The Problem: Unintentional Swab Retention
Despite established policies and procedures, issues like distraction, confirmation bias, competing priorities, and changes in swab appearance can contribute to swab miscounts and retention after vaginal procedures. Retained vaginal swabs are considered “never events” – preventable medical errors that should never occur. These incidents can have serious consequences for patients, healthcare providers, and hospital trusts.
Patients who experience unintentional swab retention may suffer from a range of complications, including pain, urinary retention, infection, heavy bleeding, and even life-threatening sepsis. The emotional impact on patients and their families can be significant, affecting bonding with their newborn and eroding trust in the healthcare system.
For healthcare providers, being involved in a swab retention incident can lead to feelings of guilt, shame, and stress as “second victims.” Organizationally, these never events can result in legal, financial, and reputational damage to hospital trusts.
The Current Approach: Manual Swab Counting
The present gold standard for preventing swab retention involves a two-person manual counting process. Before and after a procedure, healthcare professionals must visually inspect and verbally count each swab, including checking the radio-opaque marker and tail. While other safety measures, such as swab bags and trays, exist, their use is limited due to the dynamic nature of the maternity setting.
Unfortunately, even with these safeguards in place, swab retention incidents still occur in 88% of cases. Errors can arise from various factors, including:
- Swabs changing shape, color, and appearance, making them hard to distinguish from bodily tissues
- Confirmation bias during the two-person count
- Distractions, multitasking, and time pressures, especially in emergency situations
- Changes in the responsible healthcare team during a procedure
- Perception of vaginal delivery as “less of a surgical procedure”
- Environmental factors like ambient noise, low lighting, and personal protective equipment
The iCount Solution: Human-Factors Engineered Design
To address the persistent problem of swab retention, a team of researchers, healthcare professionals, and engineers collaborated to develop iCount, a human-factors engineered solution.
iCount is a low-cost device designed to act as a physical checklist when counting swabs and tampons. It consists of two main components:
- A purple plastic docking base
- Familiar vaginal swabs and tampons with overmolded plastic clips attached to their tails
The iCount device is pre-assembled in sterile packages or included in maternity sterile procedure packs. Procedures should begin and end with a complete set of swabs or tampons clipped into the docking base.
The design of iCount incorporates both visual and tactile cues to engage healthcare professionals and promote safe counting behavior. The distinct purple color and clip-in system help users quickly identify missing or misplaced swabs, addressing issues like confirmation bias and changes in swab appearance.
Evaluating the Efficiency and Perceived Safety of iCount
To assess the utility of iCount, the research team conducted a series of simulation studies and usability evaluations with healthcare professionals.
Simulation Study Findings
A timed simulation study involving 40 maternity staff (doctors, midwives, and assistants) compared the efficiency of swab counting and monitoring blood loss using traditional swabs and the iCount device.
The key findings include:
- Mean total counting time using traditional swabs was 41.06 seconds, compared to 25.96 seconds using iCount – a 36.8% reduction in time.
- Mean total weighing time for blood loss measurement was 28.24 seconds with traditional swabs and 23.76 seconds with iCount – a 15.9% reduction.
- 100% of participants believed it was easy to spot a missing swab with iCount and that the device increased their confidence when conducting swab counts.
- 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.
These simulation results suggest that iCount can significantly improve the efficiency and perceived safety of swab counting procedures, which could be especially valuable in emergency maternity situations.
Stakeholder Engagement and User Feedback
The development of iCount involved extensive stakeholder engagement, including midwives, nurses, doctors, managers, and patient safety organizations. This feedback was crucial in shaping the device’s design and addressing user needs.
For example, the initial cream-colored docking device with green/red clips was modified to a purple base with yellow clips based on feedback that the original colors could be obscured by blood-soaking and were prone to errors due to color blindness.
Usability studies and patient public involvement (PPI) sessions further reinforced the acceptability and potential benefits of iCount. Participants found the device to be simple, intuitive, and a viable solution to the problem of swab retention.
The Road Ahead: Continued Innovation and Clinical Validation
While the simulation studies and user feedback have been promising, further clinical research and widespread adoption will be needed to validate the effectiveness of iCount in reducing or preventing retained swabs after vaginal deliveries.
The research team is currently exploring the integration of camera vision and artificial intelligence (AI) technologies to enhance the iCount system. These technological advancements could automatically record swab counts, inhibit procedure closure with incomplete or inaccurate counts, and provide an additional safeguard against human error.
Moreover, the team recognizes the importance of addressing the broader system-level factors that contribute to swab retention, such as appropriate policies, training, and teamwork. iCount is envisioned as a complementary, human-factors engineered solution that can work alongside these other systemic improvements to enhance patient safety.
Conclusion: Prioritizing Patient Safety through Innovation
The persistent issue of unintentional swab retention in maternity care is a significant patient safety concern with far-reaching consequences. The development of iCount, a human-factors engineered device, represents an important step forward in addressing this problem.
By incorporating visual and tactile cues, iCount aims to promote safer and more efficient swab counting practices, potentially reducing the risk of retained swabs and the associated harm to patients. The promising simulation results and positive user feedback suggest that iCount could be a valuable tool in the ongoing effort to eliminate these preventable medical errors.
As Stanley Park High School continues to prioritize the health and safety of its community, we encourage you to stay informed about innovative solutions like iCount that have the potential to make a real difference in the lives of patients and healthcare providers alike.
References
- Desai, A., Ogrodnik, P., Desai, K., & Mapunde, V. (2021). Prevention of retention of vaginal swabs and tampons with novel device system. RCOG Virtual World Congress 2021.
- Desai, A., Ogrodnik, P., Desai, K., & Mapunde, V. (2021). iCount: a human-factors engineered solution to vaginal swab retention – an early-stage innovation report. ResearchGate. https://www.researchgate.net/publication/383577252_iCount_a_human-factors_engineered_solution_to_vaginal_swab_retention_-_an_early-stage_innovation_report
- Innovations in BMJ. (2024). iCount: a human-factors engineered solution to vaginal swab retention. https://innovations.bmj.com/content/early/2024/08/30/bmjinnov-2024-001248
- Ogrodnik, P., Lawson, J., Feather, A., Newell, A., Malik, A., Baker, E., & Crawford, R. (2020). Medical Device Design. Springer International Publishing.
- Keele University. (n.d.). Keele Repository. https://wlv.openrepository.com/handle/2436/625719?show=full
