Are your instruments as clean on the inside as they are on the outside?
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.
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!
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!
AIM CLEAR FLUSH® TECHNOLOGY
Clear Flush® 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