Patient safety

Request for Expressions of Interest

Medial Equipment Testing Laboratory

WHO is searching for a qualified Medical Device Testing Laboratory to undertake verification and certification to ensure that prototype pulse oximeters and subsequent production units are in accordance with WHO requirements and conform to current ISO 9919 standards. It is anticipated that between 10,000 and 30,000 pulse oximeters will be purchased each year for at least three years. A Request for Proposals (RFP) will be issued by WHO to quality agents who have expressed interest in becoming the quality agent for the WHO Pulse Oximetry project and who meet the minimum requirements.

Agents interested in becoming a Medical Device Testing Laboratory for this project are expected to have:

  • Experience in examining and undertaking evaluations of medical devices.
  • Experience certifying pulse oximeters against ISO standards
  • A good knowledge and experience in testing against common standards of safety including electrical safety.
  • An own laboratory capable of performing the required tests.
  • Certification of following Good Laboratory Practice.
  • An ability to provide written reports, which can be shared widely.
  • Experience in working with manufacturers to explain defects found with tested products.
  • Experience in conducting pre-production and post-production testing of samples.
  • Experience in examining products against purchase order requirements.

In addition, the contracted agent will be expected to have:

  • Experience working on international projects for both government and non-governmental organizations.
  • A broad geographic experience working for projects in several regions of the world.
  • An ability to communicate with WHO through a web based system

Laboratories who wish to express interest should click on the link below and fill out the detailed questionnaire intended to confirm the above requirements.

Any attestations and supporting documents shall be forwarded to WHO for review to ensure that minimum requirements have been met.

Experienced quality agents interested in becoming a WHO quality agent for the Pulse Oximetry project are invited to express this interest on or before 10 April 2009 by clicking on the link at the bottom of the page and completing the detailed questionnaire intended to confirm the requirements.

Only entities having demonstrated the capacity to fulfil all abovementioned requirements will be considered. Pre-qualified Laboratories will receive a Request For Proposal (RFP) by 24 April 2009. The proposal should be returned to WHO on or before 22 May 2009.

Disclaimers

WHO reserves the right to freely decide on the selection of those agents who will be invited for further consideration in WHO’s sole discretion, and without having to provide any justification to entities who will not be so selected.

WHO further reserves the right not to follow up on any expression of interest at all. WHO will advise all agents who have submitted an expression of interest whether or not they will be invited for further discussions. However, no explanation for the selection or rejection of any expression of interest will be provided.

Incomplete expressions of interest as indicated by the completed questionnaire and expressions of interest submitted after the deadline will, in principle, be disregarded (unless WHO, in its sole discretion, decides otherwise in respect of any such incomplete or late application).

WHO may request interested agents to submit complementary information. The submission of expressions of interest, any possible requests to submit complementary information and/or to submit a more detailed proposal, as well as any discussions ensuing there from, will be exploratory only, and do not mean that WHO will actually proceed to collaborating with the agent in question.

If the agent so requests, information provided can be made subject to an appropriate confidentiality agreement.

Any and all costs and expenses incurred in relation to, or ensuing from, the submission of an expression of interest, including the possible complementary information and/or a more detailed proposal, if so requested by WHO will exclusively be borne by the agent concerned. The submission of expressions of interest and the subsequent selection process as set forth in this document will not be subject to claims for financial compensation, other claims of any kind whatsoever, or appeal.

The submission of more detailed proposals and final selection procedure will be subject to similar terms and conditions as those outlined in this document.

Further information

Any further information concerning this project can be obtained online or by writing to:

World Health Organization
World Alliance for Patient Safety
Attn: Dr G Dziekan
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
dziekang@who.int

DETAILED QUESTIONNAIRE

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