​Healthcare industry representatives are sometimes present in the operating department, but is their presence problematic? That question was the subject of a November 14, 2016, article in the Washington Post. The public often does not realize that industry representatives—salespeople employed by medical device companies—are present in the operating department, but, as Josi Wergin, CPASRM, ELS, a risk management analyst at ECRI Institute, was quoted as saying in the article, "a lot of times they are the real experts on their products." However, when poorly managed, industry representatives' presence can lead to liability on both sides. A 2002 incident in which an industry representative wrongly advised a surgeon that bone cement was suitable for sealing a hole in a patient's skull resulted in a $1.75 million verdict for medical negligence. A survey conducted by a medical college in New York found that 88% of 43 industry representatives had provided verbal instructions to a doctor during surgery and 37% felt they had been "excessively involved in an operation." Meanwhile, 40% of respondents said they had attended a surgery in which they questioned the competence of the surgeon. Some say industry representatives are often more familiar with a product than the surgeons, which occasionally leads to surgeons relying too much on the industry representative. However, in its recently updated guidance article on industry representatives in the operating department, ECRI Institute repeated its warning that surgeons should not learn "how to use . . . devices on the fly," according to Wergin. The Washington Post article relayed the story of a surgeon who refused all preoperative training on a new $10,000 hip replacement system, reasoning that the industry representative would be present. The surgeon struggled to perform the procedure, the article said, and "repeatedly cursed" at the industry representative and the circulating nurse. On the opposite end, a California hospital cited in the article has largely eliminated industry representatives in orthopedics by buying implants directly from the manufacturer. This has resulted in a savings of around $1 million annually, without impacting outcomes, according to the chief of orthopedics, cited in the article. To do this, the chief orthopedist negotiated a steep discount on artificial joints by buying in bulk, and sent his surgical technicians to get the technical training normally given to salespeople. Replacing the skill set of industry representatives with his own employees, the chief orthopedist reasoned, would eliminate those conflicts of interest. The program has now been expanded to include other surgeries, such as trauma and spine operations.

HRC Recommends: Any hospital that allows someone who is neither an employee nor a medical staff member to participate directly or indirectly in a surgical procedure may risk liability—even if the procedure is a total success. Liability for failure to obtain patient consent (i.e., civil battery) is a possibility, and may also lead to regulatory violations and financial penalties. Hospitals must have policies and procedures in place that delineate the actions allowed and behavior required of healthcare industry representatives and other outsiders, such as visiting surgeons participating in a procedure. In addition, doctors and appropriate hospital staff members must know how to operate a medical device and how to apply it to patients, and it is reasonable for hospitals to insist that they obtain this knowledge. This is particularly important for new devices.