Reprocessing Validation

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes.
When used on patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices shall undergo to a detailed "reprocessing" process to clean and then disinfect or sterilize them.
When the labeling instructions for reprocessing are completely and correctly followed after each use of the device, reprocessing results in a medical device that can be safely used more than once in the same patient, or in more than one patient.
For FDA, as for others Competent Authorities in the world, this is a very critical aspect, thus in in 2015 FDA release the specific Guidance that describes how the manufacturers shall Validate the reprocessing activities (Cleaning, disinfection, sterilization) of their reusable Medical devices and how this process shall be described in the labelling, in order to be able to sell the devices on the US market.
Maytal, thanks to more than ten years of experience in validation activities and working with FDA, can support manufacturers of medical devices:
  • to develop cleaning, disinfection and sterilization protocols in line with FDA guidelines
  • it can support the company and/or the laboratory in carrying out the tests and in drafting/checking the report in order to ensure compliance with the FDA requirements
  • it can assist the company in the interaction with FDA during the review of the applicatiom, eg. 510 (k) for any additional information requested