Reprocessing Validation for Reusable Medical Device

Many regulatory authorities have issued guidelines or adopted standards for reprocessing validation of reusable medical devices.

Manufacturers of reusable medical devices should include following information as appropriate in market application:

A complete and detailed instructions for reprocessing.

A validation report providing objective evidence that the reprocessing instructions provided by the manufacturer can achieve the expected performance.

Medical devices requiring reprocessing validation include:

Reusable medical devices initially supplied as sterile to the user and requiring the user to reprocess (i.e., clean and disinfect or sterilize) the

device after initial use prior to the subsequent patient use.

Reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., clean, clean and disinfect, or clean and sterilize) the device for initial use, as well as to reprocess the device after each use.

Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.

Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

Applicable devices include, but are not limited to:

Endoscopes, ultrasonic scanners, various reusable electrodes, orthopedic surgical tools, dental tools, thermometers and etc.

Our Services:

Disinfection validation (manual and automated method)

Cleaning validation (manual and automated method)

Sterilization validation (steam, chemical, and low-temperature plasma)