Product Information Sheets (PIS)

PIS REVISION

A revision of the PIS system is underway. 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 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.

The Product Information Sheets (PIS), provide general information on the choice of equipment, together with specific technical and purchasing data for individual selected items. This is the 12th edition of the Product Information Sheets, produced by the WHO, Department of Vaccines and Biologicals in collaboration with the Supply Division of UNICEF on a regular basis since 1979.

This is the 12th edition of the Product Information Sheets, produced by the WHO, Department of Immunization, Vaccines and Biologicals in collaboration with the Supply Division of UNICEF on a regular basis since 1979.

The PIS was formerly concerned only with equipment for the Expanded Programme on Immunization (EPI). From the 1993/1994 edition onwards the scope was expanded. This edition includes equipment from the programme to reduce Acute Respiratory Infections (ARI) as well as equipment to be used in emergency campaigns and for other primary health care initiatives.

For the EPI, this edition includes the standard selection of cold chain equipment for the storage, transport and administration of vaccines, as well as equipment for the collection and transport of stool specimens for the isolation of polio virus.

A new section, Waste Disposal, has been added to this edition. This section includes all the previously listed safety products from the section E10 on Injection Accessory, and some new products. These products have been given their own section in order to highlight the importance of safe injections in immunization services, a priority project of WHO.

For the EPI equipment, standards for performance and testing of EPI equipment are contained in a series of WHO/EPI documents, Equipment performance specifications and test procedures. These publications which were prepared for use by manufacturers in the international market, provide clearly defined blueprints for the production of equipment that will meet the highest competitive standards of reliability and performance in the EPI.