When and how did ISOVAC start trading? Has it always specialized in infection control / containment products?
ISOVAC incorporated in June of 1999 and introduced the CAPSULS Patient Isolation Unit. Casualty Isolation is ISOVAC’s core competency as an organization, but we do delve into other areas of infection and disease control.
What organizations would you consider to be your primary markets?
ISOVAC works with government organizations around the world, such as US Coast Guard, US Special Operations, US Army, UK Special Operations, UAE Army, Brazilian Air Force, Veterans Health Administration (VA) Hospitals, Bahamas Ministry of Health, Mayo Clinic Hospital System, Nebraska Medical Center, NASA, and most recently ISOVAC was awarded a LTA (Long Term Agreement) contract with the United Nations for their Worldwide efforts on COVID. We also work closely with various State and Local governments to support their isolation needs, may it be for hospitals, fire departments, police departments, or private ambulance services. With the start of COVID-19 earlier this year putting restrictions on travel, we have seen a tremendous increase in aeromedical evacuation companies purchasing the CAPSULS system as well.
NASA’s request for deploying one of our Isolation capabilities on board the International Space Station (ISS) is a great example of our ever-expanding and versatile market.
The CAPSULS in ISOVAC’s portable patient isolation unit in use by several fixed-wing aeromedical providers. When did you develop the product, and was certification by the FAA a smooth process?
The concept of the CAPSULS came to light during the Gulf War due to the possibility of Chemical weapons being deployed by enemy forces. ISOVAC came up with the concept of being able to provide a safe method of transport and allowing for medical intervention of a contaminated individual while also protecting the First Line defenders and they’re assets,(ground and air transport vehicles etc...) from cross-contamination.
During the entire design process, ISOVAC welcomed the input of the experts from within their prospective fields of expertise, medical, ems and aviation from both the Military and Civilian sides. This allowed for a smooth process of obtaining all the Reps and Certs for the ISOVAC CAPSULS system.
Is the CAPSULS approved for use in jurisdictions around the world?
The CAPSULS has been designated EAR 99 by the US State Department, giving us the permission to ship anywhere in the free world. We have our technology deployed in North America, South America, Africa, Europe, Asia, the Middle East and the South Pacific. ISOVAC’s CAPSULS system is also regulated as a class ll medical device by the U.S. Food and Drug administration under 21CFR 880.5450.
How easy is it for users to clean the CAPSULS after use?
The CAPSULS Iso-shell barrier materials, Iso-weld seam technology, and glove-arm caps provide a smooth, nonabsorbent surface, free of pockets and crevices.
The ORCA (Operational Rescue Containment Apparatus) is another one of your products of interest to AirMed&Rescue readers; could you tell us about the product?
As the Search and Rescue (SAR) Coordinator and primary provider of medevac services in the US Maritime region, the US Coast Guard contacted ISOVAC during the Ebola crisis of 2014/2015 and asked us to design a system which would allow for extraction of contaminated individuals on-board ships or other maritime platforms via rotary wing (MH-60/MH-65) aircraft utilizing the 406A stokes basket.
In collaboration with USCG, ISOVAC completed all design, testing, and received FDA class ll medical device clearance by mid-2016. We are currently the sole source provider to the USCG and SOCOM for this capability. The US Army has added the ORCA and CAPSULS systems to the PMI (Patient Movement Item) AWR (Airworthiness Release) for both the H-60 and UH-72 helicopters. These Patient Movement Items, support the MEDEVAC mission that will increase patient survivability, and ensures ORCA and CAPSULS meet or exceed Army airworthiness requirements.
Which of your products are in use / could be used onboard the International Space Station? What were the main challenges your team faced when designing or adapting a product for use onboard the ISS?
NASA was to introduce the ISOVAC technology at the Aerospace Medical Association (ASMA) Show but due to the Pandemic, that product introduction has been understandably delayed. So as not to take their thunder away from them, I can comfortably say that one of ISOVAC’ s technologies was launched onboard Northrop Grumman’s Antares rocket and Cygnus spacecraft (NG CRS-13) on February 15 2020 to the International Space Station.
One of the major challenges ISOVAC faced in design was adapting the unit to operate in a zero-gravity atmosphere. Not having the ability to replicate this environment, collaborating with the NASA team allowed ISOVAC to overcome the challenges of this harsh environment and provide NASA with a superior mission ready system. NASA being pleased with the ISOVAC system, is now planning to include it on future missions.
Among the many accomplishments ISOVAC has experienced through the years, I feel this one in particular, to be one of it’s greatest.