Has That IFU Actually Been Validated? (Part I)

The most misunderstood and overlooked aspect of any reusable device manufacturer’s instructions for disinfecting, cleaning and sterilizing their product is whether those instructions for use (IFUs) have been ‘validated’ by independent laboratory testing to prove that they actually work. Several reusable device manufacturers claim that their cleaning and sterilization IFUs are ‘validated’ but, have they actually been validated and, how would you know if they were? The single most dangerous mistake that healthcare personnel make is when they purchase difficult-to-clean reusable medical devices (e.g., laparoscopic instruments, Kerrison Rongeurs, etc.) whose IFUs have not been validated. If you purchase reusable medical devices without first checking to ensure that the cleaning and sterilization IFUs have been validated by independent laboratory using AAMI and FDA validation protocols, you are increasing your patients’ risk of contracting a surgical site infection (SSI) caused by instruments that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize. According to the CDC, SSIs cost U.S. hospitals well in excess of $4 billion annually. More specifically, SSIs: Cost $57,000 per occurrence to resolve a deep organ surgical infection; Add 11 extra days of hospitalization; Increases the chance of being placed in the ICU by 60%; Five times more likely to be readmitted to the hospital; Twice the incidence of mortality; Surgical infections occur in 2-5% of clean extra-abdominal surgeries and 20% of intra-abdominal surgeries; Result in approximately 30,000 deaths annually1 A research report on hospital acquired infections (HAIs) published in JAMA Internal Medicine found that infections acquired during the course of medical treatment cost U.S. hospitals $9.8 billion annually.2 What are some of the consequences of using devices whose IFUs have not been validated? First, numerous outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE) causing patient harm and patient deaths during the past few years have been attributed to endoscopes whose cleaning IFUs had not been validated. As a result of these patient deaths, the FDA in August 2015 cited two endoscope manufacturers for failing to validate their cleaning and sterilization IFUs.3 Second, if you use devices that have not been validated, you are placing your patients at risk due to bioburden and biofilm that is not visible to the human eye remaining in the device after cleaning. A recent investigation by found that midtown hospitals have struggled for years to properly clean surgical instruments, stoking doctors’ fears about patient safety. As the article pointed out “Doctors are concerned because old blood and bone, even when sterilized, are biohazards that can trigger infection, septic shock and even death if they come into contact with patients.”4 The fears over patient safety from devices that are difficult to reprocess led the FDA to issue new requirements in March 2015 that specifically require medical device manufacturers to “validate” their cleaning IFUs. On page 22 of the FDA publication, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff,” 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). 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.” In Part II of this blog we’ll finish our discussion of the consequences of using devices whose IFUs have not been validated. Additionally, we’ll be giving you information to help you determine if a manufacturer’s IFUs have in fact been validated to ensure that they actually work to provide clean, sterile, moisture-free instruments on every reprocessing cycle.   1 “Guideline For Prevention of Surgical Site Infection” CDC 2 Journal of the American Medical Association (JAMA), September, 2013 3 “FDA issues warning to scope makers over spread of deadly superbugs,” (MPS On-Line, 8/18/15). 4 “Dirty, missing instruments plague DMC surgeries,” The Detroit News, August 26, 2016, by Karen Bouffard and Joel Kurth.