Cardinal Health™ received clearance to market the SMARTGOWN™ and SMARTGOWN™ AIR on July 29, 2020.
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable gowns. These gowns feature AAMI level 4 protection. It is intended to be worn by operating room personnel during surgical procedures.
SMARTGOWN™ and now SMARTGOWN™ AIR feature a unique RESPONSIVEMEMBRANE™ designed to protect the wearer from blood borne pathogens and transport moisture from the wearer’s skin to the surface of the fabric to help maintain comfort. The SMARTGOWN™ featured this protective layer throughout the gown, while the SMARTGOWN™ AIR increases comfort by using materials that provide air-breathability in non-critical zone back panels. These options help meet clinician preferences for complete coverage or additional breathability while maintaining AAMI level 4 protection.
Protective apparel, including surgical gowns, are governed by a set of standards and test methods. These standards are established by AAMI (The Association for the Advancement of Medical Instrumentation). AAMI Level 4 protection is the highest level of resistance to penetration by blood borne pathogens and is recommended for high risk situations where exposure to fluids may be possible. Critical zones requiring protection are those most likely to come into contact with blood or other potentially infectious material, including the arms and front of the gown, whereas other areas such as the shoulders and back require a lower level of protection.
These gowns have been tested according to a standard known as ASTM (American Society for Testing and Materials) F1671. There are typically 4 different areas that must pass this test within the critical zones, including two in the front chest and two on the sleeves. If a product passes ASTM F1671 in all applicable areas, then it qualifies as an AAMI level 4 surgical gown. This test method has been specifically designed for modeling penetration of HBV, HCV, and HIV using a bacteriophage, Phi-X174. This single-stranded DNA virus is utilized since it can be easily replicated in the lab, is easier to handle than other highly infectious viruses, and is one of the smallest known viruses at 25 – 27 nm. This size is similar to HCV, implying that impermeability to Phi-X174 will protect the wearer from HCV and larger viruses. By comparison, most Corona virions are larger and spherical with diameters of approximately 125 nm.
The SMARTGOWN™ is currently available. SMARTGOWN™ AIR is expected to be available in 2021.
- ASTM F1671 / F1671M-13, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, ASTM International, West Conshohocken, PA, 2013, http://www.astm.org/cgi-bin/resolver.cgi?F1671F1671M
- https://nsf-muses.ucdavis.edu/sites/g/files/dgvnsk1751/files/files/persentations/Barrier-Performance-According-to-AAMI-PB70-Peter-Brown.pdf, Page 5