No medical procedure is risk-free but when harm to a patient might have been avoided, the distress is somehow magnified for everyone involved. In the aftermath, many patients and families seek comfort in the reassurance that lessons have been learned.

And yet serious patient safety incidents continue to occur in hospitals, including those categorised as 'never events' because they are considered wholly preventable. According to the latest published data from NHS Improvement, 218 'never events' occurred in NHS hospitals in England between 1 April and 30 September 2017, including wrong site surgery, retained foreign objects and medication errors.

A 'never event' is intended to be a red flag for NHS organisations, who are expected to investigate the causes and take appropriate action. However, as the MDU has previously argued, the emphasis on 'intolerable and inexcusable' errors is problematic because it deflects attention from the real goal of improving safety across the board by sharing information about risks and strategies to pre-empt them.

And even though the concept is not supposed to be about apportioning blame, investigations into the causes of a 'never event' tend to focus on the acts and omissions of individuals rather than examining the context in which errors may have occurred.

Drs Maryanne Mariyaselvam and Peter Young have engineered low-cost solutions to address recognised patient safety risks such as guidewire retention and wrong route drug administration. In discussing how innovations in equipment design can prevent patient harm and help clinicians work more efficiently, they explain why they believe we should not underestimate the significance of other factors.

'The argument often goes that the doctor doing the procedure 'should have been more careful'' comments Peter, a consultant in anaesthesia and critical care at the Queen Elizabeth Hospital in Kings Lynn. 'However, there are often a number of system failures which cause clinicians to make mistakes and this clearly seen during forced error simulations of different procedures. Everyone can make a mistake but we also know that people will act correctly when the system is set up to allow this. It's about taking the risk out of the equation.'

Maryanne is a clinical research fellow at Cambridge University. She and Peter analyse procedures that are associated with higher numbers of adverse incidents to see how they can be made safer. As members of the NHS Innovator Accelerator programme (NIA) which promotes shared innovation and learning across NHS England, they have developed a number of safety innovations that address known risks in acute medicine, anaesthetic and critical care settings. With other like-minded clinicians, they have established the Kings Lynn Institute of Patient Safety (KLIPS) to promote safer practice to a wider audience.

One example is the WireSafeTM, a procedure pack that prevents doctors from leaving the guidewire in the patient when inserting a central line. A rare but underreported problem, retained guidewires are categorised as a 'never event' by the NHS and can cause devastating complications if the guidewire travels to the patient's heart. The WireSafeTM is also being used for Seldinger chest drain insertions. Retained guidewires occur in 1:3,000 procedures and account for half of all never events in emergency medicine.

Everyone can make a mistake but we also know that people will act correctly when the system is set up to allow this.

'Inserting a central line is a complex procedure which is usually undertaken by a junior doctor in a very stressful situation' explains Peter. 'Currently this error is prevented by relying on the clinician remembering to remove the guidewire by using checklists, warning alerts, reminders, or a two-person check - which is not always easy if a doctor is distracted, tired or inexperienced - and this has been shown to have a limited effect.

'We wanted to make it impossible for a doctor to forget the guidewire at the critical moment, but without the intervention having an adverse impact on the complexity of the procedure, or the time taken to complete it.'

The WireSafeTM has been engineered so that doctors must physically remove the guidewire in order to access the equipment needed to secure the central line catheter. Only the guidewire can unlock the box containing the suture, needle-holder, forceps, scissors and antimicrobial dressings and the same box can be used to collect the sharps for safe disposal.

'Our goal was to engineer a solution that was convenient and safe,' says Maryanne. 'For example, we know during that disposal of the guidewire is difficult and it can spring out at clinicians when they are attempting to dispose of it in the sharps bin. With our solution, the guidewire is contained within the lightbulb shaped channel even after it is used to unlock the box, therefore disposal into the sharps box is convenient and there is less risk of injury or cross-infection.'

Peter and Maryanne tested their solution in a randomised controlled simulation study published in 'Anesthesiology'. Participants were asked to finish a central line placement after a colleague had been called away (replicating real never events which has been reported to NHS England's National reporting and learning system). In the standard group, 80% did not recognise the guidewire had been left in situ, they completed the procedure and returned the patient to the ward.

In the WireSafe™ group, participants did not immediately recognise the retained guidewire but were prompted to look for it when they were unable to access the contents of the procedure pack. All were able to retrieve the guidewire and complete the procedure without complications.

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Highly commended at the 2016 National Patient Safety Awards and winner of the Royal College of Anaesthetists, President's Award for outstanding achievement in 2016, the WireSafeTM is already in use in several trusts and is being actively implemented now across the NHS. It sits alongside other KLIPS innovations such as a non-injectable arterial connector (NIC) which physically prevents drugs being accidentally injected into an arterial line. The NIC was recently selected for fast-track funding under NHS England's Innovation and Technology Tariff which means hospitals in England are reimbursed for two years when they adopt the device.

But while senior NHS leaders are actively recommending and promoting innovation, Peter and Maryanne say they have faced more inertia at grassroots level. They believe this highlights a disparity in accountability for patient safety between frontline staff and administrators.

'Junior doctors are the people who carry out these procedures and even if it is not their fault, they experience blame, distress and self-doubt when something goes wrong,' says Maryanne. 'At the same time, they have no power to implement solutions. It takes courage to put your head above the parapet and call for change.'

'The narrative in incident reports is often quite telling,' Peter adds. 'They tend to say things like, 'This was out of character', invoking the doctor's background and character rather than the system or inevitable human error. In effect, the brunt of the blame for patient safety failings currently falls on foot soldiers in acute medicine but there should be accountability within the procurement process too.'

Peter and Maryanne state that they strongly believe that when effective system safety solutions exist, and hospitals do not introduce them, it is no longer acceptable to simply blame the junior doctor. Maryanne goes on to say, 'I think this shift of accountability is incredibly protective and powerful for junior doctors.'

Peter reflects: 'These innovations are a great news story for the NHS, which is helping to support their development and implementation, but they should also be an attractive option for hospital trusts. As well as facilitating correct decision making by clinicians and helping to protect patients from avoidable harm, implementing these solutions reduces the chance of a clinical negligence claim and is the mark of a strong patient safety culture.'

Interview by Susan Field


This article was correct at publication on 12/12/2017. It is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

Dr Maryanne Mariyaselvam

Maryanne Mariyaselvam is a clinical research fellow at Cambridge University, and is completing a doctorate in errors in healthcare and the development of engineered solutions to prevent never events. She a fellow on the NHS Innovator Accelerator Programme, NHS Clinical Entrepreneur Programme and is a founding member of the Q Initiative.

See more by Dr Maryanne Mariyaselvam

Dr Peter Young

Peter Young is a consultant in critical care at the Queen Elizabeth Hospital, King's Lynn. He completed his MD dissertation on pulmonary aspiration in mechanical ventilation in 2000 and his research interests include the development of a number of medical devices engineered to improve patient safety.

See more by Dr Peter Young