Has That IFU Actually Been Validated? (Part II)

In Part I of this blog we discussed the fact that several reusable device manufacturers claim that their cleaning and sterilization IFUs are ‘validated.’ We then raised two important questions: have those IFUs been validated by an independent laboratory using AAMI and FDA validation testing protocols and if they were, how would you know? When it comes to surgical instruments, the single most dangerous mistake that healthcare facilities make is purchasing hard-to-clean, complex instruments (e.g., laparoscopic instruments, Kerrison Rongeurs, etc.) whose IFUs have not been validated. If your facility purchases non-validated surgical instruments, you are placing your patients at risk of contracting a surgical site infection (SSI) caused by instruments that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize. After reviewing the dangers, costs and patient risks associated with SSIs in Part I of this blog, we then looked at some of the consequences of using devices whose IFUs have not been validated. First, a significant number of patient deaths during the past few years have been attributed to endoscopes whose cleaning IFUs had not been validated.1 Second, if you use non-validated devices, you are placing your patients at an increased risk of contracting an SSI. This is because bioburden and biofilm that is not visible to the human eye remains on/in the device after cleaning. Third, there are now several dozen lawsuits against endoscope manufacturers and hospitals for causing patient deaths from contaminated scopes. These lawsuits are being brought by deceased patients’ families for using endoscopes whose cleaning IFUs had not been validated.2 As all of these cases tragically demonstrate, following a manufacturer’s IFUs that has not been validated does not ensure against patient harm or death. Fourth, while following a manufacturer’s IFUs is always a good idea, if the manufacturer’s IFUs have not been validated using AAMI and FDA validation protocols, there is no way to ensure clean, sterile, moisture-free instruments, regardless of how thorough the reprocessing effort. As Healthcare Purchasing News noted in an article:

• To ensure device cleaning, disinfection and sterilization effectiveness, SPD staff 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 FDA stipulates in its guidelines that device manufacturers validate the design, functionality and end-user operation of the devices they make, including reprocessing instructions.3

The HPN article went on to state that “Supply Chain and SPD pros (and GPOs) 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.”4 The new FDA validation requirements (5) for device manufacturers are very specific regarding the validation of processes designed to clean reusable medical devices. As stated on page 23 of the FDA publication “You (the device manufacturer) should validate the cleaning process you provide in your labeling. Your validation activities should be based on comprehensive validation protocols that use soils that are relevant to the clinical use conditions of the device. These should include the worst-case (least rigorous) implementation of the cleaning process, medical devices that represent the worst-case (most challenging to reprocess and most contaminated). These protocols should be designed to establish that the most inaccessible locations on your devices can be adequately cleaned during routine processing.”6 The last, and perhaps biggest, mistake people make is using “take-apart” or “modular” instruments who’s IFUs rely on “visual verification” to ensure the removal of bioburden and biofilm. The human eye cannot see microscopic bioburden, nor can it see biofilm, making “visual verification”’ physically impossible! Being able to “visualize” the inside of the instrument does not ensure a clean instrument (assuming that reprocessing personnel even remember to take the time to disassemble, manually clean and then properly reassemble the instrument). The only way to ensure clean, sterile, moisture-free instruments on every reprocessing cycle is to only use instruments who’s IFUs have been validated using AAMI and FDA validation protocols. Failure to demand validated cleaning and sterilization IFUs from ALL of your device manufacturers is a tremendous patient safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to use only instruments whose IFUs have been validated. 1 “Tainted Scope Leads to Death, Lawsuit,” (Surgical Products, September 3, 2015). 2 “Superbug found at suburban hospital, Lutheran General, health officials taking steps to prevent spread of CRE,” Chicago Tribune, January 10, 2014, by Robert McCoppin and Cynthia Dizikes. 3 “The V Word,” Healthcare Purchasing News, May 2016, by Rick Dana Barlow. 4 Op. Cite. 5 “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” FDA Document issued on: March 17, 2015 6 Op. Cite.