As the name suggests, a ‘never event’ should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice. This article focuses on a UK perspective, with the acknowledgment that never-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?
Background
In medical literature, retained surgical swabs are referred to as ‘gossypiboma’ (Williams et al, 1978; Zbar et al, 1998; Kiernan et al, 2008). The etymology for gossypiboma appears to derive from ‘gossypium’ (Latin for ‘cotton’) and the suffix ‘oma’ (Latin meaning ‘mass’). It was first described and reported in the literature back in 1884 (Wilson, 1884), well over a hundred years ago. More recently, it is not uncommon to find the term ‘textiloma’ instead, due to the increasing use of synthetic materials to replace cotton. All surgical swabs used in the UK contain radiopaque threads that theoretically allow swabs to be detected by X-ray and CT scans. Despite this, diagnosis is often challenging as clinical presentation varies significantly. Often, patients present with vague clinical symptoms over a significant period of time. The most common symptoms are discomfort, pain, unexplained fever or feeling generally unwell. In some cases, the patient is asymptomatic and the retained surgical swab is only diagnosed incidentally. Moreover, diagnosis can occur days, weeks, months or ever years after the surgical event, increasing the likelihood of severe morbidity associated with the retained surgical swab.
The most common site for retained surgical swabs is the abdomen and pelvis, followed by the vagina (Gawande et al, 2003; Steelman, 2018; 2019). Not surprisingly, obstetrics and gynaecology is the speciality most affected by retained surgical swabs never-event incidents. Retained swabs following a vaginal birth/perineal repair and caesarean sections are a source of serious maternal physical morbidity and psychological harm. Substantiating the extent and the seriousness of the problem affecting maternity services in the UK, in December 2019, the Healthcare Safety Investigation Branch (2019), a recently founded independent investigation body set up by the Department of Health, published a report solely dedicated to retained swabs in maternity: investigation into detection of retained vaginal swabs and tampons following childbirth.
The then National Patient Safety Agency (NPSA), now NHS Improvement, included retained instruments following surgery on its Never Events List in 2009. This requirement was broadened in March 2010 to include swabs retained following surgery. In addition, the NPSA (2010) produced a Rapid Response Report in May 2010 requiring NHS organisations to have set processes in place when using swabs during vaginal delivery or perineal repair. In January 2018, NHS Improvement revised the Never Event Policy and Framework and the Never Event List (NHS Improvement, 2018). Below are the latest figures showing an increase in incidents related to retained swabs:
- 2015/2016: 442 never events (23 vaginal swabs; 18 surgical swabs)
- 2016/2017: 445 never events (32 vaginal swabs; 23 surgical swabs)
- 2017/2018: 495 never events (26 vaginal swabs; 19 surgical swabs)
- 2018/2019: 496 never events (40 vaginal swabs; 11 surgical swabs)
- 2019/2020: 472 never events (18 vaginal swabs; 20 surgical swabs)
- 2020/2021 (provisional data, 10 months): 297 never events (15 vaginal swabs; 14 surgical swabs).
It is important to note that recent data may not be fully comprehensive nor accurate, as the data collection had been temporarily suspended in view of the COVID-19 pandemic. These two general warnings were displayed on the front page of the NHS England website at different dates: ‘Due to current operational pressures, we are temporarily unlikely to process new or outstanding data requests for NRLS or Never Events data' (17 December 2020) and ‘Due to current operational pressures, we are temporarily unlikely to process new or outstanding data requests for NRLS or Never Events data. Please check back here for further updates' (12 March 2021) (NHS England, 2021). The situation is constantly evolving; therefore the figures should be carefully monitored.
There is also a general concern that never-event incidents involving retained surgical swabs might be higher than these figures suggest, as the system relies on voluntary reporting. Actual figures reported by individual NHS Trusts are available to the public through the NHS website (NHS England, 2021).
Never-event incidents are only the tip of the iceberg when it comes to patient safety in general. It is estimated that as many as 1 in 10 patients admitted to hospital may be at risk of suffering adverse outcomes as a result of receiving medical care (Vincent et al, 2001; World Health Organization [WHO], 2014).
Never events can have a substantial, perhaps immeasurable, impact on patients and their relatives, as well as on the staff involved. Never events are also linked to clinical negligence claims, a significant financial burden for the NHS. Between 2006/2007–2017/2018, clinical negligence claims payments more than quintupled, from £0.4 billion to £2.2 billion, with the number of reported claims nearly doubling from 5 400–10 600 over the same period (NHS Resolution, 2019). The human cost of clinical incidents is incalculable.
Similarly, the legal aspect of never events should not be underestimated. Increasingly, legal teams supporting clinicians involved in retained surgical swab incidents are challenging the standard approach, which follows the maxim ‘res ipsa loquitur’ (Latin for ‘the thing speaks for itself’) that implies that a retained swab is the result of an individual error. It has become clear that the search for truth – and legal responsibility and related accountability – needs to go beyond individual actions (Wheeler et al, 2014; Nowotny et al, 2019). The Swiss Cheese Model is often used in the literature to highlight the multifactorial elements leading up to clinical incidents (Reason, 2000). Retained surgical swab never events are no different. The Care and Quality Commission report ‘Opening the Door to Change NHS Safety Culture and the Need for Transformation’ (2018) clearly identifies the need to change the institutional culture in order to consistently improve patient safety across the NHS, raising the bar from individual to collective responsibility.
To complete the background and widen the context outside the maternity setting, it is interesting to report that retained surgical swabs affect dogs as well, not just humans (Forster et al, 2011). This may well reinforce the idea of the structural nature of the problem, rather than just the circumstantial environment or the demographic of the population affected by such never events.
Discussion
The concept of a never event may suggest at first glance an existential ‘never-ness’ of such events, a sort of a wishful ontological non-existence of the problem. It is useful to clarify that the concept – and related lists - of never events arises from a taxonomic approach to help clinicians, as well as managers and politicians, to manage an otherwise confused, fluid and unmanageable situation. For this reason, never-events lists are regularly updated by NHS Improvement (2018). Guidelines and protocols follow shortly after this meticulous classification. Clinicians will be familiar with the saying that making a diagnosis is often the first step for finding the right treatment and ultimately cure the problem. Another familiar saying is that prevention is better than cure, encouraging a proactive approach to eliminate the problem before its onset. Both of these quotes are relevant to our discussion.
Incidents related to retained surgical swabs have been classified as never events because such incidents are entirely preventable. Being preventable is the key concept in the narrative of all clinical incidents but particularly relevant in incidents classified as never events because these incidents should not happen under any circumstances, if all the available preventive measures have been implemented.
Stating the obvious, nobody leaves a surgical swab behind on purpose. Never. The current evidence available in the literature suggests that the main contributing factors leading to retained swabs are human factors – in particular, poor team communication and lack of concentration/tiredness – as well as pressure linked to performing a clinical procedure in an emergency situation (Thiels et al, 2015; Koleva, 2020). In addition, clinical handover has long been identified as a critical point in patient care (Rabøl et al, 2011; Foster and Manser, 2012; Kapadia and Addison, 2012; Spranzi and Norton, 2020) and it appears to be a particularly vulnerable time in communication breakdown leading to incidents involving retained swabs (Lean et al, 2018).
There are a few themes and approaches that emerge from the literature, and are all pertinent to this discussion:
- Size of the surgical swabs
- Number of swabs in each packet and counting procedure
- Tech solutions: radiopaque strip and microchip
- Next? Surgical swabs with an anchoring point to prevent leaving one behind.
1. Size of the surgical swabs
Surgical swabs come in different sizes to suit clinical needs. The most common size currently used in maternity is 30 cm x 30 cm. When I first started working as a clinical midwife on labour ward, 10 cm x 10 cm swabs were in use. Unaware of the reason that triggered a sudden change in clinical practice, one day the 10 cm x 10 cm swabs disappeared almost instantly from labour ward and were replaced by the 30 cm x 30 cm swabs. I now know that the trigger was a never event in the unit. Increasing the swab size was thought to decrease the risk of leaving one behind. Though the change of size was clearly an interesting move; unfortunately, this failed to solve the problem. And it is hard to imagine that the swab size will be increased further, for obvious practical reasons.
2. Number of swabs in each packet and counting procedure
All surgical swabs – regardless of their size – come in packs of five. It is standard practice that two healthcare professionals count the swabs at the beginning of the procedure, halfway through and at the end. These counts should be clearly documented in the patient's notes.
The main approach is counting; a high level of maths knowledge is not required as people only need to count up to five. Provided each group of five is accounted for, there is no problem. Counting up to five is a key element in training staff responsible for swabs count. The beauty of relying on counting is that numbers don't change over time, they are universally standardised, don't suffer from language barriers – a common problem across the NHS – and numbers are easy to remember and write. Whiteboards where staff are supposed to record the number of swabs used during the clinical procedure are mounted on the walls of all theatres and delivery rooms, and checklists and forms Local Safety Standards for Invasive Procedures (LocSSIPs) are omnipresent on labour ward. LocSSIPs are checklists designed to provide a standardised approach for certain aspects of clinical procedures and were introduced in September 2015 when NHS England published a set of National Safety Standards for Invasive Procedures to be modified for local use (NHS England, 2015). LocSSIPs do not replace the WHO checklists but should be used alongside. The power of checklists remains an interesting and open debate, particularly after the publication of the Checklist Manifesto in 2010 by Atul Gawande (2010).
Counting up to five may seem a straightforward task. The five fingers on each hand can be a helpful aide. Yet, it is not as simple as it may seem. Counting up to five – and multiples of five – is an easy and low-tech solution but is fallible (Beyea, 2003; Riley et al, 2006; Egorova et al, 2008). More precisely, there seems to be three types of counting errors leading to a retained surgical swab. Firstly, no swab count is undertaken at the start, halfway through or at the end of the clinical procedure. Or at least, if a count was indeed undertaken, it has not been documented in the medical records. This is often the case when performing a clinical procedure in an emergency situation. Secondly, the swab count is documented as correct by two healthcare professionals. This is probably the most common situation when investigating an incident involving a retained surgical swab. This scenario would indicate that the expected counting procedure has been followed and that the correct boxes have been ticked but the reality appears somehow to be different. Thirdly, the swab count has highlighted a discrepancy but the team failed to rectify the error in a timely manner (Nothing Left Behind, 2021).
3. Tech solutions: radiopaque strip and microchip
A radiopaque strip was introduced in surgical swabs back in 1920, again just over 100 years ago. It doesn't stop a surgical swab from being left behind but it aims to help identify and rectify the problem as soon as it arises. Should a discrepancy in the swabs count be noted, in the first instance, every effort should be made to locate the missing swab(s) within the vicinity of the clinical field. If not found, an X-ray or a CT scan should be arranged to identify or exclude the presence of the missing swab inside the patient. If confirmed, the surgical removal of the retained swab provides a definitive cure.
Unfortunately – and similarly to the counting approach – X-ray detection is not infallible. This can be due to poor quality image, hidden location of the surgical swab and human factors. Cases have been reported where the swab count highlighted a missing swab, an X-ray was performed as per protocol, but the team failed to locate the swab due to poor imaging and/or inadequate training.
In more recent years, and mainly in the US in a limited number of healthcare facilities, microchips have also been introduced in surgical swabs with the aim to provide a more accurate counting procedure (Macario et al, 2006; Greenberg et al, 2008). This is a very expensive approach as the cost of the swabs is much higher and multiple detecting devices are needed in all clinical areas where the surgical swabs are used. At present, this approach doesn't seem to provide the final answer to the problem.
4. Next? Surgical swabs with an anchoring point?
As mentioned before, prevention is better than cure. Building on the evidence in the literature and of the shared knowledge from experience in clinical practice, a new approach is suggested: to create a physical barrier to leaving a swab behind by introducing an anchoring point linking the five swabs together (Spranzi, 2021a). It is important to note that the modified design is such that each individual swab can still be used singularly. This approach of a modified design is in line with the suggestion included in the 2018 NHS England report reviewing 38 never-event cases that specifically urge manufacturers ‘to consider design challenge for the prevention of retained foreign objects’ (NHS Improvement, 2018a). The modified swabs with an anchoring point are currently undergoing development and testing at the time of writing this article.
Conclusion
The aim of this article is to provide an overview of the current evidence regarding retained surgical swabs and explore a different and innovative approach based on the introduction of a physical barrier making it impossible to leave a surgical swab behind.
Although it is recognised that the current approaches (ie increased size of surgical swabs; counting procedures and related checklists; introduction of a radiopaque strip or microchip) do mitigate the risk of retained surgical swabs, they do not completely eliminate such risk as they do not address the human factors (tiredness, time pressure in emergency situations etc) present at the time of clinical incidents.
It is hoped that the simple and no-tech approach of adding an anchoring point linking the five swabs contained in each pack will provide an affordable and easily scalable solution to reduce the risk of never-event incidents related to retained surgical swabs-a problem that is causing an incalculable, yet preventable, level of harm affecting patients and their families, staff and healthcare institutions worldwide.
If successful, surgical swabs with an anchoring point could be introduced in clinical areas other than maternity, such as trauma centres and other open cavity surgery specialties. The core idea of surgical swabs with an anchoring point is very simple and it is believed that its simplicity is its strength.
Key points
- Retained surgical swabs in maternity, although rare, are a major patient safety concern
- Retained surgical swabs are linked to high morbidity (both physical and psychological) and financial impact-related clinical negligence claims. The human cost is incalculable
- The current approaches to reduce the risk of never-event incidents related to retained surgical swabs fail to provide a definite answer
- A new approach is suggested: the introduction of a physical barrier making it impossible to leave a surgical swab behind
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