This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Apply informed consent processes that include the surgeon’s experience in robotic procedures
2. Recall the standard competency level for robotic surgical procedures that was used in the case of Forrest v. Bonifield, 2017 N.J.
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from May 9 2018 through May 9 2020, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
The advent of robotic surgery is intersecting with key concepts related to informed consent. The surgeon’s skill set always matters for every surgery. However, when technologies are introduced, even the best of surgeons will need to learn new skills to ensure they are providing the best of care to patients. The question then becomes – how much do patients need to be informed regarding the experience of “that [person] behind the robot?” Medical societies are struggling to set standards for credentialing surgeons, especially when it comes to the minimum number of required procedures to be performed. Likewise, hospitals determine their own criteria for granting privileges for robotic surgery. Each robotic procedure has its own learning curve. Robotic surgeons are considered competent when they have performed enough procedures to learn the technique sufficiently well to have an acceptable complication rate.
In the meantime, patients undergoing these procedures must give their informed consent. ACOG recommends that the discussion of robotic procedures include the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options. ACOG asserts “the number of cases required for proficiency is not clear.” However, in addition, ACOG in a Committee Opinion (also endorsed by SGS) states
As with any surgical procedure, repetition drives competency. In addition to the didactic and hands-on training necessary for any new technology, ongoing quality assurance is essential to ensure appropriate use of the technology and, most importantly, patient safety. Surgeons should describe their experience with robotic-assisted surgery or any new technology when counseling patients regarding these procedures.
In the case of Forrest v. Bonifield, 2017 N.J. Super. Unpub. LEXIS 103, the defendant surgeon failed in his attempt to have the medical malpractice case dismissed on the grounds that the injured patient did not have a claim for lack of informed consent. The patient suffered the known potential complication of a ureteral injury when she underwent a DaVinci robotic hysterectomy. During the lawsuit, it was discovered that the surgeon had only done three such procedures when he obtained patient consent. At the time of surgery, he had performed 10 such procedures. The standard for competency that was presented as resulting in an acceptable complication rate is a minimum of 20 procedures. The court determined that a reasonable patient could have declined having the surgery performed by an inexperienced operator.
Therefore, this case suggests that surgeon experience may become further entwined with informed consent in the future. It is likely that surgeons and institutions will need to address and possibly standardize competencies to ensure consistency in patient counseling and informed consent.
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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