Coronavirus: guidance highlights potential risks for new PPE suppliers

To ensure that the process can be fast-streamed the government, in line with a European recommendation, is waiving the more formal requirements which are normally attached to the supply of PPE in the UK and within the EU, and which establish that the PPE is fit for purpose.

The last update dated 1 May (10 page / 463KBD PDF) shows a shift towards assuring safety, which may of course slow down the process of getting new sources of PPE on the market.

It provides some welcome clarifications on how the prospective PPE will be assessed by third parties through two alternative, swifter processes, before supply can begin. It makes clear that the normal approval process will need to have got past the stage of checking compliance with essential safety requirements, before PPE can be placed on the market.

The guidance also appears to shift, or at least share the responsibility, for ensuring and approving conformity with health and safety requirements from the supplier onto government or notified approval bodies.

This should offer some reassurance to manufacturers new to PPE, who under previous versions of the guidance seemed to be potentially opening themselves up to substantial liabilities in respect of any defective products. The new guidance should also provide reassurance to users about the quality of new sources of PPE coming onto the market.

The PPE must still comply with specified essential requirements, such as: providing the required protection against the identified risk whilst allowing the user to perform the at risk activity without unduly impeding them or causing another risk; and being manufactured to be easily fitted into the correct position and to be worn for reasonable periods of time.

However, the following requirements are waived under the new guidance:

• the need to have technical documentation available which sets out how the essential requirements are met
• the need to have carried out a conformity assessment procedure to demonstrate that production controls will ensure that PPE complies with that technical documentation;
• and the need for the PPE to be CE marked.

There are two alternative streamlined processes. Where the supplier supplies to the government PPE for NHS workers during the current health crisis, the PPE must now first be approved by the

cross-government decision making committee, which comprises amongst others the Health and Safety Executive, the Department of Health, and the Medicines and Healthcare products Regulatory Agency.

To allow the committee to assess the proposed PPE, the supplier must provide documentation including test reports which show the PPE has been designed to relevant standards or World Health Organisation (WHO) guidelines. The new guidance clarifies that the PPE will then be assessed and either approved (in which case government procurement will be in touch) or rejected subject to addressing specified issues.

If looking to supply more widely – for example to retailers, distributors or perhaps hospices - then the PPE can be supplied, provided the conformity assessment procedure has been started via a notified body.

Notified bodies are the independent organisations appointed by EU member states who examine the technical design of PPE and verify it meets the applicable requirements. Depending on the type of production process, they may also have some involvement in the check on production process and controls. The guidance includes a list of these bodies.

The 1 May update importantly clarifies that the process must have got to the stage of the notified body having confirmed that the supplier’s product offers an adequate level of health and safety in accordance with the essential requirements. Upon such confirmation the supplier can start selling the product, provided each product bears the notified body number on it, a batch and serial number and the supplier’s details, and comes with appropriate guidance and information. The update also requires that the Declaration of Conformity should have been completed to the extent possible.

The guidance note also points potential suppliers to a list of some 25 applicable standards hosted on the British Standards Institution (BSI) website. The BSI is currently providing free access to these standards during the Covid-19 outbreak, and is offering help to manufacturers in respect of the applicable standards.

In addition, the guidance also considers alternative solutions including those proposed by the WHO.

The updated guidance does note, for the process aimed at supplying to the wider market, that the notified body selected by the supplier will help the supplier through the process.

What are the risks for the supplier?

The new guidance counterbalances the risks otherwise faced by a manufacturer turning to PPE for the first time. A supplier lacking experience and no doubt having to work fast to get up to speed risks making mistakes.

It is clear that even existing approved CE-marked PPE may be causing risk to users – for instance it has been reported that the PPE provided is not suitable for many female workers (the larger percentage of the NHS workforce) because it is sized for a reasonably well-built man. Again, having third-party approval, at least in terms of essential health and safety requirements, is of help.

The guidance update makes it clear that the manufacturer still retains the responsibility for ensuring that its production processes are constant enough to ensure that the PPE keeps meeting the design assessed and approved by the committee or the notified body. But this is a more realistic ask of a manufacturer already established in the mass manufacture of another product.

The guidance also proposes that manufacturers should monitor any complaints and carry out sample testing in the market – something which is part of the normal obligations.

The earlier guidance, whilst setting out powers of enforcement and penalties available under the PPE legislation, gave no specific guidance or indication that enforcement bodies and courts should take a more lenient approach in the circumstances. The European Commission note which the guidance draws from does suggest that technical breaches which do not affect essential safety requirements should not be a focus.

The updated guidance note now omits to set out such powers of enforcement, which nonetheless remain in place.

Recommendations for suppliers

Our recommendation would therefore be that a manufacturer ensures it has enough documentation to show that it has considered its procedures and put quality assurance and control measures in place.

Even if a regulatory body exerts some leniency in approach, it is unclear what the situation would be in the event of a civil claim, for instance in respect of death of NHS workers or breach of contract. Whilst the government has offered an indemnity to designers and manufacturers of ventilators against product liability claims, there is not currently an equivalent for PPE.

A personal injury claim seems unlikely to succeed: the potential claimant would have to prove that the manufacturer had been negligent by comparison with the standard expected. Whether the courts would make any allowance for the current situation remains to be seen.

The claimant would also have to prove that the injury was caused by the defective PPE, which is likely to be much more difficult to evidence when thinking about the volumes of PPE being used and other exposures.

However, if a batch of PPE is declared to be non-compliant – for example because of an issue in production not picked up in the streamlined approval process – and rejected by the NHS, it remains unclear whether the supplier would receive any payment, what terms and conditions it is signing up, and whether it is exposed to any damages for failure to supply. These are all points for consideration ahead of entering into a commitment to supply.

Assisting the current effort with PPE is to be commended. The revised guidance is more evenly balanced and reduces the level of risk for both suppliers and users, which must be a positive, subject to time constraints.