FDA List of “Greater Risk” Medical Devices and Validated IFUs Part I

News / October 15, 2020

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.1

Section 3059 of the 21s Century Cures Act (Pub. L. 114-255) requires the FDA to publish a list of reusable medical devices for which validated reprocessing instructions and the validation data for reprocessing of the reusable device must be included in a new product 510(k) submission.

As required under Section 3059 of the 21st Century Cures Act, a list of these reusable devices, categorized specifically by regulation and product code or by design features for certain device types (listed below), which will require validated instructions for use (IFUs) and validation data in their premarket notifications, was published in the Federal Register (82 FR 26807) on June 9, 2017.  The products listed below are consistent with this Federal Register Notice.2

Reprocessing instructions for medical devices should be validated. However, because of the greater risks to the public health posed by the devices listed below, 510(k) submissions for these devices should include protocols and complete test reports of the validation of the reprocessing instructions so that FDA has the information it needs to evaluate substantial equivalence. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions.  The reprocessing validation data should demonstrate that the proposed reprocessing instructions will reprocess the subject device at least as well as the reprocessing instructions for the predicate device.3

According to the FDA report, these are some of the products or design features which pose a greater risk to patient safety and thus require validated reprocessing instructions:

Arthroscopes;

Laparoscopic Instruments;

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, have internal ridges or sharp angles, or are too small to permit a brush to pass through);

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);

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;

Crevices;  

Small internal parts that may become soiled;

Ridges, articulations or grooves;

Rough, irregular, discontinuous surfaces that can entrap or retain soil;  

Luer locks; 

Porous materials (smooth surfaces are desirable, where possible); 

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)

In the future this list may be updated by the FDA as additional information regarding reprocessing medical devices becomes available.4

So how does the FDA list of “Greater Risk” medical devices apply to healthcare personnel and to their patients? Unless a surgical instrument manufacturer has validated that its cleaning process removes the bioload from the instrument, healthcare personnel have no assurance that they are sending a clean, sterile and safe instrument back to the OR. In light of this FDA report, and as recent lawsuits have shown, healthcare facilities have an ethical, moral, financial and legal responsibility to demand validated IFUs from all of their surgical instrument and reusable medical device suppliers.

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

2 Op cit

3 Op cit

4 Op cit