Prevention of retention of vaginal swabs and tampons with novel device system

Desai, A; Ogrodnik, P; Desai, K; Mapunde, V

Abstract

Objective Vaginal swabs, tampons are the single most common cause of retained objects reported annually and are currently classed as 'Never events'. They can cause significant morbidity - serious physical-psychological, infection, secondary PPH, sepsis, depression, lack of bonding, and trust loss. Although Never events are uncommon and may not always cause severe harm, they are 'red flags' indicating need for system solutions. As per hazard control hierarchy principles, a human factors engineered solution is more effective than just modifying human behaviour (standardised policies, checklists, training) where design solutions and behaviours complement each other, preventing human error.

Design Findings from formative usability study done in high-fidelity simulation look at user experience, safety and acceptability; also presenting the crucial role of patient public involvement (PPI) in development.

Methods Device description - iCount is a failsafe swab docking system ensuring swabs/surgical tampons are accounted for and removed accurately. There are visual and haptic cues making the process robust. The device has been ergonomically designed in a user-centred manner; developed collaboratively by midwives, nurses, doctors, Keele Biomedical Engineering. York Health Economic Consortium did a detailed formal cost-benefit analysis showing that each device used could save more than £100 of NHS costs per patient due to high litigation, management and morbidity costs (Ref-NHS Resolution). Proof of concept usability – Experienced diverse clinicians participated (NIHR Medtech, University hospitals, Birmingham). User session lasted 40 min involving audio-video content, hands-on in high-fidelity simulation, semi-structured interviews, and written survey feedback. Detailed structured large group PPI was done by NIHR Surgical MIC, Leeds.

Results Usability study: Users had positive attitude, supported the concept (simple, intuitive) and made some valuable design recommendations based on experience. The mechanical device is external to patient and poses no risk to user or patient as observed in simulation. The usability and PPI feedback suggested accommodating for red-green colour-blindness and improving some features, respectively. The PPI was well organised and gave valuable insight into patient, healthcare users perspective. This valuable feedback led to further prototype iterations and pilot clinical study planning.

Conclusion The users and PPI group deeply cared about patient safety and proposed solution. They found the solution positive and acceptable. Further evaluation is required to establish reliability of the system and integrate it into clinical workflow. The aim is to have a ‘human factors engineered system’ with Safety II principles where a design solution and user behaviours complement, preventing error, adding system resilience. PPI also suggested engaging with NIHR Patient Safety Translational Unit.

Citation

Desai, A., Ogrodnik, P., Desai, K., & Mapunde, V. (2021, June). Prevention of retention of vaginal swabs and tampons with novel device system. Presented at RCOG Virtual World Congress 2021

• Presentation Conference Type: Speech
• Conference Name: RCOG Virtual World Congress 2021
• Start Date: Jun 9, 2021
• End Date: Jun 12, 2021
• Deposit Date: Nov 23, 2023
• Publisher URL: https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.19_16715