This is a column by Les Jebson, administrator of the Orthopedics and Sports Medicine Network at Prisma Health.
The presence of medical device representatives in surgical settings has become increasingly common in modern healthcare, particularly as procedures grow more technologically complex. These representatives, employed by device manufacturers, provide significant technical guidance on specialized equipment such as orthopedic implants and instrument selection, cardiovascular devices and robotic surgical systems. While their involvement can enhance procedural efficiency and support surgical teams, historically they have not been permitted to directly participate in surgical procedures.
One of the primary advantages of having device representatives present during surgeries is their deep product-specific expertise. Surgeons and operating room staff may not use every available device, especially in hospitals with diverse surgical offerings. Representatives can offer real-time guidance on device preparation, troubleshooting, and optimal usage, potentially reducing operative time and minimizing errors. In highly specialized procedures — such as spinal instrumentation or joint replacement, this expertise can directly contribute to improved patient outcomes. Additionally, representatives may assist with ensuring that all necessary components are available and properly configured, which supports workflow efficiency in high-pressure environments. Growing patient demands coupled with increasingly tight labor markets for circulating registered nurses and surgical technologists prompt the question — is there an environment where medical device representatives could or should directly participate in surgical procedures?
The first opponent of such a scenario would be notable ethical concerns, particularly regarding conflicts of interest. Device representatives are employees of companies with financial incentives tied to the use of their products. Their presence in the operating room may subtly influence device selection, potentially prioritizing commercial interests over patient-specific needs. Even when surgeons maintain decision-making authority, the dynamics of repeated interactions and reliance on representatives can create implicit biases. This raises questions about whether clinical decisions remain fully independent and evidence-based.
Patient consent and transparency present another issue. Patients are often unaware that personnel, such as device representatives, may be present during their surgery. Unlike operating room staff, representatives are not directly accountable to the patient and are not bound by the same fiduciary responsibilities. However, subcontracting specific services from medical device representatives and associated vendors could theoretically make them participants in care, and thus patient consent could also be captured to reflect their involvement. This could also address HIPAA and regulatory compliance.
The thought of having a competent medical device representative directly participate has operational implications. Operationally, the integration of device representatives into surgical teams can both streamline and complicate workflows. On one hand, their involvement can reduce the cognitive and logistical burden on clinical staff and in many locations address locums and staffing constraints. On the other hand, reliance on external personnel may hinder the development of in-house expertise and create dependencies that affect scheduling and consistency. Hospitals and ASCs must also consider credentialing processes, training requirements, and infection control protocols to ensure that representatives meet the same standards expected of clinical personnel in sterile environments.
The increasing prevalence of advanced surgical technologies, including robotic-assisted systems and patient-specific implants, suggests that the role of device representatives will likely expand in the future. As this occurs, healthcare institutions must develop clear policies that balance the technical benefits of representative involvement with ethical safeguards. These policies should include standardized consent procedures, strict guidelines on representative conduct, and mechanisms to mitigate conflicts of interest.
Medical device representatives can support surgical teams, but many are predominantly not trained or licensed to function as surgical technologists or circulating staff. What if the device representative has prior formal training as an RN or surgical technologist? Is it feasible, based on state-by-state regulations, that the device representative complete requisite or limited training through the hospital or ASC? Could a collaborative effort be formed with a local community training school?
In conclusion, the participation of medical device representatives directly in surgical cases presents both valuable opportunities and significant challenges. Their technical expertise can enhance surgical performance and patient outcomes, particularly in complex procedures. However, ethical concerns, conflicts of interest, patient autonomy, and transparency must be carefully managed. Very clearly defined contractual relationships require broad articulation and enforcement. However, if the technical competencies could be met — is there a valid argument for contracting with medical device representatives to help alleviate growing perioperative staffing constraints; or is this idea a recipe for legal, risk and patient safety disaster?
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
