Document Eight
Memorandum
Quality Review of Personal Protective Equipment (PPE)
Date due to MO: N/A
Action required by:
N/A
Security level:
IN CONFIDENCE
Health Report number: 20200932
To:
Hon Dr David Clark, Minister of Health
Contact for telephone discussion
Name
Position
Telephone
Keriana Brooking
Deputy Director-General, COVID-19
section 9(2)(a)
Kelvin Watson
COVID19 Health Supply Chain Manager
section 9(2)(a)
Action for Private Secretaries
N/A
Date dispatched to MO:
under the Official Information Act
Released
Document Eight
Quality Review of Personal Protective
Equipment (PPE)
Purpose of report
1.
This report is to provide you with an update on work that the Ministry of Health
(Ministry) has underway to review the quality of all Ministry-funded personal protective
equipment (PPE) sourcing (not from our regular supply arrangements) from 1 January Act
2020.
Background
2.
During the height of the recent COVID-19 pandemic in New Zealand approximately
$243 million of PPE was purchased to support the national response to the pandemic.
Much of this PPE was purchased at speed from suppliers outside of the Ministry’s
normal supply arrangements for the New Zealand health system. Many orders were
through public/private col aborations who had Chinese-based broker capability rather
Information
than directly through the manufacturer or existing wel -established medical device
distributors.
3.
At the height of the pandemic, the Ministry, through its procurement partners, sourced
PPE in a highly distressed and overly inflated competitive global market. This meant
that many orders were placed under urgency with less due diligence than would
normally be undertaken. Orders were being confirmed with new suppliers within hours
Official
during this period to secure manufacturing and freight windows. There would
otherwise be a risk of prolonged delivery delays. Business as usual procurement
processes would normal y take place over weeks/months.
the
4.
Due diligence during the height of the pandemic included reviewing certifications
provided by the broker/supplier and assessing whether the product being purchased
met New Zealand specification requirements and international standards. Some on-
the-ground due diligence of the manufacturing sites by the broker, and supplier/broker
under
company information review was also undertaken.
5.
With the transitions down alert levels and reduced procurement driven under urgency,
our attention has turned to undertaking further due diligence into the PPE orders that
have been placed throughout this period of unprecedented urgency of PPE supplies.
This has included some analysis on the legitimacy of certificates, labelling and
packaging of PPE products.
6.
Upon receiving a shipment of N95 masks in late May that raised concerns regarding
Released
labelling, we have proactively undertaken a full quality review of orders placed on our
behalf from alternative suppliers and brokers. Through this review, we have uncovered
some concerns about the quality of other PPE orders between the period of January
and May 2020.
7.
Paral el to this, we are now getting reports of potential non-compliant masks being
imported to New Zealand by other organisations. There is the potential for media
interest in this issue.
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Document Eight
Initial Review Results
8.
section 9(2)(f)(iv)
9.
section 9(2)(f)(iv)
section
Product
Our supplier Number
Quantity 9(2)(b)(ii)
of Orders
EA
Nature of the concern
Rating
ADHB P
Goggles (anti mist or equivalent)
section 9(2)(b)(ii)
1
100,000
Further information required
Hand Sanitiser (500mL equivalents)
1
100,000
Further information required
N95 Mask (or equivalent)
2
2,000,000
High levels of media coverage international y. In UK
for testing.
Procedure Mask (or equivalent)
1
1,000,000
Further information required
MoH P
section
9(2)(b)(ii)
In circulation. Canterbury DHB has raised concerns.
Isolation Gown (or equivalent)
8
2,105,000
FDA published guidelines on Isolation Gowns sent
to Regional Leads to check products labels and
requirements for IG in COVID-19
section 9(2)(b)(ii)
l Information Act
N95 Mask (or equivalent)
2
150,400
Testing lab can not be verified. Further work
required. Didn’t pass Fit Test. Label ing concerns
Procedure Mask (or equivalent)
1
2,482,500
Testing lab can not be verified. Further work
required. Didn’t pass Fit Test. Label ing concerns
Face shield (or equivalent)
1
30,000
Further information required
N95 Mask (or equivalent)
section 9(2)(b)(ii)
1 10,000,000
In UK for further testing. Package and label ing
concerns
Procedure Mask (or equivalent)
section 9(2)(b)(ii)
1 9,562,044
Further information required
Procedure Mask (or equivalent)
section 9(2)(b)(ii)
2 5,000,000
Further information required
Procedure Mask (or equivalent)
section 9(2)(b)(ii)
1 20,000,000
Further information required
22
52,
529,944
10.
Products rated as red are those where a concern has been identified and further
investigation is required. These products have a mix of issues including incorrect
product labelling, possible product non-compliance and/or questions regarding
under the
certification validity. This consists of five products (four masks, one isolation gown)
covering 16.7 million items of PPE and $44.9 million of spend.
11.
Products rated as amber are those where we have a suspicion of an issue based on
other issues with the same supplier for another product, or where we have as yet been
unable to sight the relevant documentation for the order. This consists of seven
products covering 35.8 million items of PPE and $34.7 million of spend.
12.
We have identified 3.5 million red products that have been distributed into circulation.
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We are undertaking a process to have those that are in circulation identified and put on
hold until our investigations are complete. A further 1.3 mil ion red products have been
put on hold in the central warehouse. Complicating the investigation of what is in
circulation is that some shipments from these suppliers for the same items were from
different manufacturing suppliers and we have been able to establish the veracity of
some manufacturing certifications but not others.
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Document Eight
Next steps
13.
Our immediate focus is to:
identify what additional red products are in circulation and quarantine these while
we undertake further analysis, including independent testing on the products
obtain further information needed on the amber products to assess whether there
is an actual concern requiring further investigation
confirm the initial assessments of the remaining products which are not currently
identified to have concerns.
Act
14.
We are assessing our inventory levels based on an assumption that at least some of the
red/amber products wil not be suitable for the intended purpose. This will help us
establish how much PPE we have available for use in the short term and whether more
PPE needs to be ordered pending a further outbreak of COVID-19.
15.
Where products are confirmed as non-compliant, we wil need to assess our approach
to responding on a case-by-case basis. Many of these orders were placed at speed and
detailed contractual disciplines were often not completed. This means the Ministry may
have limited solutions available in some instances.
Information
16.
Our goal is to have sufficient quantities of good quality PPE on shore in New Zealand
pending a potential further outbreak of COVID-19. We wil be placing orders for
replacement stock where required to ensure we achieve this.
17.
The Ministry wil report back to you about progress on the quality review of PPE, no
later than 24 June.
Official
18.
Officials can provide further information about this topic at your request.
the
Dr Ashley Bloomfield under
Director-General, Ministry of Health
Released
Health Report: 20200932
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