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

In Part I of this blog (Elmed blog 41) we discussed the FDA’s mandate that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices (IFUs). “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 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 (Elmed blog 42) we covered the first parts of the FDA’s criteria number three (critical and semi-critical devices). In Part III (Elmed blog 45) we finished covering criteria number 3. This blog will cover the FDA’s criteria number four.

Criterion 4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.2

As part of their IFU validation process, the FDA requires manufacturers to provide reprocessing instructions that are technically and practically feasible in the intended location (e.g., large health care facility, office-based clinic, or home use). The equipment and accessories needed to implement and follow the instructions should be clearly defined. This would include detailed descriptions and part numbers (if applicable) and must be readily available for the end users to obtain either from the manufacturer’s representative or on-line on the manufacturer’s website.

The type of sterilizer along with the manufacturer-validated sterilization cycle parameters and accessories should be available to the people who will be doing the reprocessing. The manufacturer’s recommended method of sterilization must correspond to what is readily available the end user. For example, gamma radiation sterilization is generally only used in manufacturing facilities and is not available in health care facilities. Steam sterilization is the most common method of sterilization used in the majority of health care settings. EO, H2O2, O3 and liquid chemical sterilization processes are also available in some health care settings.3

The FDA recommends that the manufacturer’s cleaning IFUs be compatible with what end users are currently doing in their health care facility. This means that the sterilization cycle parameters specified in the device’s cleaning IFUs should be consistent with validated sterilization cycle parameters for commonly available, FDA approved sterilizers. Information on other potential methods or options may be found in AAMI TIR12.

The FDA’s recommendation that the manufacturer’s sterilization methods and parameters be technically feasible for you and your staff also has a direct impact on sterilization accessories. Many sterilization accessories used in reprocessing reusable devices in health care settings are class II medical devices subject to FDA premarket notification requirements. These accessories include, but are not limited to: sterilization wraps, pouches, cassettes, and containers; biological indicators and chemical indicators; liquid chemical sterilants and disinfectants.4

These sterilization products/accessories typically receive FDA-clearance for specific process parameters or sets of parameters, which appear in the “Intended Use” sections of FDA-cleared sterilization accessories. The manufacturer’s reprocessing instructions should match these specific process parameters.  The FDA maintains a list of FDA-cleared liquid chemical sterilants and high level disinfectants for use in health care facilities. This list is available at:

Extended Cycles. The expression “extended cycle” is used to describe any sterilization cycle that includes specifications that go beyond or exceed those found on commonly used, FDA-cleared sterilizers, and for which there are limited or no FDA cleared sterilization accessories. Extended cycles typically include longer exposure times and/or higher or intermediate temperatures, which may also deviate from more conventional sterilization cycles. Implementation of extended cycles can impose serious technical challenges for you and your staff in your healthcare facility.

Extended cycles are typically developed to achieve sterilization of complex devices or larger loads.  Recommending the use of extended cycles for larger loads or more complex devices in reprocessing instructions may be appropriate provided the appropriate accessory devices have been cleared for use with such extended cycles.

While many sterilizers are designed with manual over-ride controls for time and temperature, the FDA generally evaluates physical and microbiological performance validation data and product labeling claims for discrete cycle parameter specifications as part of the premarket review process for sterilizers. As part of that premarket review, the FDA also evaluates all of the sterilizer’s accessories, including biological indicators, chemical indicators, and sterilization packaging.5

The FDA recommends that “ranges” not be used for defining sterilization cycles (for example, 121°C-132°C temperature and greater or lesser than 4 minutes exposure time), as this implies that all intermediate values have been validated, and that there are FDA-cleared accessories for all the intermediate cycles.6

It is vital for your patients’ safety to remember that the FDA’s ridged requirements for ‘validation’ 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. Your patients are counting on you.


  1. FDA Report “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015
  2. Ibid “FDA
  3. Ibid “FDA
  4. Ibid “FDA
  5. Ibid “FDA
  6. Ibid “FDA




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