Customized Request Rigid Pike Mouth Grasping Forceps for Urology Surgical Instruments

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 Packing & Shipping:

FAQ

What are the regulations and compliance requirements for urological surgical instruments?

The regulations and compliance requirements for urological surgical instruments mainly involve the following aspects:

Product standards and certification:

According to the "Pharmaceutical Industry Standards of the People's Republic of China" (YY/T 0506.8-2019), surgical instruments need to meet the specifications of design, performance, structure and folding, including sterilization requirements and biological requirements, such as sterility assurance and ethylene oxide residual limit.
Surgical instruments must pass relevant certifications, such as European CE certification, US FDA or equivalent Indian standard certificates, and meet ISO9001-2008 standards.
Use and management:

The relevant instruments of urological endoscopic diagnosis and treatment technology shall not illegally reuse disposable medical devices, and a registration system shall be established to ensure that the source of the instruments can be traced.
In the operating room, the PDCA management model is used to manage urological surgical instruments and equipment, which can standardize the instrument use process, reduce the number of failures, and extend the service life of the instrument.
Registration review and technical guidelines:

For specific surgical instruments, such as ureteral guide sheaths, there are special registration review guidelines. These guidelines specify the sterile supply and single-use requirements of the products.
The technical delivery conditions of surgical instruments should meet market requirements, normative requirements, and the requirements of the EU Medical Device Regulation (2017/745), the Medical Device Directive (93/42/EG), MPG and DMPG.
Training and qualification requirements:
Physicians who perform level 4 urological endoscopic diagnosis and treatment technology must have no less than ten years of clinical experience and have professional and technical qualifications above the level of deputy chief physician. They must also undergo systematic training and pass the assessment at the level 4 urological endoscopic diagnosis and treatment technology training base designated by the National Health and Family Planning Commission.
Equipment configuration and access standards:
When applying for the first configuration of large medical equipment, medical institutions must meet certain annual surgical volume and technical conditions. For example, the annual surgical volume of public medical institutions should not be less than 20,000 units in principle, and urology, thoracic surgery, cardiac surgery, general surgery or gynecology should be in a leading position in the city.
Safety and tracking:
Hospitals must develop comprehensive processes to identify, report and investigate serious events related to implanted devices and submit summaries of all reports to the FDA. In addition, the implantation of specific devices in patients must be recorded at multiple locations, and this task is the responsibility of the risk manager.
The safety and effectiveness of urological surgical instruments can be ensured through the comprehensive management of the above multiple aspects and strict compliance with relevant regulations and standards.

What are the differences in the regulations and certification requirements for urological surgical instruments in different countries (such as the United States and the European Union)?

There are significant differences in the regulations and certification requirements for urological surgical instruments between the United States and the European Union.

In the United States, the FDA (Food and Drug Administration) classifies and manages medical devices. According to their risk level, medical devices are divided into Class I, II and III. Among them, Class I medical devices such as diagnostic gloves and handheld surgical instruments belong to the lowest risk category and usually require a 510(k) pre-market notification to prove that they are as safe and effective as devices already on the market. For Class III high-risk devices, the FDA adopts a more stringent pre-market approval (PMA) procedure, which requires a detailed safety and effectiveness review.

In contrast, the EU's medical device regulatory system is more complex and stringent. As of May 26, 2021, all EU member states and European Economic Area (EEA) member states must comply with the new Medical Devices Directive (MDR) and In Vitro Diagnostic Medical Devices Directive (IVD). These regulations require manufacturers to pass a series of conformity assessment procedures and obtain the CE mark before they can put their products on the market. MDR emphasizes higher safety standards and requires all medical devices to be recertified, regardless of whether they are already on the market. In addition, the EU also has independent Notified Bodies responsible for independent certification and auditing of the product's quality system.

Specifically for urological surgical instruments, the EU divides them into four levels: Class I, Class IIa, Class IIb, and Class III. For example, all invasive devices related to body orifices and intended for drug administration by inhalation, except for invasive surgical devices, are classified as Class IIa. This means that different levels of devices need to meet different regulatory requirements to ensure their safety during use.

In summary, US medical device regulations mainly rely on the FDA's classification and approval procedures, while the EU ensures the safety and effectiveness of medical devices through more stringent MDR and IVD directives and independent Notified Bodies.

How to implement the PDCA management model to improve the efficiency and safety of urology equipment?

In order to improve the efficiency and safety of urology equipment, the PDCA management model can be implemented. The following are the detailed steps:

1. Planning stage (Plan)
Determine goals and solutions:

Clearly define specific goals for improving efficiency and safety, such as reducing equipment failure rates and improving the skills of operators.
Develop a detailed action plan, including resource allocation and time schedule.
Analyze the current situation and find out the problems:

Comprehensively evaluate the current use of urology equipment and collect data to identify existing problems and challenges.
Use tools such as brainstorming to analyze the various causes or influencing factors of quality problems.
2. Execution stage (Do)
Implement improvement measures:
According to the planned plan, start implementing specific improvement measures, such as regular maintenance and inspection of equipment, updating operation manuals, and providing training to operators.
Ensure that all relevant personnel understand and comply with new operating procedures and standards.
3. Check stage (Check)
Evaluate the improvement effect:
Regularly evaluate the use of equipment and feedback from operators to check whether the expected goals have been achieved.
Use statistical methods and data analysis tools to monitor the operating status of the equipment and the skill level of the operator.
IV. Processing stage (Act)
Adjustment and optimization:
According to the results of the inspection stage, make necessary adjustments and optimizations to the plan.
If it is found that some measures have not achieved the expected results, re-plan and continue to implement the new plan.
Continuous improvement
Use the PDCA cycle as a continuous quality improvement process, and repeat the above four stages to achieve continuous optimization and improvement of urological surgical equipment management.
What are the special registration review guidelines for specific types of urological surgical instruments (such as ureteral guide sheaths)?
For specific types of urological surgical instruments, such as disposable ureteral guide sheaths, the Medical Device Technology Review Center of the State Food and Drug Administration has issued special registration review guidelines. These guidelines are intended to help and guide applicants in the preparation and writing of registration application materials for disposable ureteral guide sheaths, and provide technical references for medical device technology review departments.

Specifically, these guidelines include the following:

Product structure and composition: The applicant should clarify the structure and composition of the product and provide corresponding structural diagrams. Identify the names, important dimensions and measurement locations of each component of the product in the diagram.

Scope of application: These guidelines apply to the disposable ureteral guide sheath in the entry of classification code 02-12-03 (02 passive surgical instruments-12 surgical instruments-puncture guides-03 delivery guides) in the "Medical Device Classification Catalog", and the management category is Class II. The product is used to establish a channel for endoscopes and other instruments to enter the urinary tract during urological surgery.

General requirements for registration application materials: The applicant should fully explain and refine the content of the registration application materials based on the characteristics of the specific product, and determine whether the specific content is applicable based on the characteristics of the specific product. If not applicable, the reasons and corresponding scientific basis should be specifically explained.

Draft for comments: In addition, there is a draft for comments on the registration technical review of disposable ureteral guide sheaths, which further provides technical guidance and review references.

In urological surgery, how to effectively manage and track the risks associated with implant devices?

In urological surgery, effective risk management and tracking of implant devices requires comprehensive consideration of multiple aspects. Here are the detailed steps and methods:

Medical institutions should conduct systematic risk assessments to determine the appropriate procedures and timing for removing, monitoring and managing implantable medical devices. This includes regular patient checks to ensure that the device and access points are protected from exposure to potentially pathogenic microorganisms, and closely monitoring the patient, insertion site and device for signs of infection.

Evaluating how the device interacts with the body is one of the key steps in determining device safety. Surface chemistry is important for the biological performance of implantable devices. A risk-based biocompatibility assessment framework can help manufacturers establish the safety and effectiveness of absorbable implants.

For active implantable medical devices, especially those used in magnetic resonance imaging (MRI) environments, specialized safety evaluations must be conducted. For example, the Shanghai Institute of Medical Device Inspection has established a one-stop MRI evaluation center covering all types of implants, and has strengthened research in this field by building a team of professional talents in simulation, MRI safety, implant performance safety, etc., purchasing advanced instruments and independently developing test tools, radio frequency systems and other equipment.

During the product registration and technical review process, active devices must comply with mandatory standards, such as GB16174.1-2015 "Surgical Implants-Active Implantable Medical Devices-Part 1: General Requirements for Safety, Labeling and Information Provided by the Manufacturer". In addition, the standard guide for the evaluation of absorbable polymer implants also provides general guidelines for chemical, physical, mechanical, biocompatibility and preclinical evaluation.

Surgeons must fully understand the application method and recommended surgical techniques of any device when using it to avoid the risk of loosening or displacement caused by incorrect implantation. Disposable surgical instruments must not be reused, and implants should be protected from scratches and scratches, as these factors may cause device failure.

It is not uncommon to perform revision surgery after surgery, so postoperative care and follow-up are essential. Medical institutions should develop appropriate processes and policies to regulate the use, maintenance and removal of implantable medical devices.

What are the annual surgical volume and technical requirements for the first configuration of large medical devices in medical institutions?
The "Notice on Access Standards for Class B Large Medical Equipment Configuration" issued by the Beijing Municipal Health Commission stipulates that the annual surgical volume of public medical institutions applying for the first configuration shall not be less than 20,000 units in principle. For medical institutions with strong urology, thoracic surgery, cardiac surgery, general surgery or gynecology that are in a leading position in the city, at least two specialties of comprehensive medical institutions and at least one specialty of specialized medical institutions shall meet the following conditions: more than 10 years of clinical diagnosis and treatment and more than 5 years of laparoscopic surgery, with at least 50 beds; the average annual number of routine surgeries in the past three years is greater than 1,000, of which laparoscopic surgeries account for more than 1/3.

Therefore, the annual surgical volume requirement for the first configuration of large medical equipment by medical institutions is not less than 20,000 units, and the technical conditions include but are not limited to: more than 10 years of clinical diagnosis and treatment, more than 5 years of laparoscopic surgery, at least 50 beds, and more than 1,000 cases of routine surgery in the past three years, of which laparoscopic surgery accounts for more than 1/3.

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