Manufacturers from industries including automotive want to help the UK ventilator shortage during the Covid-19 crisis - but regulations present a number of challenges

ventilator

Ventilator machines are used to help patients experiencing respiratory distress breathe (Credit: Dr James Heilman/Wikimedia)

With UK prime minister Boris Johnson calling on non-specialist firms from a variety of industries to weigh in and help solve the country’s Covid-19 ventilator shortage, regulation may be one of the biggest obstacles standing in their way.

The government’s Department of Health and Social Care (DHSC) recently revealed the NHS has about 5,000 adult ventilator machines at its disposal, and an additional 900 of these devices for children.

 

How many ventilators are needed for Covid-19 patients – and regulations obstructing manufacturing expansion

It is estimated as many as 20,000 extra ventilators could be required to treat infected patients during the coronavirus pandemic.

Because of this, a number of manufacturers with bases in the UK – including Ford, Honda, Rolls-Royce and JCB – are reportedly turning their attentions towards helping to build these life-saving pieces of equipment.

As firms attempt to collaborate amid a growing public health crisis, they may have to adhere to the same rules and regulations as the rest of the medical device sector.

And, as outgoing Medical Device Developments editor Emma Green notes, it is by no means an easy process for manufacturers to navigate their way through.

“It’s quite a closed industry”, she says. “They are typically not looking at what other industries are doing, so it tends to be quite insular.

“In light of the complexity and sheer volume of regulation, the industry is relatively slow-moving compared to other sectors. Products typically take months and years to get to market, rather than weeks.

“Given existing legislative requirements – as well as the complexities involved in obtaining relevant components and tooling – there currently aren’t clear pathways to move forward in the way the government has suggested.”

 

How UK medical devices regulation works

Medical devices in countries within the European Union – which still includes the UK during the Brexit transition period – are governed by EU legislation.

The medical device authority designated by the EU to oversee medical devices in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA), which is also part of DHSC.

All new devices must meet MHRA standards to ensure they work properly and can be used safely.

The design and manufacturing of medical devices requires MHRA approval, and the regulatory body can issue recalls if they are found to be unfit for their intended purpose, or unsafe.

Companies wishing to sell these devices also have to register with the MHRA.

uk ventilator regulation brexit
The UK will still have to adhere to EU legislation on medical devices after Brexit (Credit: Marco Verch/Flickr)

The MHRA works in tandem with EU laws – which are split into general medical devices (MDR) and in-vitro diagnostic devices (IVDR).

EU regulations also require devices to obtain a CE marking, which indicates they conform to health, safety and environmental standards.

Updated guidelines for countries in the EU were enforced in May 2017, introducing increased safety measures and stricter regulation around the clinical performance of devices.

On 26 May 2020, after an initial implementation period of three years, these guidelines will be applied to any devices already in use – in addition to all newly-produced ones.

EU restrictions on medical devices sold or manufactured in the UK will still apply after the country completes its transition period, and exits the European Union, at the end of 2020.

 

UK ventilator regulation explained

In the UK, medical devices are also given a classification depending on the level of risk associated with them – the strictest controls are placed upon products with the highest risk.

These include Class I devices, which are considered to be low risk, Class IIa and IIb devices, which are low-to-medium and medium-to-high risk respectively, and Class III devices, which are associated with the highest level of risk.

These classifications are based on a number of factors – including the intended purpose of the device; how long it’s intended to be in use for; and whether or not it is invasive, implantable or contains a medicinal substance.

As a Class II device, ventilators require clinical trials before they can be placed on the commercial market.

In order to gain a CE marking, developers must also carry out – and provide proof of – extensive quality assurance tests and examinations to ensure they conform to EU guidelines.

These extensive regulations are one of the main reasons why ventilators and other Class II devices can take months, and sometimes years, to go from being designed to reaching the commercial market.

 

Challenges presented by regulation

The coronavirus pandemic has led to talk of many manufacturers that don’t traditionally work on medical devices lending a hand to alleviate ventilator shortages.

One of the biggest obstacles facing these companies is the lengthy time frame associated with producing Class II devices from scratch, and the impracticalities of carrying out clinical trials under current conditions.

The fact that non-medical device manufacturers will not have a licence from the MHRA to produce these machines is also a problem in itself.

Even if traditional, licensed medical manufacturers subcontract their production to other sites, resulting devices will still need to undergo extensive testing in line with MHRA regulation.

The regulatory body would also still need to “sign off” on any device built on a new site as well.

To get around this, Green says many of these companies will have to use established manufacturing processes to build ventilators using existing designs.

However, this may present a new challenge, with reports suggesting it could take weeks, or even months, for non-medical manufacturing companies to ensure their production facilities are suitable for making ventilators.

Green believes another issue arising from the ventilator shortage is actually sourcing the parts required to build one.

These individual components come from all over the world – and the fact this has to be done within a limited time frame only increases the challenge manufacturers are facing.