Since these representatives are not licensed physicians, they must be careful not to operate the equipment to provide treatment directly to the patient. A case has been filed in the New York Superior Court in which the plaintiff is alleging that a representative from a medical supply company, who was present in the operating room during his wife's surgery, engaged in the unauthorized practice of medicine.
In that case, according to court documents and state health records, a 30-year-old female sought surgical treatment for the presence of fibroid tumors in her uterus. During surgery, a new device was brought into the operating room to assist with the tumor removal. A sales representative from a medical supply company had been trying to convince the hospital to purchase this new machine.
The device was used to distend the patient's uterus by filling it with saline solution so the doctors could get a clear view of the tumors in her uterine cavity. During the procedure, the patient experienced a fluid imbalance, she suffered cardiac arrest and died.
After a year-long investigation, the New York Department of Health issued a report finding that the operation violated a number of medical standards, and the hospital received the maximum fine of $30,000 for these violations. This investigation revealed that the medical equipment used for the procedure had not been authorized by the hospital. The report also found that the physicians operating the equipment were not properly trained on how to use it.
The patient's husband has sued the surgeons, the hospital, and the manufacturer in New York Superior Court for wrongful death and failure to obtain informed consent. The plaintiff will have to show that the defendants’ actions caused or substantially contributed to his wife's death. However, if he is able to do so, the plaintiff may also seek punitive damages, which would allow the jury to award money solely for the purpose of punishing the defendants.
Another issue raised by this case is whether the medical supply company representative who brought the equipment into the operating room was actually allowed to touch the device during the procedure. Although it is generally a good practice to have such representatives present in the O.R to guide a doctor who is using new equipment, these representatives must be careful not to engage in the unlicensed practice of medicine. In this case, the New York State Department of Health report found that the medical representative actually operated the machine during the procedure. This might constitute the unauthorized practice of medicine.
In his court case against the manufacturer, the plaintiff alleges that the medical rep's behavior was reckless. He also claims the medical supply company failed to train the medical rep to use and demonstrate the device properly. 1f a judge were to allow the report from the state department of public health to be presented to a jury, the manufacturer's chance of success would be greatly diminished.
The plaintiff's complaint also alleges that the hospital failed to properly establish rules and regulations to prevent the use of unauthorized medical equipment in its operating room, and to prevent unauthorized persons from entering the operating room.
Finally, the plaintiff is critical of how the physicians handled his wife's operation. He claims they did not discuss the new device with her. She didn't know it would be used on her, that it was new, and that it had not been approved by the hospital. In addition, the plaintiff believes that the physicians should have known they were insufficiently trained in this equipment.
New inventions will continually complement and expand the surgeon's capabilities. The presence of manufacturer's representatives in the O.R is integral to this progress. But clinicians using new equipment should make sure it has been authorized by the hospital and that they have been properly trained to use it. Once the equipment is approved for use, the physician should consider whether the risks of the new equipment are so significant that the patient should be informed of its use.
Both physicians and hospitals should make sure that policies clearly delineate the limited role that representatives from the equipment company can play in the O.R and that those limitations are enforced to ensure the provision of optimal patient care.
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