Preamble

Obesity has been recognized as a disease by the American Medical Association in 2013. Bariatric and metabolic surgery is a proven, effective and enduring treatment for obese patients in need. Bariatric and metabolic surgery strives to provide the most innovative therapies for obese patients. As new devices and procedures emerge, it is critical that the American Society for Metabolic and Bariatric Surgery leads the way in creating, evaluating and implementing new devices and procedures for obesity. With the advent of new obesity devices and procedures entering our field, ASMBS is proposing a pathway for official ASMBS approval and sanction of new procedures and devices.

Problem

Review of prior ASMBS policy for approval of new obesity treatment devices and procedures indicates that there is no standardized pathway. Prior procedures or devices were approved by ASMBS leadership via expert review only. However, our specialty may have procedures that have become obsolete or new procedures that emerge which may be rapidly adopted without ASMBS endorsement.

Process

  1. Application by an ASMBS Member Sponsor in active practice for a new procedure or removal of an approved procedure. Multiple ASMBS Member Co-Sponsors are allowed and encouraged.
  2. Primary ECEC Review: 75% Approval Required to Next Stage. This review will be inclusive and mainly to ensure plausibility of new procedure and device before invoking full review.
  3. Application Assessed by the ASMBS Pathway for Approval of New Devices and Procedures Committee. The Pathway for Approval of New Devices and Procedures Committee will include the Chairs of Clinical Issues, Insurance, Quality Improvement & Patient Safety, Emerging Technology and Integrated Health President or their designee. In the course of their review, a Clinical Issues Position Statement may be produced concurrently.
  4. Application Presented to Executive Council by ASMBS Member Sponsor and 1 Co-Sponsor and Pro and Con Advocates from Pathway for Approval of New Devices and Procedures Committee.
  5. Executive Council Review and Open Vote: 75% Approval Required to Next Stage.
  6. ASMBS Member Comment of New Procedure/Device Application with Pathway for Approval of New Devices and Procedures Committee Summary.
  7. Final EC Vote: 75% Approval Required for final affirmation
  8. Outcome of approval sent to major insurers and Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program once application approved.

Application Form

  1. Name(s) of ASMBS Sponsor and Co-Sponsor
  2. New or Extinct Procedure: Y/N. There may be procedures there are no longer viable and these may be removed from approval list.
  3. Device or Surgery: Y/N.
  4. Device: FDA Approval Required. Y/N.
  5. Surgery: Novel or Similar to Established Procedure. If similar to established procedure, describe how the new procedure differs from current established procedure.
  6. Conflict of Interest.
    A. Do you or your co-sponsors have a financial relationship with the new device or procedure including but not limited to consulting, ownership, proctoring, etc… Y/N.
    B. What is the relationship?
  7. Publications with evidence grades. Please provide the publications with an evidence grade utilizing established evidence scales such as, http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/
  8. If a new procedure, please respond to below:
    A. Is this a new procedure or a modification of an existing procedure?
    B. Based on current knowledge does the new procedure or modification of an existing procedure potentially have a different risk/benefit profile than an existing procedure?
    C. Does it add a new mechanism to an existing procedure?
    D. Does it have a new name or names that should be standardized as part of the approval process?

New Device Approval Considerations

Studies prior to FDA approval must be done under IRB monitoring.

After FDA approval of the device, ASMBS approval as an accepted device is possible pending final standards and review by Pathway for Approval of New Devices and Procedures Committee.

While each device may differ regarding the evidence available for review by the Committee, the suggested quantity and quality of evidence that should warrant consideration include:

Non-randomized Case Series: 5 peer-reviewed papers

AND/OR

Randomized Controlled Trial(s) with appropriate control group(s)

New Procedure Approval

New procedure performed prior to approval must be conducted under IRB and entered into MBSAQIP.

For a new procedure to be approved by ASMBS, the Pathway for Approval of New Devices and Procedures Committee should address the following questions in the review:

  1. Is this a new procedure or a modification of an existing procedure?
  2. Based on current knowledge does the new procedure or modification of an existing procedure potentially have a different risk/benefit profile than an existing procedure?
  3. Does it add a new mechanism to an existing procedure?
  4. Does it have a new name or names that should be standardized as part of the approval process?

While the Committee will determine the level of evidence required for approval on a case-by-case basis, the suggested quantity and quality of evidence that warrant consideration could include:

Non-randomized case series: 10 peer-reviewed publications. If long-term risks and benefits are an issue, data reporting medium and long-term outcomes (3-5 years) can be evaluated.

AND/OR

Randomized Controlled Trial(s): The number of trials and patient required for consideration will depend on the quality of the studies and the clinical outcomes being evaluated.

Medium-term follow-up should include weight loss, comorbidity outcomes and early and late complication rates as defined by the Standards in Outcome Reporting in SOARD.