2014-11-29-世界卫生组织-Second_WHO_Global_Forum_on_Medical_Devices_Report_236页_4mb

Summary of the Second WHO Global Forum on Medical Devices

Core Content

The Second WHO Global Forum on Medical Devices, held in Geneva, Switzerland, from 22–24 November 2013, was organized to address the challenges of ensuring access to priority medical devices as part of the Universal Health Coverage (UHC) initiative. It followed the success of the First Forum in Thailand (2010) and the World Health Assembly resolution WHA60.29 (2007), which emphasized the importance of medical devices in healthcare delivery and called for improved selection, assessment, regulation, and innovation in the field.

The Forum aimed to increase access to essential medical devices, share best practices in health technology assessment (HTA), management, and regulation, and demonstrate the development and use of appropriate and innovative technologies to meet global health needs. It also sought to evaluate the outcomes of the First Forum and the implementation of the WHA60.29 resolution.

Main Objectives

1. Define methods to improve access to priority medical devices under UHC.
2. Share evidence on best practices in HTA, management, and regulation of medical devices.
3. Demonstrate the development and use of appropriate and innovative technologies.
4. Present the outcomes of implementing the WHA60.29 resolution and the status of actions from the First Forum.

Key Outcomes

• The Forum attracted 572 participants from 103 countries, with a strong representation from low-income countries.
• A wide range of activities were organized, including 36 workshops, 25 parallel sessions, 116 posters, and 11 films.
• Participants actively engaged in discussions, proposed 263 actions, and evaluated sessions.
• The general feedback was positive, with about 90% expressing interest in future events.

Priority Recommendations

1. Collaboration and Innovation: Stakeholders should work together to develop affordable, appropriate, and innovative health technologies.
2. Health Technology Assessment: Increase the use of HTA to make informed decisions on medical device selection and procurement.
3. Regulatory Processes: Establish and improve regulatory frameworks to ensure the safety, quality, and efficacy of medical devices.
4. Procurement and Specifications: Promote transparent procurement and the development of technical specifications.
5. Patient Safety and Health Technology Management: Raise awareness among policy-makers and healthcare facilities about patient safety and HTM.
6. Biomedical Engineers: Emphasize the role of biomedical engineers in the management and maintenance of medical devices.

Supporting Activities and Collaborations

• The Forum was supported by a range of collaborating organizations, including UN agencies, NGOs, academic institutions, and professional bodies.
• The World Health Organization (WHO) played a central role in coordinating the event and ensuring its success.
• A local organizing committee was formed, comprising WHO staff and interns, to manage the logistics and program development.

Future Actions and Evaluation

• The Forum resulted in a list of 263 proposed actions to advance the topics discussed.
• The outcomes and recommendations will be implemented and evaluated in the context of the Third WHO Global Forum on Medical Devices, planned for 2016.
• The event received positive feedback, with many participants requesting more time for presentations and discussions.

Acknowledgements

• The Forum was made possible through the support of various governments, organizations, and individuals.
• Key supporters included the Ministry of Health, Labour and Welfare of Japan; the Ministry of Health, Welfare and Sport of the Netherlands; the European Commission; the Government of Switzerland; and several WHO collaborating centers.
• The Local Organizing Committee and Programme Committee members were instrumental in the planning and execution of the Forum.

Conclusion

The Second WHO Global Forum on Medical Devices highlighted the critical role of medical devices in achieving UHC and underscored the need for collaboration, innovation, and improved regulatory and management practices. It provided a platform for stakeholders to share experiences and propose actions to enhance access to essential medical technologies, particularly in low-resource settings. The recommendations and proposed actions will guide future efforts in advancing UHC through better health technology management and regulation.