Manufacturer Validation of Cleaning IFUs? (Part VI)
In Part I of this blog, we discussed the FDA’s mandate issued on March 17, 2015, that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices. According to the mandate, the “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.”1
As part of their requirement for manufacturers to validate their cleaning instructions for use (IFUs), the FDA has established six general criteria for all reprocessing instructions. In Parts I through IV of this series we covered the first four criteria. In Part V, we covered sections A to C of the FDA’s criteria number 5. This blog will cover the rest of the FDA’s criteria number 5.
D. Method of Cleaning
“The labeling should provide a detailed, validated method of cleaning. The method may be manual or mechanical (e.g., washer, washer/disinfector, ultrasonic washer) or may combine the two. However, manufacturers should be aware that some small health care settings may not have automated cleaning equipment; therefore, validated manual cleaning instructions may be needed.”2
The manufacturer’s cleaning instructions should also include a list of the appropriate parameters for each recommended method. More specifically, for manual cleaning, “The labeling should specify the duration of each processing step, as well as temperatures, water quality, and other necessary conditions. Repeated actuations, flexures, and manipulations should be specified, where appropriate, based on device design and validation activities.”3
For automated cleaning, the manufacturer’s labeling should specify all processing conditions just as they are specified for manual cleaning. The instructions should list all equipment settings including, but not limited to, time, temperature, and maximum device load size.
“Whether the cleaning method is manual, automated, or a combination of the two, the labeling should contain comprehensive directions, including photographs and/or diagrams, if appropriate, for each cleaning, rinsing, and drying step so that users can accurately follow the steps or program them into the device washer or washer/disinfector. “4 The recommendations for the use of detergents, enzymatic cleaners, and automated cleaning cycles must also be consistent with the product manufacturer’s directions for use for those products.
The FDA also requires manufacturers to provide in their validated cleaning instructions information on how to avoid damage to their device(s) during routine decontamination, cleaning and reprocessing. To avoid product damage during reprocessing, the FDA requires that “For a device whose internal components are not contaminated during clinical use but could be damaged by contact with liquids (e.g., cleaning agents, disinfectants), surface cleaning instructions should describe how to adequately clean the device and prevent contact with internal device components that are not designed for contact with liquids.”5
E. Cleaning Agents
The instructions should recommend only cleaning agents or classes of agents (quaternary ammonium compound detergents, enzymatic detergents, etc.) that were used during the cleaning validation studies, that have been demonstrated to be compatible with the device, and are effective in cleaning the device.
“Labeling should include instructions for the preparation and use of those agents (e.g., mix one ounce of detergent per gallon of water), or refer to the cleaning agent labeling for preparation and use instructions (e.g., according to the detergent manufacturer’s instructions). Labeling for use on specific medical devices should be consistent with the cleaning agent manufacturer’s instructions for use of the product.”6
Certain products may be used for both cleaning (removal of soil) and disinfection (inactivation of microbes). Other products are capable of only performing one of these two functions. “The instructions for use should address both cleaning and disinfection if both are intended, and should be clear regarding the difference between cleaning and disinfection, and the products used for each step.”7
It is vital for your patients’ safety to remember that the FDA’s requirements for the ‘validation’ of cleaning instructions for use only applies to new products that have been approved in the last few years. The vast majority (over 98%) of the reusable medical devices and instruments that you use on your patients everyday have never had their cleaning IFUs validated. Accordingly, it is up to you and your staff to request ‘validated’ cleaning IFUs from all of your reusable device and instrument suppliers.
Read this series from the start here.References
- FDA Report “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015
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