It’s logical to assume there will be many medical staff members in the operating room during a surgical procedure. Everyone expects that in addition to the surgeon(s), there will be anesthesiologists, nurses, and perhaps doctors in training. However, did you know there are often medical device sales reps helping surgeons in the OR?
Why are medical device sales reps in the OR?
Sales reps are in the OR to provide surgeons with technical expertise on devices including artificial hips and knees, cardiovascular implants, and spinal surgery devices.
Because there are so many new implants and devices sold every year, surgeons can find it hard to keep up with new developments. Therefore, surgeons often rely on sales reps in the OR to help them understand the “intricate details and nuances” of so many products.
However, these sales reps can also try to guide the surgeon to the newest, most expensive model of the device the surgeon is planning to use, even when the older version is more proven, thereby increasing the cost of a procedure.
And sometimes sales reps recommend devices that patients later claim caused harm.
How well trained are these sales reps?
Although medical device sales reps receive technical training from the device manufacturer, their formal education may be limited. According to a Kaiser Health News (KHN) article, device sales reps “have received little scrutiny”. In fact, there have been sales reps advising surgeons who have not even graduated from high school!
According to a KHN article, Stryker, a top manufacturer of spine implants, reports they spend “a significant amount of time and money” to train reps. When hired, the sales reps typically “shadow” other reps for 3-6 months. Next, they complete additional training, including a 10-day intensive “Spine School”. In a court filing, Stryker claims it typically takes 8-18 months, or longer, for a sales rep to develop “long-term relationships” with customers.
The positive impact of sales reps in the OR.
As with most things in life, there are positive and negative aspects.
Sales reps can provide valuable guidance to a surgeon because they:
- Are very knowledgeable about the particular medical device the doctor is using.
- Have observed many, maybe even hundreds, of procedures using a particular device.
- Have seen a variety of techniques used by multiple surgeons.
- Know troubleshooting options.
The negative impacts of sales reps in the OR.
Simply put, sales reps are not trained medical professionals. And sometimes their participation and advice may not be in patients’ best interests.
Patients and/or families have sued sales reps and surgeons because the reps participated in surgeries in a “meaningful way”, and/or provided faulty advice. There have even been cases alleging that the sales rep was working on the patient while the surgeon was not present!
A KHN investigation found that the reliance on sales reps in the OR has been blamed for “contributing to serious patient harm in thousands of medical malpractice, product liability and whistleblower lawsuits filed over the past decade“.
In these lawsuits, some patients allege they were injured after sales reps sold or delivered wrong-size or defective implants. Other patients accuse device makers of misleading doctors about a products’ safety and durability.
Shockingly, there are 6 multi-district federal cases that have consolidated lawsuits from over 28,000 patients seeking compensation for injuries involving hip implants, including some patients who needed painful second operations to fix implant issues.
What do the sales reps say?
Unsurprisingly, sales reps, who can earn 6 figure salaries, say their technical knowledge of devices and their skills make operations safer for patients.
However, in some cases, sales reps feel surgeons rely on them too heavily. On top of providing advice, sales reps report they sometimes must provide hands-on help to doctors who lacked sufficient expertise.
In fact, a survey of 43 device reps found that 88% said they gave verbal instructions to a doctor during a procedure, and 21% said they had direct “physical contact with hospital staff or a patient during an operation”, which may be in violation of the law.
Do doctors tell patients about this beforehand?
Do all hospitals use these medical device sales reps?
Most hospitals rely on these reps to provide expertise to their surgeons. But, some hospitals ban the reps in an effort to control costs, and others are considering bans.
Interestingly, a program using hospital-employed techs who receive the same training as the sales reps has been successfully introduced at Loma Linda University Medical Center in California. The program saved the hospital money and resulted in no difference in patient outcomes. Perhaps this is the model of the future?
What can you do about sales reps helping surgeons?
There have been studies that show surgeon experience is an important factor in determining the likelihood of successful outcomes. However, there is no known number of procedures that will assure you that your surgeon is experienced enough to minimize his/her reliance on a sales rep.
As a patient or family caregiver, you should ask any prospective surgeons the following questions before scheduling a procedure involving a medical device implant to get a sense of their potential reliance on a sales rep:
- What kind of training did you receive on this device?
- Did you watch videos?
- Attend a training session organized by the manufacturer?
- Participate in surgeries being led by more experienced surgeons? How many?
- Other training?
- How many procedures have you performed with the exact device in your career? In the past year?
- Will a medical device sales rep be present during the procedure? For what purpose?
If possible, interview more than one surgeon, and use your intuition to determine your comfort level.
For more information on the overall safety of medical devices, read How Safe are Medical Devices?
Although sales reps helping surgeons is one potential risk, there are other risks associated with surgeries. Therefore, I suggest you read the following blogs to reduce your risk surgical complications and harm: