Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The U.S. Food and Drug Administration recently published a final guidance focusing on reprocessing of reusable medical devices. The new recommendations contained in the guidance are intended to help manufacturers develop safer reusable devices.

Medical devices intended for repeated use are commonplace in health care settings and can include simple manual surgical instruments to more complex electro-mechanical assemblies. They are typically made of durable substances that can withstand reprocessing, however more complex device designs present particular challenges to cleaning and cleaning validation (e.g., shaft-within-lumen configurations, elevator channels, fine channels, seals and mated articulating surfaces).

The FDA guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. The scope of the guidance includes devices that fall into any of the four reprocessing situations below.

1. 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.
2. 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.
3. Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.
4. Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

FDA believes that a device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists the following six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions:

1. Labeling should reflect the intended use of the device.
2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
5. Reprocessing instructions should be comprehensive.
6. Reprocessing instructions should be understandable.

The guidance also recommends that manufacturers consider reprocessing challenges early in device design. For class II and class III devices and select class I devices, manufacturers must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses. 21 CFR 820.30(g). FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended. FDA recommends these validation activities demonstrate the following:

1. That the methods (manual or mechanical) are adequate to allow the device to undergo further processing and to eventually be reused safely.
2. That the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

All cleaning, disinfection, and sterilization methods should be validated, and validations should be completed prior to submission of a pre-market submission. The reprocessing instructions should reflect the validated methods. FDA identifies the following reprocessing information to be contained in the following pre-market submissions:

510(k): A 510(k) should include proposed labels and labeling sufficient to describe the device, its intended use, and the directions for its use including reprocessing instructions.

PMA, HDE, De Novo: A PMA, HDE or de novo request should include the protocols and complete test reports of the validation of the reprocessing instructions in the manufacturing and design section.

IDE: An IDE application must include a report of all prior clinical, animal, and laboratory testing of the device as part of the report of prior investigations including a summary of the validation testing of the reprocessing instructions.