Risk Management Tools & Resources


The Essential Role of Informed Consent in Robotic Surgery

Laura M. Cascella, MA, CPHRM

The Essential Role of Informed Consent in Robotic Surgery

Direct-to-consumer marketing of robotic-assisted surgery (RAS) has sparked interest in this technology among patients who may be enticed by statements about quicker recovery periods, less pain, smaller scars, lower infection risk, etc.

However, marketing and advertising efforts might paint an incomplete picture of the benefits and risks of RAS. Thus, informed consent plays a crucial and essential role in the treatment of patients who are considering robotic procedures. Just like with any other type of surgery, informed consent for RAS should involve a process undertaken by treating surgeons to educate patients about their procedures.

The informed consent process should include disclosure of standard consent information — e.g., an explanation of the procedure, the healthcare providers who will be involved in the procedure, potential risks and benefits, alternative options, etc. — as well as information specific to RAS. For example, surgeons should educate each patient about:

  • The procedure the patient is having and how it is performed
  • The potential risks of robotic surgery in relation to equipment failures and malfunctions, such as:
    • System errors
    • Video imaging problems
    • Broken components
    • Electrical arcing, sparking, and charring
    • Unintended instrument movements1
  • The potential risks of robotic surgery in relation to the patient’s specific condition and comorbidities
  • The surgeon’s past experience with RAS in general and with the recommended robotic procedure specifically
  • Alternative options or techniques for treatment and any information about how those techniques compare to RAS
  • What will happen in the event of an emergency or complication (e.g., the surgeon will switch to open surgery or traditional laparoscopy) as well as any related risks

Taking the time to provide patients with these details and answer any questions can help ensure that they have the appropriate information to make informed decisions about their treatment. Following the informed consent process, surgeons should document these discussions in patients’ health records and include copies of any related consent forms.

To learn more about the potential risks of RAS and strategies to address them, see Rise of the Machines: Robotic Surgery, Patient Safety, and Liability.

1 Alemzadeh, H., Raman, J., Leveson, N., Kalbarczyk, Z., & Iyer, R. K. (2016). Adverse events in robotic surgery: A retrospective study of 14 years of FDA data. PLoS ONE, 11(4): e0151470. doi:10.1371/journal.pone.0151470

MedPro Twitter


View more on Twitter