Mitigating The Risks Of Training Curriculum Modification Requests

Shook, Hardy & Bacon L.L.P.

Shook, Hardy & Bacon L.L.P.

Until they become fully autonomous, surgical robots will only be as good as their human operators. Training for all surgeons, nurses, bedside assistants, and other surgical team members is critical to ensuring optimal patient outcomes. Thus, many manufacturers ask surgical staff to undergo instruction and demonstrations on how to set up, handle, and operate their systems. Such training can span several days and often includes simulations, scenario role-playing, and hands-on time with the robot. But what should a robot manufacturer do when asked by healthcare providers to modify its training curriculum and change certain important elements like course length, course content, or attendee roles and numbers?

Because certain training modifications may reduce overall program effectiveness, manufacturers should strongly consider obtaining a waiver from the requesting institution. The waiver should make clear that the robot likely functions differently than other available systems, and experience on another company’s robot does not necessarily transfer over.

The waiver should also note that the robot manufacturer has not validated the effectiveness of the requested modifications. Thus, such changes may ultimately lead to participants receiving less training than envisioned in the manufacturer’s original training curriculum.

Finally, the waiver should conclude with language stating that the requesting institution is solely responsible for ensuring that the course attendees receive adequate training, and that the robot manufacturer does not have to provide any supplemental training. It should also specify that the requesting institution assumes all risks and liabilities stemming from the proposed training curriculum modifications.

Though such a waiver does not necessarily guarantee the robot manufacturer will not be roped into a lawsuit in the event of a mishap, it may help mitigate liability. Any such mitigation is desirable, particularly in the world of mass tort litigation.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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