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Achieving equitable access to obstetric devices through innovation, improvisation and off-label use.
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  • G Justus Hofmeyr,
  • Mandisa Singata,
  • Della Ripa S,
  • Andrew D Weeks
G Justus Hofmeyr
University of the Witwatersrand Johannesburg
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Mandisa Singata
University of the Witwatersrand Johannesburg
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Della Ripa S
ArcHealth Foundation
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Andrew D Weeks
University of Liverpool

Corresponding Author:[email protected]

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Abstract

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.