Achieving Equitable Access to Obstetric Devices Through Innovation, Improvisation and Off-Label Use.

The global impact of life-saving medical devices is directly related to their availability. Access may be limited by cost, 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 organisations. We discuss, with examples, three strategies to promote equity: low-cost, purpose-built innovation, improvisation and off-label use. First, developing simple, safe and low-cost innovative devices can be an effective way of increasing global access. 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. A second strategy is improvisation using commonly available hospital items. This 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), elastic catheters for uterine tourniquet, and plastic tubing for posterior axilla sling traction in shoulder dystocia. However, the lack of systematically developed evidence and governance approvals can lead to wide variation in training, technique, and device specifications. Finally, some of these quality issues are addressed by using approved medical devices 'off-label.' However, they can have similar problems of variation in technique and depend on the uncoordinated efforts of researchers and clinicians to generate an evidence base. Examples include the Foley catheter for labour induction 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 organisations also have a major role to play in providing co-ordination, platforms for data sharing, practice guidelines, instructions for use on off-label devices and robust data on their safety and effectiveness.