Medical Device Daily

One of the many problems that hospitals face daily is the threat of contamination — either from within the hospital or brought in from the outside. Whenever the first responders pull into the ER entrance bay from an accident site, the risk is always present for introduction of foreign infectious disease or contaminates into the facility. Perhaps an even more pressing issue is how do healthcare providers protect both the patient and themselves from potentially harmful infection and contamination?

Isovac Products (Romeoville, Illinois) has introduced the containment and protection system utilizing life support (CAPSULS). It is a portable patient isolation unit (PIU), which prevents particulate (biological and radiological) cross-contamination between the patient and the external environment. This product, given FDA clearance in June 2006, is designed to contain and isolate contaminated patients while at the same time protecting medical providers and caregivers. As to the usefulness and practicality of the units, Pete Jenkner, president of Isovac, told Medical Device Daily that in the future he "can see the need for one in every ambulance."

The CAPSULS is a clear, tubular, flexible PIU for use during transport or evacuation. Each unit uses a clear envelope (either polyurethane [PUR], or polyvinylchloride [PVC]) to allow visual monitoring of the patient. The unit has tubular access ports to facilitate medical intervention, and a reinforced base mat with integrated handholds and tethers to enable lifting and attachment to a standard stretcher. The unit opens like a suitcase, allowing easy setup and loading of a patient in about 10 minutes. The air blower inside the PIU uses a single battery, lasting up to 10 hours.

The chamber airflow to the patient is propelled by a purifying respirator, which is screened by a high efficiency particulate air (HEPA) filter. The type of air pressure can be adjusted depending on the particular rescue/recovery situation. The unit is operated under negative pressure mode during transport of a contaminated patient, and is operated in positive pressure mode during transport through a contaminated environment. In a negative mode, a blower draws air from inside the PIU, filters it and returns it to the outside environment. If the patient is not contaminated, but there is a threat of transporting the patient through a potentially contaminated area, filtered air is blown into the PIU to provide clean air.

Jenkner told MDD that the product "originally was designed for the Department of Defense, and homeland security . . . it was used in biological warfare." He added that "The [CAPSULS] is a single-use device, it cannot be cleaned and reused. It can also be used by organizations such as the NTSB or Department of Defense as well as by first responders, medics, and ambulances for transportation from an accident site to the ER/ICU."

The company provides products for the military, but sees opportunity in the hospital and medical field. The CAPSULS can offer temporary isolation, with or without transport, of patients already in the hospital or medical facility. Medical intervention can be provided through multiple glove arms and access ports for medical instrumentation and tubing. Jenkner doesn't discount the company's ability to cross over to other markets regarding any of its products. "We are very customer-driven and will adapt our technology to the defense department's and private sector's needs in response to our products," he said.

In addition, Isovac also makes the chem/bio containment bag (CBAG). It is a specialized remains pouch for the isolation of fluid and particulate containment of infected or chemically contaminated human remains; and provides a minimum of 24 hours protection against remains contaminated by chemical warfare agents. It is fiber reinforced with a plastic film enclosure with a liner for remains containment and transport; and also includes a gas and liquid-tight pressure-sealing zipper to prevent particle leakage. Similar to the CAPSULS, the CBAG has an exhaust/pressure release port with HEPA/NBC filters for exhausting internally generated gas and for air-transport explosive decompression.

Isovac says that they will provide training programs to staff and hospital personnel, and can build products to meet a facility's specific needs. Isovac was formed in 1999 and is a privately funded company.