Can I Use Halyard Sterilization Wrap for DIY Masks?
O&M Halyard manufactures sterilization wrap under our HALYARD brand. The intended use of the product is for the sterilization of medical instruments and devices by healthcare professionals through various sterilization methodologies, and to maintain the sterility of its contents until use. HALYARD branded sterilization wrap is cleared for this specific use by the FDA.
We are aware of the recent reports regarding sterilization wrap material being used to make face masks. The use of sterilization wrap for facial protection has not been cleared by the FDA. O&M Halyard does not endorse the off-label use of our products.
O&M Halyard only recommends using our medical devices as described in the indications for use included in the product labeling. O&M Halyard does not have data to support the safety of products used beyond the indications for use including modifications of the product to make facial protection.