The importance of equipment design in patient safety

The true nature of errors

Such factors are often (and erroneously) described in NHS incident reports as ‘human error’ but this does not reflect the true nature of why these errors occur and does not help to improve patient safety. The motivation of the user and the healthcare context need to be understood to explain how staff and patients may use equipment.

We are all capable of making errors but there are certain contexts or design features that can make it more likely that an error can occur. The design and usability of healthcare devices and equipment can impact on delivering the correct care in the context of busy and distracting healthcare environments.

Confusion between ‘use error’ and ‘abnormal use’

In the world of safety there is a concept known as ALARP – to minimise risk to As Low As Reasonably Practicable. This is applied to designing new processes, products or when accepting new devices into an organisation.

Designing equipment with the potential for likely ‘use’ errors in mind is a regulatory requirement and considered one of the most effective ways to minimise risk and increase safety.

At the moment, the NHS is often reliant on clinicians and support staff to identify risks in the devices they use in their everyday practice and adapt how they work to help overcome design features that may increase the risks to patient safety. This could be described as an ALASP principle - As Long As Staff can Prevent (ALASP) errors occurring.

Sometimes there can be confusion between ‘use error’ and ‘abnormal use’ when referring to errors involving medical devices and equipment. ‘Abnormal use’ should consider when staff actively seek to use a device not for its intended purpose or intention. This is different to ‘use error’ when staff who are trying to use devices for their intended purpose but make errors that are predictable, which may be due to devices and equipment not accommodating or being tested in the environments or conditions that staff work in.

Typical ‘use errors’ occur where the work environment or product prevents ease of use by staff. For example, where it doesn’t account for poor lighting, the impact of distractions, or may cause confusion for users where the design is not sufficiently different from similar looking devices. These characteristics may make it harder for staff to work and ensure safety in the current healthcare climate where time pressure and multi-tasking is required to deliver care.

The concept of designing to minimise ‘use error’ has been the aim of human factors professionals working over several decades within many safety critical industries. Improving patient safety through the design of equipment is as important as ensuring the safety of passengers in planes and trains.

Recognising the importance of device design for the NHS

National standards and international standards explain the need for the design of equipment to be relevant to the context it will be used in and for testing by staff who will use the equipment to help identify and understand known risks. The practise of fully evaluating products before bringing devices into the NHS, or robust user testing at a national level, are yet to be fully established in healthcare, unlike in other industries.

Limited recognition of device design and evaluation as a key feature of patient safety in the NHS can increase the risk of harm occurring from the interaction with medical devices. There is a developing role for human factors professionals and staff with appropriate human factors knowledge in roles across healthcare to ensure that the principles of safe design are embedded, recognised and applied to address safety issues and subsequent harm.

NHS Supply Chain does apply human factors principles to consider what makes it onto their product list for NHS organisations and could support safety in the NHS equipment procurement process. However, there is no requirement for NHS organisations to procure from the product list, and this can increase the variability and risk in products that are procured.

NHS staff may often be held accountable for the use of devices and equipment leading to patient safety events. How fair is it to continue to do so? We need to acknowledge this and develop a way to ensure the design of healthcare devices and equipment can help staff and promote patient safety.