Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling part4

Validation of Reprocessing Methods in Accordance with
        the Quality System Regulation

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).  Manufacturers must also
establish and maintain procedures for monitoring and control of process parameters for validated
processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b).
Establishing procedures includes implementation.  21 CFR 820.3(k).  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.  Please note that exemption from 510(k) does not mean a device is
exempt from compliance with labeling or Quality System (QS) requirements.  Some devices are
specifically exempted by regulation from most QS requirements.  Manufacturers should refer to
applicable regulations for their specific device type to determine what QS requirements apply.

It is possible that similarities in design, materials, and other factors may allow for establishing
product families (e.g., devices with a range of available sizes) for the purpose of minimizing
reprocessing validation efforts. That is, it may be possible to establish that validation data for the
most difficult to reprocess devices in a family (i.e., the worst case device or “master device”)
covers devices that present an equivalent or lesser reprocessing challenge. If this method is
utilized, all design features of the less difficult to reprocess devices in a family, such as lumen
length and diameter, materials, configuration, and texture relevant to reprocessing challenges of
the subject device should be evaluated and assured to be less challenging to reprocessing than the
master device. Any changes in design or materials that could affect sterilant penetration or
potency may result in a need to revalidate.  If a master device is used, supporting information for
the justification should be well documented.

For devices that are subject to design controls under 21 CFR 820.30, the device design, including its labeling (e.g., reprocessing instructions) is to be validated to ensure that the device conforms to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. The human factors methods used should ensure that the

characteristics of the user population and operating environment are considered, in accordance with 21 CFR 820.30(g). See Section V.C. of this guidance for more information about human factors in developing reprocessing instructions.

Cleaning, disinfection and sterilization processes should be validated to provide a high degree of
assurance that a device will consistently meet predetermined specifications, in accordance with

21 CFR 820.75.