (approved by PQS Steering Group on 14 September 2007)

:: E03 Refrigerators and freezers for storing vaccines and freezing icepacks performance specifications and verification protocols (approved by PQS Steering Group on 14 September 2007)

:: E04 Insulated containers performance specifications and verification protocols (approved by PQS Steering Group on 8 December 2008)

:: E05 Ice-packs, cool-packs and warm-packs (approved by PQS Steering Group on 8 December 2008)

:: E06 Temperature monitoring devices performance specifications and verification protocols (approved by PQS Steering Group, 9 January 2007)

:: E10 Waste management performance specifications and verification protocol

:: Reference documents for Performance, Quality and Safety (PQS) project

:: WHO accredited laboratories

22 August 2006 -- Since 1979, through 12 editions, the PIS have provided general information on the choice of equipment, together with specific technical and purchasing data for individual selected items. This joint WHO and UNICEF publication is the principal source of information and advice for those responsible for purchasing equipment for use in immunization programmes around the world. The majority of the equipment that is listed in the PIS complies with the relevant WHO/UNICEF or international standards and most have been subjected to independent testing.

The system has served EPI well but the increasing and the ever changing nature of the challenges facing the programme demand a revision. Immunization programmes, and the context in which they operate are becoming ever more varied and complex. These challenges can be summarized as follows:

• The economies of many countries are moving from 'developing to 'transitional' and wish to support their own industries rather then purchase specialist devices predominantly from the developed world.
• With the move from donor dependence to country independence the incentive to keep equipment cost to a minimum is stronger then ever.
• The introduction of multi-valent vaccines means that the traditional six antigens are no longer universal. In addition the cost of and bulk of these vaccines tends to be significantly greater, placing greater demands on inventory management and equipment reliability.
• Improvements in the thermostability of vaccines, coupled with the introduction of VVMs and innovative approaches to the cold chain, means that the range of equipment options available to programme managers is now significantly wider.
• With the increase in truly global industry standards (ISO) manufacturers throughout the world are now better placed to offer globally acceptable products.
• In many sectors, including health care, the scope of and intensity of litigation arising from product and service delivery failure has greatly increased. The international agencies cannot afford to ignore this development.

In conclusion WHO and UNICEF recognize that the PIS system needs to become more open and responsive to be better able to keep pace with global developments.

The new approach is based on three key criteria: Performance, Quality and Safety (PQS). All examples of a selected product must have performance characteristics that meet the relevant specification standards; quality and reliability characteristics that are appropriate for field conditions, and cradle-to-grave safety characteristics that ensure that no harm is caused to users, patients, or to the environment over the course of the product's life cycle. The PQS will include a closed system of user feedback.

One of the key aims of the PQS is to bring WHO and UNICEF into a more productive relationship with users, key partners and industry. The intention is to create a product development, improvement and innovation cycle comprised of three steps.

Step 1. Establish and /or adopt international standards to provide a framework of reference for the design, development and production of each product.

Step 2. For each type of product, develop and maintain technical specifications and related test procedures that adequately reflect programmatic and operational needs.

Step 3. Monitor products post-market in order to assess performance, quality and safety characteristics over a products life cycle from the perspective of the user, and monitor its suitability for programmatic and operational needs.

The intention is to build a system that will operate effectively over the long term and to provide purchasers with a document of reliable immunization equipment and devices, each proven to meet user needs. At the same time the system must encourage the continuous improvement of existing products, whilst remaining open to innovation.