NCHR Comment on Classification of Certain Wound Dressings

Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes

Docket No. 2023-N-3392

We appreciate the opportunity to comment on FDA’s Center for Devices and Radiological Health (CDRH) proposed rule regarding Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments, and products that are most effective for patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest. 

Currently, wound dressings and liquid wound washes are considered unclassified devices that are treated like 510(k) devices. The CDRH proposed rule would create new classifications and product codes for wound dressings and liquid wound washes containing antimicrobials and/or other chemicals. Solid wound dressings and liquid wound washes containing medically important antimicrobials acting as protectants (as defined by the World Health Organization) would be Class III, due to their high level of antimicrobial resistance (AMR).  Wound dressings/washings that contain antimicrobials acting as preservatives and a medium or low level of AMR concern and/or other chemicals would be Class II.  

NCHR strongly supports Class III classification for wound dressing containing antimicrobials acting as protectants (as defined by the World Health Organization) due to their higher risk for AMR.  This is a very important change that will ensure the clinical benefits of protectant wound care dressings and liquid wound washes outweigh the risks of facilitating AMR on a population-based level as well as the development of postoperative AMR infections on a patient level.  For example, inappropriate use of protectant dressings or liquid wound washes could worsen the public health burden of AMR and also may increase the risk of a patient developing an antimicrobial-resistant infection following a surgical procedure where these products are used for routine wound care. 

However, we also urge the FDA to classify wound dressings/washings containing antimicrobials acting as preservatives with a moderate level of AMR concern as Class III.  Given AMR is a major global health burden, we recognize that it is important to reduce the risk of AMR as much as possible by ensuring that the benefits of wound dressings outweigh even moderate risks of furthering AMR by inappropriate use of these products.

We support the FDA proposal that wound dressings/washings containing antimicrobials acting as preservatives with a low level of AMR concern be classified as Class II. 

These changes in classification go beyond the concerns about AMR to also ensure these dressings are proven to have clinical benefits that outweigh their potential risks. We strongly urge the FDA to require labeling to prevent unnecessary and potentially dangerous use of these products.  In addition, we support further expansion of this reclassification to include all solid and liquid wound dressings.

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