FDA’s Validated IFU Requirements For “High Risk” Devices (Part II)

In Part I of this blog  we pointed out that The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing.” The responsibility to minimize patient risk from a contaminated device is especially critical when it comes to processing surgical instruments.

The first step that you and your staff can take to minimize this risk is to recognize that certain types and categories of surgical instruments create the greatest decontamination, cleaning and sterilization challenges for everyone involved with instrument processing. Identifying the surgical instruments that cause the greatest risk to your patients’ safety is the first step in reducing that risk.

The good news is that you and your staff don’t have to try and identify those surgical instruments that cause the greatest processing challenges and represent the greatest infection risk to your patients. This is because the FDA has already identified a subset of “High Risk” surgical instruments and devices (see Part I of this blog for the FDA’s list).

Given the documented patient harm caused by these “High Risk” surgical instruments, the FDA is demanding that the manufacturers of these devices validate their instructions for use (IFU) to prove that they can be thoroughly cleaned prior to sterilization. This demand for IFU validation by the FDA is because of the greater risks to the patients posed by these instruments. Additionally “510(k) submissions for these types of devices should include protocols and complete test reports of the validation of the reprocessing instructions. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions.”1

So how does the FDA’s list of “High Risk” medical devices apply to you, to your healthcare facility and to your patients? You and your facility must start to demand validated IFUs from all of your “High Risk” surgical instrument manufacturers. Unless the instrument manufacturer has validated it’s cleaning and sterilization IFUs through independent laboratory testing to prove that its cleaning process removes all of the organic debris from the device prior to sterilization, you have no assurance that you are returning a clean, sterile, moisture-free, safe device back for use on your patients.

A major limitation of far too many manufacturers’ non-validated IFUs is that they require processing personnel to ‘visually inspect’ the device for bioburden and biofilm after cleaning and prior to sterilization. The problem with this ‘visual inspection’ requirement in their IFU is that microscopic bioburden and biofilm are invisible to the human eye which makes the task physically impossible.

Another significant problem with non-validated IFUs is that “Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor’s IFU. However, if the IFU is created by a marketing person, the IFU will explain how their product is totally different from the competitor’s product.”(2)

You and your staff can follow every step of a surgical instrument manufacturer’s non-validated set of IFUs perfectly and still be returning a contaminated instrument back to surgery where it can cause patient harm. You must insist that your reusable surgical instrument manufacturers provide your facility with validated cleaning and sterilization IFUs. In order for the IFUs to have actually been ‘validated’ and not just labeled as such, the validation testing must have been conducted by an independent biologic testing laboratory using AAMI and FDA IFU validation testing protocols.

1 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E

2 Medical Device Academy blog, https://medicaldeviceacademy.com/ifu-validation/ Rob Packard, April 12, 2017