![]() ![]() For more advanced technologies, however, I would hope that reps receive significantly more than a week of product training. It's not unreasonable to believe that a week of training is sufficient for some types of products. Neither of these policies seem to define, however, exactly how much training is considered adequate, and I imagine that's because the learning curve would vary from one medical device to another. Stryker reps also are required to complete and regularly renew a Stryker-sponsored training program related to attendance at surgery. Similarly, Stryker's policy on attendance at surgery explicitly prohibits reps 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 have been trained. For example, the rep is not allowed to interfere with the surgeon or operating room staff's independent clinical decision-making, but they are supposed to speak up if a healthcare professional plans to use a company product in a manner that poses a risk to patient safety. The document also spells out what reps are and are not allowed to do in the operating room. It describes the company's field personnel as "highly trained on the operation and safe and effective use of Medtronic technologies," and goes on to read that they must be trained on the specific technology for which they are providing support. Take Medtronic's global business conduct standards policy, for example. Such liability concerns are, in part, the reason most reputable medical device companies have corporate policies detailing expectations for field reps. "There is a fine line that, when crossed, turns a sales rep from an asset to both manufacturers and surgeons into a potential liability for third-party claims," they write. "Often knowing more about their devices than the surgeons who use them, medical device sales representatives have therefore become commonplace in operating rooms across the United States," Lisa Rice and Katie Stricklin, partners at Walsworth with expertise in life sciences litigation, writes in an article MD+DI published in 2017 that questions whether medical device sales reps in the operating room are an asset or a liability.Īccording to Rice and Stricklin, manufacturers have seen an increase in products liability claims based upon their sales reps’ alleged representations or actions during medical procedures. After all, field reps are expected to be experts on the products they sell, and until now I've never really questioned whether or not medical device reps have been adequately trained on those products. It's no secret that medical device reps often attend surgery and other medical procedures, and that they are allowed to provide information regarding the safe and effective use of their company's products. You know that complicated spine surgery you just had? There’s a good chance that critical aspects of your care were performed by your surgeon using specialized tools for the very first time, and were directed from someone like me, in real time, with no special medical training, and with maybe a week of product training," reads the first of 19 Caretaker Confessions. A recent Buzzfeed list has me questioning everything I thought I knew about how surgeons are trained on new medical devices, and how adequately the medical device reps themselves are trained on new products.
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