Achieving equitable access to obstetric devices through innovation,
improvisation and off-label use.
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.