Complications and Adverse Events Related to Robotic Surgery
Robotic surgery is a type of minimally invasive surgery. “Minimally invasive” means that instead of operating on patients through large incisions, surgeons use miniaturized surgical instruments that fit through a series of quarter-inch incisions. These miniaturized instruments are mounted on robotic arms, with an additional robotic arm containing a camera that guides the surgeon during the procedure.
The surgeon controls these instruments and the camera from a console located in the operating room. Placing his fingers into the master controls, he is able to operate all the arms of the robot, while looking through a monitor. The hoped for effect is to give the surgeon control in a minimally invasive environment.
The use of robotic technology has increased with the number of robotic-assisted surgeries performed worldwide nearly tripling in the last few years. The cost of implementing a robotic surgery program requires a substantial financial commitment from the hospital, as the cost of a robotic system runs in the range of $1.5 million to $2 million, with additional costs for maintenance of the system and purchase of special instruments. The cost of training the surgeons and the entire surgical team is estimated to be about $10,000 per surgeon.Most of the professional organizations have not reached a consensus on training or credentialing standards for surgeons. This leaves the individual hospital responsible to develop and implement training and credentialing processes that are medically sound, that promote patient safety, and that protect the hospital from undue risk.
At the national level, manufacturers, importers, and device user facilities are required to report to the FDA certain device-related adverse events involving serious patient injury and/or death, as well as product problems. Reports made to the FDA include information that may identify patterns or problems or a failure mode with a particular device that organizations can review as part of their ongoing robotic patient safety program. The FDA’s system limitations are widely known.
Pennsylvania Patient Safety Reports
Adverse events in hospitals are also reported to the Pennsylvania Patient Safety Authority. Looking at reports made to the Pennsylvania Patient Safety Authority from June 2004 through March 2014 found, 722 events directly involving robotic assisted surgery. One hundred and seventy-seven (24.5%) of these reports were reported as “Serious Events” that resulted in patient injury, including 10 events that resulted in a patient death.
In reviewing the reported complications and narrative details of the robotic assisted surgery Serious Events, the most frequently occurring complications were unintended laceration/puncture (43.5%) and bleeding/hemorrhage (17.5%). Retained foreign body and infection each accounted for 4.0% of complications. Other complications were reported in 31.1% of the Serious Event reports, of which 20.0% were related to positioning complications.
Hospitals also provide information describing contributing factors and remedies to reduce reoccurrences. It was noted that two of the Serious Events identified inexperienced staff or issues of staff proficiency as a contributing factor. Fourteen Serious Events documented that further education and training of the staff and referral of these events to medical leadership, administration, and quality/risk management for further review were recommended to prevent reoccurrence.
The following are samples of actual events reported to the Patient Safety Authority.
- Unintended Laceration/Puncture. During robotic-assisted lobectomy, the patient’s pulmonary artery was nicked. The procedure was converted to an open thoracotomy, resuscitation was not successful, and the patient died. Training and education of the staff was recommended as a remedial measure to prevent recurrence.
- Bleeding/Hemorrhage. Patient underwent robotic-assisted laparoscopic partial left nephrectomy without incident. Hemoglobin and hematocrit dropped, and increased bleeding was noted. Patient was taken back to the OR for exploratory laparoscopy. Patient was returned to unit stable; later, the patient was observed with more bleeding. The decision was made to take the patient back to the OR for open exploration. Nephrectomy was performed and adrenal gland found to be actively bleeding and also removed. Patient returned to unit in stable condition.
- Positioning. A patient underwent an elective nephrectomy via laparoscopic robotic procedure. Time patient positioned on one side in the OR exceeded the expected surgical time. Patient went to the ICU postoperatively, where the patient complained of flank pain on same side as positioned in OR. Symptoms of compartment syndrome noted. Returned to OR for fasciotomy. Return to ICU. Condition deteriorated. Renal failure, comfort measures per family request/decision. Patient expired. Education and training of staff along with review/revision of policies and procedures and referral to medical and administrative leadership for further quality review were recommended.
- Retained Foreign Body. A patient underwent a robotic thyroid surgery. Midway through the robotic dissection, the electrical power was lost on three separate occasions. During the robotic procedure, metallic clips were used and the instruments were entangled in a gauze sponge. The counts were correct and the wound was closed. The staff was informed that this patient presented to another hospital for removal of a retained foreign body.
- Infection. Debris was left on robotic instrument and was introduced into the patient’s abdominal cavity upon insertion of instrument through port. Area irrigated and patient received antibiotics postoperatively. Lack of staff proficiency noted as a contributing factor to the event.
Robotic Surgery Training and Education
As noted in several of the above event narratives, training and education, credentialing, and continuous quality reviews are often recommended to ensure that a robotic surgery program functions safely and efficiently.
Robotic surgical training provided by the manufacturer provides basic training but does not ensure that the surgeon is competent to perform robotic assisted surgery. The learning curve for a physician starting robotic surgery is steep, and the credentialing plan must address the individual learning needs. In general, research has found that robotic assisted surgeries performed by inexperienced surgeons result in longer OR times and increased complications
An example of an organization’s robotic assisted surgery training program (at Tacoma General Hospital in Tacoma, Washington) takes its cue from the air force. The military and aviation industries have a long history of requiring flight simulation training and strict regulations on licensing and maintenance of skills. Operating a robotic surgical system, has been likened to flying an airplane. As part of a hospital’s training program, the hospital can develop a system whereby the surgeons, like pilots, train and test to become credentialed, then must perform a certain number of procedures, get additional training, and take annual examinations to prove continued competency. Tacoma General Hospital required that 12 to 15 simple cases be done first before attempting complex cases They established a minimum number of cases for a surgeon to maintain skills and maintaining privileges to perform robotic surgery was set at 20 to 24 cases per year and at least one every eight weeks.
Patient Informed Consent
Specific informed consent considerations will need to be addressed with a robotic assisted surgery program. Patients need to know more than just the general risks, benefits, and alternatives that are associated with the procedure. The risk of robot malfunction and the readiness to implement a contingency plan, such as converting to an open procedure, can also be addressed in the informed consent discussion. Surgeons will need to spend time with the patient explaining the pros and cons of selecting robotic surgery over other modalities.
Plaintiff’s attorneys are alleging insufficient training and credentialing against the hospitals in medical malpractice litigation. Surgeons may be charged with failing to obtain proper informed consent even if they have disclosed surgical risk but have not disclosed the surgeon’s robotic training and where they are on the learning curve. The argument presented is that had the patient known that the surgeon lacked experience in robotic surgery, the patient would not have elected to have the procedure or would have selected a more experienced surgeon.
Robotic assisted surgery is being used in hospitals throughout the United States. The growth of robotics programs has outpaced the industry’s ability to develop and implement clear, consistent standards for training and credentialing of surgeons and surgical teams. Until clear, consistent standards have been established by the professional organizations, the responsibility rests with the hospital to develop training programs that adequately prepare the physician and the entire surgical team to safely perform robotic procedures. The hospital can ensure optimum outcomes for patients by establishing appropriate policies and procedures for training, privileging and credentialing, proctoring, informed consent, and equipment maintenance.