Validating IFUs – Distinguishing fact from fiction

Oct. 28, 2019
Check the FDA’s list of “High Risk” medical devices and what your supplier provides

The No. 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. This responsibility begins with pre-cleaning the device at point-of-use and it continues through all of the processing steps prior to its eventual use with a patient. The responsibility to minimize patient risk from a contaminated device is especially critical when it comes to processing surgical instruments.

Surgical instruments that remain contaminated after cleaning, “visual” inspection and sterilization continue to be a significant cause of surgical site infections (SSIs). SSIs are the most common and most expensive of all hospital-acquired infections (HAIs). SSIs are responsible for 20 percent of all HAIs, and SSIs occur in 2 to 5 percent of all surgeries. On average, an SSI increases the hospital length of stay by 9.7 days.1

Sadly, far too many people mistakenly believe that if a device has been sterilized, even though the device remains contaminated with organic debris after cleaning, it is safe to use on a patient. Nothing could be further from the truth. Any device that remains contaminated with residual organic debris is not safe to use, even after complete and thorough sterilization.

So what steps can you and your facility take to reduce the risk of a reusable medical device, including scopes, which remains contaminated with organic debris after processing from being returned to use and causing patient harm?

Spot the challengers

The first step that you can take is to recognize that certain types/categories of reusable medical devices create the greatest decontamination, cleaning and sterilization challenges for everyone involved with device processing. Once you’ve identified those specific types/categories of devices that pose the greatest processing challenges, you and your facility can implement steps, including your demanding validated IFUs for those devices to ensure that the devices are clean, sterile, moisture-free and safe on every processing cycle.

The good news is that you and your staff don’t have to try and identify those devices that cause the greatest processing challenges and represent the greatest infection risk to your patients. That is because “The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient infections reported in the literature or media; reports provided by the Centers for Disease Control (CDC), the Veterans Administration (VA), and other health care settings; and manufacturer-initiated surveillance studies.”2

The FDA first published its list of “High Risk” reusable medical devices on June 9, 2017. This list was compiled by the FDA “As required under Section 3059 of the 21st Century Cures Act, a list of these reusable devices (see Table 1 below), categorized specifically by regulation and product code or by design features for certain device types, which will require validated instructions for use (IFUs) and validation data in their premarket notifications.”3

Table 1: Reusable Devices that Require Validation Data and Validated Reprocessing Instructions

Bronchoscopes (flexible or rigid) and accessories; Ear, Nose, and Throat (ENT) Endoscopes and accessories; Gastroenterology and Urology Endoscopes that have elevator channels; Neurological Endoscopes; Arthroscopes and accessories; Laparoscopic Instruments and accessories; Electrosurgical Instruments and their Respective Accessories; Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth); Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise “roughened” surfaces (e.g., jaws); Interior device channels (e.g., the “I” beam and channel inside of a Kerrison Rongeur); Sleeves surrounding rods, blades, activators, inserters, etc; Shafts within lumens (e.g., the operating shaft inside of a laparoscopic instrument); Adjacent device surfaces between which debris can be forced or caught during use; O-rings; Stopcocks/Valves; Crevices; Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments that are insulated with plastic ‘shrink-type’ insulation); Instruments that have dead-ended chambers (e.g., the distal end of a laparoscopic instrument); Devices with these or other design features that cannot be disassembled for reprocessing. In the future this list may be updated by the FDA as additional information regarding reprocessing medical devices becomes available.”4

Given the documented patient harm caused by these “High Risk” devices, the FDA demands that the manufacturers of these devices validate their IFUs 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 public health posed by these devices. 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.”5

Demand validated IFUs

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” device manufacturers. Unless the device manufacturer has validated its cleaning IFU 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.

Look for copycats

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.”6 Regardless of which approach a manufacturer uses to create their IFU, the tragic fact is that the IFU was never validated to see if those instructions actually work to provide a clean, sterile, moisture-free, safe device after processing.

You and your staff can follow every step of a manufacturer’s non-validated set of IFUs perfectly and still be returning a contaminated device back to surgery where it can cause patient harm. You must insist that your reusable device 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.

When asking a device manufacturer for a copy of their validated IFUs, you need to be sure the manufacturer understands you are asking for more than just cleaning and sterilization instructions. The manufacturer must provide you with the independent laboratory validation test report that proves that their IFUs actually work for cleaning and sterilizing the device. If a device manufacturer can’t – or won’t – provide you with cleaning and sterilization IFUs that have been independently validated using AAMI and FDA IFU testing protocols, then you need to look for another device manufacturer who can and will.

In light of the FDA’s list of “High Risk” medical devices, and as recent lawsuits against endoscope manufacturers whose IFUs had never been validated have shown, healthcare facilities have an ethical, moral, financial and legal responsibility to demand validated IFUs from all of their reusable medical device manufacturers. Your patients are counting on you. 

1 Journal of the American College of Surgeons “Surgical Site Infection Guidelines, 2016 Update” January 2017 Volume 224, Issue 1, Pages 59–74
2 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E
3 Op. cit.
4 Op. cit.
5 Op. cit.
6 Medical Device Academy blog, Rob Packard, April 12, 2017
About the Author

James Schneiter

Prior to his retirement in December 2018, James Schneiter had been the founder, owner and president of America’s MedSource Inc., which designed, developed, licensed and marketed a variety of implantable vascular devices, laparoscopic devices and neurosurgical instruments. Schneiter has nearly five decades of experience in medical device design and production and is a recognized expert in the area of instructions for use (IFU) and independent laboratory IFU validation studies. Schneiter can be reached at [email protected].

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