Many people are surprised that medical device representatives are in the operating room during some surgical procedures. The issue is gaining awareness with patients and becoming a hot topic debated by many. People are asking the question “Why should medical device sales representatives be allowed in the operating room during surgery?” After extensive research and analysis, I contend that sales reps should be present in certain surgeries to provide expert technical advice to guide and inform the surgeon on the proper use of a new or complex device. Additionally, proper and thorough training of reps on operating room protocol and hospital policies ensures a safer procedure and produces a better surgical outcome. In conducting research on my topic, it is clear that this is becoming a very serious issue to be addressed by hospitals, physicians, risk managers, medical malpractice insurers and medical device companies, as the patient population is uninformed as to the reasons for participation, and therefore wary of this practice. Many believe that surgeons are biased from the marketing strategies employed by reps and device companies that work hard to develop and maintain strong relationships with doctors. It could also pose an ethical and legal dilemma if patients have not given informed consent to a rep’s presence in their surgeries and an optimal outcome is not achieved, whether or not the rep has a direct impact on this outcome. Multiple articles have been published that present both sides of the argument, claiming a value and purpose in reps attending certain cases and conversely, the risk involved with their presence, coupled with the goal of eliminating reps from cases. Some authors are clearly opposed to reps in the operating room and offer suggestions on how to accomplish a good surgical outcome without the expertise of the rep, by training hospital staff to become the resident experts with specific technical training from manufacturers on their complex devices, thereby eliminating the need for a rep’s attendance. Other authors accept that there is risk, but recommend training reps on hospital policy and setting expectations for their behavior and acknowledge the need for the manufacturer’s expert rep to attend those complex cases to guide the surgeon for the best surgical outcome. 

An important aspect of this issue is the legal implication of a rep being in the operating room. The presence of device sales reps in the operating room receives attention when an unfortunate outcome is publicized. Sandra Boodman provides commentary on this in her Washington Post article, “Why is that salesman in the operating room for your knee replacement?” She states, “A string of court cases has raised questions about their involvement in surgeries that went awry, dating back to the late 1970s when a New York sales manager who had not graduated from high school tried for three hours to fix a prosthetic hip while one of the surgeons is said to have left the OR” (Boodman 2). Boodman and her cited references point to the need for solid policies to monitor and regulate the actions of reps that participate in surgery and strictly forbid their contact with the patient or instruments used on the patient. Another example of this is highlighted in Hospital Peer Review. This journal article, “Do you have the right policies for sales reps in the OR?” by the editor, Kay Ball, presents the case of a young patient having routine surgery who died in the operating room as the device rep was operating the controls of new equipment unfamiliar to the surgeon. The hospital was fined, and subsequently, strict controls and policies were put into place to prevent any future adverse event from occurring. Aileen Killen, PhD and RN at Dartmouth Medical Center, who defends the practice of reps in the operating room, is quoted, stating “Sales reps in the OR are invaluable resources, and I’d hate to see us have to lose them because a situation got out of control” (Ball 1).  She says it is common practice for reps to attend cases and that they are a positive factor. With the implementation of device rep policies, compliance enforcement, and proper training of OR protocol for sales reps, negative outcomes from the presence of reps will be eliminated, mitigating legal issues. Another nurse, Margaret Douglass, quoted in the article, states that physicians should obtain informed consent from patients, providing a legal foundation for their presence in the OR.  Alternately, the opposite point is raised by an orthopedic surgeon quoted in an article by David Hilzenrath, who doesn’t tell his patients that a rep will be in the room, stating, “I don’t tell them there’s a circulating nurse, either. My patients look at me as being the captain of the ship. I think if I told them about a rep, they would all be supportive of it” (Hilzenrath 1). Written informed consent will never hurt and could protect all parties from legal action. This is a policy that should be implemented by hospitals to apply when reps attend surgeries. 

Paul Anderson, the Director of Risk Management at ECRI Institute, presents his position in a YouTube video titled “Sales representatives and other outsiders in the OR.” He supports the presence of a sales rep in the OR, as purposeful and valuable in providing expert guidance to the surgeon in certain complex cases or where complex devices are used. In order to reduce the risk to patients and legal action against hospitals and physicians, he recommends hospitals set expectations, forbid reps to conduct any portion of the surgery and fully train reps in OR protocol. 

In the article, “Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives,” Bonnie O’Connor presents qualitative study data on the relationships between surgeons and device reps. Her interviews with physicians and reps outline the rep’s role in the operating room and the value the surgeon places on receiving expert technical guidance and advice if complications arise. It is clear that the surgeons interviewed prefer reps in the OR for technical guidance, contributing to improved surgical outcomes. Technical expertise from the device rep will reduce the chances of poor surgical outcomes, thereby reducing the potential for legal issues.  Joy Dickerson’s article, “Salespeople in the operating room pose risks, require vetting and guidelines,” presents the liability risks of reps in the OR and explains the need to protect patients and hospitals. These risks can be mitigated with proper rep vetting, credentialing, instituting strict guidelines and controls with extensive operating protocol training, and patient consent, which will all lead to improved outcomes and patient safety. She acknowledges that reps have a purpose in some cases, and advises that hospitals have policies that specifically apply to a rep’s behavior in the OR. She quotes a lawyer and bioethics professor, Sharona Hoffman, who supports this position and states, "It’s reasonable to say that the surgeon is using a new instrument or device and might need some advice from the salesperson during the procedure. That is a legitimate reason to be there. If the salesperson wants to be there just to see the device in use, to gather information for the manufacturer, that’s probably acceptable too. If the person wants to be there just out of curiosity, probably not" (Dickerson 3) 

In another Washington Post article, “The salesman in the operating room; Business and medicine converge as reps work beside doctors and sell them, too,” David Hilzenrath presents both sides of the issue, asking the question “should they be there at all?” He points out that reps know more about their products than doctors do, so they are valuable as real time technical experts during surgeries. This leads to better surgical outcomes. He quotes orthopedic surgeon Ted Parks, “They are critical to the efficient execution of hip and knee replacements” (Hilzenrath 2). Clearly, surgeons want the device expert in the room for their contributions to the best possible surgical outcomes. Surgeons should have a say in who is in their operating rooms and are comfortable with the reps attending cases for guidance.  Hilzenrath adds the opinion of Gerald Williams, an orthopedic surgeon who is president of the American Academy of Orthopedic Surgeons. “Even if a surgeon is extremely familiar with a device, there are different teams scrubbing in who typically have less familiarity with the procedure and the surgeon’s process than a rep with whom a surgeon regularly works” (2). He includes the position of an industry association executive, stating that some devices could not be used safely without sales reps attending the surgeries. Alternately, he presents the view of Dr. Catherine Matthews, who states “They’re not in any way motivated to recommend what might be the best thing for the patient. They’re there to sell their product” (3). As a number of sources suggest, a salaried sales rep would not be incentivized to over sell during surgery, but provide technical competency only. Hilzenrath questions if the rep’s presence could put the interests of the manufacturers before those of patients.  To negate this perception, sales reps should provide technical assistance only and not make increased income on up-selling in surgery.

Another concern is that of device reps using marketing ploys and techniques to improperly sway physicians to use their products. Sunita Sah describes in her article, “Physicians Under the Influence: Social Psychology and Industry Marketing Strategies,” that medical sales reps use social psychology in their marketing practices to create bias in physicians. She emphatically states that physicians are responsible for believing that they are not victims to this influence and manipulation. She advocates for strong policies and regulations that keep physicians at arms length from the marketing practices of device companies and educating physicians to be aware of their vulnerabilities to being influenced. She states, “In addition to educating faculty and students about the social psychology underlying such manipulative marketing techniques and how to resist them, academic medical institutions need to counter-act the medical profession’s improper dependencies on industry by enacting strong policies and regulations” (Sah 4). She did not address the possibility that a rep’s participation in surgery may have value by providing the expertise necessary on a new device being used.  This value could be provided, while eliminating marketing techniques, by having the device reps salaried, instead of commissioned based on the dollar amount sold in surgical procedures, to reduce “up-selling.” Bonnie O’Connor suggests this, stating, “Perhaps salaried individuals performing the usual tasks of today’s device reps—but trained on a variety of devices, with no financial incentive to promote one over the other—ought to be employed by hospitals or health care systems. In this way, the value they surely impart could be preserved, comparative performance data gathered systematically, and undue industry influence curtailed” (O’Connor 3). O’Connor conducted research and found that device reps have undue influence on surgeons, which creates bias. After interviewing surgeons and reps, she concluded that they enjoy strong relationships and that they contend benefits the patient with safer and improved surgical outcomes. She also suggested hospital personnel become the trained experts on these sophisticated devices to reduce the dependency on device reps. She concedes that a rep may have a purpose in the surgical suite, but that there should be technical assistance provided and no selling conducted. 

Another aspect to consider is the cost of a device rep participating in surgery. Device companies include an upcharge to compensate the rep in the operating room, who is assisting the surgeon with technical expertise. In her article, “Death of the Device Salesman?” Jaimy Lee explains that some hospitals are trying out a “rep-less” (Lee 1) model by training their staff to be experts on the product. She states that this model may “not be applicable to many hospital systems that can’t handle the management of inventory of the devices, and the additional staff needed to be specialists on various devices” (3). She presents her argument based on cost reduction, claiming that device costs will go down without having the premium added to pay for the rep’s commission. She quotes Donald Casey, CEO of Cardinal Health, "A lot of the (healthcare providers) today are beginning to recognize that the rep is not a 'free' service. It's actually part of a bundle that results in prices that they may or may not want to evaluate" (4). Experts cited in her article address the concern, stating that looking at cost only and not patient safety and surgical outcome is dangerous. She states, “Others worry that it could affect patient safety if not executed well” (4). She concedes that, “Many surgeons rely on the sales rep to provide guidance during procedures” (4). In her newspaper article, Sandra Boodman offers points to consider for and against the presence of reps in the operating room. She references many opinions on the matter, most of whom support the purpose and value of a rep in the surgical suite. As a counterpoint, she details the “rep-less” model used by one hospital system as an example of eliminating reps and the risk that they pose, as Jaimy Lee detailed in her article. 

After comprehensive research and review of multiple sources on my topic, I am able to support my thesis that device representatives should be allowed in the operating room for certain complex cases. Hospitals must produce strong and clear policies and protocols to monitor and manage the rep’s actions, while reducing the undue influence from marketing strategies that instill bias in surgeons. Since their presence is becoming better known now, especially due to lawsuits from reps improperly operating the equipment or performing a function of the surgery itself, it is imperative for hospitals to protect themselves, along with their surgeons, by obtaining informed consent from patients. It is necessary for patients to consent to eliminate any potential risk for legal action against the hospital and staff due to a rep’s presence. Additionally, hospitals must create very detailed and specific policies regarding a rep’s training in OR protocol, infection control, patient privacy and product expertise and enforce them. All of this will reduce risk and ensure positive surgical outcomes. Though some research presents the case for eliminating reps in the OR, I believe that surgeons feel more confident with the expertise given from the device rep during the case, which will actually improve outcomes, not negatively affect them, as long as the rep is not conducting any portion of the surgery. A device rep has the ultimate expertise after all, having been trained by the manufacturer, and is able to handle unexpected, unusual, or difficult surgical complications better than hospital staff. It is understandable that patients and hospitals would be wary of marketing practices that unduly influence surgeons to use products that may not be in the patient’s best interest. A solution to this is presented by a number of sources. By making reps salaried instead of commissioned, the potential for up selling will be erased. The technical expert will still be guiding the physician in the operating room, providing an unbiased, sound platform for choosing the right device for each case. Cost of devices becomes a concern when manufacturers include the “cost” of the rep to attend surgery. The suggestion to make reps salaried will resolve this issue, too, by eliminating the costlier commissions paid to reps, as well as the potential use of higher priced devices that could be unnecessarily recommended during surgeries, in an effort for reps to enhance their incomes. As the issue continues to gain exposure and controversy, patients, hospitals, surgeons, risk managers and malpractice insurance companies would all benefit from a sound, unbiased, safe set of policies and procedures to implement governing the presence of device representatives in the operating room. This would yield a safer surgical environment with expert technical guidance, informed patient consent, and better surgical outcomes.
