The global impact of life-saving medical devices is directly related to their availability. Access may be limited by cost, local availability or lack of information regarding effectiveness and safety. Addressing the inequity in access requires concerted effort from device developers, the research community, global agencies and professional organizations. We discuss three strategies to promote equity with examples. Developing novel innovative devices can be an effective way of increasing global access if they are simple, safe and low cost. For example the BabySaver Kit facilitates intact-cord neonatal bedside resuscitation. Re-usability is an important design feature for both cost and environment, exemplified by the MaternaWell tray for blood loss monitoring after birth. Improvised medical devices using commonly available hospital items can extend device availability into settings where purpose-designed devices are unavailable or unaffordable. Examples include the use of condoms or glove balloons for uterine balloon tamponade (UBT) to treat postpartum haemorrhage (PPH). Whilst attractive, the lack of systematically developed evidence and governance approvals can lead to wide variation in training, technique and device specifications. Some of these quality issues are addressed by using approved medical devices ‘off-label’. However, they can have many of the same problems of variation in technique and depend on the uncoordinated efforts of researchers and clinicians to generate an evidence base. They are, however, an effective route to increasing access. Examples include the Foley catheter for labour induction or as uterine tourniquet, neonatal suction catheter for posterior axilla sling traction in shoulder dystocia and the Levin stomach tube for suction tube uterine tamponade for PPH. WHO has pathways to facilitate global access to important public health device innovations. Global agencies and professional organizations also have a major role to play in providing instructions for use on off-label devices and robust data on their safety and effectiveness.

Objective: To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage post-partum haemorrhage (PPH). Design: Grounded Theory. Setting: Tertiary facility in the North-West of England, UK. Sample: We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives. Methods: Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique. Results: Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency. Conclusions: This is the first study to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and consenters require adequate training. (197/200)

Objective: To assess whether, in those requiring ongoing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low dose oral misoprostol is superior to intravenous oxytocin. Design: Open-label, superiority randomised trial Setting: Government hospitals in India Population: Women induced with oral misoprostol for hypertensive disease in pregnancy and requiring ongoing induction after membrane rupture Methods: Participants received misoprostol (25mcg orally two hourly) or titrated oxytocin through an infusion pump. Main Outcome Measure: Caesarean birth Results: 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced by the use of misoprostol (misoprostol 32.3% vs oxytocin 27.3%; adjusted odds ratio 1.226 (95% CI 0.81-1.85, p=0.33)). There were no differences in rates of hyperstimulation, fetal heart rate abnormalities, or maternal side effects, although the geometric mean time from randomisation to birth was 31 minutes longer with misoprostol. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group) and there were no neonatal deaths in the misoprostol group, compared to 3 in the oxytocin arm. Women’s acceptability ratings were high in both study groups. Conclusion: Following cervical preparation with oral misoprostol and membrane rupture, the use of ongoing oral misoprostol for augmentation did not significantly reduce caesarean rates compared to oxytocin. The method, however, was safe for both mother and baby.

A document by Andrew D Weeks. Click on the document to view its contents.