SIR 2018 Policy on Devices in Workshops
SIR 2018 Annual Scientific Meeting Vendor Workshop Participation Policy
Hands-On Workshop: HOW
This format for hands-on workshops is intended to allow attendees with interest in specific products to interact with both products and vendors side-by-side. SIR-appointed physician moderators will provide a brief introduction and instructions for the workshop. The attendees will then break up into small groups and rotate through product displays. If desired, vendors may have physician proctors at their stations to address attendee questions or participate in demonstrations.
Advanced Procedural Technique Lab: APT
This format for hands-on workshops is intended to allow attendees to learn techniques from experts in the field in an in-vitro format. These sessions will include moderator-led discussions, case demonstrations, and/or live demonstrations of techniques and products. Moderators may request in-kind equipment or device donations from vendors, and potentially operator assistance. However, all demonstrations will be physician faculty-led.
For a device to be featured in a workshop at the Annual Scientific Meeting, regardless of whether it is a Hands-On Workshop (HOW) or Advanced Procedural Technique (APT) workshop, the following criteria must be met:
- The device must either be FDA-approved or in United States clinical trials. Note this does not preclude off-label discussion of devices in any workshop, although the latter must be indicated as such by faculty.
- The device's manufacturer must be an exhibitor at the Annual Scientific Meeting featuring the workshop in question.
- The current regulatory status and clinical indications as written in the IFU of the device must be clearly stated in the workshop.
- Products and devices featured in HOW workshops are determined through the application approval process and subject to the approval by the Annual Scientific Meeting Committee.
- The decision to feature a device in APT workshops is initiated by the workshop coordinator but is subject to approval by the Annual Scientific Meeting Committee.
- Manufacturers’ representatives may be present with prior approval in the workshop to help faculty with device set-up and/or use, but are not allowed to display or distribute any promotional materials or “sell" the device to participants. Allowable exceptions to distributed materials include Clinical User Guides, Training Instructions, and peer-review clinical reprints (unmarked or non-highlighted).
- The number of representatives present will be determined by the Annual Meeting Committee based on the nature of the program and workshop structure.