The following statement was revised by the American College of Surgeons (ACS) Committee on Perioperative Care and was reviewed and approved by the ACS Board of Regents at its June 2016 meeting.
The ACS recognizes the need for a structured system within the perioperative setting to allow for education, training, and introduction of procedures, techniques, technology, and equipment to the surgical health care team. Health care industry representatives (HCIR), by virtue of their training, knowledge, and expertise, often can provide technical assistance to the surgical team. Such assistance may expedite the procedure and may facilitate the safe and effective application of surgical products and technologies.
The purpose of this statement 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 an HCIR is present during a surgical procedure.
Therefore the ACS recommends the following:
Surgical department administrators in all facilities, including the acute care hospital, ambulatory surgery facility, and office-based operating room (OR) settings should be aware of all relevant institutional policies and incorporate them into specific written policies governing the presence of HCIRs in the OR.
These policies should define the requirements and procedures for manufacturer representatives to be present in the OR and the role and limitations of the HCIR in the perioperative setting.
These policies should comply with applicable state laws and regulations and be consistent with the institution’s existing policies, those promulgated by the OR, and those established by credentialing and privileging committees.
Institutional policies should include but not be limited to the following elements:
- Facility requirements and procedures for manufacturers’ representatives to be present in the OR are as follows:
- The institution should designate an authority for approving an HCIR’s presence in the OR. A time frame for securing this approval should be established. Among other responsibilities, the authority should do the following:
- Implement measures to ensure that the health of the HCIR is comparable to that of other personnel in the institution who are in contact with patients and should apply the same standards for assessing the health status of the HCIR as they do other personnel.
- Establish a time limit and appropriate identification (to be worn at all times) for the HCIR.
- Ensure orientation to the facility is provided.
- Verify the education and training of the HCIR in the following areas:
- Health Insurance Portability and Accountability Act (HIPAA) compliance and all other matters related to patients’ rights and confidentiality
- Appropriate conduct and attire in the OR environment
- Aseptic principles and sterile technique
- Infectious disease and blood-borne pathogens
- Occupational safety standards for biohazardous waste, fire risk and prevention, electrical safety, radiation, and other safety protocols
- All other applicable practices that may be related to the operation
- The presence of the HCIR is at the discretion of the operating surgeon. The HCIR should be introduced to the entire OR team and the purpose of the visit should be explained. The surgeon may initiate the request. If not, the surgeon should be notified and approve the visit in advance of the operation.
- The patient should be informed of the presence and purpose of the HCIR in the OR and consent in accordance with institutional policy and state law. Documentation should also be provided in accordance with institutional policy and state law.
Roles and limitations of the HCIR in the OR
The HCIR is present as an advisor to the perioperative team. The presence of the HCIR in the OR cannot substitute for preoperative training of the surgical team. The surgical team should have received training and demonstrated competence in the application of surgical devices and technologies used in the OR before the procedure.
The HCIR serves as an educator and facilitator. In this role, the HCIR:
- Should not engage in the practice of surgery, nursing, or medical decision making
- Should not scrub in or be involved in direct patient contact
- May be involved in the remote calibration or adjustment of medical devices (for example, pacemakers, laser technology) to the surgeons’ and manufacturers’ specifications
- Should have his or her activities monitored and supported by the surgeon or at the surgeon’s discretion by the perioperative nurse responsible for the patient’s care
A clearly defined institutional mechanism should exist to address any departures from these established policies.
The ACS offers this statement for consideration by surgeons, their hospitals, and health care organizations. This statement is provided as general guidance. It does not constitute a standard of care and is not intended to replace the professional judgment of the surgeon or health care administrator. This statement may be reviewed and modified as necessary to conform with the laws of the applicable jurisdiction, the circumstances of the individual hospital and health care organization, and the requirements of other allied and health care organizations.