Do you have right policies for sales reps in OR?
Nurses’ roles are critical in avoiding disaster
A 30-year-old woman died of cardiac arrest in November 1997 following routine outpatient removal of a benign fibroid tumor in her uterus. The New York state health department fined Beth Israel Hospital in Manhattan $30,000, one of the largest such fines in years against a New York City hospital.
The health department’s 12-page report says the facility violated more than 12 medical standards and that a representative from Johnson & Johnson’s Ethicon of New Brunswick, NJ, operated the controls that regulated the amount of current being used in an electrical cauterizing tool. 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 malpractice cases being brought against the institution and creates extremely bad publicity.
Jim Mandler, director of public affairs at Beth Israel, released a statement accepting responsibility for the incident. The statement said the facility had immediately notified the New York state health department and had launched an extensive investigation. Those "who acted inappropriately violated Medical Center policies and have been disciplined," stated the document.
The statement also noted that the hospital’s "plan of correction to the New York State Department of Health details actions — most of which were implemented soon after the incident occurred one year ago — that will prevent such an occurrence from happening again." In addition to tightening consent procedures, the facility made the following policy changes in the wake of the incident:
• New equipment now must be approved through appropriate channels before it can be used.
• The supervising nurse in the operating room must account for equipment there.
• Medical supply company representatives must be closely monitored.
• Fluid inputs and outputs in such procedures must be recorded every 15 minutes. Any time input exceeds 1,500 cc or more, the surgeons must be notified and the procedure halted.
Two doctors — one already on five years’ probation for professional misconduct — performed the surgery and used equipment they were unfamiliar with and unauthorized to use, according to the report. Following an internal investigation, the doctor not on probation agreed to suspend his activities at the hospital for two weeks and then was reinstated on 100% restriction, meaning an attending physician must observe him on all cases. One nurse was dismissed and two were temporarily suspended because they failed to report their concerns to their superiors.
Wayne M. Osten, director of the health department’s office of health systems management, stated, "The health department will ensure that the hospital develops management systems designed to prevent future tragedies of this magnitude."
Hospitals have varying policies about approvals before a piece of new equipment is allowed in the operating room. At St. Joseph’s Hospital and Medical Center in Paterson, NJ, surgeons who want to use a new device first must obtain three approvals — from their department head, from the chief of surgery, and from the nurse in charge of the OR, according to Frank Erlich, chief of surgery at St. Joseph’s. In the case at Beth Israel, the device — the Versapoint Bipolar Hysteroscopy Electro surgery System — had not been approved by the hospital, yet the sales representative was allowed to roll it into the building and on into the bioengineering department on the day of the surgery.
In addition, states the health department report, the patient was never given the chance to consent to the use of the equipment or the presence of the salesman.
The physicians and nurses had no formal training in use of the device. According to the report, nurses in the operating room expressed concern that they were not trained in assisting with the new equipment, but the doctors dismissed their concerns and told them not to worry because the salesperson would operate the controls — a violation of hospital policy.
Nurses should have questioned surgeons
The Beth Israel incident raises troubling questions. If the state health report is accurate, the nurses knew before the procedure was under way that the salesperson would be operating the electrosurgery system. That means there presumably was time to stop the procedure, which is different from a situation where an infraction occurs after a procedure begins, meaning the damage would already be done when staff protest.
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 in Jacksonville, FL. This incident was a clear example of when 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."
As surgery began, the patient’s uterus was slowly filled with saline through the vagina — 9,000 cc in all, more than twice what is generally used. A nurse noticed that the fluid was not properly draining; she told the doctors, according to the report, and they said not to worry. According to the state’s report, the excessive infusion caused the patient to go into cardiac arrest, and she died.
The fact that the nurses apparently did not refuse the unusual instructions is reason to question their nursing education on fluid overload as well as on procedures and the program in place at Beth Israel, according to Douglass.
It is not uncommon for medical device salespeople to observe procedures, and usually it’s a positive factor. "Sales reps in the OR are invaluable resources, and I’d hate to see us have to lose them because this situation got out of control," says Aileen Killen, RN, PhD, CNOR, clinical director of perioperative services at Dartmouth-Hitchcock Medical Center in Lebanon, NH. New equipment sometimes behaves in ways staff are not familiar with, and the salesperson can give valuable advice. But they are not permitted to participate.
Researchers at ECRI, an independent health care research organization in Plymouth Meeting, PA, recently conducted a survey of 180 hospitals and found that it is common to find salespeople and other types of visitors in operating rooms. Ninety-five percent reported that they allow salespeople and others to be present during surgery.1
Will policies alleviate risks?
Douglass advises that you have two policies on operating room visitors and formally remind staff about the policies. The first policy should require that physicians obtain informed consent from the patient for any unlicensed visitor to the operating room, including salespeople. The second policy should state that the visitor must never touch the patient or operate medical equipment in any way.
Killen, who has 22 years of experience in the OR, disagrees: "I don’t think you can write a policy about everything. That course may not be the right approach to this problem. The more appropriate approach is to make people at all levels of the organization understand the importance of quality and to have that as a part of your daily thought process."
Since 1993, the Association of Operating Room Nurses in Denver has offered a course in surgical etiquette for medical equipment sales professionals, called Introduction to the Operating Room. The course teaches two fundamental principles: "Stay out of the sterile surgical field," and "If it touches the patient, or is going to touch the patient, you don’t touch it."
Salespeople learn where to stand, when to talk, and whether they can open sterile surgical supplies. Their role is to give information about their product when asked. The course covers the role of various OR staff, traffic patterns in the OR, appropriate OR attire, the sterile area in the OR, appropriate movement around the sterile area, and universal precautions to protect against the spread of bloodborne disease.
(Editor’s note: The foregoing information came from news reports and press releases.)
Reference
1. ECRI. Managing the risk of sales representatives in the operating room. The Risk Management Reporter 1996; 15:1-7.
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