FAQ

How to evaluate the safety and effectiveness of minimally invasive surgical instruments?

Evaluating the safety and effectiveness of minimally invasive surgical instruments is a complex and multifaceted process, which usually includes the following key steps:

Experimental testing: First, the surgical instruments are experimentally tested for operational performance, reliability, and effectiveness. For example, for hand-controlled minimally invasive surgical instruments, operational performance tests and clamping force test experiments can be performed. For robot-assisted surgical instruments, the motion performance of the end effector can be tested through functional verification experiments.

Clinical trials: Clinical trials are a key link in evaluating the safety and effectiveness of surgical instruments. Through prospective, multicenter, randomized controlled clinical trial designs, the performance of surgical instruments in actual clinical applications can be systematically evaluated. For example, the new generation of minimally invasive vascular interventional surgical robot VasCure achieved a 100% success rate in the first five clinical coronary stent implantation surgeries, and no adverse complications occurred.

Safety endpoint analysis: In clinical trials, primary and secondary safety endpoints are usually set. For example, the primary safety endpoint mentioned in the technical review points for clinical trials of laparoscopic endoscopic surgical systems is the incidence of complications that meet the Clavien-Dindo grading system grade 3 or above from the first incision to 30 days after surgery.

Risk management and control: Strict risk analysis and control must be carried out during the design, manufacture and use of surgical instruments. For example, the risk analysis and control countermeasures research of minimally invasive laparoscopic surgical robots can help identify and manage potential risk factors.

Standards and specifications: Following relevant national standards and technical guidelines is also the basis for ensuring the safety and effectiveness of surgical instruments. For example, GB/T 2766-2022 "Surgical Instruments General Requirements and Test Methods for Non-cutting Articulated Instruments" provides general requirements and test methods for non-cutting articulated instruments.

Comprehensive evaluation: Finally, the safety and effectiveness of surgical instruments are comprehensively evaluated by comprehensively analyzing experimental data, clinical trial results, and risk management measures. For example, the application study of ultra-minimally invasive surgical instruments in laparoscopic sleeve gastrectomy shows that it has high safety and effectiveness in actual clinical applications.

The evaluation of the safety and effectiveness of minimally invasive surgical instruments requires comprehensive measures such as experimental testing, clinical trials, safety endpoint analysis, risk management and control, and compliance with relevant standards and specifications.

What are the test standards for the operating performance and clamping force of minimally invasive surgical instruments?

The test standards for the operating performance and clamping force of minimally invasive surgical instruments are as follows:

Operational performance:

The robot has no less than 6 degrees of freedom, and the repeatability is better than 0.5mm.

Prototype experimental verification is required to ensure performance under fine operation. For example, the doctor's main hand controls the instrument to grab the ring at the target position, and the NOKOV metric motion capture system is used to obtain the motion trajectory information of the main hand and the slave surgical instrument in real time as the experimental result.

Clamping force test standard:

The instrument clamping force is not less than 6N, which can achieve deep cavity space suturing and knotting.

Aiming at the force detection problem of surgical robot micro-instruments, an equivalent experimental platform for 3-DOF micro-instruments was built, and a driving joint comprehensive resistance model was designed based on the complete dynamic model of the flexible cable-driven micro-instrument joint. According to the experimental results, the data fitting of the back propagation (BP) neural network model was carried out to give a comprehensive resistance neural network model.

The clamping force of the end effector of the surgical instrument was studied, and a mathematical model for solving the end clamping force was established, taking into account the nonlinear friction between the wire rope and the guide wheel, the motion coupling between the finger and the wrist, and the creep deformation of the wire rope on the guide wheel.

In the clinical trial of minimally invasive surgical instruments, how to design a prospective, multi-center, randomized controlled trial to evaluate its safety and effectiveness?

When designing a prospective, multi-center, randomized controlled trial (RCT) of minimally invasive surgical instruments to evaluate its safety and effectiveness, the following steps and principles can be referred to:

Select a suitable clinical institution: The trial should be jointly participated by multiple clinical institutions, usually not less than 3, to ensure the diversity and representativeness of the data.

Develop a unified trial plan: All participating clinical institutions must operate according to the same trial plan to ensure the consistency and comparability of the trial results.

Randomly assign subjects: The subjects who meet the requirements of the clinical trial are assigned to the trial group and the control group by random assignment, and corresponding intervention measures are given. This method can minimize bias and ensure the reliability of the trial results.

Prospective study design: Prospective studies require a reasonable selection of study design, such as cohort studies are suitable for observing the relationship between disease occurrence and exposure factors, while clinical trials are suitable for evaluating the efficacy of drugs or treatment plans.

Sample selection: Sample selection is crucial, and it is necessary to ensure that the sample is representative and can reflect the usage in the real world.

Multidisciplinary cooperation: In multicenter clinical trials, cooperation between different disciplines is essential. For example, the clinical trial of covers a variety of difficult and complex surgeries in the thoracic, abdominal, and pelvic fields, which shows that multidisciplinary cooperation is essential for evaluating the comprehensive performance of surgical robots.

Strict control of trial conditions: RCT strictly controls trial inclusion, exclusion criteria and other conditions, and performs random grouping to ensure a good balance of participant characteristics in each group.

Data collection and analysis: During the trial, data needs to be systematically collected and recorded, and rigorous statistical analysis needs to be performed to evaluate the safety and effectiveness of surgical instruments.

What is the specific definition and evaluation method of the complication rate of grade 3 or above in the Clavien-Dindo grading system in minimally invasive surgery?

The Clavien-Dindo grading system is an international standard for assessing the severity of surgical complications, which is divided into five levels. The specific definitions and evaluation methods are as follows:

Level I: Complications occur but do not require medication, surgery or endoscopic treatment.
Level II: Requires medication, including blood transfusion and parenteral nutrition.
Level III: Requires interventions such as surgery, endoscopy or radiotherapy.
Level IV: Leads to patient death.
Level V: Leads to permanent functional loss.

In minimally invasive surgery, the application of the Clavien-Dindo grading system is mainly to evaluate postoperative complications and analyze their risk factors by retrospectively analyzing the patient's postoperative data. For example, after minimally invasive surgery for gastric cancer, researchers will retrospectively analyze the patient's postoperative complications and evaluate them according to the Clavien-Dindo grading standard. In addition, the system can also be used for other types of minimally invasive surgery, such as percutaneous nephrolithotomy, to evaluate perioperative complications.

In terms of risk management and control of minimally invasive surgical instruments, what are the specific risk factors and their management measures?

In terms of risk management and control of minimally invasive surgical instruments, the specific risk factors and their management measures are as follows:

Risk factors:

Equipment and instrument performance issues: The performance of equipment and instruments needs to be carefully checked before surgery to ensure their normal operation during surgery.

Risks in the design and development stage: Risk management in the design and development stage is particularly important in the entire life cycle of the abdominal minimally invasive surgical robot system, and potential design defects need to be analyzed and controlled in detail.

Irregular operating procedures: Irregular operating procedures may lead to increased surgical risks, so process improvements are needed to improve the quality of medical services.

Management measures:

Establish a special management team: The hospital disinfection supply center can establish a special minimally invasive surgical instrument management team to be responsible for improving management systems and operating procedures.

Scientific use of instruments: Instruments should be used scientifically during surgery to avoid damage or failure of instruments caused by improper operation.

Process improvement: The HFMEA model is used to improve the process of mirror instruments in the operating room, standardize the operating procedures, and reduce surgical risks.

Full life cycle risk management: Risk management of the minimally invasive surgical robot system throughout the entire life cycle, especially detailed risk analysis and control in the design and development stage.

Control system application: Use endoscopic surgical instrument control systems (such as surgical robots) to achieve precise control of endoscopes and other surgical instruments and reduce human operating errors.

What are the specific requirements of GB/T 2766-2022 "Surgical Instruments General Requirements and Test Methods for Non-cutting Articulated Instruments" for minimally invasive surgical instruments?

The specific requirements of GB/T 2766-2022 "Surgical Instruments General Requirements and Test Methods for Non-cutting Articulated Instruments" for minimally invasive surgical instruments include the following aspects:

Material requirements: The standard specifies the material requirements for non-cutting articulated instrument products to ensure that the instruments have good physical and chemical properties during use.

General requirements: The standard clarifies the general requirements for non-cutting articulated instruments, which are applicable to various clinical departments and surgical forms, and are widely used in hospitals of all levels in various cities across the country.

Test methods: The standard lists the test methods for non-cutting articulated instruments in detail to ensure that each product undergoes rigorous testing before leaving the factory to ensure its quality and safety.

Marking requirements: The standard also specifies the marking requirements for non-cutting articulated devices to ensure that product information is clear and easy to understand for easy identification and traceability.

For more photos and details please contact me:
Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden