News / April 6, 2021
This Five-Part Series has dealt with the FDA’s mandate that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices. “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 Part I of this blog we covered the first two criteria. In Part II we covered the first parts of the FDA’s criteria number three (critical and semi-critical devices). In Part III we finished covering the FDA’s criteria number 3. In Part IV we finished covering the FDA’s criteria number 4. This fifth and final blog in the series will cover the FDA’s criteria number five.
Criterion 5. Reprocessing instructions should be comprehensive.
A well written, easy to understand and comprehensive set of instructions for use should enable reprocessing personnel to comprehend exactly how to implement the entire reprocessing procedure safely and effectively. Based on the unique properties and design for a device or instrument, there may be several different, yet acceptable formats for the instructions that the manufacturer may use.
To ensure the reprocessing instructions are comprehensive, the FDA requires the manufacturer to include all of the elements (A., B. and C.) listed below in their IFU. If any element is not applicable to a manufacturer’s specific device, then the manufacturer must state this fact in their premarket submission to the FDA and provide a valid justification for its exclusion.2
The manufacturer’s IFUs should describe any additional items or accessories that are needed for the safe, effective and thorough reprocessing of the device. If the device or instrument requires any special protection during reprocessing (e.g., valves, plugs or stoppers to prevent the ingress of foreign debris or harsh chemicals), they should be described in detail in the IFU. The FDA specifically requires that “The instructions should also identify any special tools, sizes and types of brushes (including custom brushes), flush port connectors and connector size specifications, trays, test kits, specific types of sterilization wraps or containers, and part numbers, if appropriate. The instructions should also provide sufficient detail so that the user can purchase the correct items, including any custom cleaning accessories, or identify a source for the purchase of such items.”3
The IFU should also include all applicable instructions for point-of-use processing immediately after the device is used and prior to transport. “Instructions for prompt, initial cleaning steps and/or measures to prevent the drying of soil on the device surface prior to cleaning may be appropriate, as this will facilitate subsequent cleaning steps.”4
A good manufacturer’s IFU will seek to minimize or eliminate delays between the various reprocessing steps. Any and all delays incurred during the reprocessing steps may create conditions favorable to microbial growth. Any organic growth on the device will increase the difficulty of the subsequent reprocessing steps (e.g., cleaning, disinfection and sterilization). This is due to the fact that organic contamination on the surface of the device will decrease the penetration rate and effectiveness of a disinfectant or sterilant.
As reusable medical devices have become more complex over the past 20 years, more and more of them have removable parts. If a device has removable parts, then the manufacturer’s reprocessing instructions must include step-by-step instructions for the disassembly and then the reassembly of the device to help the user with the cleaning process. The equipment needed to perform these activities needs to be clearly identified in the IFUs. The FDA encourages manufacturers to incorporate diagrams, photographs, illustrations and/or videos in their IFUs.
According to the FDA “Disassembly and reassembly instructions should be explicit, device-specific, and reflect the validation activities. Expressions such as ‘disassembly, if applicable’ leave the determination of ‘applicability’ to the discretion of the user; such ambiguous language should not be used. If a device must be disassembled for cleaning, the instructions should be validated to assure that proper reassembly can be performed at the appropriate point in reprocessing. The labeling should provide the user with a validated method to verify that reassembly has been properly performed; this is to assure that the device is in operable condition for the next use.” 5
“Instructions should also specify whether to reassemble before or after sterilization. Additionally, disassembly and reassembly instructions should include information to visually inspect the device and components for wear and tear of components that cannot be assessed in the fully assembled configuration. If reassembly is to be performed by the surgeon and is described in the surgeon’s manual, then reference to this should also be made in the reprocessing instructions.”6
It is vital for patient safety to remember that the FDA’s ridged 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 are used on patients everyday have never had their cleaning IFUs validated. Accordingly, it is up to hospital personnel to request ‘validated’ cleaning IFUs from all of your reusable device and instrument suppliers.
Elmed Incorporated is an American* manufacturer and distributor providing the medical industry and its many specialties with quality products.
Elmed Incorporated is a wholly owned American company and is not associated with any other “Elmed” company based outside the United States.