ISO13485 Medical Urology Surgery Instruments Lithotriptoscope With Curved Head

ISO13485 Certified Medical Urology Instruments Lithotriptoscope with Curved Head Lithotrite

1 Introduction:
If you are looking for minimally invasive surgery medical instruments with good quality, competitive price and reliable service. Wanhe medical is manufaturing these for you. We provide general and professional laparoscopic instruments with CE, FDA approved. 

2 Specifications
Adopt 3Cr13, 304, 630 stainless steel material
Tough construction
Corrosion resistant
High durability
 

FAQ

What factors may affect the performance of urological surgical instruments?

There are many factors that affect the performance of urological surgical instruments, from design, material selection to production process and quality control, which will have an important impact on the final performance.

Design factors:

Stability and reliability: The stability and reliability of surgical instruments should be considered when designing to ensure that tissues and organs can be stably grasped and fixed during surgery, thereby ensuring the accuracy and safety of the operation.

Ergonomics: The design of surgical instruments needs to consider ergonomics, so that doctors can operate easily and comfortably when using them, reducing fatigue and operating errors.
High-tech integration: Modern surgical instruments often integrate high-tech elements such as electronic monitoring, wireless communication, and image enhancement to provide more precise surgical guidance and operational feedback.
Material selection and control:

Raw material quality: Selecting high-quality raw materials that meet standards is the key to ensuring product reliability and safety. High-quality raw materials can improve the durability and biocompatibility of instruments.
Mechanical property testing: Including tensile properties, impact properties, tear properties, compression properties, etc., these tests ensure the physical stability of the instrument in actual use.
Production process control:

Quality control during production: Strict production process control is an important part of ensuring the performance of medical devices. This includes verification, confirmation, monitoring, measurement, inspection and testing activities for major raw materials, components, outsourced parts, intermediates, finished products, primary packaging materials, labels, etc.
Quality management system: Establish and implement a comprehensive quality management system (QMS) to ensure that products meet established quality standards in all aspects such as design, production, packaging and service, and comply with relevant regulations and ISO 13485:2016 standards.
Performance testing:

Biocompatibility testing: This is one of the most important tests to ensure that the device does not cause allergic reactions or infections in patients.
Mechanical strength testing and durability testing: These tests ensure that the device maintains good performance and safety during long-term use.
Clinical application and feedback:

Clinical needs insight and research: Based on the fundamental understanding of surgical instruments and the research on clinical needs, the design and function of surgical instruments can be further optimized.
Application of robot-assisted technology: For example, although robot-assisted single-port laparoscopic technology has the advantages of less trauma and faster recovery, it also has problems such as limited operating space and interference from assistant operations, which need to be continuously improved to improve its clinical application effect.
Taking the above factors into consideration, it can be seen that the performance of urological surgical instruments is affected by many aspects, including strict management and optimization of design principles, material selection, production process control, and performance testing. Only by doing the best in these aspects can the efficiency and safety of surgical instruments in actual use be ensured.

How to optimize the design of urological surgical instruments to improve stability and reliability?

In order to optimize the design of urological surgical instruments to improve stability and reliability, the following measures can be taken:

Use high-precision sensors: Using high-precision, fast-response and durable sensor technologies such as linear magnetostrictive displacement sensors can significantly improve the control accuracy and reliability of surgical instruments.

Material selection and surface treatment: Select materials such as stainless steel and apply silver ion coatings on key components, which not only improves the antibacterial properties of the materials, but also enhances the easy cleanability of the equipment, thereby ensuring precise operation and easy maintenance during surgery.

Application of intelligent identification system and robotic arm: By introducing facilities such as intelligent identification system and robotic arm, electrical control is realized, processing difficulty is reduced, and production safety is improved. This technological innovation helps to ensure stable quality and reduce human operation errors.

Multi-camera module information fusion: Using the information fusion method of multi-camera modules to track surgical instruments can effectively reduce tracking failures caused by motion blur, thereby improving the stability and accuracy of surgical instruments.

Risk analysis and assessment: Follow ISO 14971 and other standards to conduct risk analysis and assessment of medical devices, ensure that various possible risk factors are considered from the design stage, and formulate corresponding preventive measures.

Reliability verification of robot-assisted surgical equipment: According to the standards of the State Food and Drug Administration, reliability verification of assisted surgical equipment using robot technology is carried out to ensure its safety and stability in actual application.

Intelligent testing and feedback: Implement EFT (electromagnetic field testing) of medical devices to detect and solve electromagnetic radiation problems that may occur during surgery, thereby ensuring the safety of patients. The future development direction is to develop in the direction of intelligence, digitization and precision.

Which materials in urological surgical instruments are most critical for biocompatibility testing?

In urological surgical instruments, material biocompatibility testing is crucial. The biocompatibility testing of the following materials is particularly critical:

Titanium alloy: Titanium and titanium alloys have become the main medical metal materials for surgical implants and orthopedic devices worldwide due to their excellent biocompatibility, low elastic modulus, good strength-toughness matching, and long-term stability.

Polyurethane or silicone balloon materials: These materials are used to manufacture medical devices related to bladder urination and have good biocompatibility.

Small intestinal submucosal decellularized matrix (SIS): Although its long-term effect is not good, its biocompatibility and mechanical properties as a biomaterial for bladder regeneration are still of concern.

Nano-iron traction wire: A new material used for ureteral stents, which requires evaluation of tensile strength and biocompatibility.

Polymer materials: Such as hyperbranched polylysine grafted surfaces, these materials need to be tested for detailed physical and chemical properties and antibacterial properties when used in medical devices.

In addition, other common biomaterials such as silk, polyglycolic acid and urethral sponge decellularized matrix also need to undergo corresponding biocompatibility tests to ensure their safe and effective application in tissue engineering.

In the production process of urological surgical instruments, which quality control measures have been proven to be the most effective?

In the production process of urological surgical instruments, the following quality control measures have been proven to be the most effective:

HFMEA model: By establishing an HFMEA team, a flowchart of the use of urological endoscopic surgical instruments in each operation link is formulated, and the existing and potential high-risk factors in each link are found, and improvement measures are formulated through analysis. This model has a significant effect on improving the quality of medical services, standardizing operating procedures and reducing risks.

Refined management: After the implementation of refined management, the qualified rate of storage and use of high-value medical consumables in specialized operating rooms has been significantly improved, and the satisfaction of surgeons with the supply of consumables has been significantly improved. This shows that refined management can effectively improve the management quality of high-value medical consumables in urological operating rooms and the satisfaction of surgeons.

PDCA management model: By using the PDCA management model to evaluate, implement, inspect and improve the management methods of urological surgical instruments and equipment in the operating room, it can standardize the use process of instruments, reduce the number of failures, and extend the service life of instruments. This management method has significantly improved the standardization and standardization of operating room instrument and equipment management.

Inspection and testing: This is the most common and direct quality control measure, including appearance inspection, size measurement, functional testing, etc. of products or services to ensure that they meet quality standards and requirements. These measures can be carried out during the production process or before the product leaves the factory.

Integrated nursing model: Centrally count, clean, maintain, disinfect and sterilize the instruments used in the operating room, and then send them to the operating room to meet normal supply needs. This management model can improve the cleaning, sterilization and disinfection quality of instruments used in the operating room, thereby extending the service life of the instruments and improving the cleaning qualification rate.

What are the latest advances in robot-assisted single-site laparoscopic technology, and how to solve its existing clinical application problems?
Robot-assisted single-site laparoscopic technology (Robot-assisted Laparoendoscopic Single-site Surgery, R-LESS) has made significant progress in many fields in recent years. Especially in gynecological and urological surgeries, this technology has attracted more and more attention due to its advantages such as minimally invasive, small incision and rapid recovery.

Latest progress
The sp1000 system, the first domestically developed single-port laparoscopic surgical robot system, has completed gynecological clinical enrollment and held press conferences in Beijing, Xi'an, Wuhan and other places. In addition, the "Laparoscopic Single-port Surgical System" produced by Beijing Mu Rui Robot Co., Ltd. has also been officially approved by the State Food and Drug Administration, indicating that the system can be officially used in clinical practice.

R-LESS has the advantages of clear surgical field, less instrument interference and less postoperative scar compared with traditional single-port laparoscopic surgery. In gynecological surgery, when using uterosacral ligament suspension to treat vaginal prolapse, the operation time of robotic single-port laparoscopy is not significantly different from that of traditional single-port laparoscopy, but the learning curve is shorter and safer. Similarly, in the field of urology, the domestic "Toumai" surgical robot-assisted single-port laparoscopic technology has shown its safety and feasibility.

my country has introduced a number of policies to encourage the development of domestic robotic systems. Currently, two single-port robotic systems have been verified in common benign and malignant gynecological diseases, showing good development prospects.

Existing clinical application problems and solutions
Although R-LESS technology has many advantages, there are still some problems to be solved in practical applications:

Although the da Vinci robotic single-port surgical platform (DVSSP) has been successfully applied in the field of urology, its inherent technical barriers still hinder the further promotion of R-LESS. For example, problems such as high equipment cost and complex operation need to be solved through continuous technical improvements.

Due to the steep learning curve of R-LESS technology, doctors need to undergo long-term professional training to master it. Therefore, establishing a systematic training system and experience exchange platform is the key to solving this problem.

Although there have been preliminary studies and case reports, large-scale, long-term clinical data on R-LESS technology still need to be further accumulated. This will help to better evaluate its effectiveness and safety, thereby promoting its widespread application in more fields.

How to establish and implement a comprehensive quality management system (QMS) to ensure the performance and safety of urological surgical instruments?
To establish and implement a comprehensive quality management system (QMS) to ensure the performance and safety of urological surgical instruments, the following steps need to be followed:

First, the company needs to formulate clear quality policies and quality goals. These goals should include requirements in terms of function, performance, reliability and safety. The quality policy lays the foundation for the entire quality management system.

At this stage, leaders at all levels of the organization need to prepare their minds, unify their understanding, and formulate detailed plans. This includes education and training, current situation investigation and analysis, adjustment of organizational structure and allocation of resources, etc.

This stage is mainly to carry out detailed planning and design of the quality management system. Key quality indicators and key processes need to be determined, and corresponding monitoring measures need to be formulated.

At this stage, the company needs to establish specific management systems and procedure documents based on the content of the plan. This includes setting up a quality management department, strengthening employee training, updating equipment technology, optimizing product design, etc.

After the quality management system is established, a trial run is required to verify its effectiveness and feasibility. It is generally required to run for more than three months in order to discover and correct potential problems.

After the establishment of a comprehensive quality management system, the company needs to continuously operate and maintain it to ensure the effectiveness and continuous improvement of the quality management system. This includes monitoring key quality indicators, taking timely measures to correct deviations, and ensuring the achievement of quality goals. At the same time, it is also necessary to establish an effective quality management evaluation mechanism and implement continuous improvement.

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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden