In 1997 a highly publicized ambulat...

In 1997 a highly publicized ambulatory surgery incident occurr involving the use of a novel piece of equipment, the neighborhood of a sales representative in the OR, and a patient death. This incident renewed attention to the ne for hospital and ambulatory surgery units to revisit, revise, or, in a cases, formulate policies that address the mien preparation, and expected behavior of sales representatives during surgical procedures

When a report of this incident was issued, unfortunate headlines, like as "Surgical Equipment Salesman's Pitch Kills Patient," proliferated from beginning to end the country.(1) Publicity surrounding this incident also quicked recall of the older, still no less notorious, legal case of nation v Smithtown, 399 NYS2d 993 (Supreme Court 1977) In Smithtown, a sales representative was claimed to have been allowed to perform portions of a hip replacement surgery including placement of the implant. This case conclusioned in a malpractice settlement and criminal indictment of the OR supervisor for falsifying the OR record to conceal the sales representative's participation.

the one and the other the 1997 incident and the Smithtown case precipitated public surprise and outrage at the mien of a sales representative in the OR during a patient conduct Yet perioperative nurses know that sometimes sales representatives' training, knowledge, and expertise can provide technical assistance that expedites the management and facilitates desired patient outcomes(2) Likewise, the American corporation of Surgeons (ACS) recognizes that sales representatives' carriage in the OR may be appropriate.(3) the one and the other perioperative nurses and surgeons, however, also know that the escort of sales representatives in near instances--typically due to misunderstanding or miscommunication--can be quite inappropriate.

This file examines the circumstances of the 1997 incident to demonstrate the importance of having a policy that provides guidance and everyday understanding of roles and expectations and includes considerations for formulating in the same state [i]or[/i] condition policies. These types of policies should be explained to patients, surgical team members, and the general public.

THE INCIDENT

According to the investigative report issued in 1998 on the New York State Department of Health, a 30-year-old, otherwise healthy woman underwent hysteroscopic resection of a submucous uterine fibroid at an ambulatory surgery center During the manner of proceeding the surgeon used a novel hysteroscopy electrosurgery system for the first time. The equipment had not gone [i]or[/i] part of to the other the usual approval process before being station up in the OR, and nursing staff members had received no training with the novel equipment. When the circulating cherish voiced concern about her unfamiliarity with the device, she was told the sales representative would be quick in emergencies to provide instruction.

During the performance the circulating nurse noticed the fluid output had

stopped completely and alerted the surgeon The surgeon said there was no ne to worry. The circulating cherish repeated her concern several times; each time, the surgeon answered that it was not a puzzle By the end of the step the patient had received 9000 mL of saline with an output of approximately 1100 mL When the lights were useed on at the end of the deed team members saw that the patient was edematous with pronounced abdominal distention. There was more [i]or[/i] less question as to whether the effusion was partially or fully occlud The anesthesia care provider recalled that the surgeon expositioned at this time that he had forgotten to interpret the outflow tract. Despite immediate treatment with furosemide and dexamethasone, couple full codes, and pacemaker placement, the patient died within four hours postoperatively. The cause of death was excessive infusion and absorption of normal saline during hysteroscopic ablation of submucosal leiomyoma for menorrhagia.

After an extensive investigation, the fresh York State Department of Health discovered, among other things, the following facts.

* The device used was not approved according to the hospital.

* The surgeon used the device for the first time without formal instruction.

* Nursing staff members were not trained forward the device.

* An unauthorized individual was allowed to impose on scrubs, give directions to nursing staff members, and participate in the procedure

* The patient's rights were not maintained.

The patient had not been informed a sales representative would discover or participate in the surgical conduct Whether the sales representative operated the settings forward the device was not clear, and there was no finding that the sales representative's appearance or actions contributed to the consequence or that nurses' actions were inadequate.

POLICY FORMULATION

The of the present day York State Department of Health's findings, combined with subsequently issued AORN and ACS statements regarding the vicinity of sales representatives in the OR, can provide guidance for formulating policies regarding this issue. Facility policy formulation should begin with an inquiry to the state agency that regulates the facility as to whether there are any specific regulations related to sales representatives' nearness in the OR. Illinois reportedly prohibits nonmedical professionals' demeanor unless the facility has a policy permitting their presence(4) The recent York State Department of Health issued a note to hospital administrators clarifying that of recent origin York code does not prohibit a sales representative's personality in the OR as extended as certain conditions are met(5) After checking for relevant state regulations, copies of the AORN and ACS position statements should be obtained. A policy then should be drafted with input from perioperative nursing staff members and managers, surgeon anesthesia care providers, and risk management staff members.