Surgical Urology Instruments CE Certified Urethral Filar Sound Dilator with Knife

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

3 Various Type For Your Reference:

FAQ

How is the reprocessing and reusability of urological surgical instruments?

The reprocessing and reusability of urological surgical instruments is a complex and multifaceted issue involving infection control, cost-effectiveness, equipment durability, and legal supervision.

Reusable urological surgical instruments
Reusable urological surgical instruments such as ureteroscopes are subject to rigorous cleaning, disinfection, and sterilization processes. These processes include mechanical and manual cleaning, as well as disinfection using hydrogen peroxide gas. Nevertheless, even with cleaning and disinfection, there is still a risk of cross-infection, as some instruments may be difficult to thoroughly clean during the cleaning process.

Maintenance and repair are important components of reusable instruments. Due to the complex structure of the instrument, performance degradation or damage may occur after multiple uses, which not only affects surgical efficiency, but may also cause increased pain and poor treatment effects for patients. In addition, the maintenance process is cumbersome and costly, requiring specialized techniques and equipment.

There are clear legal regulations and requirements for reusable medical devices. For example, the guidelines issued by the FDA emphasize the importance of reprocessing methods and specify the number of reprocessing cycles that the product can withstand, which should be included in the reprocessing instructions. However, some studies have pointed out that even if the reprocessing requirements are met, the reuse of instruments still has potential safety hazards.

Although reusable instruments can reduce the cost of each operation and simplify inventory management, their initial investment and maintenance costs are high. In contrast, although disposable devices increase the cost of a single operation, they eliminate complex cleaning, disinfection and maintenance steps, thereby reducing overall operating costs.

Disposable urological surgical instruments
Disposable devices such as electronic ureteroscopes are designed for single use to avoid the risk of cross-infection and instrument contamination. Studies have shown that disposable devices have obvious advantages in reducing the spread of infection and improving surgical safety.

Regarding the environmental impact of disposable and reusable devices, some studies have shown that the impact of both on the environment is comparable. Therefore, when choosing whether to use disposable devices, in addition to considering infection control and safety, environmental protection factors also need to be considered comprehensively.

With the advancement of technology and changes in market demand, disposable devices have gradually become an important branch of urology. For example, the research and development and application of domestic disposable electronic cystoscopes are constantly advancing.

Summary
The reprocessing and reusability of urological surgical instruments involve multiple considerations. Although reusable instruments can reduce overall costs and improve resource utilization efficiency in some cases, their complex maintenance and disinfection requirements and potential infection risks limit their application. In contrast, disposable devices have performed well in improving surgical safety and reducing infection risks, but they also face high single-use costs. Future development may be to develop more efficient and environmentally friendly disposable or reusable devices to meet different clinical needs and regulatory requirements.

What are the specific cross-infection risks in the disinfection and reprocessing of urological surgical instruments?

There are many cross-infection risks in the disinfection and reprocessing of urological surgical instruments, including the following aspects:

Incomplete instrument cleaning: Because complex instrument structures such as endoscopes contain multiple small and long open channels, these channels are prone to residual microorganisms, secretions and blood. Even if the cleaning and disinfection process is strict, it is difficult to completely eliminate the risk of cross-infection. In addition, more than 70% of some difficult-to-clean instruments such as duodenoscopes, flexible bronchoscopes and cystoscopes have problems with incomplete cleaning, and nearly three-quarters of medical endoscopes are contaminated with bacteria.

Improper disinfection or sterilization: Reusable instruments (such as surgical instruments, endoscopes, etc.) that have not been properly processed must be rigorously cleaned, disinfected or sterilized before contacting patients to remove potentially harmful microorganisms. If these steps are not performed properly, the risk of cross infection will increase.

Insufficient physical isolation: Use special containers to store used instruments and ensure that the instruments are in a closed and safe environment during transportation from the place of use to the place of cleaning to reduce the possibility of environmental contamination. If these measures are not implemented effectively, the risk of cross infection will also increase.

Problems with medical staff operating standards: The operating standards of medical staff directly affect the disinfection effect of surgical instruments. If medical staff fail to operate according to the regulations or the training is insufficient, it will lead to incomplete disinfection, thereby increasing the risk of cross infection.

Specificity of the surgical site: Urological surgery often requires opening the urinary tract or directly inserting an endoscope for surgery, which makes it easier for urinary tract infections that already exist before the operation to spread to the surgical site through surgery, resulting in a higher incidence of postoperative infections.

What are some specific cases of maintenance and repair problems encountered by reusable urological surgical instruments in actual applications?
In actual applications, the maintenance and repair problems encountered by reusable urological surgical instruments are mainly reflected in the following specific cases:

Tissue residues are difficult to clean: Due to the precision design and complex structure of the tool, tissue residues after use are difficult to clean thoroughly, resulting in incomplete disinfection and the risk of cross infection.

Performance degradation and failure risk: After repeated reuse of the tool, there is a risk of performance degradation or even failure in terms of sharpness and flexibility, which affects the efficiency of the operation, prolongs the operation time, increases the pain of the patient, and may lead to treatment effects that are less than expected. In addition, the operator is prone to increase the operation force due to performance degradation, causing uncontrolled operation and medical accidents.

Complicated disinfection and maintenance procedures: Due to the performance degradation after repeated reuse, a large number of meticulous and complex blade cleaning, disinfection and maintenance procedures are required, which not only increases the workload of medical staff, but also consumes the manpower and material costs of the hospital.

Insulation failure and arc phenomenon: During repeated use, especially through frequent puncture and sterilization operations, insulation failure of electrosurgical equipment may occur, and even arcing may occur, causing burns and other injuries to patients and postoperative personnel.

Improper cleaning and sterilization methods: The occurrence of related adverse events may be related to product quality problems, excessive reuse times, and improper cleaning and sterilization methods. Therefore, manufacturers should strengthen quality control to ensure the safety of clinical use of products.

Poor management: Some hospitals do not have a complete system for the management of instruments for laparoscopic surgery in urology. Nurses are not proficient in operating and managing instruments, and there is a phenomenon of disorderly storage of instruments. This management defect also increases the difficulty of instrument failure and maintenance.

These problems show that in actual applications, reusable urological surgical instruments face many challenges, including difficulties in cleaning and disinfection, performance degradation, complex maintenance procedures, potential electrical safety risks, and management deficiencies.

What are the latest guidelines and requirements of the FDA for the reprocessing methods of reusable medical devices?

According to the existing information, the latest guidelines and requirements of the FDA for the reprocessing methods of reusable medical devices are as follows:

Final version of the guideline was released: The FDA released the final version of the guideline for the reprocessing methods of reusable medical devices on March 12, 2024. This industry guide is designed to help medical device manufacturers develop and produce safer reusable medical devices, especially those with a higher risk of cross infection.

Design and testing requirements: FDA requires that the design and testing of reusable medical devices should follow special guidelines and GMP (Good Manufacturing Practice). In addition, FDA believes that such products require special supervision before they are put on the market, with a focus on the safety and effectiveness of the device.

Cleaning confirmation: When developing label instructions for reusable medical devices, you can refer to AAMI TIR 12, AAMI TIR 30, and FDA-approved consensus standards. Cleaning is the removal of dirt by physical means. The cleaning methods and reagents used should be able to effectively remove dirt and meet the requirements of minimizing contamination.

Confirmation of cleaning methods: According to the requirements of FDA guidelines, reusable medical devices should clearly state the cleaning method in the instructions and confirm the cleaning method to prove that the cleaning method can effectively clean the device, ensure further reprocessing, and ultimately make the device safe and reusable.

Reprocessing and validation requirements: Validation data for cleaning, disinfection and sterilization must be submitted in the 510(k) application, otherwise it will be deemed as non-substantially equivalent, resulting in registration failure.

Final Guidance on Remanufacturing: On May 10, 2024, the FDA officially released the final guidance on "Medical Device Remanufacturing" to clarify whether activities performed on devices may be "remanufacturing". This guidance targets activities performed on devices intended for reuse and maintenance, and discusses activities performed on such devices by original equipment manufacturers (OEMs) and third parties.

Guidance on Reprocessing Instructions and Confirmation Methods: The reprocessing instructions should clearly state the method for thorough cleaning, and the level of detail of the cleaning steps should be determined based on the complexity of the device. For devices that are difficult to clean thoroughly or may cause contaminants to remain, the registrant should provide appropriate disassembly diagrams and instructions. In addition, the registrant may choose to use measures such as protective covers to reduce the complexity of the device when cleaning, but should ensure that only legally marketed products are used. For flushable devices, appropriate flushing methods and related accessory information should be provided. The reprocessing instructions should comply with the requirements of infection control management regulations. The applicant should determine the appropriate disinfection or sterilization method based on the scope of application of the device and confirm its compatibility and effectiveness with the device.

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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
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Tel:+86 571 6991 5082
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