WireSafe®: Designing a new patient safety solution – An interview with Dr Maryanne Mariyaselvam

Summary

WireSafe® is an innovative solution designed to prevent retained guidewires during central venous catheter (CVC) insertion. Retained guidewires are never events that require urgent removal if accidentally left in. They occur in about 1 in 300,000 procedures.

We interviewed Maryanne, who developed the WireSafe®, on the innovation, the human factor considerations in designing it and the difficulties she faced getting a new product into the NHS.

Content

Questions & Answers

Hi Maryanne. Firstly, can you tell us why guidewires are a patient safety issue and why you decided to do something about it?

Yes. A retained guidewire is a retained foreign object post procedure and is classed as a never event; that is an error that should not happen. However, research shows that retained guidewires after CVC insertion occurs in roughly 1 in 300,000 procedures. When it does occur, it requires urgent removal to prevent further complications for the patient.

Clinicians can do thousands of these procedures correctly over their careers but sometimes they make mistakes.  This error occurs because the clinician can forget to remove the guidewire. Research shows this occurs due to distraction at a critical point in the procedure.

Currently, preventative measures in place to reduce this error include re-educating the clinician, reminders to remove the guide wire, checklists, or a two-person approach. However, with this type of rare error, these preventative measures don’t address the problem because they rely on the operator remembering not to make the mistake. In humans factors terms we know this is unreliable, which is why the error is still reported to occur twice per month. Our team, wanted to find another solution.

How did you come up with the idea of WireSafe®?

We spent time observing clinicians during CVC insertion, seeing what people were doing and how they were doing it; i.e, why doesn’t the error happen during the other 299,999 times? Then we looked at literature, data from NHS England and Improvement and interviewed clinicians who made this mistake, and from this we determined why the error occurred. On this basis we were able to design a solution to prevent it.

Initially we thought about using different attachments, changing the guidewire physically. However, there are many elements to take into account if you want to physically change the guidewire – the users, the manufacturing, the supply chain. Persuading the manufacturer to change the guidewire is expensive. But more importantly, if you change the guidewire, which is an integral part of the clinical procedure, it affects many stages in the process and so you can end up making the process more complicated to solve a rare error, which in turn could make this or other errors more likely to occur.

It soon became clear that we needed to design a system that has very minimal impact on the procedure and the user, that fits into the manufacturing and supply chain process and is cheap enough for hospitals to purchase.

We also had to understand human factors and human behaviours. If people don’t like a product or process, if it is too difficult or cumbersome, they won’t use it. This is not just clinicians, its true of all of us. For example, if you have ever hired a car the buttons and levers are in different places to your own car and, when you are driving the hire car, not only it is irritating because you are getting things wrong, it could be dangerous.

So you have to really think about the solution you introduce to prevent a rare error. It has to solve the problem, have minimal impact to the clinical procedure and be easier than previous practice for clinicians to ensure that the safest option is the easiest one.

Did you meet resistance to the idea from clinicians?

People know the error happens but different people have different ideas as to why the error happens. Some think it’s inexperience, staff fatigue or rushing due to emergency procedures. However, we know that very senior doctors make this error, despite having an exemplary career and performing hundreds of these procedures without errors, and this error also happens during routine elective work. Our extensive research has shown that the error occurs because the clinicians forget to remove the guidewire at a specific point (the critical point) in the procedure, usually due to distraction. If this happens there is nothing to remind the operator to remove the guidewire, as it is not needed again after the critical moment and so it can get forgotten.

It’s an error which happens all the time, over the world. It’s understandable why people don’t understand the errors in terms of human factors thinking. We’re not taught human factors at medical or nursing school. The key was to help clinicians understand why the error happened.

Once we developed a solution, the research trials and clinical studies[1] demonstrated that not only was a solution needed, but that it worked.

Doesn’t a checklist prevent this type of error?

Checklists are good solutions for common errors. The difficulty in using a checklist for an error that occurs 1:300,000 procedures is that most clinicians never see the error in their lifetimes. So the checklist for a rare error can become a tick box exercise rather than a useful preventative tool.

Also, when the clinician is performing this procedure they are scrubbed, as in a surgically sterile environment, and it’s impossible to do a checklist at this time. So the checklist is performed after the procedure has been completed, when the clinician has de-scrubbed. Having a checklist at this point is unhelpful because the mistake has already been made. Interviews with clinicians who had made the error said that they had ticked the box to confirm that they removed the guidewire. Clinicians who make this mistake have probably done hundreds of these procedures correctly over their career so would naturally assume that they would have done it correctly that time too. Comments from these clinicians have been: “I don’t know what had happened”, “I don’t know why I didn’t do it”, “this has never happened before”.

I guess it’s almost an error of familiarity; I liken it to driving home and you have parked in front of your house, but you can’t remember the journey you did, as you’ve done it hundreds of times before. That's because you’ve been on autopilot. Did you indicate when you turned into your road? Yes of course I did. I always do.

But wouldn’t a checklist be cheaper to implement?

Implementation of a checklist is not easy and not a quick fix solution. It's wrong to think it is free and an additional piece of kit costs money. In terms of time and errors, it’s not free. To do it properly, a good and easy to use checklist has to be designed, introduced into clinical practice, and all staff need to be aware and understand what they have to do. There is the time spent doing the checklist during every clinical procedure and then audits to check the checklist is being done. All of this time incurs cost.

There is also the cost of recurring errors. There are reports of hospitals having further multiple errors, despite introducing the checklist after the first error.

What are the challenges in getting a new product into NHS?

It is disheartening when you find clinicians who think the WireSafe® is amazing but say it’s too hard to get through the system. It’s the saddest thing I’ve heard. It’s not that it’s not a good product or that it won’t solve the problem, but the bureaucracy is too hard and the systems in place make it too hard to introduce. This is particularly true for a small company. And clinicians are busy, so it is unfair to ask them to spend huge amounts of their own time and effort to try and get a new innovation introduced. It’s a real shame that is the way it is at the moment.

Also, people falsely think that if they have a good idea all the really big medical companies will want it and the innovators don’t need to do anything else – but it’s simply not true. You approach companies and show them and most of the time they say prove the market first and then we’ll come back to you – then we’ll be interested. It is a long and difficult journey.

How did Venner Medical become involved?

We had worked previously with Venner Medical on another medical device and we approached them again and fortunately they said yes. I am incredibly grateful to Venner Medical for taking the WireSafe® on as it’s a risk for a company and they don’t know if it will be successful and whether they will get their investment back.

What feedback have you received on WireSafe®?

In the places that are using the WireSafe® we’ve had great feedback. Clinicians like it because not only does it prevent the error, but it makes the procedure a lot easier to perform. However, there aren’t that many sites using it in the UK; we are getting more traction in the US at the moment, which is a shame but least patients are getting the benefit there.

The Yorkshire and Humber Patient Safety ARC are currently doing a study on the impact of WireSafe® and hopefully this will encourage more trusts to take it up in the UK. 

Maryanne is undertaking a Doctorate on Understanding system and human errors in the NHS, use of engineered solutions to prevent never and serious adverse events and understanding barriers to implementation at the University of Cambridge. She is an NHS Clinical Entrepreneur and alumni of the NHS Innovator Accelerator Programme. 

References

1. Mariyaselvam MZA, Catchpole KR, Menon DK, et al. Preventing retained central venous catheter guidewires: A randomized controlled simulation study using a human factors approach. Anesthesiology 2017; 127: 658–665.

Other blogs you may be interested in:

• The story behind CARDMEDIC
• The NHS will not pay to improve patient safety: a blog by Kate Pym
• Why NHS procurement must change if we want to improve patient safety