Improving maternal safety: Usability and performance assessment of a new medical device for the treatment of postpartum haemorrhage

Candidori, Sara; Dozio, Nicolò; Osouli, Kasra; Graziosi, Serena; Zanini, Alberto Antonio; Costantino, Maria Laura; De Gaetano, Francesco

doi:10.1016/j.apergo.2023.104223

Cited by 2 publications

(5 citation statements)

References 47 publications

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“…The fulfilment of these requirements has been evaluated in a simulated environment through usability tests conducted with medical and non-medical users. The details of these tests are not included here because they have already been described in a previous study by the same authors 22 . What is discussed here is how we have used the insights gathered from the tests discussed in 22 to introduce further improvements in the connector design and, vice versa, how the in vitro tests described in this study helped elaborate the instructions for the training of the operators in the use of BAMBI.…”

Section: Resultsmentioning

confidence: 99%

“…Together with the training modality, the usability tests presented by the authors in 22 provided useful insights for improving the BAMBI design. Observation of users handling the device and analysis of use errors, combined with user comments, led to further thinking about a possible modification to the connector design.…”

Section: Resultsmentioning

confidence: 99%

“…Details about the connector design, experimental validation, production costs, and training modalities are provided in this paper. Besides, a discussion of how further improvements have been applied to the connector design based on the feedback collected by medical and non-medical users involved in usability tests (performed by the authors in a previous study and already described in 22 ) is also provided.

Figure 1 Components of the BAMBI kit and its mechanism of use.…”

Section: Introductionmentioning

confidence: 99%

“…( a ) The BAMBI kit is composed of a pre-filled saline bag equipped with a plastic clamp, a probe cover (condom), a connector, and a rectal probe. Image adapted from 22 and used under CC BY 4.0. ( b ) Mechanism of use: the assembled device is inserted into the uterus through the vaginal canal and inflated to stop the bleeding.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings

Candidori,

Osouli,

Graziosi

et al. 2024

Sci Rep

Self Cite

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The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit’s effectiveness and represents the main novelty. Results proved the device’s effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Figure 1 Components of the BAMBI kit and its mechanism of use.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings

Candidori,

Osouli,

Graziosi

et al. 2024

Sci Rep

Self Cite

View full text Add to dashboard Cite

show abstract

“…Overall, the authors agreed regarding the fact that the sample size was too small, a new technology had been introduced without proper training, no techniques to mitigate the prolapse of the balloon were used, and that there were system issues at play (e.g., understaffing, referral systems, infrastructures, consumables, training, corruption, etc.). In this scenario, Candidori et al [ 21 , 22 ] have taken advantage of the condom balloon tamponade design and proposed BAMBI, a similar device with the only difference of using a 3D-printed connector for the condom rather than sutures.…”

Section: Introductionmentioning

confidence: 99%

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation

Piaggio,

Hyland,

Maccaro

et al. 2024

PLoS ONE

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Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation’s Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

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Improving maternal safety: Usability and performance assessment of a new medical device for the treatment of postpartum haemorrhage

Cited by 2 publications

References 47 publications

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation

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