Salesman in OR leads to lawsuits after patient dies

Salesman performed part of procedure, reports say

A New York hospital is facing major malpractice lawsuits, a state-imposed fine, and a public relations disaster after an incident in which a woman died during what should have been a routine procedure. Investigators claim the woman died because two surgeons made gross medical errors. They also claim that an equipment salesman actually performed part of the procedure.

The incident should be a warning about the risks of allowing salespeople in the operating room without adequate constraints, some observers say. Even though the salesman’s alleged participation in the procedure apparently was not the cause of the woman’s death, it greatly complicates the defense of the malpractice cases and creates extremely bad publicity for the facility, Beth Israel Medical Center in New York City.

The immediate fallout from the incident was a $30,000 fine imposed on Beth Israel by New York state health officials. The officials concluded that a salesman of hysteroscopy equipment participated in the procedure, actually manipulating the new electrosurgery system because the doctors and nurses did not know how to operate it.

But that is only the beginning of the hospital’s troubles. The woman’s husband has filed suit against the hospital, both surgeons, the anesthesiologist, and Ethicon, the company whose salesman allegedly participated in the procedure. Ethicon is a division of Johnson & Johnson.

Observers also expect the incident will be considered a sentinel event by the Joint Commission on Accreditation of Healthcare Organizations, which will obligate the hospital to conduct a thorough analysis of how it happened and how it can be prevented in the future. Sentinel event status is likely because the incident was widely reported in the general media, one of the Joint Commission’s main sources for identifying sentinel events, and because it so obviously signals a major problem at the hospital.

Sam Bishop, ARM, vice president of compliance and insurance services for Wellstar Health System in Marietta, GA, says the incident shows that staff may need to be educated and reminded about issues that seem obvious to managers, Bishop says. It may be time to remind surgical staff about proper conduct of visitors in the operating room. (See p. 21 for more on how such incidents can be avoided.)

Procedure should have been routine

The incident began in October 1997, accord -ing to a report from the New York state health department. Ethicon salesman David Myers reportedly met with Allan Jacobs, MD, chairman of the hospital’s OB-GYN department, to introduce an Ethicon product used for hysteroscopies, a minimally invasive procedure. The product, the Versapoint Bipolar Hysteroscopy Electrosurgery System, allows the surgeon to cut and ablate with electrosurgery probes.

Jacobs made no commitment to purchase the product but did not dissuade Myers from seeking the support of surgeons and other administrators, according to the report. Myers arranged to have the product used in surgery about a month later with OB-GYN partners Marc Sklar, MD, and Robert Klinger, MD. The patient, Lisa Smart, 30, was a healthy accountant and financial analyst undergoing hysteroscopy for the removal of a benign fibroid tumor — a routine procedure with relatively little risk.

State health investigators say the OR nurses told the surgeons they were not familiar with the new electrosurgery system, but that the surgeons dismissed the nurses’ concerns and said Myers would operate it. The salesman was scrubbed and did operate the electrosurgery system during the procedure, according to the health department report.

However, the report does not claim the salesman’s actions led to the woman’s death. As a normal part of the procedure, the patient’s uterus was filled with saline, and nurses monitored the fluid output closely to make sure the patient was not overloaded with fluids. The salesman reportedly was operating the electrosurgery equipment and had no involvement in the fluid administration. The state report says that a nurse told the doctors several times during the surgery that the fluid output was too low, but her concerns were dismissed.

But immediately after the surgery, the patient appeared bloated from excess fluid. According to the state report, one of the OR nurses claims Klinger admitted to shutting off the fluid outflow so he could get a better view of the uterus, an action that could lead to fluid overload if not corrected quickly. Klinger denied shutting off the flow or making the statement afterward, according to the report.

As a result of the fluid overload, the woman went into cardiac arrest soon after surgery and died in the emergency department. The autopsy determined she had died of "excessive infusion and absorption of normal saline."

Sklar’s and Klinger’s offices, as well as the attorneys representing both doctors, declined comment. Beth Israel released a statement saying, "those who acted inappropriately violated Medical Center rules and procedures and have been severely disciplined."

Salespeople in the OR are nothing new, and managers have expressed concern about them in the past. The Beth Israel incident raises troubling questions nonetheless. If the state health report is accurate, the nurses knew before the procedure was under way that the salesman would be operating the electrosurgery system, which means there was, presumably, time to try to stop the procedure.

The implications of that scenario would differ significantly from those resulting from an infraction occurring after a procedure begins; in that case, the damage may be done before the staff can protest.

Nurses should act

If the incident happened as state health officials say, the nurses should have reported the surgeons’ intent to their supervisors and not proceeded with the surgery, says Margaret Douglass, MPH, RN, director of risk management at FPIC, a physicians’ insurance company based in Jacksonville, FL. Such an incident would serve as a clear example of a situation in which nurses must refuse improper orders and report the problem through the chain of command, she says.

"Absolutely, the nurses should know just from being a nurse that it’s not right for a salesperson to perform patient care," she says. "They should have questioned the doctor’s orders on the spot and then should have run right out and grabbed their OR supervisor. This certainly was out of the ordinary, and they should have acted to protect the patient.

"I would want to see the policies in place at the time, the chain of command policies, and shoot the charts through peer review to see if any education is needed for the physicians involved. In addition to the chain of command questions, I’d want to know whether there had been any education on fluid overload," says Douglass.

When nurses observe inappropriate behavior in the OR, they should determine if patients are in immediate danger and resolve that first, suggests Ramona Conner, RN, MSN, perioperative nursing specialist at the Center for Nursing Practice, Health Policy, and Research at the Association of Operating Room Nurses in Denver.

If the patient isn’t in danger, but doctors or salespersons need to have their behavior addressed, follow the chain of command at your facility, she says. Typically, the policy is to report the situation to your immediate supervisor. "And it goes on up the chain of command until it’s resolved. Some actions have to be reported clear to the top and require administrative action. Others can be resolved by the immediate supervisor or the administrator of the OR."

Often the effort should be multidisciplinary by involving persons such as the chief of the medical staff, Conner suggests.

Douglass and Bishop advise you to establish two policies on OR visitors, if you have not already done so, and formally remind staff about the policies, even if you have reminded them before. The first policy should require that physicians obtain informed consent from the patient for any unlicensed visitor to the OR, including salespeople. The second policy should state that the visitor must never touch the patient or operate medical equipment in any way.

That second policy may seem painfully obvious, but Bishop and Douglass say it is necessary to remind staff and visitors. (For more on policies, see story, below.)