Hunan EEXI Inherent Type IIR Face Mask – SKU MKTIIR0127 (ICN 1687)

Important Customer Notice Free PPE

Ref: 2022/1687 ICN Number: 1687

Next steps from quarantine notice 31 May 2022 – PPE products purchased by Department of Health and Social Care.

A further review has now been completed by a panel of independent experts.

This further review indicates that samples of this mask within batch 20200829 of this brand have fallen short of the required standard for splash resistance testing as part of the harmonised standards for this product under EN14683.

Considering the above, and as the remaining stock of the product has a shelf life less than 60 days, this brand has effectively been discontinued since early May.

The masks were originally released in late 2020. At that time, the product was reviewed and assessed showing full compliance as required on all test reports and mandatory documentation. Therefore, it is unclear whether wearers of this mask have been exposed to any risks.

There are many factors to consider when reviewing the results of this batch testing all of which are currently being investigated to establish the likely causes.

The results of this investigation will provide insights into any risks created and what mitigations may be need to ensure we are only providing safe and compliant products.

Actions

Please dispose of all stock inclusive of the 20200829 batch you have of the Hunan EEXI Inherent type IIR mask.

What do the masks do?

These are medical devices and as such provide protection to others, whereas PPE provides protection to the wearer. The standard EN14683 covers type1, type II and type IIR, the R status relates specifically to splash resistance.

The construct and BFE, bacterial filtration efficiency between type 11 and a type 11r are the same > 98%, and as such will provide the same protection in terms of bacterial filtration. The splash resistance element prevents spray, splatter, fluids from entering the mouth as it forms a barrier on the outer aspect of the mask. This fluid resistance relates to large droplets from food fluids, such as water juice etc, and, bodily fluids such as vomit, blood, etc.

These masks do not offer small particulate filtration associated with aerosol generating procedures (AGP), such as intubation, non-invasive ventilation (NIV O2) delivery and continuous positive airway pressure (CPAP) devices, which are specific interventions in the main, but not limited to, acute settings (This relates to IPC guidance in place at the time when the masks were last issued, April 2022).

IPC guidance relates to a suite of practices that when all are utilised accordingly, aid the prevention and control of disease and illness. Actions from handwashing through to donning correct PPE mitigate the risks of transmission and as such need to be adhered to in their entirety to be effective, it is important to understand that the prevention of transmission is not generated by any single piece of PPE or action.

Please note this ICN is related to PPE products available via the PPE auto-replenishment model and the PPE Portal. It is not referring to products on the NHS Supply Chain catalogue.

Change:
Our records show that a number of NHS Supply Chain customers have received the Hunan EEXI Type IIR mask, which are items of PPE that have been centrally distributed from stocks secured during the response to the pandemic.

These items are to be quarantined with immediate effect whilst the item is reviewed. Batch testing of these masks has identified the need for further testing, to ensure they can be continued to be used in a clinical setting.

Hunana XXEI Face Mask Product Image


Action Required:

  • Please undertake an immediate review of your mask stock and identify if you have any of the affected products.
  • If you have any of this product then please:
    • Quarantine all items with immediate effect.
    • Inform the NHS Product Enquiries Team on productqueries@ppeenquiries.com quoting Ref: Hunan EEXI Type IIR mask, and confirm the volume of the product in stock.
  • We will make arrangements for a replacement to be issued to you.
  • We will provide an update in due course following the outcome of the further investigation.