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

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. 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?

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 their list of “High Risk” reusable medical devices on June 9, 2017. This list was compiled by the FDAAs 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.”

The FDA document further states that “This section also gives FDA the authority to determine that a 510(k) submission for these reusable devices are not substantially equivalent to a predicate device if the validated instructions for use and reprocessing validation data submitted as part of the 510(k) are inadequate.”3

Table 1Reusable 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

In Part II of this blog we will outline the steps that you, your staff and your facility can take to meet the challenges created by the FDA’s list of “High Risk” devices.

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. cite.

4 Op. cite.

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