Seamless: Making Vendors Part of the Perioperative Team to Ensure Positive Outcomes
Given the complexity and intricacy of today’s sophisticated medical devices, it’s not uncommon for health care industry representatives, including device vendors, to be present in the operating room to help surgeons and nurses operate devices properly. While this can be helpful in the right circumstances, it could also pose a danger to patients.
“Vendors can help surgical staff stay current, but make no mistake—they are in your hospital to sell their company’s products and services,” says Anne Jones, RN, BSN, MA, a nurse surveyor with the Maryland Department of Health and Mental Hygiene Office of Health Care Quality. “Having vendors in the OR may represent an unsafe and potentially fatal OR distraction.”
According to Jones, there are wide variations in the education and training provided to medical device vendors and salespeople by their companies. “Some mandate training in OR protocols like sterile fields, OR garb and patient privacy, but other leave it up to each hospital,” says Jones. “There are no credentialing or licensing bodies, and vendors are not licensed or regulated by the state.”
AORN’s position
In its Position Statement on the role of health care industry representatives in the OR, the Association of periOperative Registered Nurses (AORN) states
that it recognizes the need for a structured process for education, training and introduction of procedures, techniques, technology and equipment to health care professionals practicing within the perioperative setting.
“By virtue of their training, knowledge and expertise, health care industry representatives can provide technical support to the surgical team to expedite the procedure and facilitate desired patient outcomes,” says Lisa Spruce, RN, DNP, ACNS, ACNP, ANP, CNOR, the Director of Evidence-Based Perioperative Practice for AORN.
“While vendors and health care industry representatives may function in any of several different positions while in the OR—including as clinical consultants, sales representatives, technicians and repair/maintenance personnel—it is the primary responsibility of the OR nurse to ensure patient safety in the operating room,” she adds. Among the core OR nursing activities that AORN believes vendors should not perform are assessment, diagnosis, outcome identification, planning and evaluation.
“The surgical setting is one of the most potentially hazardous of all clinical environments and is subject to strict regulations, clinical practice guidelines and standards of care to preserve patient safety,” notes the AORN Position Statement. “It is important that the health care industry representative understands how to safely work in the operating room to assist the perioperative team in maintaining the patient’s safety, right to privacy and confidentiality when a health care industry representative is present during a surgical procedure.”
Spruce recommends that facilities have a policy and procedures in place that govern all industry representatives prior to their entrance into the facility. “The OR nurse should be aware of and well-versed in the policy and make sure it is enforced. Knowledge and enforcement of the hospital policy will help him or her control the activities and behavior of all visitors in the surgical setting at all times.”
Adverse events
Jones cites two cases in Maryland where having medical device vendors in the OR contributed directly to adverse events. In the first case, which involved a patient undergoing bilateral knee replacement, the vendor handed the surgeon the right knee prosthesis, who then implanted it into the patient’s left leg. Complications that resulted in trying to remove the cemented prosthesis resulted in the patient having to have a larger prosthesis implanted.
In the second case, the vendor took over control of a machine that was being used on a patient having a gynecological procedure when a warning light went off. The vendor tried to override the alarm by pumping the foot pedal ive or six times, giving the patient a blast of heat each time. This resulted in thermal burns to the patient’s bowel, which required emergency surgery two days later.
In both cases, says Jones, the OR staff was over-reliant on the skill of the vendor, and there was also poor communication between the vendor and the surgeon and poor vendor supervision and control. “In the gynecological case, the hospital identified several very troubling practices by its surgeons,” says Jones, “including the fact that surgeons often had private contacts with vendors that the hospitals were unaware of. The physicians were using the vendors for just-in-time training on new equipment that the hospital had not purchased.”
Based on its systematic investigations into the causes of adverse events submitted to its office and its own literature search, the Maryland Department of Health and Mental Hygiene Office of Health Care Quality has made a number of recommendations with regard to vendors in the OR. These include:
- Formal credentialing of vendors by the hospital to verify education, training and communicable disease status.
- Specific definitions in hospital policy of the role of vendors in the OR
- Sponsorship of each vendor by a member of the medical staff who will be responsible for policy infractions.
- The prohibition of private agreements between vendors and physicians.
- Disclosure of vendor presence to patients, who can refuse to have the vendor present if they choose.
“Perhaps most importantly, the circulating nurse should have ultimate control of all personnel in the OR,” says Jones. “You have to ask where the nursing leadership was when these vendors were overstepping their bounds. Why would no one question the presence of multiple vendors in one OR?”
Jones is quick to add that while her office is not implying that vendors are incompetent or surgeons are lazy, “the OR exists for the treatment of patients, not the selling of products. The presence of vendors in the OR is often an unnecessary distraction to OR staff and a risk for the patient. Therefore, all activities in the OR need to pass through the filter of what’s best for the patient.”
Accountability and patient advocacy
While supporting the education of OR team members with regard to new procedures, techniques, technology and equipment they are not familiar with, Spruce believes that the OR nurse is ultimately accountable for the patient’s nursing care during the procedure and should advocate for the patient’s safety, privacy, dignity and confidentiality.
“Health care industry representatives may be permitted in the OR to provide technical support in accordance with facility policies and local, state and federal regulations,” says Spruce. “But they should not provide direct patient care or be allowed in the sterile field. And patients should have a right to be informed about the presence of a health care industry representative in the OR during a surgical procedure according to local, state and federal regulations that govern this.”
She adds that AORN does support health care industry representatives with specialized training and facility approval being able to perform calibration/ synchronization to adjust/ program certain devices (such as implanted electronic devices, radio frequency devices and lasers) if this is done under the direct supervision of the physician.
“Operating room nurses have ultimate responsibility for patient care—they are responsible for the safety of the patient and are the patient’s advocate at all times,” adds Spruce. “Therefore, it’s critical that OR nurses make sure that health care industry representatives understand operating room protocol to ensure that patient safety is never compromised.”
