Presence of Healthcare Industry Representatives in Perioperative Settings

May 5, 2023 | Health System Risk Management


Healthcare industry representatives (HCIRs) may be employees of healthcare product companies (e.g., clinical consultants, sales representatives, technicians, repair/maintenance personnel, pharmaceutical representatives, product specialists, scientific liaisons) (AORN; Kaul and Faigel). They may help provide nurses, surgeons, technicians, and other care team members with information they need to keep up with the changing technology of instrumentation and equipment.

The Association for PeriOperative Registered Nurses (AORN) Position Statement on the Role of Industry Representatives in Perioperative Settings states that "by virtue of their education, knowledge, and expertise, HCIRs have a valid, but restricted, role in the operative or other invasive procedures setting" (AORN). However, these individuals are outsiders in the surgical environment. When brought into the perioperative setting, they may become a hindrance, a safety hazard, or the cause of inspection violations or a lawsuit if they do not adhere to facility protocols or if the facility fails to delineate and enforce its expectations.

Although HCIRs are the focus of this article, some aspects of the discussion (e.g., infection control, informed consent, patient privacy) also apply to other outsiders in the perioperative environment, such as visiting surgeons and students.

It is important that all HCIRs be required to follow the same guidelines and restrictions whether or not the individual has previous perioperative experience (e.g., if the HCIR also happens to be a trained nurse or other healthcare professional). Restrictions should specify that HCIRs do not provide direct patient care and are not allowed to participate in sterile field activities, including the opening of sterile supplies (AORN). The role of the representative is that of an observer and advisor related to products and a source of information—not an active participant (Kaul and Faigel).

Regulatory citations and penalties for patient safety violations have occurred. For example, in 2012, a facility was cited for an infection control violation based on failure to prevent the potential spread of infection by permitting a sales representative to enter an operating room where a surgery was in progress without being appropriately dressed and without washing his hands. The facility policy required that all staff, visitors, and vendors wear clean and proper attire when entering areas where invasive procedures were performed. When surgical staff, including vendors and physicians, arrived at the facility in surgical scrub clothing, they were required to...

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