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

Area of Science:

• Global Health
• Medical Device Innovation
• Health Equity

Background:

• Availability of life-saving medical devices is crucial for global health impact.
• Access is often limited by cost, availability, and lack of information on safety and effectiveness.
• Addressing inequities requires collaboration among device developers, researchers, and global organizations.

Purpose of the Study:

• To discuss strategies for promoting equity in medical device access globally.
• To highlight low-cost innovation, improvisation, and off-label use as key strategies.
• To provide examples of successful implementation for each strategy.

Main Methods:

• Review and discussion of three primary strategies: low-cost innovation, improvisation, and off-label use.
• Illustrative examples provided for each strategy, including neonatal resuscitation kits, postpartum hemorrhage management, and labor induction devices.
• Analysis of challenges and benefits associated with each approach, emphasizing evidence generation and governance.

Main Results:

• Low-cost, purpose-built innovations (e.g., BabySaver Kit, MaternaWell tray) enhance access and sustainability.
• Improvisation using common items (e.g., condoms for uterine balloon tamponade) extends device availability in resource-limited settings.
• Off-label use of approved devices (e.g., Foley catheter for labor induction) can address specific needs but requires robust evidence and guidelines.

Conclusions:

• A multi-faceted approach involving innovation, adaptation, and evidence-based off-label use is essential for global medical device equity.
• Global agencies and professional organizations play a vital role in coordination, guideline development, and data sharing.
• Continued research and collaboration are necessary to ensure safe and effective access to medical devices worldwide.