The Need For Validated
Cleaning IFUs

Are your instruments as clean on the inside as they are on the outside?

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Breaking News!

The May issue of Healthcare Purchasing News (HPN) has a very powerful piece on the need for validated cleaning IFUs for all of your surgical instruments ( The article is especially important for you and your staff as you constantly strive to ensure clean, sterile, moisture-free instruments for every patient, every time.  According to HPN:

  • To ensure device cleaning, disinfection and sterilization effectiveness, SPD staffers should use VALIDATED IFUs provided by manufacturers.
  • Device manufacturers should provide VALIDATED IFUs to their healthcare organization customers so they know how to clean, disinfect and sterilize products effectively to prevent patient infections from improperly reprocessed devices.
  • The Food and Drug Administration (FDA) stipulates in its guidelines that device manufacturers validate the design, functionality and end-user operation of the devices they make, including reprocessing instructions (IFUs).

The article goes on to state:

“Supply Chain and SPD pros must demand that any and all devices and products include authentically validated IFUs as a requirement for contract consideration or they won’t be acquired.”

As you and your staff know all too well, many surgical instruments are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize, creating the potential for a surgical infection. Regardless of how hard you and your staff try, if the manufacturer’s IFUs have not been validated, there is no way for you to ensure clean, sterile, moisture-free instruments (including ‘take-aparts’) for every patient, every time.

When it comes to validated cleaning performance, no other brand of Laparoscopic instrument or Kerrison Rongeur have the validated* cleaning performance that even comes close to the validated* performance of the patented AIM Clear Flush® technology (in point of fact, most surgical instruments in the market, including ‘take-aparts’ have never even had their IFUs validated). Please contact us to see how the validated* AIM Clear Flush® surgical instruments can help your healthcare facility make a difference in your fight against surgical infections.

*Nelson Laboratories and Midbrook Biomedical Cleaning Validation reports

Validation Introduction

With all of the recent news concerning patient deaths and the resulting lawsuits caused by contaminated medical devices who’s cleaning Instructions For Use (IFUs) had not been validated, healthcare facilities are beginning to ask their sales representatives “Have your cleaning IFUs been validated?” In order to ensure patient safety and reduce the risk of a surgical infection, healthcare facilities must demand validated IFUs from their medical device manufacturers.

On page 22 of the FDA publication Reprocessing Medical Devices in Health Care Settings.” (Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.) the third paragraph 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). Establishing procedures includes implementation. 21 CFR 820.3(k). 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. Please note that the FDA makes no exceptions for ‘take-a-part’ or ‘convertible’ instruments when it comes to the requirement for manufacturers to validate their IFUs.

When asking your instrument manufacturers for their cleaning IFUs, make sure that their IFUs have been validated by independent laboratory testing using industry standard AAMI and ANSI testing protocols. Without this level of industry standard IFU validation, it is impossible for your facility to ensure clean, sterile, moisture-free instruments on every reprocessing cycle.

When it comes to requesting validated IFUs from your instrument manufacturers, Linda Clement, a consultant in sterile processing for STERIS Corporation warns hospital personnel, “Be sure the manufacturer understands you are asking for more than just cleaning instructions (IFUs). You must have the independent laboratory verification that those instructions actually work for cleaning the instrument.”

Noted healthcare expert and author Ann Hewitt, RN, BSN, MM, states “If a hospital is using instruments where no validation can be provided by the manufacturer, the hospital should give serious consideration to replacing those instruments. The ICP can support the OR and CS departments by exploring the moral, legal, ethical and financial liability issues associated with using instruments who’s IFUs have not been validated.”

The IFUs for all AIM Clear Flush® Kerrisons and Laparoscopic instruments have been validated by independent laboratory testing* using AAMI and ANSI testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories and Midbrook Biomedical IFU Validation reports


Clear Flush® Kerrison Rongeur

Nelson Labs Report on Clear Flush(R) Kerrison Rongeur

AIM is proud to present the latest advancement in surgical instrument technology, the AIM Clear Flush® Kerrison Rongeur. Now, one of the most difficult instruments to clean is one of the easiest and cleanest!

With its patented design and unique flushport, 99.9998% of all infectious bioburden can be removed from the instrument with a simple flush. This new design allows for increased steam penetration to permit 100% bacteria kill, and is “Moisture Free” after every sterile reprocessing cycle. The Clear Flush® design provides improved internal lubrication ensuring a smoother action and prolonged instrument life.

The AIM Clear Flush® design and cleaning results have been validated by Nelson Laboratories, using AAMI’s protocol. Please see Nelson Summary or view the validation report for more information, or contact AIM at 913-814-8015.

Clear Flush® Demo Video

Click to see why manufacturers must validate their cleaning instructions (IFUs) for surgical instruments to protect patients: The New Requirements For Cleaning Validation Of Surgical Instruments