The COVID-19 pandemic has led to a dramatic worldwide increase in demand for Personal Protective Equipment (PPE). Globally, demand is outstripping supply; many UK organisations are experiencing supply challenges, including:
- NHS, primarycare, hospices, social care and home care
- Businesses who need to carry out normal operations and protect key workers
- Businesses that don’t normally require PPE, such as supermarkets and logistics organisations.
Read this factsheet to understand:
- the types of PPE that are in demand
- the government and NHS response
- the specific regulations and certifications
- changes that have been made to help with the problem
- specific technical requirements of PPE provision.
Why is the PPE challenge so pronounced?
Before the crisis, China was the largest producer of PPE finished products, as well as of many of the raw materials needed to manufacture these products. According to Unicef, China produced an estimated 50% of surgical masks globally (estimated to be 20 million masks a day, pre-pandemic), while Taiwan alone makes up 20 percent of the global supply of face masks. With China the first to enter lock-down as PPE demand soared, the supply chain was massively disrupted.
As virus restrictions in China have lifted, the country has directed its manufacturing might toward making the PPE that health care workers need to battle the coronavirus. However, the market to procure those supplies is now very competitive. Alongside issues with traditional PPE procurement, it is challenging for companies to re-purpose as a PPE provider. There is a raft of regulations, certifications and standards that are highly technical. It’s even harder to re-purpose and produce PPE at scale.
The NHS and government response
- Paul Deighton, London 2012 Chief Executive, was appointed to lead the national effort to produce essential PPE for frontline health and social care staff on 19 April. In an unpaid position, he will work across the Department of Health and Social Care, NHS England, and other government departments. His role will be to coordinate the ‘make’ programme: the end-to-end process of design through to manufacture, including streamlining the approvals and procurement process to ensure new domestic PPE supplies are rapidly approved and get to where they are needed
- The Cabinet Office and Department for Health and Social care are working with Deloitte to increase the availability of PPE to the NHS and social care.
To meet the urgent volume requirements, the NHS set up a PPE Dedicated Supply Channel. The list of core PPE products now handled by this channel is as follows:
- Clinical Waste Bags
- Examination Gloves
- Eye Protection – Glasses
- Eye Protection – Visors
- Face Masks Type IIR
- Respirators FFP2
- Respirators FFP3
- FiTTesting Kits
- FiTTesting Solutions
- General Purpose Detergent
- Hand Hygiene
- Swabs and Test Kits
- Body Bags.
Community Healthcare Partners
- All providers including primary, adult social care, dentists, pharmacies, third sector, adult care homes and hospices are being asked to continue to order PPE from their wholesalers
- The Department of Health and Social Care is working to provide stock to wholesalers and distributors so that providers like pharmacies, GPs and dentists can order PPE through their usual supply chains
- Local Resilience Forums are being supplied with PPE products to support GPs and social care providers according to local need.
Regulations, certifications and rule changes
The legislative framework
The manufacture of PPE is governed by product safety legislation. The framework for PPE regulation stems from EU Regulation 2016/425. This has been implemented in the UK by the Personal Protective Equipment (Enforcement) Regulations 2018. Conformity assessment requirements have changed to assist the accelerated delivery of PPE (see below).
The Office for Product Safety and Standards has produced new guidance if you want to change your processes to make high volumes of PPE:
- Where you only intend to sell/donate PPE to the NHS via the UK government: the Health and Safety Executive (HSE) is the market surveillance authority and must approve products which can then by supplied without having a CE mark
- Where you intend to sell PPE to distributors, retailers or directly: no CE mark is needed but manufacturers have to have started the process of approval with an accredited laboratory. Labs are prioritizing COVID-19 approvals.
Importing and exporting PPE
- A tax relief has been made available for eligible UK-based organisations to pay no import duty and VAT on protective equipment and relevant medical devices brought into the UK from non-EU countries during the coronavirus outbreak
- Organisations will temporarily need a licence to export PPE outside the EU, EFTA member states and certain other territories.
Further information and resources
For those struggling to access PPE:
- CBI resource - accessing and providing PPE: If your business is struggling to access supplies or would like to help provide critical PPE supplies – head over to our dedicated page
- The National Supply Disruption Response line: NHS bodies and community healthcare partners can send an email or call on 0800 915 9964 if they need urgent supplies of PPE.
For further information on technical specifications for PPE:
- The Cabinet Office and the Department for Health and Social Care has published official technical specifications for many of the PPE categories
- The Office for Product Safety and Standards has produced new guidance for businesses changing their processes to make high volumes of PPE to protect users from COVID-19
- Standards relevant to PPE for COVID-19 are available free from the British Standards Institution and there are also WHO guidelines on COVID-19.
- Understand NHS procurement’s approach to PPE
- UNICEF’s COVID-19 impact assessment and outlook on personal protective equipment
- For a more detailed analysis on this topic, read the Asian Development Bank’s report on global PPE shortages.