The ASMBS Pathway for Approval for New Devices and Procedures

This column is dedicated to sharing the vast knowledge and opinions of the American Society for Metabolic and Bariatric Surgery leadership—past and present—on relevant topics in the field of bariatric surgery.

This Month: The ASMBS Pathway for Approval for New Devices and Procedures

Samer G. Mattar, MD, FACS, FRCS (Edin.), FASMBS

Samer G. Mattar, MD, FACS, FRCS (Edin.), FASMBS, is Medical Director, Swedish Weight Loss Services, Seattle, Washington. Dr. Mattar is also President-Elect, American Society for Metabolic and Bariatric Surgery

Bariatric Times. 2017;14(6):12–13.

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Dr. Mattar, thank you for taking the time to speak with us about the ASMBS Pathway for Approval of New Devices and Procedures Committee. Please tell us more about the committee. When and why was it formed? What is its mission?

Dr. Mattar: The Task Force for Approval of New Procedures and Devices was created in 2016 in response to the growing number of new products and procedures that have emerged during the year. The members of this task force comprise the current chairs of Clinical Issues, Insurance, Quality, and Emerging Technology committees and the President of ASMBS Integrated Health; thereby representing all of the relevant groups that provide input and various perspectives. The main objective of this task force is to provide approval of novel techniques or devices through a formal and rigorous process that promotes safety and efficacy.

Has the committee evolved to accommodate the changing bariatric landscape? For instance does it change according to 1) procedure rise or fall in popularity and 2) new data released on safety/efficacy for a procedure and/or device?

Dr. Mattar: Yes, precisely. As we accrue experience and follow our long-term outcomes, we discover that certain procedures or devices fall below initial expectations of safety or durability. Alternately, new technological and surgical innovations deliver new and exciting options which should ideally be scrutinized and approved before widespread use. As the standard bearer for quality and safety in all matters that pertain to bariatric surgery, the ASMBS is uniquely positioned to offer a “stamp of approval” for novel techniques and devices.

What is the current process for consideration of ASMBS approval for new devices and procedures? Do each differ?

Dr. Mattar: New devices must have received United States Food and Drug Administration (FDA) approval prior to consideration of ASMBS approval. Each application for approval of a new device or procedure must be submitted by an ASMBS member who is in active practice. These applications are available on our website at http://asmbs.org/pathway-for-approval-for-new-devices-and-procedures. Once received by our task force, the application is then marshalled along the following approval process:

• 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.

• Primary review by the ASMBS Executive Committee of the Executive Council (ECEC). Seventy-five percent approval is required to advance to the next stage. This review will be inclusive and mainly to ensure plausibility of new procedure and device before invoking full review.

• Application assessed by the ASMBS Pathway for Approval of New Devices and Procedures Committee. In the course of the committee’s review, a Clinical Issues Position Statement may be produced concurrently.

• Application presented. The application is presented to Executive Council by ASMBS Member Sponsor and one Co-Sponsor and Pro and Con Advocates from Pathway for Approval of New Devices and Procedures Committee.

• Executive Council review and open vote. Seventy-five percent approval required to advance to next stage.

• ASMBS member comment.

• Final EC Vote: Seventy-five percent approval is required for final affirmation

• Outcome of approval sent. Outcome of approval is sent to major insurers and Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program once application approved.

After a majority vote by the EC, we arrive at final approval. Once a device or procedure has been approved, the ASMBS will then use its influence in recommending it to all stakeholders, including payers, hospitals, referring physicians, and other societies that it is now to be considered a standard (not investigational) component in the armamentarium offered to patients seeking weight loss options. This process is the same for both new procedures and devices.

Currently, what procedures and devices are approved by the ASMBS?

Dr. Mattar: The following is the ASMBS list of approved procedures:

• Laparoscopic Roux-en-Y gastric bypass

• Duodenal switch

• Sleeve gastrectomy

• Adjustable gastric banding

• Bariatric reoperative procedures

• Open procedures as deemed appropriate by the surgeon

The Vertical Banded Gastroplasty is currently under review.

Do you consider different variations of procedures, such as single anastomosis duodenal switch (SADI), and stomach instestine pyloric sparing surgery (SIPS)?

Dr. Mattar: Yes, indeed. Both SADI and single-anastomosis gastric bypass (formerly known as the mini-gastric bypass) are not mere adjustments of standard operations, but rather substantial modifications that markedly depart from convention. Therefore, they must undergo the same rigorous evaluation prior to their approval by the ASMBS as standard operations. This is by no means a critique or denunciation of these new procedures, but more of a call to practice caution prior to their implementation on a widespread basis before enough experience has been accrued regarding their safety and efficacy.

Why is it important that procedures and devices be evaluated by the ASMBS Pathway for Approval of New Devices and Procedures Committee?

Dr. Mattar: As the only surgical society that safeguards bariatric patients, we have a mandate to exercise due diligence before approving new devices and procedures. ASMBS carries much influence among stakeholders and it is therefore very important that new devices and procedures be approved with the consent of the majority of its members.

Are there any new procedures or devices that you anticipate to be reviewed in 2017?

Dr. Mattar: Yes, we have very exciting new devices and procedures that will be placed under consideration. They all have the potential to expand the portfolio of options that we may be able to eventually offer our deserving patients. Approval for intragastric balloons is currently in process. We expect to also receive applications for endoscopically-placed liners and aspiration devices. With regards to procedures, we have already mentioned single anastomosis duodenal switch and gastric bypass, and also expect to receive applications for endoscopic sleeve gastrectomy, among other novel and ingenious techniques. I am forecasting a very busy year!

Funding: No funding was provided in the preparation of this manuscript.

Financial disclosures: The author reports no conflicts of interest relevant to the content of this article. 

Tags: ASMBS

Category: Ask the Leadership, Past Articles