Request for Expression of Interest for Testing of Pulse Oximeters

Item Description:

UNICEF is requesting Expressions of Interest from eligible laboratories in preparation for a solicitation exercise for testing of pulse oximetry devices.

UNICEF is shortly going to issue a tender for the supply of oxygen therapy products. Among these are three types of pulse oximeter: all-in-one finger clip, handheld and tabletop designs. As part of the tender evaluation process, sample devices of each design need to be tested to assess suitability for the population UNICEF serves, namely paediatric and neonatal patients in low and middle-income countries.

The tests required will include assessment of the supplied oximeters for performance in a paediatric population, specifically in relation to motion artefact, low perfusion, dark skin pigmentation and efficacy of neonatal/paediatric probes.  Assessment of usability and robustness shall also be included.  The test protocol will include laboratory bench based tests (e.g., simulators, phantoms) and controlled desaturation testing with healthy volunteers.  If the laboratory has capabilities in other areas, these can be proposed and costed in the response to the Request for Proposals.  Interested vendors will be invited to submit their proposal/protocols for how to complete the scope of work.

The tests need to be completed within one month of receipt of 6 – 12 sample devices.

Potential suppliers: 

This REoI is addressed to laboratories with experience of testing pulse oximeters to international standards, specifically to ISO 80601-2-61.

Laboratories will be expected to have certification to ISO 17025 for testing and calibration laboratories and to ISO 14155 for testing of human subjects.

Laboratories should describe any ethical, contractual and timescale limitations or requirements applicable to this project in their expression of interest using Annex A (attached).

Procedure for submission of EoI

Interested laboratories are encouraged to complete the attached EoI form (Annex A only – no additional details will be required at this stage) and return it to UNICEF by email to:

Dan Ilie (dilie@unicef.org) on or before 18th Feb 2019. 

Qualifying laboratories will receive notification of the Request for Proposal for pulse oximeter testing services and full details of the responses required.  Only at that stage will a detailed description of the tests that the laboratory proposes be required.

Please note: 

1. Prices are not required at this stage;
2. This REoI does not constitute a solicitation. Submitting an EoI does not automatically guarantee receipt of the solicitation document when issued;
3. UNICEF reserves the right to require compliance with additional conditions as and when issuing the final solicitation document.
4. UNICEF reserves the right to change or cancel the requirement at any time during the REoI and/or solicitation process.

Annex A – EoI pulse oximeter testing.doc