Medical devices - Re-processesing

Validation of Cleaning and Disinfection Methods for Reprocessing Medical Devices

Are you facing new requirements to document your cleaning and disinfection methods?

As a manufacturer of reusable medical devices, you are likely experiencing increasing requirements from regulatory authorities and customers.

There is also a growing focus on ensuring documentation of biological safety throughout the entire product life cycle (End-of-Life), where documentation of reprocessing is essential for compliance and patient safety.

This means you must be able to document both the effectiveness of your cleaning and disinfection methods—and understand how repeated reprocessing affects the properties and biocompatibility of your materials.

Are you facing any of these challenges?

• Require of documentation that your cleaning and disinfection processes are effective
• Need to understand how repeated reprocessing affects material properties and biocompatibility
• Difficulty ensuring consistent and effective reprocessing
• Requests from customers, such as hospitals, for specific documentation before purchase or use
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Validation of cleaning methods and disinfection methods for medical devices is our specialty.

We develop tailored solutions based on your specific needs, ensuring that you comply with all applicable standards for documentation and patient safety.

How can the Danish Technological Institute help you?

• Guidance on cleaning and disinfection requirements for medical devices according to national and international standards and guidelines
• Documentation of manual cleaning and disinfection of medical devices
• Advisory and optimisation of your cleaning and disinfection methods
• Support in selecting or optimising cleaning and disinfection agents
• Analysis of the impact of repeated reprocessing on materials and verification of biocompatibility

Contact us today if you need help to achieve documentation cleaning and /or disinfection of your medical device.