Legal Review & Commentary
Equipment failure ends in brain injury: $500,000 settlement
By Mark K. Delegal, Esq., and Jan Gorrie, Esq.
Pennington, Moore, Wilkinson, Bell and Dunbar, PA
Tallahassee, FL
News: A man was admitted to the hospital for hip replacement surgery. While being anesthetized, the expiratory valve on the anesthesia circuit was stuck in the closed position. The anesthesiology resident was unable to ventilate the patient, who suffered from the loss of oxygen. The medical malpractice claim resulted in a $500,000 settlement.
Background: The 53-year-old man was admitted to a Veterans Affairs (VA) hospital for replacement of his left hip. Before surgery, he was assessed as a low-risk patient by nursing and anesthesia staff. The next morning he was taken to the operating room. At 12:45 p.m., he was given an epidural and general induction began. Fifteen minutes later, the anesthesiology resident noted the patient was breathing well with mask ventilation. At 1:05 p.m., after being intubated, the doctor observed that the patient was unable to breathe through the endotracheal tube. At 1:20 p.m., after several attempts were made to manually intubate him and re-establish respiration, mask ventilation was resumed.
While the patient was without effective oxygen for several minutes and suffered bradycardia and complete cardiopulmonary arrest. At 1:18 p.m., his arterial blood gases were taken and the results indicated that he was in a state of respiratory acidosis. The patient gradually awoke, but several days passed before he could talk or communicate.
Records indicate that the ventilation equipment had been inspected at 7 a.m. the day of surgery and appeared to be functioning properly. The patient’s medical records indicate that the machine was again examined following the incident and the expiratory valve on the anesthesia circuit was stuck in the closed position. When the valve is closed, no oxygen can be delivered to the patient. An assessment performed by the VA medical staff showed that the patient sustained ischemic brain damage as a result of oxygen deprivation.
The plaintiff claimed injuries that included ischemic brain damage, suicidal depression, difficulty in doing simple math, mnemonic difficulty, inability to follow directions, inability to help around the house, and general irritability. Since the incident, he claimed he was noncommunicative and unable to handle stress. In his claim against the VA and its medical and nursing staff, the plaintiff contended that the defendants failed to properly inspect the anesthesia equipment immediately before it was connected to his respiratory system. The patient claimed that even if the equipment did not perform correctly, he could have and should have been manually ventilated, and his injuries would have been minimized. Given that medical residents were seemingly responsible for the administration of his anesthesia, the patient claimed that the residents were not experienced enough to check the machinery prior to use in surgery, not skilled enough in airway management to have properly intubated him, and not sufficiently trained to have managed his care under crisis. Despite the assessment by VA medical personnel to the contrary, the defendant claimed that the patient suffered no significant brain damage and, absent injury, there is no viable claim.
What this means to you: Anesthesiology historically has been risky business. The inherent risk is intensified when coupled with training and educating future health care practitioners.
"The first thing that came to mind after reading this case is the responsibility of all health care facilities, regardless of size or staff mix, to ensure that all persons who perform patient care are properly trained and qualified to do so, with documented competency assessments on file," notes Susan Keaton, RN, BSN, director of PI & RM at Summersville (WV) Memorial Hospital.
"Teaching facilities have a more complex system to deal with because of the need to balance a meaningful clinical experience for inexperienced students and trainees with the delivery of good quality patient care, but the responsibility is the same. Effective and appropriate supervision of trainees goes hand-in-hand with credentialing and privileging, and such oversight may have been lacking in this particular case. Novices should have direct supervision by a designated proctor who is experienced and proficient in their field. As the newcomer gains experience and shows progress in clinical ability and judgment, more independence may gradually be granted, but the need for them to have a seasoned professional immediately available in case of an unexpected event is constant.
"It is not uncommon for unexpected occurrences, especially life-threatening emergencies, to cause an adrenaline rush and at least momentary panic and confusion for even the most experienced veteran, let alone newcomers to health care. This may account for the resident repeatedly trying to reintubate the patient without remembering to provide adequate ventilation in between attempts. Skilled airway management is an essential requirement for anesthesia providers and proficiency in it must be proven before independent practice is permitted. Completion of courses such as Advanced Cardiac Life Support also may be beneficial as a prerequisite to certain clinical practicums; basic medicine is still good medicine," adds Keaton.
"It is conceivable that the resident in this case was not fully knowledgeable about the machinery he was using or the protocols they should follow. Checking any equipment immediately prior to use is prudent practice. When that piece of equipment is crucial to patient safety, such as an anesthesia machine, that final check must be made a gold standard. This is why training and competency assessments must include demonstration of hands-on proficiency, not just verbal understanding. Such teaching and training should include not just how the machine works but also how to troubleshoot problems and what to do in the event of a malfunction during use. In addition to initial training, periodic drills using emergency scenarios may help maintain adherence to proper protocols when a real emergency occurs and may minimize the sense of panic that can cost precious seconds or even minutes when someone’s life is in the balance," advises Keaton.
Staff training and education aside, a well-run biomedical program entails a system of checks and balances. Just as preventive medicine should be practiced; the same applies to maintenance of critical machinery.
"This case points out the need for a proactive preventive maintenance program that encompasses periodic equipment checks and calibrations by qualified biomedical engineers. A good biomedical program should include scheduled routine maintenance checks which include a general inspection, assessment of the integrity of electrical circuits and grounding, calibrations as appropriate and checking and, as needed, replacement of parts as recommended by manufacturers. Preventive maintenance functions must be well-documented in an organized and retrievable manner, and records should contain the equipment’s history, including past problems [real or suspected] and all maintenance conducted on the piece. Further, preventive maintenance varies by equipment, with the obvious note to check critical, life-preserving monitors more frequently," states Keaton.
If something does go wrong, staff should know how to respond.
"Facility policies and staff education for all employees should include how to manage any malfunctioning equipment. Any real or suspected malfunction should result in the equipment being immediately removed from service, labeled with a highly visible Do Not Use’ sign, and taken to a designated location away from patient care areas to be forwarded to the biomedical department or shipped to the manufacturer if required by service contracts. Finally, under operation of the Safe Medical Device Act of 1990 [and subsequent revisions], health care facilities are required to report all occurrences in which a medical device is believed to have caused or contributed to the serious injury of death of a patient, including injuries due to user error that are attributable to devise design and/or labeling. This would not include dropping an instrument, but might include poor placement of the valve making it difficult to read, which might have been a factor in this case. Such information must be reported to the Food and Drug Administration using uniform MedWatch forms within 10 working days of the time staff becomes aware of the event.
Reporting under the Act is often handled by the facility’s purchasing agent or biomedical program personnel. However, the risk manager should be keep in the loop of anything that is reported and contact with the risk manager should be incorporated into the facility’s Safe Medical Device Act policies and procedures," concludes Keaton.
Marco A. Velasquez and Dora Velasquez v. U.S.A., San Diego Superior Court, Case No. 970045 H (LSP).
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