The New Scope Of Reusable Device Cleaning Validations

By Patrick Kenny

Medical device manufacturers are using advances in technology to create devices that are changing the healthcare world. Along with these advances comes increased device cost as the designs, materials, and manufacturing techniques become more complicated. The cost associated with many of the devices used in today’s healthcare facilities has led to the need for the devices to be reused many times during their lifetimes. Many healthcare facilities are equipped with reprocessing departments that decontaminate the devices, clean them, and then perform disinfection or sterilization prior to their next use.

Labeling of medical devices is regulated under 21 CFR Part 801. Under these regulations, it states that a device must have adequate directions for use. With reusable devices, specifically, these directions for use need to include instructions for processing prior to use on the next patient. Typical processing steps include cleaning to remove tissue and blood debris (referred to as patient soil), testing of device performance and, finally, disinfection or sterilization. With each of these steps, the instructions for use (IFU) must be clearly written using language that anyone can follow, and must refer to materials and equipment that is available to the device user.

A validation of the cleaning procedure to remove residual patient soil must be completed by the device manufacturer. This validation should be part of the submission package and will be examined by the U.S. Food and Drug Administration (FDA) during its review. The goal of a cleaning validation is to prove that when the instructions in the IFU are followed, the residual soil levels on the device will have been reduced to acceptable levels. It is important to note that completion of a successful cleaning validation alone does not ensure that devices reprocessed by the end user are clean. The end user’s ability to perform the cleaning by understanding and following all the steps in the IFU is vital.