Adverse events reporting

HeiQ ChemTex Inc. will track adverse events and report to FDA under 21 CFR Part 803.

Contact:

HeiQ ChemTex Inc.
P.O. Box 5228
Concord, NC 28027
USA
Phone: 704.795.9322
Fax: 704.792.1417
Email: info.heiqchemtex@heiq.com

Fact sheet for healthcare providers and patients:

 As an example for a medical gown article made with the HeiQ Viroblock NPJ03 treated textile:

• Textiles provide a large hosting surface area for bacteria and viruses, benefiting their carryover
• Viruses and bacteria can remain active on textile surfaces from days to months ¹⁾
• Human coronavirus (SARS-CoV) can persist for up to 2 days on surgical gowns at room temperature ²⁾
• This gown is treated with HeiQ Viroblock NPJ03 actively inhibit viruses and kill bacteria upon contact helping to minimize the potential for re-transmission of pathogens from the gown
• Strong antiviral and antibacterial effect against enveloped viruses (incl. Coronavirus 229E) and bacteria
• Residual virus infectivity tested according to a modified ISO 20743 method (Sendai virus), rapid antiviral effect demonstrated within 2-5 minutes (99.99% reduction)
• Hypoallergenic, provides self-sanitizing and germ resistant surface
• Patent pending antiviral and antibacterial technology
• Lasts at least 20 gentle washes at 85°F
• Wear a gown that is appropriate to the task, to protect skin and prevent soiling or contamination of clothing during procedures and patient-care activities when contact with blood, body fluids, secretions, or excretions is anticipated
• Wear a gown for direct patient contact if the patient has uncontained secretions or excretions
• Remove gown and perform hand hygiene before leaving the patient’s environment
• Routine donning of gowns upon entrance into a high risk unit (e.g., ICU, NICU, HSCT unit) is not indicated
• Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment
• After gown removal, ensure that clothing and skin do not contact potentially contaminated environmental surfaces that could result in possible transfer of microorganism to other patients or environmental surfaces.

1) A.Kramer et al (2006): “How long do nosocomial pathogens persist on inanimate surfaces? A systematic review”
2) G.Kampf et al (2020): “Persistence of coronaviruses on inanimate surfaces and its inactivation with biocidal agents”