Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Part1

General Considerations for Reusable Medical Devices

A.     Design of Reusable Medical Devices

Manufacturers of reusable devices should consider device designs that facilitate easy and
effective cleaning, as well as any necessary disinfection or sterilization by the users.
Some 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). From the earliest stages of device design and
engineering, manufacturers should consider alternative designs to facilitate effective
reprocessing (e.g., replace features that are challenging to reprocess with single-use parts;
include flush ports; specify and/or provide dedicated cleaning accessories).

B.      Ensuring the Safety of Reusable Medical Devices

Manufacturers of reusable devices and accessories, as well as their users, have important
roles to play in ensuring the safe and effective reprocessing of medical devices.
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. The labeling should also clearly specify the appropriate
material and equipment parameters to adequately reprocess the devices, as well as
materials and equipment that are readily available to users. FDA encourages users to
ensure that they have the facilities, equipment, and easy access to manufacturer-specified
cleaning, sterilization/disinfection agents to implement the instructions, and that the
instructions are followed.

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.  The Device Master Record must comply with the requirements of 21 CFR 820.181; the Design History File must comply with
requirements of 21 CFR 820.30(j).