“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 (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 Labs and Midbrook Biomedical Cleaning Validation reports