How can we keep medical device reps out of the operating room, but not out of the picture?
A victim of suboptimal medical device training and support
Fred Taylor went in for a routine prostatectomy that was supposed to take five hours using the DaVinci surgical robot. However, the surgery ended up taking 13 hours with severe complications that caused him to be incontinent, leading to kidney/lung damage, sepsis then a stroke. He ultimately died a year later.
He was a victim of poor medical device support and training for surgeons that led to suboptimal outcomes and ultimately could have been a factor in his death.
Financial gains ahead of patient outcomes
The DaVinci received premarket notification approval without requiring robust safety and efficacy data in exchange for providing detailed data on how surgeons would be trained on the system. Intuitive Surgical provided a 70 question exam and three day hands on training as part of the approval.
However, within a year they dropped it down to a 10 question online quiz and one day of training.
The surgeon mentioned previously, who used the DaVinci, had never used the system during a surgery without supervision. Intuitive Surgical, the company who markets and trains surgeons on the DaVinci, was called into question on the quality of training and support they provided before surgeons use the system on actual patients.
Hospitals are responsible for setting the training requirements in order to be credentialed on using the DaVinci system.
Intuitive Surgical sales reps were responsible for pressuring hospitals to reduce the credentialing standards to drive quicker adoption.
“Don’t let proctoring or credentialing get in our way” said a Western regional sales manager when an account had only used the system 5 times when their sales target was 36.
Salesmen in the operating room
Intuitive Surgical is not alone in the medical device space. New medical device and procedures are launched that require surgeons to learn new methods and techniques. Driven by quarterly sales forecasts however, the sales reps are pressured into reducing the barriers to adoption and meeting revenue targets.
And believe it or not, these salesmen are actually present in the operating room.
There are an estimated 94,752 medical device sales reps in the U.S. with the majority being in high cost, high touch physician preference item categories.
An estimated 31 million procedures (37% of total US procedures) have a sales rep present in the operating room during the procedure.
For the DaVinci, the sales reps were physically present to assist new surgeons experiencing technical difficulties with the robot. With this level of access, the sales reps gained access to the surgery schedule and pressured surgeons to use the DaVinci on upcoming procedures and reduce the requirements for new surgeons to use the system.
Balance of Trust
Medical device companies have evolved the market to require a trusted embedded resource in the operating room that can lead to improved patient outcomes; born was the ‘medical device rep’. Medical device reps are indeed a valuable resource to the healthcare industry.
Medical device reps provide critical and timely expert guidance, support management of inventory, repurchasing and invoicing and provide an overall level of ‘comfort and convenience’ to the operating room.
But with conflicting objectives, providers and suppliers are at odds with each other in the brave new ‘value-based’ world. On one side, their expertise is valued. On the other side, they can let their quest for profits impact patient safety.
How can we keep medical device reps out of the operating room, but not out of the picture?
1 note
- lrb989-blog liked this
- nurepinc posted this