Medical Devices Reg./ Record No. Zxzz20152220578 Hysterectomy Set Morcellator

The Morcellator attached instruments include Cutting tubes, Obturator, Trocar sleeve, Dilator, Guiding bar, Convertor, Uterine forceps. To suit the needs of every procedure the model range of the Morcellator consist of instruments with three different diameters. They are available in diameter 10, 15 and 18 mm. By carefully composed and aligned instruments and accessories the system as a whole delivers excellent results at morcellation and guarantees for maximum safety at operation.

FAQ

What is the disinfection and sterilization process of minimally invasive surgical instruments?

Technical Specifications for Disinfection of Medical Institutions

Guidelines for Cleaning, Disinfection and Sterilization in Hospitals

April 6, 2022

Disinfection and Quality Control under the New Normal

Current Status and Management Countermeasures of Disinfection in Medical Institutions

The disinfection and sterilization process of minimally invasive surgical instruments includes the following steps:

Cleaning:

First, place the minimally invasive needle in the basket and rinse with running water to remove contaminants.

Then inject washing water and medical detergent (or enzyme-containing detergent), control the water temperature below 45°C, and soak for 3-5 minutes.
Use a brush or ultrasonic cleaner to scrub thoroughly, especially joints, gaps, alveoli and other parts should be opened or disassembled as much as possible to ensure thorough cleaning.

Rinse:

Rinse with clean water after cleaning and dry.

Needle repair and finishing:

Wipe the needle with an ethanol cotton ball to remove stains and adjust the needle according to the degree of bending. Needles that are severely bent or have barbs or burrs should be discarded.
Place the cleaned instruments in categories and place them in gauze pads, plastic packaging or glass syringes.

Sterilization:

For moisture-resistant and heat-resistant instruments, pressure steam sterilization is preferred. The specific operation is to place the instrument package in a high-pressure steam sterilizer, sterilize it at 134°C, and record the parameters during the sterilization process.
For instruments that are not heat-resistant or moisture-resistant, low-temperature sterilization methods such as ethylene oxide gas sterilization or dry heat sterilization can be used.

Storage:

Sterilized surgical instruments should be classified and stored in sterile storage areas. Wash or disinfect your hands before contacting sterile items.
The temperature and humidity of the storage environment must meet the standards and must be used within the validity period. Instruments that have exceeded the validity period need to complete the disinfection and cleaning steps again.

Distribution:

The distribution of surgical instruments should follow the first-in-first-out principle, confirm the validity of sterile items and the integrity of the packaging, and the instruments used to transport surgical instruments should be cleaned and stored dry after use.
The entire process must strictly comply with relevant specifications and standards to ensure that each step meets the sterility requirements, thereby ensuring the safety and health of patients.

What are the latest international standards for disinfection and sterilization of minimally invasive surgical instruments?

The latest international standards cover multiple aspects of disinfection and sterilization of minimally invasive surgical instruments. Here are some key standards:

ISO 17665:2024: This standard specifies the requirements for moist heat sterilization processes for medical devices to ensure that they have appropriate microbiocidal activity. It covers general quality management system requirements for design, development, production, installation and maintenance, and emphasizes the control of factors such as the microbiological status of raw materials or components, cleaning and disinfection procedures, manufacturing environment, equipment and personnel hygiene.

ISO/TS 22421:2021: This is a technical specification for general requirements for sterilizers for terminal sterilization of medical devices in medical institutions. It provides high-level overall requirements and corresponding test methods, and lays the foundation for further development of more detailed standards.

ISO 22441:2022: This standard defines the requirements for the development, validation and routine control of low-temperature steam hydrogen peroxide (VH2O2) sterilization processes for medical devices. It does not apply to the product itself, that is, there is no direct contact between the environment and the product at any stage in the sterilization room.

ISO 25424:2018: This standard specifies the requirements for the development, validation and routine control of low-temperature steam and formaldehyde sterilization processes for medical devices, aiming to ensure that microbial contamination is minimized before sterilization.

How to effectively evaluate the efficiency and safety of the disinfection and sterilization process of minimally invasive surgical instruments?

Effectively evaluating the efficiency and safety of the disinfection and sterilization process of minimally invasive surgical instruments requires comprehensive consideration of multiple aspects, including the selection of sterilization processes, the implementation of operating procedures, quality control measures, and monitoring and feedback mechanisms. The following is a detailed evaluation method:

Select appropriate sterilization methods according to the material and use environment of the instrument, such as pressure steam sterilization, ethylene oxide sterilization, etc., and strictly control the parameters to meet quality requirements. For example, for reusable medical devices, it is recommended to use steam sterilization parameters that meet the AAMI ST79 standard and ensure that their effectiveness is verified on specific equipment.

Develop strict sterilization operating procedures, including pre-operation inspection of the sterilizer, record the standby status of the printing device, ensure that the sterilization cabinet door is sealed, etc., to ensure the disinfection effect. In addition, it is necessary to check the operating parameters and sealing of the medical heat sealer every day, and formulate monitoring indicators and control systems for the incidence of wet packs.

In the confirmation of microbial performance, biological indicators or active spore suspensions should be placed in the most difficult to sterilize part of the product, and the microbial kill rate in the sterilization load should be proved. Physical performance confirmation includes checking whether the parameters such as temperature, humidity, and pressure of the sterilizer meet the specification requirements, as well as whether the pretreatment time and the amount of gaseous ethylene oxide used are appropriate.

When the device is contaminated, the contaminated area should include the most difficult to sterilize part of the device, and the reasons for identifying and proving the most difficult to sterilize part of the device should be documented. The effectiveness of the sterilization process is verified by contamination testing, and the amount of recovered bacteria is recorded to evaluate the sterilization effect.

Regularly review the data on the effectiveness of the cleaning/purification process to confirm that the process is still effective and can sufficiently reduce the bioburden of the device to prepare for the subsequent sterilization process. Establish appropriate policies and procedures to ensure that medical devices are fully decontaminated before sterilization.

Strengthen the inspection of sterilization and disinfection work in the sterilization supply center, conduct regular evaluations of organizations and individuals, strengthen personal responsibility, ensure the smooth implementation of the system, timely detect problems, and quickly repair and improve them. Record each monitoring result in detail as a reference for future research to ensure continuous improvement of quality.

Implement standardized surgical instrument cleaning processes, improve the takeover system, inspection system, error reporting system, etc., to reduce the probability of omissions. Statistical surgical instrument cleaning, packaging and sterilization pass rates, and record the sterility test pass rate once as an evaluation standard.

After the pasteurization cycle, use a high-efficiency particulate air filter (HEPA) to thoroughly dry the equipment, and record the content, temperature and time of each pasteurization cycle.

What are the comparative studies on the sterilization effect of minimally invasive surgical instruments at different temperatures?

The comparative study on the sterilization effect of minimally invasive surgical instruments at different temperatures mainly involves the following methods: pressure steam sterilization, low-temperature plasma sterilization and ethylene oxide sterilization. These methods have conducted detailed studies on the sterilization effect of laparoscopic instruments under different temperature conditions.

Pressure steam sterilization:

This method uses high-pressure steam for disinfection and sterilization, and is suitable for heat-resistant and moisture-resistant surgical instruments. Its advantages are no pollution, no residue and no damage, but it may cause secondary pollution.
Studies have shown that sterilization at 121°C for 10 minutes can effectively kill spores of Clostridium tetani and Clostridium perfringens.
Pressure steam sterilization has obvious advantages in time, cost and safety, and is suitable for sterilization of heat-resistant and moisture-resistant laparoscopic instruments.

Low-temperature plasma sterilization:

Low-temperature plasma sterilization is suitable for surgical instruments that are not heat-resistant and moisture-resistant. This method is pollution-free and residue-free, but it may cause secondary pollution and irritate the eyes, respiratory tract and skin of medical staff.
Low-temperature hydrogen peroxide plasma sterilization has shown good results in clinical applications, but its cost and safety issues need to be noted.

Ethylene oxide sterilization:

Ethylene oxide sterilization is also suitable for surgical instruments that are not heat-resistant or moisture-resistant. However, its killing effect on bacteria is weak and it can only effectively kill fungi.
Due to the particularity of ethylene oxide, it is usually used for sensitive instruments that cannot withstand high temperatures or high pressures.
Based on the above information, sterilization methods at different temperatures have their own advantages and disadvantages. Pressure steam sterilization is the first choice because of its high efficiency and safety, especially for heat-resistant and moisture-resistant instruments; while low-temperature plasma sterilization is more suitable for those instruments that are not heat-resistant or moisture-resistant, although it may bring the risk of secondary contamination; although the scope of application of ethylene oxide sterilization is limited, it still shows certain effects in specific cases.

What innovative sterilization technologies are there for minimally invasive surgical instruments that cannot be sterilized by pressure steam?

For minimally invasive surgical instruments that cannot be sterilized by pressure steam, there are several innovative sterilization technologies available:

Hydrogen peroxide low-temperature plasma sterilization: This technology uses hydrogen peroxide as a disinfectant and sterilizes at low temperatures. Although this method produces a slight disinfectant residue, it is less irritating to the eyes, respiratory tract and skin of medical staff. In addition, it can extend the service life of the instrument, especially for laparoscopic instruments that are not heat-resistant and moisture-resistant.

Ethylene oxide sterilization: Ethylene oxide is an effective disinfectant for instruments such as permanent pokers and permanent graspers that are resistant to high temperatures and pressures. Although this method takes a long time and has certain potential hazards to medical staff and patients, it is necessary in some cases.

Hydroxy free radical sterilization technology (PlazMax): This is a method that uses hydrogen and plasma to kill microorganisms. The device achieves residue-free sterilization by injecting hydrogen vapor into the chamber and converting it into plasma, providing an efficient, reliable and affordable way to sterilize. This method is suitable for small operating rooms or large central sterilization service departments (CSSDs) and has an easy-to-use touchscreen interface and remote monitoring capabilities.

Cold sterilization method: For heat-resistant surgical supplies, such as pacemakers, artificial heart-lung machines, artificial valves, etc., only cold sterilization methods or chemical sterilization can be used.

What are the common problems and solutions in the disinfection and sterilization process of minimally invasive surgical instruments?

In the disinfection and sterilization process of minimally invasive surgical instruments, the common problems and their solutions are as follows:

Incomplete cleaning:

Problem: Many complex medical devices are difficult to clean thoroughly, resulting in residual organic matter and microorganisms.

Solution: Use ultrasound combined with multi-enzyme solution for pretreatment to improve the cleaning effect
. In addition, methods such as coagulant inhibitors and detergents combined with proteolytic enzymes can be used to prevent organic matter from solidifying.

Incorrect configuration or improper use of disinfectants:

Problem: Incorrect disinfectant concentration or improper use method leads to poor sterilization effect.
Solution: Strictly configure according to the product instructions of the disinfectant, and regularly train medical staff to use disinfectants correctly.

Risks of rapid sterilization procedures:

Problem: Rapid sterilization procedures shorten the cold air exhaust time and drying time, and may not completely kill microorganisms.
Solution: Avoid routine use of rapid sterilization procedures, especially for laparoscopic instruments, and ensure conditions such as single packaging, low temperature and vacuum drying oven.

Maintenance and management of sterilization equipment:

Problem: Sterilization equipment such as small pressure steam sterilizers and peracetic acid sterilization systems have malfunctions or improper maintenance, affecting the sterilization effect.
Solution: Regularly check and maintain sterilization equipment to ensure its normal operation. For peracetic acid sterilization systems, special disinfectant powders must be provided and the concentration and water temperature must be controlled.

Environmental control and personnel management:

Problem: Excessive bacterial counts in the air of the operating room and improper operation by medical staff will affect the sterile environment.
Solution: Strengthen environmental control in the operating room and control the number of bacteria in the air; strictly abide by aseptic operating procedures to reduce hand contact by medical staff.

Handling of special instruments:

Problem: Complex instruments such as flexible endoscopes are difficult to clean and disinfect thoroughly.
Solution: Use a variety of methods such as ethylene oxide, low-temperature hydrogen peroxide plasma, low-temperature formaldehyde vapor and chemical immersion for sterilization.

Quality Control and Continuous Improvement:

Problem: Lack of effective quality control and continuous improvement mechanism leads to unstable disinfection and sterilization effect.
Solution: Establish a sound quality management system, regularly monitor and evaluate the disinfection and sterilization effect, and continuously optimize the process based on the results.

For more photos and details please contact me:
Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Sue
Tel:+86 571 6991 5082
Mobile: +86 18268061177