IP Requirement: Industry IP
Experience Requirement:
– Mechanical Design
– Rapid Prototyping
Problem Description
Clinical Need
Transporting patients with high consequence infectious diseases (HCIDs) presents significant challenges in infection control and patient safety. The CAPSULS device by ISO-VAC Products LLC is currently the only FDA-approved isolation pod for HCID transport. However, it lacks FAA and DOT approvals, limiting its use in emergency air and road transport without Emergency Use Authorization (EUA) approval. This significantly reduces its practicality in time-sensitive scenarios. Additionally, devices need to be rapid and easy to set up in high-pressure situations and must be safely disposable after use. Any equipment exposed to HCID patients becomes Category A waste, requiring strict protocols to protect healthcare providers (HCPs) and prevent contamination.
Current Technologies and Limitations
For short-term transport within hospitals, the containment wrap is the standard option. This liquid-impermeable barrier paired with masks and gloves works well for dry patients but poses a high infection risk when the patient becomes wet from bodily fluids like urine, feces, or vomit. CAPSULS, designed for longer transport, also has notable limitations. The arm ports are cumbersome and inefficient for patient care. Without FAA and DOT certifications, CAPSULS cannot be universally applied in air or road transport emergencies. Additionally, concerns about maintaining safe oxygen levels for patients inside the device compromise its reliability. The carbon fiber ribs that provide structural rigidity complicate disposal, as the entire device becomes Category A waste. Cutting the ribs for disposal jeopardizes HCP safety and complicates adherence to biohazard protocols.
Perceived Impact of a Solution
An isolation pod that meets FAA, DOT, and FDA requirements would greatly improve HCID patient transport. It would ensure compliance with safety regulations, enable rapid deployment in emergencies, and address critical issues like arm port usability, oxygenation, and waste disposal. Simplifying waste management and enhancing provider efficiency would reduce logistical burdens while safeguarding HCPs. This innovation would elevate the standard of care, enhance infection control, and improve outcomes for patients and healthcare systems.
