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© UNICEF/UN0488589

Historical procurement

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Unofficial values as of Feb 2024

01. Fingertip

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02. Handheld (SpO₂ only, incl. adult & paediatric sensors*)

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03. Handheld (SpO₂ + RR, incl. adult & paediatric sensors*)

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04. Handheld (SpO₂ + RR + pneumonia screening, incl. adult & paediatric sensors*)

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* Descriptions requested for other sensor types available, e.g., neonatal

Products included in tender

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© UNICEF/PHOTO CREDIT

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• Must meet UNICEF Requirements for Medical Devices (verified via documentation checks)
• Manufacturer must be certified to ISO 13485
• Supplier (if not manufacturer) must be certified to ISO 9001
• Valid market clearance issued by one of the following five (5) regulatory authorities:
• Australia: TGA Device Licence;
• Canada: Device Licence;
• European Union: European medical device (MDD 93/42/EEC or MDR 2017/745);
• Japan: Device Licence;
• USA: FDA 510(k) premarket Notification Clearance or Premarket Approval (PMA)

Technical Requirements

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© UNICEF/PHOTO CREDIT

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• WHO-UNICEF interagency specifications (2019) were the basis for the technical specifications
• Minimum product standards included:
• ISO 80601-2-61 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
• IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
• Adaptations for UNICEF 2023 tender included:
• Scored criteria for proof of performance in dark skin
• Scored Annex to gather details on after sales services (incl. training, warranty, service)

Technical Requirements (cont’d)

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Technical requirements categories

* Since this was scored, suppliers were not disqualified for not having such data

©UNICEF/UN0236705/Viet Hung

Outcomes

Some reasons products failed technical evaluation include:

• non-compliant CE risk classification
• insufficient proof of accuracy claims
• limited running time on battery only
• unable to be used for neonate patients (e.g., no appropriate probes)
• did not meet IP rating requirement

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Fingertip : 5 products technically acceptable from 7 suppliers/manufacturers

Handheld: 4 products technically acceptable from 2 manufacturers across the three handheld categories.

• Risk classification differences under EU CE
• Fingertip: ~ 7 class IIa vs ~4 products class IIb
• Handheld: ~ 4 products class IIa vs 6 products class IIb
• IIa or IIb acceptable for fingertip, only IIb acceptable for handheld
• Evidence of performance in dark skin tones variable across manufacturers; not comparing apples to apples
• Different classifications used for ‘dark skin’
• In-house vs. 3^rd part vs. peer-reviewed studies
• Many manufacturers had not completed the transition from EU Medical Device Directive (MDD 93/42/EEC) to the Medical Device Regulation (MDR 2017/745)
• close follow-up will be required

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Learnings

What’s new in the UNICEF catalogue for 2024?

Fingertip oximeter with EU class IIb risk classification

Fingertip oximeter with rechargeable battery

Handheld with RR & temp

• Updated WHO/UNICEF specifications could include MM devices and learnings from tender processes
• Third party lab testing data (e.g., OpenOx) could be a consideration as part of technical evaluation if:
• Testing is accessible to, and results are available for, any manufacturer who wants to participate in tenders (i.e., no supplier is disadvantaged)
• There is global alignment on test protocols and harmonization among UN agencies on how to use the data

How can existing tools be revised to support tender processes?

• Simplifies technical qualification process for tenders
• Proof of regulatory approval and/or compliance with international standards will be sufficient to ensure performance is met for all patients.
• Impact on existing long-term agreements (LTAs) depends on when the changes come into effect; but likely not until next tender cycle.

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How do proposed regulatory changes impact long-term agreements with manufacturers?