The Need For Validated
Cleaning IFUs

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

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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

Breaking News!

The September 11, 2015 Health Alert Advisory (HAN00323) from the CDC states:

“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.”

In view of this new Alert from the CDC, healthcare facilities should ask their current instrument representatives/suppliers for a copy of their cleaning IFUs that have been validated by an independent laboratory using AAMI and ANSI validation protocols.

When it comes to requesting validated IFUs from 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.”

The IFUs for all AIM Clear Flush® 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 Cleaning Validation reports

AIM CLEAR FLUSH® TECHNOLOGY

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