Device Representatives in the OR During Joint Replacement Surgery

Anyone having joint replacement surgery expects to have individuals in the operating room other than their surgeon. Nurses, anesthesiologists, and surgical technologists are all people we probably expect to encounter in the moments before we go under. But would you expect a representative from the company who made the implant device?

Well, the truth is, they are often there. Representatives from device companies that may have a financial interest in what is used during your surgery may be in the room while you are having surgery.

During joint replacement, most surgeons have an industry device representative in the OR during the surgical procedure. These representatives may perform different functions, and while they are not actually performing surgery, they can have a significant influence on your operation.

Normal Operating Room Staff

The personnel present in an OR may vary by hospital, by procedure, and by preference, but some of the more common people found in the OR during joint replacement include:

• Surgeons: Your surgeon will obviously be in the operating room (or should be!) while you are under anesthesia and having a surgical procedure. There has been recent controversy about surgeons operating in more than one operating room at a given time, but surgeons are obligated to be immediately available if not actually present during the entirety of your surgical procedure.
• Anesthesiologists: Of course you expected an anesthesiologist, a physician who is in charge of making you comfortable during your surgical procedure. Anesthesiologists may work in teams, and a physician is often assisted by a nurse or technologist specifically trained in anesthesia. Typically, a physician is present during the beginning and end of the surgical procedure, and possibly throughout. Other times, an assistant will be present during the procedure. These assistants may be certified registered nurse anesthetists (CRNAs) or anesthesia assistants (AAs).
• OR Nurses: Operating room nurses are specially trained nurses with skills necessary to care for and keep patients safe during a surgical procedure. Operating room nurses may perform and assist with a variety of tasks in the OR. These tasks include maintaining a sterile environment, performing assessments and procedures, ensuring safe patient care, and documenting the details of the procedure.
• Scrub Tech: The scrub tech, or surgical technologist, is an individual in charge of the instruments used during the surgery. The scrub tech maintains an organized sterile field to ensure the proper equipment is available, accessible, and ready for immediate use. There may be more than one scrub tech in a particular surgical case.
• Surgical Assistants: Many surgical procedures, including joint replacements, often require surgical assistants. Sometimes people question why an assistant is needed. I often use the analogy of a carpenter hanging a door—in order to do this perfectly, it takes more than one set of hands. Even the most skilled carpenter will use assistants to help perform the task.
  Many patients worry about who is doing the surgery. Ask your surgeon, and ask that they perform the key portions of the surgical procedure if you have concerns. Surgical assistants may be doctors in training (residents or fellows), or they may be physician assistants (PAs), nurse practitioners (NPs), nurse assistants (RNFAs), or surgical assistants.
• Medical Students: Medical students are common in teaching hospitals. Depending on the level of a medical student, they may be there to observe or there to assist. As with the surgical assistants, ask your surgeon what the role of a student may be. Teaching is a critical part of a surgeon’s job, and a good surgeon will ensure that any tasks performed by any level trainee are both appropriate and well-supervised.

Device Companies

Medical device companies manufacture and sell the implants used during joint replacement surgery. There are many companies that do this, some are very large (Johnson & Johnson, Stryker, Zimmer), and others are very small companies you likely have never heard of. Each company wants the surgeon and hospital to use their product when appropriate, and oftentimes, your surgeon or hospital has a choice in which company’s product to use.

Many companies will have a representative present in the operating room at the time of surgery. These device reps perform several functions:

• Maintain complete inventory: Many surgical implants used in orthopedic surgery come in a variety of sizes and varieties. It is not uncommon for a single type of hip or knee replacement to have hundreds of possible combinations of sizes of implants used. It is important to manage this inventory well to ensure everything needed will be ready for you when you need it. Managing this inventory is a time-consuming and difficult task—one that companies are willing to perform in order to have a surgeon use their implants.
• Ensure staff understanding: Each implant requires knowledge of how to put together and implant the device. While surgeons are expected to have this knowledge, it can be hard for the technologists and assistants to know every detail and every variety of implants. A surgeon may have a favorite knee replacement implant they use every time, but the scrub tech may see five different knee implant systems in a week. Having a rep can help ensure the tech and assistants can perform their jobs efficiently.
• Troubleshoot issues: When problems or questions come up, device reps can be very knowledgeable about how to correct the question at hand. For example, if a piece of equipment is not functioning as planned, device reps are often extremely knowledgeable about the details of the equipment they sell, and how to correct any questions or problems.

The medical device reps are not part of the operation in that they are never at the surgical field assisting in an operation. While this was a practice decades ago, this does not occur any longer. Device reps are prevented from any direct patient contact.

Concerns About OR Device Reps

While there may not be any direct patient contact, critics would argue there is significant influence the device reps can have in the OR that directly impacts the care of the patient. A device rep may communicate directly with the surgeon who is making a choice about the implant selection during a surgical procedure. However, most of these decisions are made prior to the surgery, and many hospitals regulate these choices. Device reps may also interact with surgeons in their office and at conferences and meetings in an effort to win their business.

While I believe most device reps believe in their company’s products, it needs to be recognized that most device reps lack medical training, are not implant engineers, and are being told by their company what to say to encourage the use of their products. Furthermore, representatives typically receive compensation based at least in part on their sales performance. It is not hard to see why many people find concerns about the presence of these individuals in an operating room.

The question comes: Why does anyone allow reps in the OR at all? Well, the functions listed above, in terms of managing inventory and ensuring staff knowledge, can be extremely helpful and efficient. A good representative can help ensure a surgery moves along quickly and efficiently, with all of the proper equipment and implants at hand.

A Word From Verywell

There are different approaches to managing device reps in the OR. Some hospitals have taken dramatic action to ensure the emphasis is on the patient. For example, some hospitals have made sure patients give consent before any device representative is allowed in an OR for their surgery. Other hospitals have eliminated the use of device reps all together, instead of working directly with companies to purchase inventory and training their staff to manage and use it appropriately. The reality is, most hospitals allow device reps to enter the OR without specific disclosure to patients.

So what should you do? Ask your surgeon which implants they will be using, and why that implant was selected. Ask if there will be company representatives in the OR and if their role is essential to the surgical procedure. If you have concerns about the role of the rep, ask that they not enter the OR during your surgery. Bottom line is that you should feel comfortable and confident that the attention and decisions made are in your best interest.