A dirty secret about medical device training

A recent listing from Buzzfeed has me questioning everything I thought I knew about training surgeons on new medical devices and how medical device reps themselves are trained on new products.

“Medical Device Representative here. You know that complicated spinal surgery you just had? Chances are critical aspects of your care were performed by your surgeon using specialized tools for the very first time, and were led by someone like me, in real time, with no special medical training, and with maybe a week of product training,” reads the first of 19 Guardian Confessions.

It’s no secret that medical device representatives often attend surgeries and other medical procedures, and are authorized to provide information regarding the safe and effective use of their company’s products. . After all, field reps are supposed to be experts on the products they sell, and until now I’ve never really questioned whether medical device reps have been properly trained on those products.

“Often knowing more about their devices than the surgeons who use them, medical device sales reps have therefore become commonplace in operating rooms across the United States,” Lisa Rice and Katie Stricklinpartners of Walsworth with expertise in life sciences litigation, written in an article DM+DI published in 2017 who wonders if commercial medical devices in the operating room are an asset or a liability.

According to Rice and Stricklin, manufacturers have seen an increase in product liability claims based on statements or alleged actions of their sales representatives during medical procedures. “There is a fine line that, when crossed, turns a sales representative from an asset to manufacturers and surgeons into a potential liability for third-party claims,” they write.

These liability issues are, in part, why most reputable medical device companies have company policies detailing the expectations of field representatives. Take Medtronic Global Standards of Business Conduct Policyfor example.

He describes the company’s field staff as “highly trained in the safe and effective operation and use of Medtronic technologies,” and goes on to say that they must be trained in the specific technology for which they are providing support. The document also specifies what representatives are and are not allowed to do in the operating room. For example, the representative is not allowed to interfere with the independent clinical decision-making of the surgeon or operating room staff, but is expected to speak up if a healthcare professional is considering using a product. company in a way that poses a risk to patient safety. .

In the same way, Stryker Policy on Participation in Surgery Representatives are explicitly prohibited from handling or providing advice for any product manufactured by another company or even another Stryker division other than the medical device on which they were trained. Stryker representatives are also required to complete and regularly renew a Stryker-sponsored training program related to participation in surgery.

However, none of these policies seem to define exactly what level of training is considered adequate, and I imagine that’s because the learning curve would vary from device to device. It is not unreasonable to believe that one week of training is sufficient for certain types of products. For more advanced technologies, however, I expect reps to receive well over a week of product training. Or am I naive?

The pandemic has to some extent put a stop to medical device representatives attending surgery, but many hospitals and medical device companies are using remote collaboration tools like Zoom to compensate. One of DM+DI2022 predictions for medtech trends was that there would be a continued emphasis on distance education.

“With the abundance of innovations and new medical devices and technologies in healthcare, the need for in-depth training for surgeons is becoming more and more necessary,” said Chris Luoma, senior vice president of global product management at GHX. DM+DI. “With continued restrictions on who can enter the operating room, there needs to be a remote training option to help train sales reps and medical device surgeons.”

Luoma mentions Explorer Surgical, a cloud-based platform that helps reps and doctors remotely join practices for training from anywhere in the world. “They’ve had tremendous success over the past year as the remote training options have proven to be a permanent solution for giving surgeons and reps access to the OR,” he said.

Justin Barad, MD, CEO and co-founder of Osso VR, also highlighted the lack of hospital staff as a determinant of the accelerated need for distance learning and assessment. “Initially, the concern was that trainees such as residents and fellows were falling behind given the declining case volume and sick leave. But now we are starting to see a worrying trend of burnout. and early retirement, especially in nursing,” Barad said. “We need to secure our supply chain with a more efficient and faster process to grow our HCP workforce in addition to ensuring a minimum level of proficiency that can deliver consistent and exceptional patient outcomes.”

Virtual reality technology is becoming an increasingly popular surgical training tool, and more and more studies suggest that Virtual Reality Training Really Improves Surgical Skills compared to traditional methods of surgical training.

Gamification technologies are also finding their place in surgical training. Ex-Level launched Virtual Technique Guides, described by the company as a “collaborative surgical training platform [that] applies the multiplayer interactivity of cloud gaming to enable surgeons to perform virtual procedures with medical device sales representatives on the same web conferencing platform.”

Using Level Ex’s technology, reps can send surgeons a link or QR code that takes them to cloud-based virtual surgery for a virtual patient that’s “fully interactive,” Level Founder and CEO Sam Glassenberg Ex, Told DM+DI in 2020. “We can just jump in there and do an operation.”

I hope the medical device rep who shared his dirty little secret about product training with Buzzfeed is either exaggerating the lack of new product training or portraying the worst-case scenario. My fear, however, is that their confessions may indicate a widespread problem in the industry.

Are you a medical device representative or other industry expert with knowledge on this topic? Share your thoughts with me at [email protected] Please put “medical device training” in the subject line.

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