Surgical Robots
Is Robotic Surgery Finding its Niche?
As the curtain closed on Robodoc the surgical robot, Penelope the surgical nurse held a coming-out party.

Integrated Surgical Systems, the makers of Robodoc, ceased operations following the dismissal of a product liability lawsuit filed against it. "We are suspending operations to reorganize and to secure additional capital," says CEO Ramesh Trivedi. "Our intent is not to dissolve the company."

Robodoc isn't FDA-approved. It's been used in Germany, India, Japan and Korea since the mid-1990s for high-accuracy bone drilling in hip and knee joint replacements. Last year, eight German patients initiated a class action lawsuit against ISS, claiming that Robodoc caused them muscle, nerve and bone damage. The suit, filed in California's Yolo County Superior Court, was dismissed after a judge determined that it should have been pursued in Germany.

Meanwhile, Penelope joined doctors and nurses in the OR at New York-Presbyterian Hospital to deliver instruments. Known as the Penelope Surgical Instrument Server, the robot operates as a surgical nurse, handing over surgical instruments on command, and then returning the devices to their original place once a surgeon has finished with them. Last month marked the first time a robot took commands and independently performed actions based on a surgeon's instruction.

daVinci, a robotic surgery system produced by Intuitive Surgical of Sunnyvale, Calif., is the robot predominantly used in ORs across the nation and around the world. daVinci became the leader in the surgical robotics field after Intuitive Surgical acquired competitor Computer Motion, the maker of the Zeus robotic system, Aesop endoscope positioner and other surgical applications, in 2003.

Approved for use by the FDA in 2000, daVinci features jointed arms and laparoscopic instruments that a surgeon directs from an ergonomic remote control console while viewing a three-dimensional, magnified view of the surgical site. It's hardly the autonomous robot of science fiction, but according to the company, it allows surgeons more vision, precision and control than human eyes and hands alone could deliver. Surgeons agree.

"The optics are phenomenal, better than looking through a microscope or an endoscope," says Neil Hockstein, MD, a clinical instructor of otorhinolaryngology at the University of Pennsylvania School of Medicine in Philadelphia. He also noted that the dexterity of the controls allow maneuvers such as tying and suturing that would prove difficult with conventional "chopsticks" instruments. "It really puts you in the body," he says.

Originally developed with minimally invasive cardiac surgery in mind, surgical robots have been adopted with even more success by other specialists who have begun working toward smaller incisions and shorter operating times.

"Urologists in particular said, 'This is a great technology,'" says Dr. Hockstein. "That's actually turned out to be the leading use of daVinci."

David McGinnis, MD, a urologist with the Bryn Mawr Urology Group in Rosemont, Pa., agrees. "Urology has probably been the most successful with daVinci. It shows real advantages with laparoscopic radical prostatectomy," he says.

Eric Miller, senior vice president of marketing for Intuitive Surgical, calculates that more than 300 daVinci systems have been installed worldwide, with 70 percent of those in the United States. "It's growing at a very rapid rate," he says, and not just at academic facilities. Sixty percent of the surgical robots in the U.S. are in use at community hospitals. "For us at Intuitive, it's not about the robot. It's about the outcome, what the surgeon and the robot together are able to achieve."

- David Bernard

Fluid Mix-up Fallout
Surgical Instruments Washed in Hydraulic Fluid
Washing surgical instruments in hydraulic fluid isn't hazardous to your health, Duke University officials maintain. For two months late last year, surgeons at Duke Health Raleigh Hospital and Durham Regional Hospital unknowingly used instruments that had been washed with hydraulic fluid instead of soap before being sterilized. The error happened after elevator workers drained hydraulic fluid into empty soap containers without changing the labels.

A letter Duke sent to about 3,800 patients says there's no risk of getting infections as a result. "Despite the potential problem of the pre-sterilization process, the risk of infection for you is no more than the risk normally associated with the procedure you underwent," the letter states.

Not everyone agrees, including eight patients with symptoms ranging from general malaise to swelling at the surgical site who've filed suit against Cardinal Health and the Automatic Elevator Co. The hospitals haven't been named as defendants. A report by the Centers for Medicaid and Medicare Services says the fluid mix-up put patients in "immediate jeopardy."

An infection control expert who performed a study on Duke's behalf says patients have nothing to worry about. "Replacing cleaning detergent with hydraulic fluid did not alter the effectiveness of the sterilization process as high numbers of clinically-relevant bacteria and standard test spores (relatively resistant to the sterilization process) were completely inactivated," says William A. Rutala, PhD, MPH, director of the statewide program in infection control and epidemiology at the UNC School of Medicine.

The fluid mix-up apparently occurred when workers from the elevator company drained hydraulic fluid into empty 15-gallon Mon-Klenz detergent barrels last summer at Duke Health Raleigh. Cardinal Health, the solution's supplier, later picked up the two-foot high white plastic containers and mistakenly redistributed them to Duke Health Raleigh and Durham Regional hospitals as cleansing solution.

During a normal purchase cycle, containers are shipped to facilities and never returned, says Donna Gaidamak, a Cardinal spokeswoman. In this case, Duke Health Raleigh informed Cardinal that the hospital had extra cleansing solution that it wanted to return. A driver Cardinal sent to pick up the unneeded containers picked up 12 of 13 containers, leaving one behind because it looked like it had been used, says Ms. Gaidamak. Cardinal workers performed a second visual inspection at its warehouse and restocked the containers, she says.

"The lid was intact and the containers were labeled properly when we received the returned merchandise," says Ms. Gaidamak. When the Duke hospitals placed a new order for the cleaning solution about a month later, Cardinal tapped into the stock of hydraulic fluid-filled containers.

Cardinal is a distributor for 40 different manufacturers of surgical solutions; some companies cover the lids of their containers with a plastic seal - much like the protection found on a bottle of aspirin. Steris, the manufacturer of Mon-Klenz, doesn't provide such an over-wrap. To prevent similar mishaps in the future, Cardinal has "requested that all our manufacturers put a seal over the lid so any tampering to the container will be evident," says Ms. Gaidamak.

Thomas Henson, Sr., an attorney at HensonFuerst in Raleigh, N.C., says 70 surgical patients have approached him since January. For now, Mr. Henson says his clients are more concerned with the chemical make-up of the hydraulic fluid. The Duke University Health System has been subpoenaed to provide test results on the chemical make-up of the hydraulic fluid. Duke officials say that have already agreed to provide a sample of the used hydraulic fluid and the test report concerning the fluid to the attorneys who have requested the material.

- Daniel Cook

Instrument Tech at One Hospital Caught the Problem in Time
The instruments Wake Forrest University Baptist Medical Center washed in hydraulic fluid last winter never reached the OR. When staff in central sterile processing noticed two loads of surgical instruments felt greasy after a pre-sterile wash cycle, they did a little investigating. The drum labeled as Mon-Klenz was darker in color and slicker texture than cleaning solution, says a spokeswoman for the Winston-Salem, N.C., hospital.

Here's what happened: Noticing that Mon-Klenz levels were low during a routine morning check of two ultrasonic washers, one of the hospital's instrument techs rolled new drums into place, opened the containers' caps, placed the washers' tubing in the fresh drums, started both machines and ran an instrument wash cycle, says Gary Green, MBA, administrative director surgical support services.

A certified instrument tech visually inspected the instruments after the half-hour wash cycle. The instruments didn't meet his satisfaction. The new barrels of Mon-Klenz were the only changed variable from previous cycles, so the techs inspected the containers, detaching the containers from the washer and looked through the small openings in the container's lid. That's when they realized the fluid was darker than the normal amber color of the instrument cleaning solution, as well as more viscous.

The hospital will continue to visually inspect barrels of cleaning solution until the manufacturer applies a secondary safety seal over the containers. A safety seal will provide "visual assurance that the product has not been tampered with," says Mr. Green.

"Any certified tech is empowered to pull instruments to the side," says Mr. Green. "The instruments go through two or three levels of inspection before being wrapped for sterilization."

- Daniel Cook

Headlines on Deadline
N.J. Supreme Court Upholds CRNA Restrictions for Office Surgery New Jersey CRNAs giving general or regional anesthesia in physician"s offices must work under the supervision of an anesthesiologist or a physician with anesthesia privileges. The restrictions, the first such kind in the country, took effect last month when the Supreme Court upheld the state board of medical examiners' 1998 ruling that CRNAs must be supervised during in-office procedures. The New Jersey State Association of Nurse Anesthetists (NJANA) had kept the ruling tied up in the appeals process. In cases where conscious sedation is used, the surgeon could be the supervising physician and the CRNA could administer the anesthesia, the rule states. When CRNAs administer general and regional anesthesia, the rule says the supervising physician must be in the room without concurrent responsibilities, making a CRNA's presence "superfluous," says NJANA. Meanwhile, Wisconsin has joined 13 other states in opting out of federal requirement that physicians supervise nurse anesthetists, joining Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota and Montana.

New Genetic Test Detects MH DNA testing from a sample of blood or other tissue may help you determine whether patients have a genetic susceptibility to malignant hyperthermia. This new genetic test detects 30 percent to 50 percent of the mutations on certain chromosomes and genes known to make one susceptible to MH, says Eric Johnson, PhD, director of molecular diagnostics and biobanking at PreventionGenetics, the first U.S. lab to do MH testing. The only other test for MH susceptibility is the caffeine-halothane contracture test, a muscle biopsy done at a few specialized diagnostic centers. About one in 10,000 persons have a susceptibility to MH; most won't know this unless they receive general anesthesia. If anesthesia providers know that a patient has a genetic susceptibility to MH, they can substitute IV sedatives and other drugs for the volatile anesthetic agents known to trigger MH's abnormal metabolic responses.

Overhyping Back Surgery Surgeons over-promise and under-deliver when it comes to counseling patients about the benefits of back surgery, a new study suggests. Almost 40 percent of patients in the study reported virtually no difference in back pain one year after having back surgery. But before surgery almost all of their surgeons predicted that they would have less pain and most said surgery would result in "a great deal of improvement." The research is published in the June 15 issue of the journal Spine.

Endophthalmitis on the Rise? A broad-based literature review covering four decades found that the incidence of endophthalmitis following cataract surgery has increased during the past decade. The authors of the Archives of Ophthalmology review noted that this upward trend coincided with the popularization of sutureless clear corneal incisions for cataract surgery. The effect of incision style on the incidence of post-cataract endophthalmitis has been the subject of debate in recent years.