Position Statement: Industry Representatives in the Operating Room

When the presence of an industry representative is necessary, helpful, or confers an educational benefit in this setting, the otolaryngologist and industry representative have certain responsibilities to the patient and staff in the Operating Room or Procedure Room (collectively referred to as the “OR” in this remainder of this document).  The American Academy of Otolaryngology – Head and Neck Surgery recommends that otolaryngologists be familiar with existing policies in their operating rooms and procedure rooms, and that the following minimum steps be taken:

1. The otolaryngologist should notify the patient that an industry representative may be in the room, disclose the identity of the person, and disclose the reason for this additional persons’ involvement. The surgeon should follow their hospital’s policy on documenting such discussions, and document this in the hospital record.
2. The representative should complete any hospital requirements or permissions prior to being allowed in the operating room, and the otolaryngologist should confirm this with the representative.
3. The otolaryngologist and participating surgical trainees using this device, and any surgical team members assisting with this device, should receive any needed training to use the device prior to the procedure.
4. The otolaryngologist should disclose to the patient any relevant financial relationships that may exist in using the device. The Academy discourages the use of devices that provide direct financial benefit to the surgeon if used in the OR.
5. Patient care will remain confidential, and this will be communicated to the patient, should there be any question thereof. If part of the hospital protocol, this should be reviewed in the surgical checklist at the beginning of the case.
6. The otolaryngologist should be familiar with the device and determine what is best for the patient in selecting whether or not to use the device.
7. The otolaryngologist should follow hospital and FDA protocols if the appropriate use of a device leads to an adverse patient outcome.
8. The industry representative should only be present in the OR during the time his/her instrument/device is in use, as well as for last minute training or answering of questions related to the use of the device, drug, or technology.

Drafted 11/11/2015
Submitted for Review 11/30/2015
Submitted for Review 10/12/2016
Submitted for Review 12/6/2016
Adopted 3/12/2017

References

1. Revised Statement on health care industry representatives in operating room. American College of Surgeons. https://www.facs.org/about-acs/statements/91-industry-reps-in-or. Revised October 1, 2016.
2. AORN Position statement on the role of the Health Care Industry Representative in the Perioperative Setting. https://www.aorn.org/-/media/aorn/guidelines/position-statements/posstat-personnel-health-care-reps.pdf Accessed October 1, 2015.

Important Disclaimer Notice (Updated 7/31/14)

Position Statements are approved by the American Academy of Otolaryngology—Head and Neck Surgery or Foundation (AAO-HNS/F) Boards of Directors and are typically generated from AAO-HNS/F committees. Once approved by the Academy or Foundation Board of Directors, they become official Position Statements and are added to the existing Position Statement library. In no sense do they represent a standard of care. The applicability of Position Statements, as guidance for a procedure, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these clinical Position Statements will not ensure successful treatment in every situation. As with all AAO-HNS/F guidance, this Position Statement should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results. Position Statements are not intended to and should not be treated as legal, medical, or business advice.