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!

ECRI Institute’s “Top Ten Technology Hazards for 2017”

The ECRI Institute has just published their “Top Ten Technology Hazards for 2017” (attached). The number 2 problem on the list is entitled “Inadequate Cleaning Of Complex Reusable Instruments Can Lead To Infection.” In identifying the severity of the problem of dirty instruments, the report states “Such contamination can lead to disabling or deadly patient infections.” It goes on to state that “Incidents can also expose healthcare facilities to liability that can jeopardize their reputation.”

The report points out that “Of particular concern are complex, reusable instruments whose design makes the instruments difficult to clean.” The complex design of Laparoscopic instruments and Kerrison Rongeurs make them especially difficult, if not impossible, to thoroughly decontaminate and clean.

In order to help solve this major patient hazard, the ECRI Institute recommends that healthcare facilities consider “purchasing only instruments for which the manufacturer has validated its cleaning instructions. When applicable, request written information explaining the validation process.” The ECRI Institute report also emphasizes that “FDA has become increasingly aware of the inconsistent quality of cleaning and reprocessing instructions.” The FDA now requires manufacturers of reusable instruments to validate their cleaning instructions.

Your healthcare facility should be demanding validated cleaning IFUs from ALL of your instrument suppliers, including suppliers of instruments that have to be disassembled during reprocessing. Failure to demand validated cleaning IFUs from your instrument manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to only use instruments whose IFUs have been validated using FDA validation protocols. The unique, patented AIM Clear Flush instruments have been validated* using FDA testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories and Midbrook Biomedical Cleaning Validation Reports

To learn more about the ECRI Institute, go to their website: www.ecri.org.

Healthcare Purchasing 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 (http://www.hpnonline.com/inside/2016-05/1605-FastForeward.html). 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 instruments that have to be disassembled during reprocessing) 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 instruments that have to be disassembled during reprocessing, 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 instruments that have to be disassembled during reprocessing or ‘convertible’ instruments when it comes to the requirement for manufacturers to validate their IFUs.

AIM CLEAR FLUSH® TECHNOLOGY

Clear Flush® Kerrison Rongeur

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

In cleaning validation testing done by Nelson Laboratories*, 99.9998% of all infectious bioburden was removed from every Kerrison on every cycle with a simple flush. This new, unique design allows for increased steam penetration to permit 100% bacteria kill, and is “Moisture-Free” after every sterilization cycle to eliminate the risk of waterborne pathogens. The AIM Clear Flush® design also provides improved internal lubrication ensuring a smoother action and prolonged instrument life.

The AIM Clear Flush® design and cleaning Instructions for Use (IFUs) have been validated by Nelson Laboratories, using AAMI’s testing protocol. Please see the Nelson Summary or view the entire Nelson Laboratories cleaning validation report. For more information contact AIM.

Clear Flush® Demo Video