Introduction

Bariatric and metabolic surgery stands as a well-established and lasting solution for individuals grappling with obesity. The field continually seeks to offer cutting-edge treatments for obese patients. As novel devices and procedures continue to emerge, it is imperative that the OSSI assumes a leadership role in the development, assessment, and implementation of these innovations for treating obesity. In response to the influx of new obesity interventions, OSSI is proposing a framework for granting official OSSI endorsement and approval of these fresh procedures and devices.

Process

An active practicing member of the OSSI submits an application for the endorsement of a new procedure or device in India. It is encouraged for multiple OSSI members to co-sponsor these applications. Alternatively, technology companies can also seek endorsement for their new products through OSSI.

The OSSI Pathway for Endorsement of New Devices and Procedures Committee, consisting of the President and Chairs of the Ethics Committee, will evaluate the application. During their assessment, a Clinical Issues Position Statement may be generated.

The OSSI Member Sponsor and at least one Co-Sponsor or a representative from the technology company will present the application to the Executive Council, accompanied by EC advocates both in favour and against the proposal from the Pathway for Endorsement of Ethics Committee.

The OSSI Executive Council will provide comments on the new procedure/device application, along with a summary from the Pathway for Endorsement of New Devices and Procedures Committee.

To achieve final affirmation, a 75% approval vote is required from the EC.

Once the application is endorsed, the outcome of approval will be communicated to major insurers and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.