Ethics Case Studies in Biodesign

Case 14 - The Clinical Specialist

You are a first-year fellow-in-training in Electrophysiology at your medical center. You want to learn how to implant cardiac pacemakers and automatic implanted cardioverter-defibrillators (AICDs). You note that a “clinical specialist” employed by one of the companies that manufactures AICDs is often in the operating room/cath lab when such devices are implanted. At times this woman scrubs in on the case, meaning she stands next to the primary operator and coaches him/her on the issues that come up during the implantation procedures. As you observe some cases, you note she may show the operator some “hands-on tricks” regarding the implantation procedures. You consider the possibility that the clinical specialist is acting in place of the fellow in some of these cases. You are told there are not enough cases to allow training of all the EP fellows in these procedures. The clinical specialist is very pleasant to you and offers to buy you lunch and discuss the pros and cons of various AICDs. However, you have heard in conferences that development of individuals’ experience and expertise requires that your medical center will use only this one manufacturer’s AICDs.

  • What is the proper role of the clinical specialist in this situation?
  • Is it appropriate and ethical for her to participate in the procedures as described?
  • Do you think her availability to the operator influences which AICD he requests?
  • Is there an advantage to you to meet personally with the clinical specialist in this situation?
  • Should you allow her to buy your lunch?
  • If a sales representative from the company is at the lunch, does that make a difference to you?
  • Should you cultivate a professional relationship with the clinical specialist to possibly influence the Chief of the EP service regarding your training for these implantations?
  • Can you discuss this situation with your Chief of Service?
  • If you cannot discuss this with your Chief of Service, what other person can you turn to for discussion and advice?
  • What should you do if you ultimately decide overall that this clinical specialist is a positive influence in this situation?
  • What should you do if you ultimately decide overall that this clinical specialist is a negative influence in this situation?