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PANDEMIC REFLECTIONS – A review following the PPE crisis of 2020

PPE Personal Protective Equipment Required Industry concept. Safety health and work accessories.

The pervasive marketing of non-compliant and unsafe PPE shone a bright light on the lack of regulatory control for these safety-critical products and resulted in the market being full of potentially unsafe products. The existence of poor quality PPE, while extreme during the pandemic, is not a phenomenon just of that period. These concerns and the vulnerabilities were already known to BSIF and those of the industry.

While BSIF sets out to review and reflect on the events of 2020 and their efforts to support the country’s response, it calls on action to address the current and ongoing marketing of PPE which is non-compliant and not fit for purpose.

The landscape

Many PPE items, while safety-critical, are of high volume but relatively low unit value, and much of their manufacturing has long been off-shored to China.

By late February of 2020, BSIF began hearing of interruptions in PPE supply and reports of the Chinese Government taking control of PPE manufacturing, directing products exclusively for domestic use.

BSIF advised the Health and Safety Executive (HSE) of likely shortages. The alert to the HSE was driven by concerns that PPE stocks for the industrial safety and health market would be significantly affected, but given the scale of what unfolded, in hindsight, this concern for the industrial market seems almost naïve.

Later, with Italy in lockdown and their health service overwhelmed, the demand for Covid-19 related PPE exploded, first across Europe and then globally. This was at the same point that the authentic supply chain was collapsing, a perfect storm of skyrocketing demand, coupled with dwindling resources. By the start of March BSIF was supporting the UK authorities who were scouring for immediate supplies of FFP masks for front-line healthcare staff.

By the beginning of March 2020, BSIF was providing support and information on PPE sources to the Cabinet Office, the Crown Commercial Agencies and the various structures supporting the NHS and public health agencies across the devolved nations. BSIF supplied the senior contact information for legitimate manufacturers and suppliers in the UK and across Europe, in order that the authorities could communicate directly with the right people. In addition, along with the European Safety Federation (ESF), BSIF did the same for the EU Commission which was seeking to source communally, on behalf of member states. Meanwhile, the UK’s strategic pandemic PPE stocks were being audited and often found to be beyond their useful life.

In response to the shortages, certain EU states unilaterally prohibited the export and free movement of PPE with a range of conditions applied by the various member states. The ensuing chaos of this action led to the EU publishing “Recommendation 2020/402” which required any exporting of PPE to undergo an “authorisation” process.

BSIF and ESF were active in engaging with the Commission and other authorities on the damage such a poorly designed protectionist process would do. In the first place, PPE and Covid related PPE does not have identifiable tariff codes, and furthermore, many international PPE manufacturers who warehoused centrally in EU states, including the UK, had difficulties moving products to legitimate priority markets.

In the UK, Her Majesty’s Revenue and Customs (HMRC) took the lead in providing approvals for the movement of relevant products.

Subsequently, the EU Commission produced their “Recommendation (2020/403) on allowing PPE for covid-facing healthcare workers, to be placed on the market without it having to go through the full product approval processes. Along with ESF, BSIF challenged the EU Commission on the potential dangers of this move.

In parallel BSIF began to work extremely closely with the Department of Business Energy and Industrial Strategy (BEIS) and the Office for Product Safety and Standards (OPSS) on supporting how the EU Recommendation 2020/403 could be employed in the UK.

BSIF proposed a triage system of receipt and testing of PPE, recommending appropriate laboratories with easy access to and from Heathrow. In the end, a version of the proposed system was set up, led by a dedicated OPSS/HSE technical team working out of the MoD facility in Daventry. This team was charged with “accepting and releasing, fit for purpose PPE” sourced directly by the Government on behalf of healthcare workers.

By April 2020, BEIS/OPSS produced the first Guidance on how Recommendation 2020/403 could be applied in the UK. The Recommendation changed the process by which PPE would be allowed to be placed on the UK market. Along with the consultations BSIF provided to BEIS/OPSS on creating the Recommendation Guidance, once published, it had to be interpreted and communicated to the BSIF membership and the wider market including end-users.

Recommendation 2020/403, produced in April 2020, was to be applied by member states (including the UK) as they each saw appropriate for their own specific needs. Confusion, over what the Recommendation actually allowed and how it should be applied, was significant with the member states and Notified Bodies giving approval decisions as they saw fit.

The government, in parallel, had put out the call for UK based manufacturers to convert production to Covid-PPE and many did. Once again, however, BSIF had many well-intentioned businesses lacking the appropriate knowledge in making PPE and attempting to have it certified under the temporary easement. The results were mixed. At this time the BSIF Test and Certification Association, the group of UK Notified Bodies, were debating the actions necessary to apply the Recommendation consistently in the UK. This unique collaboration provided for the Government through the BSIF Test and Certification group, was extremely valuable to BEIS/OPSS, even if ultimately the process was imperfect.

Coinciding with the soaring demand and fracturing of traditional supply chains, came an eruption of other opportunist businesses attempting to supply PPE into the UK. They were doing this without understanding the critical nature of the product and with little attention paid to compliance or product provenance. Internet portals and online marketplaces were promoting significant quantities of non-conforming, unproven PPE. It was not just the traditional online platforms selling these products, they were also being sold by individuals on personal Twitter and LinkedIn accounts, at hugely inflated prices.

While we use the term “PPE” within this text, the priority focus early on was around the supply of filtering facepiece FFPs (disposable masks). However, as the crisis wore on, the supply of other PPE items such as face shields, limited life garments and gloves were added to the list of products in short supply and subject to the same abuses as experienced with respiratory protective equipment. End users, the vast majority in healthcare and essential services, were desperate to find supplies, but often did not know what legitimate products looked like.

BSIF were asked to contribute to the creation of PPE Guidance for GP Surgeries. At this time we began to see the arrival of FFP masks with “ear loops” instead of the “adjustable head harnesses” as required by the product standard. In most cases, the FFPs being supplied were “KN95” – a classification of respirator under the Chinese domestic standard GB2626. The KN95 is not compliant with UK or European PPE standards. Many of the products were not even legitimate KN95 certified respirators. Despite it clearly being outside of the Regulation, the products flooded the market. The KN95 was being commonly marketed as KN95/FFP2, but they perform differently with testing and quality assurance requirements less stringent than an FFP2 under PPE Regulation 2016/425. The HSE were aware of the product and its drawbacks and in June 2020, the HSE position was clarified via a “Safety Alert”, warning against the use of KN95 to protect against Covid-19. However, the KN95 masks continued to be sold openly.

In addition to the KN95, FFP masks certified to EN149 with ear loops, instead of adjustable head harnesses were being seen in the UK. Such masks struggle to “face fit” properly, failing to provide a seal with the face leaving the wearer unprotected. The HSE and the NHS refused to allow the wearing of FFPs which had ear loops. While HSE insisted on the need for face fitting when any tight-fitting respirator such as an FFP was deployed, a consistent supply of the masks did not happen.

With insufficient competent face fitters available and the kit necessary for carrying out face fits also in short supply, BSIF was actively supplying the recipe for the manufacture of the test agent used in the “Qualitative” method to potential manufacturers. It must be recognised that Fit2Fit Accredited face fitters carried out more than one million face fits in the NHS Trusts and in the new Nightingale facilities in extreme circumstances.

Many areas of society were now confronting the need to wear PPE to mitigate against the risk of Covid including GP and Dental Surgeries. Dentists, closed since late March, were by June attempting to re-open but needed the appropriate PPE and face fitting for respirators. With little background in PPE, respiratory protective equipment or the need for face fitting, the situation in dental was chaotic.

The Royal College of Nursing and the British Medical Association were also concerned and wrote to BSIF on the challenge of providing respiratory protective equipment suitable for the diverse NHS workforce.

In support of the market, BSIF created a webinar to assist users in identifying safe and compliant PPE. Alongside the webinar, a series of documents were published to help users and potential suppliers identify genuine PPE amongst all of the non-compliant and illegal products being offered in the market.

BSIF produced and publicised a series of guidance documents including “Is it Genuine” to illustrate what users and inexperienced suppliers should be looking for when checking PPE paperwork. At this time there was also the conflation of medical masks and PPE requiring BSIF staff to develop at least some expertise in Medical Device Regulations, as well as reaching out and creating relationships at the Medicines and Healthcare products Regulatory Agency (MHRA).

At every turn, non-compliant PPE was being placed on the market and, central to the problem, was a number of fraudulent, dishonest and misleading documents offered in support of products. While some paperwork was clearly fictional, some were wrong or not what was required by legislation, with others misleading and copies of legitimate paperwork applied to different products.

There was also something of a growing phenomenon whereby several Notified Bodies (not scoped for PPE approvals) were providing certificates purporting to be CE certificates for PPE but which were nothing of the sort.

Along with fake certificates, bogus certification bodies offering CE PPE approval decisions emerged.
The challenge going forward is for the country to be prepared for the next time a crisis of this nature occurs. There is an enquiry scheduled in early 2022 on the pandemic response, promising to examine all the circumstances and actions in the handling of the crisis.

However, given the time such enquiries take, BSIF calls on the government now, to design and publish a PPE Strategy to enable the timely provision of adequate and suitable PPE for frontline and emergency services without billions of pounds being wasted and the safety marketplace polluted with non-compliant and potentially dangerous PPE.

This Strategy must create a workable set of contingencies involving the appropriate regulators and experienced PPE manufacturers, along with approval bodies and logistics experts.

As a minimum, a task force should be in place including but not limited to, OPSS, BEIS, HSE, MHRA, an empowered representative of Trading Standards and the BSIF. In this way, a plan can be ready and on the shelf to provide a rapid reaction for PPE security.

What lessons have we learned?

We learnt that the UK was unprepared for the pandemic and that it appeared the authorities did not understand PPE. The existing stock was inadequate and reactive supply attempts were disorganised and chaotic, with much of the stock brought in not fit for purpose.

We learnt that a great deal of non-compliant, unsafe PPE was able to be placed on the UK market with the authorities often apparently incapable of stopping it. This was not news to BSIF, but the exaggerated volumes highlighted the problem with dramatic effect. However, we also learnt that ultimately where there is enough publicity the authorities will take an interest in ensuring that PPE is fit for purpose. A dedicated technical team headed by the HSE triaged incoming shipments of PPE purchased directly by the Government on behalf of the NHS and Healthcare and the HSE also established a Product Safety Market Surveillance Unit and was then actively engaged in PPE market surveillance and intelligence gathering. Many of the HSE team involved at the time have since been re-directed onto other activities.

We learnt that the legislators, the market surveillance authorities and the institutions of this country did not have adequate PPE knowledge but with the direction and focus created by the crisis they will seek training and input. BSIF provided access to the content of our Safe Supply Qualification modules on Product Standards and Certification. The learning provided by BSIF was used by OPSS and the Chartered Trading Standards Institute (CTSI) to help their field officers.

We learned or had re-enforced, the ease by which bogus products are sold via the internet, with the market surveillance authorities impotent to stop it. Furthermore, the authorities appear content to stand behind the “safe harbour” defence of portals taking no responsibility for the PPE their platforms promote.

Ultimately the PPE crisis of 2020 will be seen as a moment in time but the problem of non-conforming PPE continues and will continue until the enforcement of the applicable Regulations are effective. PPE was a significant priority in 2020, a topic central to the political challenge of the time. It no longer is.
However, the country must be prepared for the next pandemic and in the context of PPE, it must have a robust strategy in place.

So what can be done?

We have already laid out what needs to happen on the strategic pandemic response level, but events of the pandemic highlighted the problem of product compliance we encounter every day in the safety industry. Action must be taken to protect those that rely on PPE in the general market.

PPE is critical to wearer safety and goes far wider than the narrow range of covid related PPE. The Regulation must be enforced and users kept safe in the short term and have their long term health protected. Achieving more resources and a transformation in approach by the authorities seems unlikely to happen, but some simple actions will produce disproportionately strong results in the battle against unsafe non-compliant PPE being placed on the UK market.

The non-compliant PPE will exist in the supply chain prior to its sale for occupational use and the problem should be addressed, in that supply process, prior to it reaching the wearers. Trading Standards have the experience of dealing with traders and in a wide range of supply chains, HSE does not have a history of involvement or access to suppliers. BSIF believes that Trading Standards must be the primary enforcement authority for PPE.

This document was written in its full article during the latter stages of 2021 after some of the dust had settled around the PPE crisis created by the Covid-19 pandemic.

The British Safety Industry Federation (BSIF) is the UK Trade Association for the Safety Industry, whose members include the manufacturers, importers, distributors and specialist service providers in personal protective equipment (PPE) and associated safety apparatus.

BSIF was established in 1994 and since that time has been providing leadership and authoritative information on a wide range of workplace safety issues and representing the needs of the UK market and the country’s workforce. It is our mission to support all businesses in the UK that help to keep people safe and healthy at work and we are passionate that safety and health are universally recognised for what it is – a positive force for good.

BSIF works closely with the Health and Safety Executive and Trading Standards with whom we have Primary Authority partnership. BSIF are the UK’s leading association for the Personal Protective Equipment (PPE) Regulation 2016/425 and provides guidance for PPE compliance, working closely with Regulators and are active across a range of Government departments.The events of 2020 elevated the profile of PPE to a level never seen before and highlighted the dependence the country has on extended supply chains. Alan Murray, Chief Executive Officer, BSIF reviews the PPE crisis of 2020.