Never events in orthopaedics: A nationwide data analysis and guidance on preventative measures

The intraoperative phase can be considered the most critical stage due to the stress imposed by the surgical procedure and the interaction among the different team members dealing with the prosthesis. Using written records of the prosthesis characteristics to bring the correct prosthesis from the store would limit the chance of mistakes. Real-time computerised prosthesis verification systems have been recommended and proven to be effective to avoid selection errors [17]. Although the NICE guidelines [18] did not specify how the real-time scanning should be done – computerised using special scanners or manually – due to the lack of cost-effectiveness studies, some studies from the United States have found real-time computerised verification system to be associated with decreased wasted implants and can be cost-effective in the long term []. Clear communication of the implant specifications at each step of prothesis handling is very important, especially when dealing with implants with multiple parts. The use of an instrument tray system including different plates and screws on the same tray can create a risk of confusing the types of plates. Preparing individual, sterilised packs for each different type of plate would further reduce the risk of wrong selection [20].

Postoperatively, surgeons should document the implant characteristics and submit data to the national registries where available. Instances of errors and adverse incidents should be transparently shared in a blame-free culture so that all appropriate lessons can be learnt.

Wrong-site surgery accounted for 197 incidents in 22 separate themes in eight categories in this study. Not unexpectedly for a speciality dealing with a large number of laterality-specific conditions, we found 64 laterality error incidents. Wrong side spinal procedures constituted more than half of these incidents (36/64). The second category was the wrong-level spinal procedures (63 incidents). These two findings highlight the difficulty of safeguarding measures relevant to spinal surgery. This may be attributed to the difficult skin marking and multiple-level disease. Unsurprisingly, spine surgery is associated with a significant risk of medicolegal claims and litigations [21]. Root cause analysis studies highlight imaging utilisation, operating room culture, and vertebral body marking as successful preventative strategies [22].

A review of imaging just before skin incision, intraoperative fluoroscopic navigation, and fiducial markers might help reduce wrong-site spinal incidents [23–25]. Recent studies show that the O-arm navigation had significant advantages in terms of accuracy over the C-arm fluoroscopy [26]. and when combined with neuro-navigation the radiation dose is significantly lower than the C-arm used for fluoroscopic guidance [27]. Additionally, the use of minimally invasive skin-anchored intraoperative 3 D navigation has been recently proved to limit the radiation exposure compared to fluoroscopy [28]. Another study used an oesophageal temperature probe as an affordable, non-invasive technique for intraoperative localisation during thoracic spine surgery [29]. However, anatomical variations like transitional vertebrae, lumbar ribs, butterfly vertebrae, hemivertebra, fused vertebrae, and spinal dysraphism can pose a high risk for wrong-level spinal surgery despite all the precautions. Moreover, the presence of tumours, infections, previous spine surgery, obesity, and osteoporosis can further complicate the surgical field [30]. Some authors have proposed a second time-out process to confirm the correct level using the image guidance before proceeding with the procedure [31].

The presence of cast and operating on digits can make proper site marking difficult. The surgical site should be confirmed before cast removal and marking should be immediately done after the cast or the slap has been removed. Whilst operating on tendons and digits, markings can be applied proximally and at the tip of the digit or on the anterior or posterior surface of the digit depending on the incision site. Undoubtedly, multiple simultaneous or staged procedures performed by different teams in trauma settings could increase the risk of errors. Site marking with initials of the different surgeons or the names of the procedures can limit this confusion. An additional time-out and a clear handover might further help.

We found 57 incidents of retained items post-procedures divided into 17 different themes under five categories. The commonest retained items were pieces of surgical instruments (15/57). An interesting finding here is the number of retained drill parts which included 7 drill guides and 6 drill bits. Also, there were 10 retained guidewires/peg and 6 k-wires. Authors believe that this was probably because these items are still not in the surgical count in many hospitals. Surgeons should ensure that these are included in their theatre count policy. Moreover, there should be a clear algorithm for failed reconciliation guiding the use of imaging modalities and involving the radiologists intraoperatively in challenging situations. Intentionally retained items could pose a risk for the future and a well-defined protocol should be in place to ensure timely removal. This should include colour coded bracelet or other visual markers, clear documentation, effective handover in situations when the patient is looked after by a multidisciplinary team, and during the changeover.

Another important factor to understand in this context is that there should be mechanisms for these incidents to be shared openly and widely. If they can happen in one place, they are often likely to happen in others too as the wider healthcare culture and practices are often similar from one hospital to another in any country or even across countries. One of the recent prominent changes introduced by the NHS Improvement towards establishing a blame-free culture is the removal of financial sanctions associated with NE [1]. This would hopefully encourage better reporting and further help spread the awareness of these events.

This first focussed analysis of NE of a large national dataset spanning nearly 8 years has yielded 47 specific orthopaedic themes. This specific knowledge may alert orthopaedic surgical teams around the world to commonly recurring NE themes. Our findings may further allow for further focused work aimed at understanding the reasons behind each of these themes with an overarching aim of developing better preventive strategies. We have also discussed different preventative measures specific to each category of orthopaedic never events. These recommendations can be adapted by the units providing orthopaedic surgery service to tailor their local checklist and develop local safeguarding measures based on the prevalence and trend of their adverse incidents.