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 ECRI Institute, go to their website

“Hospital Personnel Must Demand Validated IFUs” – HPN May 2016

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).

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CDC Issues Health Alert
Advisory on IFUs

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.”

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