Patient’s death after robotic surgery raises questions, results in lawsuit

Is your training, informed consent sufficient with new technology?

(In this first part of a two-part series on new technology, we discuss the training and informed consent issues regarding new technology. Next month, we’ll explore how to handle credentialing and how to respond to errors.)

A hospital in Tampa, FL, is being sued in the death of a patient who died two days after his abdominal aorta and inferior vena cava were cut during robotic surgery to remove a cancerous kidney, according to the autopsy report.1 The problem wasn’t noticed for about 90 minutes, according to a news report.2

The lawsuit says St. Joseph’s Hospital is responsible because the supervisors didn’t make sure the urologist performing the procedure was properly trained on the da Vinci Surgical System robot (Intuitive Surgical, Santa Monica, CA).3

The urologist’s experience with the robot was limited to a pig, a cadaver, three kidney removals, and a complicated prostate surgery that left a man incontinent, the lawsuit claims. The hospital had no training protocol for its surgeons or staff and no protocol in place for them to be credentialed to operate the robot, according to the lawsuit.

St. Joseph’s was contacted for comment by Same-Day Surgery and released a statement by Isaac Mallah, the CEO.

Mallah explained all the doctors had to be certified to perform advanced laparoscopic surgery before they could use the robot, but he added that an additional laparoscopic training course has been added for all physicians who use the robotic system.4

Marketing concerns were a major driving force behind the hospital’s decision to pay $1 million to purchase the robot, the lawsuit says. The surgeons and the hospital had an implicit agreement to maximize the use of the robot to justify that expense as well as to market the hospital and generate profits, it states. According to the lawyer for the patient’s family, the surgeon originally scheduled to perform the surgery the day before was not on the patient’s insurance program. The next day, the family was directed to the urologist, he said.2

Training can’t keep up with techology

The rapid advancement of new technology has raised some significant dilemmas for health care providers that go beyond the particular situation in the Tampa case, says Robert J. Fitzgibbons Jr., MD, FACS, professor of surgery at Creighton University Medical School in Omaha, NE.

"The overriding problem with the system in the United States is that patients have access to all the information about new technology and, therefore, demand it" because they perceive it as the modern care available, he says.

"The dilemma for hospitals is to get their people up to speed quickly to remain competitive, but a terrible problem like this [Florida case] is the result," Fitzgibbons points out.

The problem is with the system, he says. "If you don’t keep your ORs up to date, you’re going to be left in the dust," Fitzgibbons adds.

There is a gap between the new technologies and the training techniques that are just a few years old and the health care system’s ability to implement them in terms of training and privileges, says Richard M. Satava Jr., MD, FACS, professor of surgery at the University of Washington, Seattle.

"Technology’s a little too fast, and objective training methods and objective assessment methods, although coming along quickly compared to previous standards, are much slower than emerging technologies," he explains.

Surgeons need two types of training on new technology, he maintains. First, when a system is complicated and sophisticated, physicians need to be trained about the equipment so they can troubleshoot if something goes wrong, Satava says.

Second, physicians need to be trained on the procedure they’re going to perform, he explains.

Traditionally, surgeons have attended short courses sponsored by corporations, usually involving procedures on animals, that offer certificates upon completion, Satava adds. "This unfortunately has been misinterpreted by the hospital as sufficient evidence that they had proficiency in the new surgical procedure for which they were asking privileges," he says. Instead, surgeons need sufficient training in a comprehensive course, Satava says. The course should include objective, measurable outcomes that must be achieved and which, by consensus, have been agreed to demonstrate proficiency, he explains.

"In simple terms, surgeons should not operate on a patient with a new piece of equipment or technique until they have been thoroughly trained in the equipment and the new surgical procedure using that equipment to a level that ensures patient safety," he says.

Surgeons may obtain experience in one type of robotic surgery, but there are hundreds, points out Fitzgibbons. "It’s crucial that [managers] make sure they understand the normal training requirements to become proficient in an individual procedure."

Managers often are involved in purchasing new technology, he continues. Thus, the manager should take responsibility for knowing how much training and proctoring is needed by a more experience surgeon before performing the procedure independently, he says. National associations, such as the American College of Surgeons (ACS), and subspecialty groups, such as the Los Angeles-based Society of American Gastrointestinal Endoscopic Surgeons (SAGES) offer guidelines, Fitzgibbons says.

The manager’s job is to stay abreast of new procedures and new uses for devices and to be aware of what other institutions are doing, says Mary H. McGrath, MD, MPH, FACS, chair of the committee on emergency surgical technology and education at the American College of Surgeons and professor of surgery in the division of plastic surgery, at the University of California San Francisco Medical Center.

"The problem is that the training is very device-specific or procedure-specific," she says. "It’s difficult to come up with generalities."

Managers and surgeons can check the Food and Drug Administration web site to determine what adverse events have been reported with new technologies. (See "resources" at end of article.) Also, managers and surgeons can track outcomes within their own facilities, McGrath adds.

Many institutions require proctoring and keep track of outcomes, she says. "As an overall rule, institutions should be doing this under some parameters for any new technology or new procedure for some period of time," McGrath states.

In the interest of caution, some managers may be tempted to remain with current technology because they and their staffs are comfortable with what they know, she says.

"That’s also a mistake that ultimately will hold back advancing, particularly less-invasive procedures," McGrath stresses.

References

1. Medical Examiner’s Office, Tampa, FL. Report of Diagnoses and Autopsy on Al Greenway, File 02-05468. Hillsborough County, FL; 2002.

2. Brink G. Family of dead teacher hires lawyer for answers. St. Petersburg Times, Nov. 5, 2002. Web: www.sptimes.com.

3. Greenway v. St Joseph's Hospital Inc., No. 0311667, Division G Circuit Court for 13th Judicial Circuit for Hillsborough County, FL (Dec. 16, 2003).

4. Statement by Isaac Mallah, CEO, St. Joseph’s-Baptist Health Care, Oct. 29, 2002. Web: www.floridatoday.com.

Source and Resources

For more information on new technology, contact:

  • Robert J. Fitzgibbons Jr., MD, FACS, Professor of Surgery, Creighton University Medical School, 601 N. 30th St., Suite 3700, Omaha, NE 68131. Phone: (402) 280-4503. Fax (402) 280-4851.
  • Mary H. McGrath, MD, MPH, FACS, Professor of Surgery, Division of Plastic Surgery, University of California San Francisco Medical Center, Suite 520, 1635 Divisadero St., San Francisco, CA 94115. Phone: (415) 476-3727.
  • Richard M. Satava Jr., MD, FACS, Professor of Surgery, University of Washington, Department of Surgery, Box 643510, 1959 Pacific St., Seattle, WA 98195. E-mail: Richard.satava@yale.edu.
  • To examine adverse events that have been reported with new technology, check the Manufacturer and User Facility Device Experience Database (MAUDE). Web: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.
  • To report adverse events, go to: www.fda.gov/cdrh/mdr/index.html.