Request for Expression of Interest for Pulse Oximeters

Description of Requirements: 

UNICEF is requesting Expressions of Interest from eligible manufacturers and suppliers in preparation for a solicitation exercise for pulse oximeters. The products identified fall under two streams: the Supply Continuity Stream and the Innovation Stream.

A) Supply Continuity Stream:  

The Supply Continuity Stream is an opportunity to express interest in the upcoming tender with an objective of establishing Long-Term Arrangements for pulse oximeters that are currently available on the market. It is intended for suppliers/manufacturers of existing commercially available products that fall within the categories below:  

1. Fingertip pulse oximeters 
2. Handheld pulse oximeters 
3. Handheld pulse oximeters with respiratory rate monitoring 

Potential Suppliers for the Supply Continuity Stream: 

The Supply Continuity Stream REoI is addressed to suppliers and manufacturers with experience in the sourcing, manufacturing and supply of fingertip and handheld pulse oximeters.  

Only suppliers and manufacturers with a Quality Management System in conformity with at least one of the following standards are invited to express interest: 

1. Supplier: ISO 13485 or ISO 9001 certificate (as applicable) including scope 
2. Manufacturer: ISO 13485 including scope 

Only products with at least one of the following pre-market approvals / market clearances will be considered in the planned solicitation exercise:  

1. European Union: Regulatory agency in the European countries;  
2. USA: Food and Drug Administration (FDA);  
3. Canada: Health Canada;  
4. Japan: Pharmaceuticals and Medical Devices Agency (PMDA);  
5. Australia: Therapeutic Goods Administration (TGA).  

Multiple studies have shown that pulse oximeters can overestimate arterial oxygen saturation in patients with darker skin pigmentation. Therefore, preference will be given in the consequent tender, to pulse oximeters with test reports that show proof of consistent and accurate results in all patients independent of their skin pigmentation. 

B) Innovation Stream 

The Innovation Stream is an opportunity to express interest in an upcoming multi-year innovation tender for multimodal pulse oximeters. It is intended for manufacturers and innovators that are, or will be, involved in innovation in the multimodal pulse oximeter space. This includes any pulse oximeters that include the non-invasive or transcutaneous measurement of one or more of the following parameters in addition to the baseline parameters of oxygen saturation and heart rate:  

1. Respiratory rate 
2. Temperature  
3. Haemoglobin  
4. Blood glucose  
5. Bilirubin  
6. Blood pressure 

Potential Responders for Innovation Stream: 

The Innovation Stream REoI is addressed to manufacturers of multimodal pulse oximeters that are commercially available or in the development stage.  

Wholesalers are not eligible for this stream; however, an exception is made for wholesalers who have an exclusive agreement with a manufacturer to represent their product and thus are responding to this REOI on behalf of a manufacturer.  

Only manufacturers with existing or with the intention to seek ISO 13485 certification are invited to express interest. 

Only products with existing or with the intention to seek at least one of the following pre-market approvals / market clearances will be considered in the planned solicitation exercise:  

1. European Union: Regulatory agency in the European countries;  
2. USA: Food and Drug Administration (FDA);  
3. Canada: Health Canada;  
4. Japan: Pharmaceuticals and Medical Devices Agency (PMDA);  
5. Australia: Therapeutic Goods Administration (TGA).  

As UNICEF supplies devices suitable for all patient cadres, preference will be given to innovations that provide multimodal monitoring in all patient groups (including neonatal, paediatric and adult). 

Procedure for submission of EoI: 

Interested parties are encouraged to complete the linked survey to express interest on or before the deadline of 13th January 2023. If expressing interest for the Supply Continuity Stream, interested parties should also forward the following documents to Hauwa Mohammed (himohammed@unicef.org) on or before the same deadline of 13th January 2023: 

1. Valid QMS (ISO 13485 / ISO 9001) certificates. 

2. At least one of the acceptable pre-market approvals/ market clearances listed above. 

3. Proof of accuracy or proof of non-bias test report (e.g., additional test reports, 3rd party lab or peer-reviewed studies) conducted on patients with varying skin pigmentation for each device, if available. 

Q&A session: 

A virtual Q&A session will be held on 16th December 2022 at 10:00am EST / 4:00pm CET. Interested suppliers are requested to contact by email Hauwa Mohammed (himohammed@unicef.org) and Kanchana Perera (kperera@unicef.org) to confirm attendance and submit any questions in respect of this REoI on or before 15th December 2022 11:00am EST/5:00pm CET. 

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.  

 Thank you.