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What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part I)

The FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). These IFUs are supposed to provide reprocessing personnel with the necessary information and steps to safely and thoroughly reprocess reusable medical devices and surgical instruments. Included in every IFU are specific instructions on how to properly decontaminate and clean the device prior to sterilization.

Over the past forty years, the FDA has taken an ever increasing interest in reusable device IFUs and their impact on patient safety. The FDA’s concern with the content and the validity of manufacturers’ IFUs was codified on March 17, 2015 when the FDA issued “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationand).

In Section VII of the FDA report, Validation of Reprocessing Methods in Accordance with the Quality System Regulation, the report states:

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). 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.

Regretfully, the FDA did not make this new requirement for manufacturers to validate their IFUs retroactive. Specifically, the FDA’s IFU validation requirement only applies to new product 510(k) submissions to the FDA. This means that almost all of the tens-of-thousands of surgical instruments that are used in patients every day have never had their cleaning and sterilization IFUs validated to prove that they actually work.

“It’s the sad reality of what people in CS/SPD face — they are held accountable for returning clean, sterile, moisture-free instruments up to the OR and yet they are dealing with instruments whose cleaning IFUs have never been validated and they are having to rely on visual inspection, which is not an acceptable technique.”1

 

So, what does an instrument manufacturer have to do to ‘validate’ their cleaning IFUs? The FDA has six criteria for reprocessing instructions. These are:

  1. Labeling should reflect the intended use of the device.
  2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
  3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
  4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
  5. Reprocessing instructions should be comprehensive.
  6. Reprocessing instructions should be understandable.1

To satisfy the first criteria, the manufacturer’s IFUs must describe decontamination and cleaning methods that take into account the physical design of the device, its intended use, along with the soiling and contamination to which the device will be subject during clinical use. Appropriate reprocessing instructions also depend on whether the device will contact normally sterile tissues, blood, or bodily fluids such as cerebrospinal fluid, peritoneal fluid, aqueous humor, etc.

In order to satisfy the second criteria, the manufacturer’s IFUs must address how to thoroughly clean the device. Cleaning is the first step in reprocessing and should be described in detail as part of the overall reprocessing instructions. “Adequate sterilization or disinfection depends on the thoroughness of cleaning. Instructions to the user should clearly communicate how to achieve thorough cleaning. Details of the cleaning procedure will vary depending on the complexity of the device.” 2

Flushable devices (e.g., endoscopes, laparoscopic instruments and other devices with flush ports) are prone to bioburden/biofilm accumulation and should have instructions/diagrams to ensure proper flushing during cleaning procedures. Thorough flushing of the device is important to remove retained soil from inside of the devices during these procedures.

“Flushing instructions/diagrams should include information on how to properly flush the device, the specific accessories to be used including proper size connectors for the flush ports, and the type and volume of flushing agent to be used to ensure thorough and effective cleaning of the device.”4

 

 

1 Validated? It’s complicated” by Kara Nadeau, HPN, April 2017

2 FDA Report “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015

3 Op.cit.

4 Op.cit.

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