What does it mean when a state agency's Director of Quality and Patient Safety issues an advisory on robot-assisted surgery? I think this is more bad news if you are the company that manufactures the robot. Here's what Tracy Gay from the MA Bureau of Registration in Medicine said today in an advisory to all of the state's hospital CEOs, CMOs, and patient care coordinators:
An excerpt, which precedes a number of case studies:
The Quality and Patient Safety Division (QPSD) has issued a new advisory: “Advisory on Robot-Assisted Surgery.” A link to the advisory is below.
Over the last two years, the QPSD has received an increasing number of Safety and Quality Review (SQR) reports of patient complications associated with robot-assisted surgery. This advisory is issued to draw providers’ attention to some of the potential issues involving robot-assisted surgery, to share some of the lessons learned by the reporting health care facilities, and to support health care facilities in the review and development of their systems for safe robotic-surgical practice.
Robot-assisted surgery has increased dramatically since its introduction in the mid-2000s. A majority of radical prostatectomies and increasing percentages of other urologic, gynecologic and colorectal surgeries are now performed using robots. While there are numerous single institution, procedure-specific studies describing robotic-surgical outcomes, large-scale, high quality, prospective studies of the risks and benefits of robotic surgery as compared to laparoscopic and open procedures have not been carried out.
Robot-assisted surgeries have a number of technical advantages, such as an improved field of view and articulated instruments, but like any surgical procedure, they carry risks of complications and poor outcomes. Clinical studies and reviews of training guidelines discuss variable learning curves for surgeons, the need for significant mentoring, and greater risks associated with pursuing lengthier and more complex cases.