The role of the perioperative nurse is unique in regards to the high level of technical skill, in addition to clinical skills, necessary to function.1 Advancements in technology and minimally invasive surgery (MIS) have introduced many devices into the OR that nurses are responsible for setting up, operating, troubleshooting, tearing down, and storing. Robotic devices are among the latest technologies perioperative nurses are trying to master. There are medical robotic devices used in the specialties of orthopedics, neurosurgery, urology, gynecology, cardiothoracic surgery, general surgery, and peripheral vascular surgery. In addition, research is currently being done for applications in otolaryngology.2,3
Establishing safeguards
Establishing safe practice for robotic technology started before these systems were released for sale. The Food and Drug Administration (FDA) received authority in 1976 to require that a manufacturer must prove a device is safe, reliable, and effective before they can release it for use in a healthcare setting. Once released, postmarket surveillance begins via many avenues. Individual healthcare professionals and institutions are crucial in making postmarket surveillance effective through reports of adverse outcomes where suspicion exists that the medical device affected patient care. These reports may be made directly to the manufacturer, but must also include both voluntary (MedWatch) and mandatory reporting to the FDA. Research by the manufacturer and in the private sector will continue to be done after marketing to establish clinical outcome data on the use of robotic technology.
Establishing safe practice guidelines and standards of care doesn't stop with the FDA and manufacturer's clinical trials. Every institution and healthcare professional has a moral, ethical, and legal responsibility to examine safe care in their institutions and practices.
Healthcare industry patient safety concerns
In 2000, the Institute of Medicine (IOM) published the report: To Err is Human: Building a Safer Health System. This report disclosed that as many as 98,000 Americans may die every year as a result of medical errors,4 In a retrospective study of 15,000 charts, 9,900 adverse events were found to be surgically related, and 5,346 of these were found to be preventable.5 A second IOM report, Crossing the Quality Chasm: A New Health System for the 21st Century, continues the theme of patient safety by outlining four key aspects that contribute to problems with the quality of healthcare. One of these four aspects is "[horizontal ellipsis] the growing complexity of science and technology."6 All of these factors make it important to discuss how robotic technology, as a medical device, impacts patient safety in the OR.
Patient safety relating to medical devices in some way relates to the device's level of complexity as perceived by the user. "User complexity is a measure of both the skill required to use a device correctly and safely, and of the work required for a user to use it in that way."7 A device that is self-explanatory in its purpose and function is much less complex for the user than a device that requires instruction as to its purpose and function before a user can operate it. For example, a medical device can be complex for one user, the person who must set it up for use, and simple for another user, the surgeon using the device to operate.7
One of the most highly utilized medical robotic devices in the United States is a telemanipulative robotic surgical system (TRSS) known as the da Vinci Surgical System. This TRSS is at the higher end of the user complexity scale. This is due to the many steps necessary to set the system up, the variables involved that can lead to errors in optimal functioning of the system,8 and the instrument choices with the system for performing different functions. The TRSS can function with a wide angle, high magnification, or 5 mm camera head, and offers 0[degrees] or 30[degrees] endoscopes. The system can also function with short or long ports for the robotic instruments, and 8 mm or 5 mm instruments. (See 8mm and 5mm robotic instruments.)
Training
Properly designing training programs for medical and assistive staff on proper use of the TRSS is imperative to optimize patient safety.9 Since the TRSS is a complex medical device, it's more challenging to create orientation and training programs that achieve the desired level of competency. Orientation programs that offer a positive experience influence the effectiveness of the orientation process, and studies show a direct correlation between adequate orientation and nurse retention.1
In perioperative nursing, education and training consist of instructional educational sessions as well as clinical experience. Instructional education is a method of assisting a person in learning. Learning involves both cognitive and motor functions that lead to behaviors. Therefore it's important to incorporate both hands-on and cognitive training methods.
The first step is learning the language associated with the TRSS. This involves training on both visual and audible cues the TRSS provides, the names for parts of the equipment, and maneuvers made with the robotic arms. Computer based training modules are helpful with this, and are available through the manufacturer. They're also somewhat easy to create and incorporate into existing computer education programs by using digital photography and PowerPoint technology.
The next step is a hands-on training session with a TRSS in a dry lab setting. Perioperative nursing staff need to learn how to connect the three pieces of equipment that compose the TRSS, turn the system on, and prepare it for use. They must also know how to maneuver the TRSS's robotic arms, sterilely drape the arms and camera, load and unload robotic instruments on the arms, "drive" the robotic arms up to the patient's side, and how to correctly interpret the picture language and audible cues the TRSS provides. It's also important that team members are taught who their resource staff are and how to contact them to assist with problem solving.
The entire OR team should be educated on exactly how and when the robotic arms will move while under the control of the primary surgeon sitting at the surgeon console. This will allow nursing staff to assist with safe docking, and ensure that no injury occurs from a robotic arm resting or putting pressure anywhere on a patient. Knowing how and when the robotic arms will move also ensures that the whole OR team is aware of safety needs during a procedure when a robotic arm is repositioned to gain better access to the surgical field.
Loading and unloading robotic instruments
In order for a procedure to be efficient, and yet safe, it's important that perioperative nursing staff receive hands on training on how to load robotic instruments onto the robotic arms. Specific techniques and hand placement will ensure a successful placement of the instrument while minimizing any risk of an unintended tip movement which could compromise patient safety. It's essential that perioperative nurses have multiple opportunities to practice this technique, as this will assist with establishing motor pathway memory. (See Proper hand placement for safe loading of robotic instruments.)
Each institution needs to decide if, or under what conditions, nursing staff will be involved in loading robotic instruments into patient body cavities. Under certain circumstances, placement of the robotic instrument into the patient's body cavity for use will involve principles of laparoscopic instrument manipulation. The perioperative nurse should check both state nursing practice laws, as well as their institution's policies.
Education of nursing staff on the robotic surgical system must also include emergency procedures and how to identify the need to implement them. As with any laparoscopic procedure, nursing staff must be ready to convert the procedure into an open approach in emergency conditions. It's crucial to train nursing staff in the emergency procedure for the manual opening of a robotic instrument tip so that it can be taken off the robotic arm. Since this would only be necessary when power or vision has been lost to the system, the chances of having to perform this task are low. Lack of performance repetition makes comprehension of the procedure and regular demonstration of the technique more important in order to maintain competency with the task. Nursing staff should be trained to verify the availability for every procedure of the emergency wrench used to manually open the robotic instrument tips. This wrench should be available via two easily accessible routes: one sterile on the field, and one unsterile on the TRSS's equipment as backup.
The initial training required by the surgeons will overlap the content of perioperative nursing staff training, but then the focus of training for the two groups will diverge. Surgeons need to learn how to maneuver the TRSS's surgical arms, connect the system to the ports that pass through the patient's skin, load and unload robotic instruments, and manipulate the "masters" that control the robotic instrument tips from the TRSS's surgeon console. It's most helpful if the assisting surgeon has experience with laparoscopic/thoracoscopic surgical principles. Recommended training for surgeons includes attending an animal lab or virtual reality training session to practice robotic surgical techniques. Simulation training can include computer-based learning, full-blown enactments with humans or medical mannequins, or virtual reality worlds.10
Team approach
The highest level of care will be provided if a knowledgeable and trained team of individuals are present for every surgical procedure. This team should include perioperative nurses, surgical assistants, anesthesiologist, and surgeons. It was recommended in the IOM's report To Err is Human: Building a Safer Health System that a system, used in the aviation industry, called crew resource management be adopted by healthcare systems to increase safety. This system places an emphasis on communication between all team members. It has been shown that poor communication can lead to medical errors11,12 and that patient safety can be compromised in the OR by issues regarding conflict, communication, and control within the healthcare team.11,12
With TRSS procedures, it's essential to provide a clear line of sight from the surgeon console to the surgical field, and to keep noise levels down. This ensures that communication between the surgeon console-side physician and the patient-side assistant isn't hampered.
In addition to perioperative nursing staff, anesthesia staff are also part of the OR team, and must be included in educational sessions on robotic surgery in order to maximize patient safety. Patient safety is increased if the anesthesia provider also have some idea of how the robotic arms move during surgery. They can then assist the team in identifying potential positioning concerns. It's important that the anesthesia provider understands that the OR table can't be moved once the TRSS arms are in place and are connected to the cannulas in the patient. This prevents any miscommunication in the room leading to OR table movement at the wrong time. The anesthesia provider needs to have an understanding of the surgical procedure needs, such as placement of the patient in the Trendelenburg position, and how these needs impact patient care requirements.
Resources, policies and procedures
It has been found that job tension correlates greatly with access to resources.13 Therefore, adequate access to resources leads to decreased stress and possibly better performance by staff.
These resources can take many forms, including but not limited to: guides or checklists on equipment setup and room set up, notes on equipment providing troubleshooting hints or things to remember, policies and procedures on robotic surgery, opportunities for hands-on practice with a TRSS outside a patient procedure, instrument tray guides and documents listing tray availability, and staff with expert skill in use of a TRSS and clear, easy ways of contacting these experts.
Utilizing photos or diagrams as resources for room arrangement of equipment, set-up of equipment and instrumentation, troubleshooting procedures, and ideal storage configuration of robotic arms is also helpful for staff. Having a robotic specialist available in an institution can also be beneficial since they can be readily available to assist novice staff, or assist with troubleshooting unusual or less common scenarios that arise with a TRSS. The manufacturer provides technical support through a toll-free phone number. Staff must have access to this, and be aware that they can use it. Resources readily available in the OR for nursing staff will provide for efficient error free set up, and assist in the timeliest resolution to any problem that arises during a TRSS procedure.
Another important resource to put into place is policies and procedures on use of a TRSS. In addition to being a resource staff may utilize, having policies and procedures in place will establish a foundation for orientation and training and complement/ support competencies. They give staff a concrete model to refer to while developing their practice, and can be reviewed any time practice is in question. Policies and procedures are support resources for staff when trying to implement the best practice changes with team members. They also provide measures for evaluations. Writing policies and procedures provides an institution with an ideal opportunity to take a closer look at their practice and identify specific steps where errors can occur, and develop procedures that are clear, concise, and will prevent errors.
System specifics
Placement of the surgeon console in relation to the patient and surgical assistant is also a safety concern. The primary surgeon at the TRSS's surgeon console needs to be able to clearly and effectively communicate with the patient side assistant. An environment of inefficiency and possible error is created if the physicians can't hear each other or must look away from the surgical field to communicate. The manufacturer makes an audio system to enhance communication between the surgeon console side physician and patient side assistant.
Robotic arm placement is a patient safety concern. Visual as well as tactile inspection should be done to ensure that no point on the robotic arm is resting on or causing pressure on any part of the patient.
As with any sterilely draped piece of medical equipment, contamination must be prevented. The TRSS size increases the risk of contamination of the sterile field, especially in an OR with smaller square footage. Specifically, when moving the TRSS surgical arm cart up to the sterilely draped patient, it's important to watch for overhead contamination by lights or booms, and contamination from equipment in the room such as video towers, I.V. poles, and so on. Moving the OR table as far away from the anesthesia equipment such as the breathing circuit and I.V. lines will help tremendously in preventing contamination of the camera and endoscope during a procedure.
Light sources used for MIS generally come with a caution about the amount of thermal energy they generate. The TRSS light system also warns about the energy concentration both at the light cable connectors and the endoscope tip which is introduced into the patient's body cavity. It's recommended that the light source be placed in stand-by mode, or in older models that the intensity be turned down whenever the light cable is detached from an endoscope. It takes only 1 to 2 seconds before drape material starts to smoke and burn through. The manufacturer recommends that the distal end of the endoscope isn't allowed to come into contact with skin or tissue.
As with all surgical instruments, robotic instruments should be inspected for intactness prior to use. Because of the nature of these instruments staff may have a difficult time recognizing when a robotic instrument is broken. For optimal functioning and epidemiological reasons it's also important that staff be educated about irrigation of robotic instruments on the sterile field. Body fluids can dry on the working components of the robotic instruments causing them to slightly stick, and making it very difficult to adequately terminally clean them.
Special patient populations
Pediatric patients undergoing procedures with a TRSS present unique safety concerns based on their age and size (height and weight). Due to their size, newborns and young children under 1 year of age have a very small working space for laparoscopic and thoracoscopic surgery. This has been one of the factors preventing widespread use and development of laparoscopic and thoracoscopic MIS surgery in this patient population. For procedures utilizing a TRSS, placing two layers of convoluted foam under the infant or child creates a flexibility in his position on the OR table that is only felt under heavy pressure. (See Convoluted foam layers for infant patients.) Thus, the infant or child would tend to give somewhat if too much pressure was applied to bone, or the back wall of the chest or abdomen, therefore preventing unintended injury by creating a safety cushion. It's important to remember that because of the size of the child or infant, it's more likely that their head and face will be in close proximity to a robotic arm.
Obese patients require special precautions for safety as well. Maintaining adequate respirations for this patient population can be very difficult once they are placed in the severe Trendelenburg position necessary to gain visualization on minimally invasive gynecologic or urologic procedures. Intra-abdominal pressure for the morbidly obese patient has been shown to be higher than that of nonobese patients.14 Tech-niques of hyperventilation, increasing tidal volume, and increasing inspiratory pressure may not be enough to keep oxygenation up, and blood acid levels may increase. Besides decreasing the pneumoperitoneum pressure, there are techniques for abdominal wall lift so that pneumoperitoneum pressure can be greatly deceased during MIS.15,16 These involve a retractor system that helps to lift the abdominal wall with assistance from outside the patient, rather than intra-abdominal pressure pushing out uniformly from within the abdomen. Running a brief test in severe Trendelenburg position before prepping will sometimes identify the occasional patient that simply can't tolerate this position for very long.
Patient positioning
Depending on the procedure, patients undergoing surgery utilizing a TRSS will be a supine position, in Trendelenburg position, reverse Trendelenburg, lithotomy, or lateral decubitus. When positioning the patient, the final location of the TRSS's robotic arms must always be considered. For procedures working deep in the pelvis, it's necessary to ensure that the patient's legs are clear of the TRSS's arms, as well as to provide protection for the patient's face to protect it from the robotic camera arm. Perioperative nursing staff should ensure that the OR table pad is secured to the OR table so that it won't slide, and that the patient won't slide on the sheet on the OR table. Some institutions use padded shoulder pieces that attach directly to the OR table to keep patients from sliding in severe Trendelenburg position. Careful padding must be done to prevent nerve damage. A deflated bean bag may be used instead to mold to the patient's shoulders, but not put pressure on brachial nerves. The bean bag is best placed directly onto the OR table pad to eliminate any slipping. On mitral valve repairs, careful positioning of the right arm and shoulder is needed to gain access for the TRSS's left arm. The right shoulder can be dropped, and the arm suspended in a gel sling, or the right arm can be supported in a lateral arm support that attaches to the OR table. Attention must be given to avoid lifting the right shoulder up, as this will interfere with the mobility of the TRSS's robotic arm. For internal mammary artery harvesting, the patient should be moved over as far left on the OR table as possible. The left shoulder should be dropped as low as it will go, and the left arm suspended in a gel sling at the side of the table. This will ensure that the patient's left shoulder comes into as little contact as possible with the TRSS's robotic arm.
Conclusion
Perioperative nurses are part of a team that provides safe patient care during surgical procedures by communicating information, providing equipment, instruments, and supplies based on each individual patients needs, and using the nursing process to care for patients. Staff shouldn't forget that in this age of technical challenges the very basic function of communication is still one of the most important aspects of safe patient care. OR
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