The American College of Surgeons (ACS) recently issued an updated Statement on health care industry representatives in the operating room (OR) (see page 48, this issue), the purpose of which is to “supply guidelines to health care facilities and members of the perioperative care team to ensure optimal surgical outcomes, to ensure patient safety, and to protect patients’ rights to privacy and confidentiality when [a health care industry representative] is present during a surgical procedure.”
The College has had an active interest in this matter for some time. At Clinical Congress 2015, the ACS Committee on Ethics hosted a Town Hall meeting that brought together roughly 30 surgeons and representatives of the pharmaceutical and device industries in a session titled, Do You Want (or Need) the Sales Rep in Your OR? In light of the updated statement, this article reviews some of the issues discussed at that meeting.
Role of industry in patient care
The Town Hall participants agreed that relationships between surgeons and industry representatives are beneficial for both parties. Industry representatives can provide surgeons with important technical information and assistance. Furthermore, at a time when funding for continuing medical education and medical research is decreasing, the pharmaceutical and device industry should be a transparent partner with the medical and scientific community. Conflicts of interest need to be avoided, or at least identified and managed appropriately. Guidelines governing how to structure and operationalize the relationship also need to be established.
The conversation at the Town Hall meeting highlighted some of the realities, ethical issues, and best practices that can guide the interaction between the surgeon and the industry representative in the OR. Participants generally agreed that more open avenues of communication would help define the optimal relationship between the two.
Participants concluded that industry representatives fall into one of two categories: technical and sales. Some surgical specialties rely on the presence of the industry technical representative in the OR; vascular surgery is an example. When a graft is needed, the caliber and length of the graft selected before surgery can change based on intraoperative findings. The OR may stock only a limited number of grafts because it is financially prohibitive for the OR to stock a large selection. The industry representative has access to and can supply a selection of grafts that will accommodate the needs of the patient. Similar examples of this symbiotic relationship between the surgeon and the industry technical representative can be found in other surgical specialties, such as orthopaedics.
This relationship benefits all involved parties, including the patient. However, the patient has the right to self- determination and therefore should be informed if an industry representative will be in the OR. One of the challenges is timing. Informing the patient on the day of surgery in the preparation area may make it difficult for the patient to refuse. In addition, to preserve the patient’s privacy, the industry representative should not enter the OR until the patient is fully draped.
The introduction of new surgical equipment and technology also can benefit the patient. Surgeons usually are introduced to new devices and technology by industry sales representatives. Even when the surgeon has become proficient in the use of the new equipment or technology, the industry representative may be needed in the OR to help troubleshoot unexpected difficulties. The policies or guidelines of each hospital will facilitate the interaction between the surgeon and the industry representative without disrupting patient privacy and safety. This interaction should be transparent and organized.
Another mechanism by which surgeons become familiar with new equipment and technology is through Continuing Medical Education (CME) programs. However, some of the current regulations have made contacts between industry and the CME-sponsoring organization onerous, which has caused both parties to shy away from such interaction. It has been suggested that the ACS and other professional education organizations look for mechanisms that will avoid conflict of interest, real or perceived, which would allow industry to support CME activities for the advancement of surgical care. It also was suggested that the industry breakfast that brought industry representatives and surgical leadership together at the annual Clinical Congress in the past be reinstituted.
Some of the suggestions and/or guidelines discussed at the Town Hall meeting and incorporated into the College’s policy statement include the following:
- Industry representatives should not have access to private patient or surgeon information (such as access to the full OR schedule).
- Invited industry representatives should make an appointment and not just show up in the OR.
- Many hospitals have “industry fairs,” where industry representatives can demonstrate their equipment and devices in an area outside the OR.
- Surgeons who participated in the Town Hall meeting were of the opinion that industry representatives should not have access to the surgeons’ lounge.
- Industry representatives should be registered, verified, and distinctively identifiable. In many hospitals, the industry representatives wear different colored caps or scrubs.
- Some hospitals include in their informed consent forms for surgery that an industry representative may be present in the OR at the surgeon’s discretion.
The College recognizes the importance of the health care industry representative and the benefits that the relationship between these individuals and the surgeon can provide patients, and the revised statement on this topic provides guidelines on how to structure the relationship.