OAASC Meeting

Novo Surgical’s Educational Program at the Ohio Association of Ambulatory Surgery Centers (OAASC) Annual Meeting “Visual Inspection" vs. "Validated IFUs" An ‘Invisible’ Patient Safety Issue  Last month the Ohio Association of Ambulatory Surgery Centers (OAASC) held their Annual Meeting in Columbus, Ohio. As part of Novo Surgical’s ongoing commitment to better patient outcomes through improved technology and customer education, Novo sponsored a one-hour continuing education course for the OAASC attendees. The 1.0 hour CE credit course was entitled “Visual Inspection" vs. "Validated IFUs" An ‘Invisible’ Patient Safety Issue. A large number of OAASC attendees took advantage of this informative and timely course. When it comes to reprocessing reusable medical devices and instruments, the most misused and misunderstood word in our industry right now is validated. This is especially true when it comes to reprocessing instructions for use (IFUs). This one-hour course was designed to clarify the important patient safety issues associated with device pre-cleaning, decontamination, cleaning, sterilization and the critical role validated IFUs play in accomplishing these tasks. The majority of reusable instrument manufacturers state that their reprocessing IFUs have been validated. However, when you read their IFUs, all that is actually stated is that the instruments were sterilized at a given temperature, time and pressure. In most cases, the cleaning instructions themselves have not been validated to prove whether or not the instruments were free of bioburden and, more importantly, biofilm prior to sterilization. If a reusable medical device manufacturer wants to ‘validate’ their device’s IFUs, then they must follow the FDA’s validation requirements. These are:

1. A sample of 3 or more instruments to be contaminated along with an additional instrument to serve as the control.
2. The instruments must be thoroughly contaminated with a test soil prior to starting the cleaning process.
3. After contamination, the cleaning steps that are listed in the manufacturer’s published IFUs must be followed to their conclusion.
4. After completing the cleaning steps listed in the manufacturer’s published IFUs, the sample instruments must then be tested for residual bioburden and biofilm.
5. The percent reduction in bioburden and biofilm after cleaning must then be calculated and published in the “Validation Test Results” table of the validation report.¹

If a device manufacturer’s IFUs have not been tested using the FDA’s validation testing requirements, then the manufacturer cannot truly say that their IFUs have been validated. This presentation demonstrates why ‘validated’ IFUs from your reusable device suppliers are critical to reducing your patients’ risk of a dangerous, painful surgical infection from an instrument contaminated with ‘invisible’ bioburden and/or biofilm. Cleaning IFUs that rely on visual inspection and that have not been validated are a ‘hidden’ patient safety issue. Given that the human eye cannot see microscopic bioburden or biofilm, this ‘hidden’ organic debris is a frequent cause of surgical infections. This educational presentation shows you how to minimize your patients’ risk of a surgical infection caused by a contaminated instrument by following industry recommendations to only use instruments who’s cleaning and  sterilization IFUs have been validated using FDA validation testing protocols. The presentation also contains numerous practical ideas/suggestions that you can implement at your facility to reduce the risk of a contaminated instrument being returned to surgery. If you were not at the OAASC’s Annual Meeting, or if you were and you weren’t able to attend this informative session, please email customerservice@novosurgical.com and request your own copy of this informative and valuable presentation. 1. FDA Document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff.” March 17, 2015