Clients, please be aware of the final release of the guidance document for reprocessing of medical devices. Earlier this month news came out of a fatal bacterial infection at UCLA Medical Center. The infection was spread by an endoscope, a type of reusable medical device. This sparked discussion around the topic of what role the manufacturer plays in reducing the spread of infection for reusable medical equipment. Fortunately FDA finalized a guidance specific to this topic.
Manufacturers’ role explained:
When thinking about reusable medical devices, manufacturers should consider designs that facilitate easy and effective cleaning, as well as any necessary disinfections or sterilization by the end user.
Beyond design, manufacturers have an important role in ensuring the safe and effective reprocessing of the device. Manufacturers of reusable devices should provide adequate labeling that includes instructions for reprocessing devices and device accessories safely and preparing them for reuse. In the labeling, manufacturers should identify for users the materials and equipment, including reprocessing supplies with part numbers, if applicable, that will be needed to reprocess the devices. Manufacturers should maintain in the Device Master Record and/or Design History File, as appropriate, documentation of tests that were performed to demonstrate that the reprocessing instructions have been validated, are complete and understandable, and can reasonably be implemented by the user.
Some of the criteria that FDA listed for reprocessing instructions:
- Labeling should reflect the intended use of the device.
- Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
- Reprocessing instructions should indicate the appropriate microbicidal process for the device.
All cleaning, disinfection, and sterilization methods should be validated, and validations should be completed prior to submission of your pre-market submission.
For further information, please review the guidance document: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
? Email us at email@example.com if you have any questions regarding reprocessing requirements for submitting a 510(k) for a reusable device. Ref: Reprocessing of medical devices