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Reusable medical devicesCleaning, disinfection and sterilization
Microbial principles and aspects
Designing valid processes for cleaning, disinfecting and sterilizing medical devices for reuse
In order to safely reuse a medical device (MD), it is essential to clean, disinfect or sterilize the device prior to its use. It is the manufacturers responsibility to provide guidelines for these processes which will ensure that the patient’s safety is guaranteed during each reuse of the device. There are specific requirements and dedicated standards for each process of...Continue reading
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Issues to be covered
- Introduction
- What is cleaning, disinfection and sterilization?
- The differences between them.
- How do I know what is applicable to my product?
- The relevant standards for each method
- What are the regulatory requirements?
- Device classification and its labeling for the purpose of determining the required disinfection level
- The requirements for conducting valid processes
- Cleaning
- Disinfection
- Approved cleaning and disinfection agents
- Differences
- When and where to use each one?
- Mode of action
- Sterilization methods – why is it essential to clean and disinfect the device before sterilization?
- How to validate a reusable product
- Who is responsible for validating a product of this type?
Who should attend
- Project and R&D managers
- Validation engineers/managers
- Production Managers
- QA and RA managers
- Regulatory consultants
- Hospital’s Sterile supply managers
Benefits to the Participants
At the end of this seminar the participants will understand:
- The basic terms – cleaning, disinfection and sterilization
- The differences between them
- Common sterilization methods used in the industry and hospitals
- Relevant standards
- Regulatory requirements of health authorities in Israel and around the world
- The requirements for designing valid processes to safely reuse medical devices
- Scheduling the development and performing the validation processes
- Safety aspects of using reusable medical devices
About The Lecturer
