Engineering a Human-Factors Solution for Vaginal Swab Collection

Engineering a Human-Factors Solution for Vaginal Swab Collection

Introduction

Unintentionally retained surgical items, such as vaginal swabs, remain a persistent and poorly understood medical error with the potential to cause significant harm to patients. Despite established policies and procedures, issues like distraction, confirmation bias, competing priorities, and changes in swab appearance can all contribute to swab miscounts and retention.

These swab retention events, known as “Gossypiboma”, are considered “never events” – medical errors that are unacceptable and largely preventable. Yet, they continue to occur, with NHS England reporting 338 separate incidents of vaginal swab retention between 2012 and 2022. The true scale of the problem is likely much greater due to underreporting driven by reputational impacts and the difficulty in diagnosing these errors.

The consequences of retained swabs can be debilitating for patients, healthcare staff, and healthcare trusts alike. Complications include pain, infection, secondary bleeding, and in severe cases, maternal death from sepsis. The repercussions can harm professionals as “second victims” with feelings of guilt and shame. Organizationally, these events can lead to legal, financial, and reputational damage.

The present gold standard for swab counting involves a two-person manual process, with each swab unfolded and visually inspected. However, this approach is prone to errors, with 88% of swab retention incidents occurring despite what was perceived to be a correct count. Factors like confirmation bias, distraction, and the dynamic nature of obstetric emergencies all contribute to the problem.

To address this persistent challenge, we have developed iCount – a human-factors engineered solution designed to reduce swab miscounts and improve safety in vaginal swab collection. iCount is a low-cost, manufacture-ready device that uses visual and tactile cues to guide healthcare professionals through the swab counting process, helping to eliminate task-related errors.

In this article, we will discuss the iterative design and development of iCount, present simulation data comparing its efficiency and perceived safety to the traditional counting method, and explore the potential of this innovation to enhance patient safety and improve clinical outcomes.

Understanding the Problem: Swab Retention and its Impacts

Retained surgical items, including vaginal swabs, are a well-documented and persistent problem in healthcare. Also known as “Gossypiboma”, these events were first reported in 1884 and continue to occur despite procedural and technical innovations aimed at tackling the issue.

The UK’s never events database identifies vaginal swabs (used during perineal trauma repair) as the source of the largest number of swab retention events. NHS England data reveals 338 separate incidents of vaginal swab retention between 2012 and 2022, with evidence of global under-reporting due to significant reputational impacts and the difficulty in diagnosis.

The consequences of retained swabs can be debilitating for patients, healthcare staff, and healthcare trusts. Complications include pain, urinary retention, vaginal discharge, infection, secondary hemorrhage, stress, and long-term psychological problems that can impact mother-baby bonding. In the most severe cases, retained swabs can lead to maternal death from sepsis.

The repercussions for healthcare professionals can be equally severe, with feelings of guilt and shame as “second victims” of these events. Organizationally, swab retention incidents can result in legal, financial, and reputational damage, as “never events” are considered indicators of quality and safety processes.

Despite established policies and procedures, issues such as distraction, confirmation bias, competing task priorities, and changes in swab appearance contribute to swab miscounts and retention. The present gold standard requires a two-person manual count, with each swab unfolded and visually inspected. However, this approach is prone to errors, with 88% of swab retention incidents occurring despite what was perceived to be a correct count.

Designing a Human-Factors Solution: The iCount Device

To address the persistent challenge of swab retention, we have developed iCount – a human-factors engineered solution designed to reduce swab miscounts and improve safety in vaginal swab collection. The design and implementation of iCount were conducted sequentially and in parallel, involving key stakeholders and a comprehensive human factors systems analysis.

iCount is a low-cost, manufacture-ready device that uses visual and tactile cues to guide healthcare professionals through the swab counting process, helping to eliminate task-related errors. The device consists of two main components:

1. Purple Plastic Docking Base: A slim, rectangular base that can fit in the palm of the hand, designed to securely hold a complete set of swabs or tampons.

2. Familiar Swabs and Tampons with Overmolded Plastic Clips: The swabs and tampons used in procedures are fitted with plastic clips that can be easily inserted into the docking base.

Procedures should begin and end with a complete set of swabs or tampons securely clipped into the iCount device. This physical checklist, combined with the visual and tactile cues provided by the device, helps healthcare professionals engage consciously with the swab counting process and eliminates the risk of miscounts.

In addition to the physical design, iCount has been engineered with the potential for future technological integration. Successive design iterations have explored the incorporation of camera vision and artificial intelligence (AI) technologies to record swab counts and inhibit procedure closure with incomplete or inaccurate counts. This technological adjunct would further enhance the system-based solution to vaginal swab retention.

Evaluating iCount: Simulation Studies and User Feedback

To evaluate the efficiency and perceived safety of iCount, we have conducted a series of simulation studies and gathered user feedback from healthcare professionals.

Timed Simulation Study

A timed simulation study was conducted in 2023 with 40 maternity staff, including doctors, midwives, and maternity assistants. Participants were shown a training video and then performed a series of eight timed stations, alternating between the traditional swab counting method and the iCount device.

The focus of the simulation was to assess the time taken to ‘count in’ and ‘count out’ swabs, as well as calculate actual ‘blood loss’ – a critical parameter in every vaginal birth. The results showed a statistically significant reduction in the mean total counting time when using iCount compared to the traditional method (25.96 seconds vs. 41.06 seconds, respectively, p=3.91E-5).

Additionally, the mean total weighing time (to measure blood loss) was reduced by 15.9% when using iCount (23.76 seconds vs. 28.24 seconds, p=0.031). These efficiency gains can have a compounding effect in procedures where multiple swab packs are used, further enhancing the benefits of iCount.

User Perception and Feedback

Structured questionnaires completed by the participants revealed overwhelmingly positive feedback on iCount. 100% of participants believed it was easy to spot a missing swab with the device and that it increased their confidence when conducting swab counts. Furthermore, 100% of participants agreed that iCount was simple to use and could be integrated as part of a systems-based solution to improve safety in maternity care.

Qualitative feedback highlighted the device’s intuitiveness, with users appreciating the visual and tactile cues that guided them through the swab counting process. Suggestions for improvement included the development of a training video to address any unfamiliarity with the device, as well as the need to ensure that loose swabs are not used alongside iCount to avoid confusion.

The Potential of iCount: Enhancing Safety and Efficiency

The development of iCount has been a problem-focused, user-centric journey, with the overarching goal of supporting healthcare workers in eliminating the persistent challenge of swab retention. The simulation data and user feedback gathered during the evaluation phase demonstrate the potential of this innovation to enhance safety and efficiency in vaginal swab collection.

The statistically significant reductions in counting and weighing times observed with iCount can have a meaningful impact on clinical workflows, particularly in environments where multiple swab packs are used during a single procedure. By streamlining these critical tasks, iCount frees up healthcare professionals to focus on other important aspects of patient care, ultimately improving outcomes.

Equally important is the overwhelmingly positive user perception of the device. Healthcare professionals recognized the intuitive design and appreciated the visual and tactile cues that guided them through the swab counting process. The increased confidence and ability to quickly identify missing swabs can contribute to a more robust system-based solution, complementing existing policies and procedures.

While simulation studies provide valuable insights, clinical testing is necessary to quantify the impact of iCount on reducing or eliminating swab retention events. A planned clinical trial within an NHS trust will assess the device’s real-world performance and transferability to clinical practice.

Beyond the immediate benefits to patient safety and clinical efficiency, the development of iCount has also considered the broader sustainability of healthcare innovations. Efforts are underway to explore production methods that utilize recycled plastics, reducing the environmental burden of the device while still delivering compelling benefits to the healthcare system.

Conclusion

The persistent challenge of unintentionally retained surgical items, particularly vaginal swabs, remains a significant patient safety concern in healthcare. Despite established policies and procedures, issues like distraction, confirmation bias, and the dynamic nature of obstetric emergencies continue to contribute to swab miscounts and retention.

The development of iCount, a human-factors engineered solution, represents a promising approach to addressing this long-standing problem. By incorporating visual and tactile cues into the swab counting process, iCount helps healthcare professionals eliminate task-related errors and enhance safety in vaginal swab collection.

Simulation studies have demonstrated statistically significant reductions in counting and weighing times when using iCount, alongside overwhelmingly positive user feedback on the device’s intuitiveness and potential to improve safety. As iCount progresses towards clinical testing, it has the opportunity to contribute to a more robust, system-based solution to the challenge of swab retention, complementing existing policies and procedures.

Ultimately, the iCount innovation highlights the power of human-factors engineering in healthcare, where design and technology can be leveraged to support healthcare professionals and improve patient outcomes. By continuing to prioritize safety, efficiency, and sustainability, solutions like iCount have the potential to transform clinical workflows and drive meaningful change in the quest to eliminate preventable medical errors.

For more information on iCount and other innovative healthcare solutions, please visit the Stanley Park High School website.