Patient Safety Learning blog: Ventilators – how to ensure that they are safe in use

Summary

In response to the ongoing coronavirus situation, the Government has put a call out for businesses who can provide support in the supply of ventilators and ventilator components for the healthcare system.[1] This has been met with a positive reaction from industry, with firms such as Dyson, Smiths Group and an industrial consortium (including Rolls-Royce, Airbus, McLaren, Thales, BAE Systems and Ford) responding to this.[2]

Patient Safety Learning has been engaging with key leaders in Parliament, the healthcare system and international colleagues on matters in relation to patient safety during the pandemic. With forthcoming introduction of thousands of new ventilators, we have been collaborating with human factors/ergonomics experts and colleagues regarding the design and development of these. 

It’s important that we have ventilators. It’s important that they’re safe. 

Content

What are human factors/ergonomics? How does this relate to healthcare?

The study of human factors/ergonomics considers both the physical and mental characteristics of people, as well as wider organisational factors. It applies scientific methods to the design and evaluation of jobs, equipment, environments and systems to make them more compatible with the needs, capabilities and limits of people.[3]

How does this relate to the production of ventilators for use in healthcare? 

It’s important when designing and developing these machines to ensure their usability – that we account for the people who are using them. That means making sure they are as intuitive and easy to use for frontline staff as possible, reducing the potential for error. This is especially pertinent in the current crisis, where doctors and nurses who are not necessarily experts in the use ventilators will be deployed to operate these while working under considerable pressure. 

Ensuring that safety considerations are taken on board during the development and design of ventilators can help to reduce errors and ultimately save lives.

Procurement of new ventilators

Manufacturers are being actively encouraged by the Government to design and deliver the extra ventilators required to meet the increasing demand as a result of the coronavirus. To meet the scale of the challenge this includes not just established manufacturers of these products, but also companies who haven’t previously produced these machines. 

Understandably priority is being given to the fast delivery of additional ventilators. The Department of Health and Social Care has been 'weighing up whether manufacturers could come up with new designs, issuing specifications for a “minimally acceptable” rapidly manufactured ventilator system’.[4]

The importance of patient safety in design and development

The human factors/ergonomics experts that we have spoken to have noted that there will be risks to patient safety which are linked with the need to manufacture new ventilators as quickly as possible. There are already some existing patient safety issues that relate to the ease of use of ventilators, due to multiple designs of these machines being in use within the NHS, with different training requirements for different devices. It is important that when putting in place minimum standards to speed up production that we don’t create additional risks to patient safety.

It is also important to account for people who will be using these machines. Particularly those who may be inexperienced or untrained in the use of ventilators, meaning that ease of use is a crucial consideration when developing these. Another factor is how well you are able to operate these machines while wearing full personal protective equipment (PPE) when treating coronavirus patients.

There is a risk that by moving at speed and developing non-standard ventilators to reduced standards (some produced by manufacturers who don’t have prior experience in this area) that we may unintentionally be designing a system than has numerous points of failure, increasing risk for patients. 

Should ventilators fail to be safe in use, we may not even realise this, as patients who are already seriously unwell with coronavirus may have deaths as a result of these failures attributed to the virus itself.

The need is great, and the timescale is short

Due to the time constraints and urgency to produce new ventilators, a full human factors/ergonomics development and usability testing process is not possible. However, we are connecting with experts working in this area who are committed to collaborate to make these new ventilators as safe as possible. Human factors/ergonomics experts fundamentally want to ensure any product, particularly with relation to the safety, are usable and account for human error.

How we can ensure ventilator safety?

It is important that these ventilators are developed with the principle the residual risk is reduced as far as reasonably practicable.

It’s important that we build existing knowledge to bring in committed recognised experts and fast track the development of safe ventilators. Action is needed now. 

In the last 48 hours the human factors/ergonomics experts we have engaged have identified requirements and proposed actions:

1. Sharing current knowledge and expertise:

• Sharing usability testing from current manufacturers for the user interface/use specifications for already approved ventilators.

2. Contributing to this fast development of ventilators with specialist human factor/ergonomics and clinical input including:

• Safety in use is included in specification and procurement.
• Current knowledge of best practice and risk informs ventilator design and use.
• Ventilators can be used safely by staff.
• Patient needs are included in the design brief.

Their proposals include:

• Developing a set of user requirements.
• Human engineering and user trials with hazard identification.
• Human factors requirements must be included in procurement.

The healthcare system, working together with manufacturers and experts in human factors/ergonomics, can ensure that we not only deliver the ventilators needed to tackle the coronavirus pandemic, but that we do so while ensuring patient safety.

We call for everyone working at pace to deliver these ventilators to call on the knowledge and expertise of human factors/ergonomists to minimise the usability safety risks.

References 

1. Gov.uk. Call for businesses to help make NHS ventilators. Last Accessed 30 March 2020. https://www.gov.uk/government/news/production-and-supply-of-ventilators-and-ventilator-components

2. Financial Times. UK steps up efforts to supply tens of thousands of ventilators. 30 March 2020. https://www.ft.com/content/8eca845b-56c8-4724-bd77-d7d83c005bfb

3. Clinical Human Factors Group. What are clinical human factors? Last Accessed 30 March 2020. https://chfg.org/what-are-clinical-human-factors/

4. The Guardian. Government chooses design of ventilators that UK urgently needs. 23 March 2020. https://www.theguardian.com/business/2020/mar/23/carmakers-make-nhs-ventilators-coronavirus-uk-government-nissan-rolls-royce