Don’t end up on 60 Minutes — avoid liability with new technology
Arm yourself with education, thorough credentialing
On any given night, you can turn to one of the network news shows and be greeted with another horror story about surgery gone awry because someone somewhere performed a new procedure without adequate training.
"Well you see, Geraldo, it was like this . . . ."
Such stories are becoming increasingly common as surgical procedures evolve with the help of technological advances, such as scopes.
"When a new technique is introduced, the complication rates clearly tend to go up," says David W. Kennedy, MD, FACS, professor and chairman of the department of otorhinolaryngology: head and neck surgery at the University of Pennsylvania Medical Center in Philadelphia. Kennedy is a member of the American College of Surgeons Committee on Emerging Surgical Technology and Education.
In fact, complications can occur with new technology even when the surgeon has been adequately trained, surgery experts emphasize. "I think there is no doubt about the fact that the more cases a surgeon does of a particular type, the better the results tend to be," Kennedy says.
And technology isn’t the only factor causing an increase in surgical complications. The media also is to blame, says Richard Gregory, MD, director of Celebration (FL) Institute of Aesthetic Surgery and associate professor at University of South Florida in Tampa.
"A lot of what’s coming out new is being promulgated through the media long before it’s really ready to be used," says Gregory.
Technology needs to be tested in a fairly well-defined setting and proven before it’s covered in the media, he maintains. "I think the media is doing a little bit of injustice to the public."
Take these steps to avoid problems
Since the rush in technological advancement and the demand for these procedures from patients don’t appear ready to wane, what steps can same-day surgery managers take to ensure they don’t risk liability, not to mention negative media exposure? Consider these suggestions from experts in the field:
• Determine whether informed consent needs to change.
In addition to the general risks of having surgery, many new procedures have specific risks, such as the pigmentary changes, Gregory says. "Certainly the most common risks and the more devastating risks ought to be discussed with patients."
How informed consent should be handled for new technology depends on whether the procedure is a minor departure or a major deviation from the standard accepted technique, Kennedy says.
"When I first introduced endoscopic sinus surgery here, our feeling in the U.S. was that it was a relatively minor deviation from what had previously been often done with a microscope," he says.
Because only the instrument was different, Kennedy says, he and other surgeons didn’t think a different informed consent was required. "I believe it was an ethical and moral decision. But to take care of a cancer that would normally be done with an open en plaque procedure with a minimally invasive technique that may not get the same margin, patients need to be carefully informed about what is standard therapy, what the advantages and disadvantages of the new technique will be, and what’s known about results and outcomes."
Consider a written addendum to the chart explaining that the risks, complications, and alternatives were discussed with the patient, some experts advise. Keep in mind that poorly educated patients might not be fully capable of understanding all of the issues such as the relative risk in the outcome, Kennedy warns.
Your state laws may address new technology, advises Madelyn Quattrone, Esq., senior risk management analyst at ECRI, a nonprofit health care research organization based in Plymouth Meeting, PA. However, some laws are vague and raise additional questions. In such cases, seek advice from your legal counsel, she suggests.
• Use rational and medical evidence to select technology.
One of the most frequently asked questions that ECRI receives is whether facilities are required to purchase the most highly rated (and often most expensive) technology.
Essentially, liability would be judged by reasonableness, she says. "As long as there is rational and medical evidence for the selection being made — for example, ECRI does publish its own evaluations of medical devices and equipment — certainly there may be a range of choices that would be reasonable for the hospital or purchaser to choose from looking at those particular devices."
Health care providers can avoid liability by making a "good faith argument," which is making a good faith effort to select a safe and effective product that has been reviewed by some knowledgeable entity, she says.
• Determine whether the new technology is being used in an approved matter.
Frequently, it’s good medical practice for a device to be used in an "off-label" manner, Quattrone says. However, if a patient is harmed due to complications from the technology, and use of the technology is construed to be experimental, the provider could be liable, she warns. Consider keeping a record of the device being used in an off-label manner, Quattrone advises.
• Ensure training and education are thorough.
When new equipment is introduced in a facility, sometimes staff, and even physicians, are not completely familiar with the equipment or how to deal with problems that might arise, Quattrone says. (For information on a lawsuit related to lack of training in new technology, see Same-Day Surgery, February 1999, p. 19.)
Credentialing is an essential component
"It’s really incumbent upon the hospital to provide written materials or video materials and perhaps even an inservice on a piece of new equipment that is significantly different from equipment used in the past," she says.
• Don’t skimp on the credentialing process.
For credentialing, consider the background of the surgeon and the differences in the new technology as compared to the previous technology, Kennedy suggests. "I think one of the difficult things that come out when a procedure is developed is determining: Is it a minor modification or dramatic departure requiring new skills?"
Often the answer to that question depends on the surgeon, he says, citing endoscopic cholecystectomy as an example. There was a significant learning curve for those who hadn’t worked with endoscopes. In contrast, a surgeon with a strong background in laser surgery might not need a significant amount of additional training to master a new laser technique. In that case, a hands-on course probably would be sufficient, Kennedy says.
With the surgeon or the senior physician responsible for credentialing, determine how significant a departure the new technology is from the previous procedure, what skills are involved, and whether the surgeon has those skills, Kennedy advises. "If there’s a question, I recommend the surgeon be proctored for a certain number of cases by someone skilled in that area."
Be sure to document that the certification and additional training have been reviewed before you grant privileges, experts advise. If the manufacturer of the new technology is providing the education and training, ensure the physician has completed that certification, Quattrone advises.
"Having been a defense attorney mitigating these matters for about 20 years, I think I’ve heard about everything," she says. "Physicians may claim they’ve received training, but simply shown up at a course and not actually completed the training." Such inadequate training can lead to nightmares such as the liposuction deaths that occurred between 1992 and 1998, she says. (For more information on the liposuction deaths, see SDS, July 1999, p. 80. For more on credentialing for new procedures, see SDS, June 1999, p. 65.)
Some questions regarding new technology remain unanswered, Kennedy says. Can a surgeon’s capability with a particular technique be evaluated during a continuing medical education course? Can organizers of those courses be objective evaluators? "I don’t think we know the answer to that fully," he says.
Eventually, surgical simulators will score a surgeon objectively, Kennedy and others point out, but this technology is in its infancy. "But they are starting to become another method of developing a particular subset of surgical skills," he adds.
For more information on new technology, contact:
• Richard Gregory, MD, Director, Celebration Institute of Aesthetic Surgery, A320 400 Celebration Place, Celebration, FL 34747. E-mail: [email protected].
• David W. Kennedy, MD, FACS, Chairman, Department of Otorhinolaryngology: Head and Neck Surgery, University of Pennsylvania Medical Center, 3400 Spruce St., Philadelphia, PA 19104. Telephone: (215) 662-6971. Fax: (215) 349-5977.
• Madelyn Quattrone, Esq., Senior Risk Management Analyst, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000, ext. 5151. Fax: (610) 834-1275. E-mail: [email protected].
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