Venner WireSafe(TM) - preventing 'Never Events'

    

One of the most common "Never Events" in the NHS is the retention of guidewires.

The Venner WireSafe(tm) is a procedural pack that facilitates prevention of guidewire retention during CVC insertion,  as well as allowing safe disposal of sharps and wires.

 

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wiresafe(tm) information

Now published in Anesthesiology:

  

Preventing Retained Central Venous Catheter Guidewires: A Randomized Controlled Simulation Study Using a Human Factors Approach. Anesthesiology 2017 Aug 11

“Utilizing forced-error simulation testing, we have determined that the locked pack is an effective preventative device and is acceptable to clinicians for improving patient safety.” Anesthesiology, 2017

Background

Central lines are used in intensive care and operating theatres to measure patient’s central venous pressures and administer strong medication

Problem

 In order to insert a central line, a guidewire must be first inserted into the patient’s vein, the catheter is then placed over it and the guidewire is then removed.

If the clinician forgets to remove the guidewire, it can travel to the heart, causing devastating complications. This mistake has a mortality of up to 20% for patients(1). The mistake happens because the clinician is distracted at a critical point in the procedure. The vast majority of guidewires are simply forgotten by the clinician until hours, days or weeks later, when it is too late to easily remedy. 

When the error occurs, the patient must be transferred to be seen by an interventional radiologist or cardiac surgeon, and undergo an unnecessary procedure in order for the guidewire to be removed.

Retained guidewires are never events, and data from NHS England show that this error occurs on average 1-2 times per month in the NHS(2) However, with an incidence of 1:3000 procedures, we know that this error is under-reported(3).

Current solutions have suggested that clinicians should be more vigilant, should have two people performing the procedure, have a checklist and document guidewire removal. However, these solutions are costly to introduce and unreliable, because this error still occurs despite their introduction.

Solution

  WireSafe™ is an engineered solution designed to prevent this problem. Using human factors engineering, a forcing function has been designed into the procedure which prevents the clinician from completing the procedure unless they first remove the guidewire(4).

WireSafe™ has a locking mechanism and contains the equipment required to complete the procedure after the guidewire has been removed: the stitch, needle holder, dressings.

It is impossible to access the equipment without using the guidewire to unlock the box.

This forcing function, at the crucial point in the procedure, ensures that the clinicians cannot continue with the procedure without first removing the guidewire.

Once the guidewire has been used to access the equipment and the procedure is completed, WireSafe™ converts into a sharps box, to dispose of all sharps used in the procedure. WireSafe™ can then be safely disposed of into the sharps bin.

Training

  

Training to use WireSafe™ takes 1-2 mins.


· WireSafe™ is placed on the sterile trolley with the normal central line insertion pack

· At the point that the clinician needs to secure the central line in place, the guidewire is placed inside the channel of WireSafe™ and the box is opened

· The contents can be used to secure the central line catheter in place

· The sharps used throughout the procedure can now be placed inside WireSafe™

· WireSafe™ lid is closed, securing the sharps and guidewire safely inside the box, and is thrown into the sharps bin

Clinical Evidence

  

WireSafe™ has been designed to prevent the error of retained guidewires


In a national survey, 33% of lead ICU clinicians have seen this error occur in their ICU.  NHS England report this error occurs 1-2 times per month.

An anonymous national survey of all ICUs asked the clinical directors whether they had a retained guidewire incident in their ICU in the last 5 years. 1/3 of the ICUs responded and 33% reported that they had experienced the never event of retained guidewires in their ICU.  

  

https://www.esahq.org/~/media/ESA/Files/Downloads/Resources-Abstracts-Euroanaesthesia2015/Euroanaesthesia%202015%20Abstract%20Book.ashx

An engineered solution is required

  

The WireSafe™ is significantly better at preventing retained guidewires than standard practice alone (P < 0.001)4

A simulation study was conducted to determine to risk of retained guidewires comparing standard practice to the WireSafe™. Junior doctors were presented with a scenario where a colleage had been urgently called away mid-way through a central line procedure. Participants were required to safely complete the procedure and return the patient to the ward. The manikin model had a central venous catheter inserted in the right internal jugular vein, with the guidewire present in the distal lumen, clearly visible through the transparent portion of the lumen and retrievable with forceps if required. There was also an ECG monitor showing ectopic beats.

In the standard group, 80% did not recognise the guidewire 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. They attempted to complete the procedure, however when unable to access the contents of the WireSafe™, it triggered the participants to search for the guidewire. Participants looked in the trolley, floor and sharps bin before recognising that it was inside the patient. All were able to retrieve the guidewire and complete the procedure without complications. The WireSafe™ prevented guidewire retention in all cases and was statistically superior in preventing guidewire retention compared with standard practice (P < 0.001).   

  

Clinical Opinion

“When you make an error like this, it stays with you and affects you in so many ways. You can’t believe that you’ve been responsible for harming a patient and it makes you doubt yourself as a doctor. I’m glad that the solution has finally been developed”

“I know of doctors who have forgotten to remove the guidewire. As far as I can see the WireSafe™ makes this error all but impossible, protecting both staff and patients”

“I like the way that it turns into a sharps box and allows easy cleaning up at the end. It actually makes the whole procedure easier”

“It makes procedures safer for the patient, and safer and easier for me”

“I’ve used the WireSafe™ previously in a trial….had we been continuing to use the WireSafe™, I would have put all of the sharps inside the WireSafe™, rather than having to carry them to the sharps bin. I’m sure I would not have had this injury if we were continuing to use the WireSafe™” Foundation Training Doctor, following a sharps injury

Awards

WireSafe™ has won patient safety and innovation awards 

· Presidents award for outstanding achievement, Royal College of Anaesthetists, SALG Patient Safety Conference (2016)

· Finalist, highly commended, The National Patient Safety Award (2016)

References

  1. Guidewires Unintentionally Retained During Central Venous Catheterization. J Assoc Vasc Access 2014; 19:29-34  https://www.england.nhs.uk/patientsafety/never-events/ne-data/

2. Retained Guidewires after Intraoperative Placement of Central Venous Catheters. Anaesth Analg 2013; 117:102-108 

3. Preventing Retained Central Venous Catheter Guidewires: A Randomized Controlled Simulation Study Using a Human Factors Approach. Anesthesiology, 2017, August 11. E-pub, ahead of print http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2649249&resultClick=3

4. Guidewire Retention  – not a problem? European Journal of Anaesthesiology, 2015; Volume 32, Supplement 53, 16AP2-4  https://www.esahq.org/~/media/ESA/Files/Downloads/Resources-Abstracts-Euroanaesthesia2015/Euroanaesthesia%202015%20Abstract%20Book.ashx


WireSafe™ is a trademark of the Venner Group of Companies