Flight plan for robotic surgery credentialing: New AAGL guidelines

The AAGL, formerly the American Association of Gynecologic Laparoscopists, has approved the first-ever set of privileging and credentialing guidelines for robotic surgery.¹

Why has this prestigious minimally invasive surgery organization done that?

Maybe you’ve seen the Internet and TV ads and billboard trucks driving outside of many major medical society meetings recently, advertising “1-800-BAD-Robot.”² You also are probably aware of recent articles in the headlines of national periodicals like the Wall Street Journal claiming that robotic surgery can be harmful.³

And yet, robotic gynecologic surgery has grown at an unprecedented rate since its approval by the US Food and Drug Administration (FDA) in April 2005. Recent data from the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality indicate that robot-assisted hysterectomies have increased at a dramatic rate.⁴ In a recent study of the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, investigators found that more than 30% of injuries during robotic surgery are related to operator error or robot failure, but the majority of problems are not associated with the technology.⁵

In this article, I use the aviation industry as an example of a sector that has gotten safety right. By emulating many of its standards, our specialty can make great strides toward patient safety and improved outcomes. I also outline the main points of the new AAGL guidelines and the rationale behind them.¹ See, for example, the summary box on page 46.

A “shining example”
The robot clearly is an enabling technology. With its high-definition 3D vision and scaled motion with wristed instruments, surgeons are more comfortable performing many complex gynecologic procedures that previously would have required open surgery to safely accomplish … but the da Vinci Robot does not make a poor surgeon a great surgeon.

Hospitals now are being sued for allowing surgeons to perform robotic surgery on patients without documenting adequate surgeon training or providing consistent oversight.⁶ This new technology has outpaced the ability of hospital medical staffs to establish practice guidelines and rules to ensure patient safety.

The aviation industry is a shining example of a highly reliable industry. Each day, thousands of commercial aircraft fly all over the world with amazing safety. Most of the time, the pilot and copilot have never flown together. However, each crew member knows his or her role precisely and clearly understands what is expected. Crew members must meet standards that transcend all airlines and all aircraft.⁷ They all practice communication and undergo standardized training, including simulation, prior to taking off with live passengers on board.

In addition, all pilots must demonstrate their proficiency and competence on a regular basis—by exhibiting actual safe flight performance (over multiple takeoffs and landings) and undergoing check rides with flight examiners and practicing routine and emergency procedures on flight simulators. Airline passengers have come to expect that all pilots are equally proficient and safe. Shouldn’t patients be able to expect the same from their surgeons and hospitals? And yet there is no national or local organization that ensures that all surgeons are equally safe in the operating room. That responsibility is too often left up to the courts.

Three requirements of robotic credentialing
In 2008, the MultiCare Health System in the Pacific Northwest adopted a unique system of robotic credentialing that was based on the aviation model.⁸ This model has three main components, which are identical to the guidelines imposed on pilots:

Adoption of these tried-and-true safety principles would ensure that hospitals exercise their responsibility to protect patients who undergo robotic surgeries in their systems.

The AAGL’s Robotics Special Interest Group, formed in 2010, is now the largest special interest group in the organization. The group was initially tasked to develop ­evidence-based guidelines for robotic surgery training and credentialing. Using the aviation industry’s model, the group developed a basic template of robotic surgery credentialing and privileging guidelines that can be used anywhere in the world. This proposal is not meant to be a standard-of-care definition; rather, it is intended simply as a starting point.

Initial training