Safety Features & Protocols of Surgical Robots

*Surgical robots are advanced robotic systems that carry out complex medical procedures with precision. They are used across a wide range of surgical specialisms, including urology, gynaecology, cardiothoracic surgery, orthopaedics, head and neck surgery, paediatrics, and even in areas such as neurosurgery and plastic and reconstructive surgery. *

*One notable example of this type of system is the Da Vinci surgical robot, a widely used platform for minimally invasive operations. This robot has revolutionised surgical fields by enabling surgeons to perform some very complex operations with greater levels of precision and control. *

*But although surgical robots are notable for the level of precision they provide, it’s absolutely critical that they are safe, so they feature multiple safety systems. This guide explores the types of safety features surgical robots use and how these help ensure robots comply with biomedical regulations. *

Fail-safe mechanisms are features that enable a system to either shut down immediately in the event of an emergency or carry on operating as normal even if something goes wrong elsewhere. For those systems where safety is critical, such as surgical robots, fail-safe mechanisms are a vital means of preventing harm to patients.   

The types of fail-safe mechanisms on surgical robots include emergency stop buttons, redundant (backup) hardware, software monitoring, mechanical brakes and locks, surgeon override controls, uninterruptible power supplies, safe motion limits, and system recovery protocols. 

These mechanisms enable the robotic surgery team to intervene or stop operations rapidly if needed. They also provide the means for the surgical robot to carry on operating as normal, even if a component in one part of the system (or in the wider environment) fails or is faulty. For example, if there is a failure in the power supply at the hospital, an uninterruptible power supply can provide a backup means of power during an operation. 

If there’s a problem with the robot’s software or a temporary glitch, recovery protocols can see the robot enter a safe mode while the surgical team fixes the issue. Mechanical brakes and locks may engage to prevent movement by the robot if there is a problem. Surgical robots can also feature an override that enables the surgeon to regain full control of the robot and intervene immediately during the operation if necessary. 

Emergency stops and hardware back-ups are also vital to robotics more broadly. Let’s take a closer look at these types of systems when it comes to surgical robots.

Redundant system design in a surgical robot means having a range of back-up systems that can take over in the event of a fault without compromising the surgical procedure or patient safety. Components that might be duplicated in a surgical robot include sensors, actuators, motors, and even some computer hardware. Backup batteries and power supplies may ensure operation in the event of a power failure. There may also be backup software systems that independently perform the same calculations to check their accuracy. In the event of failure of one comms channel, another will act as a backup. 

Sensors that are vital to the process of an operation, such as cameras, may also have additional, redundant systems. Force, torque, and position sensors and the encoders that help robotic joints maintain the correct position are often duplicated. Robot systems will also continuously monitor component performance to check for problems. If the level of redundancy cannot maintain operation in the event of a part of the system failing, then the robot will safely shut down without compromising the surgical procedure. Mechanical limits may limit the range of motion of robotic arms in the event of an interruption or fault. 

Sometimes known as ‘e-stop protocols,’ emergency stop protocols for surgical robots are designed to quickly and safely stop all activity by the robot if required. They don’t just protect the patient, but also the robotic surgery team if something goes wrong. For example, the e-stop helps to prevent unintended movements of a robotic arm in the event of a fault. 

The e-stop button is typically placed on the surgeon’s control console, and there are also often e-stop buttons on the robotic arm and the surgical assistant’s control panel. The e-stop is designed to be as prominent as possible in each case and immediately accessible in the event of an emergency. Pressing the emergency stop results in loss of power or actuation to the robot arm so that the robot stops moving immediately. 

The robot will stop safely, however, and without moving in a manner that could harm the procedure being carried out. Alarms and onscreen triggers will show that the e-stop has been initiated, so the entire surgical team is aware. Following the event, the robotic system will check itself for any faults before resuming. 

The incident that led to the emergency stop must be logged. Surgical teams should be regularly trained in these emergency stop protocols to ensure they are aware of what to do in the event of an emergency that requires the surgical robot to be halted.

Sensor integration on a surgical robot helps the robot to provide real-time data for control, safety, and functionality purposes. The types of sensors a robot may use include position and motion sensors, force and torque sensors, tactile sensors, digital sensors such as high-definition cameras, proximity sensors, and environmental sensors. It can be challenging to integrate all these systems in small spaces and with reduced latency to enable real-time processing of data. Sensors must also be able to be sterilised, and durable enough to withstand the rigours of surgical applications. 

As they are medical devices, surgical robots are subject to stringent regulatory standards. They are regulated by the Food and Drug Administration in the USA and the European Medicines Agency in the EU (which subjects medical devices to CE marking). They are also subject to international standards such as ISO 13485 (quality management for medical devices), ISO 14971 (risk management for medical devices) and IEC 60601 (safety and essential performance of medical equipment), to name but a few. Other territories, such as Canada, Japan, and Australia, have their own individual regulatory requirements. 

When it comes to regulation, particular areas of focus are safety and risk management, clinical performance, human factors, and cybersecurity. Regulation is vital for protecting public health and safety when it comes to the use of surgical robots. Complying with regulations also enables surgical robot manufacturers to access international markets successfully. 

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